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第一部分
绪论
Part I
Introduction

中药炮制是什么?中药炮制的科学原理是什么?当接触这门古老而又年轻的学科时,首先应理解中药炮制的作用,其前提就是了解何为中药炮制。

一、中药炮制的定义和性质

1.定义

(1)中药炮制的定义: 根据中医药理论,按照辨证用药的需要和药物自身的性质,以及调剂制剂不同要求所采取的一项制药技术,即为中药炮制。广义包括净制、切制和炮制;狭义包括炒、炙、煅、蒸、煮、 img 、复制、发酵、发芽、制霜、烘焙、水飞等。

(2)中药炮制学的定义: 中药炮制学是专门研究中药炮制理论、工艺、规格标准、历史沿革及其发展的学科。

(3)关于中药炮制理论: 阐明炮制原理,例如药物炒炭后增强其止血作用,中医理论认为,“红见黑则止”(五行相克理论中水克火,而黑属水,红属火)。而现代理论则认为,药物炒炭后能增加鞣质含量,从而增加血中的钙、铁离子含量,可促进血凝。

(4)关于工艺方面: 目的在于提高炮制作用并规范炮制工艺。例如马钱子,有砂炒、油炸、尿泡、醋制,其中尿泡为江西樟帮的特色制法,炮制工艺研究的目的是保存药效的同时对传统工艺进行改进研究。

What is the meaning of the Processing of Chinese Herbal Medicine(PCHM)?And what is the scientific principle of PCHM?When coming into contact with this ancient and young subject,you should first understand the role of PCHM,and the premise is to understand what Traditional Chinese Medicine(TCM)is.

Section One The Definition and Nature of Processing of Chinese Herbal Medicine(PCHM)

1.Definition

(1)The definition of PCHM: According to TCM theory,PCHM refers to a kind of pharmaceutical technology,which is following the medication differentiation needs,the nature of the drug itself,and the different requirements for compounding.Broadly speaking,the contents of PCHM includes cleansing,cutting,and processing.In a narrow sense,the contents of PCHM cover frying,stir-frying,calcining,steaming,boiling,blanching,repeated processing,fermentating,sprouting,frost-like powder making,baking,grinding in water,etc.

(2)The definition of subject of PCHM: The Subject of PCHM refers to the subject specializing in the theory,technology,specification standard,history,and development of PCHM.

(3)About the theory of PCHM: It mainly refers to clarify the scientific connotation of theories and the mechanism of processing.For example,carbonizing drugs by stir-frying could enhance the hemostatic effect of the drug.The TCM theory holds that “when red blood meets with black drugs,bleeding stops”(The five elements promote and constrain mutually:metal-wood-water-fireearth).Modern studies show that carbonizing drugs by stir-frying could increase the content of tannin,increase calcium and iron ion content in blood,and promoting blood coagulation.

(4)About the technology of PCHM :The purpose to study the technology of PCHM is to enhance the efficiency of processing and to standardize the processing technology.Taking Strychni Semen(Maqianzi)as an example,there are several methods,such as stir-frying with sand technology,frying with oil technology,soaking in urine technology,and processing with vinegar technology which are applied to processing Strychni Semen.Among them,soaking in urine technology is considered the best method to relived the toxicity and enhance the effect of the drug.But considering the assistant of urine is unaccepted by normal people,finding the replacement of urine assistant and regular processing technology is necessary.

(5)有关规格标准: 目的在于规范饮片类型、规格和质量标准。包括饮片的片型、厚薄、外观色泽及成分含量等,以此确定中药饮片的质量标准,如巴豆霜,《中华人民共和国药典》(下文简称《中国药典》)规定其含脂肪油量在18%~20%之间,马钱子的炮制以士的宁含量作为指标,从而使中药饮片质量稳定可控具有可操作性,克服经验判断的局限性。

2.中药炮制学的基本任务

(1)探讨炮制原理: 炮制原理是指药物炮制的科学依据,探讨在一定工艺条件下,中药在炮制过程中产生的物理变化和化学变化,以及因这些变化而产生的药理作用的改变和这些改变所产生的临床意义。它包括对中药炮制减毒、增强疗效、缓和药性、产生新药效的原理研究等内容。例如对于黑豆汁蒸何首乌、醋制延胡索的炮制机制研究等。

(2)改进炮制工艺: 可从两方面来理解,首先是对传统炮制工艺的改进,如泽泻,从古至今都采用盐炙法进行炮制,但现代研究证明,盐炙泽泻的功效与其他非盐制炮制工艺无显著区别,因此,认为泽泻盐炙还有待于进一步商榷。其次,对传统炮制工艺从经验判别转为数据化的工艺参数,也是对炮制工艺进行改进的一方面,是实现饮片工业化和规模化的必然趋势。

(3)制定饮片质量标准: 饮片的质量标准包括外观鉴别(如色泽、气味等)和内在质量判别,如饮片的有效成分含量、有毒成分限量、农药残留量、重金属含量及指纹图谱、特征图谱等。

3.中药炮制学与其他学科的关系

(1)与传统中医药理论的关系: 中药炮制是在中医药理论指导下进行的制药技术。

(2)与中药化学的关系: 通过炮制会改变药物的化学成分,因此,须要掌握中药化学的基本知识,以此了解药物的主要成分在炮制前后可能会发生的变化,如含生物碱类成分的黄柏,其中的小檗碱易溶于水,因此,在用水处理黄柏时,要采用“抢水洗”的方式,避免有效成分小檗碱的损失。

(5)About the specification standards of PCHM: The main purpose is to standardize the types,specifications,and quality standard of processed drugs in decoction pieces.The shape,thickness of the slices,the color,and the contents of the components of slices help set the quality standards of the processed products.For example,in the Pharmacopoeia of the People's Republic of China (the Chinese Pharmacopoeia in short),the contents of fat oil in Crotonis Fructus should be contained between 18% to 20%.The content of strychnine is also the indicator to control the quality of the processed Strychni Semen,All the index of slices mentioned above are applied to make the quality controllable,so as to overcome limitations of empirical discrimination.

2.The basic task of PCHM

(1)Exploring the principle of PCHM: The principle of PCHM refers to the scientific basis of PCHM,which discuss the physical and chemical change of drugs,and thus the changes of pharmacopeia and clinical use with drugs’ processing,including the mechanism of reducing toxicity,enhancing the effect,and producing new effects.For example,the study of the processing mechanism of Polygoni Multiflori Radix(Heshouwu)steamed with black bean juice,Corydalis Rhizoma(Yanhusuo)stir-fried with vinegar,etc.

(2)Technology improvement of PCHM: The improvement of the PCHM technology includes two aspects.Firstly,to improve the traditional processing technology,such as Alismatis Rhizoma(Zexie),which is processed with salt since ancient times,but modern research showed that the effect of processing with salt had no significant difference from processing without salt,the technology of processing Rhizoma Alismatis with salt need further study.Secondly,transfer the traditional processing technology from empirical discrimination to digital processing parameters,is also the other aspect of improvement of technology of processing,which is the inevitable trend of realizing the industrialization and mass production of prepared slices.

(3)Formulate quality standard of prepared slices: The quality standard of prepared slices includes the identification of appearance(such as color,smell,etc.)and intrinsic quality judgment,such as the content of effective components,the limit of toxic components,pesticide residues,heavy metal contents,and fingerprint spectrum,Characteristic Atlas,etc.

3.Relationship between PCHM and other subjects

(1)Relationship between PCHM and the theory of TCM: The PCHM is the pharmaceutical technologies conducted under the direction of the TCM theories.

(2)Relationship between PCHM and Chemistry of Chinese Materia Medica: The components in drugs would be changed through processing,it is necessary to grasp the basic knowledge of Chemistry of Chinese Materia Medica to know the change of the main component in drugs after processing.For example,the alkaloid components exist in some drugs,such as Phellodendri Chinensis Cortex(Huangbai),the affective component of berberine in Phellodendri Chinensis Cortex(Huangbai)is easily resolved in water.In avoiding the loss of berberine,when processing this drug with water(wash,softening,and so on),it is better to process it in water as short as possible.

(3)与分析化学的关系: 分析化学包括两方面,化学分析和仪器分析。在化学分析方面,对药物的生熟制品进行化学分析,通过定性定量来判断孰优孰劣。在仪器分析方面,须要掌握高效液相色谱、气相色谱、质谱、紫外光谱、红外光谱等仪器设备的使用,以便更好地分析炮制前后成分的变化规律。

(4)与中药鉴定学的关系: 可通过掌握鉴定学知识,对药物切制成饮片之后的饮片断面进行鉴定,判别真伪优劣。

二、中药炮制的起源和发展

1.中药炮制的起源

中药炮制起源于原始社会,随着中药的发现而发展,并与火的发明、烹饪技术的发展密切相关(包括辅料和贮存器的发展)。

2.中药炮制的发展

中药炮制发展经历了四个阶段,中药炮制技术的起始和形成时期(汉以前);炮制理论的形成时期(金元明时期);炮制品种和技术的扩大应用时期(清代);炮制振兴、发展时期(中华人民共和国成立后)。

三、中药炮制的法规

2001年12月颁布的中华人民共和国药品管理法,是目前药品生产、使用、检验的基本法律,这便是中药炮制所必须遵守的法规。

《中国药典》是炮制所要遵循的国家级法规,附录设有“中药炮制通则”专篇,规定了各种炮制方法的定义、具有共性的操作方法及质量要求,是属国家级饮片质量标准。

《全国中药炮制规范》由原卫生部药政局组织编撰,于1988年出版,作为部级中药饮片炮制标准(暂行),附录中收录了“中药炮制通则”及“全国中药炮制法概况表”等。

(3)Relationship between PCHM and analytical chemistry: This relationship includes two aspects,chemical analysis,and instrumental analysis.For the aspect of chemical analysis,it is necessary to know about the qualitative and quantitative change of components through chemical analysis; For aspect of instrumental analysis,the methods of instrument use,such as HPLC,LC,MS,UV,IR,should be understood to analysis the change regulation of components before and after processing.

(4)Relationship between PCHM and identification of Chinese Materia Medica: The knowledge of identification of Chinese Materia Medica could be used to discriminate the true or false,good or bad of the drug through the cross-section of prepared slices.

Section Two Origination and Development of PCHM

1.Origination of PCHM

The PCHM was originated in primitive society,developed with the discovery of the Chinese Materia Medica,the invention of fire,and the development of cooking technology(including the development of food assistant and food storage).

2.Development of PCHM

The development of PCHM went through four stages,namely,the origination and formation period of PCHM technology(before the Han Dynasty),the formation period of processing theory(Jin,Yuan,and Ming Dynasties),the expanding application period of processing varieties and technology(Qing Dynasty),the rejuvenation and development period of processing(since the founding of the People’s Republic of China).

Section Three Laws and Regulations of PCHM

The Drug Administration Law of the People’s Republic of China(PRC)promulgated in December 2001 is the basic law for the production,use,and inspection of pharmaceuticals.This is the law that must be observed in PCHM.

Chinese Pharmacopoeia is considered the national regulations of PCHM.The appendix in the pharmacopeia contains the “General Principles of Chinese Medicine Processing”,which stipulates the definitions of various processing technologies,common technique operation methods,and quality requirements.It is the national level standard for prepared slices.

The National Chinese Herb Medicine Processing Regulations was compiled by the China Academy of Chinese Medical Sciences published in 1988.It is the ministerial level standard for prepared slices.The appendix there contains “General Rules of the Processing of Chinese Herbal Medicine” and “Overview of the National Processing of Chinese Herbal Medicine Methods” etc.

对于地方中药饮片标准,只有在国家与部级标准中没有收载此品种的情况下,才能制定适合本地的标准,同时应当报国务院药品监督管理部门备案,如《江西省中药炮制规范》《福建省中药炮制规范》等。

For the local standards of prepared slices,only under the circumstances that the varieties are not included in national level or ministerial level standard for prepared slices,the local standards of prepared slices could be used,and at the same time,they should be put on file to the Pharmaceutical supervisory and Administrative Department of the State Council.The local standards of prepared slices include Jiangxi Provincial Specifications of PHCM Fujian Provincial Specifications of PHCM ,etc.

参考文献

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