【摘要】：目的:考察硫酸嗎啡口腔崩解片制劑的穩(wěn)定性,確定其貯藏條件和有效期。方法:以性狀、崩解時(shí)限、主藥含量和有關(guān)物質(zhì)為考察指標(biāo),根據(jù)《中國藥典》相關(guān)方法要求對硫酸嗎啡口腔崩解片模擬上市包裝樣品進(jìn)行影響因素試驗(yàn)(強(qiáng)光4500 lx,高溫60℃,25℃、相對濕度75%,10 d)、加速試驗(yàn)(40℃、相對濕度75%、6個月)及長期試驗(yàn)(24個月)。結(jié)果:3種試驗(yàn)中,各指標(biāo)與0天(0月)比較未見明顯變化;本品對光、熱、濕均較穩(wěn)定,但有一定吸濕性。結(jié)論:建議硫酸嗎啡口腔崩解片于陰涼處密閉保存,保質(zhì)期為2年。
[Abstract]:Objective: to investigate the stability of morphine sulfate orally disintegrating tablets and determine the storage conditions and validity period. Methods: the characters, disintegration time, main drug content and related substances were used as indexes. According to the requirements of the Chinese Pharmacopoeia, the influence factors of morphine sulfate oral disintegrating tablets on the simulated market packaging samples were tested (high light 4500 LX, high temperature 60 鈩，

本文編號：2173246