复方彻清膏微乳的制备及稳定性研究  

Preparation and stability of Compound Cheqinggao microemulsion

作　　者：刘伟 张莹莹 周文杰[2] 杨荣平[1,3] LIU Wei;ZHANG Ying-ying;ZHOU Wen-jie;YANG Rong-ping(The Ministry of Education Key Laboratory of Standardization of Chinese Herbal Medicine,Key Laboratory of Systematic Research,Development and Utilization of Chinese Medicine Resources in Sichuan Province-Key Laboratory Breeding Base of Co-founded by Sichuan Province and MOST,College of Pharmacy,Chengdu University of Traditional Chinese Medicine,Chengdu 611137,China;Southwest University,Chongqing 400715,China;Tiansheng Pharmaceutical Group Co.,Ltd.,Chongqing 400065,China)

机构地区：[1]成都中医药大学药学院中药材标准化教育部重点实验室四川省中药资源系统研究与开发利用重点实验室-省部共建国家重点实验室培育基地,四川成都611137 [2]天圣制药集团股份有限公司,重庆400065 [3]西南大学,重庆400715

出　　处：《中草药》2018年第14期3252-3260,共9页Chinese Traditional and Herbal Drugs

基　　金：重庆市科委应用开发重大项目(cstc2014yykfC10006)

摘　　要：目的制备复方彻清膏微乳,并考察其稳定性。方法通过溶解度实验结合单因素考察绘制伪三元相图,筛选处方组成,再以乳化剂、油相和助乳化剂的质量分数为自变量,以微乳粒径和载药量为响应值,采用Box-Behnken设计-效应面法优化处方,并对其稳定性进行考察。结果复方彻清膏微乳的最优处方为聚氧乙烯氢化蓖麻油(RH40)-聚乙二醇400(PEG400)-肉豆蔻酸异丙酯(IPM)-水(0.33∶0.16∶0.16∶0.35),平均载药量为224.17 mg/mL,平均粒径为56.50 nm,在4℃和25℃避光条件下稳定性良好。结论制备得复方彻清膏微乳外观性状良好,载药量高,粒径小,稳定性较好,可明显增加彻清膏挥发油的溶解度。Objective To optimize the composition of Compound Cheqinggao microemulsion and investigate its stability. Methods Suitable emulsifier, co-emulsifier, and oil phase were selected by solubility method, and the pseudo ternary phase diagram was drawing by water titration. Then, the factors with the mass fraction of emulsifier, co-emulsifier, and oil phase as the independent variables, and the drug loading and particle size as response value, using Box-Behnken design-response surface method to determine the best prescription ratio and investigate its stability. Results The optimal composition of substrate from Compound Cheqinggao microemulsion was as follows： 33% of polyoxyethylene hychogenated castor oil（RH40）, 16% of polyethylene glycol（PGE400）, 16% of Isopropyl palmitate, and 35% of water. Under these conditions, drug loading was 224.17 mg/mL and the particle size was 56.50 nm. Compound Cheqinggao microemulsion has good stability at 4 ℃ and 25 ℃ in dark conditions. Conclusion The prepared microemulsion has good appearance, high drug loading, suitable particle size, and good stability, which could greatly increase the solubility of Compound Cheqinggao volatile oil.

关 键 词：复方彻清膏微乳 藁本内酯 挥发油 伪三元相图 Box-Behnken设计-效应面法 稳定性 

分 类 号：R283.6[医药卫生—中药学]