| 引用本文: | 陆纪宏1，张小平2，李旭东1，宋旭莹1.氢溴酸加兰他敏口腔崩解片的研制[J].中国现代应用药学,2009,(8):648-650. |
| LU Jihong1, ZHANG Xiaoping2, LI Xudong1, SONG Xuying1.Preparation of Galantamine Hydrobromide Orally Disintegrating Tablets[J].Chin J Mod Appl Pharm(中国现代应用药学),2009,(8):648-650. |
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| 摘要: |
| 目的 探讨氢溴酸加兰他敏口腔崩解片的处方及制剂工艺。方法 通过考察处方中主要辅料不同种类对制剂崩解时限的影响，筛选出最优处方，并对筛选处方进行溶出度测定。结果 优选处方中崩解剂MCC-交联PVP的质量比为2∶3，填充剂为甘露醇。片剂在体内、体外的崩解时限均小于30 s，硬度达到30～50 N，溶出度可达100%。结论 氢溴酸加兰他敏口腔崩解片处方及制剂工艺简单，在口腔中崩解和溶出迅速，口感好，且达到了普通片剂的硬度。 |
| 关键词: 口腔崩解片 氢溴酸加兰他敏 |
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| Preparation of Galantamine Hydrobromide Orally Disintegrating Tablets |
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LU Jihong1, ZHANG Xiaoping2, LI Xudong1, SONG Xuying1
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| Abstract: |
| OBJECTIVE To investigate the composition and process of galantamine hydrobromide orally disintegrating tablets(ODT). METHODS Effect of primary excipients on in vitro disintegration time of galantamine hydrobromide ODT was studied, the optimal formulation was selected based on the disintegrate time and the dissolution test was carried out. RESULTS The final galantamine hydrobromide ODT comprised MCC and PVPP with aweight ratio of 2∶3 as disintegrate and mannitol as diluents. The disintegration time was less than 30 s and the hardness was 30-50 N. The dissolution study inicated that above 90% of galantamine hydrobromide was released in 10 min. CONCLUSION The galantamine hydrobromide ODT is easy prepared and meet all the criteria of ODT. The disintegration and dissolution in oral was rapid with acceptable taste. |
| Key words: orally disintegrating tablets galantamine hydrobromide |
