工艺改进后的维C银翘片质量评价研究  

Study on Improving Process and Quality Evaluation for Vitamin C Yinqiao Tablets

作　　者：李琳 倪海峰 李怡婧 Li Lin;Ni Haifeng;Li Yijing(Ningxia Qiyuan Guoyao Pharmaceutical Co.,Ltd,Yinchuan 750000,China)

机构地区：[1]宁夏启元国药有限公司,宁夏银川750000 [2]宁夏启元国药有限公司质量技术中心,宁夏银川750000

出　　处：《亚太传统医药》2022年第8期96-101,共6页Asia-Pacific Traditional Medicine

摘　　要：目的:通过对维C银翘片薄膜衣片中化药成分对乙酰氨基酚及马来酸氯苯那敏体外溶出曲线的比较研究,考察改进工艺前后产品的体外溶出行为。方法:采用桨法75rpm,以0.1mol/L盐酸溶液500mL为溶出介质,分别于10、20、30、45、60、90min取样。马来酸氯苯那敏和对乙酰氨基酚分别用不同液相色谱条件进行测定。结果:工艺改进后的产品与改进前的产品、不同厂家同工艺产品相比,对乙酰氨基酚及马来酸氯苯那敏的体外溶出曲线有明显差异。结论:所建立的方法可准确地进行溶出曲线检测,该方法重现性良好,能客观地反映维C银翘片的溶出情况,可作为维C银翘片薄膜衣片的质量控制指标,保证工艺稳定性。另外,工艺改进后的维C银翘片60min时的溶出度显著高于原处方及其他厂家同工艺产品的溶出度,表明新的处方和工艺更科学合理。Objective:Through the comparative study on the in vitro dissolution curves of Acetaminophen and chlorphenamine Maleate in vitamin C Yinqiao film coated tablets,the in vitro dissolution behavior of the products before and after the improved process was investigated.Methods:The paddle method was used at 75 rpm and 500 mL 0.1 mol/L hydrochloric acid solution was used as the dissolution medium.Samples were taken at 10,20,30,45,60 and 90 min respectively.Chlorphenamine maleate and acetaminophen were determined by different liquid chromatographic conditions.Results:Compared with the products before the improvement and the products of the same technique procedure from different manufacturers,the in vitro dissolution profiles of paracetamol and chlorpheniramine maleate are significantly different between the improved products and the products before the improvement.Conclusion:The established method can accurately detect the dissolution curve.The method has good reproducibility and can objectively reflect the dissolution of vitamin C Yinqiao Tablets.It can be used as the quality control index of vitamin C Yinqiao Tablets and ensure the process stability.In addition,the dissolution of vitamin C Yinqiao Tablets at 60 min after the process improvement is significantly higher than that of the original prescription and other manufacturers with the same process,indicating that the new prescription and process are more scientific and reasonable.

关 键 词：维C银翘片 薄膜衣片 工艺改进 溶出曲线 

分 类 号：R284.1[医药卫生—中药学]