Establishment of a sterility test method for Compound Chlorhexidine Acetate spray
WANG Wenxi
Abstract：Objective To establish a sterility testing method for Compound Chlorhexidine Acetate spray that eliminates interference from its active ingredients(chlorhexidine acetate and metronidazole),thereby ensuring result accuracy.Methods According to the requirements of the fourth part of the sterility test method in the 2020 edition of the Pharmacopoeia of the People's Republic of China,the membrane filtration method was adopted.Six standard strains(Staphylococcus aureus,Pseudomonas aeruginosa,Bacillus subtilis,Clostridium sporogenes,Candida albicans,and Aspergillus Niger)were used as control strains,and sterile 0.9％sodium chloride injection was used as the rinsing fluid.The growth status of each strain after rinsing the filter membrane irrigation with different volumes(200,300,and 400 mL)was examined,thereby verifying the suitability of the test method.Results When the total volume of the rinsing fluid was 400 mL,all control strains could grow normally,indicating that this method could effectively eliminate the interference of the antibacterial components in the Compound Chlorhexidine Acetate spray.According to this method,the sterility test results of three different batches of Compound Chlorhexidine Acetate spray all met the regulations.Conclusion The sterility test of Compound Chlorhexidine Acetate spray can be conducted by membrane filtration,and the total volume of the rinsing fluid is 400 mL,to ensure that the antibacterial components and other interfering factors are fully removed,which can guarantee the reliability of the test results.This method is applicable to the quality control of Compound Chlorhexidine Acetate spray.
Keywords：sterility testmethod suitabilitymembrane filtrationChlorhexidine AcetateMetronidazolePolyvinyl Alcoholquality control
Publication Date：2025-11-28
Online Publishing Date：2025-12-11(First online date of this platform, not the publication date of the document)
Pages：5( 102-106 )