參麥注射液是由紅參、麥冬制得的中藥注射劑，具有益氣固脫、養(yǎng)陰生津、生脈的功效。臨床上用于治療氣陰兩虛型之休克、冠心病、病毒性心肌炎、慢性肺心病、粒細胞減少癥。主要從影響參麥注射液安全的熱原、溶血、過敏、細菌內(nèi)毒素、有機試劑殘留的質(zhì)量控制；與化學(xué)成分及輔料相關(guān)的毒性研究；與稀釋劑、常用藥物和不建議配伍藥物的臨床配伍研究3個方面加以綜述，為提高產(chǎn)品安全質(zhì)量控制、降低不良反應(yīng)發(fā)生率提供參考。

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.