羟丙基甲基纤维素偏苯三甲酸酯的性能研究

Properties Study on Hydroxypropyl Methylcellulose Trimellitate

合成了肠溶性药物辅料羟丙基甲基纤维素偏苯三甲酸酯（HPMCT）.采用红外光谱、紫外分光光度法和高效液相色谱法等进行了表征,测试了HPMCT在有机溶剂中的溶解特性、pH敏感性及在pH=6.86缓冲溶液中的溶解性能,并对HPMCT的包衣过程、包衣片的释放度等性能进行了研究.结果表明,乙醇/二氯甲烷、丙酮/乙醇/水、丙酮/乙醇、乙醇/水等都是HPMCT的良溶剂,并且在溶解过程初期不发生团聚.用悬浮包衣法制作包衣,不需要增塑剂,即可制成致密、光滑、有金属光泽的包衣膜,具有较好的包衣工艺性能;根据酯化率不同,所制备得到的HPMCTpH敏感值范围为3.8~4.0,包衣片在胃液的pH环境中不发生崩解,在pH=6.86的缓冲溶液中20 min内释放度达到92.60%,符合作为肠溶包衣材料的要求.

Synthesized a novel kind of enteric-coating material-HPMCT.Its structure and application properties such as dissolving ability in different organic solvent,pH sensibility,coating technical properties and dissolution rate in buffer solution（pH=6.86）were analyzed by IR and UV.The results indicated that ethanol/methylene chloride,acetone/ethanol/water,acetone/ethanol and ethanol /water were all good solvent systems for the HPMCT;the pH sensibility value range of the HPMCT is 3.8～4.0,the HPMCT can dissolve rapidly in buffer solution（pH=6.86）,achieving tight,smooth and having metallic brightness coating without plasticizer.Dissolution rate of the coated tablet in buffer solution（pH=6.86） in 20 minutes were 92.60%,which meet the necessity of enteric coating material.