关闭
 
读者在线:用户名 密码
首页 期刊简介 投稿须知 期刊目录 专家风采 编委会 特邀顾问 联系我们 移动出版
  1. 1
  2. 2
  3. 3
  4. 4
  5. 5



刊物信息

期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nicpbp.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

访问统计
您是第  4 6 6 2 3 1 5 位浏览者
您当前的位置:首页 >> 正文

编者按

Editor's notes

作者: 马双成 
作者(英文):MA Shuang-cheng
单位: 
单位(英文): 
关键词: 
关键词(英文):
分类号:
出版年·卷·期(页码):2019,39 (10):1721-1723
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

随着医疗保健需求的增长,中药日益受到全世界范围的关注和重视。分析技术的发展使中药分析水平显著提升,同时质量问题也逐渐凸显。历年国家药品评价性抽验结果均表明,按药品法定标准检验合格的样品,通过探索性研究,往往会发现质量隐患,如原料药材及饮片掺伪增重染色,加工不当,非药用部位使用,外源性有毒有害残留偏高等问题屡见不鲜,另外还存在生产工艺上未按处方投料,贵细药不投料或少投料,交叉污染,改变工艺,辅料及质量不一致性等问题。中成药原料以次充好,掺杂掺伪,低于处方量投料,擅自改变工艺等行业潜规则屡禁不止。劣币驱逐良币,导致中药质量良莠不齐,产品优质优价难以体现,市场公平和公正受到冲击,影响中药产业健康发展。上述现象提示,法定检验标准仅仅是中药需要满足的最低标准。部分标准存在质量控制项目缺失,使不法企业有机可乘,偷工减料;即使是对所有药味均设定了检验项目,可以依据其判断“真伪”,但难以反映质量“优劣”。在我国经济转型升级与供给侧改革的大背景下,研究中药质量评价创新模式,提出并推行国家认可,行业使用的质量等级标准,其质量科学评价和严格控制,对于规范市场秩序,打击行业潜规则,引导中医药产业健康有序发展,践行习总书记提出的“四个最严”要求,预防药品监管系统性风险,保障人民用药安全有效,具有重要和迫切的现实意义。
目前,中药材质量等级研究已成为中药质量评价的前沿热点和新兴领域。中成药的质量等级研究还处于初期探索阶段,为此,中国食品药品检定研究院通过学科带头人培养基金立项,支持“中成药质量评价创新模式研究”,针对中成药标准大部分难以真实反映质量优劣,造成产品价格成本倒挂及良莠不齐的现状,课题组以牛黄清胃丸等品种为模式药物,研究中成药质量评价新模式。为给等级评价提供科学标尺,课题组提出了“中药对照制剂的研制指导原则和技术要求”并已出版。中药对照制剂作为国家药品标准物质的新形式,系指采用道地、优质、规范加工的原料药材(饮片)和辅料,严格按照制法和生产工艺规程,并遵循药品生产质量管理规范制备的实物对照,主要用于中成药的质量控制,评价产品投料的真实性(是否投正确的原料)和投料量的可靠性(是否按处方量投料)。在研制对照制剂的同时,采用多种组合技术建立了质量评价新模式,以对照制剂含量和关键成分转移率为参考,制订等级限度标准,甄别“按GMP要求生产的放心药”和“应付标准检验生产的合格药”。
为了加强中成药质量评价创新模式的研究,中国食品药品检定研究院协同部分省市药检机构开展了系列研究工作,取得了一些研究成果。本刊特设“中成药质量评价创新模式研究”专栏,分6篇文章集中报道相关研究成果,综述了“中药质量等级评价研究进展”,并介绍了“牛黄清胃丸对照制剂的建立”、“基于对照制剂的复方丹参片质量评价新模式探讨”、“基于对照制剂的抗宫炎片质量评价新模式的探讨”、“基于对照制剂的沉香化气丸多组分含量测定研究”,旨在为中成药的质量等级体系研究提供思路、借鉴和参考。中药对照制剂和中药等级质量评价还处于探索阶段,要形成成熟的理论和应用,还需要进行更具创新性的手段和更加系统、深入的工作。

-----英文摘要:---------------------------------------------------------------------------------------

With the increased requirements of medical healthcare,traditional Chinese medicine (TCM)has received more and more attention from the whole world.
The development of analysis technique has significantly promoted the TCM analysis level, but it also gradually brings about quality issues. National post-market drug surveillance results over the years have shown that through exploratory studies, potential quality issues may also be found in the products which have been tested qualified based on mandatory drug standards,such as adulteration,weight increment and staining of the active pharmaceutical ingredients (APIs)and prepared decoction pieces,improper processing,use of non-medicinal parts,relatively high level of exogenous poisonous and harmful residues. Moreover, there are also other issues including feeding not as prescribed during the production process,no or less charging of expensive and fine medicines,cross contamination, process changes and inconsistency of excipients and quality. Other industry hidden rules, such as APIs of Chinese patent medicine which may be shoddy, doped, adulterated and feeding at an amount lower than the prescribed amount, and processed using an arbitrarily modified process, emerge persistently regardless of the prohibition. Bad money drives out good,which results in varied TCM quality,is difficult to embody the high quality and high price of the products,and triggers the impact on market equity and justice,thus influencing the healthy development of TCM industry. Above phenomena indicate that the mandatory test standards are only the lowest standards needed to be met by the TCM. Quality control item missing is reflected in some standards,so that some illegal enterprises have taken the opportunity to cheat on workmanship and materials. Although test items are set up for all medicines in order to judge the medicines' authenticity,they cannot reflect the medicines' quality. In China,under the overall background of economic transformation and upgrading and supply-side reform,it is of important and urgent practical significance in studying innovative models for TCM quality evaluation,proposing and implementing nationally recognized and industry-used quality level standards as well as scientific quality evaluation and strict control,so as to specify the market order, strike against hidden industry rules, guide the healthy and ordered development of TCM industry, practice "the Four Most Strict Requirements "proposed by General Secretary Xi Jinping,prevent medicine monitoring systemic risks and ensure the people's safe and effective medications.
Currently, the study on quality level of TCM has become a leading hotspot and new field for TCM quality evaluation. The study on quality level of Chinese patent medicine is still in the primary exploratory stage. Hence, National Institutes for Food and Drug Control has approved the project through Academic Leader Foundation, supported the "Study on Innovative Model for Quality Evaluation of Chinese Patent Medicine", and established a research group to study the new models for Chinese patent medicine quality evaluation using model medicines including Niuhuang Qingwei Pills specific to the current situation that most standards of Chinese patent medicine cannot reflect the medicine's actual quality resulting in products' cost overhang and inconsistent quality. To provide scientific scale for the level evaluation,Guideline principle and technical requirement for preparing traditional Chinese medicine reference drug has been proposed and published by the research group. TCM reference drug,as a new form of national drug standard substance, is defined as the physical control prepared with authentic, high-quality and standardly processed raw medicinal materials (pieces) and excipients, in strict accordance with the preparation method and manufacturing process, and in compliance with the quality management practices of pharmaceutical production,and is mainly used for quality control of Chinese patent medicine to evaluate the authenticity of product dosing (whether the right raw material is dosed)and the reliability of dosing quantity (whether it is dosed according to formula). Meanwhile,multiple combination techniques are used to establish the new models for quality evaluation during the research and development of reference drug, with contents in the reference drug and critical ingredient transformation rate as the references, and to establish level limit standards, so as to distinguish the "medicines manufactured based on GMP" and "eligible medicines manufactured only for standard tests".
To enhance the study on the innovative models for Chinese patent medicine quality evaluation,National Institutes for Food and Drug Control have carried out a series of studies together with drug test institutions in some provinces and cities,with some achievements obtained. This journal specially sets up "a column of Study on Innovative Model for Quality Evaluation of Chinese Patent Medicine",reports the relevant study achievements in 6 papers,summarizes "Research progress on evaluation of quality grade of traditional Chinese medicine",and introduces the "Establishment of Niuhuang Qingwei pills reference drug", "Discussion on a novel quality evaluation model for compound Danshen tablets based on reference drug", "Discussion on a novel model for quality evaluation of Kanggongyan tablets based on reference drug",and "Study on multi-component determination of Chenxiang Huaqi pills based on reference drug", aiming to provide new thoughts, reference and consultation for Chinese patent medicine quality level system study. TCM quality level evaluation is still in the exploratory stage,which needs more innovative methods and more systemic and profound studies to form mature theory and application.

-----参考文献:---------------------------------------------------------------------------------------

欢迎阅读《药物分析杂志》!您是该文第 43位读者!

药物分析杂志 © 2009
地址:北京天坛西里2号 邮政编码:100050; 电子邮件:ywfx@nicpbp.org.cn

本系统由北京博思汇文数字科技有限公司设计开发 技术服务电话:400-921-9838