2012年美国草药类膳食补充剂市场分析

通过分析2012年美国草药类膳食补充剂市场销售情况,探析各销售渠道发展的新特点以及畅销品种情况。通过回顾分析、数据分析、逻辑推理等方法,结合NBJ等分析公司的统计数据,对2012年美国草药类膳食补充剂市场整体及分渠道销售情况进行分析。整体来看,2012年美国草药类膳食补充剂市场继续保持稳定增长态势,市场前景可期。对于该市场各销售渠道畅销品种的深入研究与分析,将为我国中药企业开展国际化贸易带来更多发展机会。     

进入美国膳食补充剂市场的中草药制剂的功能确定

近年来美国草药类膳食补充剂市场的持续扩大,为中草药进入美国膳食补充剂市场提供了发展机遇。FDA规定膳食补充剂标签中可以出现符合规定的结构/功能声称(Structure/Function Claims),并列出了10条判断是否属于结构/功能声称的标准。美国市场中的中草药膳食补充由于产品标签中功能不明确、消费者对产品的功能不理解等因素,导致其真正的保健价值很难得到实现。因此,正确地表达并传递出中草药类膳食补充剂的功能,是中草药制剂进入美国膳食补充剂市场的重要环节。     

美国在华中药领域专利分析

自20世纪90年代以来，美国草药市场销售逐年上升。1994年，美国国会通过“饮食补充剂健康与教育法”（DSHEA），该法令明确规定将草药划分为食品补充剂类，允许草本药剂以食品补充剂的形式销售。该法令的颁布极大地促进了美国草药市场的发展，也吸引了众多公司和研究机构投入到草药产品的研发和生产活动中。近年，美国从事药用植物资源开发的日用保健品公司如康宝莱、新华茂、安利等，更是在华投资办厂设立研发中心。     

美国草药补充剂主流市场2005年销售额前20名排序

尽管美国草药补充剂总的销售情况呈上升趋势,但是据芝加哥Information Resources Inc.(IRI)公司统计,2005年美国主流市场FDM(即食品店、药店和大型商业中心)渠道中的草药补充剂的销售额为24942.55万美元,较2004年同期下降3.67%。IRI的数据没有包括沃尔玛、Sam’s俱乐部、其他大     

美国补充剂与植物药市场的博弈

目的:回顾2001年以来我国中药对美国进出口贸易情况,以及美国植物产品法规管理和市场环境对中药产业发展的潜在影响,探讨我国中药产业在美国的发展路径,以及植物药注册的可行性。方法:通过对进出口贸易数据、市场占比数据等分析,并结合回顾分析、逻辑推理等方法,对我国中药在美国发展现状及市场前景进行分析,以探讨我国中药产业在美国发展的未来趋势。结果和结论:2001～2010年间,我国中药产品对美国进出口贸易增长稳定,产品结构仍以提取物等原料型产品为主导,主要作为膳食补充剂的原料来应用。分析认为,美国膳食补充剂市场准入门槛较低,市场增长空间大,未来仍将是我国中药产品应用的主要市场;同时,我国中成药企业应深入研究美国药品注册法规,积极推动产品在美国的植物药注册工作。     

美国的食品监督管理

美国的联邦、州及地方等政府部门均参与食品安全监督管理。美国的“食品”概念广泛，包括草药、维生素、矿物质、氨基酸等各种膳食补充剂。本文对参与美国食品安全监督管理的主要部门及膳食补充剂的监督管理进行了简要分析，以期对促进我国的食品安全监督管理及中药产品出口有所帮助。     

FDA对膳食补充剂的不良反应进行调查

美国食品药品管理局(FDA)提出确定膳食补充剂如维生素和草药是否安全的提议。1994年通过的一项法律将膳食补充剂划分到食品类。与药物不同,膳食补充剂可在未经FDA检查的情况下便可投放到市场。     

2000年美国草药总销售额增长1％

据美国《Nutrition Business Journal》(NBJ)2001年第5/6期报道,全美草药补充剂2000年各种销售渠道的总销售额为41.3亿美元,比1999年的40.9亿美元增长1%。此项统计包括了主流市场(FDM 加各种销售俱乐部,如 Costco 等)和非主流市场(如天然食品与健康食品店、邮购、多层次消费市场、保健医生和网上销售)的销售情况。其中主流市场中的 FDM(Food,Drug and Mass Mar-ket,即食品店、药店和大型商业中心)渠道,     

美国草药补充剂主流市场2001年销售额前20名排序

据 IRI 公司统计,美国草药补充剂主流市场(即 FDM 销售渠道)2001年度零售额为3.37亿美元,比上年度下降了21%,这是连续第3年下降。此统计数字不包括非主流销售渠道,如采购俱乐部、便利店、天然食品超市、保健医生、邮购和网上销售等。其中在天然食品超市的销售额却比上年度增加了     

美国草药——市场,立法和机构

美国是世界最大的药品市场，其草药市场因受本国法律的严格限制而一直处于低糜状态，直到１９９４年，草药列入食品补充剂范畴后，草药市场才得以迅速发展。本文对美国草药市场的发展、立法和草药有关的重要商贸协会，科研组织和政府机构等作一介绍和分析。     

Herbal supplements interactions with oral oestrogen‐based contraceptive metabolism and transport

The increased use of herbal supplements as complementary or alternative medicines has become a clinical conundrum due to the potential for herb–drug interactions. This is exacerbated by an increased supply of new herbal supplements in the market claiming various health advantages. These herbal supplements are available as over‐the‐counter self‐medications. Herbal supplements are generally perceived as efficacious without side effects commonly associated with conventional drugs. However, despite regulations, claims related to their therapeutic effects are mostly unsupported by scientific evidence. These products often lack suitable product quality controls, labelled inadequately and with batch to batch variations, potentially compromising the safety of the consumer. Amongst health practitioners, the greatest concern is related to the lack of chemical characterization of the active compounds of the herbal supplements. The interaction between these different active components and their concomitant effects on other conventional drugs is generally not known. This review will focus on herbal supplements with the potential to effect pharmacokinetic and pharmacodynamic properties of oestrogen‐based oral contraceptives. The use of herbal supplements for weight management, depression, and immune boosting benefits were selected as likely herbal supplements to be used concomitantly by women on oral contraceptives.     

Ephedra-containing dietary supplements in the US versus ephedra as a Chinese medicine

Ephedra has been commonly used in traditional Chinese medicine (TCM) without significant adverse effects. Ephedra-containing dietary supplements are widely used in the United States to promote weight reduction and energy enhancement. However, there are significant safety concerns regarding the use of ephedra-containing dietary supplements, especially when such use occurs by consumers without medical supervision. This article reviews and contrasts the usage of ephedra as a dietary supplement in the US against an herbal medication in TCM. The potential adverse effects of ephedra-containing dietary supplements are also reviewed.     

基于川产道地药材及经典名方的美国膳食补充剂开发思路与路径

川产道地药材在中国道地药材资源中占有重要地位,以品种多、分布广、产量大、质量优为其特点,经典名方的安全性和有效性在中医药临床中经历了千年实践验证,是中医学传承中最有价值的部分。美国食品药品监督管理局(FDA)对膳食补充剂的管理方式和政策机制,为中药经典名方进入美国膳食补充剂市场提供了一条可行的路径。本文根据美国FDA对膳食补充剂的管理方式和本团队前期工作基础,概述了以基于川产道地药材及经典名方转化为美国膳食补充剂的思路的操作思路和方法,通过对FDA法规的分析为中医药走入国际市场提供政策依据,以实例为中医院进入国际市场提供可供借鉴的成功案例。     

Ist bei einer Risikobeurteilung der Chinesischen Medizin die Einhaltung wissenschaftlicher Standards überflüssig?

The outstanding German hepatologist, Rolf Teschke has contributed considerably to the elucidation of hepatotoxicity of herbal remedies. Recently he and several co-authors published an article in Alimentary Pharmacology and Therapeutics on the hepatotoxicity of TCM preparations as indicated by international publications between 2011 and March 2014. However, the promising approach does not conform to expectations. Most of the reported liver injuries miss Chinese Medicine but rather apply to local folkloristic practices in China and Korea, the Kampo medicine, dietary supplements from USA containing one or two Chinese herbal ingredients, and a western herb misleadingly attributed to Chinese Medicine. The included sources mostly fail to provide standardized causality assessments as well as authentication of herbal ingredients, testing for contamination and adulteration, which otherwise are considered basic prerequisites for a valid causality statement by the first author. The article exhibits many mistakes pointing to insufficient expertise in Chinese Herbal Medicine (CHT).     

中国营养保健市场潜力与进口注册管理

中国是全球营养保健产业最具发展潜力的市场,庞大的市场规模吸引着国际膳食营养补充剂产品进入中国市场。本文对中国市场发展潜力和前景做了分析,结合保健食品进口注册情况和存在的问题,就国际膳食营养产品进入中国市场提出了建议。     

Dietary quercetin supplements: Assessment of online product informations and quantitation of quercetin in the products by high‐performance liquid chromatography

Administration of the increasingly popular dietary supplements containing quercetin may interfere with drug therapy. We intended to evaluate the online availability and quercetin content of the high‐dose mono‐component quercetin products and to review the potential use of quercetin products and their interactions with drugs. We monitored the online access to quercetin‐containing dietary supplements, collected the relevant information from the websites, procured selected products from the vendors, and subjected them to substance analysis. The quercetin content was quantified by an HPLC‐UV method. Twenty‐five websites offered mono‐component quercetin products, and nine products were procured. The quercetin content of eight products differed only ±10% from the nominal dose, whereas one product contained almost 30% more quercetin. Misleading indications such as antitumor and cardiovascular effects were often found on the sellers' websites. Quercetin‐containing dietary supplements are available online with misleading indications. The recommended daily doses are often high (occasionally over 1,000 mg), which may induce clinically relevant interactions with medications. Because high‐quercetin content of dietary supplements was confirmed, health care professionals should be aware of the unregulated internet market of dietary supplements and should consider the interactions of these substances with drugs.     

Ganodone, a bioactive benzofuran from the fruiting bodies of Ganoderma tsugae

Extracts of Ganoderma tsugae, also known as the Hemlock varnish shelf mushroom, and related Reishi mushrooms are well documented in traditional Chinese medicine. Several Ganoderma sp. are currently cultivated for use in coffee, teas, and dietary supplements. We now report on the isolation and characterization of an unprecedented benzofuran, ganodone (1), from the fruiting bodies of mature growth G. tsugae. This discovery provides a key next step in evaluating the active components in their associated herbal supplements.     

The use of complementary and alternative medicine by individuals with features of metabolic syndrome

OBJECTIVE: To compare the use of complementary and alternative medicine(CAM), including dietary supplements, by individuals with and without features of metabolic syndrome(FeMS).METHODS: Using a cross sectional study design, information was obtained by self-administered questionnaires from 300 university individuals.FeMS was defined as any individuals self-reporting at least one of the clinical diagnoses of diabetes, hypertension, hyperlipidemia, or obesity.Finally, two categories were created for cross tabulation, and individuals with and without FeMS were compared.RESULTS: Of the 192 individuals completing the study, 39%(n=76) were currently using or had used CAM therapies in the past 12 months.Individuals with FeMS(n=54, 28%) were more likely(P0.05) to use different types of CAM therapies, in particular dietary and herbal supplements, aromatherapy and massage therapy compared to individuals without FeMS(n=138, 72%).CONCLUSION: Individuals with FeMS were more likely to use CAM, particularly supplements.Doctors need to properly inquire about and understand their patients' supplement use, especially if CAM therapies are used in conjunction with conventional medications.     

中药产品欧盟上市可行途径及法规解析

欧盟作为全球最大的植物药市场,是中药产品进军国际市场的重要目标。根据欧盟现行法规,中药产品可以食品补充剂、药品、化妆品和医疗器械的形式进入欧盟市场。通过对食品补充剂、药品固有应用（WEU）和药品传统应用（TU）申请等中药产品的主要上市途径以及相关欧盟法规进行简要解析,明确中药产品在欧盟上市的可行途径,以期为国内有志开拓欧盟市场的中药企业提供一定借鉴。