摘要
目的 比较贞芪扶正胶囊(女贞子、黄芪)及其中药配方颗粒、传统饮片的有效成分差异.方法 采用高效液相色谱法(HPLC)定量分析,比较贞芪扶正胶囊及其对应比例重量的饮片和配方颗粒中主要有效成分(毛蕊异黄酮葡萄糖苷、特女贞苷、黄芪甲苷)含量差异,根据药物指纹图谱进行对照分析,比较药物出峰情况,从化学成分角度分析贞芪扶正胶囊及其中药配方颗粒、传统饮片所含有效成分是否具有一致性.结果 贞芪扶正胶囊对照品中特女贞苷、毛蕊异黄酮葡萄糖苷、黄芪甲苷在各自范围内线性关系良好(r=0.999 8、0.999 6、0.999 7).重复性试验和稳定性试验表明3 种剂型供试品各成分重复性良好且在24h内稳定.加样回收率试验表明HPLC对3 种剂型供试品各成分检测的准确度良好.毛蕊异黄酮葡萄糖苷、特女贞苷、黄芪甲苷在贞芪扶正胶囊中含量分别为(5.384±0.858)、(25.849±3.142)、(36.065±3.026)μg/mL,在中药配方颗粒中含量分别为(5.825±0.965)、(25.463±3.075)、(35.618±2.847)μg/mL,在传统饮片中含量分别为(5.564±0.958)、(25.974±2.986)、(35.459±2.468)μg/mL;3 种剂型中上述有效成分的含量均无差异(P＞0.05).结论 贞芪扶正胶囊及其中药配方颗粒、传统饮片主要有效成分相同,含量无差异,为贞芪扶正胶囊及中药配方颗粒在临床上替代传统饮片提供了依据.
Abstract
Objective To compare the differences in effective components between Zhenqi Fuzheng capsules(Ligus-trum lucidum,Astragalus)and its traditional Chinese medicine(TCM)formula granules and traditional decoction tablets.Methods Quantitative analysis was performed by high performance liquid chromatography(HPLC)to compare the content differences of the main active components(calycoisoflavone glucoside,ligustrin and astragaloside)of Zhenqi Fuzheng cap-sule,its decoction tablets of corresponding proportion and weight,and formula granules of the corresponding proportion and weight,and conduct comparative analysis according to the drug fingerprint.The peak status(peak type,peak quantity and common peak content)was compared,and the consistency of active ingredients in Zhenqi Fuzheng capsule,TCM formula granules and traditional decoction tablets was analyzed from the perspective of chemical composition.Results In Zhenqi Fuzheng capsules,the linear relationship of ligustrine,glucoside and astragaloside was good in their respective ranges(r=0.999 8,0.999 6,0.999 7).Repeatability test and stability test showed that the components of the three formulations had good repeatability and were stable within 24 h.The recovery test showed that HPLC had good accuracy in detecting the compo-nents of the three formulations of the test samples.The contents of glucoside,ligustrine and astragaloside were(5.384±0.858),(25.849±3.142)and(36.065±3.026)μg/mL,respectively,in Zhenqi Fuzheng capsule,(5.825±0.965),(25.463±3.075)and(35.618±2.847)μg/mL,respectively,in TCM formula granules,and(5.564±0.958),(25.974±2.986),(35.459±2.468)μg/mL,respectively,in traditional decoction tablets.There was no difference in the content of the above active ingredients among the three dosage forms(P＞0.05).Conclusion The main active ingredients of Zhenqi Fuzheng capsule and its TCM formula granules and traditional decoction tablets are identical,and the content had no difference,which provides the basis for Zhenqi Fuzheng capsule and TCM formula granules to replace traditional decoction tab-lets in clinical practice.
维普
万方数据