丹香冠心注射液的细菌内毒素检查法的建立及探讨

目的建立丹香冠心注射液的细菌内毒素检查法,并对方法进行探讨。方法利用同一厂家生产的不同批号的丹香冠心注射液和鲎试剂通过预试验和干扰试验确定丹香冠心注射液的有效稀释浓度和相应的鲎试剂灵敏度,并确定内毒素检查限值。结果丹香冠心注射液的最大不干扰浓度为稀释75倍,最佳试验浓度为稀释75倍。丹香冠心注射液内毒素限值为18.75 EU.mL-1。结论细菌内毒素检查法适用于丹香冠心注射液,该方法安全可靠,无干扰。

Establishment and approach on the bacterial endotoxin test method for Danxiang Guanxin Injection

Objective To establish a bacterial endotoxin test method for Danxiang Guanxin Injection and discuss the method. Methods The available dilute concentration of Danxiang Guanxin Injection and corresponding TAL sensitivity were determined by preliminary test and interference test with different batch numbers of Danxiang Guanxin Injection from same producers and TAL,and the value of endotoxin test limit was determined. Results The maximum non - interference concentration of Danxiang Guanxin Injection and the best test concentration were diluted 75 - fold. The value of endotoxin test limit for Danxiang Guanxin Injection was 18.75 EU. mL-1. Conclusion The bacterial endotoxin test method was suitable for Danxiang Guanxin Injection and this method was safe,reliable and non -interference.