首页|常通舒颗粒质量控制与评价方法

常通舒颗粒质量控制与评价方法

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目的:建立常通舒颗粒质量控制与评价方法.方法:采用薄层色谱法对常通舒颗粒中的何首乌、当归、桑椹进行定性鉴别;采用高效液相色谱法同时测定芍药内酯苷、芍药苷、2,3,5,4ʹ-四羟基二苯乙烯-2-O-β-D-葡萄糖苷和苯甲酸的含量;以上述 4 个成分含量为综合指标,建立灰色关联度法评价常通舒颗粒的质量优劣.结果:薄层色谱图对应药材斑点清晰可见,分离度好,阴性样品无干扰;芍药内酯苷、芍药苷、2,3,5,4ʹ-四羟基二苯乙烯-2-O-β-D-葡萄糖苷和苯甲酸在各自线性范围内与峰面积线性关系良好,平均加样回收率为 100.19%~100.80%,RSD%为 0.48~0.90%;由最优和最差评价单元序列得到的相对关联度为 0.334~0.675,说明各样品质量有差异.其中,S3、S2、S5 排名前 3,质量相对较好.结论:建立的薄层鉴别法稳定性较好,同时测定 4 个指标成分含量和灰色关联度综合评价模型客观、准确、可靠,可为常通舒颗粒的质量控制和评价方法研究提供新思路.
Quality Control and Evaluation Method of Changtongshu Granules
Objective:To establish the quality control and evaluation method of Changtongshu Granules.Methods:Thin-layer chromatography was used to qualitatively identify Polygoni Multiflori Radix,Angelicae Sinensis Radix,and Mori Frucuts in Changtongshu Granules.The contents of albiflorin,paeoniflorin,2,3,5,4ʹ-tetrahydroxystilbene-2-O-β-D-glucoside,and benzoic acid were simultaneously determined by high-performance liquid chromatography(HPLC).The contents of the above four components were taken as comprehensive indexes,and a grey correlation analysis method was established to evaluate the quality of Changtongshu Granules.Results:The spots of the corresponding medicinal materials were clearly visible under the thin-layer chromatogram,with good separation and no interference from the negative samples.Albiflorin,paeoniflorin,2,3,5,4ʹ-tetrahydroxystilbene-2-O-β-D-glucopyranoside,and benzoic acid had a good relationship in their respective linear ranges.The average recovery was 100.19%-100.80%,and the relative standard deviation(RSD)was 0.48%-0.90%.The relative correlation degree obtained by the optimal and worst evaluation unit sequence was between 0.334 and 0.675,indicating that the quality of each sample was different.Among them,S3,S2,and S5 rank the top three,and the quality of the sample was relatively good.Conclusion:The established qualitative research method of thin-layer chromatography has good durability and specificity.The comprehensive evaluation model method of simultaneous determination of four index components and grey correlation is objective,accurate,and reliable,which can provide new ideas for the quality control and evaluation method of Changtongshu Granules.

Changtongshu GranulesTCLHPLCgrey correlation

郎淑琴、肖小武、吴旻昱、朱迪、任琦、付辉政

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江西省药品检验检测研究院 国家药品监督管理局中成药质量评价重点实验室/江西省药品与医疗器械质量工程技术研究中心,江西 南昌 330029

江西中医药大学,江西 南昌 330004

常通舒颗粒 薄层色谱法 高效液相色谱法 灰色关联度

江西省药品监督管理局科研项目

2020JS03

2024

中国现代中药
中国中药协会,中国医药集团总公司,中国药材公司

中国现代中药

CSTPCD
影响因子:0.65
ISSN:1673-4890
年,卷(期):2024.26(7)
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