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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DAS 3.0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/m L,AUCt为(204.50±57.46)μg·h/m L,AUCi为(220.15±59.51)μg·h/m L,受试试剂的Cmax为(33.08±9.05)μg/m L,AUCt为(201.20±54.14)μg·h/m L,AUCi为(220.39±62.86)μg·h/m L;TMP参比制剂的Cmax为(0.64±0.20)μg/m L,AUCt为(2.86±1.23)μg·h/m L,AUCi为(2.96±1.31)μg·h/m L,受试试剂的Cmax为(0.62±0.26)μg/m L,AUCt为(2.74±1.24)μg·h/m L,AUCi为(2.87±1.33)μg·h/m L。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。
In order to study whether the imported veterinary compound sulfamethoxazole (reference) is equivalent to the domestic compound suspension (test), the simultaneous determination of SD and trimethoprim (TMP) Chromatography-Mass Spectrometry (UPLC-MS), the trimethoprim trimethoprim (DVD) as an internal standard, methanol as a plasma pretreatment solvent, to detect plasma concentration, and software DAS 3.0 Pharmacokinetic parameters, and the AUCt, AUCi logarithmic analysis of variance, double unilateral t-test and other statistical analysis, 80% to 125% for the equivalent standard peak concentration (Cmax) to 70% to 143% For the equivalent range to evaluate the import of veterinary drugs and domestic bioequivalence of veterinary drugs. The results showed that the Cmax of SD reference preparation was (36.01 ± 6.25) μg / m L, the AUCt was (204.50 ± 57.46) μg · h / m L and the AUCi was (220.15 ± 59.51) μg · h / The AUCt was (201.20 ± 54.14) μg · h / m L, the AUCi was (220.39 ± 62.86) μg · h / m L, and the Cmax of the TMP reference preparation was (33.08 ± 9.05) μg / AUCi was (2.96 ± 1.31) μg · h / m L and the AUCt was (0.86 ± 1.23) μg · h / m L and 0.84 ± 0.20 μg / m L, the AUCt was (2.74 ± 1.24) μg · h / m L, and the AUCi was (2.87 ± 1.33) μg · h / m L. By ANOVA and double unilateral t-test, both SD and TMP in the reference formulation and the test formulation were bioequivalent.