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目的:考察抗氧剂组成及用量对辛伐他汀胶囊的影响,提高制剂稳定性。方法:分别制备含叔丁基羟基茴香醚、没食子酸丙酯、焦亚硫酸钠、维生素C、枸橼酸等不同抗氧剂的辛伐他汀胶囊;HPLC法测定加速实验6个月及长期留样12个月后制剂中的主药含量、溶出度和有关物质。结果:抗氧剂对制剂含量、溶出度、有关物质有显著影响,其提高制剂稳定性的顺序为:叔丁基羟基茴香醚>没食子酸丙酯>L-半胱氨酸>焦亚硫酸钠>维生素C;枸橼酸对没食子酸丙酯具有抗氧增效作用,没食子酸丙酯:枸橼酸=0.69 mg:0.46 mg(3:2,W/W)时抗氧化作用最佳。结论:加入优化后的抗氧剂可提高辛伐他汀胶囊的稳定性。
OBJECTIVE: To investigate the effect of the composition and amount of antioxidants on simvastatin capsules and to improve the stability of the preparation. Methods: Simvastatin capsules containing different antioxidants such as t-butylhydroxyanisole, propyl gallate, sodium metabisulfite, vitamin C and citric acid were prepared respectively. HPLC was used to determine the effects of accelerated simvastatin 6 months and long-term retention 12 Months after the preparation of the main drug content, dissolution and related substances. Results: The antioxidants had significant effects on the content, dissolution and related substances of the preparations, and the order of improving the stability was as follows: t-butylhydroxyanisole> propyl gallate> L-cysteine> sodium metabisulfite> vitamins C; Citric acid has antioxidant effect on propyl gallate. Propyl gallate: Citrate = 0.69 mg: 0.46 mg (3: 2, W / W) Conclusion: Adding the optimized antioxidants can improve the stability of simvastatin capsules.