Effect of changing coating excipient on the quality of Rendan
Objective To investigate the effect of changing coating excipients of Rendan on its quality.Methods The types and amounts of coating excipients were selected and optimized based on indicators such as moisture content,dissolution time limit,and volatile oil content,and the quality of Rendan coating excipients before and after changes was compared using indicators such as microscopy,thin-layer chromatography identification,content determination,and stability.Results The coating excipients of Rendan were changed to a mixture of carmine red,talc powder,and red iron oxide,with a dosage of 17.5 g/500 g of dried pills.Dextrin was used as an adhesive,with a dosage of 40 g/500 g of dried pills.A quality comparison study was conducted on three batches of samples before and after the change,and it was found that all indexes and dissolution conditions were basically consistent.Conclusion Changing the excipients will not cause a change of the material basis,and using a mixture of carmine red,talc powder,and red iron oxide instead of aluminum foil as the coating excipients for Rendan can solve the potential toxic side effects caused by the use of aluminum foil coating,improving GMP management and medication safety.
Rendancoating excipientprocess researchcomparative study of quality
万方数据
维普
