8个厂家74批次丹参片中脂溶性成分丹参酮ⅡA的含量比较研究

Comparative Study on the Fat-soluble Component Tanshinone ⅡA in 74 Batches of Danshen Tablets from 8 Manufacturers by RP-HPLC

目的:比较8个厂家74批次丹参片中脂溶性成分丹参酮ⅡA的含量差异。方法:采用RP-HPLC法,色谱柱:AglientC18(4.6mm×250mm,5μm)色谱柱;流动相:甲醇-水(75∶25);柱温30℃;流速为1mL·min^-1;检测波长270nm,选取本次国家评价性抽验的8个厂家74批次丹参片样品对其进行含量测定,并采用频数分布图和箱形图对其含量测定结果进行比较分析。结果:丹参酮ⅡA进样量在0.00885~0.221μg范围内与色谱峰峰面积呈良好线性关系;平均回收率(n=6)为99.6%,RSD为0.02%;8个厂家74批次丹参片中脂溶性成分丹参酮ⅡA的含量差异较大。结论:所建立的方法经方法学验证简便快捷、准确、重复性好,为丹参片的质量控制提供参考依据;不同厂家生产的和同一厂家生产的不同批次之间含量差异均较大,有待于进一步提高丹参原药材质量和规范丹参片生产工艺;采用的频数分布图和箱形图对测定结果的分析直观、准确可靠。

Objective To Compare the content difference of fat-soluble component tanshinone ⅡA in 74 batches of Danshen tablets from 8 manufacturers.Methods RP-HPLC method was adopted.The determination was performed on Aglient ZORBAX C18(4.6 mm×250 mm,5μm)column with mobile phase consisted of methyl alcohol-water(75∶25)with a flow rate of -mL·min-1 at 30 ℃;The detection wavelength was 270 nm;74 batches of Salvia miltiorrhiza tablets from 8 factories were selected for the content determination and Frequency distribution and box diagram were used to compare and analyze the results of content determination Relusts The linear ranges of tanshinone ⅡA fell within the ranges of 0.00885~0.221 μg.The recoveries(n=6) of tanshinone Ⅱ A was 99.6%, and the relative standard deviations was 0.02%.The content of tanshinone ⅡA in 74 batches of Danshen Tablets from 8 factories is quite different. Conclusions The method is simple, rapid.accurate and reproducible. It can be used for quality control of Danshen Tablets.The content difference between different batches and different manufacturers. It is necessary to further improve the quality of Salvia miltiorrhiza and standardize the production. The frequency distribution chart and box chart adopted are intuitive, accurate and reliable.