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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 a safety test method of sodium tanshinone Ⅱ_A for injection. Methods Two safety inspection items of abnormal toxicity and antihypertensive substances were set up. The inspection limits were determined and verified according to the Chinese Pharmacopoeia 2015 edition. Results The test limit of tanshinone Ⅱ_A sodium sulfonate for injection was 40.91 mg · kg -1, and the limit of determination of antihypertensive substance was 1 mg · kg -1. Conclusion This study provides experimental evidence for improving and improving the quality standard of sodium tanshinone Ⅱ_A for injection.