4.3. Considerations in the development of a prototy pe authenticated TCM plant library Between 2006 and 2010, investigators from Harvard Medical School(HMS),in collaboration with colleagues from the Beijing University of Chinese Medicine(BUCM) and Hong Kong Baptist University(HKBU), embarked on efforts to build a prototype library of 202 botanically authenticated, quality controlled, collection site-documented Chinese medicinal plants. Each plant was to be tested for pesticide and heavy metal contamination and qualified using standards defined by the Chinese Pharmacopeia [31],an official publication of the State Food and Drug Administration (SFDA)of the Peoples Republic of China. Such an artisan library could serve as a necessary prerequisite to reproducible pre-clinical studies of TCM herbs. These are mandatory prerequisites to the subsequent design and implementation of the next generation of animal and human studies of herbal remedies. Moreover, the ethnobotanical knowledge of TCM experts is essential to establish this library, and to efficiently guide drug development experts in their search for novel single compounds, novel uses of previously identified compounds and hypothetically novel demonstrations of additivity and/or synergy involving multiple plant compounds hin plants and within complex mixtures of medicinal plants In planning for, constructing and evaluating this authenticated TCM herbal library, many factors had to be considered including: the selection criteria of medicinal plants to be ncluded in the research library; quality assurance including harvest sites and gPs documentation; botanical species authentication; collection protocols; plant processing details; creation of voucher specimens; testing for pesticides and heavy metal contamination; chemical and quality assessment according to existing standards of the Chinese P9z Pharmacopeia; Chinese governmental cooperation, authorization and partnership; storage and shipping logistics of all specimens in China and the US; precise and reproducible extraction and fractionation procedures; selection of appropriate biological screening strategies; establishment of a suitable database and database management system; and continuous efforts to maintain open communications and opportunities for expanded research collaboration among all participating co-investigators 5. Methods (See Fig. I for an overview of the methods employed in the creation of this prototype TCM library) 5.1. Criteria for inclusion The selection of plants for the authenticated TCM herbal library was based on two main criteria:(1)the plants were listed in the official Pharmacopoeia of the People's republic of hina( CP)[31] and, (2)the species were not endangered. This latter criterion is of concerr since the over-harvesting of plants from wild sources for use in TCM is a growing problem [32]. For example, some plants used in Chinese medicine are on the Convention on International Trade in Endangered Species of Wild Flora and Fauna(CITES)list, including famous medicines such as Mu Xiang (Saussurea costus(Falc )Lipsch )and Rou Cong ro ( Cistanche deserticola Y C Ma)[33]. The official CP includes synthetic pharmaceut ong 于9 is study was launched, the most recent edition was the 2005 Chinese Pharmacopea he medicines, but also many traditional medicines derived from natural At the tin The first volume of the 2005 CP includes monographs on Traditional Materia Medica and comprised of substances derived from animals, minerals, plants, and fungi. A total of 471 monographs based on plant products are included in this volume, comprising 550 different species. The prototype library included a total of 200 species of plants and 2 species of fungi, representing more than one-third of all plant species listed in the CP. The 202 selected Autho4.3. Considerations in the development of a prototype authenticated TCM plant library Between 2006 and 2010, investigators from Harvard Medical School (HMS), in collaboration with colleagues from the Beijing University of Chinese Medicine (BUCM) and Hong Kong Baptist University (HKBU), embarked on efforts to build a prototype library of 202 botanically authenticated, quality controlled, collection site-documented Chinese medicinal plants. Each plant was to be tested for pesticide and heavy metal contamination and qualified using standards defined by the Chinese Pharmacopeia [31], an official publication of the State Food and Drug Administration (SFDA) of the People’s Republic of China. Such an artisan library could serve as a necessary prerequisite to reproducible pre-clinical studies of TCM herbs. These are mandatory prerequisites to the subsequent design and implementation of the next generation of animal and human studies of herbal remedies. Moreover, the ethnobotanical knowledge of TCM experts is essential to establish this library, and to efficiently guide drug development experts in their search for novel single compounds, novel uses of previously identified compounds and hypothetically, novel demonstrations of additivity and/or synergy involving multiple plant compounds within plants and within complex mixtures of medicinal plants. In planning for, constructing and evaluating this authenticated TCM herbal library, many factors had to be considered including: the selection criteria of medicinal plants to be included in the research library; quality assurance including harvest sites and GPS documentation; botanical species authentication; collection protocols; plant processing details; creation of voucher specimens; testing for pesticides and heavy metal contamination; chemical and quality assessment according to existing standards of the Chinese Pharmacopeia; Chinese governmental cooperation, authorization and partnership; storage and shipping logistics of all specimens in China and the US; precise and reproducible extraction and fractionation procedures; selection of appropriate biological screening strategies; establishment of a suitable database and database management system; and, continuous efforts to maintain open communications and opportunities for expanded research collaboration among all participating co-investigators. 5. Methods (See Fig. 1 for an overview of the methods employed in the creation of this prototype TCM library). 5.1. Criteria for inclusion The selection of plants for the authenticated TCM herbal library was based on two main criteria: (1) the plants were listed in the official Pharmacopoeia of the People’s Republic of China (CP) [31] and, (2) the species were not endangered. This latter criterion is of concern since the over-harvesting of plants from wild sources for use in TCM is a growing problem [32]. For example, some plants used in Chinese medicine are on the Convention on International Trade in Endangered Species of Wild Flora and Fauna (CITES) list, including famous medicines such as Mu Xiang (Saussurea costus (Falc.) Lipsch.) and Rou Cong Rong (Cistanche deserticola Y. C. Ma) [33]. The official CP includes synthetic pharmaceutical medicines, but also many traditional medicines derived from natural sources. At the time this study was launched, the most recent edition was the 2005 Chinese Pharmacopeia. The first volume of the 2005 CP includes monographs on Traditional Materia Medica and is comprised of substances derived from animals, minerals, plants, and fungi. A total of 471 monographs based on plant products are included in this volume, comprising 550 different species. The prototype library included a total of 200 species of plants and 2 species of fungi, representing more than one-third of all plant species listed in the CP. The 202 selected Eisenberg et al. Page 7 Fitoterapia. Author manuscript; available in PMC 2012 January 1. NIH-PA Author Manuscript NIH-PA Author Manuscript NIH-PA Author Manuscript