"The reason for the high incidence of adverse reactions of traditional Chinese medicine injection, on the one hand, with the combination of drugs, on the other hand, the size of the particle size of the Chinese medicine injection itself. Therefore, we do product promotion, to promote the use of traditional Chinese medicine injections at all levels of hospitals in the use of precision filter infusion device, but due to the national standards did not keep up, the market is not recognized." Zhejiang Ling Yang Medical Instrument Co., Ltd. General Manager Hu in the medical device quality activities told the economic reference news reporter, the relevant association is the proposal to amend the standard of Chinese Pharmacopoeia.
Check out the economic reference news reporters from the State Food and drug administration official website, the existing more than 50 enterprises production precision filter infusion device, including Shandong Weigao, Xinhua ande, Shanghai Shuangge and other well-known domestic enterprises. But because the price is higher than the ordinary infusion of many, many domestic hospitals did not accept, nor access to Medicare reimbursement.
It is reported that the 2010 edition of the Pharmacopoeia of China, the infusion device for particulate control standards for the minimum of 10 micron particles, the maximum of 25 micron particles. And the British Pharmacopoeia 1998 edition, infusion control standards for the smallest particles of 2 micron particles, the maximum of 5 micron particles.
"The Chinese standard is much lower than the British standard, on the one hand, is not conducive to the pharmaceutical companies to pursue drug quality, on the other hand, is not conducive to the health of the people." Hu Junfei said, especially in the traditional Chinese medicine injection, because of its complex composition, extraction process is not detailed, resulting in relatively large particles, resulting in a high incidence of adverse reactions. It is found that the use of precision filter infusion device can effectively reduce the incidence of adverse reactions.
According to Hu Junfei introduction, the larger the insoluble particles cause local blood vessel blockage or insufficient blood supply or tissue hypoxia, phlebitis, edema, granuloma and other transfusion reactions. "In pediatrics, infants and young children are more than normal blood vessels, their immune function is also low, the particles of their harm and response is more obvious and serious. Secondly, elderly patients, cancer patients, cardiovascular and cerebrovascular patients due to the usually associated with hardening of the arteries, tube wall thickening and luminal stenosis, particle on its influence far more serious than ordinary patients. "
Released by the State Food and drug administration may 2013 drug adverse reaction monitoring annual report shows that compared with 2012, 17.0% growth in the number of reports of traditional Chinese medicine injections, higher than the overall growth rate; 22.3% growth in the number of reports of serious, with the overall report serious growth rate essentially flat.
The difference between the precision filter infusion device and the ordinary transfusion device is that the material of the filter membrane is different from the pore size. General infusion device is the earliest use of disposable infusion device, the price is cheap, use a wide range of its use of fiber filter membrane, the membrane pore size of 15 microns. Fiber filter meet strong acid, strong alkali drugs will fall off and becomes large aperture, cause most of the particles into the patient, resulting in blockage of blood vessels, the occurrence of phlebitis, allergic reactions and adverse reaction of intravenous transfusion, so clinical use of strong acid, alkali medicine as far as possible not to choose common infusion.
It is reported that, at present, China has developed a one-time precision filter infusion device, which uses a nuclear membrane or a polyether ether membrane, pore size, respectively, 5 micron, 3 micron and other different specifications. Nuclear pore membrane or polyether sulfone membrane has high filtering precision, no matters off the advantages of, can on the particle filter, reduce local irritation, prevent the occurrence of phlebitis pain, provides a guarantee for safe transfusion.
"We made in 2004 to begin production approval has been improved, to the third generation of products. Can now be in a lot of hospitals posted a poster for promotion, some doctors do not understand the situation. But a precision infusion device 10 yuan more than the price, a lot of patients can not accept, the company only in the big three hospitals promotion." Hu Junfei said the medical device industry association is proposed to improve the Chinese Pharmacopoeia standards, reduce the adverse reactions of transfusion.