常通舒颗粒质量控制与评价方法研究
投稿时间:2024-01-15  修订日期:2024-03-11   点此下载全文
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作者中文名作者英文名单位中文名单位英文名E-Mail
郎淑琴 Lang Shuqin 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
江西中医药大学
China Provincial Institute for Drug Control, NMPA Key Laboratory of Quality Evaluation of traditional Chinese Patent Medicine, Jiangxi Provincial Engineering Research Center for Drug and Medical Devi
Jiangxi University of Traditional Chinese Midicine
1814453299@qq.com 
付辉政* Fu Huizheng 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
江西中医药大学
China Provincial Institute for Drug Control, NMPA Key Laboratory of Quality Evaluation of traditional Chinese Patent Medicine, Jiangxi Provincial Engineering Research Center for Drug and Medical Devi
Jiangxi University of Traditional Chinese Midicine
fhzfhz620@sohu.com 
基金项目:常通舒颗粒质量标准提升研究
中文摘要:[摘要] 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、2,3,5,4’-四羟基二苯乙烯-2-O-β-D-葡萄糖苷和苯甲酸含量;以上述4个成分含量为综合指标,建立灰色关联分析方法评价常通舒颗粒的质量优劣。结果:薄层色谱图下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、2,3,5,4’-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在0.334~0.675之间,说明各样品之间质量不一。其中,S3、S2、S5排名前三,该样品质量相对较好。结论:建立的薄层色谱法定性研究方法耐用性和专属性良好,同时测定4个指标成分含量和灰色关联度综合评价模型方法客观、准确、可靠,可为常通舒颗粒的质量控制和评价方法提供新思路。
中文关键词:常通舒颗粒  薄层色谱法  高效液相色谱法  同时测定  灰色关联度
 
Study on the quality control and evaluation method of Changtongshu granules
Abstract:[Abstract] Objective: To establish the quality control and evaluation method of Changtongshu granules. Methods: Thin layer chromatography was used to identify Polygoni Multiflori Radix, Angelicae Sinensis Radix, Mori Frucuts in Changtongshu granules. The contents of albiflorin, paeoniflorin, 2,3,5,4' -tetrahydroxystilbene-2-O-β-D-glucoside and benzoic acid were simultaneously determined by high performance liquid chromatography. The contents of albiflorin, paeoniflorin, 2,3,5,4'-tetrahydroxystilbene-2-O-β-D-glucopyranoside and benzoic acid were determined simultaneously. Taking the above four components as comprehensive indexes, 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, 2,3,5,4'-tetrahydroxystilbene-2-O-β-D-glucopyranoside and benzoic acid had good linear relationship in their respective linear ranges. The average recovery was 100.19-100.80 %, and RSD % was 0.48-0.90 %. The relative correlation degree obtained by the optimal and worst evaluation unit sequence is between 0.334 and 0.675, indicating that the quality of each sample is different. Among them, S3, S2 and S5 rank the top three, and the quality of the sample is 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 degree is objective, accurate and reliable, which can provide new ideas for the quality control and evaluation method of Changtongshu granules.
keywords:Changtongshu granules  thin layer chromatography  high performance liquid chromatography  simultaneous determination  grey relativity
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