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庹玲玲,董科,卢威,段张慧,黄小平,邹龙.芪七醒脑片制备工艺的优化[J].湖南中医药大学学报英文版,2023,43(3):450-456.[Click to copy
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| 芪七醒脑片制备工艺的优化 |
| 庹玲玲,董科,卢威,段张慧,黄小平,邹龙 |
| (湖南中医药大学, 湖南 长沙 410208) |
| 摘要: |
| 目的 优化芪七醒脑片制备工艺。方法 以冰片∶黄芪总苷∶三七总皂苷（7.5∶10∶25）为药粉原料，在单因素实验基础上，以颗粒收率、粒度分布、颗粒休止角、硬度、崩解时限的综合评分为评价指标，采用熵权法结合正交试验优化制备工艺。结果 设计片重0.4 g/片，药粉提取物与糊精∶乳糖（3∶1）混合，采用内加法加入崩解剂CMS-Na（用量5%），黏合剂含0.5% PVP的80%乙醇(用量23%)制备软材，挤压过16目筛，将湿颗粒置于80 ℃ 烘箱中，干燥60 min，整粒，加入硬脂酸镁（用量0.3%）混合均匀，压片。颗粒吸湿性高于片剂，临界相对湿度约70%。结论 该方法稳定可靠，所制的片剂外观完整光洁，硬度、崩解时限等指标良好，为规模化生产提供理论基础。 |
| 关键词: 芪七醒脑片 片剂 制备工艺 熵权法 正交试验 临界相对湿度 |
| DOI：10.3969/j.issn.1674-070X.2023.03.013 |
| Received:December 18, 2022 |
| 基金项目:国家自然科学基金项目（81573875）；湖南省自然科学基金面上项目（2022JJ30432）；湖南省中医药管理局重点项目（E2022001）；湖南省教育厅重点项目（19A381）。 |
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| Optimization of preparation technology of Qiqi Xingnao Tablet |
| TUO Lingling,DONG Ke,LU Wei,DUAN Zhanghui,HUANG Xiaoping,ZOU Long |
| (Hunan University of Chinese Medicine, Changsha, Hunan 410208, China) |
| Abstract: |
| Objective To optimize the preparation technology of Qiqi Xingnao Tablet. Methods With borneol, total astragaloside and total saponins of panax notoginseng (7.5∶10∶25) as powder material, the preparation technology was optimized by employing entropy weight method combined with orthogonal experiment on the basis of single factor experiment. The comprehensive score of particle yield, particle size distribution, particle restate angle, particle hardness and disintegration time were the evaluation index. Results The tablet weight was set as 0.4 g/tablet; powder extract was firstly mixed with dextrin-lactose (3∶1) mixture; then disintegrator CMS-NA (5%) was involved by internal addition method; 0.5% PVP 80% ethanol (23%) was set as the adhesive to prepare soft material. The preparation was then extruded through a 16-mesh screen; the obtained wet particles were put in an oven at 80 ℃, dried for 60 min; in turn, whole grains were added with magnesium stearate (0.3%) evenly, and were finally pressed as tablets. The hygroscopicity of granule was higher than that of tablet, and the critical relative humidity was about 70%. Conclusion The method is stable and reliable, and the prepared tablets show good appearance and indicators including hardness, disintegration time, which provides a theoretical basis for large-scale production. |
| Key words: Qiqi Xingnao Tablet tablet preparation technology entropy weight method orthogonal experiment critical relative humidity |
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