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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
朱笑颜	ZHU Xiao-yan	湖南春光九汇现代中药有限公司，湖南浏阳410331	Hunan Chunguang Jiuhui Modern Chinese Traditional Medicine Co., Ltd., Liuyang410331, China
肖功定	XIAO Gong-ding	湖南春光九汇现代中药有限公司，湖南浏阳410331	Hunan Chunguang Jiuhui Modern Chinese Traditional Medicine Co., Ltd., Liuyang410331, China
陈洁	CHEN Jie	湖南春光九汇现代中药有限公司，湖南浏阳410331	Hunan Chunguang Jiuhui Modern Chinese Traditional Medicine Co., Ltd., Liuyang410331, China
陈林	CHEN Lin	湖南省中医药研究院，湖南长沙 410013	Hunan Academy of Chinese Medicine, Changsha410013, China
欧阳习叶*	OUYANG Xi-ye	湖南春光九汇现代中药有限公司，湖南浏阳410331	Hunan Chunguang Jiuhui Modern Chinese Traditional Medicine Co., Ltd., Liuyang410331, China
金剑	JIN Jian	湖南省中医药研究院，湖南长沙 410013	Hunan Academy of Chinese Medicine, Changsha410013, China
张水寒	ZHANG Shui-han	湖南省中医药研究院，湖南长沙 410013	Hunan Academy of Chinese Medicine, Changsha410013, China

基金项目:湘九味中药材产业集群建设项目

中文摘要:目的建立基于标准汤剂的千斤拔配方颗粒质量标准，为其质量控制与评价提供参考。方法制备15批标准汤剂以建立千斤拔的特征图谱，通过对特征图谱的相似度评价及多元统计分析评价药材的产地、批间差异。制备3批千斤拔配方颗粒，比较配方颗粒与标准汤剂特征图谱的一致性，测定千斤拔标准汤剂和配方颗粒的出膏率及染料木苷的含量，计算染料木苷的转移率。结果千斤拔标准汤剂特征图谱与对照图谱相似度均大于0.9，共确定了3个共有峰。通过聚类分析与主成分分析综合评价，不同产地的饮片制备的标准汤剂质量有差异，不同批次的饮片制备的标准汤剂也存在一定的差异。计算得15批千斤拔标准汤剂的出膏率为7.3%~13.9%，染料木苷质量分数为1.29~3.39 mg·g^–1、转移率为36.2%~81.7%。3批配方颗粒特征图谱与标准汤剂对照图谱一致，出膏率，染料木苷含量、转移率与标准汤剂接近，均在质量标准范围内。结论以特征图谱、出膏率、染料木苷含量及转移率为指标，综合评价千斤拔标准汤剂与配方颗粒的一致性，建立的基于标准汤剂的千斤拔配方颗粒质量标准合理可行，可为千斤拔配方颗粒的工艺研究及质量控制提供参考。

中文关键词:蔓性千斤拔标准汤剂配方颗粒质量控制高效液相色谱法

Quality Standard of Flemingia philippinensis Dispensing Granules Based on Standard Decoction

Abstract:Objective To establish the quality standard for Flemingia philippinensis dispensing granules based on standard decoction and provide a reference for its quality control and evaluation.Methods 15 batches of standard decoction were prepared to establish the specific chromatograms of F. philippinensis. The similarity evaluation of the specific chromatogram and multivariate statistical analysis were used to evaluate differences between the origin and batch of medicinal materials. Three batches of F. philippinensis dispensing granules were prepared, and the consistency of the specific chromatograms of the dispensing granules and standard decoction was compared. The extract rate and the content of the genistin in the standard decoction and dispensing granules were determined, and the transfer rates of the genistin were calculated.Results The similarities between specific chromatograms of F. philippinensis standard decoction and control chromatograms were all more than 0.9, and three common peaks were identified. Through the comprehensive evaluation of cluster analysis and principal component analysis, the origin of medicinal materials will have a certain impact on the quality of standard decoction. There are also certain differences in the standard decoction prepared by different batches of medicinal materials. Through calculation, it was found that the extract rate of 15 batches of F. philippinensis standard decoction was 7.3%-13.9%, and the mass fraction of genistin was 1.29-3.39 mg·g^-1, with a transfer rate of 36.2%-81.7%. The specific chromatograms of the three batches of dispensing granules are consistent with the specific chromatograms of standard decoction. The extract rate, content of the genistin, and transfer rate are close to those of the standard decoction, all of which meet the quality standard.Conclusion Based on the specific chromatogram, extract rate, content of the genistin, and transfer rate, the consistency between the standard decoction and the dispensing granules of F. philippinensis is comprehensively evaluated. The quality standard of F. philippinensis dispensing granules based on standard decoction is established, and it is reasonable and feasible. It can provide a reference for the process research and quality control of F. philippinensis dispensing granules.

keywords:Flemingia philippinensis (Merr. et Rolfe) standard decoction formula granules quality control HPLC

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