摘要
目的建立高效液相色谱-荧光检测法(HPLC-FLD)测定人血浆中多潘立酮的质量浓度,研究多潘立酮片在健康志愿者体内单次给药的药代动力学特征及安全性。方法选择健康男性受试者20例,单剂量给予多潘立酮片20 mg后,测定不同时间人血浆中多潘立酮的质量浓度,计算药代动力学参数,并通过询问、体格检查和实验室检查评价药物在人体内的安全性。结果多潘立酮质量浓度在1.0～64.0 ng·mL^(-1)范围内线性关系良好,批内、批间精密度均小于10.92%,准确度均大于94.13%。口服20 mg多潘立酮片后曲线下面积(AUC_(0～t))、达峰质量浓度(C_(max))和达峰时间(t_(max))分别为42.31±15.58 ng·mL^(-1)·h,18.75±5.54 ng·mL^(-1)和0.60±0.21 h。结论建立的方法可测定人血浆中多潘立酮的血药质量浓度及临床药代动力学的研究。口服多潘立酮片后,在人体内吸收迅速,安全性和耐受性良好。
Objective To establish a specific and accurate high performance liquid chromatography-fluorescence detection method for the determination of domperidone in plasma,and to investigate the pharmacokinetics and safety of oral domperidone in healthy volunteers.Methods Twenty healthy man volunteers were recruited in study and administered at a dose of 20 mg domperidone.Plasma samples were collected at different point of time.Pharmacokinetic parameters were determined after the plasma concentration was analyzed.Safety was assessed by using physical examination and subject interviews.Results The assay allowed quantification of domperidone plasma concentrations in the range from 1.0-64.0 ng·mL^-1 .The mean precisions of quality control samples were less than 10.92%,and mean accuracies were more than 94.13%.The AUC 0- t (area under the concentration-time curve from zero up to the last measurable plasma concentration), C max (maximum concentration) and t max (the time to reach this concentration) after a single dose of 20 mg domperidone were 42.31±15.58 ng·mL^-1 ·h,18.75±5.54 ng·mL^-1 and 0.60±0.21 h,respectively.Conclusion The validated method was developed for quantification of domperidone in plasma and was suitable for the study on pharmacokinetics after oral administration.Domperidone was well tolerated and rapidly absorbed in healthy volunteers after single dose.
作者
胡岚岚
李雪
汤建林
HU Lanlan;LI Xue;TANG Jianlin(Base for Drug Clinical Trial,Xinqiao Hospital,Army Medical University,Chongqing 400037,China)
出处
《西北药学杂志》
CAS
2019年第2期213-216,共4页
Northwest Pharmaceutical Journal
