Traditional Chinese medicine injection has come to a crossroads: serious abuse, safety is still questioned

[China Pharmaceutical network industry trends] in the era of lack of medicine, traditional Chinese medicine injection actually played a very good role However, the author understands that most traditional Chinese medicine injection varieties were approved before 1985, and the clinical efficacy data and safety data are seriously insufficient At present, the safety of traditional Chinese medicine injection is still under discussion in the industry Many people in the industry say that for the traditional Chinese medicine injection, once known as the "milestone of the modernization development of traditional Chinese medicine", whether from the perspective of efficacy or side effects, it has come to a crossroads Some experts have pointed out in their published papers that the main causes of adverse reactions of traditional Chinese medicine injections are the large-scale and irrational use of large-scale infusion throughout the country, resulting in a sharp increase in infusion reactions, blind mix of traditional Chinese medicine and Western medicine, and at the same time or intravenous infusion successively The expert pointed out that "for some traditional Chinese medicine injections containing harmful ingredients that are not eliminated and lead to a variety of adverse reactions, a lot of research work needs to be carried out, not only to retain the effective ingredients, but also to remove the harmful ingredients, so as to ensure the safety, effectiveness and quality standards of traditional Chinese medicine injections." In addition, industry insiders said that it is difficult to find oral medicine for the top 50 Chinese patent medicines in hospital use cost, almost all of which are traditional Chinese medicine injections The top 10 traditional Chinese medicine injections account for more than 50% of the total cost of inpatient use of traditional Chinese medicine The number of diseases treated basically exceeds more than 100, and the average cost per time is more than 1000 yuan The serious abuse of traditional Chinese medicine injections has attracted the attention of the industry, while the safety of traditional Chinese medicine injections further raises the question of "how long can traditional Chinese medicine injections last" The author understands that according to the current research on adverse reactions of traditional Chinese medicine, the safety of traditional Chinese medicine injection is largely allergic reaction Anaphylactic mechanism is different from anaphylactic reaction Injection containing macromolecule is easy to cause such reaction As the traditional Chinese medicine injection contains high molecular components, it may also lead to anaphylaxis In addition, hemolysis, vasculitis and pain are also common safety problems of traditional Chinese medicine injection Some people also said that the safety of traditional Chinese medicine injection is related to the production process The raw material of traditional Chinese medicine injection is the extract of traditional Chinese medicine, which has the nature of biological extract, and most of them are total extract The main method of extraction is "boiling and alcohol precipitation" or "alcohol extraction and water precipitation" As the active components of traditional Chinese medicine have not been defined, the alcohol water method can extract as many chemical components as possible, which is beneficial to ensure the effectiveness of traditional Chinese medicine injection However, due to the substitution of many components, there must be active components, unrelated components, even harmful components, or both small and large molecular components However, if the injection retains as many active components as possible to remove the invalid components and impurities, the high safety efficiency can be improved pertinently The author understands that in the 2017 new medical insurance catalog, 26 traditional Chinese medicine injections are restricted Since this year, the State Food and drug administration has also issued an announcement on the revision of the instructions for the varieties of traditional Chinese medicine injection With the focus of relevant departments on traditional Chinese medicine injections, more and more traditional Chinese medicine injections are restricted to use and the instructions are revised, especially this year, the regulation of traditional Chinese medicine injections is more and more strict In the aspect of pharmaceutical enterprises, the performance of traditional Chinese medicine injection of many enterprises is also affected by the policy, with a significant decline Many traditional Chinese medicine enterprises, especially traditional Chinese medicine enterprises, are transforming to biomedicine The industry expects that in the future, the traditional Chinese medicine injection industry will be affected by more policies, and the discussion on its effectiveness and safety will gradually deepen.