文档介绍：硼酸滴耳液微生物限度检查方法学验证
 
   
 
 
 
 
 
 
 
     
 
 
 
 
 
摘要：目的 建立医院制剂硼酸滴耳液的微生物限度检验方法。方法 按《中国药典》2015年版四部微生物限度检查法规定，采用平皿法对云南省保山市人民医院3个批次的硼酸滴耳液进行微生物限度检查方法适用性试验。结果 本研究建立的检查方法对金黄色葡萄球菌、铜绿假单胞菌、枯草芽孢杆菌、白色念珠菌、～2；控制菌试验组、阳性对照组都为阳性，供试品对照组、阴性菌对照组、阴性对照组为阴性，试验结果有效。结论 硼酸滴耳液进行微生物限度检查时，可取供试品1:10,1:100的稀释液，采用平皿法检查需氧菌总数、霉菌和酵母菌总数；控制菌采用常规法。可有效的反映药物中微生物的污染情况。
关键词 :硼酸滴耳液；微生物限度；验证；常规法
Verification of microbial limit test methodology for boric acid ear drops
Abstract: Objective To establish a microbial limit test method for boric acid ear drops from hospital preparations. Methods According to the four microbial limit test methods of Chinese Pharmacopoeia (2015 edition), the applicability of microbial limit test method for 3 batches of boric acid ear drops from Baoshan People's Hospital of Yunnan Province was tested by plate method. Results The recoveries of Staphylococcus aureus, Pseudomonas aeruginosa, Bacillus subtilis, Candida albicans and Aspergillus Niger were -2. The control bacteria test group and the positive control group were positive, while the test product control group, the negative bacteria control group and the negative control group were negative, and the test result was effective. Conclusion When boric acid ear drops were used for microbial limit test, diluents of 1:10 and 1:100 samples were recommended. The total number of aerobic bacteria, molds