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目的:建立糖肝煎浓缩丸的质量标准。方法:采用薄层色谱法对当归、白术、虎杖、黄连、柴胡、茵陈进行定性鉴别;采用显微鉴别法对茯苓和五味子进行定性鉴别;采用高效液相色谱法对芍药苷和阿魏酸进行含量测定,色谱条件:色谱柱:WondaSil C18(250 mm×4.6 mm,5μm);流动相:乙腈-0.1%磷酸溶液;梯度洗脱;流速:1 mL·min-1;柱温:35℃;检测波长:230nm和316 nm。结果:薄层色谱法可对当归、白术、虎杖、黄连、柴胡、茵陈进行定性鉴别,而且重复性较好;显微鉴别法可对茯苓和五味子进行定性鉴别;在该色谱条件下,芍药苷和阿魏酸分别在0.192 5~3.85μg和0.04~0.80μg范围内呈良好的线性关系,芍药苷和阿魏酸的平均回收率分别为101.5%和99.6%,RSD为1.70%和1.35%(n=6)。结论:该质量标准方法简便可靠,专属性强,重复性好,可有效控制该制剂的质量。
Objective: To establish the quality standard of Tanggan decoction pills. Methods: TLC, Atractylodes macrocephala, Polygonum cuspidatum, Coptis chinensis, Radix Bupleuri, Rhizoma anemarrhena were identified qualitatively. The microscopic identification method was used for the qualitative identification of Poria cocos and Schisandra chinensis. High performance liquid chromatography The chromatographic conditions were as follows: column: Wonda Sil C18 (250 mm × 4.6 mm, 5 μm); mobile phase: acetonitrile-0.1% phosphoric acid solution; gradient elution; ℃; Detection wavelength: 230nm and 316 nm. Results: TLC could be used for the qualitative identification of Angelica sinensis, Atractylodes macrocephala, Polygonum cuspidatum, Coptis chinensis, Radix Bupleuri and Rhizoma Cyperi, and the repeatability was better. The microscopic identification method could be used for the qualitative identification of Poria cocos and Schisandra chinensis. Under the chromatographic conditions, Paeoniflorin and ferulic acid showed a good linear relationship in the range of 0.192 5 ~ 3.85μg and 0.04 ~ 0.80μg, the average recoveries of paeoniflorin and ferulic acid were 101.5% and 99.6%, RSD was 1.70% and 1.35 % (n = 6). Conclusion: The quality standard method is simple, reliable, specific and reproducible, which can effectively control the quality of the preparation.