目的:优化更昔洛韦口腔崩解片的处方,并评价其质量。方法:以崩解时限为评价指标,通过单因素试验筛选崩解剂、稀释剂和润滑剂的种类,并通过正交试验对崩解剂、稀释剂、润滑剂和矫味剂用量进行优化。对优选处方制得的口腔崩解片进行质量检查,包括崩解时限、含量测定、体外溶出度和加速试验。结果:最佳处方为:10%交联聚维酮、30%微晶纤维素、3%微粉硅胶和2%阿斯巴甜。三批样品的崩解时限分别为47.4,48.6,47.8 s;含量分别为100.2%,99.7%,99.8%;2 min时累积溶出度达到80%以上;加速试验3个月的样品检测指标与0天相比无明显变化。结论:更昔洛韦口腔崩解片的处方及工艺稳定可行,重复性好,制得的样品质量均符合要求。 OBJECTIVE: To optimize the formulation of ganciclovir orally disintegrating tablets and evaluate its quality. Methods: Taking the disintegration time as the evaluation index, the types of disintegrants, diluents and lubricants were screened by single factor test. The amount of disintegrant, diluent, lubricant and flavoring agent were optimized by orthogonal test. Oral disintegrating tablets made from the preferred prescriptions were inspected for quality, including disintegration time, content, in vitro dissolution and accelerated testing. Results: The best prescriptions were: 10% crospovidone, 30% microcrystalline cellulose, 3% silica gel and 2% aspartame. The disintegration time of three batches of samples were 47.4, 48.6 and 47.8 s respectively; the contents were 100.2%, 99.7% and 99.8% respectively; the cumulative dissolution reached 80% at 2 minutes; No significant change from day to day. Conclusion: The prescription and technology of ganciclovir orally disintegrating tablets are stable and feasible. The reproducibility is good. The quality of prepared samples meets the requirements.