地佐辛、酮咯酸氨丁三醇、盐酸托烷司琼与0.9%氯化钠注射液配伍在硅橡胶材料镇痛泵储药囊中的稳定性研究  

Stability Studies of Dezocine, Ketorolac Tromethamine and Tropisetron Hydrochloride in 0.9% Sodium Chloride Infusion Stored in the Silicone Rubber Material Based Analgesia Pump Reservoir

作　　者：沈安[1,2] 陈志禹 颜小锋[4] 周权[4] 

机构地区：[1]浙江大学药学院,杭州310058 [2]宁波市中医院,宁波315012 [3]宁波市药品检验所,宁波315040 [4]浙江大学医学院附属第二医院,杭州310009

出　　处：《中国现代应用药学》2016年第7期917-922,共6页Chinese Journal of Modern Applied Pharmacy

基　　金：浙江省教育厅项目(N20140209);浙江大学科研项目(H20150895;H20151562)

摘　　要：目的研究地佐辛、酮咯酸氨丁三醇、盐酸托烷司琼3种注射液和0.9%氯化钠配伍在硅橡胶材料镇痛泵储药囊中的稳定性。方法应用pH计、微粒分析仪、高效液相色谱仪分别测定4,25,35℃下硅橡胶储药囊中配伍溶液在72 h内pH值、不溶性微粒数和各成分含量的变化。结果 4,25,35℃下硅橡胶储药囊中配伍溶液的外观和pH值在72 h内均未见明显变化,不溶性微粒符合药典要求;地佐辛、酮咯酸氨丁三醇与托烷司琼的相对含量均在96%-102%。结论地佐辛、酮咯酸氨丁三醇、托烷司琼注射液与0.9%氯化钠配伍在硅橡胶材料镇痛泵储药囊中72 h内稳定。OBJECTIVE To study the stability of the mixture of dezocine, ketorolac tromethamine and tropisetron hydrochloride in 0.9% sodium chloride infusion stored in the silicone rubber material based analgesia pump reservoir. METHODS The admixture was stored at 4, 25, 35 ℃ separately for 72 h. The changes of pH value, insoluble particles and the relative contents were studied with pH meter, particle analyzer and high performance liquid chromatography. RESULTS No significant changes were found in appearance and pH value of the solution in the silicone rubber material analgesia pump reservoir under 4, 25, 35 ℃ within 72 h. The number of insoluble particles was complied with Chinese Pharmacopoeia requirements. The relative contents of dezocine, ketorolac tromethamine and tropisetron hydrochloride were retained in 96%-102%. CONCLUSION Dezocine, ketorolac tromethamine and tropisetron hydrochloride are stable in 0.9% sodium chloride infusion stored in the silicone rubber material based analgesia pump reservoir within 72 h under 4, 25, 35 ℃.

关 键 词：地佐辛 酮咯酸氨丁三醇 盐酸托烷司琼 硅橡胶 镇痛泵 静脉患者自控镇痛 稳定性 高效液相色谱法 

分 类 号：R917.101[医药卫生—药物分析学]