双黄连注射液细菌内毒素检查及其限值的确定

 目的确定合理的双黄连注射液内毒素限值，建立快速准确的细菌内毒素检查法， 以替代热原检查，提高内毒素的检出率，避免临床热原反应的发生。方法根据联合药液的内毒素总限量确定双黄连注射液的内毒素限值；利用不同厂家生产的鲎试剂与同厂家和不同厂家生产的双黄连注射液进行干扰试验，全面考察双黄连注射液对细菌内毒素检查的干扰作用，以确定其最大不干扰浓度及最佳试验浓度。结果根据临床实际应用情况，将双黄连注射液的内毒素限值定为2.5Eu·mL^-1较为合适，试验证明最大不干扰浓度为20倍，最佳试验浓度为40倍。结论 双黄连注射液内毒素限值按2.5 Eu·mL^-1进行细菌内毒素检查结果安全可靠，可以替代热原检查。

A rapid assay of bacterial endotoxin in Shuanghuanglian injection

OBJECTIVE To set up a reasonable limit of bacterial endotoxin for Shuanghuanglian injection and establish a rapid and accurate method for examining bacterial endotoxin instead of pyrogen examination. METHODS The total limit of the bacterial endotoxin in the combined medicines was used as the limit of the bacterial endotoxin for Shuanghuanglian injection.The interference test was conducted by using the reagent from the same and different factories in order to establish the maximum noninterference concentration and the best testing concentration. RESULTS The most suitable limit of bacterial endotoxin in Shuanghuanglian injection was 2.5 Eu·mL^-1.It was proved that the maximum noninterference concentration was 20 times diluted liquid and the best testing concentration was 40 times diluted liquid.CONCLUSION This method for bacterial endotoxin was accurate and reliable and can replace the pyrogen test.