Traditional Chinese medicine is an important part of the splendid culture of the Chinese nation. It is one of the most influential subject areas in the world. The traditional Chinese medicine produced under the guidance of the traditional medicine theory of the motherland has made positive contributions to the health and development of human beings. The unique advantages and charms of traditional Chinese medicine in the prevention and treatment of diseases, rehabilitation and health care, as well as the unique effects and effects of traditional Chinese medicine, have received more and more attention from the medical community at home and abroad.
The development of modern science and technology has promoted the continuous progress of the Chinese medicine industry. The production of traditional Chinese medicine has got rid of the past “workshop†production methods, widely used modern science and technology, applied new technology, new accessories, new equipment, research and development of new dosage forms of Chinese medicine, preparation The production of new preparations has fundamentally changed the backwardness of the field of traditional Chinese medicine preparations, improved the level of traditional Chinese medicines as a whole, ensured the quality efficacy and stability of traditional Chinese medicine preparations, and laid a solid foundation for the modernization of Chinese medicines and the participation of the world in international competition. basis.
1 Process and technology for preparation of traditional Chinese medicine preparations
1.1 Chinese medicine pharmaceutical pretreatment process technology
1.1.1 crushing technology
Crushing is a necessary part of the pretreatment process of traditional Chinese medicine. By pulverizing, the surface area of ​​the drug can be increased, the dissolution and absorption of the drug can be promoted, and the leaching of the active ingredient in the drug can be accelerated. According to the different sources and properties of traditional Chinese medicine, the pulverization can be carried out by separate pulverization, mixed pulverization, dry pulverization and wet pulverization. For some medicinal materials rich in sugar and having certain viscosity, traditional smashing methods such as sizing method can be used; for medicinal materials containing more fatty oil, string oil method can be used; for pearls and cinnabars, "water flying method" can be used; for thermoplasticity The material can be pulverized by a low temperature or the like.
In recent years, the application of ultrafine pulverization technology in the pulverization of traditional Chinese medicine has been increasing. Using modern ultra-fine micro-machining technology such as ultrasonic pulverization and ultra-low temperature pulverization, the powder with a central particle size of 150-200 mesh (75 μm) can be obtained from the traditional pulverization process. In the following), the center particle diameter increased to 5 to 10 μm or less, and the cell breaking rate of the general medicinal material is ≥95% under the fineness condition. The adoption of this new technology is not only suitable for a variety of different medicinal materials, but also allows the active ingredients to be directly exposed, so that the dissolution and action of the medicinal ingredients are more rapid and complete. Since the ultrafine pulverization technology adopts supersonic airflow pulverization and cold pulverization, it is completely different from the conventional pure mechanical pulverization method, and does not cause local overheating during the pulverization process, and is carried out at a low temperature state, and the pulverization speed is fast. The bioactive substances and various nutrients in Chinese herbal medicines are retained to the greatest extent, and the efficacy is improved. The traditional Chinese medicine pearl and calamine were respectively pulverized by airflow and ball milling, and compared with the pulverization time and particle size. As a result, the pulverization time of the ultrafine pulverization of the airflow was only about 1/30 of the original, and the particle size was increased. About 3 times [1]. Two kinds of different comminution techniques for the treatment of dysmenorrhea traditional Chinese medicine preparations - Chengnian Yuetai and Diabetes Capsules for the treatment of diabetes, a pharmacodynamic comparison study found that in analgesia, improvement of microcirculation, blood sugar lowering, etc. The strength of the processing of the original drug by the micro-powder technology is significantly greater than that of the conventional pulverization technology for processing the original drug [2]. The dissolution rate of the active ingredients of traditional Chinese medicines is often related to the degree of drug comminution, and there is often a correlation between the dissolution rate of the active ingredients of traditional Chinese medicines and the bioavailability of the drugs in the body. In vitro dissolution test was carried out on different smashing degree of Panax notoginseng. The results showed that the order of dissolution content of Panax notoginseng and the total amount of Panax notoginseng saponins in the order of 45 min were: micropowder>fine powder>coarse powder>granules [3].
The research and development of ultrafine powdering of traditional Chinese medicine has just started. The Chinese veterinary drug 114 network is often used for some traditional Chinese medicines with unique functions such as American ginseng and pearls. These nourishing health care Chinese medicines can greatly increase the utilization rate after micronization.
At present, the crushing machines used in the production of traditional Chinese medicine include hammer-type crushers such as SF-170, SF-170-3, and SF-200; air-selective crushers such as YF-130 and YF-240; and 30B and 30BII universal crushers; F-400, FS-320, 721 type Shibata type crusher; SQ-A, SQ-B ball mill; new dust-free crusher and so on.
1.1.2 Leaching Technology
Traditional Chinese medicine extraction methods include decoction, dipping, percolation, reflux extraction, and steam distillation [4-7]. In ancient Chinese medical records, there were records of water decoction and wine immersion extraction of medicinal materials. In the 1950s, in the climax of the Chinese pharmaceutical reforms, the mixture was prepared by a boiling method such as decoction, dipping, reflux, and percolation. In the past 20 years, the scientific and technological personnel have carried out a systematic examination of the process parameters of the traditional extraction method, and established the currently recognized parameter determination method. That is, the parameters are determined by the optimum leaching conditions, such as orthogonal design, uniform design, and comparison method, based on the leaching rate of the index component.
According to the "Chinese Pharmacopoeia" 1990 edition and the Ministry of Health "pharmaceutical standards", Chinese herbal preparations 1-9 volumes, a total of 1945 kinds of proprietary Chinese medicines, of which up to 826 kinds of water decoction extraction process, accounting for 42.5 %. In the 1995 edition of the Chinese Pharmacopoeia, 398 kinds of proprietary Chinese medicines were collected, and 100 kinds of Chinese medicines were used, accounting for 25.1% of the total. It can be seen that boiling method is still one of the most commonly used extraction methods [4-5]. Some people used 98 kinds of commonly used traditional Chinese medicine decoction pieces and 10 different prescriptions, taking the dry weight of the fried food as an indicator, and investigated the relationship between the amount of decoction, the decoction and the leaching rate [6]; The extraction efficiency of the method was studied. The leaching rate of the decoction was found to be only 55.5% [7].
With the advancement of science and technology, on the basis of multi-disciplinary infiltration and deep research on the principle and process of extraction, new methods and techniques such as semi-bionic extraction, ultrasonic extraction, supercritical fluid extraction, and swirling are extracted. Extraction method, pressurized countercurrent extraction method, enzymatic extraction and the like are continuously adopted, and the quality of the traditional Chinese medicine preparation is improved.
Semi-bionic extraction method: In 1995, Zhang Zhaowang et al [12] proposed a new concept of Chinese medicine extraction from “semi-bionic extraction methodâ€. From the perspective of biopharmaceutics, the whole drug research method is combined with the molecular drug research method to simulate the environment in which the drug is transported through the gastrointestinal tract after oral administration, and a new extraction is designed for the traditional Chinese medicine preparation administered by the digestive tract. Process. That is, the drug is first extracted with acid water of a certain pH, followed by extraction with alkaline water of a certain pH, the optimum pH of the extracted water and the selection of other process parameters, and one or several active ingredients can be combined with the main pharmacological action index, The proportional division method is preferred. The extraction rate of "semi-bionic extraction method" and traditional water decoction method of Zhigan Zhitong Granules was compared with paeoniflorin and glycyrrhetinic acid as indicators. The results of "semi-bionic extraction method" were superior to traditional decoction. Taking berberine, astragalus and gardenia as indicators, four kinds of extraction methods of cold pain and effervescent granules were examined. The results were semi-bionic extraction method>semi-bionic extraction and alcohol precipitation method>water extraction method>water extraction method. With psoralen, schisandrin and evodiamine as indicators, four extraction methods of Sishen tea were compared. The total amount of the three components was optimized by semi-bionic extraction. The extraction rate of two extraction methods of Chuanwu was compared with the total alkaloids of Aconitum. The results showed that the content of total alkaloids and aconitine aconitine in the semi-bionic extraction method was higher than that of traditional decoction [13-16]. .
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