注射用丹参多酚酸盐与21种临床常用药品配伍稳定性研究

目的 考察注射用丹参多酚酸盐与21种临床常用药品配伍后的稳定性.方法 模拟临床用药,将注射用丹参多酚酸盐200mg分别与临床21种常用药品,用0.9%氯化钠注射液250 mL或5%葡萄糖注射液稀释配伍,观察溶液外观,测定配伍后4 h内pH、不溶性微粒和含量的变化.结果 注射用丹参多酚酸盐与维生素C注射液、黄芪注射液、单硝酸异山梨酯注射液、盐酸川芎嗪注射液、地塞米松磷酸钠注射液配伍使用时pH超出注射用丹参多酚酸盐厂家质量标准;与香丹注射液配伍在0.9%氯化钠注射液为溶刺的情况下,含量在1 h后下降.注射用丹参多酚酸盐与其他15种临床常用药品配伍,0～4 h内外观、pH、不溶性微粒、含量测定方面均符合规定.结论 注射用丹参多酚酸盐与所选15种,临床常用药品配伍在4 h内基本稳定.但基于中药注射液成分的复杂性,建议临床上单独使用.

Compatible Stability of Salvianolate for Injection with 21 Kinds of Clinically Commonly Used Drugs

Objective To investigate the stability of Salvianolate for Injection after the compatibility with 21 clinical drugs.Methods By simulating clinical medication,200 mg Salvianolate for Injection was compatible with 21 kinds of drugs commonly used in clinic,and 250 mL 0.9%sodium chloride injection or 5%glucose injection as solvent to observe the appearance,pH,insoluble particles and content detected within 4 h in the mixed solution.Results In the compatibility of Salvianolate for Injection with Vitamin C Injection,Astragalus Injection,Isosorbide Mononitrate Injection,Ligustrazine Hydrochloride Injection and Dexamethasone Sodium Phosphate Injection,the pH value exceeded the quality standard of the manufactories.In its compatibility with Xiangdan Injection in 0.9%Sodium Chloride Injection as solvent,the content was decreased after 1 h.In its compatibility with other 15 kinds of clinically commonly used drugs,the inner appearance,pH,insoluble particles and content determination within 4 h were all accorded with the standard for quality control of Salvianolate for Injection.Conclusion The compatibility Salvianolate for Injection with 15 kinds of drugs commonly used in clinic is stable within 4 h.But based on the complex composition of traditional Chinese medicine injections,it is recommended to be used alone in clinic.