Materials related to features of microbiological analysis of the purity of soft dosage forms are presented. Possible requirements for microbiological quality parameters of various soft dosage forms are analyzed. The applicability of a direct inoculation technique to obtain reliable quantitative determinations of microorganisms is proven using gel, ointment, and suppositories as examples. The accuracy (K_gr 75 – 107%) and intralaboratory precision (CV 2 – 6%) are calculated and fall within the required limits. The specificity of the method is considered for a particular working range established according to recommendations of the RF State Pharmacopoeia, i.e., up to 250 CFU/dish for bacteria and up to 50 CFU/dish for yeasts and molds. Features of microbiological analysis of the quality of patches and transdermal therapeutic systems are studied. The possibilities and limitations of a membrane filtration technique are shown using 83 series of 18 items meeting regulatory requirements as examples.

介绍了与软剂型纯度的微生物分析特征相关的材料。分析了各种软剂型微生物质量参数的可能要求。使用凝胶、软膏和栓剂作为例子证明了直接接种技术在获得可靠的微生物定量测定方面的适用性。精度 ( K _gr75 – 107%) 和实验室内精密度 (CV 2 – 6%) 经计算并落在要求的限度内。根据 RF 州药典的建议建立的特定工作范围考虑了该方法的特异性，即细菌最高为 250 CFU/培养皿，酵母和霉菌最高为 50 CFU/培养皿。研究了贴剂和透皮治疗系统质量的微生物分析特征。以符合法规要求的 83 个系列 18 个项目为例，展示了膜过滤技术的可能性和局限性。