以标准汤剂为基准建立丹参的质量评价方法(1)
[摘要]市售的丹参配方颗粒质量差异大，主要原因是丹参原料饮片质量的不均一性、缺乏统一规范的生产工艺和系统的质量评价方法。配方颗粒和“标准汤剂”具有质量一致性。该文将从“标准汤剂”角度，建立评价丹参水煎液质量的系统评价方法，探索影响丹参配方颗粒质量均一性差的主要因素。制备丹参标准汤剂，建立指纹图谱并测定丹酚酸B含量，采用UPLC-QTOF-MS对主要色谱峰进行结构确认；计算出膏率、指标成分转移率和pH等参数，评价工艺的稳定性。结果显示丹参标准煎液的主要成分为酚酸类成分，丹参煎液的出膏率、丹酚酸B的转移率和pH变化不大，且所得标准汤剂的指纹图谱相似度高，表明制备工艺的稳定性良好；标准煎液中丹酚酸B含量范围波动大，主要源于丹参药材中丹酚酸B含量的差异性。
[关键词] 丹参； 标准煎液/汤剂； 质量评价； 出膏率； 转移率
[Abstract] The quality of Danshen extract granules on market is largely different from each other mainly due to the heterogeneous quality of raw materials of Salvia miltiorrhiza， various producing procedures and lack of good quality evaluation method. Formula granule and "standard decoction" have the same quality. In this paper， a systematic evaluation method for the quality of Danshen decoction was established from the perspective of "standard decoction"， in order to explore the main factors affecting the quality uniformity of Danshen extract granules. Danshen standard decoction was prepared； then the fingerprint method was developed to determine the content of salvianolic acid B； and the main peaks in the fingerprint were identified with UPLC-QTOF/MS to clarify the chemical compositions of Danshen decoction. Three indexes were calculated to evaluate the stability of whole process， including the extraction ratio； transfer rate of index components and pH value. The results showed that the main components of Danshen decoction were phenolic acids， while the extraction rate， the transfer rate of salvianolic acid B and pH value were in a relatively stable level， and the similarity in the fingerprint of standard decoction was high， indicating that the preparation procedure was stable. The level of salvianolic acid B in the standard decoction was in a large range， which was mainly due to the difference in the quality of Salviae Miltiorrhizae Radix et Rhizoma.
, http://www.100md.com
[Key words] Salviae Miltiorrhizae Radix et Rhizoma； standard decoction； quality evaluation； extraction ratio； transfer rate
丹參年需求量较大，为大宗药材品种之一，其配方颗粒的质量是众多学者讨论的焦点。丹参为唇形科鼠尾草植物丹参Salvia miltiorrhiza Bunge的干燥根及根茎，是最常用的活血化瘀中药之一。其主要化学成分为水溶性的酚酸类化合物和脂溶性的二萜醌类化合物[1]。已有学者对市场上丹参配方颗粒的质量进行了分析总结[2-4]，主要问题如下：①成分组成差异大，丹参水提液的主要成分是酚酸类，有的厂家丹参配方颗粒中含有丹参酮ⅡA等脂溶性成分，暗示该配方颗粒的生产中可能采用了乙醇提取工艺，表明已有的丹参配方颗粒生产工艺不统一；②指标成分含量不均一，丹酚酸B含量差异很大。造成上述问题的主要原因是由于原料饮片的质量不一致和缺乏统一规范的生产工艺造成的。
中药“标准汤剂”，又称中药“标准煎液”，是按照临床汤剂煎煮方法、经标准化工艺制备而成的单味中药饮片水煎液[5]。中药配方颗粒除了成型工艺外，其余的过程与传统的汤剂基本一致。所以，配方颗粒的药效物质组成和汤剂的基本保持一致，即二者的质量具有一致性。因此，可以以标准汤剂为“基准”，评价配方颗粒主要生产工艺和质量控制方法的合理性。2016年，陈士林研究员提出以中药饮片标准煎液为标准，标化不同用药形式，提高临床用药的准确性和疗效的一致性[5]。中药标准煎液质量标准的制定将为所有源于饮片水煎液的制剂的质量标准的制定提供参考。, http://www.100md.com(董青 於化桃 代云桃 赵嵘 范自全 王丹丹 朱超 陈士林)
[关键词] 丹参； 标准煎液/汤剂； 质量评价； 出膏率； 转移率
[Abstract] The quality of Danshen extract granules on market is largely different from each other mainly due to the heterogeneous quality of raw materials of Salvia miltiorrhiza， various producing procedures and lack of good quality evaluation method. Formula granule and "standard decoction" have the same quality. In this paper， a systematic evaluation method for the quality of Danshen decoction was established from the perspective of "standard decoction"， in order to explore the main factors affecting the quality uniformity of Danshen extract granules. Danshen standard decoction was prepared； then the fingerprint method was developed to determine the content of salvianolic acid B； and the main peaks in the fingerprint were identified with UPLC-QTOF/MS to clarify the chemical compositions of Danshen decoction. Three indexes were calculated to evaluate the stability of whole process， including the extraction ratio； transfer rate of index components and pH value. The results showed that the main components of Danshen decoction were phenolic acids， while the extraction rate， the transfer rate of salvianolic acid B and pH value were in a relatively stable level， and the similarity in the fingerprint of standard decoction was high， indicating that the preparation procedure was stable. The level of salvianolic acid B in the standard decoction was in a large range， which was mainly due to the difference in the quality of Salviae Miltiorrhizae Radix et Rhizoma.
, http://www.100md.com
[Key words] Salviae Miltiorrhizae Radix et Rhizoma； standard decoction； quality evaluation； extraction ratio； transfer rate
丹參年需求量较大，为大宗药材品种之一，其配方颗粒的质量是众多学者讨论的焦点。丹参为唇形科鼠尾草植物丹参Salvia miltiorrhiza Bunge的干燥根及根茎，是最常用的活血化瘀中药之一。其主要化学成分为水溶性的酚酸类化合物和脂溶性的二萜醌类化合物[1]。已有学者对市场上丹参配方颗粒的质量进行了分析总结[2-4]，主要问题如下：①成分组成差异大，丹参水提液的主要成分是酚酸类，有的厂家丹参配方颗粒中含有丹参酮ⅡA等脂溶性成分，暗示该配方颗粒的生产中可能采用了乙醇提取工艺，表明已有的丹参配方颗粒生产工艺不统一；②指标成分含量不均一，丹酚酸B含量差异很大。造成上述问题的主要原因是由于原料饮片的质量不一致和缺乏统一规范的生产工艺造成的。
中药“标准汤剂”，又称中药“标准煎液”，是按照临床汤剂煎煮方法、经标准化工艺制备而成的单味中药饮片水煎液[5]。中药配方颗粒除了成型工艺外，其余的过程与传统的汤剂基本一致。所以，配方颗粒的药效物质组成和汤剂的基本保持一致，即二者的质量具有一致性。因此，可以以标准汤剂为“基准”，评价配方颗粒主要生产工艺和质量控制方法的合理性。2016年，陈士林研究员提出以中药饮片标准煎液为标准，标化不同用药形式，提高临床用药的准确性和疗效的一致性[5]。中药标准煎液质量标准的制定将为所有源于饮片水煎液的制剂的质量标准的制定提供参考。, http://www.100md.com(董青 於化桃 代云桃 赵嵘 范自全 王丹丹 朱超 陈士林)