气管炎丸的质量标准研究

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目的完善气管炎丸的质量标准,提高气管炎丸的可控性。方法采用薄层色谱法对气管炎丸中五味子、青黛进行了定性鉴别;采用高效液相色谱法测定气管炎丸中黄芩药材中黄芩苷的含量,色谱柱采用zorbax SB-C18(4.6mm×150mm,5μm),流动相为甲醇-0.0 4%磷酸(40∶60),流量0.8 m L·min-1,检测波长280 nm。结果薄层鉴别供试品图谱中的色谱斑点清晰,且阴性样品无干扰。黄芩苷在0.026272μg~0.6568μg范围内有良好的线性关系(r=0.9999),平均加样回收率为97.90%(n=6)。结论所建立薄层鉴别及含量检测指标合理科学,所建立的方法操作简便,具有实用性,完善了气管炎丸的质量标准,提高了产品的可控性。 Objective To improve the quality standard of tracheitis pill and improve the controllability of tracheitis pill. Methods TLC method was used for the qualitative identification of Schisandra chinensis and Indigo naturalis. The content of baicalin in Radix Scutellariae was determined by high performance liquid chromatography (HPLC). The chromatographic column was zorbax SB-C18 (4.6mm × 150mm , 5μm). The mobile phase consisted of methanol -0.0 4% phosphoric acid (40:60), the flow rate was 0.8 m L · min-1 and the detection wavelength was 280 nm. Results TLC identification of the chromatogram of the test sample clear, and negative samples without interference. Baicalin has a good linearity (r = 0.9999) in the range of 0.026272μg ~ 0.6568μg with an average recovery of 97.90% (n = 6). Conclusion The established TLC identification and content detection index are reasonable and scientific. The established method is simple and practical, has improved the quality standard of tracheitis pill and improved the controllability of the product.
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