复方松馏油乳膏的制备及质量标准研究

Preparation and Quality Control of Compound Pine Tar Cream

目的:制备复方松馏油乳膏并建立其质量控制方法。方法:取硬脂酸、十六醇、甘油等为基质,以硫磺等为主药制备水包油等(均O符/W合)型20乳05膏年;版采《用中乙国醇药-典氯》仿中(的1∶相1)关溶规解定基;质平,均用回碘收量率法为测9定9.其55中%主,日药内硫、的日含间量RS。D结分果别:为所0制.5制2%剂、为0.5灰6%色。乳结膏论,性:本状制、鉴剂别制、备检查工艺简单,质量控制方法可靠,制剂质量稳定。

OBJECTIVE： To prepare Compound pine tar cream and establish its quality control method. METHODS： The O/ W-type cream was prepared with sulfur as main component and octadecanoic acid, cetanol and glycerol as matrix. The content of sulfur was assayed by I2 titration method with C2H6OH-CHC13 （1 ： 1） as dissolution base. RESULTS： The preparation was grey cream and its property, identification and tests were all in conformity with the description of Chinese Pharmacopeia （2005 edition）. The average recovery was 99.55% and the RSD of intra-day and inter-day were 0.52% and 0.56% respectively. CONCLUSION： The preparation process is simple and stable in quality while its quality control method is reliable.