穿心莲分散片的质量标准研究

目的:探讨穿心莲分散片的质量标准。方法:用溶出度测定法(篮法)检查制剂的溶出度。用HPLC法对分散片中穿心莲内酯进行定量分析。结果:溶出度含量测定线性浓度范围为5.28-26.40μg/mL(r=0.9999,n=5),平均回收率为99.15%,RSD%=0.72%(n=5)。定量分析中穿心莲内酯进样量线性范围为43.2-216.0μg/mL(r=0.9998,n=5),平均回收率为99.0%,RSD%=1.25%(n=6)。结论:所建立的方法可靠、准确、专属性强,可作为该制剂的溶出度检查和定量分析质量标准。

The quality standards of paniculta scattered tablet

Objective: To explore the quality standards of paniculta scattered tablet.Methods: Using dissloution measure method(basket method) check preparations of the dissloution degrees.;with HPLC method for quantitative analysis of andrographolide.Results: Dissloution degrees content determination of linear concentration range for 5.28-26.40 μg/ml(r=0.9999,n=5);Quantitative analysis of andrographolide incoming sample amount linear range for 43.2-216.0 μg/ml(r=0.9998,n=5),The average recovery was 99.0%,RSD%=1.25%(n=6).Conclusion: The method is reliable and accurate,strong specificity,can be used as the formulation of the dissloution degree examination and the quality standard of quantitative analysis.