琥珀酸呋罗曲坦薄膜衣片的制备及体外溶出行为考察
x
请在关注微信后,向客服人员索取文件
篇名: | 琥珀酸呋罗曲坦薄膜衣片的制备及体外溶出行为考察 |
TITLE: | |
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pH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 Frovatriptan succinate film-coated tablet, and investigate its in vitro dissolution behavior. METHODS: Using lactose monohydrate, microcrystalline cellulose, dioxide, silica, sodium carboxymethyl starch and magnesium stearate as accessories, Frovatriptan succinate tablet was prepared. Using opadry premix spray-coating liquid, Frovatriptan succinate film-coated tablet was prepared. Single factor test was used, using moisture, angle of repose, rigidity, friability, disintegration time and dissolution rate as indexes, to screen the formulation; using dissolution degree as index, coating material dosage was screened. The dissolution curves in vitro of self-made tablets and imported tablets in water, 0.1 mol/L HCL, pH of 5.5, 6.8 phosphate buffer solutions were compared. RESULTS: The optimal formulation of Frovatriptan succinate uncoated tablet was as follow as frovatriptan 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; optimal coating weighed quality was 2.0%-4.0%. In the 4 mediums, the dissolution behavior of self-made tablets and imported tablets were similar. CONCLUSIONS: Frovatriptan succinate film-coated tablet is prepared successfully, and its in vitro dissolution behavior is similar to the imported preparations. |
期刊: | 2017年第28卷第19期 |
作者: | 刘晓霞,王明刚,陈阳生,孙桂玉,臧云龙 |
AUTHORS: | LIU Xiaoxia,WANG Minggang,CHEN Yangsheng,SUN Guiyu,ZANG Yunlong |
关键字: | 琥珀酸呋罗曲坦;薄膜衣片;单因素试验;喷雾包衣;体外溶出行为 |
KEYWORDS: | Frovatriptan succinate; Film-coated tablet; Single factor test; Spray coating; in vitro dissolution behavior |
阅读数: | 603 次 |
本月下载数: | 16 次 |
* 注:未经本站明确许可,任何网站不得非法盗链资源下载连接及抄袭本站原创内容资源!在此感谢您的支持与合作!