石杉碱甲口腔崩解片的制备及溶出度考察

Preparation and dissolution of orally disintegrating tablets of huperzine A

目的：制备石杉碱甲口腔崩解片．并考察其体外溶出度。方法：采用直接粉末压片法制备石杉碱甲口腔崩解片，正交设计法优化处方和工艺．小杯法考察溶出度．HPLC法测定含量。结果：交联聚维酮和微晶纤维素的用量分别为10％和20％，片剂的硬度为3．5～4．0kg／mm^2，石杉碱甲口腔崩解片口感良好．崩解时间〈30S，2min内溶出百分率〉90％。结论：石杉碱甲口腔崩解片崩解时间短．溶出速率明显快于市售普通片。

Objective： To prepare orally disintegrating tablets of huperzine A and evaluate their dissolution features. Methods：Orally disintegrating tablets of huperzine A was prepared by direct powder compressing method. The orthogonal design was used to optimize the formulation and processing technology. The dissolution of huperzine A was measured by the small glass cup method and the content of huperzine A was determined by HPLC method. Results： The quantities of crospovidone and microcrystalline cellulose used were 10% and 20%, respectively. The hardness of the tablets was in the range of 3.5- 4.0 kg/mm^2. The disintegration time of the tablets, which tasted fine, was less than 30 seconds and their cumulative dissolution rate was higher than 90% within 2 minutes. Conclusion： The disintegration time of orally disintegrating tablets of huperzine A is short, and their dissolution is significantly faster than that of ordinary tablets.