對乙酰氨基酚論文：三廠家對乙酰氨基酚口服制劑生物等效性與體內(nèi)外-文庫吧資料
2025-04-13 03:25本頁面
【正文】 easonable clinical application and quality :Health volunteers were involved in a single dose,3period crossover test. 12 healthy male volunteers were divided into 3 groups randomly, and orally given Acetaminophen Tablets A (Anhui Lanyi Pharmaceutical Co., LTD), Tablets B (Shanhai huayuananhuirenji Pharmaceutical Co., LTD), Tablets R (Tianjin Smith Kline) , elbow vein blood were collected before and , ,1,2,3,4,7,10, after administration. All blood were heparinized and centrifuged at 4000rpm for 10 minutes, and plasma was separated and stored at20℃for analysis. Volunteers were taken Tables A, B or R after one or two washing period (7 days or 14 days), in second or thirdperiod. An HPLC method was used to determine the concentration of acetaminophen in plasma. Diamonsil (diamond) C18 column (5μm,250) with acetonitrilewater (17/83, V/V) as mobile phase at flow rate of 177。體內(nèi)吸收(hTmax表示)也存在差異,177。、B、R三種對乙酰氨基酚片體外溶出度與體內(nèi)吸收相關(guān)性分析結(jié)果顯不,Cmax,Tmax與T50,Td均有較好相關(guān)性,可在一定程度上以體外溶出速度預(yù)測體內(nèi)吸收速度和程度。結(jié)論：,A、B、R三制劑口服三交叉試驗(yàn)對乙酰氨基酚主要藥代動(dòng)力學(xué)參數(shù)AUC和Cmax藥物間及周期間無顯著性差異,但個(gè)體間存在統(tǒng)計(jì)學(xué)差異。h。)μml1h, (177。)μgh。)μg)μgmL1)μg)h和(177。)h,Tmax為(177。)h、(177。mLl)質(zhì)控樣本絕對回
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