What is the concept of traditional Chinese medicine preparation?

Analysis of traditional Chinese medicine preparations (1) Definition: 1. The definition of traditional Chinese medicine analysis is an applied subject that studies the quality of traditional Chinese medicine preparations under the guidance of modern analytical theories and methods. 2. Definition of traditional Chinese medicine preparation According to Pharmacopoeia, preparation specifications and other prescribed prescriptions, traditional Chinese medicine raw materials are processed into medicines with certain specifications, which can be directly used for the prevention and treatment of diseases. It is an important part of the treasure house of traditional Chinese medicine. 3. Definition of Chinese patent medicine. Some drugs in traditional Chinese medicine preparations have been approved by the drug administration and allowed to go on sale. They can be used by patients through doctors' diagnosis or directly by patients according to their own experience and common sense. (2) Development history As early as the Warring States Period, physicians wrote the first classic work of traditional Chinese medicine, Huangdi Neijing, which laid the theoretical foundation of traditional Chinese medicine; Zhang Zhongjing's Treatise on Febrile Diseases and Synopsis of the Golden Chamber in the Han Dynasty not only further enriched and developed the TCM syndrome differentiation and treatment system, but also collected many famous prescriptions. Ge Hong's Elbow Backup Emergency Prescription in Jin Dynasty first put forward the concept of preparation and advocated mass production for emergency use. Li Shizhen, a great medical scientist in Ming Dynasty, summed up the rich experience of medical scientists in past dynasties and wrote Compendium of Materia Medica, which contains more than 300 kinds of drugs 1892, prescriptions 1300 and nearly 40 kinds of dosage forms. It is a world-renowned classic of traditional Chinese medicine. (3) The preliminary sensory examination of evaluating history can only be carried out by experienced people, and laymen simply don't understand it and lack objective indicators. In 1950s, the quality management of traditional Chinese medicine and its preparations was brought into the track of legalization and standardization. The 63rd edition of Pharmacopoeia is divided into two parts, of which the first part contains Chinese herbal medicines and Chinese herbal preparations. By the 95th edition, 522 kinds of medicinal materials and 398 kinds of traditional Chinese medicine preparations had been collected, an increase of 44%. The dosage form is injection. Traditional sensory testing methods have been replaced by plant morphology and physical and chemical methods, such as microscopic identification, chemical identification, chromatography, especially thin layer chromatography. Check the preparation specifications of different preparations; Check impurities, arsenic salts, heavy metals and other harmful impurities. And the content of effective components in some drugs was determined, and the level was greatly improved. (IV) Introduction of Pharmacopoeia I: The standard contents include [prescription], [preparation method], [character], [identification], [inspection] and [content determination], but as far as the overall level is concerned, it is still in the development stage and there are many problems to be studied and discussed. Especially the content determination item is a weak link in the analysis of traditional Chinese medicine preparations. Take the first Pharmacopoeia as an example. Pharmacopoeia has been published in 6 volumes, and there has been no Chinese medicine for 53 years. For 63 years, there was no identification and content determination, and only prescription and traditional technology were used to control the quality. 1977 edition uses microscopic identification method to identify the powder containing the original medicinal materials, and a few varieties are added with physical and chemical analysis, and some varieties are judged according to the requirements of general principles of preparations. In version 85, TLC was used to separate various chemical components in the preparation, and then the identification test was carried out. 90 edition, chromatographic analysis technology has been widely used. The 95th edition highlights the characteristics of traditional Chinese medicine and adds varieties and detection methods. The proportion of content determination in traditional Chinese medicine preparation: 77 edition,1.48%; 85th edition, 5.31; 90 edition, 8.73%, 95 edition, 12.8 1%. Therefore, it is an arduous task to study the content determination of traditional Chinese medicine preparations, which is of great significance to improve the standard and level of drugs and ensure the quality of drugs. (5) The key problem in the analysis of traditional Chinese medicine preparation: how to determine the quality evaluation index of traditional Chinese medicine preparation. 1. The material basis of the function of traditional Chinese medicine is the chemical composition of traditional Chinese medicine, especially the compound preparation, which contains many effective components, many impurities and many unknown components, and the content varies greatly, and the function is very complicated (hawthorn is used as medicine: the content of organic acids is mainly determined in the preparation; If it is mainly used to treat cardiovascular diseases, determine flavonoids). Therefore, only by deeply studying the chemistry, pharmacology, pharmacy, drug analysis, clinical and basic medicine of natural medicines, and finding out their mechanism of action, main effective components and their relationship, can we put forward objective indicators for evaluating their quality, formulate relatively perfect quality standards, and realize the transformation from control to evaluation of the quality of traditional Chinese medicine preparations. 2. The influencing factors (growth environment, harvesting time, storage conditions) of multi-material content need to be tested; 2) process influence; 3) storage. 3. Principle: Drug taste: "monarch, minister, assistant and envoy", main drug, expensive drug and toxic drama drug; Ingredients: effective ingredients, toxic ingredients and characteristic ingredients. 4. Analysis method features: 1) Pretreatment (extraction, purification and concentration); 2) The determination method should be specific, sensitive and efficient; 3) The method should be simple; 4) It must be guided by the theory of traditional Chinese medicine; 5) Using contemporary advanced science and technology, gradually find out its mechanism of action, find new methods and new ways to evaluate and control its quality, make greater contributions to the cause of human health, and make Chinese medicine go international. 5. Chemical Classification of Traditional Chinese Medicine 1) Alkaloids Ephedra, Coptidis Rhizoma, Corydalis, Scolopendra, Stephania tetrandra, Aconitum, Uncaria rhynchophylla, Menispermum dauricum, Lycoris radiata and Colchicine. Define a class of nitrogen-containing organic compounds existing in organisms, which can combine with acids to form salts. Most of them have complex ring structures with nitrogen atoms on the ring, which have optical activity and certain physiological activity. Glycosides are defined as substances that can be hydrolyzed to form sugar and non-sugar compounds. (1) Flavonoids and their glycosides Scutellariae Radix, Quercetin and Rutin, Pericarpium Citri Tangerinae and Radix Puerariae Flavonoids (2) Anthraquinone and its glycosides rhubarb, Polygonum cuspidatum (3) Coumarin and its glycosides aescin and theanine (4) foxglove; Lily of the valley, oleander, toad (5) saponins licorice, yam, snow gall, Bupleurum (6) other glycosides containing cyanoside bitter almond; Arbutin and paeonol containing phenolic glycosides; Black and white glucosinolates containing sulfides; Alkaloid glycoside solanine glycoside; Lignan glycoside, schisandrin A, and cetin oxide; Indoside, cyanine; Geniposide and Scrophulariaceae; Other morning glory glycosides crocin. 3) Volatile oil peppermint oil, camphor oil, camphor and balsam oil. Define the general name of volatile oily components that are immiscible with water and obtained by steam distillation of traditional Chinese medicine, most of which have aromatic odor. 4) Terpenoids, such as Alpinia officinarum, Andrographis paniculata and toosendanin. 5) Organic acids cantharidin and protocatechuic acid. Acidic components widely existing in plants except amino acids. Fatty, aromatic and terpenoid compounds. 6) Quinones, shikonin and shikonin. Any compound with two carbonyl groups and a * * * yoke double bond on the carbon ring is called quinone. Besides quinone, there are benzoquinone, naphthoquinone and phenanthraquinone. 7) Cyclones, hops and hops. There are carbonyl compounds on the carbon ring. 8) Steroids b- sitosterol, ergosterol, stigmasterol, cholic acid, cholesterol, etc. 9) Tannin hydrolysis (gallnut, trans-gallnut) and condensation tannin. A class of water-insoluble precipitated polyphenol derivatives with relatively large molecules that can be synthesized with protein. 10) Polysaccharide Poria, Lentinus edodes, Yun Zhi, Ganoderma lucidum 1 1) Amino acids are nitrogen-containing organic compounds widely existing in animals and plants, and their molecules contain both amino groups and carboxyl groups, so they are called amino acids. Nearly 300 kinds of amino acids have been found in nature. Kainic acid in oyster, quixotic acid in quixote, cucurbitacin in pumpkin seed, and aspartic acid in cotton skin. 12) protein is bound to various α-amino acids of the enzyme through peptide bonds, and its molecular weight is as small as 10000 or so, and as large as 1000 million or more. Trichosanthin, pineapple protein, leiwansu. Two. Classification of traditional Chinese medicine preparations (1) liquid preparations 1. Mixture and oral liquid mixture refer to oral liquid preparations made by extracting medicinal materials with water or other solvents and concentrating the extract. The mixture packaged in a single dose is called oral liquid. 2. Tincture and medicated liquor refer to clear liquid preparations made from distilled liquor; Tincture refers to a clear liquid preparation made by extracting or dissolving drugs with specific concentration of ethanol. (2) Semi-solid preparation 1. The decocted paste, also called ointment, refers to a semi-fluid preparation made by decocting medicinal materials in water, removing residues and concentrating, adding refined honey or sugar, and some decocted pastes can also be made by adding fine powder of medicinal materials and stirring. 2. Extracts and fluid extracts. Fluid extract refers to the preparation made by leaching the effective components in medicinal materials with appropriate solvents, evaporating some solvents and adjusting the concentration to the specified standard. 1 g/1 ml, ethanol as preservative. Extract refers to a thick paste or block or powder extraction preparation with 2-5g/g, most of which are raw materials. After extracting the effective components in medicinal materials with appropriate solvents, all solvents are evaporated and concentrated. (3) solid preparation 1. Pills refer to spherical or quasi-spherical preparations made of powder or drug extract and appropriate binders or excipients. According to the different adhesives and preparation methods, it can be divided into honeyed pills, watered pills, watered pills, ointment pills, concentrated pills and pellets. 2. Powdered preparations made of a variety of medicinal materials, which are divided into oral and external use. 3. Granules, also known as granules, refer to granular preparations made of suitable excipients and medicinal extracts or fine powders. 4. Tablet refers to a tablet preparation made by pressing fine powder or extract of medicinal materials and auxiliary materials. 5. Capsules are divided into hard capsules, soft capsules and enteric capsules. Hard capsule refers to adding a certain amount of medicinal extract into medicinal powder or auxiliary materials to make powder or granules, and filling them into hollow capsules, or directly filling medicinal powder into hollow capsules. Soft capsules are made by sealing a certain amount of medicinal material extracts and appropriate auxiliary materials in spherical or other soft capsules, which are made of gelatin, glycerol or other medicinal materials. Enteric-coated capsules refer to capsules whose shells are insoluble in the stomach and can only disintegrate in the intestine after being processed by polymer materials or other methods.