注射用丹参酮Ⅱ_A磺酸钠安全性检查法的研究

Study on the Safety Test of Sodium Tanshinone Ⅱ_A Sulfonate for Injection

目的建立注射用丹参酮Ⅱ_A磺酸钠的安全性检查法。方法设置了异常毒性和降压物质2个安全性检查项目,确定了检查限值,并按照中国药典2015年版方法进行检查验证。结果注射用丹参酮Ⅱ_A磺酸钠异常毒性检查限值为40.91 mg·kg^(-1),降压物质检查限值为1 mg·kg^(-1)。结论本研究为完善和提高注射用丹参酮Ⅱ_A磺酸钠的质量标准提供了实验依据。

OBJECTIVE To establish the safety test for sodium tanshinone ⅡA sulfonate for injection. METHODS Testing items of abnormal toxicity and depressor substances and their limiting values were set separately. The correlative experiments were carried out based on the methods from Chinese Pharmacopoeia（2015 edition） general chapters. RESULTS The limiting values of abnormal toxicity test was 40.91 mg·kg^-1 and depressor substances test was 1 mg·kg^-1. CONCLUSION This study provides experimental basis for the improved quality standard of sodium tanshinone ⅡA sulfonate for injection.