曲克芦丁口腔崩解片的研制及质量评价

Preparation and evaluation quality of troxerutin oral disintegrating tablets

目的制备曲克芦丁口腔崩解片并进行质量评价。方法以微晶纤维素、乳糖和甘露醇为主要辅料,通过正交试验优化处方,采用直接压片法制备口腔崩解片,并对其崩解时限、口感进行考察。结果制备1000片曲克芦丁口腔崩解片的最佳处方为曲克芦丁100g、微晶纤维素50g、乳糖10g、甘露醇15g、交联羧甲纤维素钠5g、甜菊素3g、枸橼酸0.5g、碳酸氢钠0.5g、硬脂酸镁1.0g。制得的口腔崩解片在30s内能完全崩解。结论制备的曲克芦丁口腔崩解片为快速崩解型片剂,制备工艺方法可行,符合用药要求。

Objective To prepare troxerutin oral disintegrating tablets and evaluate its quality.Methods Microcrystalline cellulose,lactose and mannitol were used as main adjuvants. The formulation was optimized with disintegration time as a reference parameter by an orthogonal design. And the oral disintegrating tablets were prepared by direct powder compressing method. The disintegration time and were assessed. Results The optimal excipients for 1000 tablets were composed of troxerutin 100 g,microcrystalline cellulose 50 g,lactose 10 g,mannitol 15 g,croscarmellose sodium 5 g,steviosin 3 g,citric acid 0. 5 g,Sodium hydrogen carbonate 0. 5 g and Mg stearate 1. 0 g. The tablets disintegrated completely within 30 s. Conclusion The oral disintegrating tablets can be used as industrial product and clinical preparation.