Analysis on the technical characteristics of Chinese medicin
In recent years, due to the government and the public attaches great importance to the quality of drugs, pay attention to the healthy development of the medicinal materials industry norms, Chinese medicinal materials industry made great development, the emergence of a number of specialized medicinal materials production enterprises, production and R & D level increases with developed countries the gap also gradually reduced. The technical level and technical research and development characteristics of pharmaceutical accessories industry are as follows:
(1) new varieties of medicinal materials are continuously enriched. At present, in addition to the traditional accessories quality has improved, new material has been developed to include microcapsules and nanocapsules encapsulated materials; microspheres, nanoparticles, liposome carrier material, slow release, controlled release, target to the medicine materials; inclusion compound, thin film coating material; precursor drug carrier material; solid dispersion carriers; magnetic carrier material, film forming material; plasticizer; propellant; penetration enhancers; surface active agent, more than 40, thousands of varieties.
(2) the diversification of research and development channels of medicinal materials
Taking solid preparations as an example, the research and development of medicinal materials in recent years mainly have the following three ways:
Development of new medicinal materials (new chemical substances)
Since the 90s of last century, the development of new pharmaceutical excipient is relatively small, mainly due to the development of new excipients experience of time is long, need to experience various approval procedures and long processing time. The effects of the safety and toxicity and approval have expanded to the pharmaceutical manufacturers to promote their products, product market development process. New materials research and development cycle is long, high risk, large investment, low rate of return, but also to the development of medicinal materials has been a certain impact. In the future, in the solid preparation with accessories, accessories, developers and pharmaceutical companies to cooperate in R & D, will become the development direction of medicinal materials R & D model.
To change the morphological parameters of the existing auxiliary materials to develop new accessories
Each kind of solid substances have specific morphological parameters, such as molecular arrangement state (crystal type, crystal, amorphous, etc.), particle (particle shape, particle size, surface area and porosity), pile density and between these is related to each other. Changing one of the parameters will affect other parameters, for the development of new specifications and accessories and a variety of accessories for the preparation of new accessories to play a certain guiding significance.
By changing the morphological parameters of materials, at present, the development of the a series of new materials, such as: spray drying of different particle size of microcrystalline cellulose (MCC), spray dried lactose, pregelatinized starch, direct compression with calcium phosphate, excipients and particle shape, particle size, size distribution, specific surface area and the surface free energy, pressure and original accessories compared has been well improved. The fluidity and pressure of the new auxiliary materials are good, which can be used for direct compression, simplifying the production process, eliminating the influence of the factors on the stability of the drug during the production process.
Joint application of a variety of accessories for the development of new accessories
The combination of two or more kinds of auxiliary materials is developed as a new material, which is mainly through the interaction of the molecular level of the material, and it can play a synergistic role to overcome the adverse factors of the auxiliary materials.
(3) at the same time, in recent years, many of the new drug release technology, new technology research and application results and medicinal supplementary material research and application works publishing, but also a strong impetus to the research and development of new materials and application of new drugs.