Study on the Applicability of Microbial Limit Testing Methods for Vacant Gelatin Capsules
Objective:To conduct a study on the applicability of microbial limit testing methods for vacant gelatin capsules,in order to provide reference for pharmaceutical enterprises to formulate quality control acceptance standards for medicinal capsule shells and for capsule production enterprises to establish microbial limit testing methods for vacant gelatin capsules.Method:According to the General Principles 1105 and 1106 of the 2020 edition of the Chinese Pharmacopoeia,applicability tests were conducted on 30 batches of gelatin hollow capsules for counting methods and controlling bacterial testing methods.Result:The total number of aerobic bacteria,mold,and yeast were all measured using the petri dish method.For controlling Escherichia coli,28 batches used the conventional method,2 batches used the culture medium dilution method,and for controlling Salmonella,27 batches used the conventional method and 3 batches used the culture medium dilution method.Two batches of vacant gelatin capsules have exceptionally strong antibacterial effects on bacteria such as Staphylococcus aureus,Escherichia coli,and Salmonella.Conclusion:There are certain differences in the antibacterial effects of gelatin hollow capsules produced by different manufacturers,and further improvement and standardization of the microbial limit testing method and quality and safety control standards for vacant gelatin capsules are needed.
万方数据
维普
