脑精素注射液细菌内毒素检查法的研究
The discussion on the endotoxin inspection method of cerebrolysin injection
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摘要: 目的 建立脑精素注射液的细菌内毒素检查法。方法 根据中国药典2000年版二部收载的细菌内毒素检查法的要求进行实验。结果 将脑精素注射液稀释30倍,以标示灵敏度为0.5EU·mL-1的鲎试剂检查是有效的。结论 鲎试验法取代家兔法对脑精素注射液进行热原检查是可行的。Abstract: OBJECTIVE To establish the inspection method of endotoxin in cerebrolysin injection. METHODS The experiment is implemented according to the request of endotoxin inspection method colledted in China Pharmacopeia(Ⅱ, 2000Ed).RESULTS The experiment showed that the interference elements can be excluded by diluting cerebrolysin injection 30 times, and it is effective that endotoxin can be tested by amebocyte lysate with accuracy of 0.5EU·mL-1.CONCLUSION For daily pyrogon test of cerebrolysin injection,enotoxin inspection method can be used instead of domestic rabbit method.
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Key words:
- Cerebrolysin injection /
- endotoxin experiment /
- interference experiment
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