更昔洛韦口腔崩解片的研制及临床效用评价

摘要

目的：研制更昔洛韦口腔崩解片并运用于临床进行效用评价。方法以更昔洛韦为原料药制备成口腔崩解片，采用紫外分光光度法和反相高效液相色谱法控制其质量。并配合运用于艾滋病合并巨细胞病毒视网膜炎患者的治疗。结果性状、鉴别、检查、含量测定等考察指标符合质量控制的要求，运用治疗艾滋病合并巨细胞病毒视网膜炎的治愈有效率为85.71%。结论研制的更昔洛韦口腔崩解片质量稳定，质量分析方法可行性强。临床辅助用于艾滋病合并巨细胞病毒视网膜炎的治疗效果显著。%Objective To develop the ganciclovir oral disintegrating tablet and evaluate the clinical utility. Methods Using ganciclovir as raw material medicine to develop orally disintegrating tablet, controlling the quality with ultraviolet spectrophotometric method and HPLC method,applying for the treatment of AIDS patients complicated with cytomegalovirus retinitis. Results The characters, identification,inspection,content determination indexes meet the quality control requirement,the effective rate for the curative treatment of AIDS patients with cytomegalovirus retinitis was 85. 71%. Conclusion The ganciclovir oral disintegrating tablet developed had stable quality,and the quality analysis method is feasible. The adjuvant treatment of AIDS complicated with cytomegalovirus retini⁃tis has obvious effect.