维生素C片剂的处方研究

Prescription study of Vitamin C Tablets

目的比较不同处方制备的维生素C片的质量及稳定性,以筛选出本品最适宜的处方及制备方法,以制得高品质的维生素C片。方法以预胶化淀粉-乳糖(5∶4)作为稀释剂,辅以酒石酸或/和不同的抗氧剂以提高片剂的稳定性,分别以淀粉浆、乙醇溶液及聚维酮K30的稀醇溶液为粘合剂,通过普通湿法制粒方法制得维生素C片。设计不同的组方方案进行处方筛选,然后按上市包装作加速及长期稳定性考察。结果选用酒石酸与谷胱甘肽联合应用为抗氧剂,以聚维酮K30的稀醇溶液为粘合剂制备的维生素C片质量最好,且经过加速6个月及长期24个月的稳定性考察,其性状、含量及崩解时限均无明显变化,质量较为稳定。结论用所筛选的处方制备的维生素C片符合设计要求,适合临床应用。

Objective To compare the quality and stability of Vitamin C Tablets prepared by different prescriptions and bolting the optimal prescription and preparation method for preparing high - quality Vitamin C Tablets. Methods Using pregelatinized starch - lactose （5：4 ） as the diluent, supplemented with tartaric acid or/and different antioxidants to improve the stability of tablets and starch, and using ethanol solution and polyvidione K30 dilute alcohol solution as binder, Vitamin C Tablets were prepared by ordinary wet granulation method. Prescription screening was adopted by designing different prescriptions and then ac- celeration and long - term stability were studied with the listed packaging. Results Vitamin C Tablets prepared by using tartaric acid and glutathione as antioxidant, dilute alcoholic solution of polyvidione K30 as binder had best quality. The characters, content and disintegration time after aeeeleration for six month and 24 months of stability investigation had no significant change and the quality was stable. Conclusion Vitamin C Tablets prepared by the screened prescription met the design requirements and was suitable for clinical application.