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期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nifdc.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

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去乙酰毛花苷注射液稳定性研究

Study on stability of deslanoside injection

分类号:
出版年·卷·期(页码):2014,34 (3):0-0
DOI: 10.16155/j.0254-1793.2017.01.01
-----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。

-----英文摘要:---------------------------------------------------------------------------------------

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-temperature processing at 121 ℃,accelerated test,and long-term test.Change trends of main content and impurity content of deslanoside injection were determined by HPLC.The Agilent ZORBAX-SB C18 column was used with gradient 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 declined 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.

-----参考文献:---------------------------------------------------------------------------------------
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