一种孟鲁斯特纳口崩片及其制备方法

Montelukast sodium orally disintegrating tablet and preparation method thereof

Abstract

本发明提供的孟鲁斯特纳口崩片采用直接压片法和干法制粒法的进行制备,工艺简单、可重现,避免了干燥过程及湿热对产品质量的影响,使制剂稳定性得以提高。本发明提供的孟鲁斯特纳口崩片遇唾液迅速崩解分散成细微颗粒,药物溶出加快,在胃肠道面积分布大,吸收点多,可提高其生物利用度。对于幼儿、老年人、某些卧床体位难变动的患者,口崩片服药方便,无需用水也不必咀嚼,提高了患者的顺应性,改善了临床治疗的有效性及应急性。
The invention provides a montelukast sodium orally disintegrating tablet. The montelukast sodium orally disintegrating tablet is prepared by adopting a direct tabletting method and a dry granulating method, the process is simple and reproducible, the influences of the drying process as well as dampness and heat to the quality of the product are avoided, and thus the stability of the preparation is improved. The montelukast sodium orally disintegrating tablet provided by the invention rapidly disintegrates when meeting saliva so as to be dispersed into fine particles, the medicine dissolving is rapid, the distribution area in the gastrointestinal tract is large, many absorption points are available, and the bioavailability can be improved. For the patients such as infants, old people and the bedridden people having difficulty in changing body posture, the orally disintegrating tablet is convenient to take, no water is needed, no chewing is needed, so that the compliance of the patients is improved, and the clinical treatment effectiveness and emergency are improved.

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