中药分散片处方设计及优选试验.docVIP

中药分散片处方设计及优选试验[摘要] 目的：优选确定适合中药分散片生产需要的工艺处方。方法：以分散均匀性及脆碎度为评判指标，在初筛的基础上进行比较试验。结果：崩解剂L-HPC的成型性优于PVPPXL，PVPPXL的崩解性能优于L-HPC，联用效果优于单用；填充剂MCC效果优于乳糖和和淀粉；润湿剂95%乙醇的成型性好，颗粒得率高；硬度小于4.0 kg/cm2时，药片比较疏松，大于8.0 kg/cm2时，崩解时间明显延长。结论：在中药分散片的制备工艺中，崩解剂采用外加L-HPC，内加PVPPXL较好，填充剂选择MCC较佳，润湿剂以95%乙醇溶液为宜，药片硬度控制在6~7 kg/cm2比较理想。 [关键词] 中药分散片；处方设计；优选试验 [中图分类号]R283.6 [文献标识码]A [文章编号]1673-7210（2008）01（b）-044-03 The dispersible tablets formulation design of the traditional Chinese medicine and the optimization test WU Pei-yuan1, DUAN Yun2, ZHU Zu-chi3 (1.Department of Pharmacy of the People′s Hospital of Wuyuan,Jiangxi Province, Wuyuan333200,China;2.Department of Pharmacy of the People′s Hospital of Jiangxi Province, Nanchang 330006,China;3.Jiangxi Heshi Meikong Medicine Co.Ltd, Nanchang 330100,China) [Abstract] Objective: To select the technology and formulation suitable for the dispersible tablets of the traditional Chinese medicine. Methods: Judging by the dispersible homogeneity and friability, the comparative experiment was carried out based on the preliminary screening. Results: The forming property of L-HPC was better than PVPPXL; the disintegrating property of PVPPXL was better than L-HPC; the combination of two methods had a better effect than a single one. It was better to adopt MCC as fillers than lactose or starch. As for moistening agents, 95% alcohol could be more helpful to forming with a high grains yield. The hardness of the tablets controlled to 4.0 kg/cm2 was comparatively soft and loose, and to 8.0 kg/cm2 took a longer time to disintegrate. Conclusion: In preparing the dispersible tables of traditional Chinese medicine, it is better for disintegrants to adopt the method of mixing PVPPXL into the grains and adding L-HPC to the outside of the grains, for fillers to choose MCC, for moistening agents to be 95% alcohol solution and for the hardness of the tablets to be controlled to 6~7 kg/cm2. [Key words] Dispersible tablets of the traditional Chinese medicine;Formul