【作者】 周素娟；

【导师】 黄璐琦； 杜贵友；

【作者基本信息】 中国中医科学院 ， 中药学， 2007， 博士

【摘要】 中药是我国保健食品原料的重要组成部分。传统的中医养生保健理论与长期的实践经验是我国保健食品开发的丰富资源，对我国保健食品的发展具有重要的指导作用。但是目前中药原料在保健食品中的应用现状不清，不利于我国保健食品的健康有序发展。因此，对中药在保健食品中的应用情况进行系统整理研究，具有重要的现实意义和实用价值。研究目的对近年来我国保健食品中药的应用现状与特点加以系统整理、分析与总结，研究中药在保健食品的组方应用、用量安全等方面的规律与特点，为管理部门决策提供数据支持，为规范保健食品技术审评和探索新的审评模式提供参考。研究方法以保健食品审评系统后台数据库信息和近年批准注册的保健食品原始档案配方资料信息为基础，选用MySQL数据库软件建立起我国保健食品原料数据库信息系统。分析研究2003-2005年SFDA注册的2659个产品中中药原料的应用状况、组方规律及用量安全。结果1中药应用概况2003-2005年注册保健食品以中药类产品为主，占功能类产品的75.6％，占注册保健食品总数的64％。中药原料使用频次分布不均衡。枸杞子、黄芪等少数原料使用极为频繁，而高达60％以上的原料较少使用。中药提取物的使用较为普遍，占保健食品产品总数的8％，但缺少统一规范的质量标准。涉及中药的功效／标志性成分有50余种，主要集中于总皂甙、总黄酮和粗多糖三种，特异性较差。与1996-1999年卫生部注册产品相比，两个不同历史时期保健功能分布、常用原料的使用频次趋势基本一致。但2003-2005年注册产品保健功能的种类趋于多元化，中药原料的使用也趋于安全化。2中药分类整理将目前允许使用的201种中药原料分别按中医功效和27项保健功能进行了分类。按中医功效分类法分为18类，其中补益类中药最多(占全部中药种数的1／4)，也最为常用。参考《中国药典》(2005年版)补充了原料的种属名称、拉丁学名和使用部位。这两种分类方法具有一定的互补性。将这两种方法很好地结合起来，对于研究和认识中药类保健食品具有一定的意义。卫法监发[2002]51号文件两个附件名单存在部分原料名称不规范，个别品种有重叠现象，部分原料的炮制方法、产地、鲜品不明确等问题。3组方分析以改善营养性贫血功能产品为例分析其组方的特点，其组方模式以中药与铁等营养素配伍最为多见(占该类产品总数的75％)，全部以中药组方的产品仅占8％。所选用的中药以补血、补气、活血、安神等类为主。并对其它类功能产品组方特点进行了归纳总结。中药类保健食品“君臣佐使”的的组方原则不突出，主要以现代药理学研究结果为基础组方。4用量与安全对其中40种最常用中药的用量情况进行了分析，并与《药典》(2005年版)规定的用量进行了比较。上述中药的用量多低于药典相应用量的下限值，卫法监发[2002]51号文件附件1和附件2原料用量(中位数)多集中于药典用量下限的20％～30％。原料用量区间多集中在(0-3]和(3-6]两个区间范围，且以(0-3]区间为主。选取枸杞子、西洋参、黄芪等6种最为常用原料，分别对其主要的保健功能每日用量(中位数)进行了比较。各原料在不同保健功能上用量很接近，但统计学有显著性差异。白果、苦杏仁、栀子、决明子、五味子、芦荟、何首乌等有潜在安全性问题的中药用量中位数均较低。但极个别产品五味子、制何首乌、生何首乌的最大用量超过了药典用量。决明子和芦荟的最大用量在药典用量范围之内，但高于其动物毒性试验报道剂量，应引起高度重视。结论1急需加强中药类保健食品的基础研究，建立统一规范的中药提取物质量标准，进一步完善我国保健食品功效成分的分类体系，加强功效／标志性成分的理论研究及检测水平。2建议尽快修订中药原料名单，规范原料名称，增加拉丁学名和药用部位，对个别有重叠现象的品种进行调整，并对原料的炮制方法、产地、鲜品等予以明确规定。3中药类保健食品在组方上应加强中医药理论的指导作用，并充分利用现代高新技术深入研究揭示其作用的本质。4加强对中药原料用量有效性和安全性的研究。对于有潜在安全性问题的中药原料用量不应过高。建议对附件1中有一定毒性的白果和苦杏仁作出限量规定，以制何首乌代替生何首乌的使用。本研究首次建立了我国保健食品原料数据库信息系统，实现了原料及其用量、原料与组方、功能等信息的便捷查询和综合分析。本研究利用该数据库全面系统分析了近年来保健食品中药的应用现状与组方以及用量安全等方面的特点，指出中药在保健食品中应用所存在的问题，对于完善保健食品技术审评工作及探索新的保健食品审评模式具有实际意义，为科学合理地制定保健食品监督管理政策提供了依据，也为中药在保健食品的研究发展提供了新的研究课题。更多还原

【Abstract】 Traditional Chinese Medicine (TCM) constitutes an important source for China’s health foods. Its theories of preservation as well as its long history of practice contributes abundant resources and provides important guidance for the development of China’s health foods. At present, however, the applicability of the TCM sources to health foods is unclear. Such uncertainty greatly impedes the healthy and orderly development of China’s health foods. Therefore, a systematic classification and study of the TCM’s application in health foods has significant practical and pragmatic values.ObjectiveTo systematically classify, analyze and summarize the status quo and characteristics of the TCM’s application in health foods; to study the principles and characteristics of the TCM’s compositional application and safety dosage issues; to provide data support for decision makers; to provide references and guidance for regulating the technological evaluation of health foods and exploring new evaluation models.MethodThis research is based on the back-end database of the Health Food Evaluation System and raw data of compositions of health foods which have been approved to register in recent years. MySQL database software is used to generate the health food raw database information system. Conditions, components, principles, and safety dosages of TCM components used in 2659 products registered with SFDA between 2003 and 2005 have been studied and analyzed. Results1. Overview of Application of Traditional Chinese MedicineTraditional Chinese medicine products constitutes a major portion of the health foods registered between 2003 and 2005, accounting for 75.6% of the utility category of products and 64% of the total registered health foods. There is a disparity in the usage of different traditional Chinese medicine components. A few components such as Fructus Lyeii and root of Mongolian milkvetch are frequently used while over 60% of the traditional Chinese medicine components are rarely used. Processed traditional Chinese medicine is commonly used, accounting for 8% of the total health food products. There are 50 functional/nominal ingredients, however, mostly focusing on total ginsenosides, total flavonoid and amylose. Compared to products registered between 1996 and 1999 with the Ministry of Public Health, the allocation and the usage frequency and trend of common components are consistent. However, the health food products registered between 2003 and 2005 are more diversified, and their use of traditional Chinese medicine components tends to be safer.2. Classification of Traditional Chinese MedicineWe divide the 201 kinds of traditional Chinese medicine components into 18 categories based on their medical functions and effects. Among them, the species of supplemental medicine constitute the largest group (accounting for 1/4 of the total number of traditional Chinese medicine) and are also more commonly used. We referenced to "Chinese Medicine Dictionary" (2005) and added categorical names of each component, their Latin names as well as the applicable body part. There are some issues with the two attachments to the Public Health Order [2002]51. For instance, names of certain component are mislabeled. There is overlapping between a few categories. Manufacturing processes, production sources and fresh components are not specified for some components.3. Composition AnalysisWe used the anemia improvement products as an example to analyze its compositional characteristics. The typical composition comprises traditional Chinese medicine and supplemental such as iron (about 75% of this category of products). There are only 8% of products which are comprised of pure traditional Chinese medicine. The traditional Chinese medicine selected are mainly blood enrichment, vital energy invigorating, blood circulation stimulating, and/or mind tranquilizing. Summary of the characteristics of the remaining functional ingredients is also provided.4. Dosage and SafetyWe analyzed the dosages of the 40 most commonly used traditional Chinese medicine and compared them against the dosages mandated by the "Chinese Medicine Dictionary" (2005). The abovementioned traditional Chinese medicine dosages are mostly below the lower limit of the corresponding dosages required in the "Chinese Medicine Dictionary." The raw material dosages (median) provided in the Exhibits 1 and 2 of the Public Health Order [2002] 51 Order are mostly congregated within the 20%~30% range of the minimum dosage specified in the "Chinese Medicine Dictionary." The raw material dosages usually are between the (0-3] and the (3-6] scope, predominantly around the former.We selected six commonly used components including Fructus Lyeii, panaxquinquefoliuml and root of Mongolian milkvetch, and compared their daily dosages (median) for their primary health-nourishing functions. The dosages of the same individual component are quite close for its various health-nourishing functions. However, such variations have significant statistical implications.The median dosages of traditional Chinese medicines which have potential safety issues, such as, Ginkgo, Bitter Apricot Seed, Gardenia, Cassiae Torae Semen, Schisandra and Aloe are relatively low. However, the maximum dosages of Schisandra and Radix Polygoni Multiflori Preparata exceed the dosages required by "Chinese Medicine Dictionary." The maximum dosages of Cassiae Torae Semen and Aloe are within the range given by "Chinese Medicine Dictionary." However, they are higher than the reported dosages used in toxic experiment on animals, which should invite serious attention. Conclusions1. There is an urgent need to strengthen the fundamental research on health foods made of traditional Chinese medicine, to establish uniform and normative TCM ingredients purification standard, to perfect the classification system of China’s health food ingredients, and to improve the theoretical research and experimental examination of the functional/nominal ingredients.2. We suggest that traditional Chinese medicine component list be revised as soon as possible, that medicine names be formalized, Latin terms and applicable body parts be added, overlapping categories be adjusted, and manufacturing process, product source region and fresh ingredients be specified.3. We suggest strengthening the application of traditional Chinese medicine theories in the prescription of herb health foods, and modern high tech be used to study the functionalities of traditional Chinese medicine.4. We suggest strengthening the utility and safety of traditional Chinese medicine components. The dosages of components which have potential safety issues should not be high. We recommend that a limitation be imposed to Ginkgo and Bitter Apricot Seed which has some toxic effects.This research provides abundant data information for administrative divisions enacting relevant policies and has significant implications in improving the technical review of health food and for exploring new health food evaluation models.更多还原