Validation of Microbial Limit Test Method for Compound Fluconazole Cream
In order to establish the microbial limit checking method of compound fluconazole cream,the test was conducted using the 2020 edition of Chinese Veterinary Pharmacopoeia(Ⅰ),Appendix 1105,1106 and 1107.Five kinds of bacteria were selected as test bacteria,and the plate method and membrane filtration method were selected to check the suitability of microbial enumeration method.Staphylococcus aureus and Pseudomonas aeruginosa were used as test bacteria,and the suitability of control bacteria method was examined by medium dilution method and membrane filtration method.The results showed that a 1:10 solution of the test material was prepared by adding 1％polysorbate 80 to the buffer and preheating to 40 ℃,which resulted in a homogeneous dispersion of the test material.Microbial counting method:conventional flat dish method could not eliminate its bacteriostatic activity,the method was not valid,further membrane filtration method was used,the total rinsing volume was 800 mL,when microbial counting was carried out,the bacterial recovery ratio of 5 bacteria were between 0.5 and 2,the method meets the requirements.Control bacteria test:conventional medium dilution method,increase the volume of medium to 800 mL,no corresponding test bacteria were detected in the drug bacteria adding group,membrane filtration method was further used,the total washing volume was 500 mL,corresponding test bacteria were detected in the test solution bacteria adding group and bacteria solution control group.It indicates that compound fluconazole cream has strong bacteriostatic activity,and for microbial counting and control bacteria examination,the test solution needs to be eliminated by membrane filtration to eliminate its bacteriostatic activity.In accordance with the 2020 edition of the Chinese Veterinary Pharmacopoeia,the microbial examination method of this product was successfully established.
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