黄芩提取物制备过程的关键工段辨识研究

Identification of critical sections in the preparation of Scutellaria baicalensis extract

目的辨识黄芩提取物制备工艺的关键工段。方法首先对液相色谱分析方法进行了方法学验证,然后采用多批次黄芩药材进行水煎、酸沉、碱溶、乙醇洗涤和干燥等工艺制备黄芩提取物。将制备工艺分为8个工段,分别检测了药材、中间体和黄芩提取物中总固体、黄芩苷、汉黄芩苷和黄芩素的含量,并根据结果计算总固体产量、黄酮产量和纯度。计算了过程中间体和黄芩提取物的组成相似度变化情况,提出采用一致性变化量(TVC)作为指标定量表征制药工艺对批次间一致性影响。结果欧氏距离是较灵敏的相似度指标。根据TVC和相似度变化大小确定了关键工段为工段1、工段2和工段4,其对应的工艺包括水煎、酸沉和乙醇洗涤等。结论综合考虑相似度变化和TVC可以用于辨识中成药生产关键工段,该方法适合用于分析流程较长的中成药生产工艺。

Objective To identify the critical sections in the preparation of Scutellaria baicalensis extract.Methods First,liquid chromatography analysis was verified.Then,different batches of Scutellaria baicalensis were used to prepare Scutellaria baicalensis extract with water decoction,acid precipitation,alkali dissolution,ethanol washing and drying.The preparation process was divided into 8 sections.The content of total solid,baicalin,wogonoside and baicalein in multiple materials was analyzed.The total solid yield,flavonoid yield,and flavonoid purity were calculated according to the results.The similarity changes of the intermediates and Scutellaria baicalensis extract in the process were measured.A quantitative indicator,namely total variation change(TVC)was proposed,and used to characterize the impact of pharmaceutical processes on batch-to-batch consistency.Results Euclidean distance is a more sensitive indicator of similarity.According to total variation change and similarity,the critical sections included section 1,section 2,and section 4.The corresponding processes included water decoction,acid precipitation,and ethanol washing.Conclusion Comprehensive consideration of similarity changes and consistency changes helps identify the critical sections of Chinese medicines,which is suitable for analyzing Chinese medicine production with many procedures.