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目的:建立丹参标准提取物的质量标准。方法:采用定性、定量分析方法,依照《中华人民共和国药典》2005年版二部有关规定,对丹参标准提取物各项指标进行检测。结果:3批丹参标准提取物的水分<5%,炽灼残渣<1.0%,重金属<20ppm,砷盐<2ppm,高效液相色谱法测定丹参酮ⅡA含量>0.25%,丹酚酸B含量>6.0%。结论:各项指标均符合标准提取物的相关规定,所建标准可用于丹参标准提取物的质量控制。
Objective: To establish the quality standard of Salvia miltiorrhiza extract. Methods: Qualitative and quantitative analysis methods, in accordance with the “People’s Republic of China Pharmacopoeia” 2005 edition two of the relevant provisions of the standard extract of Salvia test indicators. Results: Three batches of standard extract of Salvia miltiorrhiza were less than 5%, the residue on ignition was less than 1.0%, the heavy metal was less than 20ppm, the arsenic was less than 2ppm, the content of tanshinone ⅡA was> 0.25% and the content of salvianolic acid B was more than 6.0 %. Conclusion: All the indicators are in line with the relevant provisions of the standard extract, the standard can be used for the quality control Salvia standard extract.