丹参麦味颗粒质量标准研究

Quality Standard of Danshen Maiwei Granules

目的建立丹参麦味颗粒的质量标准。方法采用薄层色谱法(TLC)对丹参麦味颗粒中丹参、赤芍、佛手、芦根、麦冬、当归、川芎、酒女贞子、制何首乌进行定性鉴别,采用高效液相色谱法(HPLC)对丹酚酸B进行含量测定。色谱柱:Shim-pack VP-ODS柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.1%磷酸水(22∶78),检测波长286 nm,流速1.0 mL/min,柱温30℃。结果TLC鉴别图谱显示:主斑点清晰,分离度好且阴性无干扰;丹酚酸B 0.1728~0.6048μg范围内线性关系良好(r^(2)=0.9993),低浓度、中浓度、高浓度的平均加样回收率分别为95.58%、96.60%、98.19%,相对标准偏差(RSD)为1.50%。结论建立的鉴别和含量测定方法专属性强、准确度高、可重复性和稳定性好,为有效控制丹参麦味颗粒的质量控制提供参考和数据支持。

Objective To establish the quality standard for Danshen Maiwei Granules.Methods Qualitative identification of Salviae Miltiorrhizae Radix et Rhizoma(Danshen),Paeoniae Radix Rubra(Chishao),Citri Sarcodactylis Fructus(Foshou),Phragmitis Rhizoma(Lugen),Ophiopogonis Radix(Maidong),Angelicae Sinensis Radix(Danggui),Chuanxiong Rhizoma(Chuanxiong),and wine-fried Ligustri Lucidi Fructus(Jiunvzhenzi)and Polygoni Multiflori Radix Praeparata(zhiheshouwu)in Danshen Maiwei Granules by thin-layer chromatography(TLC).Determination of salvianolic acid B were tested by high performance liquid chromatography(HPLC).With chromatographic column:shim-pack VP-ODS column(250 mm×4.6 mm,5μm),mobile phase:acetonitrile-0.1%phosphoric acid water(22∶78),detection wavelength 286 nm,flow rate 1.0 mL/min,column temperature 30℃.Results TLC identification map showed:the main spot was clear,the separation was better without negative interference,salvianolic acid B 0.1728~0.6048μg showed a good linear relationship in the concentration range(r^(2)=0.9993),and the average sample recovery rates of low concentration,medium concentration and high concentration were 95.58%,96.60%and 98.19%,respectively.The relative standard deviation(RSD)was 1.50%.Conclusion The established identification and content determination method might be a method with strong specificity,high accuracy,good repeatability and stability,which could provide reference and data support for the effective quality control of Danshen Maiwei Granules.