心宁缓释片的质量标准研究

Quality Standard for XinNing Sustained Tablets

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2.5-25μg/mL、1.6-16μg/mL、0.88-11μg、0.08-0.8μg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.

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 μg/mL,1.6-16 μg/mL, 0. 88-11 μg, 0. 08-0. 8 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.