盐酸昂丹司琼口腔崩解片的制备以及崩解时间影响因素的考察

目的考察影响盐酸昂丹司琼口腔崩解片崩解时间的因素。方法采用湿法制粒压片法制备盐酸昂丹司琼的口腔崩解片，浆法测定崩解时间，考察了口腔崩解片的硬度、交联聚维酮（PVPP）和微晶纤维素（MCC）的用量对崩解时间的影响。结果片剂硬度与崩解时间成正比，交联聚维酮和微晶纤维素的用量与崩解时间成反比。调节片剂硬度为4．6kg／mm、交联聚维酮的用量为15～20mg／片和微晶纤维素的用量为50-70mg／片，可获得较理想的崩解时间和良好的片剂性质。结论湿法制粒压片法简便易行；制备的盐酸昂丹司琼口腔崩解片符合质量要求。

Preparation of ondansetron hydrochloride orally disintegrating tablet and the influential factors on its disintegrating time

Objective To investigate the influential factors on the disintegrating time of ondansetron hydrochloride orally disintegrating tablet. Methods Orally disintegrating tablets of ondansetron hydrochloride were compressed with wet granule preparing method. The disintegrating time was determined by a paddle method. The influences of hardness of orally disintegrating tablets and the dosage of PVCC and MCC on the disintegrating time were investigated. Results The disintegrating time was proportional to hardness but was inversely proportional to the dosage of PVCC and MCC. To obtained ideal disintegrating time and proper tablet quality, hardness should be adjusted to 4. 6 kg/mm,the dosage of PVCC and MCC should respectively be adjusted to 15- 20 mg and 50-70 mg per tablet. Conclusion The method is feasible and The tablets prepared in this method could fulfill the requirement of quality.