益母草饮片标准汤剂研究(1)
[摘要]建立益母草饮片标准汤剂质量评价标准。制备13批不同品质的益母草饮片标准汤剂，对盐酸益母草碱和盐酸水苏碱进行含量测定、计算其转移率、测定出膏率及pH、建立HPLC指纹图谱分析方法。结果13批益母草饮片标准汤剂中盐酸益母草碱和盐酸水苏碱转移率分别为300%～534%，670%～826%，干膏得率121%～183%，pH 587～622，并用中药色谱指纹图谱相似度评价系统(2012A)软件进行指纹图谱分析，确定了12个共有峰，对13批益母草饮片标准汤剂分别进行相似度评价，其相似度均大于09。该研究中益母草饮片制备方法规范，指纹图谱相似度高，其方法精密度、稳定性和重复性良好，可为益母草配方颗粒质量控制提供参考。
[关键词]益母草； 标准汤剂； 盐酸益母草碱； 盐酸水苏碱； 指纹图谱
Standard decoction of Leonuri Herba
DENG Zhe1，2， ZHANG Fan3， ZHANG Jun1， ZHANG Qing1， JIAO Mengjiao1， ZHANG Guoyuan1，CHENG Jintang1， LIU An1， WANG Yuesheng1*
, http://www.100md.com
(1. Institute of Chinese Materia Medica， China Academy of Chinese Medical Sciences， Beijing 100700， China；
2. Jiangxi University of Traditional Chinese Medicine， Nanchang 330004， China；
3. Shanghai University of Traditional Chinese Medicine， Shanghai 201203， China)
[Abstract]To build an evaluation standard for quality of Leonuri Herba standard decoction 13 batches of Leonuri Herba standard decoction with different quality were prepared The contents of leonurine hydrochloride and stachydrine hydrochloride were determined； then the transfer rate and the extract rate were calculated and pH value was measured； and HPLC fingerprint method was established for analysis The results of 13 batches of samples revealed that the transfer rate of leonurine hydrochloride and stachydrine hydrochloride was 300%534% and 670%826%， respectively； the extract rate was 121%183% and the pH value was 587622 Moreover， 12 common chromatographic peaks were determined based on fingerprint by using Similarity Evaluation System for Chromatographic fingerprint of Traditional Chinese Medicine (2012A) The similarity of 13 batches of samples was analyzed and compared， and the results showed that the similarity was higher than 09 In this study， the preparation method for Leonuri Herba decoction was standard， with high similarity in fingerprint， showing high precision， stability and repeatability in fingerprint analysis Thus， this study can provide a reference for the quality control of Leonuri Herba dispensing granules
, 百拇医药
[Key words]Leonuri Herba； standard decoction； leonurine hydrochloride； stachydrine hydrochloride； fingerprint
益母草為唇形科植物益母草Leonurus japonicas Houtt的新鲜或干燥地上部分，具有活血调经、利尿消肿、清热解毒等功效，临床常用于月经不调、痛经闭经、产后恶露不尽、水肿尿少、疮疡肿毒等病症。因其疗效显著，享有“妇科要药”“经产良药”之美誉。除此之外，现代研究表明益母草潜在多种药理活性，主要表现在对血液系统(如改变血液流变学、改善微循环等)、心血管系统(如保护心肌细胞、抗心肌缺血等)及免疫系统等方面以及还有抗炎镇痛、抗氧化、降血糖、美容等作用[16]。因此，益母草的成方制剂也极其的多。经统计，关国家食品药品监督管理总局批准的仅由单味益母草组成的制剂就多达16个，包括益母草颗粒、益母草膏、益母草片、益母草注射液等等，这些产品由遍及全国30个省份292家药品生产单位生产。可见益母草在临床发挥作用之巨大，其确切的疗效已被大众所认可。, 百拇医药(邓哲张凡章军张庆焦梦姣张国瑗程锦堂刘安王跃生)
[关键词]益母草； 标准汤剂； 盐酸益母草碱； 盐酸水苏碱； 指纹图谱
Standard decoction of Leonuri Herba
DENG Zhe1，2， ZHANG Fan3， ZHANG Jun1， ZHANG Qing1， JIAO Mengjiao1， ZHANG Guoyuan1，CHENG Jintang1， LIU An1， WANG Yuesheng1*
, http://www.100md.com
(1. Institute of Chinese Materia Medica， China Academy of Chinese Medical Sciences， Beijing 100700， China；
2. Jiangxi University of Traditional Chinese Medicine， Nanchang 330004， China；
3. Shanghai University of Traditional Chinese Medicine， Shanghai 201203， China)
[Abstract]To build an evaluation standard for quality of Leonuri Herba standard decoction 13 batches of Leonuri Herba standard decoction with different quality were prepared The contents of leonurine hydrochloride and stachydrine hydrochloride were determined； then the transfer rate and the extract rate were calculated and pH value was measured； and HPLC fingerprint method was established for analysis The results of 13 batches of samples revealed that the transfer rate of leonurine hydrochloride and stachydrine hydrochloride was 300%534% and 670%826%， respectively； the extract rate was 121%183% and the pH value was 587622 Moreover， 12 common chromatographic peaks were determined based on fingerprint by using Similarity Evaluation System for Chromatographic fingerprint of Traditional Chinese Medicine (2012A) The similarity of 13 batches of samples was analyzed and compared， and the results showed that the similarity was higher than 09 In this study， the preparation method for Leonuri Herba decoction was standard， with high similarity in fingerprint， showing high precision， stability and repeatability in fingerprint analysis Thus， this study can provide a reference for the quality control of Leonuri Herba dispensing granules
, 百拇医药
[Key words]Leonuri Herba； standard decoction； leonurine hydrochloride； stachydrine hydrochloride； fingerprint
益母草為唇形科植物益母草Leonurus japonicas Houtt的新鲜或干燥地上部分，具有活血调经、利尿消肿、清热解毒等功效，临床常用于月经不调、痛经闭经、产后恶露不尽、水肿尿少、疮疡肿毒等病症。因其疗效显著，享有“妇科要药”“经产良药”之美誉。除此之外，现代研究表明益母草潜在多种药理活性，主要表现在对血液系统(如改变血液流变学、改善微循环等)、心血管系统(如保护心肌细胞、抗心肌缺血等)及免疫系统等方面以及还有抗炎镇痛、抗氧化、降血糖、美容等作用[16]。因此，益母草的成方制剂也极其的多。经统计，关国家食品药品监督管理总局批准的仅由单味益母草组成的制剂就多达16个，包括益母草颗粒、益母草膏、益母草片、益母草注射液等等，这些产品由遍及全国30个省份292家药品生产单位生产。可见益母草在临床发挥作用之巨大，其确切的疗效已被大众所认可。, 百拇医药(邓哲张凡章军张庆焦梦姣张国瑗程锦堂刘安王跃生)