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GAP Production of TCM Herbs in China

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GAP Production of TCM Herbs in China 1948 Reviews GAP Production of TCM Herbs in China Authors Bengang Zhang1, Yong Peng1, Zhao Zhang1, Haitao Liu1, Yaodong Qi1, Shuang Liu2, Peigen Xiao1 Affiliations 1 Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P.R. China 2 Certification Committee for Drugs, State Food and Drug Administration of the Peopleʼs Republic of China, Beijing, P.R. China Key words Abstract for TCM herbs in 2002. Up to 2010, a total of 99 l" GAP ! GAP bases were formally adopted by GAP certifi- l" TCM herbs In this paper, we briefly review international cation. They cover 22 provinces/municipalities, l" GAP base Good Agricultural Practice (GAP) regulations re- and 49 species of TCM herbs are currently culti- l" China lated to traditional Chinese medicine herbs (TCM vated in these GAP bases. Finally, we discuss the l" cultivation herbs) and the background of the drafting process main problems in GAP implementation for Chi- and the implementation of GAP for TCM herbs in nese crude drugs and put forward some sugges- China. We also have summarized progress and tions to tackle them. achievements since the implementation of GAP Introduction GAP for TCM herbs ! GAP for TCM herbs, referred to as Chinese crude Traditional Chinese medicine (TCM), one of the drugs (CCD) in Chinese official documents, is in- treasures of the Chinese nation, has made great tended to control various factors affecting the contributions to the development of both Chinese production quality of medicinal plant materials, and world civilization for thousands of years. As to standardize various crude drug production traditional medicine and the research technology processes and even the whole process so as to en- of TCM develop more rapidly than ever before, sure that TCM herbs are authentic, safe, effective, much attention is being paid to it worldwide be- and consistent in quality [1]. Herein, TCM herbs received October 1, 2010 cause of its abundant resources, unique curative cover CCD, herbal medicines, ethnodrugs, and in- revised October 13, 2010 effects, low toxic and side effects, and more is troduced botanical drugs. accepted October 14, 2010 being invested in its research and development Bibliography while posing more demanding requirements for Formulation of GAP for TCM herbs DOI http://dx.doi.org/ the quality of TCM products. However, many Along with the worldwide trend for returning to 10.1055/s-0030-1250527 problems exist during the conventional TCM the nature, people are paying more attention to Published online November 12, herbs production process in China, including un- the medical and health care function of tradition- This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited. 2010 clear germplasm resources, substandard planting al medicines, especially TCM, and some countries Planta Med 2010; 76: 1948–1955 © Georg Thieme and processing techniques, excessive pesticide have formulated relevant legislations concerning Verlag KG Stuttgart · New York · residue and poor quality of TCM herbs, thus lead- the quality control of herbal medicines. ISSN 0032‑0943 ing to inconsistent quality of Chinese-made TCM Many countries have taken a series of standard- Correspondence products and severely affecting the stability of ized measures concerning quality control of pro- Prof. Peigen Xiao the curative effects of TCM as well as the lead po- duction of raw materials for natural medicines. Institute of Medicinal sition of Chinese TCM products in the world drug For example, the Japanese Ministry of Health, La- Plant Development Chinese Academy of Medical market. These challenges can be tackled in part bor, and Welfare revised Medicinal Plants Plant- Science and Peking through a Good Agricultural Practices (GAP) ap- ing and Quality Evaluation in 1992; the US gov- Union Medical College proach, which aims to standardize the cultivation, ernment issued a draft FDA Guidance for Indus- No. 151, Malianwa North Road, Haidian District collection, and processing of TCM herbs, improv- try: Botanical Drug Products in 1996; the Euro- Beijing 100193 ing their quality and bringing TCM in line with pean Herb Growers Association (Europam) pro- P.R. China the international practice, being therefore a key posed Good Quality Control of Medicinal Plants Phone: + 861063011294 Fax:+861062899715 to the modernization and internationalization of and Animals in August 1998; later, the European [email protected] TCM. Union (EU) drafted Guidelines for Good Agricul- Zhang B et al. GAP Production of… Planta Med 2010; 76: 1948–1955 Reviews 1949 tural Practice (GAP) of medicinal and aromatic plants, commonly duction sites. The environmental conditions of the production known as EU GAP, which were published officially in May 2002; sites should meet the requirements of the related national stan- the World Health Organization (WHO) began formulating guide- dards: “Atmospheric Conditions Standard (GB 3095-1996)”, lines on good agricultural and collection practices (GACP) for me- Grade 2 for air quality; “Soil Quality Standard (GB 15628-1995)”, dicinal plants in August 2001 and published them in 2003. The Grade 2 for soil; “Farm Irrigation Water Standard (GB 5084-92)”, international development trend of GAP indicates that its imple- Grade 2 for irrigation; “Drinking Water Standard (GB 5749-85)” mentation is a common approach of various countries to ensure for animal drinking water. consistent quality and safety of medicinal plants or herbal medi- Germplasm and propagation materials: At first, propagation ma- cines. terials should be identified accurately as to their relevant taxo- The State Food and Drug Administration (SFDA) of China put for- nomic rank. Homonyms and synonyms of TCM herbs are very ward GAP for TCM herbs for the first time in November 1998. common in traditional Chinese medicine. For example, the origi- Based on domestic and foreign experiences in management of nal plant of Dang Gui is Angelica sinensis in the Pharmacopoeia of medicinal plants and animals, Good Agricultural Practice for Chi- the PRC. However, Dang Gui involves 8 species of 2 families in folk nese Crude Drugs (Interim; “Chinese Crude Drug GAP”)wasoffi- and traditional usage, while there are 11 vernacular names of cially published on April 17, 2002, and enacted as of June 1, 2002. A. sinensis in traditional literature and local nomenclature sys- In order to effectively implement GAP for TCM herbs, SFDA for- tems. Therefore, the adopted and Latin names of TCM herbs mulated and enacted the “Management Measures of Chinese should be clearly recorded to avoid nomenclatural confusion. Crude Drug GAP Certification” (Provisional) and “Chinese Crude Secondly, the germplasm of propagation materials should be paid Drug GAP Certification Evaluation Criteria” (Provisional) on Sep- more attention to in practice. Many cultivars of medicinal plants tember 19, 2003, which symbolized the commencement of the with good agronomic traits have been selected and bred during standardization of TCM herb production in China. the long cultivation history of China, such as Rehmannia glutinosa cv. “Jin Zhuang Yuan” and R. glutinosa cv. “Xiao Hei Ying”.They Significance of GAP for TCM herbs have significant differences in stress resistance and yield. Finally, TCM herbs are the basic material of the decoction pieces and for when certain species have different secondary metabolites in dif- the production of Chinese traditional patent medicines. Safety ferent populations, the propagation materials should be well and consistent quality of TCM herbs is the physical prerequisite chosen. The reason lies in the fact that different ecological factors for the clinic application of TCM. GAP for TCM herbs is intended could cause diverse secondary metabolic pathways. For example, to control their quality during the whole process of production Securinega suffruticosa in the Beijing population contains d-se- and ensure their safety, consistent quality, and controllability. curinine, while l-securinine appears in the northeastern China The safety and consistent quality of TCM herbs also provides solid population, and the two kinds of securinnine coexist in the assurance for GLP, GCP, GMP, and GSP of TCM. GAP is therefore a Chengde population. requisite to standardize and modernize TCM. It also is the key to Cultivation and feeding management: TCM herb cultivation man- enhance international competitiveness of TCM and to realize its agement demands formulating standard operating procedures internationalization. (SOPs) for the production technology. The contents of SOPs in- The GAP approach is one of the important measures to the indus- clude a fertilizing program, irrigation technology, pest control trialization of TCM herb agriculture. Standardization, commercial measure, determination methods, and limitation standards of scale, and industrialized production of TCM herbs are a prerequi- toxic and harmful substances in TCM herbs, as well as application site for their use as pharmaceuticals and in health care. It also is a of specific fertilizers for TCM herb cultivation and pesticide resi- way to improve rural livelihoods and income [1]. Furthermore, due standards. Medicinal animal feeding and management also the collections of wild resources are standardized in the imple- require developing SOPs, including the condition of facilities, mentation of GAP, which plays a role in protecting wild herb re- health management, feed, feed additives, drinking water, disease
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