从中药的不同业态看中药产业的整体发展趋势

看病贵、看病难一直是一个世界性难题。中国人均医疗费用只有美国的1/30,底子薄,基础差,城乡发展不均匀,却在新冠肺炎疫情下打了一场“漂亮”的战役。虽说眼下全球疫情还没有明显放缓迹象,治疗新冠肺炎(COVID-19)的特效药亦未面世,但能够在有限资源下,控制住了疫情的肆虐,走出一条中国式的抗“疫”道路,中医药在重大疫情防治中发挥的作用不容忽视。

Medical treatment has always been an expensive and challenging problem worldwide. China’s per capita medical expenses are only 1/30 of that of the United States. It has a weak and poor foundation, and uneven urban and rural development. However, it has fought a “beautiful” battle under the coronavirus epidemic. Although the global epidemic has no obvious signs of slowing down, and no specific medicine for the treatment of new coronavirus (COVID-19) is available, with limited resources, the raging epidemic is under control and embarks on a Chinese-style anti-epidemic path. The role played by Chinese medicine in the prevention and control of major epidemics cannot be ignored.

在这次疫情抗击中,中医药在抗击疫情整个过程中(包括预防、治疗和康复全过程)发挥的作用大家有目共睹,中医药参与面之广、参与度之深、受关注程度之高,都是新中国成立以来前所未有的。

In fighting against the epidemic, the role played by traditional Chinese medicine throughout this period, including prevention, treatment and rehabilitation is obvious to all. The width and depth of participation of traditional Chinese medicine and its level of attention is unprecedented since the founding of New China.

本文将在这一时代背景和发展下对几种中药应用形式(传统饮片、配方颗粒、经典名方标准颗粒、中成药、天然药物)的市场表现及相应的技术特点进行简要分析。

Based on this background of the current generation and development, this article will briefly analyze the market performance and corresponding technical characteristics of several kinds of traditional Chinese medicine application forms (traditional Chinese herbal medicine decoction, dispensing granules, classic formula standard granules, Chinese patent medicine, natural drugs).

 

一、中医药行业持续增长,超过医药行业平均水平
There has been consistent growth in the traditional Chinese medicine industry, and it has been growing above the average level of the pharmaceutical industry.

中药是指在中国传统医药理论指导下,应用于临床疾病防治的药物总称(含中药材、中药饮片、中成药等)。近年来,国家对中医药产业的支持力度不断加大,相继出台了《关于扶持和促进中医药事业发展的若干意见》、《中医药健康服务发展规划(2015-2020年)》以及《中华人民共和国中医药法》等,推动了中医药产业发展,取得显著的成就。另外在“互联网+”的时代大背景下,中医药发展不断突破传统模式,涌现出“互联网药房”等新形式,适应着患者对中医药服务的新需求,进一步拉动了产业发展。

Traditional Chinese medicine refers to the general name of medicines applied to the prevention and treatment of clinical diseases under the guidance of Chinese traditional medicine theory (including Chinese herbal medicine, Chinese herbal medicine decoction, Chinese patent medicine, etc). In recent years, China has increasing the support for the traditional Chinese medicine industry, and issued Several Opinions on Supporting and Promoting the Development of traditional Chinese Medicine, Development Plan of Chinese Medicine Health Service (2015-2020) and Chinese Medicine Law of the People’s Republic of China, etc., which have promoted the development of the traditional Chinese medicine industry and accomplished remarkable achievements. In addition, under the backdrop of the “Internet” era, the development of traditional Chinese medicine continues to break through the traditional model, new forms such as “Internet pharmacies” have sprang up all over the country. They serve to the new demand of patients for traditional Chinese medicine services, and promoted the development of the industry further.

据中国产业竞争情报网《我国中药产业的大势与前景》报道,2015年全国医药产业完成产值21,682亿元,同比增长17.9%,其中中药饮片1259亿元,同比增长26.9%;中成药5065亿元,同比增长21.1%,中药行业增长率继续保持在20%以上,超过医药行业平均水平。

According to the report of ” The Trend and Prospect of Chinese Traditional Medicine Industry” by China Industry Competition Intelligence Network, the output value of the national pharmaceutical industry in 2015 was 2.1682 billion yuan, a growth of 17.9% year over year. Among which,Chinese herbal medicine decoction was 125.9 billion yuan, it grew 26.9% year on year. Chinese patent medicine was 506.5 billion yuan, a growth of 21.1% year on year. The growth rate of the Chinese medicine industry continues to remain above 20%, and has exceeded the average level of the pharmaceutical industry.

 

二、中药饮片及中药配方颗粒在以中医药为特色的中医院的应用情况
Application situation of Chinese herbal medicine decoction and Chinese medicine dispensing granules in Traditional Chinese Medicine Hospital characterized by traditional Chinese Medicine.

在中国古代,关于药物起源的传说颇多。“伏羲氏尝味百药而制九针”“神农尝百草”与“伊尹制汤液”的传说反映了中华先民认识和使用药物的起源。基于考古学、民族学、生物学和古代文献记载等诸方面综合研究,一般认为中医药的知识起源于原始社会。经过世代人们无数次尝试和经验积累,逐渐获得了鉴别食物、药物和毒物的知识,并有意识加以利用。随着人们更多的生产和医疗实践,逐渐发现了越来越多具有药用价值的植物、动物和矿物,并积累发展了药物知识。

In ancient China, there were many legends about the origin of drugs. Legends such as Fuxi made nine needles by tasting all kinds of herbs, Shen Nong tasted hundreds of herbs, Yi Yin formulated decoction, they reflected the origin of Chinese ancestors’ understanding and use of drugs. Based on a comprehensive study on various aspects of archaeology, ethnology, biology and ancient literature records, it is generally believed that the knowledge of traditional Chinese medicine originated from primitive society. After countless attempts and experiments by generations, we have gradually acquired knowledge of the identification of food, drugs and poisons, and consciously make use of it. Along with more production and medical practice, more plants, animals and minerals of medicinal value have been gradually discovered. And we have accumulated and developed knowledge of drugs.

中药饮片作为中国传统药物,尤其在以中医特色为主的中医院临床中应用较多,中药饮片及其汤剂具有随证加减、个性化给药等优点,体现了中医学整体观念及辨证论治的原则,受到中医医师的青睐;又因其善于调节机体机能、副作用小等优点,受到慢性病、亚健康患者的认可。而中药代煎服务的出现,解决了传统中药饮片用药便捷性的问题,且正在形成区域优势。在国内大部分医院及部分药店就提供了饮片代煎服务;

As a traditional Chinese medicine, Chinese herbal medicine decoction are used more especially in clinical applications in traditional Chinese medicine hospitals characterized by traditional Chinese medicine. Chinese herbal medicine decoction and its decoction have advantages of increasing or decreasing with syndrome,personalized medication and so on, which embodies the whole concept of traditional Chinese medicine and the principle of treatment based on differential diagnosis, and is favored by traditional Chinese medicine doctors. Moreover, as it is good at regulating the body function, and has little side effects and other advantages, it wins recognition of patients with chronic diseases and poor health. The emergence of decocting service for Chinese medicine has solved the problem of the convenience of taking Chinese herbal medicine decoction, and is forming a regional advantage.Decocting service for traditional Chinese medicine is provided in most domestic hospitals and some pharmacies.

中药配方颗粒是由单味中药饮片经水提、浓缩、干燥、制粒而成,在中医临床配方后,供患者冲服使用。中药配方颗粒无需煎煮、即冲即服,作为对传统中药饮片的补充,迎合了患者方便、快捷的用药需求,能适应现代化快节奏社会生活,同时满足了中医“随证加减”、方便调剂的基本需求。中药配方颗粒经过20年的发展,得到了部分临床患者和医者的认可,2015年中药配方颗粒全国销售额达到80.85亿元。中药配方颗粒虽然在方便服用方面颇受患者青睐,但是与饮片相比价格昂贵。高附加值阻碍其成为中药市场的主流应用形式。

Chinese medicine dispensing granules are made of single Chinese herbal medicine decoction by water extraction, concentration, drying, and granulation. It is taken with water by patients according to the clinical prescription of traditional Chinese medicine. Chinese medicine dispensing granules are ready-to-take without being decocted. As a supplement to traditional Chinese herbal medicine decoction, it meets the needs of patients for taking medicine easily and quickly. It can not only adapt to modern fast-paced social life, but also meets the basic needs of addition or subtraction with syndrome and easy to adjust the dosage in Chinese medicine. After 20 years of development, Chinese medicine dispensing granules have been recognized by some clinical patients and doctors. In 2015, the sales of traditional Chinese medicine dispensing granules in the country reached 8.085 billion yuan. Although traditional Chinese medicine dispensing granules are favored by patients in terms of easy to take, they are expensive compared with Chinese herbal medicine decoction. High additional value has stunted it from becoming the mainstream application form of the traditional Chinese medicine market.

 

三、中成药的应用情况
Application situation of Chinese Patent Medicine

中成药是在中医理论指导下,以饮片为原料,按处方要求和标准加工而成,供临床医生辩证使用或患者直接使用的一类药物。中成药的历史可追溯到夏商时期,当时甲骨文有中药酒剂的记载,出现了中成药的雏形。现代中成药是中医药精髓的延续和创新,因其较汤剂使用简便、药性稳定、不良反应小等优势,日益受到市场青睐。

Chinese patent medicine is made from Chinese herbal medicine decoction and processed according to the requirements and standards of prescription under the guidance of the theory of traditional Chinese medicine, which is a kind of drug used by clinicians for treatment based on differential diagnosis or directly used by patients. The history of Chinese patent medicine can date back to the Xia and Shang dynasties, at that time,there were records of traditional Chinese medicine liquor in oracle bone inscriptions, and the embryonic form of Chinese patent medicine appeared.Modern Chinese patent medicine is the continuation and innovation of the essence of traditional Chinese medicine, compared with decoction, it has the advantage of easy to use, stable drug properties and small adverse reactions, so it is increasingly favored by the market.

近年来,中国中成药行业取得了快速发展。据中国产业信息网《2015年中国中成药行业发展概况分析》显示,2007-2014年中成药的复合年增长率为22.54%。《国家基本药物目录(2012年版)》中含中成药203种,约占39%(除中药饮片外,共520种药品),比2009年版有大幅度提高。可见,中成药的需求越来越多,临床应用广泛。

In recent years, Chinese patent medicine industry has achieved rapid development. According to the “ Analysis of the Development of the Chinese Patent Medicine Industry in 2015” by the China Industry Information Network shows that the compound annual growth rate of Chinese patent medicine is 22.54% from 2007 to 2014. The National Essential Drugs List (2012 Edition) contains 203 kinds of Chinese patent medicine, which accounts for about 39%(there are 520 kinds of medicines except Chinese herbal medicine decoction). It has been greatly improved compared with the 2009 edition. It can be seen that the demand of Chinese patent medicine is increasing, and its clinical application is extensive.

在细分领域中,尤其在心脑血管疾病、癌症、呼吸系统疾病、骨骼肌肉系统疾病等慢性病、难治病以及化药治疗手段具有明显副作用和耐药性的细分病症方面,中成药的临床应用较多。数据显示,2014年心脑血管中成药在医院终端中成药市场中占比达到35.16%,是市场份额最高的药物种类;肿瘤中成药2014年市场份额为16.34%;2014年呼吸系统疾病用药市场份额为12.61%。

In subdivisions, Chinese patent medicine is used more in clinical applications, particularly in cardiovascular and cerebrovascular diseases, cancer, respiratory diseases, bone and muscle diseases and other chronic diseases, diseases which are difficult to treat, and diseases of subdivision that the chemical treatment have obvious side effects and drug resistance. The latest data showed that the proportion of Chinese patent medicine for cardio-cerebrovascular reached 35.16% of Chinese patent medicine market in the hospital terminal in 2014, was the highest in market share of the drug classification; The market share of Chinese patent medicine for cancer in 2014 was 16.34%; The market share of drugs for respiratory diseases was 12.61% in 2014. The market share of all kinds of Chinese patent medicine in Chinese hospitals from 2007 to 2014 is shown in Table 1.

List of the market share of all kinds of Chinese patent medicine
in Chinese hospitals from 2007 to 2014.

中成药的市场近年来表现较好、需求明显增加,主要原因是国家加强了对中成药临床的应用管理。中国于2010年6月制定了《中成药临床应用指导原则》,其中要求临床使用中成药时,需要辨证用药、辨病辨证相结合用药,不能仅根据西医诊断选用中成药。在实际应用过程中,除了中医院或中医师使用中成药,综合医院的西医师也广泛使用,甚至于零售终端的患者自行选购中成药。

The Chinese patent medicine market has performed well in recent years, and the demand is increasing. The main reason is that China has strengthened the clinical application management for Chinese patent medicine. In June 2010, China formulated the Guiding Principles for Clinical Application of Chinese Patent Medicine, which requires the clinical application of Chinese patent medicine should be based on differential diagnosis and combination of diseases differentiation and symptoms differentiation, and Chinese patent medicine can not be selected only according to western medicine diagnosis. In practical applications, Chinese patent medicine is used by Chinese medicine hospitals or traditional Chinese medicine practitioners, besides, they are also widely used by western doctors in general hospitals, and even purchased by patients on their own at retail locations.

现代中成药是传统中医药剂型上的创新,中医依据处方、遵循传统中医理论进行辩证,根据药性为患者选用,这就要求从处方饮片到制剂成型的过程中,应保证中成药的药性相对稳定。依据中医药经典专著描述,经典名方标准颗粒按照原处方、原用法、原适应症的研究思路,生产工艺方面以水为溶剂进行提取,采取低温浓缩、干燥方式控制损失,制剂过程不加或少加辅料,最终制成与传统汤剂关键质量属性基本一致的颗粒剂。质量标准方面,建立包含多药味鉴别、多指标含量测定、指纹图谱等检测项的质控标准,全方位反映产品质量并与传统汤剂进行一致性评价。

Modern Chinese patent medicine is an innovation in dosage forms of traditional Chinese medicine, Chinese medicine is selected for the patients based on prescription, following traditional Chinese medicine theory to make symptom differentiation, and according to the medicinal properties. This requires that the property of Chinese patent medicine should be relatively stable from prescribed decoction pieces into preparation and formation.
According to the description in classic monograph of Chinese traditional medicine, classic formula standard granules are finally made into the granules basically consistent with the critical quality attributes of Chinese traditional decoction, by following the research method based on the original prescription, the original usage, and the original indication, in the matter of production technology, using water based solvent for extraction, adopting low temperature for concentration and drying to control loss, and adding no or less excipients in preparation. In the matter of quality standards, establishing standards of quality control in test items such as identification of multi-drug taste, determination of multi-index content, fingerprints and so on, so as to reflect the product quality in an all-round way and make a consistency evaluation with traditional decoction.

 

四、天然药物的应用情况
Application situation of natural drugs

近年来天然产物在抗癌、抗感染、免疫和中枢神经系统药物等方面已显示巨大优势,已成为发现治疗重大疾病的药物或重要先导化合物的主要源泉之一。如从太平紫杉树皮中提取的抗癌新药“紫杉醇”,以植物喜树为原料的“喜树碱”系列衍生物被美国食品药品管理局(FDA)正式批准为抗癌新药,江苏康缘药业开发的银杏内酯注射液也于2012年在国内获批生产,预计市场空间可达20亿等。2015年,屠呦呦研究员荣获诺贝尔医学奖,填补了中国本土科学家在诺贝尔自然科学奖的空白,这将一定程度上改变中国天然药物开发关注度不高的现状,并将激发十亿、甚至几十亿的大品种的诞生,带动整个行业发展。

In recent years, natural products have shown great advantages in drugs for anti-cancer, anti-infection, immunity and central nervous system, and has become the discovery of a drug for major diseases and one of the main sources of important lead compounds.For example, the drug for anti-cancer “paclitaxel” is extracted from the bark of Taiping yew trees, a series of camptothecin derivatives using plant camptotheca as raw material has been approved by the Food and Drug Administration (fda) as a new anti-cancer drug, ginkgolide injection developed by Kangyuan Pharmaceutical Company of Jiangsu Province was also approved for production in China in 2012, it is expected that the market space will be up to 2 billion. In 2015, researcher Tu Youyou won the Nobel Prize in Medicine, filling this gap of Native Chinese scientists in The Nobel Prize for Natural Science. These will change the present state that the concern on the development of China’s natural drugs is low to some extent, and will inspire the birth of large varieties of traditional Chinese medicine of billions, even billions, and revive the development of the whole industry.

综上所述,传统饮片、中药配方颗粒、经典名方标准颗粒、中成药、天然药物等中药应用形式具有巨大的市场潜力。随着几种应用形式在各自发展的情况下的相互补充,进一步提升了中药在全球的市场竞争力,将为解决“看病贵、看病难”这个世界性难题贡献一份力量。

In summary,application forms of traditional Chinese medicine such as traditional decoctions, traditional Chinese medicine dispensing granules, classic formula standard granules, Chinese patent medicine, natural drugs have great market potential. As several application forms complement each other in their respective development, the global market competitiveness of traditional Chinese medicine has been further improved, which will contribute a strength on the solution of the world problem“Seeing a doctor is difficult and expensive”.

参考文献:《中国现代中药》
References: Modern Chinese Medicine

文章来源于中国国家食品药品监督管理总局网站,欢迎持续关注!
The above article is from the State Food and Drug Administration of China. Your continuous attention is welcome!

 

德成行(tsEMPORIUM.com)始于1979年,是美洲最大参茸药食商城,美洲第一滋补养生品牌。40多年来坚持为每位顾客提供物超所值的美国花旗参、冬虫夏草、金丝燕窝以及最全品类的中药和滋补品,让每个人都能轻松受益更健康的生活。

T S EMPORIUM ( www.tsEMPORIUM.com) – established in 1979, we are the largest purveyor of American Ginseng and Traditional Chinese Medicine in the Americas and the No. 1 Chinese nutritional goods brand in the Americas. Since 1979, we have insisted on providing every customer with “Excellent Value” for American Ginseng, Cordyceps, Golden Swiftlets’ Nests, and the most comprehensive line of Traditional Chinese Medicine, so that everyone can easily benefit from a healthier life!

赞 (13)