I. Project Background In the early 1980s, the research on bismuth reagents was one of the major scientific research projects issued by the Ministry of Health. In the early stage, the production technology of Chinese cockroach reagents was low, and the problem of poor product quality was outstanding. From the relevant technical database or literature reports from 1982 to 1988, the sensitivity of the sputum reagent is only 5-0.1 ng/ml (equivalent to 50-1 Eu/ml), and the degree of self-contamination is high. In October 1988, the National Ministry of Health's self-aggregation time for the sputum test standard was 2 hours, and the effective period was 1 year. Due to the low quality of sputum reagents, the popularization and popularization of bacterial endotoxin test methods in China has great limitations.
How to improve the quality level of sputum reagents is a common concern. In order to meet the needs of the majority of users, the author in order to save raw materials or protect precious resources. In June 1988, the factory carried out research on the active production process of bismuth reagents. In June 1989, it was successfully produced in small batches and put into pilot production in 1990. The technology was approved by the Guangdong Provincial Science and Technology Commission in November 1991 [(1991) Yueke Jianzi No. 123], and the product patent number is ZJ95105652.2.
Second, the technology promotion The factory is the first in Guangdong Province, the first batch of manufacturers approved in the country [Ministry of Health (88) Wei Yao Zhunzi SJ-04] new reagent production number. At the same time, it is one of the few manufacturers and a few technicians in the world who have the raw material production technology, and the technical level is domestically leading. This product is sent to the US FDA for quality verification, and all indicators are in full compliance with the regulations. The single indicator (sensitivity) is superior to similar products of some companies in the United States. This product enjoys an excellent reputation at home and abroad, and has been sold to more than 8,000 users in Hong Kong and Macao or drug inspection agencies, pharmaceutical companies, research institutes and hospitals in various provinces and cities in China, in order to ensure the quality of medicines and ensure the safety of people's medication. A positive role.
Since 1989, due to the active cooperation and unremitting efforts of the factory, it has won honors for China's sputum reagent production technology and international academic exchange. For the Chinese Pharmacopoeia, the basic work of the bacterial endotoxin test method "draft reagent quality standard draft"; "bacterial endotoxin test water standard draft"; "bacterial endotoxin test method standardization operation" and other important contributions.
Third, information feedback In recent years, there are many areas in the country (due to the use of sputum company sputum reagents), the detection of missed products, resulting in hospital clinical "pyrogenic reaction" (medical accidents) is not uncommon. This not only causes pain to the patient or endangers the patient's life, but also causes serious economic and reputational losses to pharmaceutical companies and medical units. When these problems occurred, the arbitration unit used the sputum reagent produced by Zhanjiang Marine Biological Products Factory to compound the results. Therefore, in order to ensure the accuracy of the experimental results, please be sure to pay attention to the quality of the reagents. And before use, the bacterial endotoxin standard provided by the laboratory should be used as the sensitivity compound of the sputum reagent, which is extremely important for grasping the quality of the sputum reagent and avoiding the misjudgment of the experimental results.
Zhanjiang Marine Biological Products Factory has been considering the product quality for many years, and the application and evaluation of this product in the drug inspection agencies of various provinces and cities nationwide have been reflected. Therefore, the use of our factory's sputum reagents as an experimental comparison can avoid the occurrence of "false positives" and "false negatives" of the products, and ensure the credibility of your experimental results.
IV. Essential materials for bacterial endotoxin examination 1. Select qualified sputum reagents issued by the competent national authority with production approval number.
2. There is a bacterial endotoxin test water dispensed by professional manufacturers.
3. Bacterial endotoxin working standard.
4. Sterile pyrogen-free glass pipettes and test tubes.
5. Have a clean laboratory or have a clean bench.
6, equipped with a constant temperature (meter) water bath, test tube rack, vortex oscillator, alcohol disinfection cotton ball and sealing film.
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