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目的建立肝血管瘤活血胶囊的质量标准。方法采用TLC法对制剂中的黄芩、牡丹皮、栀子和延胡索4味中药进行鉴别;采用HPLC法对制剂中的主要成分黄芩苷进行含量测定,色谱柱为Agilent Eclipse XDB-C18(4.6 mm×150 mm,5μm),流动相:甲醇-2%磷酸水溶液(47∶53);检测波长:280 nm。结果在TLC中可清晰的观察到黄芩、牡丹皮、栀子和延胡索乙素的斑点,方法具有很强的专属性;所建立的含量测定方法,黄芩苷在1.012~20.24μg·ml-1范围内线性关系良好(r=0.9999),平均回收率为99.91%(n=6),RSD为1.40%,该方法简便、快捷、结果准确。结论本文建立的方法可实现肝血管瘤活血胶囊准确的定性鉴别和精确的定量检测,可为肝血管瘤活血胶囊的质量标准研究提供较为充分的试验依据。
Objective To establish the quality standard of Hepatic Hemangioma Huoxue Capsule. Methods TLC, HPLC method was used to determine the content of baicalin in Radix Scutellariae, Paeonia Suffruticus, Gardenia jasminoides and Rhizoma Corydalis. The content of baicalin in the preparation was determined by Agilent Eclipse XDB-C18 (4.6 mm × 150 mm, 5μm), mobile phase: methanol-2% phosphoric acid solution (47:53); detection wavelength: 280 nm. Results The spots of Scutellaria baicalensis, Paeonia suffruticosa, Gardenia jasminoides and Tetrahydropalmatine were clearly observed in TLC, and the method was highly specific. The determination method of baicalin in the range of 1.012-20.24 μg · ml-1 (R = 0.9999). The average recovery was 99.91% (n = 6) and the RSD was 1.40%. The method was simple, rapid and accurate. Conclusion The method established in this paper can achieve the accurate qualitative identification and accurate quantitative detection of Hemangioma Huoxue Capsule, which can provide a more adequate experimental basis for the study of the quality standard of Hemangangmang Huoxue Capsule.