5-HT3RAs与地塞米松磷酸钠注射液在注射器中的相容性  

Compatibility of 5-hydroxytryptamine 3 Receptor Antagonists with Dexamethasone Sodium Phosphate Injections in Syringes

作　　者：何光照 张晓璐 王玲娜 邓玉琴 薛宏波 HE Guangzhao;ZHANG Xiaolu;WANG Lingna;DENG Yuqin;XUE Hongbo(Department of Pharmacy,Office of Drug Clinical Trial Institution,Changzhou Cancer Hospital,Soochow University,Changzhou 213032,China;Changzhou Food and Drug Supervision and Inspection Center,Changzhou 213022,China)

机构地区：[1]常州市肿瘤医院,苏州大学附属常州肿瘤医院药剂科,药物临床试验机构办公室,常州213032 [2]常州市食品药品监督检验中心,常州213022

出　　处：《药学与临床研究》2020年第1期47-50,共4页Pharmaceutical and Clinical Research

基　　金：常州市卫生计生委重大科技项目(ZD201611);常州市科技计划指导性项目(2017331)

摘　　要：目的:研究5-羟色胺3受体拮抗剂(5-hydroxytryptamine 3 receptor antagonists,5-HT3RAs)与地塞米松磷酸钠注射液在注射器中配伍的相容性,以评价临床配伍用药的合理性和可行性。方法:模拟临床实际情况,在室温(25±2)℃不避光环境下,取3支注射器,各抽取单次常用量的盐酸托烷司琼、盐酸阿扎司琼、盐酸帕洛诺司琼注射液,每支加入适量生理盐水稀释,在混匀后,再分别加入10 mg地塞米松磷酸钠注射液,在3支注射器中混合均匀,得3种配伍液。对配伍液在制备后0 h(配置后5 min内)、2.5 h、5 h的物理相容性(外观、不溶性微粒和pH值)、化学稳定性(浓度)进行考察。结果:配伍液在5 h内保持无色、澄清,未见有气泡、絮状物和沉淀产生,不溶性微粒、pH值与配伍液中两药浓度变化均符合配伍要求,且色谱图均未发现异常色谱峰。结论:在室温(25℃)不避光时,上述3种5-HT3RAs与地塞米松磷酸钠注射液在注射器中配伍是相容的。Objective : To study the compatibility of 5-hydroxytryptamine 3 receptor antagonists(5-HT3 RAs) with dexamethasone sodium phosphate injections in syringes, in order to evaluate the rationality and feasibility of clinical admixture. Methods: Simulating the actual clinical situation, tropisetron hydrochloride, azasetron hydrochloride and palonosetron hydrochloride injections of common dosage were respectively extracted by three syringes at room temperature(25 ℃) with indoor light. After adding proper saline in each injection and initial mixing, 10 mg dexamethasone sodium phosphate injection was extracted separately, and the three solutions were evenly mixed in each syringe. The physical compatibility(appearance, insoluble particles and pH value) and chemical stability(concentration) of three solutions at 0 h(within 5 min), 2.5 h and 5 h after mixing were investigated. Results: The three solutions remained colorless and clear within 5 hours. No bubbles, turbulent substances or precipitation were observed. The insoluble particles, pH value and concentrations of the mixed two drugs in the solutions met the compatibility requirements, and no abnormal peaks were found in the chromatogram. Conclusions: The above three 5-HT3 RAs are compatible with dexamethasone sodium phosphate injections in syringes.

关 键 词：盐酸托烷司琼 盐酸阿扎司琼 盐酸帕洛诺司琼 地塞米松磷酸钠 配伍相容性 

分 类 号：R942[医药卫生—药剂学] R969.2[医药卫生—药学]