国产氯沙坦钾片在老年健康人体内的药动学和生物等效性研究

Study on the Pharmacokinetics and Bioequivalence of Domestic Losartan Potassium Tablets in Healthy Elderly People

目的观察国产氯沙坦钾片在老年健康人体内的药动学特征,评价其单次口服氯沙坦钾片受试制剂与单次氯沙坦钾胶囊的生物等效性。方法选取自2019年3月至2021年3月,选取在河南神火集团总医院自愿接受研究的80名≥60岁男性健康受试者作为研究样本,以随机交叉设计将其分为A组(单剂量口服氯沙坦钾片)与B组(单剂量口服氯沙坦钾胶囊),以高效液相色谱法(HPLC)法对受试者血浆内药物浓度进行测定,并以方差分析血药浓度等。结果A组、B组制剂的T_(max)、C_(max)、AUC_(0→40)对比无显著差异(P>0.05);A组、B组制剂的生物等效性、平均药时曲线对比无显著差异(P>0.05)两种制剂安全性均比较高。结论国产氯沙坦钾片与氯沙坦钾胶囊在老年健康人体内具有生物等效性。

Objective The pharmacokinetic characteristics of domestic losartan potassium tablets in healthy elderly people were observed,and the bioequivalence of the single oral losartan potassium tablet test preparation and the single losartan potassium capsule was evaluated.Methods 8060-year-old male healthy subjects from Henan Shenhuo Group General Hospital from March 2019 to March 2021 were divided into group A(single dose oral losartan potassium tablet)and B(single dose oral losartan potassium capsule),and plasma drug concentration was determined by HPLC(HPLC),and blood concentration was analyzed by variance.Results T_(max),C_(max) and AUC_(0→40) in groups A and B(P>0.05),and their bioequivalence and mean curve comparison(P>0.05).Conclusion Domestic losartan potassium tablets and losartan potassium capsules are bioequivalent in the elderly and healthy people.