乌贝肠胃胶囊质量标准及指纹图谱研究

Study on the Quality Standard and Fingerprint of Wubei Changwei Capsule(乌贝肠胃胶囊)

目的:建立乌贝肠胃胶囊的质量标准及其指纹图谱,完善其质量评价方法。方法:采用薄层色谱法(TLC)鉴别乌贝肠胃胶囊;用高效液相色谱法(HPLC)建立乌贝肠胃胶囊的指纹图谱并测定其含量;运用SPSS 21.0软件进行聚类分析、主成分分析以评价乌贝肠胃胶囊的综合质量。结果:薄层色谱鉴别专属性良好;桂皮醛、去氢木香内酯质量浓度的线性范围分别为0.0080~0.0780 mg/mL、0.0050~0.0550μg/mL(r均大于0.999),精密度、稳定性、重复性试验的RSD均小于3%,平均加样回收率分别为102.43%(RSD=2.60%,n=6)、101.25%(RSD=0.8%,n=6)。10批乌贝肠胃胶囊共有14个共有峰,相似度为0.943~0.990。其中指认了4个化合物,包括桂皮醛、胡椒碱、木香烃内酯、去氢木香内酯。聚类分析与主成分分析结果一致,10批样品可分为5类,其中S1、S7、S8聚为一类,S2为一类,S3、S4、S5聚为一类,S6为一类,S9、S10聚为一类,并得到3个主成分因子在此评估中有主要的优势。结论:新建立的中药复方制剂乌贝肠胃胶囊质量标准、含量测定方法和HPLC指纹图谱稳定,为全面控制制剂的质量提供了依据。

Objective:To establish the quality standard and fingerprint of Wubei Changwei Capsule and improve its quality evaluation method.Methods:Wubei Changwei Capsule was identified by TLC.The fingerprint of Wubei Changwei Capsule was established by HPLC and its content was determined.SPSS 21.0 software was used for cluster analysis and principal component analysis to evaluate the comprehensive quality of Wubei Changwei Capsule.Results:The specificity of TLC was good.The linear range of mass concentration of cinnamaldehyde and dehydroandrolactone were 0.0080-0.0780 mg/mL and 0.0050-0.0550 respectivelyμg/mL(r>0.999).The RSD of the precision,stability and repeatability tests were all less than 3%,and the average sample recovery rates were 102.43%(RSD=2.60%,n=6)and 101.25%(RSD=0.8%,n=6),respectively.There were 14 common peaks in 10 batches of Wubei Changwei Capsule,with the similarity of 0.943-0.990.Among them,four compounds were identified,including cinnamaldehyde,piperine,lignanolide and dehydroandrolactone.The result of cluster analysis was consistent with that of principal component analysis.10 batches of samples can be divided into five categories,among them,S1,S7 and S8 aggregate into one category,S2 aggregate into one category,S3,S4 and S5 aggregate into one category,S6 aggregate into one category,and S9 and S10 aggregate into one category,and 3 principal component factors had major advantages in this evaluation.Conclusion:The newly established quality standard,content determination method and HPLC fingerprint of Wubei Changwei Capsule are stable,providing a basis for the overall control of the quality of the preparation.