2016 Shanghai International Medical Powder/Granule Preparation Technology Exchange

The main purpose of the preparation of the medicinal powder / granule is to crush the medicine raw material to be sufficient to increase the dissolution rate of the drug, which is beneficial to the extraction of the effective components or to increase the dispersion of the drug. The research in this field, Chinese scholars have put forward the concept of "biological powder", but because of the lack of professional media industry to follow up publicity, know the connotation of the enterprise is relatively small, so this is according to the concept of "the most acceptable medicinal powder / granule preparation" to explain.

One of the focus of attention: particle characterization of medicinal powder
The particle size of the medicine particles has an effect on the dissolution rate of the drug (API), so as to affect the dissolution rate, which can affect the blood drug concentration and so on. Considering the effect of the powder is finer, absorbed more quickly, but side effect is more obvious; if more coarse powder, did not reach the appropriate standard, the human body absorption effect is poor, the effect will play out. So to control the powder particle size range, the drug efficacy, toxicity of slow release medicinal powder particle characterization is to achieve such a request. However, for some drugs, pharmaceutical raw materials or to electrostatic accumulation, but water is easy to appear the phenomenon of air, and the influence of the dissolution. For suspension, the size of the particle size affects the sedimentation volume ratio, as well as the dispersion uniformity, it is not the smaller the better, the particle size is too small, long-term placement is easy to deposit at the bottom into a cake shape, it is difficult to disperse. Obviously, the particle characterization of medicinal powder is of great significance to the study of medicine.

Focus two: Chinese medicine cell wall technology and plant tissue protein extraction
Cell wall technology refers to the Chinese herbal medicine for crushing cells break purpose. If the conventional way of traditional Chinese medicine pieces, the single particle is often composed of several or dozens of cells, the cell wall broken rate is very low. Chinese medicine ultrafine grinding technology of Chinese herbal medicines crushed to 1250 (10 m), general medicine cell wall broken rate greater than 95%. The cell wall, Chinese medicine lipid solubility enhancement, can easily pass through the membrane, rapid blood concentration of human body, to achieve the purpose of healing. Of course, the theory also has scholars put forward different views. In addition, a hot spot for the pharmaceutical industry recently is the plant tissue protein extraction technology is used in liquid nitrogen under the protection of sand mill superfine grinding, and then the extraction process, the technology popularization and application will open up a new application field for sand mill equipment enterprises.

Focus of the three: medicinal powder / particle continuity and pollution-free production
Continuous production is the scale of the requirements of medicinal powder / granule preparation, is also the main ways to reduce the cost of drug production, the European Pharmaceutical Engineering Association (APV) will share research achievements in the field of European countries. The medicine powder without pollution, first of all, the requirements of the pharmaceutical product itself is high purity, free of impurities. The second is no pollution to the environment, the powder generally have certain toxicity, if no external grinder protective cover or good air exchange, is likely to be absorbed into the body, for R & D personnel and operation personnel is a potential threat to the medicinal powder / granule preparation process and equipment it has put forward higher requirements.

Focus of the four: FDA and GMP
Most of the units to provide equipment for pharmaceutical companies have been in contact with CFR 21 Part FDA 11, the specification is the 21 chapter of the federal regulations, the eleventh paragraph, the main provisions relating to electronic records and electronic signatures. The pharmaceutical manufacturing industry only in accordance with this standard, the manufacturers of products can be normally sold in foreign markets, and comply with the standards and retention of data can be traced through the inspection or the future effective data source. And for the pharmaceutical enterprise itself, FDA and GMP specification and what significance, Chinese version of GMP "drug production quality management standards (revised in 2010)" to improve the existing pharmaceutical companies ultimatum, must reach new drug GMP requirements before December 31, 2015. How the implementation of the current situation, and what impact. How the implementation of the current situation, and what impact.