脉络宁注射液中聚山梨酯80的含量测定与安全性分析

Quantitative analysis and safty assessment of tween 80 in Mailuoning injection

目的：测定了79批脉络宁注射液中聚山梨酯80的含量，并对其安全性作出分析。方法：采用Agilent GF-250柱（250mm×9．4mm，4μm）色谱柱，以20mmol·L^-1醋酸铵溶液-乙腈（90：1）为流动相，流速0．6mL·min^-1；柱温30℃；ELSD漂移管温度110℃；空气流速2．3L·min^-1结果：聚山梨酯80含量在8．0～11．1g·L^-1，均值为9．2g·L^-1（RSD为8．2％，n为79）。结论：测得的数据与本制剂中聚山梨酯80的工艺规定的加入量基本相符，但静脉滴注质量浓度达0．4g·L^-1，参照注射液中聚山梨酯80的滴注浓度不应高于0．1g·L^-1的有关要求，在临床应用时可能存在风险。

OBJECTIVE To evaluate the safety of use of Mailuoning Injection. the reliable and accurate SEC ELSE） method was used to assay Tween 80 in 79 batches of Mailuoning Injection from 23 propvinees. METHODS The chromatographic analysis were carried on a Agilent GF-250 column（250 mm × 9.4 mm,4μm） , the mobile phase consisted of 21） mmol. L^-1 animonium acetate and acetonitrite（90： 10）, and ELSD was used as a detector. The flow was 0. 6 mL-min^-1 ,and the column temperature was set at 30 ℃. The air flow was 2. 3 L·min^-1, and the temperature of drift tube was 110 ℃. RESULTS The results showed that Tween 80 fell in the range of 8.0-11.1 mg.mL^-1 , with average value of 9.2 mg · mL^- 1 （RSD = 8. 2%, n = 79）. CONCLUSION The results basically comply with the required concentration of Tween 80 by the procedure. However, the concentration of intravenous drip reaches to0. 4 mg mL ^-1 in Mailuoning Injection, therefore, it exists potential riskiness in use based on the request that Tween 81） should not exceed 0. 1 mg.mL^-1 in injection when used for intravenous drip.