疏经防痛胶囊的定性定量分析

Qualitative and Quantitative Analysis of Shujing Fangtong Capsule

目的:研究疏经防痛胶囊的质量控制方法。方法:采用TLC对疏经防痛胶囊中丹参、当归、乳香及没药进行定性鉴别;采用HPLC方法,以乙腈-0.1%磷酸溶液为流动相,进行梯度洗脱,在检测波长230 nm处同时测定芍药苷、柚皮苷、新橙皮苷及丹酚酸B共4种成分含量。结果:TLC鉴别分离度好,专属性强。芍药苷在25.30~506.00 mg·L^(^(-1)),柚皮苷在12.68~253.60 mg·L^(^(-1)),新橙皮苷在15.24~304.80 mg·L^(^(-1)),丹酚酸B在27.72~554.30 mg·L^(^(-1))分别具有良好的线性关系,相关系数分别为1.000 0,0.999 9,0.999 9,0.999 9,平均加样回收率分别为100.69%(RSD 0.9%),100.08%(RSD 1.6%),100.85%(RSD 1.2%)和100.42%(RSD 2.0%)。结论:该质量控制方法简便、准确、重复性好,可有效的控制疏经防痛胶囊质量。

Objective： To establish the method for quality control of Shujing Fangtong capsule.Method： TLC method was used to qualitatively identify Salvia Miltiorrhiza,Angelica Sinensis Radix,Olibanum and Myrrha in Shujing Fangtong capsule; the contents of paeoniflorin,naringin,neohesperidin and gsalvianolic acid B were simultaneously determined by HPLC,with acetonitrile-0. 1% phosphoric acid solution as the mobile phase for gradient elution at a detection wavelength of 230 nm. Result： The TLC identification method was distinct and highly specific. Paeoniflorin,naringin,neohesperidin and gsalvianolic acid B showed good linear relationship in ranges of 25. 30-506. 00 mg·L-1（ r = 1. 000 0）,12. 68-253. 60 mg·L-1（ r = 0. 999 9）,15. 24-304. 80 mg·L-1（ r = 0. 999 9） and 27. 72-554. 30 mg·L-1（ r = 0. 999 9） respectively. The average recovery rate of samples was 100. 69%（ RSD 0. 9%）,100. 08%（ RSD 1. 6%）,100. 85%（ RSD 1. 2%） and 100. 85%（ RSD2. 0%） respectively. Conclusion： This quality control method is simple,accurate and reproducible,which can be used to effectively control the quality of Shujing Fangtong capsule.