| Zhenqi Fuzheng Capsule is a kind of capsule made of Ligustrum lucidum and Astragalus.It has the functions of improving human immunity,protecting bone marrow and adrenal cortex.It is mainly used for the treatment of chronic deficiency of body and deficiency of Qi and Yin.Zhenqi Fuzheng capsule has significant curative effect and many applicable diseases,but the research on its quality control is far from enough,which seriously affects its market prospects and potential value development.At present,the current quality standard of Zhenqi Fuzheng capsule only qualitatively and quantitatively analyzes the astragaloside in the compound Chinese herbal medicine,but the composition of the compound Chinese herbal medicine is complex and only studies the single component or characteristic component,which can not fully control the quality of its medicine.Therefore,in order to explore a more scientific quality control system of Zhenqi Fuzheng capsule,the study used fingerprint technology to carry out the whole process quality control of Zhenqi Fuzheng capsule from raw materials to preparation intermediates to finished product preparation of Zhenqi Fuzheng capsule,so as to provide reference for improving the quality evaluation of Zhenqi Fuzheng capsule.The main results were as follows:(1)In this study,L.lucidum was taken as the research object of the raw material in Zhenqi Fuzheng capsule.The method of fingerprint determination of L.lucidum was studied by HPLC,and it was verified in accordance with the relevant guidelines of “Chinese Pharmacopoeia”.The fingerprint of L.lucidum was established and its characteristic map was constructed with the help of fingerprint evaluation software.33 common peaks were identified in the experiment,and the area of the common peaks was used as the clustering parameter.The cluster analysis showed that the L.lucidum seeds collected in the experiment could be divided into class I and class II.The first group is further divided into two groups: A and B.Among them,batches S25,S31,S26,S28,S30,S27,S29,S19,S22,S23,S24,S32,S33,S17,S20,S43,S11,S12,S1,S44,S41,S42,S16,S40,S4 and S20 were first grouped together;S9,S14,S10,S8,S2 and S7 were grouped together;S54 and S55 were grouped together;S57,S53,S52,S36,S49,S50 and s56 were grouped together;S18,S21,S58,S59,S60,S48,s51,s47,S13,S37,S15 and S5 were grouped together;S45,S46,s38,S39,S34,S35 and S3 were grouped together,indicating that there were certain differences in L.lucidum from different regions.(2)In this study,the semi-finished product of Zhenqi Fuzheng Capsule was taken as the research object,and the fingerprint of the semi-finished product of Zhenqi Fuzheng Capsule was determined by HPLC.The results showed that S01,S02,S03,S04,S06,S07,S08,S09,S10,S11 and S13 were the first category,and the semi-finished products of Zhenqi Fuzheng capsule of S05 and S12 were the second category.The area of the second kind of common peak was relatively high,and the areas of the two kinds of common peaks are similar.It is confirmed that the content of the common peak compounds in the HPLC chromatogram of 13 batches of the semi-finished products of Zhenqi Fuzheng capsule was basically the same.Through the cluster analysis of different batches of samples,the results showed that there was a significant correlation between the cluster results and the content of common peak area,which provided a theoretical basis for judging the quality of Zhenqi Fuzheng capsule semi-finished products.(3)In this study,the product preparation of Zhenqi Fuzheng capsule was taken as the research object,and the HPLC technology was used to carry out the research on the fingerprint determination method of the product preparation of Zhenqi Fuzheng capsule.The fingerprint of the product preparation of Zhenqi Fuzheng capsule was established by using the fingerprint evaluation software and its characteristic map was constructed.28 common peaks were determined,and the area of the common peaks was used as the cluster reference.The results showed that S01,S02,S03,S10 and S11 were in the first category,and S04,S05,S06,S07,S08,S09 and S12 were in the second category.The area of the common peaks of the two groups was similar,which confirmed that the content of the common peaks of the 13 batches of Zhenqi Fuzheng capsule was basically the same.Through the cluster analysis of different batches of samples,the results showed that there was a significant correlation between the cluster results and the content of common peak area,which provides a theoretical basis for judging the quality of Zhenqi Fuzheng capsule.(4)In order to elucidate the in vitro inhibitory activity and bioactive components of L.lucidum extracts on xanthine oxidase,the high-throughput screening method was used to detect the inhibitory effect of L.lucidum extract on xanthine oxidase,the HPLC fingerprint of L.lucidum was established based on ultraviolet spectrophotometry,the principal component analysis,grey correlation analysis and partial least square method were used The relationship between the bioactivity of L.lucidum extract and its HPLC fingerprint was discussed.The results showed that the extracts of L.lucidum had obvious inhibitory effect on xanthine oxidase,and there were differences among different batches of medicinal materials,with the similarity between 0.635-0.968.The 33 characteristic peaks(1-33)were corrected by the fingerprint evaluation software of TCM.The results showed that the contents of 1,2,4,5,6,7,14,17,25,28,31 and 33 peaks were closely related to the inhibition of xanthine oxidase activity,which could be used as a potential key component in the quality control of L.lucidum. |
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