本文選題：吲哚美辛　切入點：乳膏　出處：《遼寧醫(yī)學院》2015年碩士論文　論文類型：學位論文

【摘要】：目的采用正交設計法優(yōu)化乳膏劑處方,制備吲哚美辛乳膏。建立吲哚美辛乳膏體外釋放度的測定方法�？疾熳灾七胚崦佬寥楦鄤┑馁|(zhì)量和穩(wěn)定性�？疾爝胚崦佬寥楦鄤┑逆�(zhèn)痛消炎作用及是否具有皮膚刺激性。方法以吐溫80、單硬脂酸甘油酯、液體石蠟、凡士林的用量為考察對象,以乳膏劑外觀性狀、離心試驗及耐熱耐寒試驗是否分層為指標,采用正交設計法優(yōu)化乳膏劑處方。以立式擴散池為實驗裝置、以小鼠腹部皮膚為滲透屏障、以20%乙醇-p H 7.4緩沖液為接受液,并采用HPLC法測定乳膏在釋放介質(zhì)中的累積滲透量。對自制乳膏劑的外觀性狀、p H、粒度以及均勻性進行檢查,對藥品含量進行測定,并考察樣品的穩(wěn)定性。以小鼠為實驗對象考察吲哚美辛乳膏的鎮(zhèn)痛消炎作用;以家兔為實驗對象,分別進行了單次及多次給藥的皮膚刺激性試驗。結(jié)果經(jīng)過單因素和正交設計試驗優(yōu)化得到的最佳處方是吐溫80 0.45 g,單硬脂酸甘油酯0.9 g,液體石蠟0.9 g,凡士林0.6 g,按照最優(yōu)處方制備3批吲哚美辛乳膏進行驗證,乳膏在6 000 r·min-1離心20 min,在55℃的恒溫箱中放置6 h,在-20℃的冰箱中放置24 h,結(jié)果3批乳膏的外觀無任何變化。將吲哚美辛乳膏的累積滲透量對時間進行線性回歸,回歸方程為Q=5.6436t+12.1370,r=0.9906,表明吲哚美辛乳膏的累積滲透量與時間呈良好的線性關系,乳膏具有良好的滲透性能。通過對乳膏劑的質(zhì)量及穩(wěn)定性考察,結(jié)果顯示乳膏劑的各項檢查指標均符合規(guī)定標準。通過小鼠對乳膏鎮(zhèn)痛抗炎作用的考察,證實乳膏有明顯的鎮(zhèn)痛消炎作用,通過家兔單次及多次給藥的皮膚刺激性試驗,試驗結(jié)果顯示吲哚美辛乳膏無皮膚刺激性。結(jié)論采用正交設計法優(yōu)選出了乳膏劑處方,成功的制備了吲哚美辛乳膏,色澤均勻、質(zhì)地細膩、便于涂布。吲哚美辛乳膏的累積滲透量與時間呈良好的線性關系且滲透性能良好,累積滲透量的測定方法簡單可靠。自制樣品的外觀性狀、p H、粒度、均勻性、藥品含量、穩(wěn)定性均符合規(guī)定標準。吲哚美辛乳膏具有很好的鎮(zhèn)痛消炎作用且無皮膚刺激性,達到了實驗預期的設計目的。
[Abstract]:Objective to optimize the formulation of cream by orthogonal design. To prepare indomethacin cream. To establish a method for determining the release rate of indomethacin cream in vitro. To investigate the quality and stability of indomethacin cream. To investigate the analgesic and anti-inflammatory effect of indomethacin cream and whether it has skin. Method Twain 80, glycerol monostearate, The dosage of liquid paraffin and vaseline was used as the object of investigation. Taking the appearance character of cream, the stratification of centrifugal test and heat tolerance test as indexes, the formulation of cream was optimized by orthogonal design method. The vertical diffusion pool was used as experimental device. The abdominal skin of mice was used as the permeation barrier, the 20% ethanol-pH 7.4 buffer solution was used as the receiving solution, and the cumulative permeation of the cream in the release medium was determined by HPLC method. The appearance, particle size and uniformity of the self-made cream were examined. The analgesic and anti-inflammatory effects of indomethacin cream on mice and rabbits were investigated. The skin irritation tests of single and multiple doses were carried out respectively. Results the optimum prescription was Tween 800.45 g, glycerol monostearate 0.9 g, paraffin 0.9 g, vaseline 0.6 g. Three batches of indomethacin cream were prepared according to the optimal prescription. The cream was centrifuged at 6 000 r 路min-1 for 20 min, placed in the incubator at 55 鈩，

本文編號：1618423