心宁缓释片的质量标准研究

Quality Standard for XinNing Sustained Tablets

  • 摘要: 目的:建立心宁缓释片的质量标准控制方法.方法:采用TLC对丹参提取物、B草SFE-CO2萃取物进行定性鉴别, 采用紫外分光光度法对制剂中总酚酸与总生物碱进行含量测定,采用HPLC法测定制剂中丹酚酸B、HJJ的含量及其释放度.结果:薄层色谱图斑点清晰,具有专属性. 总丹酚酸、总生物碱、丹酚酸B、HJJ分别在2.5~25.0 μg/mL、1.6~16.0 μg/mL、0.88~11.00 μg、0.08~0.80 μg范围内线性关系良好,相关系数R分别为0.999 9、0.999 8、0.999 5、0.999 9,其平均回收率分别为98.26%、99.34%、97.34%、97.86%,RSD分别为2.1%、0.58%、0.95%、1.53%,累计释放率在2 h时约为25%、8 h时约75%、12 h时达94%以上.结论: 该方法能准确可靠地进行定性、定量检测,能有效地控制心宁缓释片的质量.

     

    Abstract: Object: to establish the quality standard for XinNing sustained tablets. Methods: the extracts of salvia miltiorrhiza and SFE of B herb were identified by TLC. The salvianolic acids and total alkaloids in preparation were determined by Spectrophotometry. The contents of salvianolic acid B and HJJ were determined by HPLC. So and its releasing degrees. Results: TLC method was specific, The calibration curves showed good linearity over the range of 2.5~25.0 μg/mL,1.6~16.0 μg/mL, 0.88~11.00 μg, 0.08~0.80 μg for salvianolic acids, total alkaloids, salvianolic acid B and HJJ, respectively. And its coefficient correlation were 0.999 9、0.999 8、0.999 5、0.999 9 respectively. The recovery was 98.26%、 99.34%、97.34%、97.86% for salvianolic acids, total alkaloids, salvianolic acid B and HJJ. And its RSD was 2.1、0.58、0.95、1.53 respectively. The accumulative release rates was 25% at two hours,75% at eight hours,94% at twelve hours. This standard can be used for the quality control of XinNing sustained tablets.

     

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