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目的:分析基于21种医院外用制剂微生物限度检查方法学验证。方法:按照2010年版本的《中国药典》规定,选取本市21种医院外用制剂完成细菌、霉菌及酵母菌计数方法以及控制菌检查法完成相应的检验工作。结果:在21种医院外用制剂中,有14种外用制剂回收率≤70.00%,控制菌检查结果得到,其中有8种制剂品种试验菌无法检出,需要进行深入的培养基稀释法、薄膜过滤法、离心法以及中和法等方法来完成试验。结论:被检样品一定要完成微生物限度检查方法学验证,这样才可以促使检验结果具有高度的有效性以及准确性。
OBJECTIVE: To analyze the validation of microbial limit tests based on 21 types of hospital external preparations. Methods: According to the 2010 edition of “Chinese Pharmacopoeia”, 21 kinds of hospital external preparations in this Municipality were selected to complete the counting of bacteria, fungi and yeasts and the test of control bacteria to complete the corresponding tests. Results: Among the 21 kinds of topical preparations for external use, 14 kinds of topical preparations had a recovery rate of ≤70.00%. The test results of control bacteria were obtained. Among them, 8 kinds of preparations could not be tested for the test bacteria. In-depth media dilution method and membrane filtration France, centrifugation and neutralization method to complete the test. Conclusion: The test sample must complete the microbial limit test methodological verification, so as to promote the test results with a high degree of validity and accuracy.