At present, my country's traditional Chinese medicine extract industry has formed a certain scale, with more than 200 professional production companies, and many Chinese patent medicine, fine chemical and other manufacturing companies also produce extracts. There are 200-300 operating enterprises, and the operating scale is generally small, with a maximum of no more than 10 million US dollars.
Abroad, extracts are an important link and method in the application of botanical medicines. Among the speeches delivered at the 41st Annual World Medicinal Plant Research Conference held at Heine University in Dusseldorf, Germany, in February 1993, 10 of them introduced research on the activity of plant extracts and ingredients. Japan began to use traditional Chinese medicine extracts in the late 1970s, and Singapore and other places have also developed and widely used them. 25% of prescriptions in European and American countries contain at least one extract or compound from higher plants. In the United States, plant extracts account for more than 95% of the herbal medicine market, while raw medicinal materials and other products account for less than 5%. In Germany, herbal products in the main form of extracts account for 10% of the total national pharmaceutical market and nearly 30% of the national OTC market. Their herbal products are considered drugs rather than food supplements and are covered by medical insurance. It can be seen that botanical extracts have a good application foundation and a wide market abroad. The main types of traditional Chinese medicine extracts exported from my country include: Ginkgo biloba, Perforatum perforatum, Acanthopanax senticosus, Angelica sinensis, ginseng and other extracts. The management of herbal medicines in the United States is relatively backward. In the Dietary Supplement Health and Education Act, the definition of "dietary supplements" includes "herbal medicines or other plants" and "any concentrates" thereof. There is no doubt that The legal status of plant extracts as dietary supplements is established. The 2000 edition of the United States Pharmacopeia includes 20 types of botanical extracts (including vegetable oils, aromatic oils, etc.).
The German legislative process allows plant extracts to be registered as prescription drugs. About 60,000 registered drugs in Germany contain herbal ingredients, most of which are herbal infusions. These drugs are based on 600-700 kinds of plants. There are about 5,000 kinds of extracts or preparations. If traditional Chinese medicines want to enter Germany as botanical medicines, there are strict approval procedures. First, you need to fill out an application form. The quality of the product should comply with the German translation of the Chinese Pharmacopoeia. The heavy metal content should not exceed the standard. The pesticide residue amount should be less than 0.1-1.0mg/kg. The chemical and microbial test results must meet the standards. There must also be a production license from the country of origin. Certificate and other supporting materials and various supporting documents such as German expert certificate. Generally, Chinese traditional medicines enter Germany in the form of health products and are applied for under food management.
The European Union divides drugs into 8 categories, namely patented drugs, generic drugs, over-the-counter drugs, natural botanical drugs, vaccine products, blood products, biological products and antidepressants. In addition to the United Kingdom and the Netherlands, countries such as Germany, France, and Italy all classify natural botanical medicines as prescription drugs or OTC drugs for control. In November 2003, the European Parliament passed amendments to the European Botanical Medicine Registration Procedure Directive, stipulating that traditional botanical medicines can contain non- botanical medicine ingredients and partially relaxing the clinical use time requirements for traditional botanical medicine registration. After the directive comes into force, traditional botanical medicinal products that were originally subject to relevant food regulations will still be governed by relevant food regulations if they contain natural botanical substances or natural botanical extracts in amounts below the medical dose.
The "European Pharmacopoeia" lists the general principles of extracts (Extracts). The 2000 supplement contains three standardized extracts: standardized extracts of aloe vera, senna leaves and belladonna leaves, and is officially Explore further standardization and classification of extracts. According to the intrinsic quality, they are divided into Quantifide Extracts, Standardized Extracts and Purified Extracts. Europe produced standardized extracts of various medicinal plants: echinacea, valerian, brevet palm, and ginkgo biloba, among others.
Although Japan has been deeply influenced by Chinese culture in history and is the largest market for Chinese traditional medicine exports, the use of Kampo medicine is also greatly restricted. In addition to the 210 kinds of prescriptions that have been approved, the Ministry of Health and Welfare is extremely strict on the approval of new Kampo drugs. It treats Kampo drugs in the same way as new compound drugs, which is almost equivalent to closing the door. There are also many restrictions on the approval of imported Chinese patent medicines. measure. However, in recent years, the Japanese government's control over health foods has obviously relaxed, such as eliminating restrictions on dosage forms and relaxing restrictions on the types of natural botanicals that can be used in health foods.
Japan will launch a new "Pharmaceutical Affairs Law" next year. The basic principle is "regulation relaxation" and the implementation of the "yuan sales responsibility system" to further move closer to Europe and the United States. The management of drug production and circulation will loosen restrictions that were too strict in the past. At present, the use of western medicine in the field of veterinary medicine is increasingly restricted, while traditional Chinese medicine extracts have strong antibacterial and antiviral effects without tolerance and toxic side effects, and are increasingly valued by the field of veterinary medicine production.