地佐辛与酮咯酸氨丁三醇注射液配伍后变化及镇痛试验  

Compatible changes of dezocine injection mixed with ketorolac tromethamine injection and the analgesic test

作　　者：胡海勋 姚景春 宋洪运 商庆节 罗涟荣 

机构地区：[1]鲁南制药集团股份有限公司新药药理中心,山东临沂273400

出　　处：《中国医院药学杂志》2013年第24期2050-2053,共4页Chinese Journal of Hospital Pharmacy

摘　　要：目的:研究常温下不同质量浓度地佐辛注射液与酮咯酸氨丁三醇注射液配伍后,放置在不同的时间段,溶液pH值、微粒数量及配伍液相对含量的变化,为临床使用提供科学依据;筛选2种注射液最佳镇痛作用配伍比例。方法:应用微粒分析仪、pH计和高效液相色谱仪分别测定溶液中微粒数、pH值以及相对含量的变化;采用正交试验设计筛选最佳配伍比例并用小鼠醋酸扭体法进行镇痛实验。结果:地佐辛注射液与酮咯酸氨丁三醇注射液按临床常用量配伍,有不溶性微粒产生;配伍液用0.9%氯化钠溶液稀释3,6,12,20,25倍后,不溶性微粒随稀释倍数增加而减少,相对含量增大;配伍液及其稀释液pH值12 h内无变化;地佐辛与酮咯酸氨丁三醇2种注射液的最佳比例是A1B3。结论:临床常用剂量的配伍液用0.9%氯化钠溶液稀释12倍以上,在相对含量、pH值、可见异物和不溶性微粒符合《中国药典》要求下进行配伍使用;经小鼠醋酸扭体实验,2种注射液配伍具有镇痛协同作用。OBJECTIVE To study the changes of stability, pH and particles in different concentrations and time periods of dezocine injection mixed with ketorolac tromethamine for providing scientific basis to clinical usage; to screen the best analgesic effect of compatible proportion of the two injections. METHODS The changes of particles, pH value and the relative contents were studied with particles analysator , pH meter and HPLC. Orthogonal experimental design was accepted to screen the best compatible proportion. Acetic acid writhing test was used to study the analgesic effect in mice. RESULTS There were insolu hie particles in compatibility for dezocine injection and ketorolac tromethamine injection after mixed in clinic; The number of in soluble particles decreased and the relative content increased with the dilution multiple increasing when the compatibility was di- luted 3, 6, 12, 20, 25 times with 0.9%NS. There was no change in pH value after 12h at room temperature. The optimum compatible proportion of the two injections was A1B3. CONCLUSION When the compatibility was diluted more than 12 times with 0. 9%NS, the relative contents, the pH value and the number of insoluble and visible particles were coincidence with Chi nese Pharmacopoeia and the two injections can be used; According to the writhing test in mice, there were synergistic effects to the two injections.

关 键 词：配伍 微粒 稳定性 高效液相色谱法 镇痛 

分 类 号：R969.3[医药卫生—药理学]