Features of Microbiological Analysis of the Quality of Vaginal Medicines
摘要
The paper presents materials related to features of the analysis of the microbiological purity of some vaginal drugs. Possible pharmacopoeial requirements for the microbiological quality of various types of vaginal dosage forms and standards for the permissible content of microorganisms presented in regulations are analyzed. The applicability of the direct seeding technique on nutrient media to obtain a reliable result of the quantitative determination of microorganisms, including mold and yeast fungi, is proven using suppositories and vaginal therapeutic systems in the form of rings as examples. The characteristics of accuracy (growth coefficient, Kg = 84 – 115%) and intralaboratory precision (CV = 1.1 – 15.0%) were calculated. The obtained values were within the required limits. The absence of specificity of the method was shown for a specific working range established according to the recommendations of pharmacopoeias: up to 250 CFU/dish for bacteria and up to 50 CFU/dish for yeast and mold fungi. The obtained values of the characteristics for the statistical parameters of accuracy and precision for all studied microorganisms proved the ability to isolate bacteria, yeast, and mold fungi from both a unit of vaginal drugs and 1 g of samples. Approaches to standardization of the microbiological quality of probiotic drugs for vaginal use were studied. Promising areas of development associated with harmonization of international pharmacopoeias were discussed.