Difficulties in the development of traditional Chinese medicine: authentic medicinal materials are often adulterated

　　Tao Hongjing of the Southern and Northern Dynasties said: "All medicines have their own realm." In fact, Chinese medicine has always paid attention to the true nature of medicines since ancient times. Authentic, that is, authentic, means that the effect is authentic, reliable and reliable. But in recent years, not only patients, but also medical workers have gradually discovered that authentic Chinese medicine, which has been passed down for thousands of years, is no longer authentic!

　　“The medicinal effects of traditional Chinese medicine are closely related to the soil, climate and other environments where they are planted. In the natural environment, aconite grows in moist and dark places with little sunshine, which has developed its ability to withstand cold. But now it is planted in sunny and fertile land, the yield has increased, but the medicinal effect has definitely decreased." Hao Wanshan, a professor at Beijing University of Chinese Medicine, said helplessly.

　　“The growth cycle of red peony root takes three to four years, and that of astragalus takes at least five or six years. However, due to the influence of supply and demand and market fluctuations, many astragalus are now annuals," said Hao Jinda, a researcher at the Institute of Traditional Chinese Medicine, China Academy of Chinese Medical Sciences. "This naturally affects the accumulation of active ingredients in the plant."

　　“Oranges grown in Huainan are called tangerines, and those grown in north Huaibei are called tangerines. Artificial planting also depends on the production area. Only medicinal materials grown in the original area have the purest texture and the best efficacy." Yang Baolin, chief physician of the Brain Department of Beijing Dongzhimen Hospital, told the Health Times reporter, "Look at the current ginseng, which is artificially grown everywhere. Some people ridiculed that it is as big as a radish and has the effect of a sweet potato!”

　　Of course, when it comes to authentic medicinal effects, wild medicinal materials deserve the top spot. However, with the rapid expansion of market demand, especially the rapid rise of the modern Chinese medicine industry, wild Chinese herbal medicines have been almost exhausted.

　　According to statistics from the Third National Traditional Chinese Medicine Resource Census, taking licorice as an example, my country consumes more than 40,000 tons a year, 85% of which comes from wild sources. Excessive plunder has turned wild licorice from a common psoma plant to an endangered plant. “The modern production of traditional Chinese medicine has brought convenience to people, but the soaring demand has also further shrunk wild medicinal resources," said Tang Zuxuan, a representative of the National People's Congress and a doctor at the National Normal University.

　　The shortage of medicinal materials has led many clinicians to use "substitutes" when prescribing. Musk has the effects of rejuvenating the mind, reducing swelling and relieving pain, stimulating menstruation and activating blood circulation. Because of its strong smell and very strong channeling property, it often plays a guiding role in medicine. It is a very rare medicine for treating neuromotor diseases such as stroke, syncope, limb paralysis, joint pain, and surgical carbuncle and ulcer. It is a good medicine, but it is difficult to prescribe it in our hospital now, said Zhu Qingjun, deputy director of the Traditional Therapy Center of the First Affiliated Hospital of Anhui University of Traditional Chinese Medicine. "When necessary, we can only use other medicines, such as Angelica dahurica and Jiuxiangworm. Although it has a certain effect, it is much worse than musk. ”

　　When wild Chinese medicinal materials are unable to meet demand, artificial cultivation naturally becomes a way to meet actual needs. In 1995, the planting area of ​​Chinese medicinal materials accounted for only 0.19% of the crop area in my country. By 2014, this proportion had increased to 1.2%. The planting area of ​​Chinese medicinal materials had exceeded 1985.36 thousand hectares (excluding understory planting and wild tending), surpassing tobacco and sugar (data from China Statistical Yearbook [DB/OL]. 1996-2013). Therefore, poor efficacy due to irregular planting has become the number one problem affecting the efficacy of traditional Chinese medicine.

　　“"Good medicinal materials make good medicine." In order to standardize the quality of Chinese medicinal materials, my country has promulgated and implemented the "Certification Methods for the Good Manufacturing Practice of Chinese Medicinal Materials (Trial)" (commonly known as GAP) since 2003. However, because it only examines the standardization of the planting process of Chinese medicinal materials from the perspective of inspection, it lacks The lack of supporting policies and measures makes it impossible to distinguish the medicinal materials it produces from ordinary medicinal materials, and it is impossible to achieve high quality and low prices for GAP medicinal materials. As a result, the enthusiasm of enterprises is low. Many GAP bases exist in name only. In the end, they could only be canceled in February this year, 12 years after the trial.

　　Huang Luqi, academician of the Chinese Academy of Engineering, executive vice president of the Chinese Academy of Chinese Medical Sciences, and director of the Traditional Chinese Medicine Resource Center, believes that many wild Chinese medicinal materials are currently endangered. If we want to effectively solve the problem of resource scarcity, we will ultimately have to rely on artificial cultivation. The top priority is to select planting bases through the fourth national survey of traditional Chinese medicine resources, extract technologies available to farmers from the fields for promotion, and establish a dynamic monitoring mechanism to ensure smooth information.

　　The failure rate of decoction pieces is shocking

　　The curative effect of traditional Chinese medicine depends not only on the medical skills of traditional Chinese medicine doctors, but also on the guarantee of high-quality traditional Chinese medicine preparations. From the raw materials of traditional Chinese medicine to the prepared pieces of traditional Chinese medicine, there is a very important process: processing of traditional Chinese medicine. In other words, if the medicinal materials are not prepared properly, no matter how clever the prescription is, the efficacy will be greatly reduced.

　　At present, there are very few Chinese medicine experts in China who are most proficient in processing technology. The master of traditional Chinese medicine, Jin Shiyuan, is 88 years old, and the master of traditional Chinese medicine, Wang Xiaotao, is 86 years old. It is said that there are only three apprentices under Mr. Jin who are currently engaged in the processing work.

　　Preparing traditional Chinese medicine is like cooking. How much salt to add and what heat to use depends more on experience. It is difficult to follow the requirements in the pharmacopoeia. Taking the simplest cutting as an example, cutting thinly and thickly is directly related to the efficacy of the medicine.

　　Traditional Chinese medicine processing personnel in the past paid special attention to the cutting of Chinese medicinal materials. The thickness of the cutting directly reflected the level and skill of the cutting personnel. “For example, the hard-textured betel nut and white peony root can be cut into pieces as thin as paper by old pharmacists in the past. Modern science has also confirmed that the thinner the medicinal materials, the larger the contact area with water, which is more conducive to the dissolution of the active ingredients of the medicine and the efficacy of the medicine. Gao Feng, general manager of Hebei Baicao Kangshen Pharmaceutical Co., Ltd., said that the magic of "Hundred Betel Nuts" lies in its exquisite skills. They can hand-cut betel nuts the size of pigeon eggs with more than a hundred knives, and the cut betel nut slices, If you catch it and blow it, it will fly. However, after the pharmacopoeia unified the standards, they must be followed. For example, cut bulbs such as Alisma and Atractylodes into thick slices of 30 to 40 mm, and white peony root into thin slices of about 1 to 1.5 mm. Any more or less will affect the pass rate, and many similar traditional techniques have gradually disappeared.

　　In addition, the processing technology is not included in the Pharmacopoeia, and because there are no standards, companies that prepare slices are not allowed to do it. “For example, the method of cooking rice water commonly used in ancient Chinese medicine, or using the water boiled with one medicine to prepare another medicine, which is what is now called improvised preparation, is not in the pharmacopoeia now, so we can't produce it." Regarding why skills such as "Hundred-knife Betel Nut" will disappear, Gao Feng said, "If your father has a certain skill, but you can't even make a living after learning it, will you still learn it?"”

　　At the same time, the national policy's tilt towards Western medicine has indirectly led to the loss of processing technology and talents year by year. "The post-job evaluation qualification requires you to publish a number of SCI papers, but if you hold research and preparation articles, you will not be able to be published in the so-called SCI." "Elegant", Hao Jinda explained, "If you want to be evaluated for professional titles, you have to pay attention to pharmacological analysis and chemical analysis of modern medicine. Naturally, fewer people will pay attention to traditional Chinese medicine traditions such as variety identification and processing, which will gradually cause these traditional disciplines to shrink."

　　“As long as the prepared pieces are unqualified, the blame will be placed on the prepared prepared pieces factory. In fact, the problem of unqualified prepared prepared pieces mostly occurs in the circulation field," Gao Feng said. "Things like passing off as good quality, gaining weight, and dyeing are all done by drug dealers in the medicinal materials market, and this is also the crux of the problem that affects the quality of prepared prepared pieces!”

　　“There are many patients from other places who can only get reimbursement if they take medicine locally. After filling the prescription, they take it back to their hometown to buy the medicine. However, some people often report that after taking the medicine, they feel that it has no effect, and even the texture and taste are different from the medicine they took in Beijing before. They bring medicine from other places to our medicine. When Master Fang looked at it, we discovered that they actually used the stems and leaves of Bupleurum instead of Bupleurum!" Hao Wanshan said that the root of the hard Bupleurum produced in the north is called Bupleurum, which has the best antipyretic and liver-clearing effects. However, the ground part of Bupleurum has almost no antipyretic and liver-clearing effect. It does not reduce fever, so eating it will naturally have no effect.

　　“The prepared pieces from Switzerland and Germany are very clean and neat from packaging to appearance, and the cooked liquid is also very clear," Zhu Qingjun said. "But we often have patients here who report that the cooked liquid is turbid and unclear, and there are scum underneath! I also have this experience myself. I imagine that with such pieces that affect the purity of the medicinal materials, even if the pesticides and heavy metals do not exceed the standards, the efficacy of the medicine will be affected. ”

　　“Colored medicinal materials such as safflower, skullcap, and Yuanhu are most likely to be dyed after they do not sell well or become moldy," Gao Feng said. "Some people even use industrial dyes illegally!”

　　“Medicines are for medical purposes, and medicines are for medical purposes. ”If the quality of medicinal materials cannot be guaranteed, the effectiveness will be reduced in the least, or life-threatening in the worst, and it will inevitably damage the reputation of traditional Chinese medicine.

　　There are more than 2.5 million outpatient and emergency visits per year, and nearly 8 tons of decoction pieces are delivered every day. How to ensure that every bag of decoction pieces is a high-quality decoction piece?

　　“80% of the decoction pieces used in our hospital are supplied by our own hospital-run decoction piece factory Hebei Baicao Kangshen Pharmaceutical Co., Ltd.," said Xu Fengqin, deputy director of Xiyuan Hospital of the China Academy of Chinese Medical Sciences. "In order to ensure the authentic supply of traditional Chinese medicine, we have also arranged for pharmacists to guide all aspects of planting and harvesting at the contracted base, and strictly control the source process to ensure the quality of the medicine as much as possible. For example, March is the best time to pick wormwood. If you miss this season, we will never accept it. In addition, we will also test pesticide residues and heavy metal residues in medicines to ensure the safety of medication. ”

　　“If the hospital has its own planting base and slice factory, the source of the medicinal materials is reliable, and the clinical efficacy can naturally be guaranteed," Zhu Qingjun said. "But it is not realistic to invest in the construction on its own. At present, it seems that it can still be achieved by choosing honest pharmaceutical dealers or directly cooperating with medicinal material growers and providing long-term supervision to ensure quality.

　　 Granules require national standards

　　“The market lacks supervision, the quality is uneven, the efficacy varies greatly, and the market development is chaotic. ”During the two sessions last year, Yan Xijun, a representative of the National People's Congress and chairman of the board of directors of Tasly Group, submitted a motion, bluntly stating that the market for traditional Chinese medicine granules urgently needs to establish national standards.

　　From 1993, Chinese medicine granules were listed as the "Spark Plan" of the National Science and Technology Commission, to 2001, my country officially included them in the category of traditional Chinese medicine pieces for management, and now has a huge market with an annual output value of nearly 10 billion for six pilot production companies. Although Chinese medicine granules have developed rapidly in terms of production technology and market, so far, a unified national standard is still missing. Even among the six pilot production companies, the standards are different, and the risk assessment and adverse reaction monitoring mechanisms are very imperfect.

　　The controversy that followed never stopped. The so-called Chinese medicine granules are actually a new type of Chinese medicine pieces made by extracting, concentrating, drying, and granulating single-flavored Chinese medicine pieces. Although compared with traditional Chinese medicine pieces, they do not need to be boiled and can be taken directly and are easy to carry. But how effective is it? Can it be comparable to traditional Chinese medicine pieces? The academic community has been debating for a long time, and there is still no conclusion.

　　Wang Chengde, former director of the Taiwan, Hong Kong and Macao Cooperation and Exchange Center of the State Administration of Traditional Chinese Medicine, said that since the 1950s, the country has begun to modernize traditional Chinese medicine granules. However, for a long time, granule preparations have indeed had outstanding advantages in terms of convenience, but the problems of "unstable efficacy and difficult to control standards" cannot be avoided. “The biggest advantage of traditional Chinese medicine is that it has multiple ingredients, multiple benefits, multiple targets, and multiple pathways. When brewed, the plant activity will undergo some chemical reactions, which is more conducive to human body absorption. In clinical practice, I still recommend using decoction pieces whenever possible," said Wang Chengde.

　　Deng Guiming, deputy chief physician of the Department of Pharmacy of the First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, also thinks so. The decoction process of traditional Chinese medicine is a dynamic reaction process, and its medicinal properties are related to the decoction method and time. “If conditions permit, it is best to choose self-fried medicinal pieces. ”

　　“Traditional Chinese medicine pays great attention to the nature and taste, and the odor plays an important role in it. Today's granules are all refined. When brewed, they will not have the special fragrance of the original fried ones, and the efficacy of the medicine will naturally be weakened a lot," Zhu Qingjun said. "And I always suspect that during the purification process, some components of traditional Chinese medicine will be lost."

　　In addition to doubts about efficacy, since traditional Chinese medicine granules have lost the appearance and shape characteristics of traditional medicinal pieces, how to control their quality is also one of the key issues that raises questions.

　　“For traditional Chinese medicine pieces, the quality can often be judged by seeing, touching, tasting, and smelling. However, for traditional Chinese medicine granules, the properties and quality of the medicine can only be judged by testing specific chemical components and infrared spectrum detection. ”Li Ming, the pharmacist in charge of Dongzhimen Hospital of Beijing University of Chinese Medicine, reluctantly told reporters that to a certain extent, this method of judgment is indeed difficult to prevent the emergence of substandard products.

　　Li Ming told the Health Times reporter that traditional Chinese medicine has its own special characteristics. Even if it is the same medicinal material, different origins, seasons, and picking parts will cause differences in medicinal effects. Once ground into particles, this difference cannot be determined by testing the chemical composition. For example, if Chinese patent medicines containing ginseng are not managed from the source, it will be difficult to determine whether the source of the medicine is ginseng leaves, ginseng fibrous roots, or ginseng taproots. Naturally, it is difficult to guarantee the effectiveness.

　　“But what is worthy of recognition is that the relationship between traditional Chinese medicine granules and traditional Chinese medicine decoctions is coordinated development and mutual complementation," Cao Hongxin, member of the National Committee of the Chinese People's Political Consultative Conference and director of the Science and Technology Department of the State Administration of Traditional Chinese Medicine, told reporters. “On the basis of maintaining the advantages of traditional Chinese medicine preparations for thousands of years, it is also necessary to appropriately develop granules to supplement the shortcomings of traditional Chinese medicine decoctions. The advantage of granules is that they are convenient and easy to carry and use. There are also some mineral drugs and animal drugs that cannot be made into granules, so traditional Chinese medicine pieces are still used. ”

　　In-hospital preparations are struggling

　　From China’s Liushen Pills to Japan’s Jiuxin Pills; from China’s Niuhuang Qingxin Pills to South Korea’s Niuhuang Qingxin Liquid, in recent years, more and more traditional Chinese medicine treasures have traveled across the ocean and been patented by foreign pharmaceutical companies. They have turned into “foreign Chinese medicines” and have become very successful, even going global. However, in China, the excellent varieties of traditional Chinese medicine are shrinking year by year, and the development and use of in-hospital preparations are even more difficult.

　　“In recent years, due to high application requirements and difficulty, many hospitals have rarely issued new approvals for in-hospital preparations. ”Chen Yanfen, director of the Preparation Office of the Guangdong Provincial Hospital of Traditional Chinese Medicine, told a Health Times reporter that the hospital currently has more than 300 varieties of well-known traditional Chinese medicine preparations. These preparations have been verified by many years of clinical practice and are effective, safe, reliable, easy to use, and low-cost. In recent years, hospitals have vigorously supported the development of in-hospital preparations, but the progress is still not ideal.

　　The same situation also happened at Beijing University of Chinese Medicine Dongzhimen Hospital. “Not only us, but almost all the types of in-hospital preparations in traditional Chinese medicine hospitals are shrinking. ”Li Ming, the pharmacist in charge of Dongzhimen Hospital of Beijing University of Chinese Medicine, believes that this is closely related to the relevant policies and cost issues of in-hospital preparations of traditional Chinese medicine.

　　According to my country's "Measures for the Registration and Management of Preparations in Medical Institutions", applying for self-made traditional Chinese medicine preparations requires inspection of production technology, toxicology, efficacy, quality standards and clinically valid data, and finally obtains a preparation approval number from a medical institution. “The strict requirements are out of responsibility for the safety of patients' lives. As a hospital, of course you will understand. However, the recent increasingly stringent requirements for in-hospital preparations of traditional Chinese medicine will indeed put a lot of pressure on the hospital. ”Chen Yanfen feels this deeply.

　　“Traditional Chinese medicine preparations in medical institutions are mostly clinical prescriptions with many varieties and dosage forms and small batches. Some preparations can only produce tens of milliliters at a time, making it impossible to form batch and large-scale production. ”But at the same time, it costs tens to hundreds of thousands to complete all experimental projects for a preparation variety, and experimental research and registration can take up to two years. Therefore, it is difficult for traditional Chinese medicine medical institutions, especially grassroots traditional Chinese medical medical institutions, to bear it financially and time-wise.

　　“Even among the preparations available now, many are sold at a loss. ”Chen Yanfen told reporters, “Take traditional Chinese medicine eye drops as an example. Due to the special application site, R&D is difficult and production costs are high, and it needs to be produced in a nearly sterile environment. A machine costs hundreds of thousands of yuan, and the daily electricity bill during production is also thousands of yuan, but each eye drop only costs more than one yuan, which is far lower than the production cost. ”

　　In addition, Commissioner Wang Chengde also pointed out that from the perspective of registration approval, the positioning of in-hospital preparation approval is unclear, and the review should be done in the same way as new drugs. Due to the over-emphasis on safety, it is required that there be no poisonous materials or incompatible materials, and no medicinal materials outside the pharmacopoeia. This will inevitably restrict clinical originality to an extremely narrow scope. Routine toxicology, pharmacological efficacy and other tests are indispensable. Before obtaining clinical approval, at least 500,000 to 1 million yuan will be spent. This is an important reason for the shrinkage of nosocomial preparations.

　　The pricing of in-hospital preparations is based on the cost-weighted average price of raw materials and excipients over the years. At a time when the prices of traditional Chinese medicines are soaring, hospitals are also in trouble. “Take sublimated sulfur as an example. Five or six years ago, its price was still 15 yuan per kilogram, but now the price has climbed to 300 yuan per kilogram. If calculated based on the weighted average price, the calculated price will be far lower than the actual cost. ”

　　At this year's joint meeting of the medical and health groups of the two sessions, Member Wang Chengde particularly emphasized the need to liberalize the approval of in-hospital preparations, changing from an approval system to a filing system, which is registered by the Chinese medicine administrative department at the same level and independently managed by medical institutions to ensure quality and safety and give full play to the specialty characteristics of traditional Chinese medicine.

　　“If it can be realized, I believe it will bring great development to the in-hospital preparations of traditional Chinese medicine. ”The "Traditional Chinese Medicine Law" (draft) that was just introduced not long ago stipulates that only traditional Chinese medicine preparations prepared using traditional techniques can be prepared by filing with the drug regulatory department of the people's government of the province, city, autonomous region, or municipality directly under the Central Government where the medical institution is located, and there is no need to obtain a preparation approval number. Although it has not yet been officially implemented, such regulations undoubtedly give Chinese medicine hospital preparations hope to welcome spring again. (Lin Jing Liu Zichen)