两种复方磺胺嘧啶混悬液在肉鸡体内药动学及生物等效性研究

Pharmacokinetics and Bioequivalence of Compound Sulfadiazine in Broilers

为了解多益与相同成份进口产品的生物等效性,在建立血浆中磺胺嘧啶(SD)和甲氧苄啶(TMP)的HPLC检测方法基础上,比较两种制剂在肉鸡体内的药代动力学特征。选用30只健康白羽肉鸡,进行单剂量口服给药,给药剂量均为20mg/kg(以SD计),用反相高效液相色谱法测定血浆中SD和TMP浓度,计算其药动学参数并评价两种制剂的生物等效性。用Kinetic药动学软件处理血药浓度-时间数据,得出受试制剂和参比制剂中SD的主要药动学参数分别为:Cmax分别为:(10.60±6.68)、(11.45±5.96)mg/L,Tmax分别为:(4.93±4.25)、(3.87±4.06)h,AUC分别为:(89.31±48.50)、(86.81±45.78)mg/L·h,Clearance分别为:(7.94±14.06)、(6.54±7.70)L/kg·h,Vz分别为:(3.57±6.12)、(10.43±31.75)L/kg。受试制剂多益相对参比制剂的相对生物利用度为102.88%,表明受试制剂与参比试剂具有生物等效性。

To study the pharmacokinetics and bioequivalence of two compound sulfadiazine suspensions thirty broilers were divided into two groups and were administrated two compound sulfadiazine suspensions dose （20 mg/kg b.w.） respectively. The plasma concentration of SD and TMP were determined by reverse performance liquid chromatography （HPLC）, and pharmacokinetic parameters of SD were calculated in broilers, by a single phase high by Kinetic program. At the same time, the bioequivalence of two suspensions was evaluated. The main pharmacokinetic parameters of SD in two compound sulfadiazine suspensions were shown as following：Cmax were （10.60±6.68）,（11.45±5.96）rag/L, Tmax were （4.93±4.25）, （3.87±4.06） h,AUC were （89.31±48.50）, （86.81±45.78） mg/L. h, Clearance were （7.94±14.06）, （6.54±7.70） L/kg/h,Vz were （3.57±6.12）, （10.43±31.75）L/kg. The results showed that the relative bioavailability of two test suspensions calculated with AUC was 102.88%. The two compound sulfadiazine suspensions, Doge and Sulfaprim, were proven to be bioequivalent.