Technical Features of Chinese Pharmaceutical Accessory Industry

In recent years, as the government and the public attach great importance to the quality of medicines and pay attention to the healthy and standardized development of the pharmaceutical excipient industry, China's pharmaceutical excipient industry has made considerable progress, and a number of specialized pharmaceutical excipient production enterprises have emerged. The level of production and R&D has also increased, and the gap with developed countries has gradually narrowed. Technical level and R&D characteristics of pharmaceutical accessories industry are as follows:

(1) New varieties of medicinal excipients are constantly enriched. At present, in addition to the improvement of the quality of traditional excipients, new excipients have been developed to include microcapsules, nanocapsules, microspheres, liposome carrier materials, sustained-release, controlled-release, targeted drug delivery materials, inclusion complexes, film coating materials, precursor drug carrier materials, solid dispersion carrier materials, magnetic carrier materials; Film-forming materials; plasticizers; ejectors; transdermal absorption enhancers; surfactants and other more than 40 categories, thousands of varieties.

(2) Diversification of research and development channels for pharmaceutical excipients

Taking solid preparations as an example, the research and development of pharmaceutical excipients in recent years mainly includes the following three ways:

(1) Development of new pharmaceutical excipients (new chemicals)

Since the 1990s, the newly developed pharmaceutical excipients are relatively few, mainly due to the long time of development of new excipients, which requires a variety of approval procedures and a long time of examination and approval to investigate their safety and toxicity. After approval, it will also experience the process of promoting products to pharmaceutical manufacturers and expanding the product market. The research and development of new excipients is affected by many factors, such as long development cycle, high risk, large investment and low return. In the future, in the field of solid preparations excipients, the cooperative research and development of excipients developers and pharmaceutical companies will become the development direction of pharmaceutical excipients research and development mode.

(2) Developing new excipients by changing morphological parameters of existing excipients

Each solid material has specific morphological parameters, such as molecular alignment (crystalline, polymorphic, amorphous, etc.), particle state (particle size, particle size, surface area, porosity), bulk density, and these physical properties are interrelated. Changing one of the parameters will affect the other parameters, which will play a guiding role in the development of new specifications of excipients and the preparation of new excipients by the combination of various excipients.

By changing the morphological parameters of excipients, a series of new excipients have been developed, such as spray drying of microcrystalline cellulose with different diameters, spray drying lactose, pre gelatinized starch, calcium phosphate such as direct compression, etc. the particle shape, particle size, particle size distribution, specific surface area, surface free energy, compressible and so on of the new excipients are comparable to those of the original. The excipients have been greatly improved. These new excipients have good fluidity and compressibility. They can be used for direct tableting, simplify the production process and eliminate the influence of humidity and heat in the production process on the stability of drugs.

(3) Developing new excipients by combining various excipients

The development of two or more excipients as a new excipient mainly through the interaction at the molecular level between the materials to play a synergistic role to overcome the adverse factors of each excipient.

(3) At the same time, in recent years, many monographs on the research and application of new drug release technology, new technology and pharmaceutical excipients have been published, which has also greatly promoted the application of new excipients and the research and development of new drugs.