确定性筛选设计优化一种复合钙制剂的工艺

Deterministic Screening Design for Optimizing the Process of A Compound Calcium Preparations

研制一种适用于孕妇服用的复合钙咀嚼片。采用确定性筛选设计(definitive screening design,DSD),对辅料用量、湿法制粒及总混工艺进行筛选及优化,确定辅料用量和最佳工艺。辅料最佳用量为羧甲基纤维素钠2.00%,聚维酮K30 2.00%,聚维酮水溶液浓度为10.00%,用赤藓糖醇补足配方量;采用湿法制粒,外加维生素D3和叶酸,用三维混合机进行混合。所制得的产品口味较好,甜味适中,香味和硬度适宜,钙、铁、铜、叶酸和维生素D3的含量均匀,质量稳定,易于工业化大生产。

A compound calcium chewable tablet for pregnant women was developed.Definitive screening design(DSD)was used to screen and optimize the amount of excipients,wet granulation and total mixing process.The amount of excipients and the optimum process were determined.The optimum dosage of excipients was 2.00%carboxymethyl cellulose sodium,2.00%polyvinyl ketone K30 and 10.00%polyvinyl ketone aqueous solution.Wet granulation,vitamin D3 and folic acid were used to mix.The product had sweet taste,suitable fragrance and hardness.The content of calcium,iron,copper,folic acid and vitamin D3 was even,the quality was stable,and it was easy to be industrialized.