Injection of microspheres were made new progress – injectable microspheres – pharmaceutical industries
Copy the success of our first release microspheres for injection?? "Injection of leuprolide release microspheres," the recent regulatory approval, is expected to supply markets in the short term. This indicates that China-made technology in the clinical treatment of microspheres taken an important step, but also means that China's technology industry in the preparation of microspheres made new progress.
Today, sustained release, controlled release, targeting agents such as new technology is developing rapidly up. Medical microspheres is with biological materials, clinical medicine and pharmacology, the development of a gradual rise of biological materials for medical products. Microsphere drug delivery methods are oral administration, subcutaneous implants, intramuscular injection, intravenous injection, intraperitoneal injection, intraocular, intra-articular injection. Small diameter microspheres for injection in order to be able to be administered by syringe. With sustained-release microspheres for injection, long-lasting effect, and the advantages of targeting can be achieved 1 month or 3 months or even longer time delivery, greatly enhance the convenience of the patient medication, improve compliance. Targeting the features you can increase efficacy and reduce side effects. Therefore, the injection and as a controlled release microsphere formulation and direction of development of targeted therapy is the major international Medicine Giant pie.
Former Navy General Hospital Director of Pharmacy of China's Ministry of Health, Office of the National rational drug monitoring expert Professor Sun Zhongshi that the development of preparation is very important. China is Pharmacy Power, but not pharmaceutical power, an important reason is that agents technology is not strong. A large number of foreign countries from China Import API , Using high-tech processing into high value-added agents, then sold back to China. In the process, they earn a high value-added of the high profits, while the high pollution to remain in China. "China must become a pharmaceuticals powerhouse technical efforts in preparation." Sun faithful believe.
Injectable microspheres for protein and peptide in the nature of unstable, drug degradation in the body, is a high technical barriers, market barriers to low-field preparations. China is also actively developing microsphere technology, "Long peptide microsphere injection project" is listed as the national "Ninth Five-Year" research topics, and many research institutes and pharmaceutical companies are active in the relevant R & D, and published a large number of research papers, but so far most of our microsphere technology have stayed at the laboratory stage, and there is a certain gap between foreign technology.
Our market now Sell There are four kinds of microspheres for injection products, imported products are: Japan, Takeda Pharmaceuticals enantone (leuprolide microsphere), general health benefits of biotechnology companies in France Duffy Lin (Triptorelin microspheres), guides the Hengde (risperidone microspheres) and Novartis good dragon (octreotide acetate injection microsphere). In the treatment of cancer, metabolic diseases and chronic diseases such as has been widely used. The approved listing of leuprolide microspheres Pharmaceutical Co., Ltd., Beijing Bo Ente introduce American technology and library-based microsphere delivery system, developed by the industrialization of research methods, but also is the first successful injection of imitation using microspheres.
Industry is the development of injectable microspheres of China's difficulties. Sun faithful, said, microspheres for injection is the key technology of production of raw materials, production processes and technical parameters. China now can produce microspheres of some varieties of raw materials, but the stability can not meet the requirements. According to Bo Ente medicine person in charge, they have also done a lot of pre-screening of the original laboratory Accessories Work, made of raw materials when production, the stability can not be guaranteed. Therefore, the final choice of the Bo Ente microspheres imported raw materials. View from the entire industry, supporting research and development and stability to meet the requirements of raw materials and microsphere suspending agent, support agents, wetting agents, osmotic pressure regulating agents, auxiliary materials, will benefit the whole industry to promote the microsphere process.
In addition, as a new preparation techniques, micro-sphere technology is also a lack of uniform specifications. Sun faithful recommendations as soon as possible the development and introduction of relevant standards, specifications from the initial stage of the development of microsphere formulations.
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