Shadab Mohd, Shamsi Shariq
Department of Ilmul Saidla (Unani Pharmacy), National Institute of Unani Medicine, Bangalore 560091, Karnataka, India.
Department of Ilmul Saidla (Unani Pharmacy), National Institute of Unani Medicine, Bangalore 560091, Karnataka, India.
J Ayurveda Integr Med. 2020 Jul-Sep;11(3):199-205. doi: 10.1016/j.jaim.2018.01.006. Epub 2018 Nov 17.
Vitiligo is not only a cosmetic problem, but also a social and psychological problem worldwide with the prevalence rate being highest in India. Treatment is unsatisfactory in Western System of Medicine. Unani System of Medicine (USM) possesses various drugs to treat vitiligo in both topical and oral dosage forms. Safoof-e-Bars (SB) is an important powdered dosage form used widely to treat vitiligo, internally as Zulal. Externally as Sufl (Sediment remained after decanting the soaked drug) is used. Babchi, a component of SB, is reported to contain psoralen, an important therapeutically active compounds for treating vitiligo. But as Psoralen - the active marker compound is very slightly soluble in water, so only negligible amount of it comes in zulal and most of the amount remains in sufl. That might be the reason for local application of sufl as recommended by Hakeems. But clinically it is observed that application of sufl is not followed by most of the patients, due to side effects associated with its application on skin.
The present study is designed to convert Safoof-e-Bars into a more convenient and appealing newly evolved dosage form 'emulgel' of same composition as of SB, so that it can be used by the patients easily without any side effects.
MATERIALS & METHODS: Various batches of emulgel were prepared as preliminary batches and final batches using hydro-alcoholic extract of SB and different excipients in different concentrations. Preliminary batches were formed for selecting composition and concentration of extract and excipients for final batches. Total eight batches (F1F8) were prepared as final batches. Among these eight batches, batch F7 was selected as final batch, which was further evaluated on various parameters. Comparative quantitative analysis was done in Zulal, Hydro-alcoholic extract of SB and emulgel using HPLC.
Optimized emulgel showed good result in physicochemical parameters. Highest percentage of psoralen was found in SB extract while lowest percentage was found in zulal. No growth of yeast and mould, and viable aerobic were found in emulgel on microbiological analysis. Emulgel was found to be stable for 3 months.
Newly developed emulgel may be recommended with zulal instead of traditionally used sufl with zulal. In future emulgel will provide a solution for topical delivery of hydrophobic drugs and more convenient dosage form to apply locally.
白癜风不仅是一个美容问题,在全球范围内也是一个社会和心理问题,印度的患病率最高。西医治疗效果不尽人意。尤纳尼医学体系(USM)有多种治疗白癜风的药物,包括外用和口服剂型。Safoof-e-Bars(SB)是一种重要的散剂剂型,广泛用于治疗白癜风,内服为Zulal,外用为Sufl(浸泡药物倾析后的沉淀物)。据报道,SB的成分补骨脂含有补骨脂素,这是一种治疗白癜风的重要治疗活性化合物。但由于补骨脂素——活性标记化合物在水中的溶解度非常低,所以在Zulal中只有极少量的补骨脂素,大部分都留在了Sufl中。这可能就是哈基姆推荐局部应用Sufl的原因。但临床上观察到,由于Sufl应用于皮肤会产生副作用,大多数患者并未遵循使用Sufl的方法。
本研究旨在将Safoof-e-Bars转化为一种更方便、更具吸引力的新剂型“乳胶凝胶”,其成分与SB相同,以便患者可以轻松使用且无任何副作用。
使用SB的水醇提取物和不同浓度的不同辅料制备了各种批次的乳胶凝胶,分为初步批次和最终批次。初步批次用于选择最终批次提取物和辅料的组成和浓度。共制备了八个批次(F1-F8)作为最终批次。在这八个批次中,批次F7被选为最终批次,并对其进行了各种参数的进一步评估。使用高效液相色谱法对Zulal、SB的水醇提取物和乳胶凝胶进行了比较定量分析。
优化后的乳胶凝胶在理化参数方面显示出良好的效果。在SB提取物中发现补骨脂素的百分比最高,而在Zulal中发现的百分比最低。微生物分析显示乳胶凝胶中未发现酵母菌和霉菌生长以及需氧菌存活。乳胶凝胶在3个月内保持稳定。
新开发的乳胶凝胶可以与Zulal一起推荐使用,而不是传统上与Zulal一起使用的Sufl。未来,乳胶凝胶将为疏水性药物的局部给药提供解决方案,并提供更方便的局部应用剂型。