中医药
样例:中药指纹图谱质控技术的意义和作用
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- 中药业发展到今天，中成药指纹图谱质控技术已是牵动行业全面进步的关键技术。其应用研究，对保证中成药功效，提高中药工业整体水平，带动中药农业现代化，推进中药走向世界，具有非常重要的现实意义。
一、采用指纹图谱质控技术是保证中成药功效实现中药现代化的必需
从二十世纪五十年代中叶起到现在，中成药从剂型工艺到生产方式发生了根本的变化。片剂、颗粒剂、口服液等现代剂型已取代“丸、散、膏、丹”占主体地位。制剂主料也由提取物取代原料粉。已有上百中成药工业企业规模化、机械化，年产亿元以上，前三名达十亿元以上。与此同时，从一九五八年起，各地为解决需求供应短缺，广泛引种药材，许多药材地道性显著淡化。所有这些巨大变化都表明中成药生产质量稳定性的传统基础基本已不适应。中成药业和世界上一切产业发展过程一样，在由手工业小生产向工业大生产过渡的同时，其产品质量也必须实现由凭过程经验控制到事后检验控制的过渡。时至今日，中成药功效的稳定性，已到必须建立在现代化成品内在质量标准的基础上，予以检验控制的时候。
随着三十多年来现代化学分析技术的不断进步，中药材和中成药内在化学成分的研究手段和方法越来越多，越来越好。将研究知晓的内在成分及其测定方法用于质量控制，制定相应检验标准，在近二十年来，有了很大进展。如中国药典一九六三年版收载的中药材只有基源与外观状鉴别，中成药则仅有处方和制法，没有任何检验项目。14年之后颁布的七七年版药典大量采用了显微鉴别。从八五版药典开始，色谱、光谱技术在中药质量控制上被采用，应用的具体方法、技术、测定的成分和被要求的品种，都不断增长，最新二OOO年版药典，收载含量测定的品种已达308种。把已知的主要成分或有药效作用的成分，作为指标成分予以检测控制，这比之过去，是很大的突破和进步。但是从中医药的观点看，指标成分的控制，难以真正控制中药功效。中医辩证施治用的是药味而非某个化学成分。麻黄素和麻黄、甘草酸和甘草、人参皂甙和人参等等在中医来看是两回事。
中药的“补气”、“活血”、“温里”、“发表”、“滋阴”、“健脾”等等诸如此类的中医药功效，是药材饮片或成药方剂内含物质群的整体作用结果。此物质群的整体情况，包括所含的物质数、物质量及组成比例差异，都会对功效发生影响。中医传统上有“传方不传量”之说，意即方剂功效不仅取决于构成方剂药味，还取决于药昧的绝对量及配伍比例。所以方子的组成药味可告之，但各味药的用量是技术核心秘密，不可外传。如张仲景伤寒论中的发表剂“桂枝汤”由桂枝、芍药、生姜、炙甘草、大枣等五味药组成。仅仅把其中芍药用量加倍再加上饴糖，即成为补虚散寒，温建中脏(脾胃)的补益剂“小建中汤”。所以要控制中药功效，不能只针对某一、二个化学成分，必须对方剂物质群整体予以控制。
错误译文 During the development of traditional Chinese medicines up to today, the quality control technology of Chinese patent medicines has become a key technology that affects the overall progress of this industry. Studies on its application have an important practical significance for ensuring the efficacy of Chinese patent medicines, increasing the overall level of traditional Chinese medicine industry, inducing agricultural modernization of traditional Chinese medicines and promoting traditional Chinese medicine to the world.
1. Using the quality control technology of fingerprint is necessary for ensuring the efficacy ofChinese patent medicines and achieving the modernization of traditional Chinese medicines
From the middle of 1950s until now, there have been changes in the dosage forms and production methods of Chinese patent medicines. Tablets, granules, oral liquid and other modern forms have replaced “bolus, powder, plaster and pellet” in the dominant position. The extracts have also replaced raw material powder as the main materials for preparations. There have been hundreds of large-scale and mechanized industrial enterprises of Chinese patent medicines that have an annual yield of more than 100 million yuan, in which the top three are more than1 billion yuan. At the same time, since 1958, medicines have been introduced widely to solve the supply shortages in many regions; the idiomaticity of a large number of medicines is significantly watered down. All these great changes indicate that the traditional foundation of quality stability of Chinese patent medicines is no longer suitable. The industry of Chinese patent medicines, similar to all the other industries over the world, develops from handicraft small-scale production to industrial large-scale production, at the same time, the quality control of products should also transit from relying on the experience of the process to the afterward testing. Today, the stability of the efficacy of Chinese patent medicines is ready to be controlled with testing based on the internal quality standards of modernized products.
With the continuous progress of modern chemical analysis technology within more than 30 years, there are more and more research means and methods for internal chemical components of Chinese herbal medicines and Chinese patent medicines, getting better and better. A great progress has been made in recent 20 years in using internal components known from research and the measurement methods to control the quality and make corresponding testing standard. For example, there were only sources and appearance identification for Chinese herbal medicines and prescription and preparation for Chinese patent medicines in the 1963 version of Chinese Pharmacopoeia, without any testing items; 14 years later, in the 1977 version, the microscopic identification was used widely in the Pharmacopoeia; from the 1985 version, chromatography and spectroscopy had been adopted for quality control of traditional Chinese medicines; the applied specific methods, technologies, determined components and required species all grew continuously; in the latest 2000 version, 308 kinds of varieties were included in the Pharmacopoeia. To take the known main components or effective components as the indicator and control with testing is a great breakthrough and progress compar[1] [2] [3] 下一页
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