秦艽药材与饮片标准汤剂的质量传递性研究

Mass transfer of Radix Gentianae Macrophyllae medicinal herb and standard decoction of medicinal slices

建立了15批秦艽药材与饮片标准汤剂的HPLC指纹图谱,流动相为乙腈-0.1%醋酸,检测波长为254 nm。同时,结合含量测定、出膏率,进行药材、饮片标准汤剂的质量传递性研究。药材、饮片标准汤剂的指纹图谱与各自对照图谱相似度良好,以龙胆苦苷为参照峰,确定共有峰5个,指认5个色谱峰。15批药材、饮片标准汤剂平均出膏率分别为20.43%、19.71%,龙胆苦苷、马钱苷酸从药材到饮片的平均转移率为80.56%、80.98%,未出现离散数据。结果表明,采用物质群整体控制的指纹图谱与出膏率、含量测定指标相结合的模式,建立的药材、饮片标准汤剂的质量控制及传递性研究,可为经典名方以及中药配方颗粒研究提供参考。

High-performance liquid chromatography(HPLC) fingerprint spectra were created for 15 batches of Radix Gentianae Macrophyllae medicinal herb and standard decoctions of medicinal slices.Acetonitrile and 0.1% acetic acid were used as the mobile phase,and 254 nm was maintained as the detection wavelength.Simultaneously,in combination with content determination and extract yielding rate,mass transfer was examined with respect to the medicinal herb and standard decoctions of medicinal slices.The fingerprint spectra of the medicinal herb and the standard decoctions of medicinal slices shared high similarity with the respective control spectra.With gentiopicroside as the reference peak,five common peaks were confirmed and five chromatographic peaks were identified.The average extract yielding rate of the 15 batches of both the medicinal herb and the standard decoctions of medicinal slices was 20.43% and 19.71%,respectively.The average transfer rate of gentiopicroside and loganic acid from the medicinal herbs to the slices was 80.56% and 80.98% respectively;no discrete data were obtained.The results showed that the quality control and transferability of the herbs and the slices were investigated using the pattern(with overall control over the material group) of combining the fingerprint spectra with extract yielding rate and content determination indicators;this can serve as a reference for research concerning classic prescriptions and traditional Chinese medicine formula granules.