本文關(guān)鍵詞： 復(fù)方維A酸乳膏 穩(wěn)定性 有效期 HPLC　出處：《中國新藥雜志》2015年02期 　論文類型：期刊論文

【摘要】：目的:研究復(fù)方維A酸乳膏的化學(xué)穩(wěn)定性并預(yù)測其有效期。方法:HPLC法同時測定復(fù)方維A酸乳膏中3組分(維A酸,尿囊素和維生素E)的含量及異構(gòu)化產(chǎn)物異維A酸。對高濕、光照和熱穩(wěn)定性進(jìn)行考察;從4個不同溫度避光條件下不同時間測得的含量,求出各溫度的反應(yīng)速率常數(shù);按Arrhenius方程求出25℃下的t0.9,從而預(yù)測其有效期。結(jié)果:該復(fù)方乳膏高濕條件下穩(wěn)定,當(dāng)其常溫條件下暴露于4 500 Lx照度下光照5和10 d,其中維A酸含量分別下降至85%和70%左右,同時測得異維A酸含量相應(yīng)上升。其他2種成分含量未見明顯下降,單方維A酸乳膏在此條件下,降解顯著。3種成分的受熱降解符合一級動力學(xué)。該復(fù)方乳膏25℃避光條件下維A酸、維生素E和尿囊素的t0.9分別為370,476,482 d,單方維A酸的t0.9僅為253 d。根據(jù)加速試驗預(yù)測40℃下放置1個月的降解與實測值吻合。正常條件下存放亦與預(yù)測相符。結(jié)論:3種成分中維A酸最不穩(wěn)定,易見光異構(gòu)化,對熱則相對穩(wěn)定;組成復(fù)方制劑后,維A酸化學(xué)穩(wěn)定性較其單方大有提高,該復(fù)方乳膏的有效期在1年左右,應(yīng)避光保存。
[Abstract]:Objective: to study the chemical stability of compound retinoic acid cream and to predict its validity period. Methods: the contents of three components (retinoic acid, allantoin and vitamin E) and isomerization product isoretinoic acid in compound retinoic acid cream were determined by HPLC. The light and thermal stability were investigated, and the reaction rate constants were obtained from the contents measured at four different temperatures and at different times. According to the Arrhenius equation, the t0.9 at 25 鈩，

本文編號：1529865