羟氯扎胺阿苯达唑复方混悬液微生物限度检查方法的研究

Study of microbial limit inspection method for oxyclozanide-albendazole compound suspension

建立并验证羟氯扎胺阿苯达唑复方混悬液的微生物限度检查方法和控制菌检查方法。参考2015年版《中华人民共和国兽药典》四部通则进行微生物限度检查方法适用性试验,分别考察采用常规法、中和法以及联合稀释法对消除羟氯扎胺阿苯达唑复方混悬液中抑菌成分的抑菌效果,比较不同方法对试验菌株的回收率。结果发现中和法联合稀释法可以较好地消除羟氯扎胺阿苯达唑复方混悬液中的抑菌活性,最终选择采用中和法联合稀释法对本品进行需氧菌总数、霉菌及酵母菌总数检测,各试验菌株的回收率均在0.5%~2.0%之间,符合《中华人民共和国药典》规定;采用中和法联合增菌常规法进行控制菌检查,阳性对照组中菌落生长良好,阴性试验组中均无细菌生长,符合《中华人民共和国药典》规定。说明所建立的微生物限度检查方法(中和法联合稀释法)准确可行,适用于羟氯扎胺阿苯达唑复方混悬液微生物限度检查。

To establish and validate a microbiological limit test method and a control bacteria test method for oxyclozanide-albendazole compound suspension. Referring to the four general rules of the 2015 edition of the Veterinary Pharmacopoeia of the People’s Republic of China for the applicability test of microbial limit inspection methods,the effects of conventional,neutralization and co-dilution methods on the elimination of the inhibitory components of oxyclozanide-albendazole compound suspension were investigated respectively,and the recovery rates of the test strains by the different methods were compared. The results showed that the neutralization method combined with the dilution method could better eliminate the antibacterial activity in the oxyclozanide-albendazole compound suspension. The final choice of the total aerobic bacteria,mold and yeast detection by the neutralization method combined with dilution method,the recovery rate of each test strain was between 0.5% and 2.0%,in line with the pharmacopoeia regulations. The control bacteria were examined by the neutralization method combined with the bacteriophage enrichment routine method,and the colonies grew well in the positive control group,and no bacteria grew in the negative test group,in accordance with the pharmacopoeia. The established microbiological limit check method(neutralization method combined with dilution method) was accurate,feasible and applicable to the microbiological limit check of oxyclozanide-albendazole compound suspension.