丹参酮ⅡA注射剂与心血管药物混合输注可行性研究  

Tanshinone ⅡA injections mixed with cardiovascular drugs: A feasibility study

作　　者：王楠[1] 宋小骏[1] 谢学建[1] 张婷婷[1] 蒋凤[1] 

机构地区：[1]南京军区南京总医院药品科,南京210002

出　　处：《医学研究生学报》2013年第4期388-391,共4页Journal of Medical Postgraduates

基　　金：南京市2011年度科技发展计划(药学项目)(2011YX009)

摘　　要：目的丹参酮ⅡA磺酸钠注射液临床用于治疗心血管等疾病,存在多种药物混输引起不溶性微粒的现象,但相关报道较少,文中建立静脉注射丹参酮ⅡA磺酸钠与心血管药物配伍后不溶性微粒检测的方法,并确立药物之间是否存在配伍禁忌及经过滤器过滤后的微粒变化。方法参阅相关文献及对医嘱中与丹参酮ⅡA配伍的心血管药物品种以及混合配制情况进行综合归纳。按临床操作规程配置输液,采用光阻法,用GWF-8JA激光微粒分析仪对不溶性微粒进行测定。结果测定了不同药物配伍溶液中的不溶性微粒,各配伍液中≥25μm和≥10μm的不溶性微粒均有增加,不同直径的不溶性微粒增加的程度有别,经过滤后微粒有大幅减少。结论丹参酮ⅡA磺酸钠与重组人胰岛素注射液存在配伍禁忌即微粒增加幅度较大,超过《2010中华人民共和国药典》标准;混合溶液经一次性输液器过滤器过滤后微粒有大幅减少,但药物有效成分含量可能有所下降,以上情况值得临床工作人员注意。Objective Clinically tanshinone ⅡA sulfonate is often injected in combination with other drugs for the treatment of cardiovascular and other diseases, but reports are rarely seen on their incompatibility. The purpose of this study is to establish the methods of detecting insoluble particles in intravenous tanshinone ⅡA sulfonate combined with cardiovascular drugs, and determine possible incompatibility among different drugs and the variation of the amount of particles after filtration. Methods We reviewed rel- evant literature on the cardiovascular drugs prescribed with tanshinone ⅡAinjection and their compatibility. The infusion solution was prepared according to the HIS rules of operation, and the insoluble particles were measured with the photoresistive method using the GWF-8JA laser particle analyzer. Results The number of ≥ 25 μm and ≥ 10 μm insoluble particles was increased in all the mixed solutions, and those of different diameters were increased in different degrees. After filtration, the amount of particles was sub- stantially reduced. Conclusion Incompatibility was found between tanshinone ⅡA sulfonate and Humulin R, with more particles than stipulated by the 2010 Pharmacopoeia of China. The amount of particles can be substantially decreased after filtration, but the content of active ingredients may be reduced accordingly.

关 键 词：丹参酮ⅡA磺酸钠 不溶性微粒 检测方法 配伍禁忌 输液器过滤器 

分 类 号：R541.4[医药卫生—心血管疾病]