基于指纹图谱及多指标成分定量的丹参提取工艺对比研究

目的 对已上市制剂中丹参不同提取工艺的提取效果进行对比分析.方法 按照冠心丹参胶囊、复方丹参片、复方丹参滴丸、丹参片4种代表制剂的提取工艺制备丹参提取液,研究建立同时测定提取液指纹图谱及多指标含量的HPLC方法,测定不同丹参提取液的丹参素钠、丹酚酸B和丹参酮ⅡA含量及指纹图谱,采用中药色谱指纹图谱相似度评价软件计算指纹图谱的相似度.结果 4种丹参提取液中丹参酮ⅡA、丹参素钠、丹酚酸B含量分别为0.27~1.25、1.44~4.46、33.77~93.92 mg·g-1;冠心丹参胶囊与丹参片、复方丹参滴丸、复方丹参片的指纹图谱相似度分别为0.781、0.853、0.758,复方丹参滴丸与复方丹参片的指纹图谱相似度为0.879.结论 4种代表制剂丹参提取工艺的丹参酮ⅡA、丹参素钠、丹酚酸B含量及指纹图谱均存在明显差异,针对相同的临床适应症,需深入研究以实现丹参工艺的标准化、规范化.

A Contrastive Study on the Extraction Methods of Radix Salviae Miltiorrhizae by HPLC Fingerprint and Multi-component Quantitative Analysis

Objective To compare and analyze the extraction effect of different extraction methods of Radix Salvia Miltiorrhiza among the listed preparations. Methods The salvia miltiorrhiza extracts were prepared according to the extraction methods of the four representative preparations including Guanxin Danshen capsules, compound Danshen tablets, compound Danshen dripping pills and Danshen tablets. The HPLC method for simultaneous determination of the fingerprints and the content of the multiple indexes of Salvia miltiorrhiza extracts were established to determine the content of sodium Danshensu, salvianolic acid B and tanshinone ⅡA and the fingerprints of different Salvia miltiorrhiza extracts. The similarity evaluation software of traditional Chinese medicine chromatographic fingerprint was adopted to calculate the similarity degree of fingerprints. Results The contents of sodium Danshensu, salvianolic acid B and tanshinone ⅡA in the four Salvia miltiorrhiza extracts were 0.27~1.25,1.44~4.46,33.77~93.92 and 36.26~97.90 mg·g-1 respectively. The fingerprint similarity of Guanxin Danshen tablets with Danshen tablets, compound Danshen dripping pills and Compound Danshen tablets were 0.781, 0.853 and 0.758 respectively. The fingerprint similarity between compound Danshen dripping pills and compound Danshen tablets was 0.879. Conclusion The fingerprints and the content of sodium Danshensu, salvianolic acid B and tanshinone ⅡA in the Salvia miltiorrhiza extracts of the four representative preparations are obviously different. Further research is needed to realize the standardization and normalization of the process for the same clinical indications.