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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.
Subject(s)
Animals , Administration, Oral , Anaphylaxis , Drugs, Chinese Herbal , Injections , Medicine, Chinese Traditional , TechnologyABSTRACT
Cytokine-release syndrome (CRS) triggered by mon-oclonal antibodies ( mAbs) is characterized by rapid onset and severe damage, and difficulty in prediction and control. Recent years,it has been a research focus on establishing a reliable ani-mal model in vivo and cytokine release assay( CRA) in vitro to predict CRS for preclinical safety evaluation. In this paper we summarize matters related to CRA applicable objects, considera-tions of method design and method optimization, aiming to pro-vide suggestions for the optimization of CRA prediction platform.
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Objective Long-chain triacylglycerol (LCT) by three producers,each mixed with the same medium-chain triacylglycerol (MCT),were compared with the brand MCT/LCT in causing focal necrosis of hepatocytes in beagle dogs (a bioequivalence evaluation).Methods 21 beagle dogs (male,0.7-1.5 years old,10-15 kg) were used in this study.According to the sources of the LCT,the animals were divided into Group A (LCT made in China),Group B (LCT made in Japan),Group C (LCT made in Germany),and the control group (the brand 10％ MCT/LCT).Central venous port was placed via the lumber vein of the animals under general anesthesia.After 2 weeks of rehabilitation,MCT/LCT was administered through this port for 28 days at 9 g/ (kg · d) [while the routine dose used clinically was 1 g/ (kg · d)].The laboratory indexes and the pathomorphism of the liver and kidney were studied single blindly.Results Laboratory tests,including liver and kidney function,blood coagulation function and lipid metabolism,did not identify differences among emulsions with different sources of LCT.Liver biopsy at day 28 showed no focal necrosis in Group C and the control group;there was minor damage in Group B;and Group A had obvious liver necrosis.and the pathological findings of other organs are similar.No significant difference was observed in biopsies of other organs.Conclusions Emulsions with different sources of LCT varied in their damage to the liver.Generics with LCT of higher quality were equivalent to the brand MCT/LCT in terms of safety.
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Concerned literature on four kinds of andrographolide injections in recent 15 years were searched in CNKI, Wanfang and VIP databases. The adverse drug reaction(ADR) cases of Chuanhuning, Yanhuning, Xiyanping and Lianbizhi injections were classified and analyzed statistically, including a total of 194 articles and 3 479 cases. The ADR clinical characteristics and occurrence regularity of these four andrographolide injections were analyzed and compared from the gender, age, primary disease, emergence time of ADR, clinical manifestation, allergy history, dosage, prognosis and combined medication of the patients. It is useful to provide valuable references for rational use of these andrographolide injections in clinical practice.
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Post-marketing safety studies are an important tool for understanding and monitoring the safety profiles of drugs in the clinical setting. Their importance has attracted not only the attention of regulators for reinforcing legislation but also led to recent changes in European Union (EU) regulations; these regulations have influenced the practice of Post-Authorization Safety Study (PASS) by marketing authorization holders. Korea conducts post-marketing surveillance (PMS) studies, but their execution is very different. This editorial reviews the PMS system in Korea in comparison with the recent legislative changes affecting the EU system. Ultimately, it suggests that changes to the PMS system are necessary to obtain quality safety data while maintaining a global standard of operation. Such efforts to refine the system will enhance the credibility of the PMS in Korea and, in due course, produce safety profiles that will be valuable for public health.
Subject(s)
European Union , Korea , Marketing , Public Health , Social Control, FormalABSTRACT
A long-term safety study was conducted with astaxanthin derived from <i>Haematococcus pluvialis</i> algae extract. Fifteen healthy volunteers took 9 mg of astaxanthin daily for 12 weeks. Physiological (including doctor’s consultation), haematological, biochemical, and urinary markers were examined at weeks 0, 4, 8 and 12. No adverse effects or clinical changes were observed throughout the test period. It was concluded that a healthy adult can consume 9 mg of astaxanthin derived from <i>Haematococcus pluvialis</i> algae extract for 12 weeks without any safety concern.<br>
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OBJECTIVE:To probe into the application of pharmacoepidemiology in safety study of TCM injection for sale in order to provide new idea for the study of TCM injection for sale. METHODS:Based on reported ADR events caused by TCM injection in recent year,the main approaches of pharmacoepidemiology were introduced to analyze the safety of TCM injection for sale. RESULTS & CONCLUSION:Pharmacoepidemiology is the main mean for safety study of TCM injection for sale and important basis for the selection of essential drug in China. Descriptive study can provide testimony for countermeasure in the early stage of ADR and analytical study can be used for the selection and detection of etiological hypothesis. Many other methods of pharmacoepidemiology can be used as approaches for safety study of TCM injection for sale.