subject: Cephalosporins Product Package Material Compatibility Injection Into Focus - Cephalosporins, [print this page] Recently, Pharmaceutical and Biological Products Antibiotic Director, researchers are working to resolve HU Chang-Qin Cephalosporin The problem of antibiotic adverse busy. Early last year, from the National Testing Center of adverse drug reaction monitoring data show that antibiotic injection high incidence of adverse drug reactions, of which ceftriaxone and other cephalosporins product quality testing within the limitation period is relatively high failure rate.
HU Chang-Qin said that to find the cephalosporin class of product quality testing because the high failure rate, he has led the Chinese Pharmaceutical and Biological Products by the studio staff of antibiotics for nearly two years of painstaking research, now, do not cephalosporins injection Qualified key indicators?? clarity the reasons for non-compliance has basically clear: general Butyl rubber stopper And cephalosporins is the main cause of poor compatibility.
Clarity crack problem
HU Chang-Qin introduced, according to China Pharmacopoeia Standards, national authorities in the cephalosporin injection product quality testing, there is a project of the clarity of the color liquid, which liquid can not occur in the life of turbidity, color change phenomenon. Drugs Once these phenomena, it is considered substandard products. However, cephalosporins injection products from quality inspection situation, turbid liquid, the high incidence of discoloration. Cephalosporin injection in case of turbidity, discoloration, it may lead to adverse drug reactions. Hu Chang-qin that led to cephalosporins preparations is mainly due to dissolved turbid liquid butyl rubber stopper and good compatibility.
The data show that although the cleanliness of butyl rubber, chemical stability, hermeticity and biological performance are superior to ordinary rubber, but because of the complexity and the formulation of raw materials increases the concentration gradient of the relationship between the butyl rubber stopper in Some elements of the stronger activity of encapsulated drugs, the rubber plug in the part of the dissolved material will slowly release the medication absorption, thus creating a rubber plug compatibility issues with drugs. Drugs dissolved in solution exceeded the sample to clarify the degree of clinical allergy appears related toxicity.
Shanghai Food Pharmaceutical Packaging Materials Testing Institute also made a special pair of cephalosporins and the compatibility of domestic butyl rubber stopper test done. The results show that the products in the store longer is valid within the index exceeded proportional to the clarity. This shows that the problem of formation of clarity two factors: on the one hand may be liquid and unstable quality, with the extension of storage time within the validity clarity problems arise; the other hand, rubber plugs compatible with the liquid is bad, with the storage time, a chemical reaction occurs clarity problems.
HU Chang-Qin said that the international market, the butyl rubber stopper of the varieties is very large, very high selectivity. Despite the domestic relevant departments to replace the butyl rubber stopper to give enterprises more than two years of the transition period, but the stopper of the species less, pharmaceutical companies there is very little choice. In addition, the compatibility of our test levels have a certain gap with foreign countries.
Since 2003, China's rapid expansion into the infusion industry, products have been supply exceeds demand, market competition, corporate profits meager. In this case, the compatibility of drugs with the rubber plug has not been given sufficient attention, companies survive difficult circumstances on the compatibility test input is insufficient. Meanwhile, the rubber plug production industry is also showing the status of product excess, low-price competition has become the primary means for the downstream customers, rubber plugs the same lack of R & D investment.
To seek a proper solution
"In our discussion group to resolve the clarity issue, when busy with experiments, Jiang Yin Lanling initiative to contact us and recommend their patented product?? Coated stopper. Experimental results show that products using the coated rubber plug cephalosporins after , greatly improve the clarity index, basically does not appear muddy, discoloration. In fact, foreign long to reply and for various polymer materials (coating) technology to produce complex (coated) butyl rubber stopper, and this kinds of rubber plugs can solve the compatibility problem. between the butyl rubber stopper as liquid and membrane separation, butyl rubber stopper of the active substance can not be released, this rubber plug is known as Universal Film Stopper .
