药品微生物限度检查预实验及方法验证的探讨

Validate Test for Determination Methods of Microbacteria Limit

目的:选择正确的检查方法,提高药物的微生物检出率,保证检验结果的正确性和可信性。方法:采用薄膜过滤法贴膜法和药典规定的常规法、培养基稀释法、沉淀离心法对药物进行回收率、增殖值实验。结果:扑热息痛片、阿莫西林胶囊、头孢氨苄片、牛黄解毒片常规法回收率均在75％以下且增殖值差异大于1/5,薄膜过滤法回收率均高于80％,增殖值差异小于1/5。结论:被检样品必须使用回收率或增殖值进行预实验和方法的验证,才可保证检验结果的正确性。

Choose correct determination method to improve the detectable rate of Antibacterials polluted microbac-teria,assure the creditability. Method: Use sticked filter membrane method and general method and culture medium diluted method and deposit centrifugal method to do the test for microbacteria limit determination. Result:The recovery rates of the general method is all under 75% and the sticked filter membrane method is above 80%. The multip lication ralue difference of general method is above 1/5 and slicked filter method is under 1/5. Conclusion recovery rate and multipicalion value must be used to do the advace test and method validation for Sample in order to assure the Creditability nesult of test.