玄参饮片标准汤剂制备及质量标准研究

Preparation and quality standard of standard decoction of Scrophulariae Radix pieces

中药饮片标准汤剂是衡量中药不同用药形式与临床汤剂是否基本一致的标准参照物,为有效解决中药配方颗粒等现代中药剂型中存在的质量参差不齐等问题提供了新的思路和方法。该研究从'标准汤剂'的角度,制备玄参饮片标准汤剂,并建立评价其质量的系统方法,为玄参配方颗粒等剂型的质量控制提供参考。试验收集不同产地的15批玄参饮片,以水为溶剂,按照标准化工艺制备15批原料的标准汤剂,采用哈巴苷和哈巴俄苷作为定量检测指标,测定其含量,计算转移率,测定出膏率,并使用HPLC建立标准汤剂指纹图谱分析方法。结果表明15批玄参饮片标准汤剂中哈巴苷和哈巴俄苷转移率分别为(70. 84±13. 39)%,(48. 56±6. 40)%;出膏率为(57. 47±5. 89)%;指纹图谱共有峰9个,且15批玄参饮片标准汤剂指纹图谱与对照指纹图谱相似度均高于0. 97。该研究所采用的玄参饮片标准汤剂制备工艺符合传统汤剂制法,15批玄参饮片样品具有一定代表性,建立的指纹图谱方法稳定可行,可为玄参配方颗粒质量标准制定及质量控制提供参考。

The standard decoction of Chinese herbal decoction pieces is a standard reference substance to measure whether different dosage forms of Chinese medicine are basically consistent with those of clinical decoction,and provides new ideas and methods for effectively solving the problems of uneven quality in Chinese medicine dispensing granules.In this study,a systematic method for evaluating the quality of Scrophulariae Radix decoction was established from the perspective of'standard decoction',providing reference for the quality control of the Scrophulariae Radix dispensing granules.15 batches of Scrophulariae Radix decoction pieces from different origins were collected,and 15 batches of standard decoctions were prepared according to the standardized process with water as solvent.Harpagide and harpagoside were used as quantitative detection indicators to determine the content,calculate the transfer rates and determine the extraction rate.The high performance liquid chromatography(HPLC)was used to establish a standard decoction fingerprint analysis method.The results showed that the transfer rates of harpagide and harpagoside in 15 batches of Scrophulariae Radix pieces standard decoction were(70.84±13.39)%and(48.56±6.40)%respectively;the extraction rate was(57.47±5.89)%.Nine peaks were identified in the HPLC fingerprint,and the similarity was higher than 0.97 between the fingerprints of 15 batches of standard decoction and the control fingerprint.In this study,the preparation process of standard decoction of Scrophulariae Radix pieces conformed to the traditional decoction preparation method.The sources of the samples were representative,and the established fingerprint method was stable and feasible,which can provide reference for the preparation and quality control of Scrophulariae Radix dispensing granules.