1. 1 identify the quality of Chinese medicine varieties.
1, the varieties of traditional Chinese medicine generally refer to species, different species, different components and different curative effects. A certain variety of Chinese medicine is the material basis of Chinese medicine treatment. "Although there are good doctors, the medicine is fake, but good doctors are useless", which is the primary factor affecting quality. Based on the investigation of 1982 in 523 units of medicinal materials system at or above the county level in Shaanxi Province, there are 26 kinds of "fake" and 43 kinds of confused and mistaken products/kloc-0, and the wild vines sold in 35 counties and the wild plums sold in 22 counties are bitter plums and wild apricots.
1995 1 month received 9 kinds of mixed medicinal materials from Han Xi, including bungarus multicinctus (2 kinds), Cortex Moutan, Rhizoma Smilacis Glabrae, Oletum Trogopterori and Radix Peucedani.
Multi-source phenomenon Dendrobium 10 species.
Rhubarb belongs to three kinds.
Fritillaria cirrhosa belongs to 4 species.
Variety confusion rhubarb purging heat and relaxing bowels is effective in treating acute abdomen, but it has no effect for a period of time, delaying the illness. 65438-0980 The investigation of planting rhubarb in Shaanxi shows that 30% of the area is rhubarb, and one area is full of rhubarb. Rhubarb belongs to rhubarb and has antibacterial effect, but it does not contain sennoside, a laxative component.
Pinellia ternata commodities include Pinellia ternata and Pinellia ternata, and Pinellia ternata has no antiemetic effect.
Rhizoma Arisaematis is a tuber of Araceae, but Pinellia ternata is effective in treating cervical cancer, and its trade name is Rhizoma Arisaematis.
The phenomenon of foreign objects with the same name and different names for the same thing is caused by habitual drug abuse in this area.
China kadsura-piperaceae kadsura and photinia.
Hubei province
Piper kadsura and heather of Piperaceae-called "Lithocarpus"
The complex stone of Apocynaceae is called "Photinia"
Sankoh thunderbolt is called "complex stone".
The nature of the species called "Schisandra chinensis" in Ustilaginoideae is dual, with and without existence. On the one hand, species classified according to discontinuous standards of morphology and reproduction are universal in nature, on the other hand, there is no discontinuous standard to divide all living things into unified biological units. Species are discontinuous and continuous, and the continuous part occurs at the intersection of species, and the variation is diversified and transitional.
In the case of changes in the ecological environment, the varieties also change, the advantages and disadvantages are quantitative changes, and the authenticity is qualitative changes.
4. Quality: variety degradation, content of effective components, content of impurities and toxic substances, and mildewing degree of genuine medicinal materials.
Geographical change: Inner Mongolia Astragalus membranaceus is cultivated in Hebei, with many branches, strong firewood and low sweetness.
Ecological changes: Bupleurum cultivation, small taproot, many fibrous roots, large firewood, microstructure changes.
Improper processing: Sophora flavescens is soaked in water-matrine cannot be extracted.
Counterfeit drugs:
Schisandra chinensis extract;
Honeysuckle adheres to impurities 40%
Sand content of sea gold sand is -30%
Myrrh contains 30 ~ 50% bark and gravel (1).
According to the prescription preparation containing Chinese herbal medicine powder, whether the variety contains Chinese herbal medicine powder of each component is observed by microscope.
2) Physical and chemical identification
Analyze the effective components of the main drugs in the Chinese patent medicine to be tested by spectrum or chromatography, and detect whether they contain effective components and content. 1) Textual research of materia medica, clarifying the source.
For thousands of years, we have accumulated more than 3,000 precious historical materials of traditional Chinese medicine, which are the basis for guiding modern drug use. However, there are numerous ancient documents, some of which are inevitably wrong and need textual research and herbal research.
Zhang Hu and South Star are the same. According to the investigation, Zhang Hu is the tuber of Pinellia ternata, which contains a lot of alkaloids, and it is a South Star variety for treating cervical cancer. Araceae is the tuber of Araceae, Araceae and Araceae.
2) Sort out the varieties and clarify the confusion (one thing has one name)
China has a vast territory, many varieties, different medication habits and names, and the phenomenon of the same thing with different names is serious, which needs to be sorted out urgently.
The cases in Guanzhong come from 35 species in 6 families.
Dryopteris crassirhizoma has good insecticidal effect.
Osmunda zhongnanensis contains steroids that promote peeling and promote metabolism.
Another example is Lysimachia christinae, Lysimachia christinae and Lysimachia kwangsiensis. , used as medicine under different names.
3) research and investigation, inheritance and development. Reference to materia medica is not only materia medica, but also takes materia medica as the only measure.
Artemisia annua: Compositae plants Artemisia annua and Artemisia annua, Artemisia annua does not contain artemisinin, 90 yards deleted.
Artemisiae Scopariae: Artemisiae Scopariae is traditionally used as a seedling, but the content of 6.7- dimethoxycoumarin and Artemisiae Scopariae, the effective components of cholagogue, is high in bud stage. Now Herba Artemisiae Scopariae and Herba Artemisiae Scopariae are used as medicine together. Seeking common ground while reserving differences, modernity and tradition coexist, new seedlings and old stems coexist, and * * * develop together. 1, Drug Administration Law
First promulgated 1984.9.20, implemented 1985.7. 1.
200 1.2.28 Revision 2001.12./implementation
2, Chinese medicine quality standards
① The standard meaning of traditional Chinese medicine:
It is the technical regulation made by the state on the quality of traditional Chinese medicine and its inspection methods, and it is the legal basis followed by the production, management, use, inspection and supervision and management departments of traditional Chinese medicine.
② Formulating principles: safety, effectiveness, advanced technology and economy.
③ Scope of application: Re-evaluation of new Chinese herbal medicines, new Chinese patent medicines and old medicines.
④ Standards and policies
1994 research guide for new Chinese medicine (pharmacy, pharmacology, toxicology) by the Bureau of Pharmacy of the Ministry of Health.
1999 "technical requirements for research of new Chinese medicines" by the State Administration of Pharmaceutical Products.
SFDA Drug Registration Management Measures was implemented on June 5438+0, 2002.
At present, the quality control of Chinese medicinal materials and preparations in China is mainly based on the conventional methods stipulated in People's Republic of China (PRC) Pharmacopoeia and China Pharmacopoeia (Part I), but some medicinal materials and preparations have 1 or several index components. Judging from the current situation, in many cases, these methods alone can not achieve the purpose of better controlling the quality of traditional Chinese medicine. For example, adverse reactions often occur in the use of approved traditional Chinese medicine injections, which is closely related to the nonstandard quality control methods of the preparations, leading to unstable quality of the preparations.
The fingerprint of traditional Chinese medicine has the characteristics of integrity, macroscopic and fuzzy analysis. By describing the overall characteristics of traditional Chinese medicine and adopting appropriate fuzzy processing methods, the overall quality control can be realized.
It has become an international consensus to use fingerprint as a means of quality control. In order to modernize the quality standards of traditional Chinese medicine and connect with the international standards, the US Food and Drug Administration issued the "Research Requirements for Fingerprint of Traditional Chinese Medicine". First, it is required to study the fingerprint of traditional Chinese medicine injections, and is stepping up the establishment of a fingerprint database to gradually modernize the quality standards of traditional Chinese medicine and proprietary Chinese medicines.
The inevitable mode of research on quality control method of traditional Chinese medicine is to combine the fingerprint of all components with the qualitative and quantitative determination of standard components, and establish a unified intelligent method system for quality control of traditional Chinese medicine series that conforms to the characteristics of traditional Chinese medicine. 40438.65438386064
4. 1 natural resources
(1) is rich in varieties.
According to the investigation of China Medicinal Materials Corporation in 10 (1984~ 1994), there are 12807 species of medicinal plants and animals in China. Among them, medicinal plants1146 species (about 87%), medicinal animals 158 1 species (about 12%), and medicinal minerals 80 species (less than/kloc-)
(Dictionary of Traditional Chinese Medicine 1977, 5800~6000 species, 5000 strains)
There are 320 kinds of plant raw materials and 29 kinds of animal drugs, with a total reserve of 8.5 million tons. Wild resources are the most precious resources.
Licorice. Ephedra, Angelica pubescens and Cordyceps sinensis all come from wild plants.
Venenum Bufonis, Mylabris, Scolopendra and Cicada come from wild animals.
Gypsum, mirabilite, cinnabar and native copper come from natural minerals.
(2) Totally imported wild resources were found, such as picrorhiza picrorhiza, nux vomica, benzoin, agarwood, aucklandia root, Ferula, etc.
4.2 Chinese medicine production
There are 600 kinds of conventional varieties and 50 kinds of domestic bulk medicinal materials/kloc-0, which can provide a planting area of 4.8 million mu and an annual output of 300,000-350,000 tons.
(1) Amomum villosum, cinnamon, clove, banksia rose, terminalia chebula and cardamom were successfully imported.
(2) Gecko, Agkistrodon, sika deer, scorpion and pearl were successfully cultivated.
(3) Angelica sinensis, Poria cocos, Rehmannia glutinosa, Chinese yam, etc. The output exceeds 10,000 tons.
(4) Synthetic traditional Chinese medicines: borneol, artificial bezoar and artificially cultivated bezoar.
4.3 Time, place and manpower of authentic medicinal materials (domestic varieties+wild)
Inner Mongolia: Radix Astragali and Radix Glycyrrhizae
Jilin: ginseng, velvet antler
Gansu: angelica sinensis
Guangxi: Ruditapes aurantium
Qinghai: rhubarb
Jiangsu: Mint
Ningxia: medlar
Anhui: Cortex Moutan and Paeonia lactiflora
Yunnan: Notoginseng Radix and Coptis Rhizoma
Guangdong: Amomum villosum, Areca catechu, Alpinia oxyphylla and Morinda officinalis.
Henan: Chinese yam, Achyranthes bidentata, safflower, rehmannia glutinosa and chrysanthemum.
Zhejiang: Radix Scrophulariae, Fritillaria thunbergii, Radix Ophiopogonis, Chrysanthemum morifolium, Radix Curcumae, Rhizoma Corydalis, Radix Paeoniae Alba and Atractylodis Rhizoma.
Sichuan: Coptidis Rhizoma, Radix Aconiti Lateralis Preparata, Bulbus Fritillariae Cirrhosae, Rhizoma Chuanxiong, Radix Aconiti, and Cortex Phellodendri are 12 medicinal animals, which are known as the "new three treasures" in China.
In Hong Kong: "New Three Chickens" (silky fowl, guinea fowl and colorful pheasant) each 160 HK dollars.
Three new species of birds (partridge, quail and pigeon) cost HK$ 40 each.
The new three turtles (grass turtle, money turtle and golden head turtle) are 300,950 and 650 yuan per kilogram.
Pearl belongs to traditional aquaculture.
There are nearly 100 kinds of medicinal nutritional animals exported from China, such as pigeon, soft-shelled turtle, Monopterus albus, loach, mandarin fish, cuttlefish and grass carp, especially live soft-shelled turtle, sweet-scented osmanthus fish, live Monopterus albus and live loach. The reason is that the demand for animal medicinal materials has increased sharply, and the resources of wild medicinal animals have been exhausted day by day, marking the arrival of the golden age of breeding medicinal animals.
According to experts' prediction, the price of nutritious medicinal animals will be tight for a long time to come, and the prospect of vigorously developing medicinal animals is broad. 1. According to the law that biological families and genera are closely related and generally contain similar components, we are looking for traditional Chinese medicines with similar curative effects.
Imported Ferula Ferulae, Semen Strychni and Aquilaria Resinatum-made in China
Rhododendron dauricum (Rhododendron Hinggan) in the northeast is used to treat tracheitis, and Loquat (Viburnum davidii) in the northwest is used to treat Rhododendron kwangtungensis, and the curative effect is similar.
Fritillaria, Fritillaria Xinjiang, Fritillaria Iridium, Fritillaria Sichuan and Fritillaria Hubei all moisten the lungs and relieve asthma.
Ginseng, notoginseng, Osmunda japonica. And panax japonicus. Contains ginsenoside; (and Gynostemma pentaphyllum, non-ginseng)
The contents of polysaccharides and saponins of Ophiopogon hupehensis and Ophiopogon breviscapus are similar to those of Ophiopogon japonicus, but their anti-hypoxia and immune functions are the same as or better than those of Ophiopogon japonicus. "Ophiopogon japonicus" 1995 entered the Pharmacopoeia.
2. Take active ingredients as clues.
Diosgenin-Dioscorea nipponica, Dioscorea zingiberensis, Dioscorea zingiberensis (Dioscorea), Dioscorea zingiberensis and Dioscorea Fuzhou.
Berberine can be used as a resource plant of berberine, including Cortex Phellodendri of Rutaceae, Thalictrum of Ranunculaceae and Berberidaceae.
Bergenin is an antitussive component contained in Ardisia Ardisia, which was first discovered in Chinese cabbage of Saxifragaceae. After screening from Saxifragaceae plants, it was found that Aster was rich.
Indigo Naturalis made from leaves of Isatis indigotica, Polygonum cuspidatum and Isatis indigotica.
3. Take pharmacology and clinical efficacy as clues.
Schisandra chinensis, Pennisetum, etc.
4. Expand the medicinal parts.
Tortoise shell (tortoise shell)-carapace+tortoise shell (tortoise shell)
5. New uses of old drugs
Salvia Miltiorrhiza, Ligusticum Chuanxiong, Radix Puerariae, Fructus Crataegi, Radix Notoginseng, and Ginkgo biloba-cardiovascular diseases
6. Artificial cultivation and reproduction
Wild belamcanda chinensis, white snake, deer, musk deer, centipede, scorpion, ground beetle.
7, artificial synthesis, substitute research
Artificial bezoar and cultured bezoar in vitro-natural bezoar
A new type of donkey hide gelatin-donkey hide gelatin
8. Tissue culture and bioengineering (biotechnology): Paclitaxel has a vast territory, rich resources, rich products and various varieties.
The number is rapidly decreasing, population reproduction is difficult, and endangered species are increasing.
Global reasons: tropical forests are severely damaged (Madagascar, 90% of forests are destroyed). Twenty years ago, one species disappeared every day on the earth, but today one species disappears every hour.
Regional reasons:
1) The ecological environment is seriously damaged, with population = cultivated land ↓ desertification = water and soil ↓
From 57 to 86, 7.9 million mu/year, 9.37 million mu/1993 (cultivated land in Qinghai province)
Population/160,000/year, Australia148,000, which is 3.5 times the population of Qinghai province.
2) The awareness of wildlife protection is poor and the legal system is not perfect.
Marine animals (whales, seals, etc.). ) is restricted from catching, while land wildlife is generally prohibited from catching.
A large number of wild medicinal animals have been killed in China, including bears, tigers, snakes and musk deer.
Catfish, a first-class rare animal, is sold as a turtle (Qingchuan Hotel/KLOC-0 bought 80 kilograms of catfish in the freezer in September, 1994).
3) unscientific indiscriminate mining and logging
Wild rare plants are not allowed to enter the pharmaceutical industry before they are cultivated in large quantities (protecting enterprises and plants).
Related courses: Chinese medicine resources, medicinal botany, Latin Chinese medicine, Chinese medicine commodities. ......
Identification of traditional Chinese medicine is an important subject, and it also occupies a very important position in various examinations. At the undergraduate stage of Chinese medicine, Chinese medicine identification accounts for 6 credits and is divided into two semesters; Traditional Chinese medicine identification is included in the examination subjects of licensed pharmacist qualification examination and health professional qualification examination. Therefore, it is necessary to learn Chinese medicine identification well.