盐酸美沙酮口服溶液微生物限度检查的方法学验证研究

Validation method used for microbial limit test of methadone hydrochloride oral solution

目的建立盐酸美沙酮口服溶液的微生物限度检验方法。方法按中国药典2005年版规定,分别采用常规法、培养基稀释法对样品进行微生物限度检查。根据5株阳性对照菌的回收率结果进行其方法学验证试验研究。结果大肠埃希菌、金黄色葡萄球菌、黑曲霉、白色念珠菌采用常规法回收率为74%以上;枯草芽孢杆菌采用培养基稀释法回收率为81%以上;控制菌(大肠埃希菌)采用常规法可检出。结论经验证,盐酸美沙酮口服溶液微生物限度采用常规法检查霉菌及酵母菌、控制菌,培养基稀释法检查细菌;方法有效可行。

OBJECTIVE To set up a method for determining microbial limits in methadone hydrochloride Oral Solution. METHODS According to the Chinese Pharmacopoeia 2005 edition, the routine and culture diluting method had different percentage recovery with 5 control trains. RESULTS The recoveries were over 74% when routine test method was used with eseheriehia eoli, staphylococcus aureus, candida albieans and aspergillus niger. The recoveries were over 81% when culture diluting method was used with bacillus suhtilis. Routine test method can be test for control baeterias （escherichia coli）.CONCLUSION With conventional method, molds and soccharmyces and controled bacteria can be determined in methadone hydrochloride Oral Solution, With diluted culture method, the amount of baeteria can bedetermined, also.