雌三醇栓微生物限度检查方法的验证

The Validated Method for the Microbionlogical Examination of Oestriol Suppository

目的确认雌三醇栓的检验条件和方法,保证微生物限度检查方法的科学性和检验结果准确性。方法采用中国药典2005年版二部附录微生物限度检查法项下方法的验证。结果确定了雌三醇栓微生物限度检查的操作方法。结论为雌三醇栓的微生物限度检查提供了依据,对药品的生产及检验部门有实用的价值。

OBJECTIVE The best condition and operation method was determined for the microbiological examination of Oestriol Suppository. METHODS Complies with the test for microbiological examination （CP2005Volume Ⅱ , Appendix Ⅺ ）. RESULTS the best condition and operation method for the microbiological examination of Oestriol Suppository were determined. CONCLUSION The results were credible and accurate, The method has useful value to the manufacturer and identifier of drugs.