葡萄糖酸锌含片的研制  

Preparation of buccal zinc gluconate tablets

作　　者：钱春梅[1] 梁清[1] 程新萍[1] 吴娇芬[1] 

机构地区：[1]西安交通大学药学院,陕西西安710061

出　　处：《西北药学杂志》2004年第6期262-264,共3页Northwest Pharmaceutical Journal

摘　　要：目的制备口感好、形体小、口内滞留时间长的葡萄糖酸锌含片,供治疗复发性口腔溃疡应用。方法选用含片常用的填充剂(蔗糖、甘露醇、糊精等)、黏合剂(CMC-Na胶浆、明胶浆),以样片的硬度为指标,进行单因素筛选;继而以样片的溶散时间与脆碎度为指标,采用优良单因素(填充剂甘露醇、黏合剂CMC-Na-明胶混合浆)进行正交试验。结果优选出的最佳处方及工艺(按1000片计)为:称取葡萄糖酸锌17g,依递加法与甘露醇210g混合均匀;用150mg·g-1明胶浆与75mg·g-1CMC-Na胶浆(1:1)112g作黏合剂制软材;10目筛制颗粒,于45℃下干燥;加入硬脂酸镁混匀后压片。结论按最佳处方及工艺制备的葡萄糖酸锌含片,符合药典规定。体外溶散试验表明,含片在水中不松散,30min释出葡萄糖酸锌(63.8±1.6)%,100min全部葡萄糖酸锌释出。Objective To prepare buccal tablets of zinc gluconate for curing oral ulcer, which would be effective for long time in mouth and with good taste. Methods Single factor test was used to select the adjuvants, filler (sucrose, mannitol, dextrin) and binder (CMC-Na or gelatin) baseing on the hardness of tablet samples. Then orthogonal test was done to select the optimum formulation according to dissolution time and fragmentary degree of tablet samples. Results The optimum formulation and process were as following one or another: mixing 17g of zinc gluconate with 210 g of mannitol step by step, binding with 112 g of the mixtured: 1) of CMC-Na(75 mg·g-1) and gelatin(150 mg·g-1), preparing the granules, drying at 45℃, adding 1. 2g of magnesium stearate into dried granules, compressing. Conclusions The tablet samples were complied with the items for quality control. The tablets were not loose in water and zinc gluconate in the tablets was released to(63. 8±1. 6)% in 30min and 100% in 100 min.

关 键 词：葡萄糖酸锌 含片 甘露醇 明胶浆 羧甲基纤维素钠(CMC-Na)胶浆 

分 类 号：R944.4[医药卫生—药剂学]