中药保健品是中药走向世界的主体

吕圭源（中国药理学会常务理事，中国药理学会中药药理专业委员会副主任委员，浙江中医药大学现代中药与健康产品研究所教授、所长，主要从事中药抗高血压药、代谢药理和中药新产品开发研究。）

1 非感染性疾病的主体性【Main body of noninfectious diseases】

多项调查结果显示，成人高血压患病率约为30%，有的国家更高，并还在继续增长，且最近高血压诊断标准下移，高血压患者大増。高血压又可引发心脑血管疾病（含心室肥厚及心衰、主动脉夹层动脉瘤等）、眼底视网膜病变及肾病等。我国糖尿病发病率约为11.6%，城市居民发病率高达14.3%，总人数超过1亿；又可引起高血酮、酮尿、脱水、电解质紊乱和代谢性酸中毒，严重者可导致昏迷，甚至危及生命。我国城乡居民的超重、肥胖率分别为33.6%和11.9%；肥胖对人体健康也可造成威胁。高尿酸血症患病率＞10%，是心脑血管病发病的独立危险因素，也是引起肾结石和尿路结石的重要因素，更是痛风的直接原因。1091例空腹血液标本血流变测定血液黏度升高占22.73%，血液黏稠，流速减慢可导致心肌缺血、脑血栓和肢体血管血栓等疾病。免疫力低下者会感到疲倦，易感冒，容易感染，易患癌症，肠胃功能下降及旧病容易复发等。我国亚健康人群比例为60%～70%，且多数为脑力劳动者。肿瘤、抑郁症、失眠和老年病等的发病率均快速 增 加 。【A number of survey results have showed thatthe incidence ofhypertension among adults is about 30%,and is higher in some countries and keeps increasing.With the recent decline in the diagnostic criteria for hyper⁃tension,the number of hypertension patients has increased a lot.Hypertension can also lead to cardio-cerebrovascular diseases(including ventricular hypertrophy,heart failure,aortic dissection aneu⁃rysm),retinopathy,and kidney diseases.The inci⁃dence of diabetes is about 11.6%,but as high as 14.3%among urban residents,and the total num⁃ber of diabetic patients exceeds 100 million in China.It can also cause hyperketonemia,phenyl⁃ketonuria,dehydration,electrolyte imbalance and metabolic acidosis,coma and even lifethreatening diseases under severe conditions.The overweight and obesity rates of urban and rural residents in China are 33.6%and 11.9%,respectively.Obesity can also pose a threat to human health.The incidence of hyperuricemia exceeds 10%,which is an independent risk factor for the development of cardiovascular and cerebrovascular diseases.It is also an important factor causing kidney stones and urinary tract stones,and is the direct cause of gout.22.73%of the 1091 cases of blood samples for blood rheology had an increased blood viscosity.Increased blood viscosity and slow flow of blood can lead to myocardial ischemia,cerebral throm⁃bosis,and limb vascular thrombosis and other diseases.People with weakened immune systems are vulnerable to fatigue,cold,infection,cancer,stomach delicacy,and a relapse.The proportion of sub-health population in China is 60%-70%,and most of them are mental workers.The inci⁃dence of cancer,depression,insomnia,and geri⁃atric diseases is rapidly increasing.】

2 现代药物对非感染性疾病治疗或预防的局限性【Limitations of modern drugs for treatment or prevention of non-infectious diseases】

国内外最有效的降压药治疗高血压，从开始用1种药物到最后用4种药物，有的患者还未能完全控制，且需要终身用药。糖尿病也是终身用药。高脂血症也是长期用药。肥胖、高尿酸血症和高黏血症等目前尚未有较好治疗药物。恶性肿瘤的药物治疗越来越受到争议，品牌药物无效不断被发现，治疗效果非常有限，有人还认为基本无效或毒性为主，总之，恶性肿瘤的治疗极为困难。抑郁症、失眠和老年病等药物治疗也很不理想。免疫力低下、亚健康或身体不适等更无合适药物可用。因此，通过调整机体功能，减少疾病发生发展或维持机体健康状态，提高机体的舒适度已成为全人类的迫切要求。国外大量使用的维生素、矿物质类产品，主要是补充维生素和矿物质，未能产生中药具有的保健功能。【Despite the most effective antihyperten⁃sive drugs at home and abroad for hypertension,with one drug used at first to four drugs combined eventually,some patients fail to fully controll,and their symptoms require lifelong medication.Diabetes also need lifelong medication.Hyperlip⁃idemia also needs long-term medication.There are no better drugs for obesity,hyperuricemia or hyperviscosity.Drug treatment of malignant tumors is increasingly controversial,ineffective branded drugs continue to be available,and the therapeutic effect is very limited,so that some people think that they are ineffective or toxic.In short,the treatment of malignant tumors is extremely diffi⁃cult.The effects of drug treatment of depression,insomnia and other aging diseases are also not desirable.There are no proper drugs for poor immunity,sub-health and physical discomfort.Therefore,adjusting the function of the body to reduce the occurrence of disease development or maintaining the body′s health status to improve the body′s comfort has become an urgent need of all mankind.Vitamins and mineral products that are widely used abroad are mainly supple⁃ments of vitamins and minerals and fail to produce the health care functions of TCM.】

3 中药保健特点与保健功能优势【Health-care features and health advantages of traditional Chinese medicine】

中药在中医药理论指导下应用，对某些疾病或疾病的某个阶段具有非常独特的疗效，这被长期医疗实践证明，已成为医生和患者的共识，特别是高水平现代医学（西）医生的共识。按照现代医学的认识过程，中药药效物质不清，作用机制不明，但中药确能治好病，确有很好的保健功能。请问是治好病或产生明显保健功能重要呢？还是先按照现代医学的认识过程去认识它重要呢？我想我们首先要解决问题，解决治疗和保健问题，发挥其应有的治疗和保健功能，提高民众健康水平；并应该有民族自信，对我们自主的有价值的传统成果必须坚持、必须发扬光大。外国人听不懂或不想听都没有关系，中医药的保健功能及产品客观上已经超过国外。中药药效物质和作用机制是否需要按现代医学的要求去搞清楚，很值得深入思考；一个本来就安全有用的物质，非要加一个国外认可的说法才可用吗？！按照这样的思路和方法去做有可能搞清楚吗？！至少在目前尚未搞清楚的阶段，仍有重大的使用价值。把中药有重点分阶段进行研究应该更合理，即先重点开展应用阶段的深入研究，对有实际应用价值的产品再进行深入的基础理论研究。【The application of TCM under the guidance of Chinese medicine theory has a very unique effect on certain diseases or stages of disease,which has been proved by long-term medical practice and has become the consensus of doctors and patients,especially of high-level modern medical(western)doctors.In accordance with the understanding process of modern medicine,TCM drug substances are unclear,the mecha⁃nism of action is unknown,but it can really cure the disease and perform good health care func⁃tion.To cure the disease and deliver obvious health care function,or to fit in with the under⁃standing of modern medicine to learn about it,which is more important?I think we must first solve the problems of treatment and health care,give full play to its proper treatment and health care functions and improve people′s health status.We should also have national confidence.We must uphold our traditions and valuable traditional achievements and carry them forward.Whether foreigners can understand or want to listen does not matter,health care function and products of TCM have surpassed those of foreign countries objectively.Whether it is worthwhile to clarify TCM effective substances and mechanism according to the requirements of modern medicine needs to be taken into serious consideration.Why do people use a safe and useful substance only after getting foreign recognition?It is impos⁃sible to make everything clear in accordance with this idea and method!TCM still has significant use value,although it has not been elucidated yet.It is more reasonable to focus on the phase-byphase study of TCM,that is,we should first conduct in-depth research on the application phase and conduct further basic theoretical research on products of practical application value.】

中药基本通过调整整体功能发挥治病疗效，同样也通过补益等作用调整整体功能而发挥保健作用，这与维生素和矿物质等营养素补充剂发挥单一营养素补充作用有非常显著差异，即具有显著特色或优势。中药的养生保健作用主要有以下几方面：①预防保健：中医防治疾病的一个显著特点是“上工治未病”，即最好的医生是帮助需要者养生保健。如《内经》所言：“正气存内，邪不可干”。早在一千多年前，就有用动物肝预防夜盲症，用海带预防甲状腺肿大，用谷皮和麦麸预防脚气病，用葱白和生姜预防感冒，服桑葚水煎膏具有滋补肝肾、耳聪目明之功能等。现代研究也充分证实或将被证实中医药所述食物预防保健作用的科学道理。②滋补保健：中医药滋补包括平补、清补、温补、峻补等，通过益精、补气、养血及调补脏腑虚损达到补充正气、增强体质的目的。如正心丸用于心虚血少，心神不宁之证；用食料包括鸭、鸡、猪、鱼肉、蔬菜、豆制品、绿豆、瓜类蔬菜和水果、绿豆粥、扁豆粥、荷叶粥、薄荷粥、枸杞子、百合、玉竹、黄精、莲子、山药等滋阴清热或药性平和之品，即所谓“清滋法”；温补如脾胃虚寒用理中汤，肾气虚寒用右归丸等。③延缓衰老：中医通过饮食调理而产生延缓衰老功能，如人参，味甘微苦，性温。《本经》谓其：“主补五胜，安精神”，“明目开心益智，久服轻身延年”。茯苓，味甘淡、性平。《本经》谓其：“久服安魂养神，不饥延年”。龙眼肉，味甘，性温。《本经》谓其：“久服强魂聪明，轻身不老”；枸杞子，味甘，性平。《本经》谓其：“久服坚筋骨，轻身不老”。白术补脾，益胃，燥湿，和中，安胎，《神农本草经》云，味苦性温，主风寒湿痹死肌，痉疸，止汗，除热，消食，作煎饵。久服轻身延年，不饥。【TCM basically exerts its curative effect by adjusting the function of the body as a whole,and also adjusts this function through the tonic effect,which plays a role of health care.There is very significant difference between TCM and the single nutrient supplement such as vitamins and minerals.The former has significant features or advantages.Health care of TCM has the following features.①Preventive care:a notable feature of prevention and treatment of TCM is"preventive treatment of diseases that have not occurred",that is,the best doctor is to help those in need of health care.As the"Neijing"says,if upright within,evil cannot disturb you.As early as more than a thousand years ago,there was prevention of night blindness with the animal liver,prevention of goiter with kelp,prevention of beriberi with millet skin and wheat bran,prevention of colds with scallion and ginger,mulberry water decoction that can nourish the liver and kidney,improve hearing and vision and so on.Modern research has also fully confirmed or will prove the scientific truth of the role of TCM in the preven⁃tion of health care.②Nourishing health care:TCM tonic,including gentle tonic,clear-up tonic,warming tonic,and strong tonic,restores the nourishing vital energy and enhances physical fitness by improving the essence,supplementing the spirit,nourishing blood,adjusting and mending viscera.Zhengxinpills are used for a weak heart,blood deficiency,and uneasy feeling.Gentle foods which can nourish and cool include ducks,chickens,pigs,fish,vegetables,soy products,mung beans,melons vegetables and fruits,mung bean porridge,lentils porridge,lotus leaf porridge,Rhi⁃zoma Polygonati,wolfberry,lily,Polygonatum,lotus seed,and yam,which are regarded as"purifica⁃tion purgation dispersion tonicity".Lizhong Tangis used for spleen and stomach deficiency andYouguipills for kidney spirit deficiency.③Antiaging:TCM delays aging by adjusting diet.For instance,ginseng,sweet slightly bitter and natu⁃rally warm,is recorded inShenNong′sHerbal Classicas"a drug that mainly complements five viscera and brings tranquility","benefits eyesight,increase body life after long use".Poria,which tastes sweet,and feels mild,is recorded inShenNong′s Herbal Classicas"able to keep one energetic peaceful and healthy if used for a long time".Longyanfruit,which tastes sweet and feels mild,is recorded inShenNong′s Herbal Classicas"capable of bringing peace and energy after long use".Wolfberry,sweetand mild,is recorded inShenNong′s Herbal Classicas"able to build strong bones and lighten the body".Atractylodes,which can nourish the spleen and stomach,drive away dampness,balance the essence,and stabilize the fetus,is recorded to be bitter and mild,and able to be to treat cold dampness to dead muscle,jaundice,antiperspirant,clear heat,digestion,and to extend life expectancy after long-term use as recorded inShenNong′s Herbal Classic.】

中药通过其独特的功效可产生预防保健、滋补保健、延缓衰老保健作用，具有领先的传统功能、显著的现代功能和潜在的保健食品新功能显示其优势，通过进一步的现代研究，对人体健康和产业发展将产生巨大贡献。【TCM,through its unique efficacy,contributes to preventive health care,nourishing health care and anti-aging health care.It has leading traditional functions,signifi⁃cant modern functions and potential health food functions to show its advantages.Through further modern research,it will make tremen⁃dous contributions to human health and industrial development.】

4 中药保健功能的优势研究【Study on healthcare function advantages of traditional Chinese medicine】

现有保健食品品种多，但大多数品种生产规模小、技术含量低，可能也有一些品种保健功能不可靠，造成产品生存周期短，生存能力差。中药虽具有明显优势特色，但中药保健食品的优势特色多数尚未展示；市场期盼新的保健功能食品，需要加强应用基础研究，加快新功能保健食品研发。这些已成为中药保健食品研究的当务之急。【There are many types of existing health food products,but most of them have a small scale of production and low technical contents.It is possible that some health functions of health products are unreliable,resulting in short product life cycles and poor survivability.Although TCM has obvious advantages,most of the advantages of TCM health foods have not yet been demonstrated.The market calls for new health-care functional foods,so we need to step up application of basic research and accelerate the development of new functional health foods.These have become the top priority of Chinese health food research.】

4.1 现有功能的可靠性研究【Reliability study on existing functions】

现有保健食品批准生产的文号已10 000多个，但有些保健食品功能较弱，或不可靠，或甚至个别基本无保健功能，迫切需要加强产品功能可靠性研究。保健食品功能可靠性研究，包括配方原料的功能研究、文献资料系统分析、配方组成研究、工艺与功能相关性研究、产品功能研究等。研制单位应自行开展基础研究和人体试验，其试验要求应该超过功能学试验规范要求的内容，如增加动物模型和指标等；研究时还应多参考中药药理学研究方法和要求，选择或建立适当的动物模型研究，且开展重复的功能学评价实验，再开展适当的功能学机制研究和功能因子研究，以保证保健食品功能的可靠性。【There have been more than 10 000 approval numbers ofhealth foods thathave been approved,but some health food functions are weak or unreliable,or even some have few health care effects,which is why there is an urgent need to strengthen product function reliability study.The study on the functional reliability of health foods includes functional study on raw materials,systematic analysis of literature,study on formulation of components,study on the correla⁃tionsbetween technologyand function,and study on product function.Research institutes and manufacturers should carry out basic research and human experiments on its own and their test requirements should exceed those required by functional test norms,such as increasing the animal models and indicators.In the research,more refer⁃ence about methods and requirements of TCM pharmacology should be made,select or establish appropriate animal model research,and carry out repeated functional evaluation experiments,and then carry out appropriate functional mecha⁃nism research and functional factor research to ensure the functional reliability of health foods.】

4.2 现有功能的特色研究【Study on features of existing functions】

中药具有非常丰富的功效，如人参，2015年版《中华人民共和国药典》一部记载，其功效为“大补元气，复脉固脱，补脾益肺，生津，安神”；《本经》记载，“久服安魂养神，不饥延年”，人参还有降逆止呕功能。白术补脾，益胃，燥湿，和中，安胎；《神农本草经》云，味苦性温，主风寒湿痹死肌，痉疸，止汗，除热，消食，作煎饵，久服轻身延年，不饥。而现有保健食品一般只是利用其某个功效或某个药理作用，需要对其功能特色进行深入研究。【TCM has diversified effects.For example,ginseng,according to theChinese Pharmacopoeia 2015,has the efficacy of"reinforceing vital energy,benefiting the spleen and lung,promoting the secretion of saliva or body fluid,and calming the nerves".ShenNong′s Herbal Classicrecords that it leads to good health and prolongs life expectancy if taken for a long time.Ginseng can also stop vomiting.Atractylodes,which can nourish the spleen and stomach,drive away dampness,balance the essence,stabilize the fetus,is recorded to be bitter in taste and mild in nature,abe to treat cold dampness to dead muscle,jaundice,antiperspirant,clear heat,and digestion,extend life expectancy after long-term use and not hungry inShenNong′s Herbal Classic.However,the existing health food generally only utilizes one particular effect or one particular pharmacological effect,making it necessary to further study the functional characteristics.】

中药的功能特色可表现在2个方面，一是功能比较显著，另一个是多个功能同时存在。通过多个方法或模型的规范试验和重复试验，使保健功能可靠；同时，进一步开展功能比较试验，使获得的功能更加显著。中药又由于其成分复杂，可同时产生多个功能，如具有辅助降血压功能的产品，其可能同时存在降血脂、降血糖、降血黏度等功效。可以对同一产品开展相关的多个功能学研究，若能证明某个产品确实存在3个功能，若批准的是1个功能，另外2个功能是该产品的特色；若批准的是2个功能，另外1个功能是该产品的特色；假如3个功能均被批准了，也是该产品的特色，因为这个产品具有3个功能，对具有3个相关功能异常的人群使用更合适。另外，还可进一步开展功能机制和功能因子研究。【The functional characteristics of TCM can be manifested in two aspects:one is its significant function,and the other is its multiple functions.Through standardized testing and repeated testing of multiple methods or models,the healthcare function is reliable.At the same time,further func⁃tional comparison tests are conducted to make the obtained functions more significant or powerful.TCM,because of its complex composition,can produce multiple functions at the same time,such as products with auxiliary blood pressure lowering function,which may induce hypolipid⁃emia,hypoglycemia,hypoproteinemia and other effects at the same time.We can conduct studies on different functions of one product.If you can prove that a product does have three functions,and one of these functions is approved,the other two are the characteristics of the product.If two functions are approved,the other one is the product′s feature.If three functions are approved,they are all the characteristics of the product.Because the product has three functions,it can be more appropriately used by populations abnormal in these three related functions.In addition,func⁃tional mechanisms and functional studies can be further developed.】

4.3 新保健功能产品研究【Study on new healthcare products】

目前批准保健食品功能最多27个功能，但人体功能异常远不止这27种情况，社会期盼更多的保健功能产品，即新保健功能产品。新的保健食品功能学研究，目前尚未确定规范的研究方法和评价标准。开展这项工作，首先要选择、确定或建立研究方法，并制定评价标准，该标准有较详细指标，利于实际操作。同时，该方法和评价标准还需审评专家和具体管理部门认可。【The number of health food functions currently approved is up to 27,but cases of body abnormalities are far more than 27 kinds,so society looks forward to more healthcare products,that is,new health care products.Research methods and evaluation criteria have not been stipulated about new health food func⁃tional studies so far.To carry out this work,we must first select,determine or establish a research method,and develop evaluation criteria.The criteria have more detailed indicators,which is conducive to the actual operation.At the same time,the method and evaluation criteria still need to be approved by experts and specific management departments.】

如降高尿酸血症保健功能，先应选取或确定动物实验的研究方法，包括制备高尿酸血症动物模型的方法（一般需要2种模型动物）、动物给药时间、测定指标和有效标准等。降尿酸研究还应有人体试验，受试人群的选择标准、产品的食用方法和食用量、检测指标、评价标准等。【If you want to study the health care function of uric acid reduction,you should choose or confirm the research method of animal experiments,including the method of preparing animal models of hyperuricaemia(usually needs two kinds of model animal),animal admin⁃istration time,measurement index,and effective standard.Study on uric acid reduction should include human test,the test population selection criteria,product consumption methods and consump⁃tion amount,test indicators,and evaluation criteria.】

4.4 产品工艺技术研究【Studyonproducttechnology】

中药是复合多成分发挥作用或功能，又由于炮制或配伍可以改变药性或功效，充分利用中药有效物质或功能因子是中药保健食品研究的功能基础，也是充分利用中药资源、发挥优势，并与世界接轨或领先的关键所在。应用中药制药研究领域的新技术，形成保健食品生产控制的数字化和智能化模式以保障产品的生产质量，从而保证产品的功能和安全性。【TCM works with multi-component com⁃pounds.Because processing or compatibility can change the potency or efficacy of drugs,making full use of effective substances or functional factors of TCM is the functional basis of health food research.It is also the key to making full use of TCM resources,giving full play to advantages,and integrating with the world to reach the leading level.The application of new technologies in the field of TCM research entails the formation of digital and intelligent mode of health food production and control to ensure product quality,thus ensuring the function and safety of products.】

中药保健食品虽然有片、粒、囊、糕、液等口服剂型，但仍需有明显食品属性，如具有色、香、味、形、体的特征，以满足人们对食品口感、观感和风味的需求。但目前市场上流行仍主要是片剂、胶囊和口服液等，其他剂型、包括食品形式茶、酒、饼、面、饭、粥、羹、饮、膏、丸、散、糕点、菜肴、蜜饯、糖果等，也可作为保健食品的剂型。因此，需充分应用现代科学技术，针对保健食品产品形式和中药原料的特点，加强保健食品原料提取和成型工艺研究，研发功能因子相对清楚、中药成分被充分应用，且保健功能突出，优势明显的中药保健食品，满足消费者的实际需求，提高中药保健食品的市场竞争力，并推动产品走向国际。【Although there are tablets,granules,capsules,cakes,liquids and other oral dosage forms,TCM health food products still have obvious food attributes such as color,aroma,taste,shape and body to meet people′s taste,perception and flavor demand.However,the market is still dominated by tablets,capsules and oral liquids.Other dosage forms and food forms,including tea,wine,cakes,noodles,rice,porridge,soup,drink,ointment,pills,powder,cakes,dishes,preserves and candies can also be used as health food formulations.Therefore,it is necessary to make full use of modern science and technology,strengthen the research on raw material extraction and shaping technology of health food according to the forms of health food products and characteristics of raw materials of TCMs.Research and develop professional TCM health foods whose functional factors are rela⁃tively clear,ingredients of TCM are fully used,health care functions are outstanding,advantages are obvious to meet the actual needs of consumers and improve the market competitiveness of TCM health food products and promote products to become international.】

5 结语【Conclusion】

中药保健食品有显著的功能优势，通过深入研究可以研制出更多的特色产品，并用现代科学技术和理论阐述其优势特色，对国人的身体健康将产生前所未有的重大作用，对产业经济发展产生巨大推动作用。【TCM health foods have significant func⁃tional advantages.Through in-depth study,more special products can be developed.If the advan⁃tages and characteristics are expounded with modern scientific technology and theory,it will exert an unprecedented significant effect on the health of people and serve as a powerful force behind the economic development of the industry.】

由于展示的是功能特色，表现出来的是民众健康水平的提高，见到的是健康指标的趋好，如免疫力提高、睡眠改善、血压下降或维稳、性功能提高、更年期延后、尿酸下降等；同时，也有现代医学理论的表述，适应不同人群的健康需求，必将受到国外人群大力追求，产品自然走向世界，并成为中药走向世界的主体。使中药及其保健食品为人类健康和产业大发展作出巨大贡献。【Due to the display of functional characteristics,demonstrated by the improvement of public health is demonstrated,and increasinglybetterhealth indicatorsare seen,such as improved immunity,sleep improve⁃ment,lowering blood pressure or stability mainte⁃nance,improved sexual function,delayed meno⁃pause and decreased uric acid and soon.Simul⁃taneously,modern medical theory is adapting to the health needs of different populations,so TCM products will be vigorously pursued by foreign people and recognized by the world and become the main body of TCM proceeding to the world.TCM and its health foods will make a significant contribution to human health and industrial devel⁃opment.】