药学与临床研究
藥學與臨床研究
약학여림상연구
Pharmaceutical and Clinical Research
2015年
5期
462-464
,共3页
闫明%韦迎春%李雪峰%吴云%孙永成%萧伟
閆明%韋迎春%李雪峰%吳雲%孫永成%蕭偉
염명%위영춘%리설봉%오운%손영성%소위
双鱼薄膜衣片%片剂%成型工艺%辅料
雙魚薄膜衣片%片劑%成型工藝%輔料
쌍어박막의편%편제%성형공예%보료
Shuangyu film coating tablet%Tablet%Formation technology%Excipient
目的：研究制定双鱼薄膜衣片的工艺。方法：以压片前颗粒的性状、休止角、引湿性以及压片后片面光洁度、素片硬度、崩解时限作为指标，考察筛选适合的辅料及其比例，并取得稳定的成型工艺。结果：该片的工艺为：浸膏粉与淀粉比例为2∶1，以88%乙醇作为润湿剂进行湿法制粒，50℃干燥，整粒；加入1%硬脂酸镁、8%微晶纤维素混匀，压片；70%乙醇作为溶剂，配制浓度为10%的包衣液，包薄膜衣即得。结论：本成型工艺稳定，所制得的成品外观及相关检查符合《中国药典》2010年版的要求。
目的：研究製定雙魚薄膜衣片的工藝。方法：以壓片前顆粒的性狀、休止角、引濕性以及壓片後片麵光潔度、素片硬度、崩解時限作為指標，攷察篩選適閤的輔料及其比例，併取得穩定的成型工藝。結果：該片的工藝為：浸膏粉與澱粉比例為2∶1，以88%乙醇作為潤濕劑進行濕法製粒，50℃榦燥，整粒；加入1%硬脂痠鎂、8%微晶纖維素混勻，壓片；70%乙醇作為溶劑，配製濃度為10%的包衣液，包薄膜衣即得。結論：本成型工藝穩定，所製得的成品外觀及相關檢查符閤《中國藥典》2010年版的要求。
목적：연구제정쌍어박막의편적공예。방법：이압편전과립적성상、휴지각、인습성이급압편후편면광길도、소편경도、붕해시한작위지표，고찰사선괄합적보료급기비례，병취득은정적성형공예。결과：해편적공예위：침고분여정분비례위2∶1，이88%을순작위윤습제진행습법제립，50℃간조，정립；가입1%경지산미、8%미정섬유소혼균，압편；70%을순작위용제，배제농도위10%적포의액，포박막의즉득。결론：본성형공예은정，소제득적성품외관급상관검사부합《중국약전》2010년판적요구。
Objective: To establish the best preparation technology of Shuangyu tablets. Methods: The particle properties, angle of repose, hygroscopicity, tablet surface roughness, disintegration time and hardness were used as the index to optimize tablet formulations. Results: The best prescription was as follow: ratio of extract powder ∶ starch at 2∶1, 88% ethanol as wetting agent, wet-granulating, drying at 50℃ and then shaping; granules mixed with 1% magnesium stearate and 8% microcrystalline cellulose for compressing tablets; film coated with 10% coating solution dissolved in 70% ethanol. Shuangyu tablets were prepared successfully. Conclusion: This process was simple and each index was accorded with the quality request in the 2010 edition of Chinese Pharmacopoeia.
