去乙酰毛花苷注射液稳定性研究  

Study on stability of deslanoside injection

作　　者：李舸远[1] 陈东亚[2] 陈民辉[1] 

机构地区：[1]江苏省食品药品检验所,南京210008 [2]江苏省疾病预防控制中心,南京210009

出　　处：《药物分析杂志》2014年第3期453-456,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:研究去乙酰毛花苷注射液的稳定性。方法:分别采用酸破坏、碱破坏、氧化破坏、光照破坏、121℃灭菌条件破坏、加速试验、长期试验对去乙酰毛花苷注射液的稳定性进行考察,用HPLC法测定去乙酰毛花苷注射液中主药及有关物质的含量变化。采用Agilent ZORBAX-SB C18色谱柱,乙腈-甲醇(232∶148)为流动相A,水为流动相B,进行梯度洗脱,流速为1.0 mL·min-1,检测波长为220 nm。结果:去乙酰毛花苷注射液在酸、碱、氧化、光照、121℃灭菌条件破坏下均不稳定,有关物质均明显增加;加速试验0、1、2、3、6个月末3批药品含量测定结果均值分别为标示量的99%、97%、95%、92%、88%,长期试验0、3、6、9、12、18、24个月末3批药品含量测定结果均值分别为标示量的99%、98%、97%、96%、94%、92%、89%。结论:去乙酰毛花苷注射液需要严格控制灭菌温度与时间,贮藏宜采用遮光、密封、低温的条件,并制订合理的有效期。Objective： To study stability of deslanoside injection. Methods： The stability of deslanoside injection was investigated through acid destruction, alkaline destruction, oxidative destruction, light destruction, high - temper- ature processing at 121 ℃ ,accelerated test,and long -term test. Change trends of main content and impurity con- tent of deslanoside injection were determined by HPLC. The Agilent ZORBAX - SB C18 column was used with gradi- ent elution, taking acetonitrile -methanol （232：148 ） as mobile phase A and water as mobile phase B. The flow rate was 1.0 mL · min^-1. The wavelength of detector was 220 nm. Results： Deslanoside injection was unstable under conditions of acid destruction, alkaline destruction, oxidative destruction, and light destruction, high - temperature processing at 121 ℃ ,the content of its impurities obviously increased under all of these conditions. In accelerated test, after being stored for 0,1,2,3, and 6 months, the average main content of 3 batches of deslanoside injection de- clined to 99% ,97% ,95% ,92% ,88%. In long -term test, after being stored for 0,3,6,9,12,18,24 months, the average main content of 3 batches of deslanoside injection declined to 99%,98% ,97%,96% ,94%,92%, 89%. Conclusion： Sterilization temperature and time should be well controlled for deslanoside injection which should be tightly closed and kept out of light at a low temperature. Besides, rational expiration date should be specified for deslanoside injection.

关 键 词：去乙酰毛花苷注射液 有关物质 稳定性研究 加速试验 长期试验 破坏试验 有效期评价 HPLC高效液相色谱 

分 类 号：R917[医药卫生—药物分析学]