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

Abstract

ObjectiveTo establish microbial limit test methods for 44 pediatric drugs.MethodsAccording 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.ResultsTotal 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.ConclusionThe microbial limit test methods for the 44 pediatric drugs are established and the results are reliable and can be used in the quality control．

Keywords

• pediatric drug
• microbial limit test
• suitability of method
• traditional chinese medicine preparation
• granule
• oral liquid