Study on Microbial Limit Inspection Methods for Alcohol Containing Lini-ment
To establish microbial limit inspection methods of indometacin liniment,which can provide references for drug inspection and control institutions and manufacturers,according to"microbial limit test of non-sterile products:microbial count method,control bacteria test method"in Chinese Pharmacopoeia(2020 edition,Vol.Ⅳ),the recovery rates of 5 test strains,including of Staphylo-coccus aureus,Pseudomonas aeruginosa,Bacillus subtilis,Candida albicans and Aspergillus niger,were measured for validation of the methods for counting of total aerobic bacteria,molds and yeasts,and applicability test of control bacteria Staphylococcus aureus and Pseudomonas aeruginosa was also validated.The membrane-filter procedure was used for the microbial limit inspection methods of indometacin liniment,pH 7.0 sterile sodium chloride peptone buffer as washing liquid,washing volume:100 mL/film,3 times in total,the above method can count total aerobic bacteria,molds and yeasts,and detect control bacteria.Methodology validation indi-cates that the established method can effectively remove the interference of antibacterial components such as alcohols,and provide a re-liable basis for the microbial limit test of indometacin liniment.
AlcoholsIndometacinLinimentMicrobial limitInspection methodMembrane filtrationAntimicrobial activitySuita-bility test
NETL
NSTL
万方数据
