复方五黄骨伤软膏的制备工艺研究

目的: 优选复方五黄骨伤软膏的制备工艺。方法: 考察软膏基质的类型、种类、加入顺序, 在此基础上采用离心试验和高温试验, 通过L₉(3⁴)正交设计, 以软膏剂离心试验和高温试验油层与水层高度比的综合评分OD值为指标, 考察制备软膏的乳化时间、乳化温度和搅拌速度3个因素, 对乳化工艺进行优化;并通过验证试验确定最优制备工艺。结果: 复方五黄骨伤软膏最佳制备工艺为:处方药材粉碎成细粉备用, 取硬脂酸、蓖麻油、液状石蜡置适当容器中, 加热至70~80 ℃, 加入上述药材细粉, 趁热搅拌, 作为油相;另取三乙醇胺、甘油、纯化水置另一容器中, 加热至70~80 ℃, 作为水相。油相、水相趁热混合, 以转速2 000 r·min^-1搅拌0.5 h, 使完全乳化, 放冷至室温, 即得。结论: 该制备工艺简便、可行, 成品性状符合规定, 稳定性良好, 适用于我院复方五黄骨伤软膏的生产。

Study on preparation process of compound Wuhuang Gushang cream

OBJECTIVE To study preparation process of compound Wuhuang Gushang cream. METHODS Based on types, variety and adding sequence of cream matrix, centrifuge test and high temperature test were used. L₉(3⁴) orthogonal test was adopted, OD values for ratios of oil layer to water layer in centrifuge test and high temperature test were adopted as the assessment indicators, to investigate 3 factors including emulsifying time and temperature, and the stirring rate, thus to optimize the emulsification process. RESULTS The optimal preparation technology of compound Wuhuang Gushang cream: herbs were crushed into fine powder; stearic acid, castor oil and liquid paraffin heated to 70-80 ℃ as oil phase; triethanolamine, glycerinum and distilled water heated to 70-80 ℃ as water phase; oil and water phases were heated to mix, stirred for 0.5 hours at a rotate speed 2 000 r·min^-1 until complete emulsification, and then cooled to room temperature. CONCLUSION The preparation process is convenient and feasible, can produce qualified finished products. The process can be used to prepare ompound Wuhuang Gushang cream.