Pharmaceutical Powder Engineering Technology and Modernization of Traditional Chinese Medicine

Pharmaceutical powder engineering technology includes pharmaceuticals (including auxiliary materials) and intermediate materials in powdery solid phase, liquid-solid two-phase (including molecular state), gas-solid two-phase, gas-liquid two-phase, gas-liquid-solid three-phase, etc. Equipment, materials and technology for working in the state, including: pharmaceutical powder machinery, powder process technology, special functional powder materials, and testing equipment. Its main classifications are as follows: 1. Pharmacy powder granule mechanical inclusion: pulverization, pulverization; classification, separation, sieving; magnetic separation; dust collection, cleaning; storage tank, feeding; transportation; drying, cooling; granulation, coating, surface modification, composite Mixing, stirring, dispersing; crystallization, emulsification, dissolution; extraction, extraction; filtration, pressing, dehydration, concentration, membrane separation, centrifugation, temperature separation; mixing, kneading; forming, tableting; reaction; packaging, filling , metering, opening bags, and so on. Pharmaceutical powder machinery is closely matched with pharmaceutical powder technology, with a wide variety and support. 2. Powder physical property measurement and laboratory research equipment This is the equipment for quality control and research and development of pharmaceutical process testing. 3. The development and production of auxiliary equipment and materials auxiliary equipment and materials for powder machinery is very beneficial to improve the overall level. 4. Pharmaceutical powder engineering automation device and detection and metering sensor device This is one of the important professional contents in compliance with GMP in the pharmaceutical process. 5. Functional food powder materials for pharmaceuticals and foods With the high technology of traditional Chinese medicines, functional powder materials are indispensable. 6. Pharmaceutical powder process technology This is the core of pharmaceutical powder engineering technology, and the development of powder process technology is a multidisciplinary synthesis. In any country, the formulation of the drug must be made public, but the pharmaceutical powder process technology can not be disclosed. For the enterprise, the technology is top secret, and it is generally impossible to purchase it when purchasing equipment. Second, the key research direction of pharmaceutical powder engineering technology With the improvement of human living standards, countries around the world are improving people's quality of life. Under this request, the research direction of key technologies for the international powder engineering industry in recent years for the pharmaceutical industry is as follows: Ultrafine powder and related technology Ultrafine powder is the basis for improving the efficacy of pharmaceuticals. Micronization of western medicine can improve the bioavailability of the drug and reduce the dosage. The same is true for traditional Chinese medicine. After cell-level micro-pulverization, the cell breaks the wall and greatly improves the efficacy. . However, after the micronization of the drug, there are some difficulties in the pharmaceutical operation process, so after solving the ultrafine powder device, the related powder operation problem must be solved at the same time. The ultrafine pulverization of traditional Chinese medicine mainly refers to cell-level micro-grinding. The main medicinal components of animal and plant medicines are usually distributed in cells and interstitial cells, and are mainly intracellular. When the cells are broken, the active components in the cells are exposed, so the efficacy is greatly improved, and the onset speed is fast. The only equipment that can do this work is the vibration mill, ball mill and planetary mill. Due to the low production efficiency of the ball mill and the long pulverization time, it is generally not applicable. Although the planetary mill has high production efficiency, but the single machine capacity is too small and inconvenient to use, it is not used. Therefore, the current ultrafine pulverization of animal and plant medicines in Germany and Japan Use a vibrating mill. However, the vibration mill has one, two and three generations. Only the third generation vibrating mill is a highly efficient superfine crushing device. It is used for plants with spore structure (particle size only 10μm). For example, the broken wall of Ganoderma lucidum spore powder can be completed in a short time, and the breaking rate is 99%. For any Chinese medicine, it can be superfinely pulverized. We use the third generation. The vibrating mill has been subjected to ultrafine pulverization of hundreds of Chinese medicines, and very successful, such as very difficult drugs such as blood, Ganoderma lucidum, etc. can be ultra-fine pulverized for mineral medicine crushing up to 0.3 microns. The international research of jet mill is not able to reach D50<3μm. This machine is only a micro-grinding equipment, it is not a superfine crushing equipment, and it is very difficult to crush fiber and toughness Chinese medicine, especially when there is relatively high-speed airflow during the crushing operation. The ingredients are taken away, causing the loss of efficacy. Therefore, the machine is suitable for the micro-grinding of chemicals with certain brittleness, or the crushing of mineral-based Chinese medicines, which is not suitable for the ultrafine grinding of Chinese herbal medicines. A variety of screen rotor shredders have a material head, which can not guarantee the full composition of the medicine. It can never be used for the micro-pulverization of traditional Chinese medicine, especially the crushing of compound Chinese medicine. It is suitable for crushing operations in the chemical industry. It is very important to choose a reasonable pulverizing equipment for the ultrafine pulverization of traditional Chinese medicine. 2. Compounding and precision coating technology is a combination of ultrafine powder (submicron grade fine material) or material molecules on the surface of some larger particle size special materials or in the molecular level material with internal pores. It can also be compounded in ultrafine powders with ultra-micro tunnels, etc. In traditional Chinese medicines such as cyclodextrin packs and borneol, it is such an operation. For example, the volatile components in the pharmaceutical process can be packaged in a variety of combinations and in the auxiliary or semi-finished drugs to ensure that the drug components do not escape. Precision coating is a kind of single-layer or multi-layer micro-powder coating of certain nuclear materials, which can improve the quality of many drugs, such as multi-level release. 3. Particle design and surface modification technology Particle design is the powder microscopic design using ultra-fine powder technology, composite technology, and precision technology according to the required properties of the material or the higher performance that can be achieved. The drug must be designed for particle design. For example, in addition to component simulation, the composition of the simulation drug should also be simulated, which can be achieved by particle design. Especially for high-efficiency drugs, it is necessary to carry out this work. After particle design, it can achieve good results. The surface modification of the drug powder is also an essential operation in the production process of the drug, and can produce a very important therapeutic effect or powder performance. 4. Mechatronics and Total Automation Technology In the pharmaceutical process, excessive human intervention can cause product instability and pollution. The electromechanical integration of pharmaceutical equipment can achieve high performance and high level of pharmaceutical powder machinery, and the amount of labor is reduced by Zui Land to ensure the quality of the medicine. In particular, single-machine multi-function automation (pharmaceutical powder mechanical flexibility, FMC) can make small-volume drug production as easy as large-volume drug production. 5. Cleansing and safety technologies Pharmaceutical processes should meet GMP cleanliness requirements. Pharmaceutical products should be tested and evaluated for safety and compliance with GLP-qualified institutions. In the process of traditional Chinese medicine, powder machinery must ensure that pharmaceutical processes and products meet the requirements. Such equipment should have GMP-compliant design: such as multi-function machine, multi-purpose machine, reduce pollution, reduce the burden of washing work; ensure the material is completely discharged inside the device; machine capacity is good fit; when the machine is detachable and cleaned, the disassembled parts The weight shall not exceed 10 kg; the inside and outside of the machine shall be smoothed; the flow of materials and liquids, air and other pipes (or channels) in contact with the materials shall be hygienic in the machine or device, and the length of each section shall not exceed 2 meters, and shall have a fast compliance. Open interface (note that it is not a stainless steel sheet bending interface used in the chemical industry) connection and so on. In order to meet the requirements of the safety assessment of GLP institutions, in addition to the prevention of pesticides and heavy metal pollution during drug planting, the production process must comply with GMP requirements, and the pharmaceutical powder industry should also develop equipment that can improve the safety level of drugs. Third, the pharmaceutical powder engineering technology to promote the modernization of traditional Chinese medicine using water extraction compound Chinese medicine, extracts added to the accessories dry, and then made into granules, sold as a commodity, when washed, can be reduced to a soup. This method successfully applied modern powder engineering technology to commercialize traditional Chinese medicine decoction and improved the level of traditional Chinese medicine. At present, the research on the new technology of cell-level micro-grinding of traditional Chinese medicine carried out by relevant research institutions in China is also using modern powder engineering technology to improve the efficacy of Chinese traditional pills, powder, cream and dan, reduce the dosage and improve the preparation level. Traditional Chinese medicine is high-grade. With the deepening of research, this method will be widely promoted and contribute to the modernization of traditional Chinese medicine. The above is an example of success. If modern Chinese medicine, raw materials, and precious drugs are further researched and developed using modern powder technology, it is believed that there will be some higher-level Chinese medicines available, and these drugs will undoubtedly be high-tech products. IV. Problems and current main tasks Due to the modern powder engineering technology that has not been able to promote microscopic research in the past, traditional equipment has restricted the modernization process of Chinese medicine. 1. There are mainly problems: (1) The assimilation of mechanical products is serious: the production of products is large, but the variety is too small to cover the scope of new pharmaceutical technology requirements. (2) Insufficient technical development capabilities of pharmaceutical machinery enterprises. Heavy equipment and light application process requirements are more common. For example, the smashing equipment with a sieve can not completely pulverize the medicine, and at the same time, the material is produced. Although the sieve can separate the fine materials, the material that cannot be pulverized takes away some of the active ingredients of the medicine, so that the fine materials do not completely meet the requirements. The full composition of the drug. Such equipment is used for the smashing of inorganic or western medicine. Blind production for the Chinese medicine industry has caused significant damage to the quality of pharmaceutical production. (3) Short-term behavior of pharmaceutical production enterprises, lack of innovation awareness, blind introduction of domestic and foreign equipment, and even introduction of chemical industry equipment into the pharmaceutical industry. In fact, the chemical equipment made of stainless steel is considered from the perspective of corrosion resistance, and generally does not meet the GMP requirements of the pharmaceutical industry. For example, the currently used vibrating screen, also called the vibrating screen, was designed by a factory in China in 1981 and was certified as a * product by the state at that time. It is currently manufactured by many factories in counterfeit or partially modified. However, the screen is for the general industry. Its stainless steel products are for chemical services and do not meet GMP requirements at all. This sieve is currently produced in many pharmaceutical machinery plants. Vibrating screens that meet GMP requirements are completely different from current screens. There are many other examples. Therefore, we must pay close attention to the research, development and production of modern pharmaceutical powder engineering technology. 2. Current main tasks (1) Formulate regulations for pharmaceutical machinery that meet GMP requirements, and promptly carry out product transformation on existing Chinese medicine pharmaceutical machinery and devices. (2) Develop urgently needed technical equipment that can meet the technical requirements of the Chinese medicine industry and develop essential equipment to meet the needs of scientific research and technological advancement in the pharmaceutical industry. For example, granulation equipment should generally have nearly 30 kinds of machines, each with different series of products, some of which can be used for precision coating. However, there are only a few products in China, and the performance is not ideal. We should develop special granulation machines suitable for the characteristics of traditional Chinese medicines. Of course, they should be diversified. Other machinery is the same, but the development work should be carried out according to the principle of technical completeness. (3) Actively promote the research and development of special powder process technology for modernization of traditional Chinese medicine. The pharmaceutical powder process technology is the basis of modernization of traditional Chinese medicine. It is the whole process of traditional Chinese medicine production. It should increase the technical input and capital investment in the development of new drugs and the secondary development of traditional products, and study and adopt this technology. At the same time, it is necessary to explore the establishment of relevant laws and regulations, respect the intellectual property rights of new drug processes, and ensure the confidentiality and inviolability of the technology in the development and production of new drugs by enterprises or research institutions. (4) Establish and improve the quality evaluation system of powder particles. While solving the technology related to ultrafine powder equipment and powder operation, it is necessary to establish and improve the quality evaluation system of powder particles. The quality evaluation index of the ultrafine pulverized particles of traditional Chinese medicine is not only the particle size or particle size problem, but should be introduced into the cells. The concept of breaking rate and particle size spectrum must establish a complete and standardized quality evaluation system. V. Conclusion Modern pharmaceutical powder engineering technology is a micro-combination of drugs, making full use of micronization, compounding, precision, surface modification and particle design technology to achieve high levels of drugs. The technical space that can be studied and utilized in this respect is very broad. The in-depth research and application of this technology will be a new technological growth point and a new economic growth point for Chinese medicine. Traditional Chinese medicine is China's national treasure. We should use modern pharmaceutical powder engineering technology to assist Chinese medicine technology and product development science and technology community colleagues to continue to carry forward. To improve the quality of life of our people with modern Chinese medicine, and to contribute to the growth of the national economy with modern Chinese medicine. There is a long way to go, and we need the joint efforts of various industries and the support of the leaders of relevant government departments. As long as we work hard, I believe that it will take a long time for our modernization of Chinese medicine to take a new step and start a new phase. Source: Chinese medicine research Author: Shen Ping Mother how to build students

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