| 盐酸苯海拉明咖啡因口崩片的研究 |
| 投稿时间：2021-08-18 修订日期：2021-11-30 点此下载全文 |
| 引用本文：樊莉,曾媛,谢向阳,刘辉,熊菁,张莹,原源.盐酸苯海拉明咖啡因口崩片的研究[J].药学实践杂志,2023,41(1):45~49 |
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| 中文摘要:目的 以盐酸苯海拉明和咖啡因为模型药物，研制盐酸苯海拉明咖啡因口腔崩解片。方法 采用盐酸苯海拉明与硬脂酸熔融制粒掩味，交联羧甲基纤维素钠（CCMC-Na）为崩解剂，用干粉直接压片法制备盐酸苯海拉明咖啡因口腔崩解片。采用正交实验优化处方，达到最短崩解时间和最佳矫味效果。结果 最优处方中含主药盐酸苯海拉明25 mg、咖啡因60 mg、硬脂酸25 mg、阿司帕坦40 mg、蓝莓香精7 mg、甘露醇45 mg、MCC 210 mg、CCMC-Na 25 mg、SDS 8 mg、硬脂酸镁5 mg。结论 盐酸苯海拉明咖啡因口腔崩解片制剂可行，质量可控。 |
| 中文关键词:口腔崩解片 盐酸苯海拉明 咖啡因 |
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| Studies on orally disintegrating tablet of diphenhydramine hydrochloride and caffeine |
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| Abstract:Objective To optimize the formulation and preparation of diphenhydramine hydrochloride and caffeine orally disintegrating tablet. Methods Melt granulation technology of steric acid and API was used to mask the unpleasant tasting of diphenhydramine hydrochloride. The tablets were prepared by direct pressing the dry powder with CCMC-Na as disintegrating agent. The formulation was optimized by orthogonal experiments to achieve the shortest disintegration time and the best taste correction. Results The optimized formula of orally disintegrating tablet was as follows： diphenhydramine hydrochloride 25 mg, caffeine 60 mg, stearic acid 25 mg, aspatan 40 mg, blueberry essence 7 mg, mannitol 45 mg, MCC 210 mg, CCMC-NA 25 mg, SDS 8 mg and magnesium stearate 5 mg.Conclusion This preparation method for orally disintegrating tablet of diphenhydramine hydrochloride and caffeine is practical and easy for quality control. |
| keywords:orally disintegrating tablet diphenhydramine hydrochloride caffeine |
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