利福平注射液生物安全性检查标准研究

Study on the Biological Safety Standards for Rifampicin Injection

摘要: 目的在利福平注射液现行国家标准的基础上对其生物安全性检查标准提高研究。方法按中国药典2010年版二部有关附录要求对利福平注射液的异常毒性、细菌内毒素、降压物质检查法进行研究。结果建立了异常毒性检查，将热原检查法改为细菌内毒素检查法。结论利福平注射液可以新增异常毒性检查，建立细菌内毒素检查，不能建立降压物质检查。

Abstract: OBJECTIVE To improve the biological safety standards for rifampicin injection base on the national standard. METHODS Study on the abnormal toxicity test, bacterial endotoxins test and hypotensive test of rifampicin injection by Ch.P(2010)Vol II. RESULTS Established the standard of toxicity test and bacterial endotoxin test to replace the pyrogen test. CONCLUSION Toxicity and bacterial endotoxin test can be added as new standards for rifampicin injection. While hypotensive test standard could not be established.