| 摘要: |
| 目的 探讨氢溴酸东莨菪碱(scopolamine hydrobromide,SH)口崩片制备工艺,优化口崩片处方。方法 将湿法制粒与直接压片法进行比较,选择合适的制备方法；以硬度、崩解时间和溶出度为指标,采用正交设计综合评分法优化SH口崩片的处方和制备工艺,并进行优化后验证实验。结果 确定以湿法制粒法制备SH口崩片；优化处方为甘露醇 40%,微晶纤维素 35%,乳糖 0,羧甲基淀粉钠10%。以此处方制备SH口崩片的硬度为3.8 kg,崩解时间为54 s,溶出度T50在2.5 min以内。结论 该口崩片处方合理,质量可控。 |
| 关键词: 氢溴酸东莨菪碱 口崩片 剂型 正交试验 |
| DOI：10.3724/SP.J.1008.2010.0558 |
| 投稿时间：2009-12-24修订日期：2010-04-15 |
| 基金项目:国家科技重大专项课题(2009ZXJ09004-069). |
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| Preparation of orally disintegrating tablets of scopolamine hydrobromide |
| Lv Wei-ling, HU Jin-hong*, LIU Si-heng, LI Feng-qian, ZHU Quan-gang |
| (Department of Pharmacy, Changhai Hospital, Second Military Medical University, Shanghai 200433, China) |
| Abstract: |
| Objective To optimize the formula and the preparation technique of orally disintegrating tablets of scopolamine hydrobromide(SH).Methods The wet granule compressing method and the direct compressing method were compared to choose the suitable preparation method. The orthogonal design was used to optimize the formula of SH tablets while taking the hardness, disintegrating time and dissolution rate of the tablets as indices, and the optimization was verified. Results The wet granule compressing method was chosen for preparation. The optimized formula was composed of mannitol 40%,MCC 35%,lactose 0,and CMS-Na 10%. And the hardness, disintegrating time and T50 of the optimized tablets were 3.8 kg, 54 s, and 2.47 min, respectively. Conclusion The obtained formula and preparation technique for orally disintegrating tablets of SH is satisfactory; the quality of the prepared tablets can be well controlled． |
| Key words: scopolamine hydrobromide orally disintegrating tablets dosage forms orthogonal test |
