橡胶贴膏剂供试液制备和微生物限度检查方法的优化  

Optimization of preparation of test solution and microbial limit test method for rubber paste

作　　者：佘凡 刘刚 伏超 SHE Fan;LIU Gang;FU Chao(Drug Testing Monitoring and Evaluation Center,Yangling Agricultural High-Tech Industrial Demonstration Zone,Shaanxi 712100,China)

机构地区：[1]杨凌示范区药品检验监测评价中心,陕西杨凌712100

出　　处：《中国药品标准》2022年第2期224-228,共5页Drug Standards of China

摘　　要：目的:优化橡胶贴膏剂微生物限度检查方法供试液制备方法。方法:参考《中国药典》2020年版四部1101无菌检查法中膏剂和黏性油剂供试液制备方法和1105非无菌产品微生物限度检查法中油脂类供试品供试液制备方法,探讨利于微生物限度检查方法系统适用性试验,确认供试液制备方法的合理性。结果:无菌十四烷酸异丙酯可完全溶解膏料,用水萃取后,油水两相分层清晰,宜取水相作为供试液进行微生物限度检查。12批次橡胶贴膏剂微生物计数回收比值在0.5~2范围内,控制菌试验组均检出试验菌。结论:橡胶贴膏剂可用十四烷酸异丙酯作为助溶剂制备供试液,该法可以客观反映样品中微生物污染情况,方法可行,结果可靠。Objective:To optimize the microbial limit test method of rubber patch and the preparation method of the test solution.Methods:According to section the preparation of plaster and viscous oil of chapter 1101 test for sterility and section the preparation of oils of chapter 1105 microbiol limit test for non-sterile product in the Chinese Pharmacopoeia 2020 volume IV,the system suitability microbiol limit test was explored and the rationality of the preparation method for the test solution was checked.Results:The paste was completely dissolved by sterile isopropyl tetradecanoate,and oil-water two phases are well separated following extraction with water,therefore the aqueous phase was used as a test solution for microbial limit examination.The microbial count recovery ratio was 0.5-2 for 12 batches of rubber plaster,and the added test bacteria were detected in the control bacteria test group.Conclusion:Rubber paste test solution was prepared by isopropyl tetradecanoate as a cosolvent,which objectively reflected the situation of microbial contamination in samples.The method was feasible and the results were reliable.

关 键 词：橡胶贴膏剂 供试液制备 十四烷酸异丙酯 水相 微生物回收 

分 类 号：R921.2[医药卫生—药学]