Chemical technology of raw materials of traditional Chinese medicine preparations

Chemical technology of raw materials of traditional Chinese medicine preparations

One of the important premises for the production of traditional Chinese medicine preparations is the raw material medicine, which plays an important role in the processing and manufacturing of raw materials in the pharmaceutical industry in all links of the traditional Chinese medicine preparation industry chain. But most of them are outsourced production. The so-called Chinese medicine preparation technology outsourcing process service refers to the Chinese medicine preparation company entrusting other medical institutions to carry out the raw material outsourcing process research and development and production. The production process includes chemical synthesis, fermentation, plant (animal) extraction, etc. At present, TCM preparation outsourcing technology has become an important purchase and sales model in the global pharmaceutical intermediates and TCM raw materials market. Most of the TCM preparation raw materials and intermediates required by Japanese and Korean preparation manufacturers are purchased in my country. The drug outsourcing process of most of its traditional Chinese medicine products, the production process of traditional Chinese medicine raw materials is much more complicated, the process is long, the pipeline is many, the operation is complicated, and most of the traditional Chinese medicine raw materials are unstable, such as environmental parameters such as temperature, humidity, light and other requirements The related raw materials are mostly flammable and explosive. Different from the preparation product process, most of the production process of traditional Chinese medicine raw materials is a cross-fusion process of chemistry and physics, such as product dissolution, decolorization, extraction and adsorption. Because the production of traditional Chinese medicine raw materials pays attention to the control of process parameters and environmental parameters, such as light, temperature, and pressure. According to the common classification of raw materials of traditional Chinese medicine preparations, there are synthetic raw materials, animal and plant extract raw materials, and raw materials obtained from fermentation and cell culture. According to the microbiological level of the product and the target dosage form, the raw materials of traditional Chinese medicine preparations are divided into sterile raw materials and Non-sterile Phenibut Manufacturers APIs. The conventional Chinese medicine preparation raw material medicine production process is as follows: 1. Chemical synthesis Chinese medicine preparation raw material medicine production process In the traditional Chinese medicine preparation chemical raw material production process, various raw materials can obtain products with certain medicinal effects through chemical reactions under certain conditions, and then undergo crystallization and drying. The process enables it to reach various indexes of medicines, and the development services of Chinese medicine preparations and chemical medicines include pre-prescription research, drug analysis, drug stability research, and preparation development. One-stop service including CMC service. The main method for the production of raw materials of traditional Chinese medicine is chemical synthesis of drugs, and its chemical structure is generally the target product obtained by a certain step of chemical reaction between the starting material and other compounds, such as condensation, substitution, acylation, redox; and then another step Or a few steps of refining, such as decolorization, recrystallization, etc., the final raw material drug product of Chinese medicine preparation. The production of intermediates and crude products is mostly carried out in areas without cleanliness, while the finishing process of final products is carried out in clean areas. The design effect of the chemical synthesis raw material medicine workshop of Chinese medicine preparations is very important to the production of Chinese medicine preparation raw material medicine manufacturers. Workshop layout is an important part of process design. Only reasonable process layout can achieve the advancement of traditional Chinese medicine preparation process and equipment, and create a good environment for workshop production, operation, equipment installation and maintenance, and safety, health, and environmental protection. 2. Fermentation of the production process of the raw materials of traditional Chinese medicine preparations Fermentation of the production process of traditional Chinese medicine preparations, especially the raw materials of antibiotic preparations, such as penicillins and cephalosporins, are usually obtained through semi-synthesis and fermentation combined with chemical synthesis. First, the main structure of the t Phenibut on sale arget compound is obtained through biological fermentation, such as the specific 3-lactam structure of penicillin, and then the structure is modified to obtain the final target compound; finally, the final API product is obtained through purification and recrystallization. The fermentation process generally needs to go through the process of culture medium preparation, tank treatment, inoculation, fermentation, wall breaking, filtration, precipitation, centrifugation, drying and other processes. 3. The production process of the raw materials of sterile traditional Chinese medicine preparations is the same as that of the sterile preparations of traditional Chinese medicines. The sterile raw materials of traditional Chinese medicines are also divided into terminally sterilized and non-terminally sterilized sterile raw materials. It is sensitive to high temperature and high heat, high humidity and high pressure, radiation, etc., and there are few sterile APIs for terminal sterilization. At present, non-terminally sterilized sterile APIs usually combine the final step of product refining or salt formation with the sterilization process, using pre-filtration plus two-stage 0.22 um sterilization filtration to achieve sterility of the final product. The traditional Chinese medicine preparation liquid after sterilization and filtration is usually crystallization, freeze-drying or spray drying to obtain the final sterile raw material drug product of the Chinese medicine preparation. In the traditional production of sterile raw materials of traditional Chinese medicine preparations, the dissolution and decolorization of crude products are carried out in a C-level clean area, and sterilization filtration, product formation, centrifugation/filtration, drying, and packaging are performed in a local A-level environment under a B-level background In progress. At present, aseptic raw materials of traditional Chinese medicine preparations are increasingly used in closed production, especially the use of three-in-one, isolation, crushing, and packaging equipment integrated isolation, crushing and packaging system, which greatly reduces the exposure of traditional Chinese medicine products to microorganisms. Or the possibility of pyrogen contamination. Therefore, the production of sterile raw materials of traditional Chinese medicine preparations in a closed type can also be carried out Phenibut powder wholesale under a C-level background, and laminar flow protection or isolation environments are only set up in places where there is a risk of local exposure. Compared with non-sterile APIs, the production of sterile APIs for TCM preparations not only needs to pay attention to the requirements of chemical quality indicators such as product impurities and physical and chemical properties, but also pay attention to the guarantee of product sterility from the beginning of the process design of TCM preparations. Therefore, the production of sterile APIs has higher requirements on the environment and equipment. 4. The production process of raw materials for animal and plant extracts of traditional Chinese medicines is a treasure house of natural compounds in nature. Animals or plants produce many products that cannot be synthesized but are currently not available for treatment. Diseases are compounds of traditional Chinese medicine preparations, so animal and plant extraction is an important way to obtain target compounds of traditional Chinese medicine preparations, and it is also one of the main methods for producing raw materials of traditional Chinese medicine preparations. For example, artemisinin used to treat malaria and heparin extracted from animal organs used to treat cardiovascular diseases. In recent years, high-level intermediates for the production of raw materials of traditional Chinese medicine preparations have been extracted from animal and plant tissues, and then through certain chemical synthesis and structural optimization, the target compounds of traditional Chinese medicine preparations have been finally obtained. This will not only greatly improve its efficacy, but also further Reduce its side effects. For example, the anti-cancer drug camptothecin has been further modified to obtain traditional Chinese medicine preparations such as irinotecan hydrochloride and topotecan with better selectivity and less toxic side effects. Many TCM preparation R&D companies provide TCM outsourcing process services, which guarantee the continuous and effective production of TCM preparations that meet the predetermined specifications and quality of the process that runs within the predetermined process parameters. In the process of R&D and production of raw materials for traditional Chinese medicine preparations, the production quality management standards for traditional Chinese medicine preparations are based on production, and quality can only be achieved by production. The quality of traditional Chinese medicine preparations is produced, not inspected, and production management should be carried out in accordance with GMP.