Micronization of traditional Chinese medicine refers to the micronization of Chinese herbal medicines, Chinese herbal medicine extracts and traditional Chinese medicine preparations under the premise of following the theory of traditional Chinese medicine. According to the characteristics of the Chinese medicines, the currently recognized fine powder of Chinese medicine has a particle size of 0.1-75 μm and a particle size distribution center of D50≈10-15 μm. Micro-powdering of traditional Chinese medicine is also known as ultra-fine pulverization and cell-level micro-pulverization of traditional Chinese medicine; the obtained traditional Chinese medicine micro-powder is also known as ultra-fine powder of Chinese medicine, micro-micro powder of micro-organism, micro-medicine of traditional Chinese medicine, and super-drinking tablets of traditional Chinese medicine. Due to the increasingly scarce resources of traditional Chinese medicine, the application of micro-powder technology of traditional Chinese medicine has revealed its unique advantages and broad application prospects.
1. Technical characteristics
Increase the specific surface area of ​​the drug particles
The size of the drug particles and the structure of the powder are important factors influencing drug absorption. After micronization of traditional Chinese medicine, the drug particles are fine and uniform, the specific surface area is increased, the porosity is increased, the drug can be better dispersed and dissolved in the gastrointestinal fluid, and the contact area with the gastrointestinal mucosa is increased, so that it is more easily gastrointestinal. Absorption enhances its bioavailability.
Saving raw materials
After micronized Chinese herbal medicines, the original prescription effect can be achieved by using less than the original prescription. Micronization generally saves 30% to 70% of medicinal materials and reduces waste of resources. After micronization of traditional Chinese medicine, there is no need to perform decoction, leaching and the like, and the loss of active ingredients can be reduced, the utilization rate of the medicinal materials can be improved, the production efficiency can be improved, and the production cost can be reduced.
Conducive to the homogenization of the active ingredients in the pulverization of the compound
Most of the traditional Chinese medicine is a compound, composed of a variety of medicinal materials. After the cells are broken, the water and oil in the cells migrate out, so that the surface of the microparticles is semi-wet, and a semi-stable particle cluster is formed between the particles and the particles (or called Microparticles), each particle cluster contains the same proportion of Chinese medicine ingredients. Due to the combination and interaction of the HLB value (hydrophilic, lipophilic balance), ductility, breakability, water (oil) rate, water absorption (oil), specific gravity, etc. of the components in the component, the particle cluster The physical structure is also different. However, this structure makes the active ingredients of the Chinese medicinal materials uniform, and thus the various components can be uniformly absorbed by the human body, thereby enhancing the effect of the drug.
Can be carried out at different temperatures
Micronization can be carried out at different temperatures according to different medicinal materials, so that it can retain biological active substances and nutrients to a large extent, and improve the efficacy. It is suitable for Chinese medicinal materials containing sugar, oily and aromatic volatile components. Processing and production. It is superior to the dense animal shells, bone medicinal materials and mineral medicines, and is also suitable for fibrous, high toughness, high hardness or materials with a certain moisture content. It can be used for both dry pulverization and wet pulverization, so it has a wide range of applications.
Easy to shape
The micronized powder is even and delicate, has good oral taste, can avoid bad odor, can improve the uniformity and disintegration of the surface of the tablet, and can be made into instant granules. The powder prepared by the micronization technology can be directly granulated without adding any auxiliary materials, which is not only easy to form, but also maintains the original characteristics of the medicine, and is convenient to take, convenient to adjust and convenient to carry.
GMP compliant
Micronization is generally carried out in a fully enclosed dust-free system, which can effectively avoid external pollution, improve the working environment, and effectively control the microbial content and dust of the product, and meet the GMP requirements for pharmaceutical production.
2 Application range
Micronization of single Chinese medicine
At present, the micronization of traditional Chinese medicine has many researches on the pulverization of single-flavored traditional Chinese medicine. The results show that the micronized technology can increase the dissolution rate and bioavailability of traditional Chinese medicine, reduce the dosage of traditional Chinese medicine, retain the volatile active ingredients of traditional Chinese medicine, and enhance the pharmacological effects. It also increases the specific surface area, improves the uniformity of the particles, and the like.
Micronization of traditional Chinese medicine compound
The micronization research of traditional Chinese medicine compound is mainly the research on the dissolution amount of active ingredients, the stability of preparation and the improvement of pharmacological effects.
3 important significance of modernization of traditional Chinese medicine
Improve dosage form quality
Traditional Chinese medicine pills and powders occupy a considerable proportion in solid preparations. Traditional processing techniques are not conducive to the full absorption of active ingredients, and some topical powders may even produce local irritation. The use of micronization technology can significantly improve the dissolution and absorption of internal preparations in the body, and may achieve the effect of meeting or exceeding the original prescription in small doses. The introduction of micronized technology into the external powder will improve the dispersibility of the drug, facilitate coating and adhesion, and the active ingredient is more easily absorbed through the skin and reduces side effects. The processing of certain medicines and foods and valuable nourishing Chinese medicine into ultra-fine powder can improve absorption and improve taste.
Conducive to enriching and perfecting Chinese medicine processing technology
The application of micronized technology makes the suitable drug for smashing to achieve the appropriate particle size of Zui, can better exert the efficacy and save the medicinal materials, thus further enriching and perfecting the processing technology of traditional Chinese medicine.
Conducive to the development of new formulations of traditional Chinese medicine
Precious medicinal materials such as ginseng, antelope horn, velvet antler, and Cordyceps sinensis, and volatile aromatic drugs (such as agarwood), animal drugs (such as gunsan, scorpion, sputum), drugs whose active ingredients are hardly soluble in water (such as Tianzhu Huang) , cinnabar, amber), can be directly made into traditional Chinese medicine oral powder, capsules, microcapsules, etc. by micronization technology, and some Chinese medicines can be micronized and directly mixed with the matrix to prepare a transdermal absorption preparation.
Adjustment is more convenient
After micronization of Chinese medicinal materials, the adjustment work is more convenient, quicker and more sanitary, which improves the utilization rate of medicinal materials and improves work efficiency.
4 problems to be solved
Screening and determination of micro-powder zui suitable particle size
When the particle size is reduced, the solubility does not increase indefinitely. To a certain extent, as the specific surface area increases, many problems will be revealed. The surface of the fine particles is more likely to adsorb air and have a charge, which affects the absorption of the active ingredients and increases the difficulty of storage. Using orthogonal design or uniform design method, it can screen out the appropriate particle size for a certain medicinal material or compound, so that the micro-powder can be dissolved in vitro and the effect in vivo is better, and the aggregation is overcome, and at the same time, suitable fluidity and dispersibility are also achieved. Research to carry out this work will lay the foundation for the establishment of controllable standards for micronized products.
Strengthen clinical research work
At present, the research on micronization of traditional Chinese medicine is mainly limited to animal experiments or in vitro dissolution tests, and there are few reports on clinical research. After micronization of traditional Chinese medicine, its physical properties, chemical properties, toxic and side effects may change, and its clinical formula and dosage may also change. These depend on the strengthening of clinical research work of traditional Chinese medicine. The application of micronization technology in traditional Chinese medicine should be studied on the basis of clinical basis and efficacy.
Micronization safety study
The fine powder of traditional Chinese medicine has a small particle size. Will they adhere to the gastrointestinal mucosa and affect the gastrointestinal function? After the cell wall of Chinese medicine is destroyed, will the active components in the cells undergo chemical changes and have adverse effects in the kidney, liver, blood, cardiovascular, nervous system and other parts? Problems such as this need to be further studied, so it is necessary to carry out safety research work after micronization of traditional Chinese medicine.
Basic research on micronized related industries
After micronization of Chinese medicinal materials, preparation of the preparation, absorption in the body, hardness of the tablet, disintegration, etc., are for further study. The successful resolution of these problems can further expand the application of new technologies in traditional Chinese medicine decoction pieces and prescriptions, and accelerate the process of modernization of traditional Chinese medicine.
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