肠溶性药用辅料HPMCP的合成研究

STUDIES ON SYNTHESIS OF EXCIPIENT HPMCP

研究了肠溶性药用辅料 HPMCP 的合成工艺,投料比以50 cps HPMC:醋酸:醋酸钠:邻苯二甲酸酐为100:400:80:120为宜,于85℃反应3.5h,反应后应选择适当的沉淀剂(包括用量)、沉淀方式和搅拌速率。所得产物符合美国药典要求,主要理化性能与国外同类产品类似。

The synthesis of enteric coating material HPMCP was studied.Dried HPMC(50cps),acetic acid,sodium acetate,and phthalic anhydride(100:400.80:120 parts) were heated at 85℃ for 3.5h.The precipitant and its con-sumption,and the conditions of precipitation had been selected.The quality ofsynthesized HPMCP was in accord with USP requirements and similar to theproduct made in Japan.