天麻素口腔崩解片的制备和质量控制  

Preparation and Quality Control of Gastrodin Orally Disintegrating Tablets

作　　者：邹萍[1,2] 齐同珍 刘辉[1] 张婧[1,2] 吴迪[1,2] 

机构地区：[1]中国人民解放军广州军区武汉总医院药剂科,湖北武汉430070 [2]湖北中医药大学药学院,湖北武汉430065 [3]湖北省荆州市第三人民医院,湖北荆州434001

出　　处：《中国药业》2013年第23期39-41,共3页China Pharmaceuticals

摘　　要：目的制备天麻素口腔崩解片并建立其质量控制方法。方法以口感为评价指标,采用单因素法优选矫味剂;在预试验基础上,以崩解时限为指标,设计正交试验筛选天麻素口腔崩解片最优处方;采用粉末直接压片法制备天麻素口腔崩解片。结果优化处方制得的天麻素口腔崩解片口感良好,30 s内崩解完全,2 min溶出达98.0%,各项指标符合药典规定。结论天麻素口腔崩解片处方合理,制备工艺简单,适合工业生产。Objective To prepare Gastrodin Oral Disintegrating Tablets and to establish its quality control method. Methods With taste as the evaluation index, the single factor method was used to optimize the flavoring agent; on the basis of preliminary experiment, the orthogonal experiment was designed to optimize the prescription with the disintegration time as the evaluation index; Gastrodine Oral Disintegrating Tablets was prepared by the direct compression method. Results The prepared Gastrodine Oral Disintegrating Tablets by using the optimization prescription tasted good and could disintegrate within 30s. The dissolution amounts reached to 98.0% within 2min. Various indexes of the preparation accorded with the requirement of the pharmacopoeia. Conclusion The prescription of Gastrodine Oral Disintegrating Tablets is reasonable. Its preparation process is simple and suitable for the industrial production.

关 键 词：天麻素 口腔崩解片 崩解时限 

分 类 号：TQ461[化学工程—制药化工] R282.71[医药卫生—中药学]