论文部分内容阅读
该文尝试将多指标成分同时定量分析和生物效价分析方法联合使用的模式应用于中药配方颗粒的质量评价,并以大黄配方颗粒为模式药进行了示范性研究。采用超高效液相色谱法同时测定大黄配方颗粒中芦荟大黄素-8-O-β-D-葡萄糖苷等10个蒽醌类化学成分的含量;在复方地芬诺酯片致小鼠便秘模型上,测定不同批次大黄配方颗粒致泻生物效价;在体外抗大鼠血小板聚集模型基础上,测定不同批次大黄配方颗粒的活血生物效价;采用SPSS统计软件对测定的10个蒽醌类化学成分与致泻、活血生物效价之间的相关性进行统计学分析。多指标化学含量测定结果显示10个批次间大黄配方颗粒的化学表征差异较大,与此同时,致泻、活血生物效价均存在一定的差异性;相关性分析结果显示大黄配方颗粒的致泻生物效价强弱和其含有的结合型蒽醌糖苷类成分的含量有显著相关性(P<0.01),活血生物效价的强弱和其含有的游离型蒽醌成分的含量有显著相关性(P<0.01)。综上,采用多组分化学表征和生物效价检测联用的模式可以客观量化、更全面的反映不同批次大黄配方颗粒的整体质量差异。
This paper attempts to apply the combination of simultaneous quantitative analysis of multi-index components and bio-potency analysis to the quality evaluation of traditional Chinese medicine granules. The rhubarb granules are used as model drug. To determine the content of 10 anthraquinones such as aloe-emodin-8-O-β-D-glucoside in rhubarb granules by ultra performance liquid chromatography (HPLC) On the basis of the in vitro anti-rat platelet aggregation model to determine the biological activity of different batches of rhubarb granules; using SPSS statistical software on the measured 10 anthraquinone The correlation between chemical composition and diarrhea and blood-activating biological potency was statistically analyzed. The results of multi-index chemical assay showed that there were significant differences in the chemical characterization of Rhubarb formula particles among 10 batches, meanwhile there were some differences in the potency of Diarrhea and Huoxue biochemistry. The correlation analysis showed that Rhubarb formula particles There was a significant correlation between the potency of diarrheal organisms and the content of anthraquinones glycosides contained in them (P <0.01). The biological potency of blood was significantly correlated with the content of free anthraquinones (P <0.01). In summary, the combination of multi-component chemical characterization and bio-potency detection can objectively quantify and reflect the overall quality differences of rhubarb formulating granules in different batches.