复方苦参蛇床子止痒乳膏剂制备工艺研究

Preparation Process of TCM Compound Sophorae Flavescentis Radix-Cnidii Fructus Antipruritic Cream Preparations

目的优选中药复方苦参蛇床子止痒乳膏剂的处方及制备工艺。方法以复方苦参蛇床子坐浴药浓缩液为水相,根据浓缩液酸碱性选择乳化剂类型(离子型、非离子型),筛选乳化剂处方,采用反相快速加入法制备水包油(O/W)型乳膏剂,并对其外观性状、乳滴粒径、离心试验、pH适宜性、耐热试验、耐寒试验进行考察。结果优选的工艺为以2倍复方苦参蛇床子坐浴药浓缩液为水相,以司盘-60和吐温-60为混合乳化剂,以单硬脂酸甘油酯为辅助乳化剂,以硬脂酸为主要固态油相,固态油相总比例为17.16%。结论优选的处方及制备工艺所制得O/W型乳膏剂质量合格,性质稳定。

Objective To optimize the prescription and preparation process of traditional Chinese medicine(TCM)compound Sophorae Flavescentis Radix-Cnidii Fructus Antipruritic Cream Preparations.Methods The concentrated solution of compound Sophorae Flavescentis Radix-Cnidii Fructus decoction for sitz bath was taken as the water phase.Different emulsifier types(ionic and non-ionic emulsifiers)were selected according to the acidity and alkalinity of the concentrated solution.The prescription of the emulsifers was screened.The oil-in-water(O/W)cream preparations were prepared by the reverse-phase-rapid-addition method,and their appearance properties,size of emulsion droplet,centrifugation test,pH suitability,heat-resistance test and cold-resistance test were investigated.Results The optimal preparation process was as follows:the twice volume of concentrated solution of compound Sophorae Flavescentis Radix-Cnidii Fructus decoction for sitz bath was as the water phase,the Span-60 and Tween-60 were as the mixed emulsifiers,the glycerol monostearate was as the auxiliary emulsifier,the stearic acid was as the main solid oil phase,and the total proportion of solid oil phase was 17.16%.Conclusion The O/W cream preparations prepared by the optimal prescription and preparation process are qualified and stable.