本文選題：環(huán)孢素　切入點：微乳　出處：《中國醫(yī)院藥學(xué)雜志》2017年14期 　論文類型：期刊論文

【摘要】：目的:制備0.05%環(huán)孢素滴眼液(微乳型),建立其質(zhì)量控制方法,并考察其穩(wěn)定性。方法:采用高效液相色譜法對其進(jìn)行含量及有關(guān)物質(zhì)的檢測,并依據(jù)《中國藥典》制劑穩(wěn)定性指導(dǎo)原則的要求,將其分別置于高溫、高濕、光照條件下進(jìn)行影響因素試驗,在(25±2)℃,濕度(60%±10%)Rh的條件下進(jìn)行加速實驗,在(6±2)℃的條件下進(jìn)行長期實驗,考察其穩(wěn)定性。結(jié)果:0.05%環(huán)孢素滴眼液(微乳型)在100.28~350.98μg·mL-1濃度范圍內(nèi)呈良好的線性關(guān)系,回歸方程為A=19 749.21C+76 828.91,r=0.999 9。環(huán)孢素日內(nèi)和日間精密度RSD為0.45%和1.07%(n=6)。3批樣品中環(huán)孢素標(biāo)示量均在90%~110%的范圍之內(nèi),有關(guān)物質(zhì)小于1.5%,符合相關(guān)規(guī)定。在各項穩(wěn)定性試驗觀察中,其各項指標(biāo)與0月同批樣品結(jié)果進(jìn)行比較,均無明顯變化。結(jié)論:該方法穩(wěn)定,重復(fù)性好,可作為0.05%環(huán)孢素滴眼液(微乳型)的含量及有關(guān)物質(zhì)的檢測方法。穩(wěn)定性檢測結(jié)果符合要求。
[Abstract]:Objective: to prepare 0.05% cyclosporine eye drops (microemulsion), to establish its quality control method and to investigate its stability. Methods: the content and related substances of 0.05% cyclosporine eye drops were determined by HPLC. According to the requirements of the guidelines for the stability of Chinese Pharmacopoeia, the influence factors were tested under the conditions of high temperature, high humidity and light, and accelerated experiments were carried out under the conditions of 25 鹵2 鈩，

本文編號：1580894