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Dr. Obstruction Of The U.s. Broker Api To A "heparin Incident"
"Heparin incident" Recently, a different voice. United States Pharmacopoeia Editorial Committee Director Dr. RogerL.Williams wrote in The New York Times alleged that the incident caused by heparin, the culprit is the black heart of Changzhou intermediaries rather than heparin plant. Of course, Roger Ph.D. article only represents his personal views and not the official views the U.S. FDA, but the fact is that around the "heparin incident," the media, I am afraid to continue for a long time.
This year by the end of February, the U.S. FDA issued a warning to the national health sector: the U.S. pharmaceutical company Baxter heparin use of imports from China API Production of injection has caused dozens of hospitals across the country 350 cases (after a total of more than 1000 cases of verified according to) the patient's serious adverse reactions, and a four deaths. As of the end of May, due to deaths caused by injection of heparin has risen to 21; by the end of September, because of heparin sodium injection and died has reached 81. American medical profession so concerned that the number of deaths caused by injection of heparin, the future will continue to increase.
Domestic production order through the reorganization, substantially improve product quality
Heparin China API Chondroitin sulfate is by far the country with two drugs and biochemical raw materials exports. Domestic chemical and biological pharmaceutical industry uses more advanced refining heparin macroporous resin to make the color and quality of higher level products, has been able to meet the USP or the European Pharmacopoeia quality standards. Together since 2000, China's great efforts to rectify the order of the domestic heparin raw material drug production and strengthen the unified management of the quality of export products, so the quality of domestic heparin can be increased significantly. Heparin domestic manufacturers also dropped from the original to the present hundreds of less than 50.
At the same time, European and American countries "mad cow" epidemic, also contributed to the international production to China as raw material from pig small intestine heparin API products, a lot of demand, since 2001 the number of China-made heparin, increased year by year , 2006, China exported heparin to more than 100 tons mark for the first time, up to 113 tons. However, the domestic market by 2007, pork prices are low impact, sharp drop in the number of farmers raising pigs, resulting in heparin production and exports declined sharply, only exported more than 80 tons. Dr.
Roger middlemen in the adulteration in the crude
After the FDA informed the United States, its adoption of a new detection method to find some products contain called "multi-chondroitin sulfate," the impurities, the United States may be more medical experts speculate that chondroitin sulfate is a serious matter of non-heparin allergy response and more than 80 U.S. deaths, but so far not yet reached any decision. FDA officials said the United States a technology: a batch in the Baxter heparin sodium injection products have been detected up to 50% more than the content of chondroitin sulfate components. More chondroitin sulfate can significantly improve the taste, but generally not as drugs but as a senior food additives, and their market prices are also a lot cheaper than heparin.
Said the Chinese side have expressed doubts. Injection of heparin, because China has so far no deaths reported in the Chinese heparin sodium injection is a commonly used clinical drugs. What is the link wrong?
Roger noted author Dr.: Changzhou Cape company does not directly produce crude heparin, but the acquisition of crude from the hands of middlemen further refined by qualified injection fine, to export U.S. products 100%, not Chinese market. Dr.
Roger, as crude heparin selling price is not high, to increase economic benefits, brokers are likely to buy from rural self-employed in the heparin to the incorporation of more crude in chondroitin sulfate. Since the current biochemical testing methods are more backward class of drugs, so even the use of ordinary professional heparin plant instrumentation, generally can not be detected in more than chondroitin sulfate (and heparin because of its chemical structure is very similar).
, Of course, Dr Jacques Rogge, published in the New York Times article only represents his personal views and not the official views the U.S. FDA.
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