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目的对注射用氢化可的松琥珀酸钠细菌内毒素的检查方法进行验证。方法采用《中国药典》2010年版二部附录ⅪE的凝胶法。结果注射用氢化可的松琥珀酸钠在稀释至浓度为0.83mg/ml时对试验无干扰。结论注射用氢化可的松琥珀酸钠在稀释至浓度为0.83mg/ml时,采用凝胶法可行,可用于此品种的细菌内毒素检查。
Objective To verify the method of examining bacterial endotoxin of hydrocortisone sodium succinate for injection. Methods using “Chinese Pharmacopoeia” 2010 edition two Appendix XIE gel method. Results The sodium hydrocortisone succinate for injection did not interfere with the assay when diluted to a concentration of 0.83 mg / ml. Conclusion The hydrocortisone sodium succinate for injection is feasible to be gelled when diluted to a concentration of 0.83 mg / ml and can be used for the bacterial endotoxin test of this variety.