葡萄糖酸锌泡腾片的制备及质量控制  

Preparation for zinc gluconate effervescent tablets and its quality control

作　　者：洪求兵[1] 刘祖雄[1] 张红[1] 周时光[1] 

机构地区：[1]解放军广州军区武汉总医院药剂科,湖北武汉430070

出　　处：《临床军医杂志》2013年第2期192-193,202,共3页Clinical Journal of Medical Officers

摘　　要：目的介绍葡萄糖酸锌泡腾片的制备及质量控制方法。方法选用碳酸氢钠为碱源;枸橼酸为酸源;甘露醇为填充剂;羧甲基淀粉钠为崩解剂;阿斯帕坦为矫味剂;薄荷油为芳香剂;微粉硅胶为助流剂;硬脂酸镁为润滑剂。用酸、碱分开制法制备葡萄糖酸锌泡腾片,并对其性状、鉴别、装量差异、发泡量、崩解时限、含量测定、稳定性等进行了检测。采用络合滴定法测定其含量。结果制得的葡萄糖酸锌泡腾片口感好、表面光滑美观、色泽均匀、硬度适中、服用方便。葡萄糖酸锌的平均回收率为100.05%,RSD为0.19%(n=9)。本品在5min内可完全崩解。结论本品处方合理,制备工艺简单,可进行推广开发。Objective To study the preparation technology of zinc gluconate effervescent tablets, and to establish its quality control method. Methods We selected sodium bicarbonate for base resource, citric acid for acid resource, mannitol for diluents, sodium carboxymethyl starch for disintegrants, asipatan for flavoring, pepperraint oil for aromatic, aerosil for glidants, and magnesium stearate for lubricants. The tablets were prepared with acid resource and base resource respectively. Its character, distinguishability, weight deviation, foam volume, disintegration time, content, and stability were tested. Complexometric titration was used to determine the content of zinc gluconate. Results The zinc gluconate effervescent tablets could be obtained with good taste, smooth surface, uniform color, appropriate rigidity and convenience for taking. The average rate of recovery was 100.05% , and RSD was 0.19% （n = 9 ）. The tablets disintegrated entirely in 5 minutes. Conclusion The formulation is feasible. The preparation technique is simple, and worthy of widely spreading.

关 键 词：葡萄糖酸锌 泡腾片 制备 质量控制 

分 类 号：R943[医药卫生—药剂学]