小儿碳酸钙维D_3咀嚼片处方工艺研究

Studies on Formulation and Preparation of Children Calcium Carbonate and Vitamin D_3 Chewable Tablets

目的研究小儿碳酸钙维D3咀嚼片的处方工艺及检查方法。方法处方采用正交试验,通过对辅料用量的筛选为考察项目,以颗粒休止角为考察指标,最终确定最优的处方及工艺。结果采用辅料麦芽糊精、阿司巴坦、枸橼酸、山梨醇做为辅料,采用20目筛网制粒,在60℃条件下烘干,水分控制在2.5%以下,稳定性良好,符合质量要求。结论采用该处方及生产工艺,符合咀嚼片剂的要求,可以用于大生产。

OBJECTIVE The prescription process and inspection method on children Calcium Carbonate and Vitamin D3 Chewable Tablets.METHODS The prescription by orthogonal test,through the screening of excipients as research project,to the repose angle,tablet hardness,friability,content as the indexes,finally determined the opti-mal prescription and technology.RESULTS To usr the excipients maltodextrin,aspartame,citric acid,sorbitol as materials,using 20 mesh sieve granulation,drying in the 60 conditions,Moisture control below 2.5%,good stability and meet the quality requirements.CONCLUSION To use the materials and production process, in accordance with the requirements of a chewable tablet,Can be used for mass production.