复方地西泮灌肠剂的制备及应用  

PREPARATION AND APPLICATION OF DIAZEPAN-COMPOUND ENEMA

作　　者：王凯[1] 王明月[2] 吴晓燕[3] 刘健[2] 马承立 

机构地区：[1]济南市中心医院儿科,济南250013 [2]济南铁路中心医院 [3]山东省荣军总医院

出　　处：《齐鲁医学杂志》2002年第1期45-46,共2页Medical Journal of Qilu

摘　　要：①目的　探讨复方地西泮灌肠剂的制备、质量标准及相关毒性试验。②方法　用TSP高效液相色谱法测定样品中地西泮的含量 ,并进行稳定性试验和临床疗效观察。③结果　地西泮在 17～ 5 1ng/L ,布洛芬在0 .39～ 1.18g/L范围内 ,峰面积与浓度呈良好的线性关系。复方地西泮灌肠剂预防热性惊厥的作用优于单方制剂。④结论　本质量标准可有效地控制复方地西泮灌肠剂的用量 ,本制剂适于预防热性惊厥。Objective\ To study the preparation of diazepan compound enema, its standard of quality and related toxicity test. \ Methods\ The amount of diazepan in the sample was detected by TSP high performance liquid chromatography, the stability and therapeutic efficacy of the preparation were investigated. \ Results\ There was a good linear relation between the peak area and the density when the density of diazepan was 17-51ng/L and ibuprofen was 0.39-1.18g/L. Diazepan compound enema was more effective than diazepan alone in the prevention of febrile convulsion . \ Conclusion\ This standard of quality may effectively control the quality of diazepan compound enema. The preparation is applicable to the prevention of febrile convulsion.

关 键 词：地西泮 复方合剂 灌肠 发热性惊厥 制备 质量标准 毒性 

分 类 号：R943[医药卫生—药剂学]