摘要
目的 建立HPLC测定舒他西林颗粒剂中氨苄西林血药浓度的方法,并研究其在健康人体内的药物动力学。方法 待测血样经除蛋白、水解后进样,以0.05 mol·L^(-1)KH_2PO_4 (pH=4.0)-乙腈(78:22,v/v,内含0.05 mol·L^(-1)戊磺酸钠)为流动相,激发波长为360nm,发射波长430nm。9名健康志愿者,单剂量口服舒他西林颗粒刑750mg,经时采集静脉血测定血药农度,3P87程序处理药时数据。结果 氨苄西林在0.22～13.8mg·L^(-1)浓度范围内线性关系良好,平均回收率为97.08％±4.13％,日内RSD≤5.7％,日间RSD≤6.7％。舒他西林颗粒剂中氨苄西林药物动力学参数分别为:t_(1/2)(0.89≤0.12)h,T_(pk)(0.59±0.16)h,c_(max)(15.42±2.33)mg·L^(-1)。结论 此方法具有较强的专属性,简便、准确,可用于舒他西林颗粒剂中氨苄西林血药浓度测定。
OBJECTIVE To establish an HPLC-FLU method to measure the plasma concentration of ampicillin in sultamicillin granules and study the pharmacokinetics in healthy volunteers. METHODS The pretreatment included removing protein and dialysis. Mobile phase was a mixture of 0.05 mol·L^(-1) potassium dihydrogen phosphate (pH=4.0) and acetonitrile contained 0.05 mol·L^(-1) sodium pentanesulfonate. A fluorescence detector of 360 nm for excitation and 430 nm for emission was used. A single dose of 750 mg sultamicillin granules was given to 9 healthy volunteers. The blood samples were collected at the given time and the plasma levels of ampicillin were detected. The concentration-time data were processed with 3P87 program. RESULTS The assay procedure showed that the linear calibration curve was over the range of 0.22 mg·L^(-1) to 13.8 mg·L^(-1), and the recovery was 97.08%±4.13%. The coefficients of variation within a day and between days did not exceed 5.7% and 6.7%. The pharmacokinetic parameters of ampicillin in sultamicillin granules were: t_(1/2) 0.89±0.12) h, T_(pk) (0.59±0.16) h, and c_(max (15.42±2.33) mg·L^(-1). CONCLUSIONS This method is sensitive, accurate and simple for clinical pharmacokinetic study of ampicillin in sultamicillin granules.
出处
《中南药学》
CAS
2004年第3期150-152,共3页
Central South Pharmacy
