国产盐酸溴己新可溶性粉在鸡体内的生物等效性评价  

Bioequivalence Evaluation of Domestic Bromhexine Hydrochloride Soluble Powder in Chickens

作　　者：孙健[1] 李彦 段笑笑 郭莉莉 吴宁鹏 李慧素 杨洁 赵永达 SUN Jian;LI Yan;DUAN Xiaoxiao;GUO Lili;WU Ningpeng;LI Huisu;YANG Jie;ZHAO Yongda(College of Veterinary Medicine,Qingdao Agricultural University,Qingdao 266109,China;Qingdao Municipal Center for Animal Disease Control and Prevention,Qingdao 266073,China;Henan Veterinary Medicine and Feed Inspection Institute,Zhengzhou 450015,China;Qingdao Bolin Biotechnology Co.,LTD.,Qingdao 266111,China)

机构地区：[1]青岛农业大学动物医学院,山东青岛266109 [2]青岛市动物疫病预防控制中心,山东青岛266073 [3]河南省兽药饲料监察所,河南郑州450015 [4]青岛博霖生物科技有限公司,山东青岛266111

出　　处：《青岛农业大学学报（自然科学版）》2022年第4期252-258,共7页Journal of Qingdao Agricultural University(Natural Science)

基　　金：泰山产业领军人才工程资助;2020年度山东省新旧动能转换重大工程重大课题攻关项目“畜禽呼吸道疾病防治新型兽用原料及其制剂的开发”;青岛市科技惠民示范引导专项(21-1-4-ny-11-nsh);青岛农业大学横向课题(横20210342)。

摘　　要：旨在研究国产盐酸溴己新可溶性粉与参比制剂在鸡体内的生物等效性。采用平行试验设计,将70只健康黄羽肉鸡随机分成2组,给药剂量250 mg/kg(以本品计),用高效液相色谱-串联质谱法(HPLC-MS/MS)测定鸡血浆中盐酸溴己新浓度,用Phoenix WinNonlin 5.2.1软件计算主要药物代谢动力学参数,评价2种制剂的生物等效性。结果显示,受试制剂、参比制剂从0到计算时间(t)的药时曲线下面积(AUC_(0-t))分别为(551.13±371.33)h·ng/mL、(575.55±308.75)h·ng/mL,从0到无限长时间(∞)的药时曲线下面积(AUC_(0-∞))分别为(621.18±396.46)h·ng/mL、(636.56±325.58)h·ng/mL,峰浓度(C_(max))分别为(128.50±83.83)ng/mL、(164.09±152.04)ng/mL,峰时间(t_(max))分别为(0.86±1.32)h、(0.86±1.18)h。AUC_(0-t)值、AUC_(0-∞)值、C_(max)经自然对数转换、方差分析和双单侧t检验结果说明,受试制剂、参比制剂盐酸溴己新在鸡体内具有生物等效性。研究为国产盐酸溴己新可溶性粉在兽医临床上的合理使用提供参考。To study the bioequivalence of domestic bromhexine hydrochloride soluble powder and reference preparation in chickens,using parallel experimental design,70 healthy yellow feather broilers were randomly divided into 2 groups with the dosage of 250 mg/kg(calculated by this product).The concentration of bromhexine hydrochloride in chicken plasma was determined by high performance liquid chromatography-tandem mass spectrometry(HPLC-MS/MS).The main pharmacokinetic parameters were calculated by Phoenix WinNonlin 5.2.1 software,and the bioequivalence of the two preparations was evaluated.The results showed that the areas under the concentration-time curves(AUC 0-t)of the test preparation and reference preparation from 0 to the calculated time(t)were(551.13±371.33)h·ng/mL and(575.55±308.75)h·ng/mL,respectively;The areas under the concentration-time curves(AUC_(0-∞))from 0 to the infinite time(∞)were(621.18±396.46)h·ng/mL and(636.56±325.58)h·ng/mL,respectively;The peak concentrations(C_(max))were(128.50±83.83)ng/mL and(164.09±152.04)ng/mL,respectively,and the peak time(t_(max))values were(0.86±1.32)h and(0.86±1.18)h,respectively.Based on natural logarithmic conversion,analysis of variance and two one-side t-test,the results of AUC_(0-t) values,AUC_(0-∞)values and C_(max) values showed that the test preparation and reference preparation of bromhexine hydrochloride were bioequivalent in chickens.This study provides a reference for the rational veterinary use of domestic bromhexine hydrochloride soluble powder in veterinary clinic.

关 键 词：盐酸溴己新 高效液相色谱-串联质谱法 药物代谢动力学 生物等效性 

分 类 号：S859.5[农业科学—临床兽医学]