[关键词]
[摘要]
目的 比较冰片的加入方式以寻找制备复方丹参薄膜包衣片的最佳工艺。方法 考察冰片外加法和内加法两种复方丹参薄膜包衣片片芯制备工艺对粉体的物理性质、片芯物理性质、片剂外观以及片剂中冰片的加速试验的影响。结果 两种方法制备的样品颗粒流动性、片芯物理性状无明显差异。冰片外加法制备的片芯加速试验后表面含有较多的孔洞,不光滑,冰片下降较快,而采用冰片内加法制备的片芯无明显孔洞,外观细腻,冰片挥发较慢。结论 冰片内加法为制备复方丹参薄膜包衣片片芯的优化方法。
[Key word]
[Abstract]
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..
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[基金项目]
国家“十二五”科技支撑计划项目(2011BA107B01);天津市科技计划项目(13ZCZDSY00200)