常用儿童药品的微生物限度检查方法的建立及评价

杨燕; 李芳; 秦峰; 刘浩; 杨美成

doi:10.19428/j.cnki.sjpm.2022.21345

常用儿童药品的微生物限度检查方法的建立及评价

Establishment and analysis of microbial limit test methods for commonly used pediatric drugs

摘要

摘要:
目的建立44种常用儿童药品的微生物限度检查方法。
方法按《中国药典》2015及2020年版四部通则，采用常规法、中和法或稀释法等分别对44种常用儿童药品的微生物限度检查方法进行适用性试验。
结果需氧菌总数计数：化学口服液体制剂采用1∶10平皿法检查；中药制剂需对样品进行中和处理，其中，中药口服液体制剂采用1∶10平皿法检查，中药颗粒剂采用1∶100平皿法检查。所有样品的霉菌和酵母菌总数计数均可采用1∶10平皿法检查。所建立的检查方法对5种试验菌株的回收比值在0.5~2.0之间，试验组控制菌均可检出，阴性对照组均未检出，符合《中国药典》要求。
结论建立的方法准确可靠，可用于44种常用儿童药品的微生物限度检查及质量控制。

Abstract:
Objective To establish microbial limit test methods for 44 pediatric drugs.
Methods According to the general guidelines in Chinese Pharmacopoeia （2015 and 2020 edition， volume Ⅳ），a suitability test of the methods for 44 drugs was carried out by pour-plate method， neutralization method or dilution method.
Results Total aerobic microbial count： chemical oral liquid samples can be tested by 1∶10 plate method；traditional Chinese medicine need to be neutralized firstly. Then oral liquids could be tested by 1∶10 plate method and 1∶100 plate method was used for granules. Total count of molds and yeasts： all the samples can be tested by the 1∶10 plate method. The recoveries of five test strains were between 0.5 and 2.0. The specified microorganisms were all detected in the test group， while not found in the negative control group.
Conclusion The microbial limit test methods for the 44 pediatric drugs are established and the results are reliable and can be used in the quality control．

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