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目的:建立保心宁分散片的薄层鉴别与含量测定方法。方法:用薄层色谱法鉴别三七、当归、枳壳,用高效液相色谱法测定本制剂中丹参酮ⅡA的含量。结果:薄层鉴别的色谱斑点清晰,阴性对照无干扰;含量测定丹参酮ⅡA进样量在0.042～0.672μg范围内与峰面积呈良好的线性关系(r=0.9999),平均回收率为100.50%,RSD为1.56%(n=6)。结论:本方法准确、简便,灵敏度高,可作为该制剂质量控制。
Objective: To establish a thin layer identification and content determination method for Baoxinning dispersible tablets. Methods: TLC was used to identify Panax notoginseng, Angelica sinensis and Citrus aurantium. The content of tanshinone IIA in the preparation was determined by HPLC. RESULTS: The chromatographic spots identified by the thin layer were clear, and the negative control had no interference. The content of tanshinone IIA in the range of 0.042-0.672 μg showed a good linear relationship with the peak area (r=0.9999). The average recovery was 100.50%. The RSD was 1.56% (n=6). Conclusion: The method is accurate, simple, high sensitivity and can be used as the quality control of the preparation.