|
|||||
|
|
| 3种滴耳液微生物限度检查法的验证 | |
| 引用本文： | 胡明珊,孙国祥. 3种滴耳液微生物限度检查法的验证[J]. 中南药学, 2013, 0(12): 928-931 |
| 作者姓名： | 胡明珊 孙国祥 |
| 作者单位： | [1]中国医科大学附属第一医院药学部,沈阳110001 [2]沈阳药科大学药学院,沈阳110016 |
| 摘 要： | 目的 建立3种滴耳液的微生物限度检查方法。方法 按2010年版中国药典二部附录微生物限度检查法中细菌、霉菌及酵母菌计数方法和控制菌检查法进行验证。结果 常规法测定碳酸氢钠滴耳液和硼酸滴耳液的回收率〉70%;采用培养基稀释法可消除氯霉素氢化可的松滴耳液的抑菌活性,使其回收率符合要求。结论 建立了3种滴耳液的微生物限度检查方法,可有效控制其质量。 |
| 关 键 词： | 微生物限度 方法验证 碳酸氢钠滴耳液 硼酸滴耳液 氯霉素氢化可的松滴耳液 |
Validation of microbial limit tests for 3 ear drops |
|
| HU Yue-shan,SUN Guo-xiang. Validation of microbial limit tests for 3 ear drops[J]. Central South Pharmacy, 2013, 0(12): 928-931 | |
| Authors: | HU Yue-shan SUN Guo-xiang |
| Affiliation: | 1. Pharmacy Department, First Hospital of China Medical University, Shenyang 110001; 2. College of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016) |
| Abstract: | Objective To establish the microbial limit tests for 3 ear drops with antibacterial ingredients. Methods Common methods in Chinese Pharmacopoeia （edition 2010） were used to cultivate media dilution, with recovery rate of the bacteria in the comparison experiment. Results The recovery rates of 5 representative bacteria in the sodium bicarbonate ear drops and boric acid ear drops determined by plate count method were more than 70%. Culture medium-diluting methods eliminated the antiblastic effect of chloramphenicol and hydrocortisone ear drops. Conclusion The microbial limit tests for the quality control of 3 ear drops have been established. |
| Keywords: | microbial limit method validation sodium bicarbonate ear drop boric acid ear drop chloramphenicol and hy-drocortisone ear drop |
| 本文献已被 维普 等数据库收录！ | |