本文選題：鹽酸左西替利嗪 + 咀嚼片��； 參考：《中國藥房》2015年28期

【摘要】：目的:制備鹽酸左西替利嗪咀嚼片,并考察片劑穩(wěn)定性。方法:采用濕法制粒制備鹽酸左西替利嗪咀嚼片。以45 min內(nèi)的累積溶出度為指標,以微晶纖維素內(nèi)-外加比例、羧甲淀粉鈉內(nèi)-外加比例及硬脂酸鎂的用量為因素,正交試驗優(yōu)化處方;驗證最優(yōu)處方所制片劑的溶出度和含量均勻度,考察其高溫(60℃)、強光(4 500 lx)、高濕(濕度92.5%)下10 d內(nèi)的外觀、溶出度、有關物質(zhì)和含量變化。結(jié)果:每片片劑的最優(yōu)處方為鹽酸左西替利嗪5 mg、乳糖30 mg、微晶纖維素90 mg(內(nèi)外加入量比例為4∶5)、甘露醇60 mg、阿斯巴甜10 mg、羧甲基淀粉鈉12 mg(內(nèi)外加入量比例為1∶1)、硬脂酸鎂1.0%。3批最優(yōu)處方所制片劑的累積溶出度分別為(97.23±1.21)%、(98.49±1.28)%、(98.15±1.94)%,含量均勻度分別為2.30、2.34、2.60,穩(wěn)定性考察除高溫下10 d、高濕下5 d時有關物質(zhì)略有升高外其他指標均無明顯變化。結(jié)論:成功制得鹽酸左西替利嗪咀嚼片,且穩(wěn)定性較好。
[Abstract]:Objective: to prepare levcetirizine hydrochloride chewable tablets and to investigate the stability of the tablets. Methods: levcetirizine hydrochloride chewable tablets were prepared by wet granulation. Taking the cumulative dissolution within 45 min as the index, the proportion of microcrystalline cellulose and the proportion of sodium carboxymethyl starch and the dosage of magnesium stearate as the factors, the prescription was optimized by orthogonal experiment. To verify the dissolution and content uniformity of the tablets prepared by the best prescription, the changes of appearance, dissolution, related substances and contents in 10 days under the conditions of high temperature (60 鈩，

本文編號：1785992