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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。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2．5 EU·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。
Objective: To determine the reasonable limit of endotoxin in Shuanghuanglian injection and establish a rapid and accurate bacterial endotoxin test. METHODS: The limit of endotoxin of Shuanghuanglian Injection was determined according to the total limit of endotoxin of the combined drug solution; the Shuanghuanglian injection produced by the same manufacturer and different manufacturers was used for the interference test with the limulus reagents produced by different manufacturers, and the Shuanghuanglian injection was thoroughly investigated. The interference of the liquid on the bacterial endotoxin test to determine its maximum non-interfering concentration and optimal test concentration. Results:According to the actual clinical application, the limit of endotoxin of Shuanghuanglian injection was set to 2.5 EU·mL-1. It was proved that the maximum non-interfering concentration was 20 times, and the optimal concentration was 40 times. Conclusion: The bacterial endotoxin test results of Shuanghuanglian Injection were 2.5 EU·ml-1 for the safety and reliability of bacterial endotoxin test.