丁酸氯维地平细菌内毒素检查法质量标准研究

目的建立丁酸氯维地平细菌内毒素检查法质量标准。方法按《中国药典》2010年版(二部)附录方法及丁酸氯维地平注射液临床使用剂量,计算本品细菌内毒素限值。分别采用凝胶法研究80%乙醇溶解并采用BET水稀释过程对内毒素标准品的影响,以及丁酸氯维地平细菌内毒素干扰试验。结果以内毒素检查用水复溶内毒素标准品,制成含乙醇80%的内毒素溶液,并稀释至含乙醇约2.8%,不干扰内毒素与鲎试剂的反应。以80%乙醇溶解供试品,内毒素检查用水稀释至0.035 7 mg·mL-1浓度时对试验无干扰作用。结论本品可采用凝胶法进行细菌内毒素检查,建立了本品细菌内毒素检查法质量标准。

Quality specification study of bacterial endotoxin test in clevidipine butyrate

Objective To establish the criterion for bacterial endotoxins test of clevidipine butyrate. Methods The limit for bacterial endotoxins in this product was calculated according to CP2010 and clinical dosage of clevidipine butyrate for injection. The influence to endotoxin standard substance was studied when dissolved by eighty percent alcohol and dilu- ted with BET water with gel method,and bacterial endotoxins interference test of clevidipine butyrate was carried out. Re- sults Redissolved standard endotoxins by bacterial endotoxins examined water, obtained a endotoxins solution contained 80% alcohol. Then diluted above solution into containing 2.8% alcohol, there was no interference on the reaction of endo- toxin with TAL. There was no interference in test when dissolved cleyidipine butyrate by 80% alcohol, and diluted to 0.035 7 mg . mL -1 by BET water. Conclusion The gel method was suitable for bacterial endotoxin test of elevidipine butyrate, the criterion for bacterial endotoxins test of this product was established.