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Preparation of Amoxicillin-colistin Sulfate Suspension and Its Pharmacokinetics, Residue Determination in Broilers

Author: XiaoFei
Tutor: QiuYinSheng
School: Wuhan Polytechnic University
Course: Animal Nutrition and Feed Science
Keywords: Amoxicillin Colistin sulfate Suspension Injection Broiler Pharmacokinetic Residues
CLC: R96
Type: Master's thesis
Year: 2009
Downloads: 83
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Abstract


Compound preparation consisting of amoxicillin (AMO) and colistin sulfate (COS) in foreign countries have been listed, but there are no related products listed. The subject of foreign reference product formulations prepared AMO-COS compound injectable suspension, and the injection in broiler vivo pharmacokinetic studies, two main drug residue detection method in broilers. AMO-COS suspension injection preparation and quality assessment: soybean oil as a solvent, formulated per 1mL the suspension injection containing AMO100mg, the COS250000IU, aluminum stearate 20mg, vitamin E25mg, Span-803 mg of lecithin 0.5mg suspension, the set speed for the dispersion after 10min 10000r/min dispersing machine, transferred to a colloid mill, cyclic 2min. This product is white oily suspensions, the sedimentation volume ratio and the re-dispersibility. The the suspension injection AMO and COS HPLC detection method, AMO in the linear range of 2 ~ 200μg/mL good linear relationship (r = 0.999); COS 30 ~ 100μg/mL linear range a good linear relationship ( r = 0.998). AMO and COS Determination results were 99.29% of the labeled amount of test samples in three batches, 98.76% and 99.23%; 98.41%, 99.60% and 97.65%. AMO 2,25,200 μg / mL average recovery of 97.99% to 99.04%, RSD 0.16% to 2.13%; COS 30,60,90 μg / mL average recovery of 97.95% to 99.2%, and the RSD 0.89% to 7.07%. Naturally after 12 months of storage, three batches of samples AMO total related substances increased by 1.71%, 1.72% and 1.78%, respectively, were less than 5%. Indicating the good stability of the suspension. AMO-COS suspension injection in the broiler vivo pharmacokinetic study: AMO and COS plasma by HPLC method. Plasma AMO concentration in 0.1 ~ 8μg/mL range linearly good relationship (r = 0.999), plasma COS concentration in 0.1 ~ 4μg/mL range linearly good relationship (r = 0.998). AMO and COS lowest limit of detection in plasma are 0.05μg/mL; level 0.5μg/mL, 1.0μg/mL, and 2.0μg/mL three kinds of add AMO average recovery of 85.13% to 98.36%, and the RSD 1.73% to 6.55%; 0.1μg/mL, 0.5μg/mL, 2.0μg/mL three spiked levels of COS average recovery was 71.53% ~ 74.07%, RSD 0.96% to 4.49%. 24 healthy Ivy broiler test weight 2.5 ± 0.5kg, were randomly divided into three groups, each group of eight, suspension respectively intramuscular injection AMO, COS solution and AMO-COS suspension dose AMO20mg/kg, COS50000IU/kg. Administration after 5min ~ 24h wing vein blood collection, high performance liquid chromatography (HPLC) assay of plasma concentration of AMO and COS. AMO and COS plasma concentration - time data were fitted DAS2.1.1 software to calculate the pharmacokinetic parameters. After the suspension of the intramuscular injection of AMO main pharmacokinetic parameters were as follows: Tmax was 0.97 ± 0.08h, Cmax 3.73 ± 0.97mg / L, t1/2β 7.46 ± 2.97h; COS aqueous solution pharmacokinetic parameters: Tmax 0.5h, Cmax was 1.04 ± 0.35mg / L, t1/2β 4.46 ± 0.43h; AMO-COS suspension pharmacokinetic parameters: AMO: Tmax 1h, Cmax to 3.92 ± 0.63mg / L, t1/2β 7.52 ± 3.61h COS: Tmax was 1.06 ± 0.18h, Cmax was 1.23 ± 0.12mg / L, t1/2β 6.63 ± 2.28h. The test results show that intramuscular injection of the pharmacokinetic characteristics of homemade the AMO-COS suspension for the absorption of aqueous solution was slowly, elimination half-life than an aqueous solution of long. AMO and COS in broiler tissue residue detection method: the broiler liver, kidney, muscle, sebum tissues AMO and COS HPLC detection methods. Four blank organization AMO concentration of 0.025 ~ 0.8μg / g good linear relationship; COS in the concentration range of 0.05 ~ 1.0μg / g, a good linear relationship. The minimum detection limit of AMO and COS in four organizations were 0.025μg / g and 0.05μg / g. AMO recoveries in four organizations (concentration 0.025,0.05 and 0.4μg / g) in the range of 68.22% to 81.79%, RSD of the range of 1.3% to 4.73%; COS in four organizations (the concentration of 0.1,0.15 and 1.0μg / g) recoveries ranged from 76.96% to 100.73%, RSD of 1.41% to 7.09% range. The test methods in line with the Ministry of Agriculture has issued the AMO and COS maximum residue allowable limits testing requirements.

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