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茵胆平肝胶囊的质量标准研究

         

摘要

OBJECTIVE: To develop the quality standard of Yindan pinggan capsule. METHODS: TLC was applied to the identification of Herba Artemisiae Scopariae, Sus scrofa domestica, Fructus Gardeniae, Paeonia lactiflora, Angelica sinensis in Yindan pinggan capsule. In addition, HPLC was used to determine the content of baicalin in Yindan pinggan capsule. RESULTS: The TLC identification of Herba Artemisiae Scopariae, S. scrofa domestica, Fructus Gardeniae, P. lactiflora, A. sinensis was with good resuits, high resolution and without interference of negative sample. Baicalin had good linearity in the range of 0.475~2.390 μg (r=0.999 9) with an average recovery of 100.69% (RSD=0.12% ,n=6). CONCLUSION: The method can be used for quality control of Yindan pinggan capsule.%目的:建立茵胆平肝胶囊的质量标准.方法:采用薄层色谱(TLC)法鉴别茵胆平肝胶囊中的茵陈、猪胆粉、栀子和白芍、当归;采用高效液相色谱法测定制剂中黄芩苷的含量.结果:茵陈、猪胆粉、栀子和白芍、当归的TLC鉴别效果好、专属性强、分离度高,且阴性对照无干扰.黄芩苷进样量在0.478~2.390μg范围内与峰面积积分值呈良好的线性关系(r=0.999 9);平均回收率为100.69%,RSD=0.12%(n=6).结论:所建标准可用于茵胆平肝胶囊的质量控制.

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