12种市售亚微乳制剂稳定性评价及稳定性考察方法研究  

Study on the Stability Evaluation of 12 Kinds of Submicro Emulsion in Market and the Test Method for the Stability

作　　者：陈伟[1] 周君卓 董武军[2] 王宇[1] 乔涌起[1] 李国辉[1] 

机构地区：[1]国家癌症中心/中国医学科学院肿瘤医院,北京100021 [2]中国医学科学院药物研究所,北京100050

出　　处：《中国药房》2017年第13期1769-1773,共5页China Pharmacy

基　　金：中国癌症基金会"北京希望马拉松"专项基金资助项目(No.LC2014B05)

摘　　要：目的:评价12种市售亚微乳制剂的稳定性,并筛选稳定性考察方法。方法:选取市售的12种亚微乳制剂,分别采用高压灭菌(121℃,30 min)、高速离心(4 000 r/min,15 min)、加速试验[温度(40±2)℃、相对湿度(75±5)%的条件下放置6个月]3种考察方法对亚微乳的pH、粒径等指标进行测定,通过SPSS 22.0软件进行粒径分布方差、卡方检验并评价3种考察方法的相关性。结果:在稳定性考察方面,12种亚微乳p H值在加速试验后有不同程度下降,平均粒径大于300 nm的亚微乳有6种;9种亚微乳的粒径方差分布在0.05~0.15之间,8种亚微乳卡方检验结果分布在1以下;加速试验后4种亚微乳平均粒径变化大于10 nm。在稳定性考察方法方面,高压灭菌与加速试验皮尔森(Pearson)卡方渐进显著性为0.665>0.05,表明两者无相关性(没有显著性),高压灭菌稳定性结果并不能说明加速试验的结果;高速离心与加速试验Pearson卡方渐进显著性为0.004<0.05,表明高速离心稳定性与加速试验结果有显著相关性。结论:市售亚微乳稳定性评价结果均符合要求;高速离心可在一定程度上代替加速试验。OBJECTIVE：To evaluate the stability of 12 kinds of submicro emulsion in market,and screen the test method for the stability. METHODS：12 kinds of submicro emulsion in market were selected,high pressure sterilization （121 ℃,30 min）, high speed centrifugation（4000 r/min,15 min）,accelerated test [placing 6 months under temperature of（40±2）℃,relative hu-midity of （75 ± 5）%] were conducted to investigate the pH,particle size and other indexes,and SPSS 22.0 was used to analyze the distribution variance and chi-square test,and investigate the correlation of 3 evaluation methods. RESULTS：In terms of stabili-ty investigation,the pH value of 12 kinds of submicro emulsion decreased to some extent after accelerated test,average particle size of 6 kinds of submicro emulsion samples were greater than 300 nm,the variance of the particle size distribution of 9 kinds ap-peared in 0.05-0.15,the chi-square test results of 8 kinds distributed below 1. The average particle size of 4 kinds of submicro emul-sions changed more than 10 nm after accelerated test. In terms of stability test method,Pearson chi-square progressive significance of high pressure sterilization and accelerated test was 0.665,which was higher than 0.05,indicating there was no correlation （no significance）,the stability results of high pressure sterilization can not represent the results of accelerated test;that of high speed centrifugation and accelerated test was 0.004,which was lower than 0.05,indicating stability results between high speed centrifuga-tion and accelerated test results were significantly correlated. CONCLUSIONS：The submicro emulsion in market can meet the re-quirements of stability. To a certain extent,high speed centrifugation can replace the acceleration test.

关 键 词：亚微乳 稳定性 高压灭菌 高速离心 加速试验 粒径 

分 类 号：R944.1[医药卫生—药剂学]