目的:建立26种医院制剂的微生物限度检查方法。方法:按2005年版《中国药典》二部附录微生物限度检查法中细菌、霉菌及酵母菌计数方法和控制菌检查法进行验证。结果:采用常规法试验26种医院制剂中有19种对不同的试验菌的回收率低于70%,控制菌检查中有10种制剂试验菌不能检出,需采用培养基稀释法、薄膜过滤法、离心法、中和法及联用这些方法试验,使试验菌回收率符合要求。结论:被检样品必须进行微生物限度检查方法验证,才能保证检验结果的准确性。 Objective: To establish a method of microbial limit test for 26 kinds of hospital preparations. Methods: Bacteria, molds and yeasts count method and control bacteria test method were verified according to the method of Microbial Limit Test in the appendix of “Chinese Pharmacopoeia” of 2005 edition. Results: Nineteen of the 26 hospital preparations were routinely tested for less than 70% recovery of different test organisms, 10 of which were not detectable in the control bacteria test. Media dilution, membrane filtration France, centrifugation, neutralization and combined with these methods test, the test bacteria recovery to meet the requirements. Conclusion: The sample must be tested for microbial limit test method validation, in order to ensure the accuracy of test results.