基于标准汤剂的鲜益母草配方颗粒质量标准研究  

Study on the quality standard of fresh Leonurus japonicus Houtt.formula granules based on standard decoction

作　　者：刘燎原 洪婉敏 张志鹏 张正 程钰洁 黄瑶 徐杰 孙冬梅 LIU Liao-yuan;HONG Wan-min;ZHANG Zhi-peng;ZHANG Zheng;CHENG Yu-jie;HUANG Yao;XU Jie;SUN Dong-mei(Guangdong Provincial Key Laboratory of Research and Development in Traditional Chinese Medicine,Guangzhou 510095,China;Guangdong Provincial Key Laboratory of Traditional Chinese Medicine Formula Granule,Guangdong Yifang Pharmaceutical Co.,Ltd.,Foshan 528244,China)

机构地区：[1]广东省中医药研究开发重点实验室,广州510095 [2]广东一方制药有限公司广东省中药配方颗粒企业重点实验室,佛山528244

出　　处：《天然产物研究与开发》2024年第10期1761-1776,共16页Natural Product Research and Development

基　　金：广东省中医药研究开发重点实验室开放基金(KFKT02-007);2023年度广东省中医药局中医药科研项目(科研平台专项)(20233006);国家工信部2022年产业技术基础公共服务平台项目-中药全产业链质量技术服务平台(2022-230-221)。

摘　　要：建立基于标准汤剂的鲜益母草配方颗粒质量标准。采集20批鲜益母草药材,依据《医疗机构中药煎药室管理规范》和《中药配方颗粒质量控制与标准制定技术要求》进行饮片炮制、煎煮、浓缩、冷冻干燥,制备成鲜益母草标准汤剂,测定20批鲜益母草标准汤剂的出膏率、盐酸益母草碱和盐酸水苏碱的含量,并构建表征鲜益母草主要化学成分的特征图谱。同时,以与鲜益母草标准汤剂出膏率、指标成分的含量及特征图谱的一致性为基准,进行3批鲜益母草配方颗粒的放大生产,验证制定的鲜益母草配方颗粒质量标准的合理性。结果表明20批鲜益母草标准汤剂出膏率范围为4.43%~8.02%;盐酸益母草碱与盐酸水苏碱含量分别为2.11~9.05、16.86~82.59 mg/g;确定配方颗粒干浸膏范围为5.0%~8.5%,盐酸益母草碱与盐酸水苏碱含量分别为1.0~5.3、9.0~60.0 mg/g;特征图谱标定8个特征峰,配方颗粒图谱信息与标准汤剂一致。可知本研究基于标准汤剂的鲜益母草配方颗粒质量标准合理可行,可为鲜益母草配方颗粒国家标准的制定提供参考。This study amis to establish the quality standard of fresh Leonurus japonicus Houtt.formula granules based on the standard decoction.Twenty batches of fresh L.japonicus medicinal materials were collected,according to the management standard for traditional chinese medicine decocting room in medical institutions and the technical requirements for quality control and standard formulation of traditional Chinese medicine formula granules,the decoction slices were processed,decocted,concentrated and freeze-dried to prepare L.japonicus standard decoction,the paste rate,the content of leonurine hydrochloride and stachydrine hydrochloride of 20 batches of L.japonicus standard decoction were determined,and the chromatogram which could characteriz the main chemical components was constructed to characterize fresh L.japonicus.At the same time,based on the the consistency with the paste rate,content of indicator components,and chromatogram with the standard decoction of fresh L.japonicus,three batches of fresh L.japonicus formula granules were produced in scale to verify the rationality of the formulated quality standards for fresh L.japonicus formula granules.The results showed that the extract rate of 20 batches of fresh L.japonicus standard decoction ranged from 4.43%to 8.02%,the contents of leonurine hydrochloride and stachydrine hydrochloride were 2.11-9.05 mg/g,16.86-82.59 mg/g,respectively the range of dry extract was 5.0%-8.5%,and the contents of leonurine hydrochloride and stachydrine hydrochloride were 1.0-5.3 mg/g,9.0-60.0 mg/g.And on the characteristic chromatogram 8 characteristic peaks were calibrated,respectively the information of formula granule pattern was consistent with standard decoction.So the quality standard of fresh L.japonicus formula granules based on standard decoction is reasonable and feasible,which can provide reference for the formulation of national standard of fresh L.japonicus formula granules.

关 键 词：鲜益母草 标准汤剂 配方颗粒 出膏率 含量 特征图谱 

分 类 号：R284.1[医药卫生—中药学]