yousef javadzadeh
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Increasing use of amphetamine as a highly abused psychotropic agent has irreversible side effects and damages to both the consumer and the community. In this study, different solid-phase extraction methods in urine samples as well as various quantitative determination amphetamine methods were compared systematically. Web of Science, Scopus, and PubMed databases were searched up to April 12, 2022, for relevant articles. The random-effects model was used to estimate the pooled measurements and 95% confidence intervals (95% CI). All analyses were performed with STATA version 15.0. Bias publication was performed for available studies reported in the literature. After applying limit of detection (LOD) criteria, solid phase extraction, and amphetamine, 36 articles remained. Among the collected studies, 16 were included in the meta-analysis. This meta-analysis revealed that the minimum detection (i.e., the limit of detection or LOD) value for the solid-phase extraction method coupled to high-performance liquid chromatography/UV (HPLC/UV) quantification technique is equal to 7.88 ng/mL (95% CI: 3.35–12.40), while for the gas chromatography/mass (GC/MS) method, the LOD value is equal to 2.75 ng/mL (95% CI: 0.77–4.73). Despite the use of different absorbents and their varied efficiency, the methods based on GC/MS can detect the analyte with higher sensitivity than that of HPLC/UV.
Keywords: Amphetamine, HPLC, GC, LOD, Meta-Analysis -
Recurrent Aphthous Stomatitis (RAS) is a prevalent inflammatory disorder that affects the mouth and is defined by painful ulcers. The precise cause of the condition is still unknown, and the major approach to treatment is mainly centered around managing the symptoms. Triamcinolone acetonide (TA) is a commonly used medication for several conditions. However, due to its potential benefits, there is growing interest in exploring novel drug delivery systems, such as medicated chewing gum (MCG). This study introduces a novel MCG formulation containing TA (T-MCG). We investigated its in vitro drug release and content uniformity before conducting a clinical trial comparing the efficacy of T-MCG versus placebo in patients with RAS. The T-MCG formulation exhibited a sustained release of TA for 120 minutes. The clinical findings demonstrated a notable decrease in the ulcer's size and the mean wound healing period. The results suggest that T-MCG not only improves the effectiveness of TA treatment by releasing the drug over a longer period and allowing it to stay in the mouth longer but also increases patient adherence due to its pleasant composition.
Keywords: Triamcinolone Acetonide, Recurrent Aphthous Stomatitis, Drug Delivery, Oral, Chewing Gum -
زمینه
طعم مناسب فرآورده ی دارویی یک فاکتور مهم در تهیه اشکال دارویی خوراکی می باشد. یکی از روش های کارآمد برای بهبود طعم فرآورده استفاده از روکش پلیمری است.
هدفدر این پژوهش غلظت های مختلف پلیمر اودراژیت E[1] روی گرانول های داروی دیمن هیدرینات اسپری شد و کارآیی این پلیمر در پوشاندن طعم تلخ دارو بررسی شد.
روش هاگرانول های دیمن هیدرینات با روش گرانولاسیون مرطوب تهیه شدند. پودر دارو با نشاسته و آویسل با نسبت 1 - 5/0 -5/0 به طور یکنواخت مخلوط شد و از محلول HPMC به عنوان چسب گرانول سازی استفاده شد. سپس از غلظت های %2.5 تا %15 اودراژیت برای روکش کردن گرانول ها استفاده و تعداد 4 فرمول تهیه شد. ویژگی های جریان پذیری گرانول ها و میزان بهبود طعم فرآورده ارزیابی شدند. همچنین تست آزاد سازی دارو در pH های 8/6 و 1 انجام شد.
یافته هابا افزایش ضخامت روکش پلیمری، طعم فرآورده به طور معناداری بهبود یافت (P < 0.05). محلولیت اودراژیت وابسته به pH است که این ویژگی سبب ممانعت از رهش دارو در حفره دهان می گردد و دارو در محیط معده آزاد می گردد. بیشترین سرعت آزاد سازی مربوط به فرمولاسیون 1 (با کمترین ضخامت روکش پلیمری) و کمترین سرعت مربوط به فرمولاسیون 4 (با بیشترین ضخامت روکش پلیمری) بود و پس از گذشت 90 دقیقه بین 334/84-359/96 درصد دارو آزاد شد. ارزیابی فیزیکی گرانول نشان داد که جریان پذیری فرمولاسیون بهبود یافت. همچنین بازده تکنیک روکش کردن (Pan coating) بین 80 تا 90 درصد در فرمولاسیون های مختلف بود.
نتیجه گیرینتایج نشان دادند که اودراژیت E قابلیت پوشاندن طعم نامناسب دارو را دارد. تکنیک های مورد استفاده جهت تهیه کردن گرانول ها و روکش دهی آنها با هزینه ی کم و به سادگی قابل اجرا می باشند، بنابراین قابلیت تولید را در مقیاس صنعتی دارند.
کلید واژگان: طعم پوشانی، دیمن هیدرینات، روکش پلیمری، اودراژیتBackgroundSuitable taste is an important factor in the preparation of oral dosage forms. Polymer coating is one of the effective methods to improve the taste of the product.
ObjectiveDifferent concentrations of Eudragit E polymer were sprayed on dimenhydrinate granules and the effectiveness of masking the bitter taste of the drug was investigated.
MethodsWet granulation method was used to prepare dimenhydrinate granules. The drug powder was uniformly mixed with starch and Avicel with a ratio of 0.5-0.5-1 and HPMC solution was used as binder. Then concentrations of 2.5%-15% of Eudragit E were used to cover the granules and 4 formulations were prepared. The flowability of the granules and the product taste improvement were evaluated. Also, the drug release test was performed at pH 6.8 and 1.
ResultsThe results of the product taste showed that with the increase in the concentration of the coating polymer, the product taste improves significantly (P < 0.05). Solubility of Eudragit is pH dependent, hence, prevents the release of the drug in the oral cavity and the drug is released in the stomach environment. The highest release speed was related to formulation 1 (with the lowest thickness of polymer coating) and the lowest speed was related to formulation 4 (with the highest thickness of polymer coating) and after 90 minutes, between 84.334-96.359 % of the drug was released. Evaluation of the physical characteristics of the granules showed the flowability of the formulation improved. Also, the yield of pan coating technique was between 80 and 90% in different formulations.
ConclusionEudragit E has the ability to mask the bitter taste of the drug. The techniques used to prepare the granules and coat them are low-cost and easily applicable, so they can be produced on an industrial scale.
Keywords: Taste Masking, Dimenhydrinate, Polymer Coating, Eudragit -
Phytomedicine has been used by humans since ancient times to treat a variety of diseases. However, herbal medicines face significant challenges, including poor water and lipid solubility and instability, which lead to low bioavailability and insufficient therapeutic efficacy. Recently, it has been shown that nanotechnology-based drug delivery systems are appropriate to overcome the above-mentioned limitations. The present review study first discusses herbal medicines and the challenges involved in the formulation of these drugs. The different types of nano-based drug delivery systems used in herbal delivery and their potential to improve therapeutic efficacy are summarized, and common techniques for preparing nanocarriers used in herbal drug delivery are also discussed. Finally, a list of nanophyto medicines that have entered clinical trials since 2010, as well as those that the FDA has approved, is presented.
Keywords: Phytomedicine, Herbal drug, Nanotechnology, Drug delivery systems, Nanophytomedicine -
Introduction
Episiotomy is a usual midwifery surgery. Iran is a country with an abundant source of medicinal plants. This study aimed to investigate ginger extract ointment’s effects on the pain and recovery of episiotomy incisions in nulliparous women.
MethodsThis randomized clinical trial was conducted in a public hospital in Iran on 70 nulliparous women with an episiotomy incision. The women were randomly assigned to ginger extract ointment and placebo groups. The primary outcomes included pain and wound healing that were assessed using a visual analog scale (VAS), redness, edema, ecchymosis/bruising, discharge, and an approximation scale (REEDA). The participants were followed up before discharge from the hospital and 5 × 1 and 10 × 1 days after the intervention. The secondary outcome was the number of painkillers used during the study. Data were analyzed by chisquare, independent t test, and the Mann-Whitney U via SPSS-13. The significance levels were determined to be P ≤ 0.05.
ResultsThere was no significant difference between participants treated with ginger extract ointment and placebo in the pain and wound healing scores before the intervention, 5 × 1 and 10 × 1 days after the intervention. But, the pain intensity decreased, and the recovery speed increased clinically. Also, regarding the secondary outcome of this study, no significant difference between the placebo and intervention groups in the number of painkillers participants took.
ConclusionThe ginger ointment could not significantly improve episiotomy wounds’ pain and healing rate, but it was clinically helpful. So more studies with different doses of this ointment are needed.
Keywords: Episiotomy, Wound healing, Pain, Ginger -
Purpose
This research introduces a polymeric nanosphere as a new dispersive solid phaseextraction (DSPE) adsorbent for the extraction of methylphenidate (MPH) from urine and itshigh performance liquid chromatography (HPLC) analysis.
MethodsPolymeric nanosphere is a kind of copolymeric network obtained by copolymerizationof an ionic liquid monomer and styrene in the presence of vinyltriethoxysilane and2-hydroxyethylmethacrylate. HPLC coupled with ultra violet detector was applied for thedetermination and quantification of MPH. Dominant parameters in extraction were modified bythe one-parameter-at-a-time method. The results are as follow: 10 mg of polymeric nanospheres(PNS), 400 μL of acetonitrile (ACT), 5 mL of urine with the pH value of 9, and the extractionand desorption times of 2 and 5 minutes, respectively, which can be selected as the optimumextraction conditions.
ResultsCalibration curve was plotted through optimized conditions, and the proposed methodwas validated. The results demonstrated that the method presented linearity in the concentrationrange of 30-1200 ng/mL. Selectivity, matrix effect and metabolites interference effect wereinvestigated and the method presented no obvious interference effect during the analysis runtime. Repeatability, limit of detection (LOD) and limit of quantification (LOQ) values of themethod can be reported in this section as well. The method showed satisfactory results with98.8% relative recovery in the analysis of positive urine samples.
ConclusionThe findings convinced the applicability of the introduced method for DSPE andHPLC analysis of the positive urine samples in different laboratories.
Keywords: Polymeric nanosphere, Methylphenidate, Dispersive solid phase extraction, Urine -
Purpose
This paper established the application of synthesized graphitic carbon nitride nanosheets (GCNNs) as an influential dispersive solid phase extraction (DSPE) adsorbent in extracting methamphetamine from complicated urine media coupled with high performance liquid chromatography.
MethodsThe GCNNs were synthesized easily and applied as adsorbent in the extraction process. The effective extraction parameters were investigated by one-parameter-at-a-time. Under optimized conditions the method was validated.
ResultsThe calibration curve was plotted in the concentration range of 50-1500 ng/mL through the optimized conditions and the proposed method was validated. The method was used for the analysis of positive urine samples and showed satisfactory results with the average 99.7% relative recovery.
ConclusionThe results persuade the capability of this novel method in analyzing of the positive urine samples in diverse clinical and forensic laboratories.
Keywords: Graphitic carbon nitride, Dispersive solid phaseextraction, Methamphetamine, Urine -
Background
Application of natural-based herbal medicine is on a growing trend in some countries and people prefer to use plant-originated drugs rather than chemical-based ones. The present study describes an interesting sample preparation method for extraction and determination of cyproheptadine in herbal supplements as appetizing stimulant by using carbon nitride nanosheets as dispersive solid phase extraction method coupled with HPLCUV.
MethodsVarious techniques used for characterization of adsorbent such as: Infrared spectroscopy (IR), scanning electron microscopy (SEM), Zeta potential analysis and powder X-ray diffraction (XRD). Optimization of the important extraction parameters were conducted by one parameter-at-a time method. Next, method validation was carried out.
ResultsThe optimized cyproheptadine extraction parameters were introduced and under optimized conditions the method presented a good linearity in the concentration range of 300-2000 ng/g. The limit of detection (LOD) was 100 ng/g for the introduced method.
ConclusionQuantitative analysis of fifteen real samples (Tablets or capsules) by proposed method confirmed the illegal presence of cyproheptadine in herbal appetizing stimulants supplements of the markets.
Keywords: Appetizing Stimulant, Herbal Supplement, Cyrproheptadine, Carbon Nitride Nanosheets, HPLC -
Introduction
Due to the increasing resistance to synthetic antifungal drugs, the use of drugs with a natural origin, with low side effects and low prices is a priority. This study was performed to evaluate the effect of topical honey gel and clotrimazole cream in treatment of signs of vaginal candidiasis.
MethodsThis randomized clinical trial was conducted to evaluate the topical use of honey and clotrimazole in the signs of vulvovaginal candidiasis in clinics and medical centers in Tabriz. The study was performed on 106 non-pregnant women (18 to 45 years old) who had clinical signs of candidiasis. Patients were randomly divided into two groups receiving honey gel and clotrimazole vaginal cream (53 people per group). Each group was treated for 8 days. Before, 4, and 8 days after the intervention, patients recorded the sings of disease and possible side effects of drugs using a researcher-made questionnaire. The results were analyzed using SPSS software ver. 22. Inter-group comparison was carried out using McNemar, Cochran Q and independent t tests. P value < 0.05 was considered statistically significant.
ResultsIn the three evaluation periods, a significant reduction in the sings was observed compared to the before starting of treatment regimes. The results of the cultures were similar and there was no significant difference between the two honey gel and clotrimazole cream groups.
ConclusionOur results may suggest that honey gel could have promising benefits in the treatment of vulvovaginal candidiasis as the main drug or as an adjunct to other antifungal drugs.
Keywords: Honey, Clotrimazole, Vulvovaginal candidiasis, Signs -
Protein and peptide delivery systems attract great attention nowadays. They play crucial role in several diseases, but their way of administration has some disadvantages that makes patients dissatisfied. In this study, we choose insulin as a peptide that is used for type I and type II diabetic patients, but injection way of its usage is not suitable in diabetes as a chronic remedy. Although oral way is a needle-free one, but its bioavailability through that would be decreased because of degradation in gastro-intestine and consequently, further dosage should be used to get the desired hypoglycemic effect. Administration of insulin through non-parenteral and less enzymatic pathways, such as intranasal, pulmonary, transdermal, colon and vaginal routes, is new that attracts researchers’ attention considerably. Although the bioavailability of insulin may be lower than the current injection way, but it may be improved by some strategies like the use of permeation enhancers. There are also some limitations in each way, but propagation of them would result in improvement of patients’ quality of life and may cause some economic profits. The objective of this review was to introduce the convenient ways for long term insulin administration with few enzymatic barriers.Keywords: Insulin, Delivery ways, Non- invasive, Less enzymatic
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BackgroundDiaper dermatitis is one of the most prevalent skin disorders in neonates and children. The purpose of this study was to compare the effects of Aloe Vera and chamomile ointment on the degree of diaper dermatitis in children.Materials and MethodsIn this double-blinded randomized clinical trial, 90 children below two years of age, who had diaper dermatitis and were hospitalized in the Tabriz Pediatric Hospital, Tabriz city- Iran, were included in the study using random sampling. The children were divided into three equal groups, with one group receiving routine treatments and the other two receiving chamomile and Aloe Vera ointment three times a day. The samples were examined on the first, third, and sixth day of the study using a diaper rash five-point scale. The data were analyzed by descriptive and analytical tests in SPSS software version 22.0.ResultsBaseline criteria such as age, gender, and education of mothers were similar in all the groups (P>0.05). Moreover, the dermatitis extent recovery was achieved over time (P<0.001) in all the three groups; however, comparison among the three groups showed no significant difference in all the types of treatment (P>0.05).ConclusionThere was no difference between the Aloe Vera, chamomile, and routine treatments in dermatitis extent recovery.Keywords: Aloe vera, Chamomile, Children, Diaper dermatitis -
Background
Women with borderline gestational diabetes mellitus (BGDM) have a greater risk of complications in comparison with normal women.
ObjectivesThe aim of this randomized clinical trial was to determine the effects of garlic pill on fasting blood sugar (FBS) and relapse of prediabetes symptoms (primary outcomes), as well as blood pressure, neonatal anthropometric indices, and mode of delivery (secondary outcomes) in pregnant women with prediabetes.
MethodsThis triple-blind, randomized clinical trial was conducted on 49 women with prediabetes at 24 to 28 weeks of gestation in Tabriz, Iran, 2015 - 16. The participants were assigned to the intervention (n, 26) and control (n, 23) groups using block randomization. The intervention group received a 400-mg garlic pill per day, while the control group received a placebo pill per day for 8 weeks. Four and eight weeks following the intervention, FBS and blood pressure were measured. The newborns anthropometric indices and mode of delivery were also recorded after delivery.
ResultsThe mean FBS level in the garlic group decreased from 106.6 (11.1) mg/dL before the intervention to 83.6 (6.3) mg/dL at 4 weeks after the intervention and 79.4 (6.1) mg/dL at 8 weeks after the intervention (adjusted mean difference, -3.7). The garlic pill also led to a significant decrease in prediabetes symptoms at 4 weeks after the intervention (P
ConclusionsThe results revealed that garlic pill could reduce FBS level, prediabetes symptoms, and diastolic blood pressure. However, further research with a larger sample size is required for more accurate results.
Keywords: Garlic, Pregnancy, Prediabetes, Fasting Blood Sugar -
BackgroundOne of the symptoms of mucositis caused by chemotherapy is pain. Mucositis management is initiated by assessment of oral hygiene and management of pain. Many uses have been mentioned for Satureja hortensis in traditional medicine. The study was carried out with the aim of determining the effect of Satureja hortensis extract mucoadhesive gel of 1% on severity of mucositis-induced pain in children under chemotherapy.
Materials and MethodsThis randomized parallel double-blind clinical trial was carried out on 60 children who were affected by mucositis following chemotherapy in 2016. The samples were randomly assigned into two groups of intervention and control. The intervention group applied Satureja hortensis extract gel of 1% and the control group applied the placebo gel twice daily for 5 days after the onset of mucositis along with routine treatment. Oral mucosa was evaluated daily. Also, the Oucher pain tools and a demographic checklist were used. The data was analyzed using SPSS version 13.0 software.ResultsThe obtained data showed that the two groups had statistical difference in terms of the severity of the pain relief during the time, and pain severity reduced from 3.5±2.1 to 0.0 ± 0.0 in intervention group and 3.1 ± 1.8 to 0.4 ± 1.0 in control group in fifth day (p ConclusionThe study showed that the extract 1% of Satureja hortensis is effective in healing mucositis induced pain and can be used as a new treatment method in relieving reducing mucositis pain.Keywords: Children, Chemotherapy, Mucositis, Pain, Satureja hortensis -
Oral drug administration is used for a large number of medications, intended to create a systemic effect in the body. Over the recent years, an increasing attention has been directed by pharmacists toward the development of successful formulations for oral drug delivery. However, this issue is still controversial in pharmaceutical technology with many limitations due to the numerous barriers against the absorption and permeability in the gastrointestinal tract. On the other hand, drug carriers play an important role in providing prolonged release and delivery and overcome the multiple barriers of maintaining appropriate bioavailability. Nano scaling of the particles, carriers, and polymers has also provided the capability to characterize and control materials in order to produce unique pharmaceutical components and structures. Furthermore, personalized healthcare, rational drug design, and site-specific targeted drug delivery are some of the profits gained from a nano-based formulation approach. This review aimed to evaluate the evidence on some different types of nanoscaled drug delivery systems, which allow for the delivery of small-molecule drugs and facilitate the merging of larger particles, such as nucleic acids, peptides, and proteins. The delivery of these molecules to the exact target areas inside the body can be accomplished, which would decrease systemic adverse effects and allow for more effective application of the pharmaceutical preparationsKeywords: Oral drug delivery, nanoparticles, bioavailability, nanotechnology
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ObjectivesTo compare the effects of mefenamic acid versus quince on menorrhagia and quality of life.MethodsThis randomized controlled trial was conducted on women with menorrhagia. The participants were allocated into 2 groups through block randomization. The first group (n, 72) received quince pills, while the second group (n, 74) used mefenamic acid pills for 3 consecutive cycles. The participants completed the pictorial blood loss assessment chart (PBAC) before and during the intervention. Moreover, the short-form health survey (SF-36) was completed before and 3 months after the intervention.ResultsThe mean PBAC scores decreased significantly in both groups. The mean PBAC score in the quince group decreased from 173.6 (SD, 53.8) before the intervention to 116.7 (51.7), 86.4 (43.1), and 68.9 (36.4), respectively in the first, second, and third months after the intervention. The mean PBAC scores in the mefenamic acid group was 176.8 (54.3) at baseline and 106.6 (50.40), 81.6 (38.7), and 63.8 (33.8), respectively in the first, second, and third months after the intervention. There was no significant difference between the groups in terms of the mean PBAC score (P = 0.183). Similarly, after the intervention, there was no significant difference between the groups in terms of physical health (P = 0.476) and mental health (P = 0.572) components of quality of life.ConclusionsQuince pills were as effective as mefenamic acid pills in reducing the intensity of menstrual bleeding. Therefore, they seem to be a proper alternative for mefenamic acid.Keywords: Mefenamic Acid, Quince, Menorrhagia, Quality of Life
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International Journal of Women’s Health and Reproduction Sciences, Volume:5 Issue: 4, Autumn 2017, PP 332 -338Objectives
To assess the effect of co-administration of calcium and magnesium and calcium alone on pain intensity in primary dysmenorrhea.
Materials And MethodsIn this study, 63 students with primary dysmenorrhea were randomly allocated into 2 intervention (receiving one tablet a day combined 600 mg calcium carbonate and 300 mg magnesium stearate, or only 600 mg calcium carbonate from 15th day of cycle until no pain day on the following cycle) and 1 placebo groups. The subjects filled in a diary including pain intensity (0-10 visual analog scale) and rest length for 2 cycles before intervention and 2 cycles under intervention. Univariate general linear model was used for data analysis.
ResultsOne from each intervention groups were lost to follow up. Both combined calcium- magnesium and calcium alone groups had better outcomes than the placebo group in pain intensity (adjusted difference -1.9, 95% CI -2.2 to -1.7 and -0.9, -1.2 to -0.6, respectively), rest length (-2.5 hours, -3.2 to -1.9 and -1.7, -2.4 to -1.1) and number of Ibuprofen taken (-2.6, -4.1 to -1.1 and -1.5, -2.9 to -0.1). The calcium-magnesium group had significantly better outcomes than the calcium group in pain relief and rest length but not in the Ibuprofen group. No side effect was reported.
ConclusionBoth combined calcium-magnesium and calcium alone are effective in relieving the pain and decreasing the rest length due to primary dysmenorrhea, but better efficacy was obtained from combined calcium and magnesium in comparison with its counterpart.
Keywords: Calcium, Dysmenorrhea, Magnesium, Pain -
International Journal of Women’s Health and Reproduction Sciences, Volume:5 Issue: 2, Spring 2017, PP 129 -136ObjectivesDue to enhanced life expectancy and an increasing elderly population, sexual and physical problems related to menopause are essential from the health point of view. This study was performed to evaluate the effect of Ginkgo biloba tablet and aromatherapy inhaler combination (lavender, fennel and geranium and rose) in decrement of sexual dysfunction in postmenopausal women.Materials And MethodsThis double blind randomized clinical trial was performed on 180 postmenopausal women with age range of 45-55 years referring to health care centers in Ardabil University of Medical Sciences, Iran. The participants were randomly divided into 3 groups of 60 subjects: Ginkgo biloba tablet and placebo aroma solution users, aroma solution with placebo Ginkgo biloba users, and placebo aroma with placebo Ginkgo biloba users who received 40 mg Ginkgo biloba either in tablet or placebo and 2-3 drops of aroma solution or placebo on the skin, 3 times a day for 6 weeks. The tool for collecting data was a questionnaire encompassed questions on the socio-demographical features and female sexual function index (FSFI). The primary outcome was the sexual function mean score after intervention in the research groups. The analysis was conducted according to intention-to-treat.ResultsThe mean (SD) scores of total sexual function at baseline in aromatherapy, Ginkgo biloba and placebo groups were 18.4 (5.4), 17.5 (6.8) and 15.8 (5.7) that enhanced to 22.9 (3.3), 21.6 (4.5) and 17.2 (4.2) in the mentioned groups respectively after intervention. Analysis of covariance (ANCOVA) test indicated significant discrepancy after intervention in total (PConclusionAromatherapy inhaler combination and Ginkgo biloba tablet improved sexual function in postmenopausal women.Keywords: Aromatherapy, Ginkgo biloba, Menopause
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IntroductionThe potential of combining liquisolid and co-grinding technologies (liquiground technique) was investigated to improve the dissolution rate of a water-insoluble agent (glibenclamide) with formulation-dependent bioavailability.MethodsTo this end, different formulations of liquisolid tablets with a wide variety of non-volatile solvents contained varied ratios of drug: solvent and dissimilar carriers were prepared, and then their release profiles were evaluated. Furthermore, the effect of size reduction by ball milling on the dissolution behavior of glibenclamide from liquisolid tablets was investigated. Any interaction between the drug and the excipient or crystallinity changes during formulation procedure was also examined using X-ray diffraction (XRD) and differential scanning calorimetry (DSC).ResultsThe present study revealed that classic liquisolid technique did not significantly affect the drug dissolution profile as compared to the conventional tablets. Size reduction obtained by co-grinding of liquid medication was more effective than the implementation of liquisolid technique in enhancing the dissolution rate of glibenclamide. The XRD and DSC data displayed no formation of complex or any crystallinity changes in both formulations.ConclusionAn enhanced dissolution rate of glibenclamide is achievable through the combination of liquisolid and co-grinding technologies.Keywords: Glibenclamide, Liquisolid, Liquiground, Dissolution rate, Co-grinding
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مقدمهلاکتوباسیلوس مهم ترین عامل حفظ فلور طبیعی واژن است. عدم وجود آن، زمینه را برای ابتلاء به عفونت های قارچی فراهم می آورد. شایع ترین دلیل مراجعه زنان به مراکز درمانی واژینیت کاندیدیایی است که برای درمان آن از داروهای شیمیایی آزول، با عوارض جانبی بسیار استفاده می شود. عسل یکی از درمان های غیرشیمیایی با خاصیت ضد قارچی است که به نظر می رسد قدرت حفظ فلور طبیعی واژن را داشته باشد. مطالعه حاضر با هدف مقایسه تاثیر ژل واژینال عسل با کرم واژینال کلوتریمازول بر فلور طبیعی واژن در زنان مبتلا به واژینیت کاندیدایی انجام شد.روش کاراین مطالعه کارآزمایی بالینی یک سوکور در سال 1394 بر روی 106 زن مبتلا به واژینیت کاندیدایی در مراکز بهداشتی منتخب شهر تبریز انجام شد. نمونه ها با شکایت سوزش، خارش و داشتن کشت آزمایشگاهی مثبت و سایر معیارهای ورود وارد مطالعه شدند، سپس به صورت تصادفی در دو گروه 53 نفره کرم واژینال کلوتریمازول و ژل واژینال عسل قرار گرفتند. پس از پایان دوره درمان 8 روزه مجددا کشت و معاینه انجام و نتایج در دو گروه با استفاده از نرم افزار آماری SPSS (نسخه 22)، Minitab، آزمون های فریدمن، جنرال میکس مدل، کای دو و تی مستقل با مورد تجزیه و تحلیل آماری قرار گرفت. میزان p کمتر از 05/0 معنی دار در نظر گرفته شد.یافته هادر گروه عسل بعد از تکمیل دوره درمان و بهبود علائم بالینی، میزان لاکتوباسیل ها افزایش یافت که نسبت به قبل درمان اختلاف معنی دار بود (001/0p<). در گروه کلوتریمازول اختلاف معنی داری در فراوانی میزان لاکتوباسیل قبل و بعد از درمان مشاهده نشد (705/0=p).نتیجه گیریعسل در مقایسه با کلوتریمازول علاوه بر برای درمان واژینیت کاندیدیایی، فلور طبیعی واژن را تغییر نمی دهد.کلید واژگان: عسل، فلور نرمال واژن، کلوتریمازول، کاندیدیاز، لوواژینالIntroductionLactobacillus is the most important factor for protection of vaginal normal flour. No existence of vaginal normal flour provide the background for fungal infections. Vaginitis candidiasis is the most common reason for women referral that azole agents are used for its treatment that have many side-effects. Honey is a nonchemical treatment with anti-fungal property that seems has the ability to affects vaginal normal flour. This study was performed with aim to compare the effects of vaginal honey gel with clotrimazole cream on vaginal normal flour.MethodsThis single-blind randomized clinical trial study was conducted on 106 women with vaginitis candidiasis in Tabriz health centers at 2015. The samples were enrolled to the study with clinical complaints such as itching, burning, positive cultures and other inclusion criteria. Then, they were randomly divided into clotrimazole cream and honey gel groups (53 in each group). After the end of eighth day treatment, culture and examination were again performed. The obtained results were analyzed by SPSS software (version 22) and Minitab, Friedman, general mix model, Chi-square, and independent t tests. PResultsIn honey group, after treatment completion and improvement of clinical symptoms, lactobacillus increased that the difference was significant compared with before treatment (PConclusionHoney in addition to treatment of vulvovaginitis candidiasis, does not change vaginal normal flour compared to clotrimazole.Keywords: Clotrimazole, Candidiasis, Honey, Vaginal normal flour, Vulvovaginal
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Low solubility and dissolution rate are the primary challenges in the drug development which substantially impact the oral absorption and bioavailability of drugs. Due to the poor water solubility, Albendazole (ABZ) is poorly absorbed from the gastrointestinal tract and shows low oral bioavailability (5%) which is a major disadvantage for the systemic use of ABZ. To improve the solubility and dissolution rate of ABZ, different classes of hydrophilic excipients such as sugars (lactose, sucrose, and glucose), polyols (mannitol and sorbitol), ionic surfactant (sodium lauryl sulfate) and non-ionic surfactant (Cremophor A25) were co-spray dried with ABZ. The crystallinity changes in the processed drug were characterized by differential scanning calorimetry and X-Ray diffraction methods were used to interpret the enhanced solubility and dissolution rate of the drug. Results showed that the solubility and dissolution rate of ABZ were increased 1.8-2.6 folds and 3-25 folds, respectively. Unexpectedly, SLS decreased the solubility index of drug powder even lower than the unprocessed drug which was attributed to drug-SLS ionic interaction as depicted from Fourier transform infrared spectroscopy. It was concluded that by applying the facile, one-step, industrially scalable technique and the use of small amounts of excipient (only 4% of the formulation), a great improvement (21 folds) in dissolution rate of ABZ was achieved. This finding may be used in the pharmaceutical industries for the formulation of therapeutically efficient dosage forms of class II and IV drugs classified in biopharmaceutical classification system.Keywords: Albendazole, Spray drying, Dissolution rate, Solubility, Surfactants
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BackgroundReadiness of the cervix is required for successful induction of labor, and there are a number of ways in which this can be achieved.ObjectivesThe aim of the present study was to assess whether taking saffron orally could have an effect on the cervical readiness (primary outcome) and some delivery and neonatal outcomes (secondary outcomes) in women in the stage of term pregnancy.
Patients andMethodsIn this double-blind trial, 50 women with a gestational age of 39 to 41 weeks, no indication of cesarean section, a Bishops score of less than 4, who had plan to have vaginal delivery at Shohada hospital of Bonab, Iran were randomized into two groups receiving three 250mg saffron or placebo pills in 24 hours. The readiness of the cervix was assessed using the Bishops score. The Mann-Whitney U test was used to compare the scores between the groups.ResultsThere were no significant differences between the groups in terms of the Bishops score at the baseline (P = 0.792) and 10-12 hours after starting the intervention (P = 0.159). The Bishops score was significantly higher in the saffron group 20 - 24 hours after the intervention was started (P = 0.029) and just after onset of active uterine contractions (P = 0.003). In the saffron group, there was no cesarean section and 1 meconium staining of the fetus, but 3 and 4, respectively, in the placebo group. There was no statistically significant difference between the groups in terms of the timing of the onset of spontaneous active uterine contractions, the duration of the first and second stages of labor, the need for delivery augmentation, and the first and fifth minutes of neonatal Apgar (P > 0.05). No adverse event was reported in any of the groups.ConclusionsSaffron can increase the readiness of the cervix in term pregnancies. However, the study limitations do not allow for any definite conclusions for its use in clinical practice, and more research is needed to assess its effect on delivery and neonatal outcomes.Keywords: Saffron, Readiness, Cervix, Term Pregnancy, Bishop's Score, Herbal Medicine -
BackgroundTwo simple, precise and accurate multivariate calibration methods, partial least square (PLS) and principal component regression (PCR) have been applied for the simultaneous determination and dissolution profile evaluation of atorvastatin (ATV) and ezetimibe (EZT) in their binary mixtures and commercial tablets. Due to the closely overlapping spectral bands of the mentioned drugs, simultaneous determination without previous separation is not possible by conventional spectrophotometric methods. In the proposed methods (PLS and PCR) determination of chemicals was performed by the use of a full-spectrum multivariate calibration method.MethodsThe experimental calibration matrix was designed orthogonally with 16 samples composed of different mixtures of both compounds in related mediums. The simultaneous determination of ATV and EZT was accomplished in mixtures through recording the absorption spectra within a range of 210 to 300 nm.ResultsThe concentration of ATV and EZT were considered in the linear range, between 8 to 14 µg.ml-1. The specificity of the methods was evaluated by analyzing laboratory prepared mixtures of the mentioned drugs in specific proportions.ConclusionThe applied methods were successfully employed in simultaneous spectrophotometric determination and dissolution profile evaluation of ATV and EZT in their prepared mixtures and pharmaceutical formulation.Keywords: PLS, PCR, Atorvastatin, Ezetimibe, Simultaneous determination
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PurposeLocal therapy is a valuable and strategic approach in the treatment of lung associated diseases and dry powder inhalation (DPI) formulations play the key role in this plan. Transfersome has been introduced as a novel biocompatible vesicular system with potential for administration in pulmonary drug delivery. The present study was designed to prepare Itraconazole-loaded nanotrantransfersomal DPI formulation.MethodsItraconazole-loaded nanotransfersomes with three different types of surfactant in varying concentrations were prepared and characterized in the point of particle size distribution and morphology by laser light scattering and scanning electron microscopy (SEM) methods. The optimized transferosomal formulations were co-spray dried with mannitol and the aerosolization efficiency and aerodynamic properties of dry powders were determined by next generation impactor using a validated HPLC technique.ResultsThe volume mean diameter of optimized nanotransfersomal formulation with lecithin:Span® 60 in the ratio of 90:10 was 171 nm with narrow size distribution pattern which increased up to 518 nm after drug loading. Different types of surfactant did not influence the particle size significantly. SEM images confirmed the formation of aggregated nanoparticles in the suitable range (1-5 µm) for the pulmonary drug delivery. Aerosolization evaluation of co-spray dried formulations with different amounts of mannitol indicated that 2:1 ratio of mannitol:transfersome (w:w) showed the best aerosolization efficiency (fine particle fraction (FPF)=37%). Increasing of mannitol significantly decreased the FPF of the optimized formulations.ConclusionThe results of this study was introduced the potential application of nanotransfersomes in the formulation of DPIs for lung delivery of various drugs.Keywords: Pulmonary drug delivery, Dry powder inhaler, Transfersome, Itraconazole, DP
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زمینه و هدفسندروم پیش از قاعدگی باعث اختلالات قابل توجهی در زندگی و فعالیت های روزانه می شود. این مطالعه با هدف مقایسه تاثیر بذر کتان و ویتاگنوس بر نشانه های سندروم پیش از قاعدگی در زنان، انجام گرفته است.روش بررسیدر این کارآزمایی بالینی تصادفی کنترل شده سه سوکور 159 زن مبتلا به سندروم پیش از قاعدگی تشخیص داده شده از طریق فرم ارزیابی نشانه های قبل از قاعدگی (PAF= The Shortened Premenstrual Assessment Form) از میان زنان مراجعه کننده به مراکز بهداشتی درمانی شهر تبریز از آبان 1392 تا شهریور 1393 انتخاب و به روش بلوک بندی تصادفی در 3 گروه 53 نفری قرار گرفتند. گروه اول پودر بذر کتان و پلاسبوی قرص ویتاگنوس، گروه دوم قرص ویتاگنوس به علاوه پلاسبوی بذر کتان و گروه سوم پلاسبوی هر دو دارو را دریافت نمودند. فرم ارزیابی نشانه های قبل از قاعدگی توسط نمونه ها قبل از مداخله، یک و دو ماه بعد از مداخله تکمیل گردید. از آزمون اندازه های تکراری (Repeated Measurement) برای آنالیز داده ها استفاده شد.یافته هانمره نشانه های قبل از قاعدگی در هر دو گروه مداخله هم در ماه اول و هم در ماه دوم به طور معناداری بهبود یافت. به طوری که میانگین نمره شدت سندروم قبل از قاعدگی به طور معناداری در ماه اول بعد از مداخله در گروه ویتاگنوس (1/2- تا 0/4-: فاصله اطمینان 95%، 3/3-: تفاوت میانگین تعدیل یافته) و بذر کتان (0/3- تا 5/5-، 3/4-) و ماه دوم پس از مداخله در گروه ویتاگنوس (7/4- تا 0/7-، 8/5-) و بذر کتان (7/5- تا 1/8-، 6/6-) کم تر از گروه شاهد بود. تفاوت معناداری بین دو گروه ویتاگنوس و بذرکتان مشاهده نشد.نتیجه گیریبراساس نتایج این مطالعه، بذر کتان و ویتاگنوس هر دو جهت بهبود سندروم قبل از قاعدگی موثر می باشد.
کلید واژگان: سندروم قبل از قاعدگی، بذرکتان، ویتاگنوسHayat, Volume:21 Issue: 1, 2015, PP 68 -78Background and AimPremenopausal syndrome affects daily activities of many women. This study aimed to compare the effects of Vitexagnus and Flaxseed on premenstrual symptoms in women referred to health centers of Tabriz from October 2013 to September 2014. Methods & Materials: This randomized controlled trial was conducted among 159 women suffered from premenstrual syndrome (PMS). The PMS was measured using the premenstrual assessment form (PAF). The participants were allocated into three groups (n=53 per group) using block randomization. The group I received 25 grams/d Flaxseed powder and placebo of the Vitexagnus; group II received 3.2-4.8 mg/d Vitexagnus tablets and placebo of the Flaxseed; and the control group received both placeboes. The PAF was completed at baseline and 1 and 2 month after the intervention. Data were analyzed using the general linear model.ResultsThe PMS improved significantly in both intervention groups during the first and the second month after the intervention. In the Vitexagnus and Flaxseed groups, the mean total PMS score were significantly lower than that in the control group at the first months after the intervention (adjusted mean difference: -3.3 (95% CI: -4.0 to -2.1); -4.3 (-5.5 to -3.0), respectively). In the second month after the intervention, the mean total PMS score was -5.8 (-7.0 to -4.7) in the Vitexagnus group and -6.6 (-8.1 to -5.7) in the Flaxseed group. There was no significant difference between the Vitexagnus and Flaxseed groups in terms of the PMS score.ConclusionAccording to the results of this study, Flaxseed and Vitexagnus are effective in improving PMS.Keywords: Premenstrual syndrome, Flaxseed, Vitexagnus -
BackgroundEpisiotomy, a common surgical practice in midwifery, is accompanied with high levels of pain and discomfort for mothers. The importance of medicinal herbs and traditional medicine in wound healing cannot be neglected.ObjectivesConsidering the positive effects and easy accessibility of Equisetum arvense, this study examined the effectiveness of topical application of Equisetum arvense ointment in wound healing, reduction of inflammation and pain relief after episiotomy in nulliparous mothers.Patients andMethodsThis double-blind clinical trial was performed on 108 postpartum nulliparous mothers (54 women in horsetail group and 54 women in placebo group) in Alzahra Educational-Medical Center (Tabriz, Iran). About 5 ± 1 and 10 ± 1 days after the childbirth, the primary outcomes of episiotomy, i.e. wound healing and pain intensity, were assessed based on redness, edema, ecchymosis, discharge and approximation of the edges (REEDA) scale and a visual analogue scale (VAS), respectively. The secondary outcomes evaluated in the current research were the number of used painkillers and the adverse events during the 10-day period of the study. Data was analyzed using independent t and Mann-Whitney U tests.ResultsThe case and control groups had no significant differences in for the mean wound healing score (5.0 ± 1.6 vs. 4.1 ± 1.6) and mean pain intensity (5.7 ± 2.4 vs. 5.3 ± 2.2) at baseline. During both follow-up sessions (5 ± 1 and 10 ± 1days after delivery), the mean scores were significantly lower in the case group than the control group. The adjusted pain score difference (MD) after 5 ± 1 and 10 ± 1 days was -2.3 (95% CI: -3.2 to -1.3) and 3.8 (95% CI: -4.7 to -3.0), respectively. The mean numbers of acetaminophen pills used in the control and case groups during the 10-day period of the study were 6.8 ± 4.4 and 11.6 ± 7.1, respectively (P < 0.001).ConclusionsAccording to our findings, 3% Equisetum arvense ointment promoted wound healing and relieved pain during the 10-day period after episiotomy. Since this study was the first to assess the effects of Equisetum arvense ointment on wound healing and pain intensity following episiotomy in humans, further research is warranted to fully clarify the beneficial effects of prepared ointment.Keywords: Equisetum, Horse, Tail, Episiotomy, Wound Healing, Pain
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