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目的:制定龙黄降压胶囊质量标准。方法:采用薄层色谱法(TLC)对龙胆和黄芩进行定性鉴别;以高效液相色谱法(HPLC)对君药龙胆、白芍中的龙胆苦苷和芍药苷、臣药黄芩和地黄中的黄芩苷和毛蕊花糖苷进行含量测定,色谱柱为Waters Sunfire C18(250 mm×4.6 mm,5μm)柱;流动相(龙胆苦苷和芍药苷):乙腈-0.1%磷酸(9∶91);流动相(黄芩苷和毛蕊花糖苷):乙腈-0.1%磷酸水溶液进行梯度洗脱,0~30 min(16∶84),30~50 min(21∶79);流速:1.0 m L·min~(-1);柱温:30℃;检测波长:270 nm(龙胆苦苷),230 nm(芍药苷),280 nm(黄芩苷),334 nm(毛蕊花糖苷)。结果:龙黄降压胶囊中龙胆、黄芩的薄层鉴别色谱斑点清晰,阴性对照无干扰;4个成分含量测定线性关系良好,回收率实验符合《中国药典》2015年版四部要求。结论:该方法可准确用来定性、定量检测,具有简便、准确及专属性强的特点,可用于龙黄降压胶囊的质量控制。
Objective: To develop dragon yellow buck capsules quality standards. Methods: Qualitative identification of gentian and Scutellaria baicalensis Georgi by TLC was carried out. The contents of gentiopicroside and paeoniflorin, Scutellaria baicalensis and Radix Scutellariae The contents of baicalin and verbascoside in Rehmannia glutinosa were determined by column chromatography on a Waters Sunfire C18 (250 mm × 4.6 mm, 5 μm) column with mobile phase (gentiopicroside and paeoniflorin): acetonitrile-0.1% phosphoric acid (9:91 ); Mobile phase (baicalin and verbascoside): gradient elution with acetonitrile-0.1% phosphoric acid solution at 0 to 30 min (16:84), 30 to 50 min (21:79) ~ (-1). The column temperature was 30 ℃. The detection wavelength was 270 nm (gentiopicroside), 230 nm (paeoniflorin), 280 nm (baicalin) and 334 nm (verbascoside). Results: TLCL of Gentiana scabiflorum and Scutellaria baicalensis Georgi was clear and the negative control had no interference. The linearity of four components was good, and the recovery experiment accorded with the four requirements of Chinese Pharmacopoeia 2015 edition. Conclusion: This method can be used accurately for qualitative and quantitative detection. It is simple, accurate and specific and can be used for the quality control of Longhuang Capsules.