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Throughout the domestic and international research, a consensus has been reached on the advantages and application prospects of nano-medicine and its preparations. However, there are many kinds of traditional Chinese medicines, various kinds of prescriptions, and complex ingredients. How to carry out research on new preparations of nanometer Chinese medicine under the guidance of TCM theory is a problem that must be considered in the research of Chinese medicine nanotechnology.
1 nanometer preparation technology has already reported on the nanocrystallization of traditional Chinese medicine. Xu Huibi uses a high-energy ball mill under vacuum or inert gas, and supersonic airflow pulverization to produce realgar of 50-80 nm [2]. Luo Guoan prepared the carboplatin liposome lyophilizer by reverse phase evaporation method, and prepared each breviscapine polyacrylate nanoparticle by microemulsion polymerization [3]. Zui is the world's first nano-Chinese medicine microcapsule production technology that applies nanotechnology to Chinese herbal medicine processing. It was born in Xi'an National High-tech Industrial Development Zone and passed the product technology appraisal. The licorice powder and Gynostemma powder produced by this technology have reached the nanometer level [4]. At present, nano Chinese traditional medicine preparations mainly have the following preparation methods.
1.1 Superfine pulverization technology The original medicinal materials or extracts are pulverized using special mechanical equipment to achieve nanoscale. China has developed a high turbulent pulverizer that uses turbulence principle to pulverize. The pulverization experiment of Chinese licorice shows that the particle size of the product can reach below 1μm, the pulverization of minerals reaches below 100nm, and the particle size distribution is narrow. Experts foresee that this technology may provide an efficient and convenient shortcut for the physical preparation of nano drug particles.
1.2 Solid Dispersion Technology This is to uniformly disperse the drug in a micropowder, microcrystalline or molecular state in a carrier bag having no physiological activity, and the particle diameter of the drug in the carrier is less than 100 nm. The technology obtains nano drug particles by physical dispersion, and if the drug is embedded in a polymer of different properties, an immediate release or sustained release solid dispersion can be formed. The solid dispersion of the drug is prepared by a solid dispersion technique, and is usually a melting method, a solvent method, a solvent-melting method, a solvent-spray (freezing) drying method, or a grinding method. The solid dispersion technique used by different drugs depends mainly on the nature of the drug and the structural properties, melting point and solubility of the carrier material.
1.3 Micro-emulsification technology Oil, water, emulsifier and co-emulsifier are obtained by mixing according to a certain ratio at a certain temperature by an appropriate method. The drug is a colloidal dispersion system formed by dispersing emulsion droplets having a particle diameter of 10 to 100 nm in another liquid.
1.4 Chemical vapor deposition method A chemical change in a gaseous state forms a desired compound and rapidly condenses under a protective gas to form a nano drug particle.
1.5 Supercritical fluid technology The nano drug particles can be prepared by using the rapid expansion of supercritical solution and supercritical anti-solvent technology.
1.6 Supersonic jet technology instantaneously collides with supersonic microjets of fluid under high pressure conditions, resulting in strong impact between particles, high turbulence and ultrasonic cavitation, so that the material instantaneously reaches the nano-dispersed state, in the impact In the process, the auxiliary material can be coated with the nanoparticles to achieve stable dispersion. In the impact process, the auxiliary materials can be coated on the nanoparticles to achieve stable dispersion.
1.7 High-pressure milk uniform technology With the development of emulsification technology, especially after the high-pressure milk homogenizer has been successfully applied in the pharmaceutical industry, people have further developed physicochemical stability, smaller particle size, less toxicity, and targeted slow release. A nano-new dosage form that is suitable for multi-channel administration. It is prepared by dissolving the drug in a fat higher than 5-10 ° C, adding emulsified milk to the aqueous phase containing the surfactant, and then passing the colostrum through a high-pressure emulsion homogenizer to prepare a nano-emulsion.
1.8 package and technology mainly use beta-cyclodextrin as carrier material, after packaging and can increase the solubility and dissolution of poorly soluble drugs, reduce the irritancy of drugs, especially after the volatile components of traditional Chinese medicine are encapsulated, The retention rate can be significantly improved and the stability of the drug during storage can be increased.
The choice of preparation methods for 2 nanometer Chinese medicine research and development direction mainly depends on the nature of the material, the size of the particle size, and the nature of the drug to be embedded and the requirements of the dosage form. At present, there are about 145 Chinese traditional medicine nano-species and their preparation methods applied for a patent. They are mainly made by microwave extraction, and then made into nano-medicine decoction pieces by supersonic jet technology, and then prepared into traditional Chinese medicine. Although some forward-thinking colleges and universities and research institutes have invested a certain amount of manpower and material resources to carry out the corresponding basic research on traditional Chinese medicine nano-preparation, it has laid a certain foundation for nano-Chinese traditional medicine preparations. However, it is also faced with how to realize the nanotechnology of traditional Chinese medicine, the stability of nano-medicine in the preparation process, the selection of nano-medicine surface modification materials, and the preparation factory must meet the requirements of GMP and meet the problems of quantitative production. Therefore, from the current research and development of nano-medicine preparations, it is still waiting for the hard work of science and technology workers.
Basic research on 2.1 nanometer Chinese medicine Some people have searched for patents involving nanotechnology in US patents from 1998 to 2000, and 80% belong to the field of biomedicine [5]. Chinese scientists have also done a lot of work on the application of nanotechnology in medical towels, but mainly limited to the field of western medicine and western medicine. Therefore, the nano-drug medicine lacks certain theoretical guidance, and the nano-medicine preparations have just started, and most of them are still in the in vitro and in vivo experimental stages. The problem of research and development of towel medicine is the separation and purification of active ingredients, pharmacodynamics, pharmacology, toxicology, quality standards, indications and other issues. These problems have not been solved naturally with the advent of nanotechnology. Therefore, we should focus on the development of nano-Chinese medicine preparation technology, and establish a systematic evaluation method of pharmacology, efficacy and toxicology.
2.2 Nano-Chinese Medicine Safety Traditional Chinese medicines have been made into nano-Chinese medicines, which may enhance the original efficacy, and may also reduce or eliminate the original efficacy, and even new toxic side effects. Under the guidance of the theory of traditional Chinese medicine, how to maintain or enhance the original efficacy of traditional Chinese medicine, reduce the elimination of toxic and side effects, make three effects (high efficiency, quick-acting, long-acting), three small (small dose, low toxicity, small side effects), Modern Chinese medicine preparations, which are easy to store, easy to carry and easy to take, are also issues that must be considered when carrying out traditional Chinese medicine nano preparations.
2.3 Nano-Chinese medicine test The quality inspection technology of nano-Chinese medicine has not been reported in this respect so far. How to test whether it has reached the level of nanometer, how to control its quality, relevant standards, evaluation indicators, test basis, is also worth Research questions.
In short, with the development of preparation technology, traditional Chinese medicine preparations have evolved from the classic passive carrier technology to the active control of drug action. The drug acts in the body at a precise rate, for a predetermined period of time, at a stable site, and for the needs of the disease. However, the traditional Chinese medicine "rough, large, black" appearance, especially the complexity of the composition of traditional Chinese medicine and the complexity of the mechanism of action, the use of traditional Chinese medicine nano-preparation, especially the study of the nano-delivery system of the towel medicine compound, relying on one kind The power of disciplines is difficult to do, and multidisciplinary research will be an important part of the way to solve this problem. China is a big country in traditional Chinese medicine. Research in this area will help China's Chinese medicine to go global and serve the health of the people of the world.
references
[1]Feng Nianping, Wu Peiyi, Tao Jiansheng. Discussion on Nano-formulation of Traditional Chinese Medicine[J].World Science and Technology-Modernization of Traditional Chinese Medicine,2003,5(4):52-55
[2]Xie Changsheng, Yang Xiangliang, Xu Huibi, et al. Nano-realgar and its preparation method [p]. Chinese Patent, 1288723, 2001, 03, 28.
[3] Luo Guoan. Nano-Chinese Traditional Medicine Preparations[J]. China Medical Engineering, 2005, 3(2): 149-151.
[4] Wang Zhuyu. Nano Pharmacy [N]. China Medical News, 2001, 07, 03.
[5] Yang Xiangliang, Xu Huibi, Wu Jizhou, et al. Research on the basic problems of traditional Chinese medicine based on nanotechnology[J]. Journal of Huazhong University of Science and Technology, 2000, 28(12): 104-106.
Research direction of traditional Chinese medicine nano preparations
After the traditional drug delivery route and dosage form, the drug has developed into a long-acting and sustained-release preparation, a controlled release preparation and a targeted preparation stage of modern medicine, and has now entered the stage of intelligent drug delivery system. With the understanding and understanding of pharmaceutical preparations, pharmaceutical preparations are no longer just a "formulation" of a drug with a certain dosage form, but a "device" for delivering and delivering drugs [1], which brings new to traditional Chinese medicine. Claim. However, due to the particularity of traditional Chinese medicine, its preparation has just stepped out of the conventional preparation stage. How to solve the existing deficiency of traditional Chinese medicine, the emergence of nanotechnology has provided new ideas and methods for the study of traditional Chinese medicine nano preparations.