阿司匹林缓释片微生物限度检查方法验证

The validation of microbiological test for aspirin sustained-release tablets

目的建立阿司匹林缓释片微生物限度检查法。方法样品用常规法、酸碱中和法、薄膜过滤法三种方法进行微生物限度方法学验证试验。结果样品酸碱碱度经碳酸钠调节至中性,可消除其抑菌作用。结论经碳酸钠调节供试液可消除其抑菌作用。该法较薄膜过滤法简单、可靠,可用于阿司匹林缓释片的微生物限度检查。

Aim A microbiological test method was established for aspirin sustained-release tablets. Methods There kinds of methods were used as the normal regulation method, the sodium carbonate neutralization method and the membrane filtration method for validation of microbiological test. Results The results showed that when the alkalinityacidity of the sample was regulated to the neutrality by the sodium carbonate, the bacteriostasis was vanished. Conclusion The method is accurate and reliable, it can be used for the microbiological test for aspirin sustained-release tablets.