Only traditional Chinese medicine injection mm self-help Injection heat source project failed .3 24, Ministry of Health, State Food and Drug Administration a paper emergency notice, to stop the batch Xiangdan injection use and sales.
in recent years, traditional Chinese medicine injection adverse events occurred in succession after the injection of Chinese medicine is suffering from an unprecedented crisis of confidence the public. An industry source commented: reflect awareness of adverse events
1941 birth year, successfully created Bupleurum injection marks the birth of Chinese medicine injections. However, injection of Chinese medicine is truly the rapid development in recent years in this. as the modernization of traditional Chinese medicine and Chinese medicine industry development in the direction of First, the development of traditional Chinese medicine injection has become a craze, a variety of products, projects have been started in various places. According to statistics, from 1999 to 2006, the national Chinese medicine injection market average growth rate of more than 30%. before the injection of Chinese medicine industry has annual sales of more than 200 billion.
2006 年 6 months, due to serious adverse reactions, Houttuynia injection, seven types of compound dandelion with Houttuynia injection agent or a new injection of sodium Houttuyfonate, was suspended from the State Food and Drug Administration use and approval.
days in that period, the State Food and Drug Administration for Drug Evaluation Office to visit people, staff, would like to inquire about the Houttuynia years, Acanthopanax injection, Yinzhihuang injection, Shuanghuanglian injection, adverse events Xiangdan injection one after another. Although adverse events for different reasons, some product quality problems, some adverse drug reactions, of which there are also reasons for using unreasonable, but the safety of traditional Chinese medicine injection ever questioned by the public.
the general industry view is that Chinese medicine injection limited to the most prosperous golden age 2006 .
Since then, traditional Chinese medicine injection safety issues have been repeatedly concerns, talk about traditional Chinese medicine injections each, given that some restrictions on the media habits of words: -------< br> Since then, traditional Chinese medicine injection market has also been no small impact. Once a species has a traditional Chinese medicine injection sign of trouble, all manufacturers will follow the Mishap where traditional Chinese medicine injection.
TCM injections in preclinical studies has many deficiencies. an enterprise of TCM injections CEOs said that in the development cycle, traditional Chinese medicine injections from the selection of subjects to pre-clinical studies, should be based on rigorous scientific approach treatment, ready to enter human trials safe, effective, quality control of high-quality preparations.
he said, abnormal toxicity, blood pressure substances, allergic reactions, hemolysis and cohesion, pyrogen, bacterial endotoxin methods. But look at now commonly used in clinical Qingkailing, Xuesaitong, Xueshuantong, Salvia, puerarin, Houttuynia , Shuanghuanglian than 100 kinds of TCM injections, if the use of the Chinese herbal medicines used in traditional Chinese medicine injection sources and materials affect the quality of the finished product quality traditional Chinese medicine injection. National Pharmacopoeia Committee, Chairman Xiao Kang Wei edge medicine, for example, the base was originally honeysuckle Lonicera, Lonicera confusa base of the original gray carpet Mao honeysuckle, red honeysuckle, or southern honeysuckle gland, which makes ingredients and honeysuckle Lonicera confusa different, Lonicera confusa luteolin content was lower and higher levels of chlorogenic acid, if used instead of honeysuckle, may cause sensitization. Meanwhile, the quality of Chinese herbal medicines of different origin lead to instability, resulting in different components of traditional Chinese medicine injection. Currently, many Chinese herbal medicines has not yet fixed place of origin, has been established, GAP planting base in the quality, quantity and so can not fully Chinese manufacturers meet the requirements of injection. In addition, the lack of some materials for injection standards, quality is difficult to control, such as Tween -80, sodium bisulfite.
different varieties of traditional Chinese medicine injection process of the same phenomenon is still more. different manufacturers with a variety of traditional Chinese medicine injection preparation process because the differences, the inherent quality of different products, such as Xiangdan injection 169 number, a total of 196 Houttuynia Cordata symbol. In addition, some of the production process is relatively traditional Chinese medicine injection backward, leading to preparation, tannins, proteins, resins, etc. In addition to macromolecular impurities difficult.
clinical use of links, how to use the existence of errors. in the clinical front line, especially in Western medicine, the Shuanghuanglian, cardiovascular disease, needle use Hong Dan, ; medicine. Academy of Sciences, the researchers said plant chemical experts Qiaoshan Yi, Chinese medicine injection into Chinese medicine from the oral injection, and the lack of long-term clinical observation and experiment, the quality control standard is far from established. its research and development, approval, production and clinical use of all aspects of there is a need for improvement.
will minimize the security risks facing a crisis of confidence, many people in the industry call to protect traditional Chinese medicine injection. grounds that traditional Chinese medicine injection represents first , the public and not the efficacy of TCM injections doubt, nor is it in the end care is not part of the culture of Chinese medicine, but simply treat it as a drug in question its safety.
the fact that occurred in recent years a continuous injection of adverse events in medicine, public and not the efficacy of TCM injections doubt, but questioned its safety; and the other fact is that, for a number of factors, traditional Chinese medicine injection can not be light words repealed.
how to do these problems? State Food and Drug Administration, Wu Zhen, deputy director, said, beginning this year, drug regulatory authorities in accordance with effort to Implementation of Chinese medicine injection standard to improve performance programs to improve standards and implement the most stringent standards to address the TCM injections deficiencies;
of traditional Chinese medicine injection comprehensive re-evaluation. re-evaluation of traditional Chinese medicine injection safety and effectiveness, to evaluate its safe, effective and risk-benefit ratio to decide whether to continue to improve, and constantly improve, or temporarily stop production, or completely withdraw from the market;
strengthen the use of traditional Chinese medicine injection process guidance. Ministry of Health, State Food and Drug Administration Bureau and the State Administration of Traditional Chinese Medicine has been jointly issued , pharmaceutical sector is a comprehensive listing of 123 kinds of Chinese medicine to improve injection safety and quality control methods and indices of production of traditional Chinese medicine injection medicine must be fixed place of origin, strict control of raw materials, intermediate products and finished products, the full realization of the quality of production and processing control.
The industry believes that regulators recently issued a number of the whole field of traditional Chinese medicine injection into a rational, standardized, and more safely serve the clinical use of drugs.
2007 12 months, the State Food and Drug Administration issued a , necessity three aspects of development of traditional Chinese medicine injection increased the threshold for re-evaluation of traditional Chinese medicine injection provides an important basis.
January 13 this year, the State Food and Drug Administration issued re-evaluation work, better reflect the industry that regulators can not do without good rules active participation of enterprises.
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