The development and maturity of Chinese medicine formula particles are gradually improved and matured

Chinese medicine formula particles are extracted,concentrated,dried by Chinese medicine tablets that conform to the norms of preparation, and are used by the clinical group of Chinese medicineIts development began in 199
2
years, by Jiangyin Tianjiang Pharmaceutical industry first implementedWith the guidance andof the State administration ofandof Chinese Medicine and the
FoodDrugSupervision Administration,
after ten years of research, thewas recognized by the eight ministries of the State in 2002 and included in the Outline for the Modernization of Chinese Medicine in the 2
002 years Over the past fifteen years, we have completed 15 national scientific research projects, the development of Chinese medicine formula particles gradually improved and mature, has been widely used at home and abroad Chinese medicine clinical The and raw materials research through the comparative study of the quality of multi-source and multi-source, fixed the of the base source, origin and specification grade of the of medicinal materials, stabilizes the of the procurement base of Chinese herbal medicines, and ensure the stability of the of the quality of products 1 Multi-source varieties to determine the base source: in order to ensure the stability of the quality of Chinese medicine formula particles , determine the of medicinal herbs base source and medicinal sites In the study to compare the quality of different sources of medicinal , and consider the supply of mainstream varieties in the market , finally determine the source of medicinal herbs and medicinal sites Such as mutton: 2
000 edition of the Pharmacopoeaia loaded with 5 sources, after research, the North Korean mutton in the mutton content of mutton glycen, up to 1.08-1.76%, so determine the base source of mutton is the ground part of the North Korean mutton 2
Multi-origin varieties determined: Some varieties due to the origin, growth mode of difference, resulting in a large difference in the content of the active ingredients of medicinal herbs By comparing the content of active ingredients in different origin medicines, the origin of raw materials is finally determined to ensure the quality of raw materials Such as jaundice, through the comparative study of the content of jaundice in different origin of medicinal herbs, the results, the content of jaundice in jaundice in the area of Shandong Pingyu can reach 19.8% to 22.3%, therefore, to determine the raw material origin of jaundice formula particles for Shandong Pingqi In addition to the above-mentioned varieties, origin confirmation, the collection, processing and preparation has detailed provisions second, the theoretical basis of process research: traditional theory: follow the theory of chinese medicine , according to the preparation characteristics of traditional soup, in principle, water as a dissolving medium The agent theory: according to the root, leaf, flower, fruit, seeds, whole grass and other types of medicinal materials of the organizational characteristics and the chemical composition of (
such as alkaloids, flavonoids, argon, saponins, volatile oil, etc.) nature, classification research 1 Immersion process research (1) volatile oil extraction process: according to the differences in the properties of volatile oil contained in different varieties, such as polarity, boiling point, density, etc., the use of water vapor distillation to extract volatile oil The volatile oil is included in the wrap and the parameters such as the closing time, temperature and oil-water ratio are examined (2) Water-soluble composition extraction process research: the application of orthogonal test or uniform design method to select extraction process parameters a According to the nature of the chemical composition contained in the taste of the drug, the process parameters such as water addition, number of cooking swells and cooking time are optimized by orthogonal test or uniform design b Through the study of the extraction process of various representative varieties, it provides the basis for the development of other similar organizational structure or similar chemical composition of the material of the dipping process c At the same time in determining the specific varieties of leaching process, but also combined with the traditional soup preparation method
(
such as first frying, then down, long frying, mashed after frying, etc.), to develop a scientific, but also economic practical leaching production process 2 Separation process research: according to the nature of the need to remove impurities, especially in the difficult to filter the mucus, starch, pectin and more ingredients of medicinal herbs, research and application of suitable filtration process and equipment, to ensure the quality of the product 3 Enrichment process research: the study developed a vacuum film concentration process, so that the extract in a vacuum decompression state, only a lower temperature can be concentrated to the specified relative density, effectively retain the active components of the drug 4 Spray drying process research: according to the relative density of concentrated paste, content and other parameters, as well as the nature of the content sequester, the test of spray drying air temperature, air temperature, negative pressure in the tower and other process parameters 5 The research of graining process: to investigate the variety and dosage of accessories, the main side pressure, feed speed and other process parameters, pay special attention to the study of moisture-absorbing clumps and achieved satisfactory results Third, quality standards
research
quality standards
research projects such as characteristics, identification, inspection, content determination and so on 1 Establish exclusive identification methods: use TLC, HPLC, IR and other chromatography and spectral identification methods, select positive control, establish a strong properties, high sensitivity, good reproducibility of the identification method Commonly used 300 varieties have established thin layer chromatography identification, and in 2004 in the country for the first time launched the "Chinese medicine formula particleth layer color spectrum color atlas", recorded a single variety 152, 6 compound Chinese medicine formula particleth color spectrum and 5 Chinese medicine formula particlecomprehensive map , with 188 chromatography, medicinal and drink ingress photo 156 In the artant production process, each variety takes multiple batch samples for analysis, and compares the differences of thin-layer chromatography between different batches 2 Establish ingestion project: According to the physical and chemical properties of the measured components, we have established a simple and reproducible content determination method by means of thin layer scanning, ultraviolet spectrophotometric method, high-efficiency liquid chromatography and so on According to the results of the determination of the content of 10 batches of formula particles, the content limit is established If it is stipulated that the yellow formula particles contain small carnal acid to hydrochloric acid small pyridine meter shall not be less than 15% The glycitine in the fried white herring formula particles shall not be less than 3.0% The Gegen formula particles must contain no less than 10% of gergen The tweezers in the formula particles must not contain less than 10% Fourth, pharmacological efficacy research choose raw vein drink, flavored biochemical soup, Gegen lian soup, Ho Xiang positive gas scattered 10 sides, by the Chinese Academy of Traditional Chinese Medicine Institute of Traditional Chinese Medicine, Nanjing University of Traditional Chinese Medicine, China University of Pharmacy and other units to carry out joint frying and sub-frying comparative experimental pharmacology Raw vein drink and joint frying have anti-utoic-induced arrhythmia in mice, no difference in drug effect All have anti-blood loss shock effect in rats, no difference in drug effect Both the flavored biochemical soup and the joint frying promote the contraction of the uterus; The results of pharmacological results show that each prescription is divided into frying and frying, both have obvious efficacy, the pharmacodynamic effect of the two is similar, there is no obvious difference, in some pharmacodynamic indicators, the efficacy of formula particles is better than the drink tablets Fifth, clinical research the selection of clinical efficacy is accurate, there are objective test indicators of the side of 10 Select hospital qualified for clinical research on new drugs By Nanjing University of Traditional Chinese Medicine Clinical Research Office (
the Ministry of Health clinical pharmacological research base of new drugs) to carry out a comparative study of clinical efficacy of sub-frying and frying The results show that: both the sub-frying and the joint frying have obvious effect, of which 2 prescription sifry results are better than the combined frying, the other 8 prescriptions are fried, the joint frying has no obvious difference, clinical formula application is feasible We are in the country's 26 provinces, cities, county-level more than a thousand Chinese medicine hospitals long-term application, the use of nearly 200 million people, involving internal, external, women, children, five officials and other departments, have proved the effectiveness of Chinese medicine formula particles Relative drinking tablets not only provide convenience, in agricultural residues, heavy metals, aflatoxin and other indicators of control have reached the standard (
Jiangyin Tianjiang Pharmaceutical Co., Ltd /
Wang Jianguo)