地骨皮配方颗粒质量标准提高研究

Study on Improvement of Quality Standard of Lycii Cortex Formula Granules

目的:通过优化定性鉴别方法和建立指纹图谱分析研究,提高地骨皮配方颗粒的质量控制标准。方法:采用薄层色谱(TCL)法,以地骨皮对照药材作为阳性对照,对地骨皮配方颗粒进行定性鉴别;采用高效液相色谱法,色谱柱以C18为填充剂,甲醇-0.1%甲酸溶液为流动相,流速为0.8mL·min-1进行梯度洗脱,柱温为25℃,建立地骨皮配方颗粒指纹图谱分析方法。结果:在薄层鉴别中,地骨皮配方颗粒斑点清晰,分离度好;在指纹图谱研究中,建立了地骨皮配方颗粒的HPLC指纹图谱,确定了9个共有峰。结论:所建立的鉴别与指纹图谱分析方法简单可行、稳定可靠,重复性良好,完善和提高了地骨皮配方颗粒的质量控制标准。

Objective:To improve the quality standard of Lycii Cortex formula granules by optimizing the qualitative identification and establishing the fingerprint analysis.Methods:The TLC method was established for the qualitative identification of dispensing granules of Lycii Cortex,the contrast medicinal materials of Lycii Cortex as the positive control.The HPLC analysis was carried out in a C18with a mobile phase of consisted of Methanol-0.1%formic acid solution in gradient mode at a flow rate of 0.8mL·min-1.Column temperature was 25℃,wavelength set at 280nm.Results:In qualitative identification,the TLC spots of dispensing granules of Lycii Cortex was clear with good separation degree.The HPLC fingerprint of Lycii Cortex formula granules particles was established,and nine common peaks were identified.Conclusion:The method is simple and feasible,it has good stability and repeatability,which can be used to perfect and improve the quality control of Lycii Cortex formula granules.