维生素C咀嚼片的制备工艺研究  

Study on the Preparation Process of Vitamin C Chewable Tablets

作　　者：莫秋瑜 江先再 崔健[3] 赵凤仙 魏江存 陈宏夏 MO Qiu-yu;JIANG Xian-zai;CUI Jian;ZHAO Feng-xian;WEI Jiang-cun;CHEN Hong-xia(Guangxi International Zhuang Medicine Hospital,Guangxi Nanning 530201;Nanning Women and Children's Health Hospital,Guangxi Nanning 530028;The First Affiliated Hospital of Guangxi University of Chinese Medicine,Guangxi Nanning 530023;Guangxi University of Chinese Traditional Medicine,Guangxi Nanning 530200,China)

机构地区：[1]广西国际壮医医院,广西南宁530201 [2]南宁市妇幼保健院,广西南宁530028 [3]广西中医药大学第一附属医院,广西南宁530023 [4]广西中医药大学,广西南宁530200

出　　处：《广州化工》2020年第11期79-81,115,共4页GuangZhou Chemical Industry

基　　金：广西科技厅重点研发项目(No:AB19110003);2019年度广西高校中青年教师科研基础能力提升项目(No:2019KY0341);2019年广西中医药大学青年基金项目(No:2019QN036)。

摘　　要：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.

关 键 词：咀嚼片 制备工艺 溶出度 高效液相色谱 

分 类 号：R917[医药卫生—药物分析学]