Development Status and New Technology of Traditional Chinese Medicine Preparations and Dosage Forms
- Clicks:1259 Release time:2011/3/28
Study on new dosage forms of traditional Chinese medicine
The application of the drug delivery system research commonly carried out in western medicine to the development of traditional Chinese medicine preparations is a new research field with Chinese characteristics. It has been very active in recent years. Although the composition of traditional Chinese medicine is complicated, it is much more difficult to study and develop than similar projects of chemical drugs. However, once successful, it means new products with independent intellectual property rights.
Traditional Chinese medicine transdermal absorption drug delivery system
Basic experimental research, transdermal formulation and modern methodological systems have been made in this area. Studies have shown that the active ingredients of some Chinese medicines can be transdermally absorbed, especially under the action of transdermal enhancers.
The determination of scopolamine, the main component of the golden flower in the transdermal receptor, was determined by HPLC , and the effects of different transdermal enhancers on the rate of the rind through the snake skin were compared, which provided a basis for screening the components; Good results were obtained by a transdermal tracer study of the berberine sputum marker as a tracer for Ruyi Golden Powder. It lays a theoretical foundation for traditional Chinese medicine coating agents, films and patches. And with the application of traditional Chinese acupoint theory, the use of acupoint transdermal drug delivery to obtain better results.
Traditional Chinese medicine microcapsule preparation
This study made conventional dosage forms: tablets, granules, and capsules more effective, safe, and convenient. The prepared microcapsules can be prepared according to different particle diameters, and can solve the problem of unstable quality of certain dosage forms, and can also prepare sustained release and long-acting preparations. For example, the aphid medicinal herb Hericol tablet has poor disintegration degree and release degree. In order to increase the dispersibility and stability of the drug in the preparation, it is dispersed in the gastrointestinal tract, so that it is in a specific part of the upper part of the small intestine. The parasitic pathogens are in contact, and the therapeutic effect of the drug is fully exerted. The microcapsule granules are prepared by the complex coacervation method. The release rate is measured, the cumulative release rate reaches a peak in 2 hours, and the high concentration is caused in the upper part of the small intestine. A new dosage form in which a drug is controlled to release at a specific site.
Chinese medicine sustained release, controlled release and targeted drug delivery system
Timed, targeted, constant-rate drug delivery systems and targeted drug delivery systems that have been successfully used in chemical drugs have been used in traditional Chinese medicine preparations. For example, the ethyl acetate contained in the Tripterygium wilfordii tablets is equivalent to the ordinary tablets, and the daily dose is the same, but the bioavailability is improved and the side effects are alleviated. A composite anticancer drug consisting of a combination of traditional Chinese medicine compound " Sanjie Huayu Granule " extract and fluorouracil is added to gelatin and magnetic micropowder to prepare a magnetic microsphere release system. The preparation is concentrated under magnetic field guidance in vitro. The drug is accumulated in the cancer tissue of the target area, and the drug is slowly released, thereby achieving the purpose of improving the therapeutic effect, reducing the dosage and reducing the toxicity.
Traditional Chinese medicine bioadhesive preparation
Traditional Chinese medicine powder is a common type of treatment for oral ulcers, but it is easy to disperse with saliva, and the residence time in the lesion is short, which affects the curative effect and pollutes the oral cavity. The introduction of bioadhesive technology in the oral cavity can significantly prolong and improve the curative effect, and the drug capacity is large. Reduce the number of medications.
The basis of new Chinese medicine preparations - standard extract of traditional Chinese medicine
The standard extract of traditional Chinese medicine refers to a traditional Chinese medicine product which has a clear pharmacological substance basis and strict quality standards by using modern science and technology to extract and process traditional Chinese medicinal materials, and can be used as a raw material medicine for traditional Chinese medicine preparations. Its chemical composition is a collection of various pharmacologically active substances in a specific proportion. It inherits the characteristics of traditional Chinese medicine and reflects the specific Chinese medicine effect of the original Chinese herbal medicine. Whether it is a single-flavor medicine or a compound compound, it can completely replace the original medicine. It has unparalleled superiority in quality control, has a relatively clear material basis and specific pharmacological activity, and can be said to be the basis of modern Chinese medicine preparations.
3 . New technology of traditional Chinese medicine preparation
Modern Chinese medicine preparation has developed into a systematic discipline of multidisciplinary convergence, and Zui's new process technology is constantly being applied in this field.
Extraction separation and purification process
The composition of traditional Chinese medicine is complicated, how to extract the active ingredients as much as possible, and at the same time, Zui's extensive elimination of impurity is the key to reduce the dose and improve the curative effect. The water extraction and alcohol precipitation method widely used at present is expensive, high in cost, long in production cycle, and low in extraction efficiency. The following new processes have been reported:
Supercritical fluid extraction
Supercritical extraction technology uses a certain fluid ( CO2 ) to have a special solubility in the critical point for the extraction and separation of substances. It has the following characteristics:
Strong extraction ability and high extraction rate
The supercritical ( CO2 ) critical temperature is low, the operating temperature is low, and the active ingredients of the traditional Chinese medicine can be preserved intact without damage, and no secondary biochemistry occurs.
Fast extraction time and short production cycle. Complete extraction in 2-4 hours
The operating parameters are easy to control, the active ingredients and product quality are stable, and the pharmacological and clinical effects can be guaranteed or better.
It has a sterilization effect, which is beneficial to ensure and improve product quality.
The process is simple, easy to operate, save labor and a large amount of organic solvents, and reduce pollution of the three wastes.
It has been successfully applied to the extraction and separation of volatile oils, alkaloids and lactones.
Flocculation precipitation
The flocculation precipitation method is to add a flocculating precipitant to the suspended Chinese medicine extract or extract concentrate, and take molecular action with protein, pectin and the like by adsorption bridging and electric neutralization to precipitate, and remove the solution. Coarse particles, a new technology for refining and improving product quality. The anti-cold granules are prepared by using chitosan as a flocculating clarifying agent, which retains the content of the index component more effectively than the water extraction and alcohol precipitation process, and the antibacterial effect is better than the alcohol precipitation process, and the cost is reduced.
Ultrasonic method
The method of extracting the active ingredient by ultrasonic wave is time-saving, low in temperature and high in extraction rate, and the extraction effect by the method is better than the conventional water extraction and alcohol precipitation process.
This technology can solve the problems of traditional extraction methods being complicated, cumbersome, low extraction rate and serious pollution caused by a large number of application of organic solvents. It is used to remove a large amount of enamel, protein, polysaccharide macromolecular substances and many fine particles, sub-micro particles and flocs which are present in the extract of traditional Chinese medicine.
Ultrafiltration technology
The utility model mainly utilizes a porous semi-permeable membrane to separate, purify and concentrate the components in the liquid, thereby eliminating the steps of alcohol precipitation, water sedimentation, concentration, filtration, cold sinking and sterilization, thereby greatly saving man-hours, shortening the production cycle, and the active ingredient content. It is higher than the traditional process, thus ensuring the quality of the preparation.
In addition, there are enzyme chemistry techniques, microwave radiation-induced extraction techniques, high-speed countercurrent chromatography techniques, and semi-bionic extraction methods.
nanotechnology
The current nanomaterials are divided into two levels: nanoparticle and nanosolid. At present, China is researching and developing traditional Chinese medicine nanoparticles with a single particle size of only 1-100 nm, and using them as basic units, and appropriately arranging them into three-dimensional nano-solids, that is, nano-medicine. Due to its special structure, it exhibits many physical, chemical and therapeutic effects different from traditional Chinese medicine. The use of nanotechnology for the ultra-fine development of traditional Chinese medicine can not only greatly improve the absorption of drugs by the human body, but also reduce the dosage, which can save Chinese medicine resources in a broad sense.
Application of new excipients in traditional Chinese medicine preparations
The reform and innovation of Chinese pharmaceuticals is based on the application of new excipients. The progress of new excipients has created favorable conditions for the new dosage forms of traditional Chinese medicines and promoted the development of traditional Chinese medicine preparations. For example, cyclodextrin derivatives can be used as effective penetration enhancers and absorption enhancers; cellulose derivatives can improve the disintegration degree of traditional Chinese medicine tablets, and solve the problem of whole-life tablets due to more fibers, less viscosity, high elasticity, and easy to loosen tablets. problem.
Conclusion
I think that the focus of research on new Chinese medicine preparations should be on the leaching and purification process of traditional Chinese medicine compound preparations and the evaluation methods and indicators of extract quality. Only the scientific and rational leaching process will leaching the active ingredients contained in each medicinal material in the effective prescription. In order to maintain the characteristics of comprehensive efficacy of traditional Chinese medicine compound preparations, we can achieve the purpose of making full use of Chinese herbal medicines, saving and protecting resources. Strengthen capital and technology investment, and promote the development of modern Chinese medicine with independent intellectual property rights.
Current status and prospects of the development of traditional Chinese medicine preparations
The development of modern science and technology has promoted the continuous advancement of the Chinese medicine industry. Traditional Chinese medicine has shaken off the production of “ workshop †in the past , laid the foundation for the modernization of Chinese medicine, and has entered the world to participate in international competition. It has widely adopted modern science and technology and applied new technologies. New excipients, new equipment, research and development of new dosage forms of traditional Chinese medicine, preparation and production of new preparations are fundamentally changing the backward appearance of the field of traditional Chinese medicine preparations, and improving the fundamental way of traditional Chinese medicine pharmaceutical technology.
Pretreatment technology of traditional Chinese medicine
Crushing technology
Crushing is a necessary part of the pretreatment process of traditional Chinese medicine. The pulverization may be carried out by separate pulverization, mixed pulverization, dry pulverization, and wet pulverization. In recent years, the application of traditional Chinese medicines ultra fine pulverization is increasing, the use of jet milling, cryogenic grinding and other modern processing techniques, may be native drug particle size obtained from the conventional pulverization process 150 - mesh powder 200 (75um or less), to improve the Up to now, the center particle size is about 10um , so that the dissolution and onset of the ingredients of the medicine are more rapid and complete.
Leaching technology
The traditional extraction methods of traditional Chinese medicine include boiling method, dipping method, percolation method, reflux extraction method, steam distillation method and the like. In the past 20 years, the scientific and technological personnel have carried out a systematic examination of the process parameters of the traditional extraction method, and established the currently recognized parameter determination method. That is, the parameters are determined by the optimum leaching conditions, such as orthogonal design, uniform design, and comparison method, based on the leaching rate of the index component. With the advancement of science and technology, on the basis of multi-disciplinary infiltration and deep research on the principle and process of extraction, new methods and techniques such as semi-bionic extraction, ultrasonic extraction, supercritical fluid extraction, and swirling are extracted. Extraction method, pressurized countercurrent extraction method, enzymatic extraction and the like are continuously adopted, and the quality of the traditional Chinese medicine preparation is improved.
Separation and purification technology
Common separation methods include sedimentation separation, filtration separation, and centrifugal separation. Common purification methods include water extraction and alcohol precipitation (aqueous alcohol method), alcohol precipitation method (alcohol water method), acid-base method, salting-out method, ion exchange method and crystallization method. In recent years, some new methods of separation and refinement have emerged. Such as flocculation precipitation method, macroporous resin adsorption method, ultrafiltration method, high speed centrifugation method and the like. In the process of extraction and refining, two or more processes can be used in combination to achieve better results. For example, ZTC clarifying agent is combined with macroporous resin adsorption; macroporous resin adsorption combined with ultrafiltration technology; combined with adsorption clarification-high speed centrifugation-microfiltration.
Concentrated drying technology
In recent years, the application of thin film evaporation technology in the concentration of traditional Chinese medicine extracts has become more and more perfect. At the same time, many drying equipment suitable for the production of traditional Chinese medicines have also improved the drying efficiency and the quality of dry products. The commonly used drying methods are: far infrared radiation drying oven, boiling drying, spray drying, freeze drying and the like.
Traditional Chinese medicine preparation technology
Granulation technology
Wet granulation technology used in the preparation of traditional Chinese medicine granules in the 1950s , and the use of excipients was often limited to starch, powdered sugar, dextrin. In order to reduce the amount of excipients in the granulation process, fluidized bed granulation technology (one-step granulation technology), rapid stirring granulation technology, and dry granulation technology are often used.
Coating technology
In recent years, with the birth of various new high molecular polymers and the successful development of high-efficiency coating pans, the film coating technology has developed rapidly, and there is a tendency to gradually replace the sugar coating process.
By selecting the coating material and designing the coating prescription, the purpose of achieving sustained release, sustained release, and immediate release, or by making the drug into a positioning piece released at the point of action and a targeted preparation for delivering the drug exactly to the target tissue, The film coating has a strong vitality and a wide range of appearance.
Solid dispersion technology
Water-soluble and highly hydrophilic substances are often used as solid dispersion carriers to increase the solubility and dissolution rate of some poorly soluble drugs, and increase the bioavailability of drugs after oral administration. Some water-insoluble carriers or poorly soluble materials are also used as drugs. The carrier prevents the release of the drug for the purpose of sustained release or controlled release.
Inclusion compound technique
The inclusion compound technology currently used by Zui is Ð’- cyclodextrin. The drug molecule is encapsulated or embedded in the tubular structure of the cyclodextrin to form an ultrafine particle dispersion which is an ultramicro drug carrier. The dispersion effect is good, easy to absorb, slow release, and low side reaction. Especially for the inclusion of volatile components in traditional Chinese medicine, the preservation rate can be greatly improved and its stability can be increased.
Microencapsulation technology
The micro-encapsulation technology is a technique in which a polymer material (commonly referred to as a capsule wall) is used to embed a powder particle or a drug droplet (commonly referred to as a capsule) into a micro substance. In recent years, the technique of preparing microcapsules by spray drying has been particularly attractive.
Sterilization technology
Hot press sterilization, flow steam sterilization, boiling sterilization, filtration sterilization, and gas sterilization are common sterilization methods. The research and application of 60Co -ray irradiation sterilization and microwave sterilization have also developed rapidly in recent years.
Research on the dosage form
The application of traditional Chinese medicine preparations has a long history, a wide variety, the advancement of science and technology, the development of pharmaceutical industry, and the improvement and innovation of dosage forms is an inevitable trend. The development of Chinese medicines has created favorable conditions for accelerating the process of modernization of Chinese medicine and promoting the progress of Chinese medicine.
Oral administration form
Oral administration is the main route of traditional Chinese medicine. On the basis of traditional Chinese medicine decoction, pills, powder and other traditional dosage forms, it is convenient to take in order to meet the needs of clinical medicine, and has continuously improved the dosage form. At present, the main research and development of traditional Chinese medicine oral administration are granules, capsules, tablets, pills, oral liquids and the like.
Injection dosage form
The development and development of traditional Chinese medicine injections is a major breakthrough in the traditional Chinese medicine administration route. At present, the research and development of traditional Chinese medicine injections is in a relatively active stage. The sources of pharmaceutical raw materials are more extensive, the preparation methods are increasing, and the scope of application is expanding. On the basis of the original research, membrane separation ultrafiltration, freeze drying and other technologies are adopted. The quality and stability of traditional Chinese medicine injections have been significantly improved. The preparations include not only general solution-type injections, but also emulsions, suspension-type injections and solid powder injections, and the administration routes include intramuscular injection, acupoint injection, intravenous injection and the like. At present, the preparation of traditional Chinese medicine injections pays more attention to the improvement of the extraction and separation methods, and the effective monomer components or effective parts of the traditional Chinese medicines are used as raw materials to improve the content of the active ingredients in the injection. At the same time, new technologies are widely used to enable Chinese medicine injections to meet the requirements of sustained release, controlled release and targeted preparation.
Transdermal dosage form
There are many dosage forms for transdermal administration of traditional Chinese medicine. Traditional transdermal administration forms include bath, lotion, tincture, tincture, oil, ointment, plaster, paste, iron, etc.; The development of modern transdermal drug-coated dosage forms, films, gels, cataplasms, acupoint patches, and tablets. The application of these dosage forms has expanded the development of traditional Chinese medicines for external use. It embodies the treatment principle of TCM internal disease treatment and provides technical guarantee for the expansion of Chinese medicine application range.
The Transdermal Drug Delivery System ( TDS ) is also a trend in the study of transdermal formulations in recent years. In order to increase the amount of drugs permeating through the skin in the preparation for transdermal administration, more and more use of transdermal absorption enhancers in preparations, especially traditional Chinese medicines or their active ingredients as natural enhancers for transdermal absorption, have attracted widespread attention. .
Mucosal administration form
Mucosal administration refers to the manner in which a drug is in intimate contact with the surface of a biological mucosa through which epithelial cells enter the circulatory system. The site of mucosal administration may be oral cavity, nasal cavity, eye, vagina, rectum, etc., and the dosage form may be a tablet, a film, a stick, a powder, an ointment or the like as needed.
Thoughts on the Modernization of Traditional Chinese Medicine Preparations
The modernization of traditional Chinese medicine preparations is the premise and foundation for the modernization of traditional Chinese medicine. We should seriously consider ways and means to realize the modernization of traditional Chinese medicine preparation.
1. To carry out basic research work on the theory and methodology of traditional Chinese medicine preparation, to further study the relationship between pharmaceutical dosage forms and curative effects, and to provide theoretical basis for the innovation of new dosage forms and new preparations.
2. Adhere to the traditional Chinese medicine theory as a guide, and strive to develop and research traditional Chinese medicine compound preparations based on the theory of compound compatibility.
3. To carry out research on new technologies, new technologies and new equipments for traditional Chinese medicine, so as to lay the foundation for the development of new dosage forms of traditional Chinese medicine.
4. Pay attention to the development of new Chinese medicines and the creation of new Chinese medicines. It is necessary to pay attention to the transformation of traditional dosage forms, and pay more attention to the development of new Chinese medicines. The focus of new drug development is the research of new drugs of Class I and II, and research on therapeutic pharmaceutical preparations for major diseases and intractable diseases. At the same time, with the help of modern science and technology, with advanced foreign dosage forms as the goal, according to the needs of traditional Chinese medicine clinical drugs, research and development of sustained release preparations, controlled release preparations and targeted pharmaceutical preparations.
5. Pay attention to the development, promotion and application of new Chinese medicine accessories. Promote the improvement of the quality of traditional Chinese medicine preparations
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