粉末包衣技术在辛伐他汀片中的应用

顾煜* 高静胡岩（上海信谊万象药业股份有限公司上海201703）

【摘要】摘要目的：研制一种提高辛伐他汀片稳定性的处方工艺。方法：使用共聚维酮S630作为隔离材料对辛伐他汀原料进行包衣，再混合辅料干压。结果：本品经加速试验（40 ℃，相对湿度75%）6个月，其各项质量指标仍符合国家质量标准（单一杂质≤1%，总杂质≤3%）。结论：新工艺可以有效解决产品的稳定性问题。

【期刊名称】上海医药

【年(卷),期】2016(037)005

【总页数】5

【关键词】关键词辛伐他汀片稳定性粉末包衣有关物质ABSTRACT Objective:To develop a formula for improving the stability of simvastatin tablets.Methods:PVP S630 was used as an isolation material to coat the simvastatin first,and then mixed with other excipients,which finally was squashed.Results:The quality indicators of the product were remained in line with national quality standards (single impurity ≤ 1%,total impurity ≤ 3%) after an accelerated test （T=40 ℃，relative humidity=75%）was performed for 6 months.Conclusion:The new technology can effectively solve the problem of the stability of the product.

KEY WORDS simvastatin tablet; stability; powder coating; related substances