| 第 54 卷第 1 期 |  | Vol. 54 No. 1 | | 2024 年 2 月 | Feb 2024 |
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所屬欄目：醫藥及中間體
鹽酸苯海拉明微丸型口腔崩解片的制備工藝研究 |
| 張 毅，王會(huì )盈
（陜西步長(cháng)高新制藥有限公司，陜西 西安 710119） |
| 摘 要：采用擠出滾圓及包衣制備緩釋微丸，濕法制粒法制備輔料顆粒，將緩釋微丸、輔料顆粒及外加物料混合壓片制備了鹽酸苯海拉明口腔崩解片。結果表明：鹽酸苯海拉明與微晶纖維素以質(zhì)量比1∶1混合后擠出滾圓，并采用乙基纖維素乙醇溶液包衣制備緩釋微丸，然后再與其他輔料混合壓片制備口腔崩解片，其溶出曲線(xiàn)與原研制劑不同介質(zhì)中體外溶出相似。采用緩釋微丸壓片的方法制備口腔崩解片可以減緩藥物溶出速度，達到與原研制劑不同介質(zhì)中溶出曲線(xiàn)相似目的，該技術(shù)可為其他溶出類(lèi)似口腔崩解片的研究開(kāi)發(fā)提供參考。 |
| 關(guān)鍵詞：鹽酸苯海拉明；微丸壓片；口腔崩解片；溶出曲線(xiàn) |
| 中圖分類(lèi)號：R943 文獻標識碼：A 文章編號：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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作者簡(jiǎn)介：張 毅（1985—），男，陜西商洛人，工程師，執業(yè)藥師，研究方向：藥品口服固體制劑的工藝及質(zhì)量研究（E-mail:328384232@qq.com）。
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收稿日期：2023-11-21
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