目的 比較冰片的加入方式以尋找制備復(fù)方丹參薄膜包衣片的最佳工藝。方法 考察冰片外加法和內(nèi)加法兩種復(fù)方丹參薄膜包衣片片芯制備工藝對(duì)粉體的物理性質(zhì)、片芯物理性質(zhì)、片劑外觀以及片劑中冰片的加速試驗(yàn)的影響。結(jié)果 兩種方法制備的樣品顆粒流動(dòng)性、片芯物理性狀無(wú)明顯差異。冰片外加法制備的片芯加速試驗(yàn)后表面含有較多的孔洞，不光滑，冰片下降較快，而采用冰片內(nèi)加法制備的片芯無(wú)明顯孔洞，外觀細(xì)膩，冰片揮發(fā)較慢。結(jié)論 冰片內(nèi)加法為制備復(fù)方丹參薄膜包衣片片芯的優(yōu)化方法。

Objective To compare adding method of borneol, and to optimize the preparative method for Compound Danshen Film Coated Tablets. Methods The physical properties of powder, physical properties of core, appearance of tablets, and borneol changes in accelerated stability test were studied by internal additive and external additive of borneol into non-coated tablet of Compound Danshen Film Coated Tablets. Results The difference of flow of particles and physical properties of core by two methods was not statistically significant. Non-coated tablets prepared by external additive of borneol after accelerated stability test had lots of holes in it, the surface was not smooth, and there was severe loss of borneol. On the contrary, non-coated tablets prepared by internal additive were better than above results. Conclusion The adding method of internal additive of borneol was the optimized method for preparation of non-coated tablet of Compound Danshen Film Coated Tablets..

國(guó)家“十二五”科技支撐計(jì)劃項(xiàng)目（2011BA107B01）；天津市科技計(jì)劃項(xiàng)目（13ZCZDSY00200）