复方一把针口腔崩解片的研制

摘要

Objective To optimize the preparation technology of Compound Yibazhen Orally Disintegrating Tablets,and to evaluate its quality. Methods The orthogonal test was used to optimize Compound Yibazhen Orally Disintegrating Tablets. The tablet disintegration time and taste were evaluated to determine the optimal prescription. Direct powder tableting method was used. And in vitro disintegration time and dissolution was investigated as quality evaluation index. Results In vitro disintegration time of the optimal prescription was 34 s, the oral disintegration time was 32 s. Within 3 min,the in vitro dissolution was up to 85%. Conclusion Excellent Compound Yibazhen Orally Disintegrating Tablets can be prepared successfully using this method.%目的：优选复方一把针口腔崩解片的制备工艺，并评价其质量。方法以片剂崩解时限为指标，采用正交试验筛选复方一把针口腔崩解片的处方，结合口感，确定最优工艺。通过粉末直接压片法制备片剂并测定其主药含量、体内外崩解时限及溶出度等质量评价指标。结果优选处方的体外崩解时限为34 s，口腔崩解时间为32 s，3 min各成分的体外平均溶出度均可达85%以上。结论该工艺可制备质量优良的复方一把针口腔崩解片。