中国药业2016，Vol.25Issue(9)：68-69,70,3.
克霉唑乳膏质量分析及稳定性考察
Quality Analysis and Stability Test of Clotrimazole Cream
马丽 1郭海平 1刘长明 1张磊1
作者信息
- 1. 河北省承德市食品药品检验检测中心，河北 承德 067000
- 折叠
摘要
Abstract
Objective Through the stability test on the drugs' wholesale, retail and especially the storage conditions of family medicine, to provide improvement recommendations, and to assess the quality status and existing problems for clotrimazole, as well as establishing its near infrared qualitative detection model. Methods According to the statutory inspection method in Chinese Pharmacopoeia ( 2010 ver partⅡ) , 55 batches of clotrimazole cream from 9 domestic manufacturing enterprises were methodologically studied. The stability of the samples, which exceeded a temperature of 5 ℃ compared with the prescribed storage conditions were studied. Results Test results showed that 51 batches were qualified and 4 batches were unqualified, with a pass rate of 92. 73%, and the unqualified 4 batches all failed in the item of the diphenyl-( 2-chlorophenyl ) methanol. Stability test results showed that the longer the storage time of the drug at an exerted predetermined storage temperature, the content of the main ingredient clotrimazole decreased, the impurity content in-creased. Conclusion Failing to meet the requirements of storage conditions may affect the intrinsic quality of clotrimazole cream. Thus it is recommended that the drug regulatory departments should strengthen the inspection efforts of storage conditions of the pharmaceuti-cal wholesale and retail departments.关键词
克霉唑乳膏/稳定性考察/药品贮存Key words
clotrimazole cream/stability test/drug storage conditions分类
医药卫生引用本文复制引用
马丽,郭海平,刘长明,张磊..克霉唑乳膏质量分析及稳定性考察[J].中国药业,2016,25(9):68-69,70,3.
