| 第 54 卷第 1 期 |  | Vol. 54 No. 1 | | 2024 年 2 月 | Feb 2024 |
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所属栏目：医药及中间体
盐酸苯海拉明微丸型口腔崩解片的制备工艺研究 |
| 张 毅，王会盈
（陕西步长高新制药有限公司，陕西 西安 710119） |
| 摘 要：采用挤出滚圆及包衣制备缓释微丸，湿法制粒法制备辅料颗粒，将缓释微丸、辅料颗粒及外加物料混合压片制备了盐酸苯海拉明口腔崩解片。结果表明：盐酸苯海拉明与微晶纤维素以质量比1∶1混合后挤出滚圆，并采用乙基纤维素乙醇溶液包衣制备缓释微丸，然后再与其他辅料混合压片制备口腔崩解片，其溶出曲线与原研制剂不同介质中体外溶出相似。采用缓释微丸压片的方法制备口腔崩解片可以减缓药物溶出速度，达到与原研制剂不同介质中溶出曲线相似目的，该技术可为其他溶出类似口腔崩解片的研究开发提供参考。 |
| 关键词：盐酸苯海拉明；微丸压片；口腔崩解片；溶出曲线 |
| 中图分类号：R943 文献标识码：A 文章编号：1009-9212（2024）01-0030-07 |
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| Preparation Process of Diphenhydramine Hydrochloride Pellet Orally Disintegrating Tablets |
| ZHANG Yi，WANG Hui-ying
(Shaanxi Buchang High-tech Pharmaceutical Co., Ltd., Xi’an 710119, China) |
| Abstract：Diphenhydramine hydrochloride orally disintegrating tablets were successfully developed by a method including extruding and coating the sustained-release pellets and the preparation of excipients by wet granulation. The results showed that diphenhydramine hydrochloride and microcrystalline cellulose were mixed at a mass ratio of 1:1, extruded and rolled, coated with ethyl cellulose ethanol solution to prepare slow-release pellets, and then mixed with other excipients, the dissolution curve of oral disintegrating tablets was similar to that of the original preparation agent in different media. The preparation of oral disintegrating tablets by the method of sustained-release pellet pressing can properly slow down the dissolution rate of drugs and achieve the purpose of similar dissolution curve with the different media of the original preparation agent. The technology can provide a reference for the research and development of other oral disintegrating tablets with similar dissolution varieties. |
| Key words：diphenhydramine hydrochloride; pellet tableting; orally disintegrating tablets; dissolution curve |
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作者简介：张 毅（1985—），男，陕西商洛人，工程师，执业药师，研究方向：药品口服固体制剂的工艺及质量研究（E-mail:328384232@qq.com）。
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收稿日期：2023-11-21
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