维生素C咀嚼片的制备工艺研究

Study on the Preparation Process of Vitamin C Chewable Tablets

建立维生素C咀嚼片的最佳制备工艺及质量评价,采用湿法制粒压片,以正交实验筛选优化处方;通过片剂外观、片重差异、硬度、脆碎度等进行质量评价;利用高效液相色谱技术对其溶出度和含量均匀度进行考察,咀嚼片最佳制备工艺处方为:维生素C 28.5 mg、乳糖21.6 g、预胶化淀粉1.8 g、15%的PVP-70%乙醇溶液适量、硬脂酸镁0.3 mg;维生素C溶出度在80%以上,维生素C嚼片制备工艺简单、稳定可靠,符合《中国药典》质量标准要求,适于批量生产。

Established the best preparation process and quality evaluation of vitamin C chewable tablets.Wet granulation and tableting were used to optimize the prescription by orthogonal test;the quality was evaluated by tablet appearance,tablet weight difference,hardness,friability,etc.In addition,its dissolution and content were analyzed by high performance liquid chromatography the uniformity is examined.The optimal preparation process of the chewable tablets was:Vitamin C 28.5 mg,lactose 21.6 g,pregelatinized starch 1.8 g,The appropriate amount of PVP-70%ethanol solution,0.3 mg of magnesium stearate;the dissolution rate of vitamin C is above 80%.The preparation process of vitamin C chewable tablets is simple,easy,stable and reliable.It meets the requirements of Chinese Pharmacopoeia quality standards and is suitable for mass production.