碘化钾骨架缓释片的工艺研究

Craft of framework sustained-release tablets of potassium iodine

目的 研究碘化钾骨架型缓释片的处方与工艺。方法 采用熔融法制粒,考察加热方法、冷却方法、压片时机、骨架材料的量、助流剂等影响因素,以释放度为主要指标,结果用方差分析来处理。结果 最后筛选的处方(处方:KI 25mg·片^(-1)、骨架材料332mg·片^(-1)、硬脂酸镁6mg·片^(-1)、微粉硅胶12mg·片^(-1))在合适的工 艺条件下(夹层蒸汽加热、快速冷却、制粒后第3d左右压片)制备的缓释片,在8h内以理想的释药曲线释药。结论 碘化钾缓释片的释药特性主要取决于辅料的性质和比例以及制备的工艺。

OBJECTIVE To study the prescription and craft of framework sustained-released tablets of potassium iodine. METHODS Mcltdown mcthod was used to manufacture the grain, and we investigated the heating method, the cooling off method, the timing of pressing tablets, the quantity of framework materials, lubricant and other influence factors. The release degree was considered the main index sign and the results were evaluated by analysis of variance. RESULTS The final result of screening prescription (prescription.. KI 250 mg/tablet, framework material332mg/tablet, magnecium stearate 6mg/tablet, SiO_2 12 mg/tablet), and the sustained-release tablets were made under the fit craft condition (After the mezzanine steam heating and fast cooling, the grain was pressed at the third day), released by ideal curve within 8 hours. CONCLUSIONS The release of drug from the tablet was mainly controlled by the properties and proportions of adjuvant, as well as the manufacturing craft.