制草乌、姜半夏中药配方颗粒与饮片煎剂的急性毒性比较研究

详细信息    查看全文 | 推荐本文 |

英文篇名：Comparative Study on Acute Toxicity of Aconiti Kusnezoffii Radix Cocta, Pinelliae Rhizoma Praeparatumcum Zingibere Et Alumine Formula Granule and Decoction 作者：业康 ; 叶兴法 ; 黄晶晶 ; 韩鹏 ; 金捷 ; 毛培江 英文作者：YE Kang;YE Xingfa;HUANG Jingjing;HAN Peng;JIN Jie;MAO Peijiang;Zhejiang Research Institute of Traditional Chinese Medicine;Zhejiang Jingyuetang Pharmaceutical Limited Company; 关键词：制草乌 ; 姜半夏 ; 配方颗粒 ; 饮片煎剂 ; 毒性 英文关键词：Aconiti Kusnezoffii Radix Cocta;;Pinelliae Rhizoma Praeparatumcum Zingibere et Alumine;;formula granule;;decoction;;toxicity 中文刊名：XDYD 英文刊名：Chinese Journal of Modern Applied Pharmacy 机构：浙江省中药研究所;浙江景岳堂药业有限公司; 出版日期：2018-09-20 17:20 出版单位：中国现代应用药学 年：2018 期：v.35 基金：浙江省科技计划项目(2018F10079) 语种：中文; 页：XDYD201809017 页数：4 CN：09 ISSN：33-1210/R 分类号：78-81

摘要

目的比较制草乌、姜半夏配方颗粒与饮片煎剂的急性毒性差异。方法参照国家药品监督管理局2014年发布的《药物单次给药毒性研究技术指导原则》,对制草乌、姜半夏配方颗粒与其饮片煎剂进行小鼠急性毒性实验,根据毒性实验结果的不同,分别以最小致死量(minimum lethal dose,MLD)或最大给药量(maximum administration dosage,MAD)来反映制草乌、姜半夏配方颗粒与其各自饮片煎剂的毒性差异。结果制草乌饮片煎剂的MLD值在生药25.6~32 g·kg~(-1)之间,而制草乌配方颗粒的MLD值在生药40~50 g·kg~(-1)之间;姜半夏饮片煎剂与姜半夏配方颗粒小鼠灌胃的MAD均为生药238.872 g·kg~(-1),以姜半夏在中国药典2015年版中的上限用量9 g·d~(-1)计算,相当于人用剂量的1 592.48倍。结论制草乌颗粒的毒性明显低于制草乌饮片煎剂;姜半夏配方颗粒与饮片煎剂均未见毒性表现。
        OBJECTIVE To compare the acute toxicity between formula granule and decoction of Aconiti Kusnezoffii Radix Cocta and Pinelliae Rhizoma Praeparatumcum Zingibere Et Alumine. METHODS Referring to Technical Guidelines for the Study of Single Dose Administration Drug Toxicity published by CFDA in 2014, the acute toxicity test of formula granule and decoction of Aconiti Kusnezoffii Radix Cocta and Pinelliae Rhizoma Praeparatumcum Zingibere et Alumine was performed. According to the experimental results, the toxicity differences were studied with minimum lethal dose method(MLD) and maximum administration dose method(MAD) respectively. RESULTS The MLD value of the decoction was between 25.6-32 g·kg~(-1), and the MLD value of the formula granule was between 40-50 g·kg~(-1) of Aconiti Kusnezoffii Radix Cocta. The MAD value of formula granule and decoction of Pinelliae Rhizoma Praeparatumcum Zingibere et Alumine were both 238.872 g·kg~(-1). It was equivalent to 1 592.48 times of the upper limit(9 g·d~(-1)) dose of the 2015 Edition of Pharmacopoeia. CONCLUSION The toxicity of formula granule is significantly lower than the decoction of Aconiti Kusnezoffii Radix Cocta. Formula granule and decoction of Pinelliae Rhizoma Praeparatum Cum Zingibere et Alumine are both non-toxic.

引文

[1]ZHOU J L.Historic review and future prospect of TCM formula granules[J].Mod Chin Med(中国现代中药),2016,18(9):1093-1096.
    [2]GUO M X,WU C,TONG W H.Research progress in equivalence study of TCM dispensing granule and traditional herbal decoction[J].Mod Chin Med(中国现代中药),2016,18(9):1107-1110.
    [3]ZHUANG J R,XU D S,LIU L,et al.Analysis of superiorities and inferiorities of Chinese medicine dispensing granule[J].Chin J Inf Tradit Chin Med(中国中医药信息杂志),2014,21(7):8-10.
    [4]王永和.中药配方颗粒的现状及最新研究进展[J].中国卫生产业,2014,11(8):188-189.
    [5]中国药典.一部[S].2015:236-237,119-120.
    [6]杨蓉.大承气汤配方颗粒与汤剂的比较研究[D].北京:北京中医药大学,2014.
    [7]吴昊,刘同彥,刘佳,等.人参饮片与配方颗粒药效的比较研究[J].人参研究,2017,29(1):8-10.
    [8]QUAN Z H,ZHAO Z M,HUANG X J,et al.Comparison on inhibition between Aconiti Radix Cocta formula granule and standard decoction on ear swelling of mice induced by dimethyl benzene[J].Drug Eva Res(药物评价研究),2014,37(4):309-316.
    [9]任艳青,李葆林,田宇柔,等.栀子、连翘等中药配方颗粒体外肝细胞毒性研究[J].河北中医药学报,2017,32(1):43-46.