口腔速崩片的研制与评价

 目的：研制及评价口腔速崩片。方法：选用微晶纤维素(MCC)和低取代羟丙基纤维素(L-HPC)作为崩解剂，通过湿法制粒压片工艺制备口腔速崩片。并考察速崩片的性质，如硬度、润湿时间、吸水率、崩解时间来初步阐明其润湿及崩解的特性。此外，选用萘普生为模型药物，考察其含量对崩解时间的影响及润滑剂硬脂酸镁的含量对崩解时间的影响，同时也测定了速崩片在口腔内的崩解时间。结果：当MCC/L-HPC的比例从3∶7至9∶1时，其体外崩解时间均在10 s以内，体内崩解时间均在30 s以内。随着萘普生和硬脂酸镁的含量增大，其崩解时间相应延长，但也都在30 s以内。结论：当MCC/L-HPC的比例为9∶1时，崩解时间最短，润湿时间最短。疏水性药物萘普生和疏水性润滑剂硬脂酸镁的含量分别增大至50%和5%时，其崩解时间分别在13 s和28 s以内，仍具有速崩片（在30 s内崩解）的特性。

Preparation and evaluation of a Fast-disintegrating Oral Tablet

OBJECTIVE To prepare and evaluate a Fast-disintegrating Oral Tablet.METHODS Microcrystalline cellulose and low-substituted hydroxypropylcellulose are used as disintegrants, fast disintegrating tablets could be prepared by wet process compression method.The properties of these tablets,such as hardness,the time required for complete wetting of a tested tablet (wetting time), water uptake, and disintegration time were investigated to elucidate the wetting and disintegration characteristics of these tablets, naproxen as a model drug. The relationship between disintegration time and naproxen content, the relationship between disintegration time and magnesium stearate content, disintegration time in the mouth were investigated. RESULTS When the MCC/L-HPC ratio was in the range of 3∶7 to 9∶1,the disintegration time was within 10 s in vitro test and was within 30 s mouthl, respectively. Disintegration time increased with an increasing percentage of naproxen and magnesium stearate , but that was all within 30 s. CONCLUSIONS When the MCC/L-HPC ratio was 9∶1, the shortest disintegration time and the shortest wetting time were observed. Disintegration time was within 13s and within 28 s when percentage of naproxen and magnesium stearate was 50% and 5%, respectively.