摘要
目的 建立检测血清中氯硝西伴(clomazepam,CZP)的高效液相色谱法,监测CZP血药浓度,为临床应用提供依据.方法0.5ml样品用Tris－HCI缓冲液-乙醚系统萃取净化.色谱条件;以C_(18)反相柱为分析柱,流动相为甲醇-乙睛-0.01%磷酸溶液(35:15:50V/V),流速1ml/min,柱温30℃,检测波长254mm.结果CZP在20-1400ng/ml范围内呈线性,血清中最低检测限5ng/ml,绝对回收率91.8-94.2%.9例使用剂量为0.078-0.36mg/(kg·d)的癫痛患儿稳态谷血药浓度在79.8－274nl/mg之间,症状得到有效控制,除困倦和嗜睡外未见其它副作用.结论 本法简便、快速、准确,适合于体液中CZP的监测及药物动力学研究;本研究也提示儿科所用的CZP抗癫病有效血药浓度范围的可靠性值得进一步探讨.
ve To develop a method for determination of the clonazepam(CZP) in seum for provides a scientific basis for rationalized use of CZP, Methods 0. 5ml serum was added to the test tube packed with 0. 5ml Tris - HCl buffer solution, and then was extrracted by 3ml ×2 ethyl ether, C18 reversed column was used, mobile phase: methanol - acetonitrile -0. 01% phosphoric acid solution (35: 15: 50 V/V), flow rate 1ml/min, colum temperature 30℃, The detection was carried out with an ultraviolet detector at 254nm. Results The liearity was in the rage of 20 - 1400ng/ml. The detection limit of CZP in serum was 5ng/ml. The absolute recoveries of three concentrations of CZP in se um were 91.8%, 93. 4% , 94. 2% respectively. CZP(0. 078 - 0. 36mg/ (kg.d)) was administered orally to 9 epileptic children, The(C33)min was in the range of 79. 8 -274ng/ml, All were up to the super limit of therapeutic ranges, Seizure was controlled, adverse effects except sleepy and somnolence weren' t discovered. Conclusion This paper provides a rapid, convenient, sensitive and accurate method which is suitable for monitoring and pharmacokinitics of CZP, It indicated that the reliability of currently used therapeutic serum concentration range for CZP in children will be investigated further.
出处
《儿科药学》
2000年第3期14-15,共2页
Journal of Pediatric Pharmacy
