参麦注射液的质量控制、毒性及临床配伍研究进展

Advances in quality control,toxicity and clinical compatibility of Shenmai Injection

参麦注射液是由红参、麦冬制得的中药注射剂,具有益气固脱、养阴生津、生脉的功效.临床上用于治疗气阴两虚型之休克、冠心病、病毒性心肌炎、慢性肺心病、粒细胞减少症.主要从影响参麦注射液安全的热原、溶血、过敏、细菌内毒素、有机试剂残留的质量控制;与化学成分及辅料相关的毒性研究;与稀释剂、常用药物和不建议配伍药物的临床配伍研究3个方面加以综述,为提高产品安全质量控制、降低不良反应发生率提供参考.

Shenmai Injection is a traditional Chinese medicine injection made from Ginseng Radix et Rhizoma Rubra and Ophiopogon Japonicus.It has the functions of benefiting qi and removing solids,nourishing yin and promoting fluid production,and reinforcing pulse.It is clinically used to treat shock,coronary heart disease,viral myocarditis,chronic pulmonary heart disease and granulocytopenia caused by deficiency of qi and yin.This article mainly focuses on the quality control of pyrogens,hemolysis,allergies,bacterial endotoxin,and organic reagent residues that affect the safety of the product,product toxicity studies related to chemical components and excipients,and clinical trials with diluents,commonly used drugs,and non-recommended drugs.The three aspects of compatibility research are reviewed to provide reference for improving product safety and quality control and reducing the incidence of adverse reactions.