基于定量指纹图谱技术的中药质量控制

定量指纹图谱技术是中药指纹图谱技术与多指标成分定量分析相结合的中药质量控制模式。定量指纹图谱技术的发展包括定量组分的制备、过程控制的指纹图谱技术和产品含量测定3个主要部分。本文以丹参为例,通过水提、醇沉、过膜、大孔树脂分离和工业色谱分离5个工艺流程制备了丹参定量组分,对各个工艺步骤以指纹图谱技术考察其稳定性和重复性。对丹参定量组分中的原儿茶醛、迷迭香酸、丹酚酸B 3个成分进行含量测定。3个成分的含量总和大于50%。定量组分的制备以现有的活性成分为目标,经过去粗存精的工艺过程,其质量标准得到了有效的提高。

Development of full-quantified fingerprint for quality control of traditional Chinese medicines

Full-quantified fingerprint technique combines the fingerprint technique and multiple-target determination technique. The development of full-quantified fingerprint technique includes the preparation of full-quantified fraction, the quality control in preparation process with fingerprint technique and determination of products. In this paper, the full-quantified fractions of Salvia miltiorrhiza Bge. were prepared by water extraction, deposition with the ethanol, membrane filter, separation on macroporous resin and separation with preparative high performance liquid chromatography (HPLC). Fingerprint technique was used to test the reproducibility of preparation. Three ingredients, protocatechualdehyde, rosmarinic acid, salvianolic acid B were determined and the sum of their contents was more than 50%. The pharmaceutical active compounds were taken as the preparation target. The impurities were removed effectively by multiple preparations, and the specification of full-quantified fraction was improved greatly.