盐酸右美托咪定注射液与给药器具的相容性研究

Study on the compatibility of Dexmedetomidine Hydrochloride Injection with drug delivery equipment

目的建立盐酸右美托咪定注射液的含量测定方法,并对其临床使用注射器、输液管的相容性进行研究,为临床使用过程中的药品质量提供依据。方法采用高效液相色谱法,色谱柱:Kromasil Enternity-5-C_(18)柱(250 mm×4.6 mm,5 m),流动相:0.01 mol/L磷酸二氢钠溶液-乙腈(60∶40),柱温30℃;检测波长210 nm。分析玻璃注射器、天然橡胶活塞注射器、合成橡胶活塞注射器、无活塞注射器、输液管与盐酸右美托咪定注射液在室温条件下不同时间点的相容性。结果建立的含量测定方法学验证,能准确地测定其含量的变化情况。天然胶塞的注射器对盐酸右美托咪定有较大的吸附,在注射器中保留24 h含量吸附下降到81%左右,相容性差;合成胶塞的注射器对盐酸右美托咪定有一定的吸附,在注射器中保留24 h含量吸附下降到93%左右,相容性一般。无胶塞的注射器、输液管与盐酸右美托咪定相容性好,在注射器或输液管中保留24 h含量几乎无吸附(<2%)。结论临床上使用盐酸右美托咪定注射液时应优先选择无胶塞的注射器或者合成胶塞的注射器。

Objective To establish the content determination method of Dexmedetomidine Hydrochloride Injection,and study its compatibility with clinical syringes and infusion tubes,so as to provide basis for drug quality in in the process ofclinicaluse.Methods High performance liquid chromatography was used.The chromatographic column was kromasil entity-5-C_(18) column(250 mm×4.6 mm,5 m),the mobile phase was 0.01 mol/L sodium dihydrogen phosphate solution acetonitrile(60∶40),and the column temperature was 30℃.The detection wavelength is 210 nm.The compatibility of glass syringe,natural rubber piston syringe,synthetic rubber piston syringe,piston free syringe,infusion tube and Dexmedetomidine Hydrochloride Injection at different time points at room temperature was analyzed.Results The established content determination method was verified,and the change of its content could be determined accurately.The syringe of natural rubber had great adsorption on Dexmedetomidine Hydrochloride.The content of Dexmedetomidine Hydrochloride retained in the syringe for 24 h decreases to about 81%,and the compatibility was poor.The synthetic rubber syringe had a certain adsorption of dexmedetomidine hydrochloride.The content was retained in the syringe for 24 h,and the adsorption drops to about 93%,with general compatibility.The syringe and infusion tube without rubber plug had good compatibility with Dexmedetomidine Hydrochloride,and the content remained in the syringe or infusion tube for 24 h without adsorption(<2%).Conclusion When Dexmedetomidine Hydrochloride Injection is used clinically,syringes without rubber stopper or syringes with synthetic rubber stopper should be preferred.