中药分散片的处方设计与优选试验

The dispersible tablets formulation design of the traditional Chinese medicine and the optimization test

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4.0kg／cm^2时，药片比较疏松，大于8.0kg／cm^2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PVPP巍较好，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6-7kg／cm^2比较理想。

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/cm^2 was comparatively soft and loose, and to 8.0 kg/cm^2 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/cm^2.