摘要
目的建立基于标准汤剂3大质量指标的夏枯草配方颗粒质量评价方法。方法收集14批不同产地的夏枯草药材,根据技术要求制备14批夏枯草标准汤剂及3批配方颗粒,计算出膏率;采用超高效液相色谱法(UPLC)建立夏枯草标准汤剂和配方颗粒指纹图谱,计算配方颗粒与标准汤剂指纹图谱的相似度,测定迷迭香酸含量并计算转移率。结果标准汤剂平均出膏率为(12.59±2.32)%,3批配方颗粒的出膏率分别为11.14%、10.78%和10.39%;标准汤剂迷迭香酸平均含量为(18.99±9.74)mg/g;平均转移率为(60.58±7.87)%;3批配方颗粒含量分别为7.40、7.49、7.09 mg/g,转移率分别为52.06%、50.10%和50.40%。标准汤剂和配方颗粒指纹图谱均标识出9个共有指纹峰,通过对照品比对,指认其中2个指纹峰分别为迷迭香酸和咖啡酸。配方颗粒与标准汤剂对照指纹图谱的相似度分别为0.954、0.973和0.952。结论3批配方颗粒的质量指标与标准汤剂一致,该方法可为夏枯草配方颗粒质量标准的制定提供依据。
Objective To establish the quality evaluation method of Prunellae spica dispensing granules based on three quality indexes of standard decoction.Methods Fourteen batches of Prunellae spica were collected from different habitats.According to technical requirements,fourteen batches of Prunellae spica standard decoction and three batches of formula granules were prepared and the paste-forming rates were calculated.The fingerprints of Prunellae spica standard decoction and formula granules were established by Ultra High Performance Liquid Chromatography(UPLC).The similarity values of fingerprints between dispensing granules and standard decoction were calculated.The content and transferring rate of Rosmarinic acid were determined and calculated.Results The average paste-forming rate of Prunellae spica was(12.59±2.32)%.The paste-forming rates of the three batches were 11.14%,10.78%and 10.39%respectively.The average content of Rosmarinic acid in standard decoction was(18.99±9.74)mg/g.The average transferring rate was(60.58±7.87)%.The contents of three batches were 7.40 mg/g,7.49 mg/g and 7.09 mg/g.The transferring rates were 52.06%,50.10%and 50.40%respectively.Nine common fingerprint peaks were identified in the fingerprints of standard decoction and formula granules,two of which were identified as Rosmarinic acid and Caffeic acid by comparison of reference substance.The fingerprints similarity of Prunellae spica dispensing granules and standard decoction were 0.954,0.973 and 0.952,respectively.Conclusions The quality indexes of three batches of formulation granules are consistent with standard decoction.This method could provide reference for the establishment of quality standard of Prunellae spica dispensing granules.
作者
李振雨
丁青
陈万发
王利伟
梁月仪
潘晓君
周湘媛
潘礼业
霍文杰
Li Zhenyu;Ding Qing;Chen Wanfa;Wang Liwei;Liang Yueyi;Pan Xiaojun;Zhou Xiangyuan;Pan Liye;Huo Wenjie(Guangdong Yifang Pharmaceutical Co.,Ltd,Foshan 528244,China;Guangdong Provincial Key Laboratory of Traditional Chinese Medicine Formula,Foshan 528244,China)
出处
《国际中医中药杂志》
2022年第2期188-194,共7页
International Journal of Traditional Chinese Medicine
基金
广东省省级科技计划项目(2018B030323004)
“广东特支计划”科技创业领军人才项目(2017TY04R197)。
关键词
夏枯草
标准汤剂
配方颗粒
迷迭香酸
质量控制
Prunellae spica
Standard decoction
Dispensing granules
Rosmarinic acid
Quality control
