摘要
对抗抑郁症胶囊进行了成型工艺研究和质量考察。将处方药材提取、浓缩制成浸膏,浸膏减压浓缩、干燥,添加淀粉、二氧化硅和磷酸氢钙制成颗粒,对颗粒的吸湿性、流动性进行考察,筛选出最优处方;将制得的颗粒填充入0号胶囊壳,检测胶囊的体外溶出度、水分含量和装量差异。结果表明:淀粉加入量为干膏量的14.43%时,干膏成颗粒状,没有黏结现象;m(磷酸氢钙)∶m(二氧化硅)∶m(颗粒)=0.6∶0.4∶4.0时,药物颗粒吸湿率最低,颗粒休止角为14.06°。制得的胶囊装量差异不超出-7.5%～7.5%的范围,含水率为1.24%,均符合药典标准;溶出45 min后,溶出度在80%以上。优选的处方工艺合理,制得的胶囊剂质量符合药典标准。
The paper studied on the molding process and quality of anti-depression capsule. The prescription crude drugs of traditional Chinese medicine were extracted and concentrated to obtain the extract, and then the extract was concentrated under reduced pressure and dried. Starch, silica and calcium hydrogen phosphate were added to the dry extract to make granules, whose hygroscopicity and liquidity were studied to select the optimal formulation. The prepared granules were filled into 0~#capsule shell, and the dissolution, moisture content and loading of capsules were detected.When the amount of starch was 14.43% of the dry extract, the dry extract was granular, and there was no adhesion. When the mass ratio of calcium hydrogen phosphate, silica and drug granules was 0.6 ︰0.4︰4.0, the granules had the lowest rate of moisture absorption with the repose angle of 14.06 degrees. The load differences of the capsules were less than7.5%, the moisture content was 1.24%, and the dissolution rate was above 80% after 45 minutes of dissolution, indicating that the capsules quality was in accordance with the Chinses Pharmacopoeia, and the optimized formulation was reasonable.
作者
毛淑芳
陈芳
田蓓
许腊英
MAO Shufang;CHEN Fang;TIAN Bei;XU Laying
出处
《上海化工》
CAS
2019年第4期16-19,共4页
Shanghai Chemical Industry
基金
武汉华夏理工学院科研基金项目(11025)
关键词
抗抑郁症胶囊
成型工艺
溶出度
Anti-depression capsule
Molding process
Dissolution rate
