1. The basic principle of macroporous resin adsorption technology
The macroporous adsorption resin technology is a new process developed in the 1970s. In short, it is to pass the decoction of traditional Chinese medicine compound through the macroporous resin, absorb the active ingredients, and then elute and recover to remove impurities. A purification method.
1. The basic principle of macroporous resin adsorption technology
The macroporous adsorption resin technology is a new process developed in the 1970s. In short, it is to pass the decoction of traditional Chinese medicine compound through the macroporous resin, absorb the active ingredients, and then elute and recover to remove impurities. A purification method. Depending on the composition of the drug solution and the substance extracted, different types of resin are selected. The components of the adsorption resin, especially the non-polar adsorption resin in the adsorption liquid. Mainly the physical structure (such as specific surface, pore size, etc.) functions, such as for the extraction of stevioside, commonly used AB-8 type, and the separation and extraction of traditional Chinese medicine and the purification of antibiotics commonly used X-5 type, different resins have different targeted . The basic procedures of its operation are mostly: Chinese medicine extraction solution-through the macroporous resin-resin adsorbed with active ingredients-elution-eluent-recovery solution-drug solution-drying-semi-finished products. This technology has been widely used in the development of new Chinese medicines and the production of Chinese patent medicines, mainly used in separation and purification processes.
Second, the superiority of macroporous resin adsorption technology in the application of traditional Chinese medicine
The extraction and separation of traditional Chinese medicine is the most critical link in the production process of Chinese patent medicine, and it is also a key issue that currently restricts the improvement of the quality of traditional Chinese medicine. It directly affects the quality of the product and its clinical efficacy. In the past 30 years, the old traditional Chinese medicine extraction process and equipment have basically been used to this day. There are no obvious reforms and breakthroughs. The method of removing impurities by boiled alcohol and alcohol precipitation is still very common, resulting in my country's traditional Chinese medicine pharmaceutical technology lagging behind the international pharmaceutical industry. Traditional Chinese medicine extraction and refining process crude medicine (more impurities), large (large dosage), black (dark color), is one of the main factors restricting the development of Chinese medicine industrialization and expanding the international market. Compared with the traditional method and process of removing impurities, the use of macroporous resin adsorption technology to remove impurities in the extracted liquid has the following three advantages:
First, it can reduce the dosage and improve the inherent quality and preparation level of traditional Chinese medicine. The refined product obtained after the treatment with macroporous resin adsorption technology can make the medicinal components highly dense, with few impurities, the extraction yield is only 2-5% of the original drug, and the general boiling method is about 20-30%, alcohol precipitation The method is about 15%, the dosage is reduced, the impurities are less, the internal quality is improved, which is conducive to making Chinese medicine in modern dosage forms and is also convenient for quality control. Both the pharmacodynamics and the clinic have confirmed the improvement of the efficacy of the same class of drugs after adopting this process. The process has completed two processes of impurity removal and concentration at one time. For example, ginsenosides are also contained in the ginseng stems and leaves, which can be extracted for medicinal use, but the content is low, and it is troublesome to extract by general methods. After purification by macroporous resin adsorption technology, the content of ginsenosides can reach more than 70%, and extraction is also very convenient. As another example, the decoction of Chinese herbal medicine has a large volume, a low content of active ingredients, and a large dosage. It is difficult to select a dosage form, which brings difficulties to production. If it is treated with macroporous resin adsorption technology, the problem is better solved.
Second, reduce the moisture absorption of the product. Most of the Chinese patent medicines prepared by the traditional process have strong hygroscopicity, which is a long-term problem in the production and storage of traditional Chinese medicine. After being treated by the macroporous resin adsorption technology, it can effectively remove a large amount of sugar, Moisture-absorbing ingredients such as inorganic salts and mucus quality are conducive to the production of a variety of Chinese medicines and enhance the stability of the product.
Third, the macroporous resin adsorption technology can shorten the production cycle, and the equipment required is simple, eliminating the time-consuming work such as static precipitation and concentration, saving packaging, reducing costs, and creating conditions for Chinese medicine to enter the international market.
Three, the effect of applying macroporous resin adsorption technology on the efficacy and the matters needing attention in the application
It has been confirmed by pharmacodynamic tests and clinical observations that a set of mature technological procedures can not only ensure the efficacy of the drugs, but also improve the efficacy of the drugs after purification. However, there are many technical issues that must be noted in the application: such as the choice of resin model. The specifications and quality requirements of the resin itself play a decisive role in the purification effect and safety of the extract of traditional Chinese medicine. Different models have different performances. The composition of the Chinese herbal compound water extract is extremely complex, and it is not appropriate to use one type of resin for refining and purification. In the process of purification and refining, you must select pharmacodynamic experimental methods related to the efficacy according to the needs of the treatment of the disease and track it. At the same time, The effective chemical composition of the drug must be tracked to ensure that the effective component is not lost during the purification process, the drug effect is not reduced, and the quality is stable and reliable. The process conditions such as the amount of resin, the maximum adsorption capacity, the adsorption and elution speed, the height of the resin column, the diameter, and the concentration of the type of elution solution must be selected first to ensure the quality of the drug. Only the correct process conditions can Ensure good medicine.
Four problems in the application of macroporous resin adsorption technology
The hot point of controversy for the adsorption technology of macroporous resins is the toxicity of porogens and degradants. Because the resin has a network structure and large pores, some organic solvents need to be added during preparation. These organic solvents are mostly toxic liquids and stay in The voids in the resin, commonly known as porogens, make many people worry. Before use, the porogen is not completely removed. In long-term use, the resin will not degrade, causing problems such as pollution of toxic substances. However, after many tests, we have figured out the treatment method of porogen and degradant before using the resin, and formed a complete set of detection methods. We have established quality control standards for benzene and toluene, and passed Review by the State Drug Administration. As for the problem of secondary pollution caused by the residue of medical liquid, it is rare in large manufacturers. Because in a large-scale production, a resin is only for the purification and refining of a drug, it is impossible for a resin to adsorb several drugs, people always have to selectively retain the effective ingredients according to the composition of each drug, so it is a Correspondingly, the problem of adsorption amount has also attracted extensive attention, but as long as the index component in the chemical solution before and after the column is frequently detected, the adsorption amount drops, and timely treatment or replacement of new resin can be solved.
Five, the application prospect of macroporous resin adsorption technology
The extract obtained by the macroporous resin adsorption separation process is small in volume, does not absorb moisture, and is easy to be made into various dosage forms with beautiful appearance, especially suitable for granules, gums and tablets, and upgrades the coarse, large and black preparations of traditional Chinese medicine For modern preparations. As far as the macroporous resin technology itself is concerned, the process is easy to operate, not very tedious, and the difficulty is not difficult. Moreover, the resin can be used multiple times and reused again. The cost is not very high, the equipment is simple, and this process can save A large amount of energy consumption, auxiliary materials, packaging materials, storage, transportation and other costs. At present, the macroporous resin adsorption technology is widely used in the production of Western medicine. In my country, more and more companies are exploring the application of macroporous resin adsorption technology in the research and production of traditional Chinese medicine, such as Chengdu Diao Pharmaceutical Co., Ltd. has been applied. Yangzijiang Pharmaceutical Group also uses this technology to produce ginkgo preparations. The manufacturers of western medicines in Beijing are more commonly used, and Tongrentang Pharmaceutical Factory is also trialing. It can be seen that the application prospect of macroporous resin adsorption technology is very broad.