Research progress on adverse reactions and pseudo-allergic reactions of traditional Chinese medicine injections / 中国中药杂志

Since the safety re-evaluation of traditional Chinese medicine(TCM) injections began in 2009, some TCM injection companies and research institutes have done a lot of work. And with the increase of drug development and drug production technology levels in China, the safety of some TCM injections has been greatly improved. There are safety risks in TCM injections, which are mainly reflected in unclear basis of medicinal materials, simple production process, poor controllability of quality standards, nonstan-dard drug instructions and irrational medication in the use process. This paper describes the research progress of the above-mentioned aspects of TCM injections. In addition, the author team found that adverse reactions of TCM injections are mainly pseudo-allergic reactions. Therefore, a lot of work has been done in detection of pseudo-allergic reactions, mechanism research and risk control. This part of the work is also described in this article.

Preliminary study on the mechanism of anaphylactoid reaction induced by natural product germacrone / 药学学报

The Chinese medicine injections prepared by the natural products containing sesquiterpenoids caused various adverse reactions in clinical use, among which skin allergic reactions are the most common. However, whether the reason of allergic reaction was related to the three isoprene units contained in the sesquiterpenoids is not clear, so the evaluation of drug safety has important guiding significance. The sesquiterpenoids are small molecular substances, and they are not antigens or haptens. They may induce anaphylaxis reactions by acting mast cells directly. Current research confirmed that Mas-related G protein-coupled receptor-X2 (MRGPRX2) which is a 7-transmembrane G protein coupled receptor on mast cells was a key target mediated allergic reactions induced by many small molecular drugs. Unlike IgE-mediated allergic reactions, pseudo-allergic reaction is related to dosage and dosing rate, and occurs in the first exposure to the sensitizer. In this paper, a series of experiments in vitro found that not all sesquiterpenoids caused anaphylactoid reactions. Ginsenoside Re, ginsenoside Rb1 and germacrone were selected as representative of sesquiterpenoids for calcium imaging assay. The data confirmed that only germacrone activated calcium mobilization through MRGPRX2, causing an increase in intracellular calcium ion concentration in mast cells. Furthermore, the release rate of β-hexosaminidase and the release amount of histamine analysis confirmed that germacrone induced mast cells degranulation directly. Knockdown of MRGPRX2 expression by siRNA and competitive binding experiments against ciprofloxacin were used to prove the target of germacrone was MRGPRX2. The results indicated that germacrone could activate mast cells directly to induce anaphylactoid reaction via MRGPRX2, which might be the reason of skin allergic reactions caused by injections containing germacrone.

Safety of animal traditional Chinese medicine (TCM) injections / 中国中药杂志

Animal medicine injection is an important part of traditional Chinese medicine (TCM) injections. All or part of animals with a significant curative effect and little side reactions as raw materials as well as modern technology are used to produce traditional Chinese medicine injections with a reliable and rapid drug efficacy and high bioavailability. Due to the complex composition of traditional Chinese medicine injections, imperfect quality standards, and unreasonable clinical use, the incidence of adverse reactions of traditional Chinese medicine injections has been significantly higher than that of traditional Chinese medicine for oral use. Animal medicine injections contain rich protein and fat, and heteroproteins are the main sensitization source in animal medicine injections. At present, the adverse reactions of animal medicine injections are mainly manifested in the anaphylaxis-like reactions at skin, mucous membranes and organ systems. The adverse reactions that occur during the first medication are more common. Specific causes for allergic-like adverse reactions in animal injections and related substances in traditional Chinese medicine injections made of animals that induce allergies or anaphylactoid reactions are currently not specifically reported. This article reviews the current adverse reactions of animal TCM injections, allergies and pseudoallergic reactions of animal TCM injections, the pharmacokinetics of animal TCM injections, and the combined use of drugs, in order to improve the quality standards of Chinese medicine injections for animals and provide reference for further safety related research.