Glucose natural rubber stopper has been banned since July.
there is still a large number of natural rubber in Kunming medical market.
natural rubber is inevitably polluted by bacteria, plant branches and leaves, pollen, etc. in the process of rubber cutting and processing. After being made into natural rubber stopper, it will leave serious hidden dangers for drug safety. In January this year, the State Food and Drug Administration issued the notice on Further Doing a good job in the elimination of ordinary natural rubber plugs, which adjusted the time limit for some drugs to stop using ordinary natural rubber plugs, of which the deadline for the use of nine injections such as glucose is June 30; The deadline for the use of other large volume injections is December 31
yesterday, it was learned from Kunming Food and drug administration that at present, the relevant preparations in Kunming are in full swing, and the natural rubber stopper of drugs we have used for decades is about to be out of the market. In this regard, some hospitals, pharmacies and drug production enterprises in Kunming were investigated and interviewed
expert: natural rubber plugs can cause cancer or deformity
a professor from Kunming Medical College said that rubber plugs used in drugs are divided into natural rubber plugs and butyl rubber plugs. The natural rubber plug material is impure in composition, easy to aging, poor in chemical stability, shielding performance and sealing performance, and contains impurities harmful to human body. There is an overflow of additives in the rubber plug production process, which affects the quality of drugs and therefore has hidden dangers to human health. Due to its good air tightness, butyl rubber plug solves the above problems and becomes a substitute for natural rubber plug. He analyzed that the natural rubber stopper is made of latex and contains non rubber components, which are easy to absorb moisture and mold, providing suitable conditions for the growth of mold. Some components can also cause cancer or deformity, which is one of the reasons for the adverse reactions of patients with infusion
hospital: natural rubber stopper injection is still being used
in the infusion room of a large hospital in Kunming, I saw that the medicine bottle plugs for patients were all Khaki yellow natural rubber plugs, and none of the medicine bottles were dark gray butyl rubber plugs. He visited four or five major hospitals in a row, and the situation was similar
glucose injection is sold in some big pharmacies in Kunming, but almost all the glucose seen on the container is rubber stopper. A large pharmacy also has an infusion room, and natural rubber plugs are also used for infusion of glucose to patients. "Is there glucose with butyl rubber stopper?" A female doctor in the consulting room of the pharmacy said, "no, the purchase price of butyl rubber plugs is high, and it is difficult to buy goods. We all use natural rubber plugs." "Ding has established a new benchmark base rubber plug for the design and construction of hot summer and cold winter areas? I haven't heard of it." A patient who was undergoing infusion said, "it has been decades since my first infusion. Isn't it all glucose with a kind of yellowish glue plug? Since there are hidden dangers, why should I produce and use it?" In several small clinics, the staff did not know that there was a butyl rubber plug
pharmaceutical factories: replace butyl rubber plugs after June 30
although China began to introduce a series of policies 10 years ago to eliminate natural rubber plugs, due to the high cost of new processes and raw materials, the price of butyl rubber plugs is significantly higher than that of natural rubber plugs
on the varieties of antibiotic powder injection preparations, 1. The hydraulic material testing machine should be installed at the temperature ⑴ 0 ⑵ 6 according to the laboratory standard. The price difference between butyl rubber plug and natural rubber plug in the laboratory is about 45 cents; In terms of infusion varieties, the difference between the former and the latter is more than 0.2 yuan. "This is an expenditure of millions or even tens of millions of yuan for enterprises that produce tens of millions or even hundreds of millions of bottles of infusion products every year."
the person in charge of an infusion agent manufacturer in Kunming said that they were already in the process of replacement. The infusion agents produced after June 30 have begun to use butyl rubber plugs. According to the requirements of the State Food and drug administration, the drugs produced before June 30 can still be packaged with ordinary natural rubber plugs, and the deadline for the packaging of high-volume injections with ordinary natural rubber plugs has been extended to January this year to achieve the speed control of the moving beam of the experimental machine on February 31, There is still a transition period of fiveorsix months
Drug Administration: those who use new drugs in old bottles will be severely punished
the relevant person of Kunming Food and Drug Administration said that at present, an in-depth and detailed investigation has been carried out on the use of medicinal butyl rubber plugs instead of medicinal natural rubber plugs by drug production enterprises within the jurisdiction. While supervising and inspecting the packaging of drug varieties that have required the use of medical butyl rubber plugs, we should focus on the investigation of the use of natural rubber plugs by production enterprises, urge production enterprises to carry out compatibility tests as soon as possible, select appropriate butyl rubber plugs, and actively make preparations for replacement. For pharmaceutical butyl rubber stopper manufacturers, urge them to strengthen production quality management, produce qualified products according to national standards, and ensure drug quality
Kunming Food and Drug Administration said that it would inspect and supervise the replacement of ordinary natural rubber plugs for drugs. If violations were found, such as failure to replace them within the specified time limit, old bottled new drugs, change the production date, etc., they would be severely punished according to law
source: Chuncheng Evening News
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