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目的:建立复方苯佐卡因凝胶的微生物限度检查方法。方法:照中国药典2015年版四部通则,分别采用常规法、中和法、中和法加稀释法进行方法适应性试验。通过比较试验菌回收比值,选择采用中和法加稀释法对本品进行需氧菌总数、霉菌及酵母菌总数检测,采用中和法进行控制菌检查,中和剂为聚山梨酯80和卵磷脂。结果:中和法加稀释法可消除药物抑菌作用,微生物计数试验中各试验菌的回收比值均在0.5~2.0之间,符合药典规定,控制菌检查中阳性对照试验分别能检出大肠埃希菌、铜绿假单胞菌和金黄色葡萄球菌,阴性试验均未检出。结论:方法可用于复方苯佐卡因凝胶的微生物限度检查。
Objective: To establish a microbial limit test method of compound benzocaine gel. Methods: According to the Chinese Pharmacopoeia 2015 edition of the four General Rules, respectively, by conventional methods, neutralization method and the method of adding dilution method adaptability test. By comparing the recovery ratio of test bacteria, the choice of neutralization plus dilution method for the total aerobic count of this product, mold and yeast detection, using neutralization method for control bacteria check, neutralizing agent polysorbate 80 and eggs Phospholipid. Results: Neutralization method and dilution method can eliminate the bacteriostatic effect of the drugs. The recovery ratio of each test microorganism in the microbial count test is between 0.5 and 2.0, which is in accordance with Pharmacopoeia. The positive control test in the control bacterium can detect the large intestine Bacillus coli, Pseudomonas aeruginosa and Staphylococcus aureus, negative tests were not detected. Conclusion: The method can be used for the microbial limit test of compound benzocaine gel.