【摘要】 目的:以抗脑衰胶囊为对象,研究准确反映制剂内在整体质量的分析方法。方法:采用高效液相色谱分析法建立抗脑衰胶囊制剂的指纹图潜,指纹图谱中28个共有吸收峰为抗脑衰胶囊内在物质的指纹特征。通过成药、药材、标准物对照品及相应药材阴性的对比研究,确定了相对保留时间21.3 min 为葛根素专属吸收峰（9号）,相对保留时间23.2 min 为芍药苷专属吸收峰（12号）,相对保留时间36.7 min 为黄芩苷专属吸收峰（19号）。其 HPLC 指纹图谱条件为:天河 Kromasil ODS C₁₈柱（4.6 mm×250 mm,5μm）;甲醇-0.6%醋酸水溶液系统梯度洗脱:流动相比例0 min,10:90;60 min,90:10;流速:0.9 mL·min^-1;柱温25℃;检测波长:280 nm。利用2004年 A 版《中药色谱指纹图谱相似度评价系统》计算软件,对10批次制剂指纹图谱的相似度进行评价。结果:不同批号制剂的相似度有较大差异,其中010105、020523、020850三个批次制剂相似度低于0.8,说明这些批次制剂可能在原料药材选择、提取工艺及干燥过程中存在问题。结论:抗脑衰胶囊制剂的指纹图谱能够全面反映制剂的整体质量,是一种有效的中药制剂质量分析的方法。更多还原

【Abstract】 Objective:To study on method for evaluating the quality of Kangnaoshuai capsule.Methods:The finger- print of Kangnaoshuai capsule were established by HPLC method.Total of shared 28 peaks were determined as char- acters of the medicine.The relationship of the shared peaks between Kangnaoshuai capsule and medicinal herbs confirmed the retention time 21.3 min absorptive peaks specific for paeoniflorin（number 9）,the retentiuon time 23.2 min absorptive peaks specific for puerariu（number 12）and retentiuon time 36.7 min absorptive peaks specific for baicalin（number 19）.The optimal HPLC condition for Kangnaoshuai capsule was ODS C₁₈column（4.6mm× 250mm,5μm）.The mobile phase was composed of methanol and 0.6% acetic acid with a linear gradient elution. The retio of methanol and 0.6% acetic acid was:0 min,10:90,60 min,90:10.The flow rate was 0.9 mL·min^-1 with DAD detected at 280 nm.The column temperature was maintained at 25℃.The similarity evaluation system for chromatographic fingerprint of TCM（Version 2004A）was used to ten batch samples（from 2001 to 2004）. Result:The results showed that batch similarity of number 010105,020523 and 020850 were under 0.8.indicating that there existed problem in medicinal materials select,extract technics or dryness.Conclusion:The method repor- ted in this paper can be used scientifically and effectively to evaluate the quality of Kangnaoshuai capsule.更多还原