琥珀酸呋罗曲坦薄膜衣片的制备及体外溶出行为考察

发布时间：2018-03-30 21:04

本文选题：琥珀酸呋罗曲坦　切入点：薄膜衣片　出处：《中国药房》2017年19期

【摘要】：目的:制备琥珀酸呋罗曲坦薄膜衣片,并考察其体外溶出行为。方法:以一水乳糖、微晶纤维素、二氧化硅、羧甲淀粉钠和硬脂酸镁为辅料制备琥珀酸呋罗曲坦素片,以欧巴代预混包衣液喷雾包衣制备琥珀酸呋罗曲坦薄膜衣片。采用单因素试验,以水分、休止角、硬度、脆碎度、崩解时限和溶出度为指标筛选素片处方,以溶出度为指标筛选包衣材料用量。比较自制片剂与进口片剂在水、0.1 mol/L HCl和p H为5.5、6.8的磷酸盐缓冲液中的体外溶出曲线。结果:素片最优处方为琥珀酸呋罗曲坦3.91 mg、一水乳糖99.18 mg、微晶纤维素33.06 mg、硬脂酸镁1.40 mg、羧甲淀粉钠1.05 mg、二氧化硅1.40 mg;最优包衣增质量在2.0%~4.0%范围内。在4种介质中,自制片剂与进口片剂溶出行为均相似。结论:成功制得琥珀酸呋罗曲坦薄膜衣片,其体外溶出行为与进口制剂相似。
[Abstract]:Objective: to prepare furotritam succinate film and to investigate its dissolution behavior in vitro.Methods: furtrotam succinate tablets were prepared from lactose monohydrate, microcrystalline cellulose, silica, sodium carboxymethyl starch and magnesium stearate.Single factor test was used to select the prescription of the coated material with the indexes of moisture, angle of repose, hardness, brittle degree, disintegration time and dissolution degree, and the dissolution rate was used as the index to screen the coating material dosage.The dissolution curves of the tablets in vitro were compared with those of imported tablets in aqueous solution containing 0.1 mol/L HCl and 5.5N 6.8 pH.Results: the optimum formulation of furotretan succinate 3.91 mg, lactose monohydrate 99.18 mg, microcrystalline cellulose 33.06 mg, magnesium stearate 1.40 mg, sodium carboxymethyl starch 1.05 mg, silica 1.40 mg, the optimal coating quality within 2.0%.In the four kinds of media, the dissolution behavior of self-made tablets and imported tablets were similar.Conclusion: furotritam succinate film was successfully prepared and its dissolution behavior in vitro was similar to that of imported preparations.
【作者单位】：青岛正大海尔制药有限公司;
【分类号】：R943

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