摘要
为研究进口兽药复方磺胺嘧啶混悬液（参比）与国产复方混悬液（受试）是否等效，建立了同时检测磺胺嘧啶（SD）与甲氧苄啶（TMP）的超高液相色谱质谱联用方法（UPLC—MS），将甲氧苄啶的类似物二甲氧苄啶（DVD）作为内标，甲醇作为血浆的前处理溶剂，来检测血药浓度，并用软件DAS3．0计算药动学参数，并对AUCt、AUCi的对数值进行方差分析、双单侧t检验等统计学处理，以80％－125％为等效标准，药峰浓度（Cmax）以70％～143％为等效区间来评价进口兽药与国产兽药的生物等效性。结果显示：SD参比制剂的Cmax为（36．01±6．25）μg／mL，AUCt为（204．50±57．46）μg·h／mL，AUCi为（220．15±59．51）μg·h／mL，受试试剂的Cmax为（33．08±9．05）μg／mL，AUCt为（201．20±54．14）μg·h／mL，AUCi为（220．39±62．86）μg·h／mL；TMP参比制剂的Cmax为（0．64±0．20）μg／mL，AUCt为（2．86±1．23）μg·h／mL，AUCi为（2．96±1．31）μg·h／mL，受试试剂的Cmax为（0．62±0．26）μg／mL，AUCt为（2．74±1．24）μg·h／mL，AUCi为（2．87±1．33）μg·h／mL。经方差分析和双单侧t检验，参比制剂与受试制剂中的sD与TMP均具有生物等效。
To study bioequivalence of imported veterinary drug compound sulfadiazine suspension （reference preparation） and that of domestic （test preparation）. The method of simultaneous detection SD and TMP was established by ultra-high liquid chromatography combined with mass spectrometry. Diaveridine,the analogues of trimethoprim was used as internal standards, methanol as the pre-treatment solvent with the established method to determine the concentration of the both compound. The pharmacokinetic parameters of the two preparations were calculated by DAS 3.0 program. The lnAUCt and lnAUCi were used to evaluate the bioequivalence of the two preparations by analysis of variance and two one-side t-test. 80% to 125% was as the equivalent standard,Cmax with 70% to 143% was for the equivalent interval. The Cmax of reference was （36.01±6.25）Ixg/mL,AUCt was （204.50±57.46）μg.h/mL,AUCi was （220.15±59.51）txg＇h/mL, and the Cmax of test was （33.08±9.05） μg/mL,AUCt was （201.20±54.14） μg·h/mL and AUCi was （220.39±62.86） μg·h/mL for SI）;The Cmax,AUCt and AUCi of reference were （0.64±0.20） μg/mL, （2.86±1.23） μg·h/mL,（2.96±1.31）μg·h/mL, and the Cmax,AUCt and AUCi of test were （0.62±0.26）μg/mL,（2.74±1.24）μg.h/mL,（2.87±1.33）μg·h/mL for TMP. SD and TMP of reference and test preparations were bioequivalent after the analysis of variance and two one-side t-test.
出处
《中国家禽》
北大核心
2014年第24期23-26,共4页
China Poultry
