归芪养血止痒颗粒剂制备工艺及质量标准研究

Study on the preparation process and quality standard of guiqi nourishing blood and relieving itching granule dosage

目的:研究归芪养血止痒颗粒剂的制备工艺及质量标准。方法:对颗粒剂粒度、水分、溶化性、装量差异和微生物限度进行相关检查。采用L9(33)正交试验对加水量、提取时间和提取次数进行考察,确定各因素水平,并以大黄素含量为指标,优选制备工艺。用薄层色谱法对颗粒剂中大黄素和黄芪甲苷进行鉴别,高效液相色谱法对颗粒剂中大黄素含量进行测定。结果:归芪养血止痒颗粒剂的成型率为97.13%,颗粒剂相关检查均符合规定。优选的最佳制备工艺为加水量的8倍,提取时间2 h,提取2次。薄层色谱法(TLC)结果显示,斑点清晰,专属性强。高效液相色谱法(HPLC)法结果显示,大黄素的平均含量为0.0156 mg/g。平均加样回收率为98.28%,相对标准偏差(RSD)为0.35%。结论:优选的最佳制备工艺稳定,且方法简便准确。建立的质量标准专属性强、重复性好,可用于归芪养血止痒颗粒的质量控制。

Objective:To study the preparation process and quality standard of guiqi nourishing blood and relieving itching granules.Methods:Particle size,moisture,solubility,loading difference and microbial limit of granules were examined relevantly.L9(33)orthogonal test was used to examine the amount of water added,extraction time and number of extractions to determine the levels of factors,and the content of rhodopsin was used as an index to optimize the preparation process.The identification of rhodopsin and astragaloside in granules was carried out by thin-layer chromatography,and the content of rhodopsin in granules was determined by high performance liquid chromatography.Results:The molding rate of radix astragali nourishing blood and relieving itching granules was 97.13%,and the relevant examinations of the granules complied with the regulations.The preferred optimal preparation process was 8 times of water,extraction time of 2 h,and 2 times of extraction,and the results of thin layer chromatography(TLC)showed clear spots with high specificity,and the results of high performance liquid chromatography(HPLC)showed that the average content of rhodopsin was 0.0156 mg/g,and the average recoveries were 98.28%with RSD of 0.35%.Conclusion:The optimized preparation process was stable and the method was simple and accurate.The method is simple and accurate,and the established quality standard is exclusive and reproducible,which can be used for the quality control of guiqi nourishing blood and relieving itching granules.