尤特奇L30D-55在肠溶制剂中的工艺研究
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摘要
目的对尤特奇L30D-55理化性质进行测定,对其在肠溶制剂上的应用提供合理的依据。方法采用差示热扫描测定其玻璃化温度(Tg),考察增塑剂对玻璃化温度及最低成膜温度的影响。以双氯芬酸钠作为药物模型,通过体外释放实验考察尤特奇L30D-55肠溶制剂的性能。结果 L30D-55在应用时其Tg、最低成膜温度的变化是主要监测点,并可以通过增塑剂的加入调整二者的变化。其水分散体和有机溶剂包衣成膜原理不同。在生产中片床温度、固含量设定及配制包衣时的设备参数设定不当均会导致包衣质量不合格。结论通过对尤特奇L30D-55物理性质的测定,为肠溶制剂制备中各项参数的设定提供依据。
OBJECTIVE To determine the physicochemical properties of Eugradit L30 D-55 and provide a reasonable basis for its application in enteric agents.METHODS The glass transition temperature was measured by differential scanning and the effect of plasticizer on the glass transition temperature and minimum film formation temperature was investigated.To investigate the characteristics of Eugradit L30 D-55 enteric-coated formulations,a vitro release test was design while diclofenac sodium as a drug model.RESULTS The L30 D-55 was the main monitoring point for its Tg and minimum film formation temperature when applied,and the change of both could be adjusted by the addition of plasticizer.Its aqueous dispersion and organic solvent coating film of its different principles.In the production of bed temperature,the solid content setting and configuration of the equipment parameters are not properly set the coating quality will lead to unqualified.CONCLUSION The determination of the physical properties of Eugradit L30 D-55 provides a basis for the setting of various parameters in the preparation of enteric agents.
OBJECTIVE To determine the physicochemical properties of Eugradit L30 D-55 and provide a reasonable basis for its application in enteric agents.METHODS The glass transition temperature was measured by differential scanning and the effect of plasticizer on the glass transition temperature and minimum film formation temperature was investigated.To investigate the characteristics of Eugradit L30 D-55 enteric-coated formulations,a vitro release test was design while diclofenac sodium as a drug model.RESULTS The L30 D-55 was the main monitoring point for its Tg and minimum film formation temperature when applied,and the change of both could be adjusted by the addition of plasticizer.Its aqueous dispersion and organic solvent coating film of its different principles.In the production of bed temperature,the solid content setting and configuration of the equipment parameters are not properly set the coating quality will lead to unqualified.CONCLUSION The determination of the physical properties of Eugradit L30 D-55 provides a basis for the setting of various parameters in the preparation of enteric agents.
引文
[1]汉斯乌利奇·彼得厄特,Hans-Ulrich Petereit.尤特奇(聚甲基丙烯酸酯)应用技术指南[M].化学工业出版社,2009.
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[6]王洁敏,王雄飞,王娇,等.尤特奇在纳米制剂中的应用进展[J].中国新药杂志,2016,(14):1613-1616.
[7]李扬,李金,陶涛.尤特奇在口服固体制剂中的应用[J].中国医药工业杂志,2016,47(5):629-636.
[2]韩敏,李海杰,胡富强,等.混合水分散体肠溶迟释薄膜性能研究[J].中国现代应用药学,2014,31(12):1487-1492.
[3]Longet S,Aversa V,O′Donnell D,et al.Thermostability of the coating,antigen and immunostimulator in an adjuvanted oral capsule vaccine formulation[J].Int J Pharm,2017,534(1-2):60-70.
[4]Rujivipat S,Bodmeier R.Moisture plasticization for enteric Eudragit L30D-55-coated pellets prior to compression into tablets[J].European Journal of Pharmaceutics & Biopharmaceutics Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E V,2012,81(1):223.
[5]Kucera S,Shah N H,Malick A W,et al.Influence of an Acrylic Polymer Blend on the Physical Stability of Film-Coated Theophylline Pellets[J].Aaps Pharmscitech,2009,10(3):864.
[6]王洁敏,王雄飞,王娇,等.尤特奇在纳米制剂中的应用进展[J].中国新药杂志,2016,(14):1613-1616.
[7]李扬,李金,陶涛.尤特奇在口服固体制剂中的应用[J].中国医药工业杂志,2016,47(5):629-636.