法莫替丁口腔崩解片的研制

The Preparation of Famotidine Orally Disintegrating Tablets

目的：研制法莫替丁口腔崩解片并制订其质量标准。方法采用粉末直接压片法制备口腔崩解片，正交试验筛选最优处方，对各项质量指标进行考察。采用高效液相色谱法测定其含量及溶出度，以健康受试者进行口感和口腔崩解时间测试。结果各项质量指标均符合药典规定，体外平均崩解时间11 s，5 min溶出达95％以上；法莫替丁质量浓度在10～100μg/mL范围内与峰面积呈良好的线性关系（ r＝0.9999），质量含量约为标示量的98％，含量均匀度符合药典规定；口腔内平均崩解时间14 s，无沙砾感，口感良好，对口腔黏膜无刺激。结论研制的法莫替丁口腔崩解片处方合理，制备工艺可靠，测定方法简便、可行，各项指标符合质量标准。

Objective To PrePare orally disintegrating tablets of famotidine and establish its quality control standard. Methods Direct Powder comPressing method was used to PrePare orally disintegrating tablet; orthogonal test was used to screen the oPtimal PrescriP-tion. The quality indicators were all investigated;high Performance liquid chromatograPhy method was used to determine its content and dissolution;the mouthfeel and oral disintegrating time were tested on healthy subjects. Results The quality indicators were conform to the requirement of PharmacoPoeia;mean disintegration time was 11 s in vitro and dissolution was more than 95% within 5 min in vitro;the concentration of famotidine showed good linearity with the Peak area in the concentration range of 10-100 μg/mL （ r=0. 999 9 ）;the content of was famotidine is about 98% of the labeled amount;content uniformity was in accordance with the Chinese PharmacoPoeia;mean disintegrating time was 14 s in oral and there was no gravel sense or stimulation to the oral mucosa and taste good. Conclusion Selfmade famotidine orally disintegrating tablets PrescriPtion is reasonable; the PreParation technology is reliable; the method of content determination is simPle and feasible. Indicators of quality are in line with quality control standards.