The side of brand-new group makes the domestic iron determine a pair of reagent enter new era in liquid
The bright iron of staff reporter's ginger is one of the important microelements of human body, total iron content is about 4 grams in the human body, the iron content 70% exists in hemoglobin molecule in the human body, 20% exist in tissues such as the liver, spleen, bone marrow,etc. in the form of storing irons, the others widespread in enzyme or coenzyme of many kinds of cellular respiration, this includes hemoglobin; The iron content is relatively low in the blood plasma, only accounts for 0.1% of total iron quantity in the body. The total iron content is 3~4 milligrams in human serum, exist in the form of combining with transferrin. The density that serum hits the iron is adjusted through speed that the erythrocyte produces or degrades, function of the human blood forming organ that serum hit the content of the iron to react. In addition, internal iron store trends of quantity, influence the intersection of serum and density of Chinese Railway too, when such as hepatitis, the iron transfers from stem cell to other organizations, make the iron density of serum increase. Serum iron density increase or lower, can give hematopoietic the intersection of function and disease ' Iron deficiency anemia, regenerated obstacle anaemia, pernicious anemia and dissolve courageous and upright anaemia, leukemia and erythrocyte, increase disease,etc.) ,Can reflect other disease of system ' Such as infective disease, acute hepatitis, liver cirrhosis, blood color disease and nephropathy,etc.) ,So the determination that serum hits the iron density is to begin a important checking project clinically. As " 863 " The key item of the plan " Key reagent of biomedicine " Take the lead in by unit,last the north China last biotechnology Co., Ltd. last dry powder at the form reagent and dry powder pairs of foundation of reagents at irons original, in " 863 " Plan under the support of key item, research and develop new the intersection of product and " iron determine reagent box " (liquid a pair of reagent of inferior iron piperazine law) . This product person in charge Jiang Lin says: "China has already to accuse of had dry powder reagent products to grow the north, have already set up the research platform where serum iron is determined too, and accumulate, appraise by a large number of the intersection of serum and clinic that iron determine, ' 863 ' support that plan, the development of carrying on irons and determining liquid a pair of reagent on this basis, the condition is richly endowed by nature. " Find mainly there is atom that absorbs spectrum law in the serum iron method and than the color analytic approach. It is to determine the serum iron reference method at present that the atom absorbs the law, but its instrument is expensive, it is complicated to operate, it is difficult to popularize and apply in the clinical labs. There are many kinds of methods than in the color analytic approach because reducing agents or developer adopted are different. Jiang Lin says: "Divide all luminosity law to determine the serum iron with piperazine of inferior iron recommended while " examining the operational procedure national clinically ", the sensitivity is low, serum consumption is great, the operating sequence is convoluted, time is long, difficult to popularize. How popularize, to the full-automatic biochemical analysis instrument, enable their have large-scale sample analytical capacity inferior the intersection of iron and the intersection of piperazine and law, the good good, linear range with high, linear sensitivity of having stability of developing the color at the same time is great, characteristic with better precision, with higher accuracy, become the focus developed on the market of reagent of clinical diagnosis at present. " Determine in reagent box, most products are dry powder reagent with iron sold on the domestic market at present. According to the introduction of Jiang Lin, because traditional the iron determines what reducing agent in reagent used is ascorbic acid, and it is extremely unstable in solution to be ascorbic and sour, aqueous solution its stand, will oxidize getting yellow 24 hour under room temperature, so can only be formulated into a form of the dry powder in reagent box. Need to dissolve dry powder of R1 with R1 liquid first during detection like this, reuse after mixing into R1 job liquid, the operating sequence is convoluted. At clinic, full-automatic analysis instrument popularize day by day increase of case, the demand for liquid reagent increases gradually. In traditional technology, the intersection of preservative and piles of sodium toxicity large nitrogen taken, lead to the fact the injury to producers and the user while being easy. In addition, traditional technology uses acidly to buffer liquid glycine, it is acid and relatively weak, guanidine hydrochloride is indifferent in the sex change among them, it is tall in density so will cause the lowest detection of reagent box too, the sensitivity is low. China grows the brand-new iron accused of in the north and determines liquid a pair of reagent, adopt the side of brand-new group, have improved the defect of the above-mentioned traditional reagent effectively. It is reported, this product can be applied to the full-automatic biochemical analysis instrument of brands such as Hitachi, Olympus,etc., China grows the north and accuses of the company while getting the medical equipment registration certificate of this product, set about, carry on patent application already, now is common to show during this period. It research and develop write down notes as far back as 2003,of grow by the north accuse of not lasting dry powder form reagent and dry powder pairs of reagent iron to last reagent box already biotechnology Co., Ltd., used in semi-automatic biochemical analysis instrument and full-automatic biochemical analysis instrument separately. In real clinical practice, find dry powder dosage form has a lot of shortcomings. First of all, during detection, need to dissolve dry powder of R1 with R1 liquid first, reuse after mixing into R1 job liquid, the operating sequence is convoluted. Take second place, dry powder of R1, while packaging, apt to produce the difference among the bottles, leads to the fact that determines that repetitiveness is bad to fruit. In addition, determine reagent box uses glycine as acidly and buffers the liquid with traditional iron, sex change pharmaceutical is indifferent in the sex change among them, so the lowest detection of reagent box is tall in density, the sensitivity is low. Moreover, a pile of toxicity of the nitrogen sodium of preservative used in traditional reagent is very great, it blocks the electronic delivery system of cytochrome. Pile of nitrogen sodium can impair one's health because suck, swallow or the skin is absorbed. Use a large amount of piles of nitrogen sodium while producing in enormous quantities, if protect and will produce the injury to worker's body tightly. In addition, a pile of nitrogen sodium and acid solution reflect that will emit the poisonous gas, examining the regular operator may suck the poisonous gas when opens reagent bottle lid. Because of all above-mentioned defects, the company determines to employ the new technology, research and develop the new iron and determine reagent box. At the beginning of 2006, this project entered and researched and developed stage formally. Research and develop personnel according to the intersection of reagent and the intersection of reaction and principle of box, separately to the intersection of reaction and the intersection of albumen and the intersection of quality and the intersection of sex change and pharmaceutical, reducing agent, acid to buffer liquid and developer, go on the screening in the system. Through literature research and experiment, have confirmed fine albumen sex change pharmaceutical finally; Use sodium salt of vitamin C as reducing agent, has strengthened the stability of reagent; Selecting for use at the same time can already act on sex change pharmaceutical together, has made the albumen change the sex, release and tap a blast furnace ion, can be used as the acid buffer liquid of preservative, replace a pile of nitrogen sodium, have reduced the toxicity of reagent; Developer has been chosen the sensitivity with wide high, linear range, inferior iron piperazine with good repetitiveness. Formed irons and determined the prescription of a pair of reagent of box liquid of reagent in 2007. It is good that new reagent has repetitiveness, the sensitivity is high, anti-interference is strong, the characteristic with low toxicity. Will get the registration certificate in 2009, has already produced and sold now, has won the favorable comment on the market. (Jiang Lin: China grows the north to accuse of " Determine reagent box with iron " Person in charge of the project)
The side of brand-new group makes the domestic iron determine a pair of reagent enter new era in liquid
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