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目的:研究并建立益髓通经缓释颗粒的质量控制方法。方法:采用薄层色谱法(TLC)对处方中的鹿茸和甘草进行定性鉴别;采用高效液相色谱法(HPLC)对益髓通经缓释颗粒中的马钱子碱和士的宁进行含量测定。结果:鹿茸和甘草的薄层鉴别斑点清晰,阴性无干扰;马钱子碱在0.007 284～0.182 100 mg.mL-1范围内线性关系良好(r=0.999 9),平均回收率为101.05%,RSD为1.50%;士的宁在0.007 44～0.186 00 mg.mL-1范围内线性关系良好(r=0.999 6),平均回收率为100.87%,RSD为1.25%。结论:所建立的分析方法简便可行、重复性好,结果稳定、准确,可用于该制剂的质量控制。
Objective: To study and establish the quality control method of Yisutongjing sustained-release granules. Methods: TLC and TLC were used to qualitatively identify the velvet and licorice in the prescription. The contents of strychnine and strychnine in Yizhitongjing sustained release granules were determined by high performance liquid chromatography (HPLC) Determination. Results: The spots of pilose antler and licorice were clear and negative without any interference. The linear relationship of strychnine in the range of 0.007 284 ~ 0.182 100 mg.mL-1 was good (r = 0.999 9), the average recovery was 101.05% RSD was 1.50%. The calibration curve was linear over the range of 0.00744-0.1860 mg.mL-1 (r = 0.999 6) with an average recovery of 100.87% and a RSD of 1.25%. Conclusion: The established analytical method is simple and feasible, reproducible, the results are stable and accurate, and can be used for the quality control of the preparation.