本文選題：蘭索拉唑 + 生物等效性　； 參考：《山東大學(xué)》2014年碩士論文

【摘要】：采用高效液相色譜法(HPLC)法測(cè)定健康受試者血清中蘭索拉唑濃度。方法驗(yàn)證結(jié)果顯示血清雜質(zhì)不干擾樣品測(cè)定,線性范圍：0.028～2.80μg/ml,最低定量下限0.028μg/ml,平均提取回收率為79.69%～94.73%,日內(nèi)和日間的相對(duì)標(biāo)準(zhǔn)差(RSD)均小于15%。該方法符合生物樣品分析要求。 24名健康志愿者按體重隨機(jī)、配對(duì)交叉口服試驗(yàn)制劑蘭索拉唑片和參比制劑蘭索拉唑片,劑間間隔為1周,劑量均為30mg。用HPLC法測(cè)定血清中蘭索拉唑濃度,實(shí)驗(yàn)結(jié)果為：試驗(yàn)制劑t1/22.166±1.217h、Cmax1.644±0.677μg/ml、Tmax2.688±0.640h、AUC0.15h5.977±3.692μg·h/ml;參比制劑t1/21.771±0.763h、Cmax1.490±0.569μg/ml、Tmax3.292±0.779h. AUC0-15h5.609±3.015μg·h/ml。 以汕頭經(jīng)濟(jì)特區(qū)泙濱制藥廠的蘭索拉唑片為參比制劑,用面積法估算濟(jì)南利民制藥有限責(zé)任公司的蘭索拉唑片的相對(duì)生物利用度為105.46%±33.03%,符合生物利用度要求。 試驗(yàn)制劑和參比制劑In(AUC0-15h)、In(AUC0-∞)經(jīng)方差分析,結(jié)果表明兩制劑間無(wú)顯著性差異,經(jīng)雙向單側(cè)t檢驗(yàn),兩制劑[1-2a]置信區(qū)間分別為89.7%-112.7%、91.3%-115.1%,在80%-125%范圍內(nèi),說(shuō)明兩制劑在吸收程度上具有生物等效性。試驗(yàn)制劑和參比制劑In(Cmax)經(jīng)方差分析,兩制劑間無(wú)顯著性差異,經(jīng)雙向單側(cè)t檢驗(yàn),兩制劑[1-2α]置信區(qū)間在70%-143%范圍內(nèi),說(shuō)明兩制劑在達(dá)峰濃度上具有生物等效性。
[Abstract]:The concentration of lansoprazole in the serum of healthy volunteers was determined by high performance liquid chromatography (HPLC). The results showed that the serum impurity did not interfere with the determination of samples. The linear range was: 0.028 ~ 2.80 渭 g / ml, the lowest limit of quantification was 0.028 渭 g / ml, the average recovery was 79.69 ~ 94.73 and the relative standard deviation between day and day was less than 15g / ml. The method met the requirements of biological sample analysis. Twenty-four healthy volunteers were randomly matched to each other according to their body weight to take lansoprazole tablets and lansoprazole tablets with an interval of 1 week and a dose of 30 mg. The concentration of lansoprazole in serum was determined by HPLC. The experimental results were as follows: t _ 1 / 22.166 鹵1.217 h ~ (-1) C _ (max1.644 鹵0.677) 渭 g 路ml ~ (-1) C _ (max) 2.688 鹵0.640 h AUC _ (0.15) h 5.977 鹵3.692 渭 g 路h ~ (-1) ml 路ml ~ (-1), t _ (1) / (21.771 鹵0.763) h ~ (max) 1.490 鹵0.569 渭 g 路ml ~ (-1) T _ (max3.292 鹵0.779 h). AUC 0-15 h 5.609 鹵3.015 渭 g / h 路ml. Taking lansoprazole tablets of Shantou Special Economic Zone as reference preparation, the relative bioavailability of Lansoprazole tablets of Jinan Liming Pharmaceutical Co., Ltd was estimated to be 105.46% 鹵33.03, which met the requirement of bioavailability. The results of ANOVA showed that there was no significant difference between the two preparations. The confidence intervals of the two preparations [1-2a] were 89.7-112.7%, 91.3% -115.1%, respectively, in the range of 80-125%. It shows that the two preparations have bioequivalence in the degree of absorption. There was no significant difference between the two preparations by ANOVA. The confidence interval of [1-2 偽] between the two preparations was within 70% -143%, which indicated that the two preparations had bioequivalence in the peak concentration.
【學(xué)位授予單位】：山東大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2014
【分類(lèi)號(hào)】：R969

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本文編號(hào)：2019441