论文部分内容阅读
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 the stability of stilbene injection. Methods: The stability of desacetylmacrose injection was investigated by long-term test using acid damage, alkali damage, oxidative damage, light damage, sterilization at 121 ℃, accelerated test, respectively. Glycosides in the main drug and related substances in the content of changes. The mobile phase A was acetonitrile-methanol (232:148) as mobile phase A and gradient elution was performed on an Agilent ZORBAX-SB C18 column with a flow rate of 1.0 mL · min-1 and a detection wavelength of 220 nm. Results: The stilbene injection was not stable under the conditions of acid, alkali, oxidation, light and sterilization under the condition of 121 ℃, and all the related substances were obviously increased. Accelerated test was carried out in three batches at the end of 0,1,2,3,6 months The mean value of the drug content determination results were 99%, 97%, 95%, 92%, 88% of the labeled amount, respectively. The mean values of the three drug content determination results of the long-term test at 0,3,6,9,12,18,24 months 99%, 98%, 97%, 96%, 94%, 92%, 89% of the labeled amount. Conclusion: The acetylation of Maohua glycyrrhizin requires strict control of sterilization temperature and time. Shading, sealing and cryogenic conditions should be adopted for storage and reasonable expiration date should be established.