清开灵注射液细菌内毒素检查法研究

Bacterial Endotoxin Test on Qingkailing Injection

目的 :建立清开灵注射液的细菌内毒素检查法。方法 :通过预试验和干扰试验确定清开灵注射液的有效稀释浓度和相应的鲎试剂灵敏度。结果 :清开灵注射液经 32倍稀释 ,可用灵敏度为 0 .0 3Eu/ ml的鲎试剂进行细菌内毒素检查。结论 :细菌内毒素检查法适用于清开灵注射液。

Objective: To study the bacterial endotoxin test on Qingkailing Injection. Methods: The valid concentration of Qingkailing Injection and the sensibility of the tachypleus amebocyte lysate were determined by interfering test. Results: Bacterial endotoxin test can be used to detect the endotoxin in 32 times dilute solutions of Qingkailing Injection and the sensibility of the tachypleus amebocyte lysate is 0.03 Eu/ml. Conclusion: Bacterial endotoxin test is applicable to Qingkailing Injection.