The development of natural medicine traditional Chinese medicine dosage form is closely related to excipients

With the trend of "back to nature" sweeping the world, natural drugs have been attached great importance, which brings opportunities for the research and development of new Chinese medicine The research and development of new traditional Chinese medicine can be carried out through many ways, among which, it is an important way to improve the dosage forms of traditional Chinese medicine, such as traditional famous prescriptions, ancient prescriptions and empirical prescriptions, which are still used in decoction or other traditional dosage forms, so as to make them more in line with the needs of modern people In a sense, whether high-quality preparations can be produced and new dosage forms can be developed successfully depends on the supporting supply of pharmaceutical excipients sometimes "The development of pharmaceutical excipients often reflects the level of pharmaceutical production in a country." Lu Guiyuan, a professor at the school of medicine, Zhejiang University of traditional Chinese medicine, points out that choosing suitable film-forming materials is one of the keys to prepare high-quality liposomes In the storage type or framework type transdermal drug delivery system, in addition to the main drug, there must also be transdermal absorption accelerators, solvents, controlled-release films or controlled-release materials, pressure-sensitive adhesive, backing materials and protective films and other pharmaceutical excipients Therefore, after the main drug of the transdermal drug delivery system is determined, the selection of pharmaceutical excipients becomes the main work of the development of the transdermal drug delivery system The core of the improvement of traditional Chinese medicine dosage form is to make the medicine into a more applicable, more effective and more scientific dosage form, so that the original medicine can play a better effect Zhang Jiawei, director of the R & D Department of Hunan Erkang Pharmaceutical Co., Ltd., said that in recent years, the results of the improvement of traditional Chinese medicine dosage forms have enriched the types of traditional Chinese medicine dosage forms and promoted the development of traditional Chinese medicine preparations With the development of medical technology, some new dosage forms should be developed according to the characteristics of traditional Chinese medicine For example, many of the effective ingredients of traditional Chinese medicine are volatile oil or oil, which can be made into emulsions Kanglaite emulsion made from coix seed oil is a successful example In addition, liposomes have obvious advantages in cancer treatment Astragalus polysaccharide liposomes can improve stability and immune activity There are also Cordyceps polysaccharide liposomes and Ginkgo biloba leaf effective component liposomes Skeleton preparation refers to the preparation of tablet, granule or other forms made of drugs and one or more solid skeleton materials by pressing or fusion technology, which is mainly used to control the release rate of drugs and achieve the purpose of slow-release and controlled release Microcapsules, microspheres, microporous membrane coated tablets, osmotic pump controlled-release preparations, pulse and self-adjusting drug delivery systems, new formulations for transdermal, oral, eye, nose and rectum administration, as well as implantable drug delivery systems, etc., can be studied and transplanted in combination with the characteristics of traditional Chinese medicine preparations, so as to enrich the drug types When talking about the principles of selecting medicinal excipients for traditional Chinese medicine preparation, Dr Zhang Yongwen, a professional reviewer of traditional Chinese medicine and natural medicine in the drug evaluation center of the State Food and drug administration, said that the first is good formability, small dosage and strong effect, that is, the dosage should be appropriate, and the least dosage can not only save raw materials, reduce costs, but also reduce dosage, making application convenient 。 Secondly, it has great physiological safety, that is, no teratogenesis, sensitization, mutation, no reduction of drug efficacy, no side effects, no interference with quality control Third, the chemical property is stable and does not react with the main drug Usually, the excipients are required to be "inert", that is, they are stable in physical, chemical and biological properties, but it is difficult to find the absolute "inert" substances Fourth, it has no biological activity, does not affect the efficacy of drugs, and can be used in combination with a variety of drugs According to Zhang Yongwen, the current new dosage forms of traditional Chinese medicine include effervescent tablets, dispersible tablets, dropping pills, soft capsules, freeze-dried powder needles, etc New pharmaceutical excipients can be divided into the following categories: polymer compounds, such as polyvinylpyrrolidone (PVP), polyacrylic acid resin, etc.; biosynthetic polysaccharides, such as cyclodextrin (CD), xanthan gum, etc.; semi synthetic ones, such as pre gelatinized starch, sodium carboxymethyl starch, etc.; plant extracts, such as alginate, red algae glue, carrageenan, etc.; animal extracts, such as chitosan, etc The application of new excipients in the new dosage form of traditional Chinese medicine can improve the performance of the preparation, such as increasing the dissolution, improving the bioavailability of the drug, and improving the clinical efficacy At the same time, it can also have a positive impact on the safety of the drug, for example, the new pharmaceutical excipients can absorb the toxic taste or ingredients "There are many problems with excipients in the quality standard of traditional Chinese medicine There are no clear regulations on the use of excipients The degree of clarity of excipients in the standard is confused Most of them have no dosage regulations, and the role of excipients in preparations is not clear." Zhang Yongwen pointed out that there are 72 kinds of excipients in the second part of the 2005 Chinese Pharmacopoeia, as well as other standards for medicinal excipients and local excipients At present, the current situation of the use of excipients in the prescription of traditional Chinese medicine is not optimistic Some enterprises have no clear understanding of the quality standards of excipients Some excipients only have internal control standards Some excipients have unclear sources and standards However, with the continuous emergence of new excipients, there are many problems in the use or change of excipients that have been listed Zhang Yongwen stressed that in the future, the pharmaceutical excipients industry should actively develop new pharmaceutical excipients, constantly improve the standards of excipients, adapt to the improvement of traditional Chinese medicine dosage forms, and promote the development and improvement of traditional Chinese medicine pharmacy.