How to tcmi safe

Our correspondent FanDan

China's traditional Chinese medicine reported

        Tcmi mentioned, people and to love and fear is. Because of its work fast, in the emergency department and major disease in the treatment of has irreplaceable advantage and function, which has been widely used in clinical, in the pharmaceutical market occupy the important share; And because of its complicated composition lead to adverse event occur frequently, and the lack of trust by the public.

        What are the factors lead to tcmi adverse reaction, how to guarantee its safety? In a Chinese medicine by the newspaper in 2012 tcmi risk control project symposium, the state food and drug supervision bureau, head of the Chinese medicine experts in traditional Chinese medicine and the enterprise representatives are discussed from quality, management, and medicine etc give advice.

        Why bad reaction happened frequently

        In 2011, the total receiving adverse drug reaction report of 850000, more than 2010 years of 690000 a growth rate of 23%. Among them, the number of tcmi report a year-on-year increase of 35%; The report tcmi, serious report number occupies 60%, an increase of 34%. The state food and drug supervision bureau drug evaluation center, deputy director of the DuXiaoXi reveal this digital said tcmi safety is not optimistic.

        DuXiaoXi introduction, tcmi adverse reaction rate and a variety of factors, including the raw material medicine doesn't pass, production quality is not standard, the basic research weak, the improper storage, all these factors will lead to drug quality controlled, cause adverse reaction.

        Chinese traditional medicine by origin, climate, raw materials of plantation, storage way, influence, the effective or harmful components are very different. Traditional Chinese medicine contain ingredients are too complex, single herb in Chinese chemical components from dozens of species to hundreds of differ, difficult to separation and purification, only depending on the current have technology can't fully understand the valid and harmful components. Together with different enterprise production technology is not the same, lead to the same variety of different manufacturer production quality difference is big, and even the same manufacturer different batches of the drug quality is not the same. YouBo pharmaceutical chairman LiZhenGuo eases analysis holds that the quality of the drugs is not stable, led directly to the clinical safety and efficacy no guarantee.

        At the same time, clinical medicine is not reasonable could also lead to adverse reactions tcmi. At present, most Chinese medicine injection is still not fully expounds the composition and adverse reaction mechanism, the clinical medicine and the matters needing attention of rationality study also not clear. A data shows, in tcmi adverse reactions in the report, with the use of drug 25%, of serious 33%, 67% of the death. This phenomenon is more prominent in the primary.

        Countermeasures to improve the quality of a technology

        In the future, effective component is not clear, content and quality control of the low poor tcmi varieties, will be gradually withdrawn from the market. In recent three years, 100 have tcmi enterprise because they do not meet the standards related to production, more than 30 varieties production, it is at present in the production enterprise in 154. Facing more and more severe challenges, many enterprises practicing skills in building our herbal base guarantee the quality GAP apis, on the basis of technology, quality unceasingly in the control, logistics link to work for improvement.

        YouBo pharmaceutical in mudanjiang as an example, the influence of various factors on safety, and carried out the compatibility of Chinese traditional medicine injection stability studies and allergens study in 2010, and began to optimize the risk management system. In the quality control of monitoring, using the fingerprint technology, raw materials, intermediates fingerprint of detection methods all has applied for patent protection. After hundreds of experiments, design the low temperature superfine grinding ", "repeated freeze-thaw", "molecular sieve filter", "hot pressing process" national 4 patent production technology, the maximum retained the efficacy compositions and active, put away the ineffective material and cause allergic reactions with protein, high molecular weight of material, 10 batch HPLC fingerprint similarity of more than 99%, to ensure that the products of uniformity and stability, and to ensure the safety of the drug clinical use.

        The countermeasures to improve the way out "pay equal attention to

        In Japan, for drug adverse reactions are monitoring system, and auditing system and then appraisal system, more than 80% of the prescription needs to be monitored. In Britain, there are yellow and green card system system, and drug public publications report some special drug adverse reactions. The United States is freewill report system of monitoring and enforcement report system, in clinical constantly on the varieties clinical adverse reaction monitoring.

        To strengthen the risk control, the food and drug administration initiated in 2009 safety evaluation of tcmi again, and to enhance the tcmi standard, partial to carry out two tcmi sample work, strengthens to tcmi varieties of adverse reaction monitoring, and to focus on the organization carries out the comprehensive evaluation of the varieties, and now has made great progress.

The state food and drug supervision bureau chief of drug safety newspaper YanMin introduces, in the last three years, the pharmaceutical supervisory and administrative departments at all levels of Chinese medicine to check 3000 injection many times, and in 742 the approval document number of production status, basically half the total, some can't control the production enterprise also risk initiative stopped production.

        "Enhancing risk management, perfect the basic research work, improve the overall quality of tcmi standard, and cannot guarantee the safety of out to the variety of drug use." YanMin revealed plans this year and 11 varieties out, related to 22 production enterprise, is currently in the argument.

        Part of the enterprise representative called for, the traditional Chinese medicine injection carries out "the improvement and eliminated" pay equal attention to management mode. A "high quality special" review of the enterprise and HuoPing varieties, the pharmaceutical supervision department released its executive quality standards, and according to the standard supervision, unmet varieties, cancel its "special skilled workes" qualification, in order to achieve the purpose of improving and eliminated, make quality better varieties has a bigger share of the market, and thus to in general, reduce the incidence of aderse eents.

        Three standard clinical medication countermeasures

        With impurity tcmi more, including harmful material also more complex, its cause adverse reactions varied clinical performance and weight is differ, mainly including allergic reaction, gastrointestinal reaction, transfusion reactions. How to use tcmi to avoid or reduce adverse reactions happen?

        Chinese medical academy chief researcher WengWeiLiang pointed out, Chinese traditional medicine injection adverse events main and clinical unreasonable use relevant, mainly by medicine, dose not suit the too big, compatibility is not reasonable, drug improper way, this in XiYiYuan and grassroots is more outstanding. "Should strengthen the basic doctors and XiYiShi medication guide."

        "In fact instruction is a firewall, and protect the enterprise, protect the doctor, and also protect people." Academician of Chinese academy of engineering, said ZhangBoLi per capita, to strengthen tcmi risk control, in addition to developing clinical adverse reaction of the research, revised and perfected the drug is also important.

        So, clinical rational drug use should follow the principle of what? The expert reminds, in strict accordance with the drug instructions usage and dosage, according to the regulation of concentration with liquid, don't optional increase dosage. Traditional Chinese medicine and western medicine injection should not be used at the same time, in order to avoid both between prone to compatibility taboo, produce adverse reactions. At the same time, in use process, and closely observe the reaction of patients, strengthen drug monitoring and emergency rescue prepared.