Holistic quality evaluation of Panax notoginseng extract and injection using an UPLC-QTOF-MS^E based metabolomics approach

In the present study, we established an UPLC-QTOF-MSE based metabolomic approach in order to evaluate the holistic qualities and compare the quality difference by finding characteristic components of Panax notoginseng extracts （PNE） and Xuesaitong （XST） injection samples from different manufacturers. The data were processed through unsupervised principal component analysis （PCA） and supervised orthogonal partial least squared discrimination analysis （OPLS-DA） to compare the quality differences. Two-dimensional PCA score plots showed a tendency to separate the XST injections and extracts, and most XST injection samples were clearly clustered into two groups. Especially, the injections from He and YB companies were distinguished into two groups. In addition, only injection samples of Hu company were near the cluster of PNE. To explore the potential chemical components contributing most to the differences between XST injection samples from different manufacturers and PNE, an S-plot was constructed following the OPLS-DA. Ginsenoside Rd, ginsenoside Rgl, ginsenoside Re, ginsenoside Rbl, 20（S）-ginsenoside Rhl, gypenoside VII, ginsenoside Rg2, ginsenoside Rh4, ginsenoside Rkl or Rgs, notoginsenoside Fc, 20（R）-ginsenoside Rg3, ginsenoside F2 and protopanaxadiol were recognized as characteristic chemical markers that contributed most to reflect the difference between XST injections and PNE. Ginsenoside Rd, ginsenoside Rgl, ginsenoside Re, ginsenoside Rbl and gypenoside VII were revealed as index components contributing most to the differences of PNE and XST injections, and quantitative analysis of these components could ensure the consistent quality of XST injections. Based on the fact that the injections should be standardized with the characteristic components as quality control chemical markers, it is most important to keep the quality of extracts of raw materials stable and reliable.

MHC-2D LC STRATEGY FOR THE HOLISTIC QUALITY CONTROL OF NOTOGINSENG-CONTAINING CHINESE PATENT MEDICINES

Current China Pharmacopoeia(ChP)standards employ diversified and case-dependent assay methods to evaluate the quality of different Chinese patent medicines(CPM)that contain Panax notoginseng as the monarch drug.These conventional HPLC-based approaches utilizing complex sample preparation procedure can easily result in low analytical efficiency and possible component loss.We thereby propose a'monomethodheterotrait matrix'(MHM)

Progress and Challenges of Reference Standard and Its New Form: Digital Reference Standard

Number and quantities of reference standards (RS) needed for the quality control of drugs are increasing, bringing great pressure to the calibration and using company. This manuscript summarized the four generations for the development of RS including physical RS, paper atlas, substitute RS and electronic databases. The advantages and disadvantages of each generation were summarized. The concept of digital RS (DRS) was proposed based on this, and summed up the definition, advantages, and technical architecture of DRS. The 10 characteristics of five aspects of the DRS were discussed including digital, multi-dimension, big data, cloud computing, internet, internet of things, sharing, multi-terminal, intelligence, and compliance certification. Then, the necessity of its formation and application in the medicine holistic quality control of internet plus era was discussed in this manuscript.

Comparative study on main compounds in Ginkgo biloba L. base on mathematical statistics

In this paper,an HPLC-DAD-ELSD method was developed to determine main 20 components of Ginkgo biloba L.leaves from different ages and sources,including six flavonol glycosides,five terpene lactones and nine organic acids.Using statistics method and establishing relevant mathematics models,the measured data has proceeded correlation analysis,principal component analysis,and regression statistics and the results showed generality and specific characteristics.We defined p-hydroxybenzoic acid,catechinic,KRcG and ginkgolide A as characteristic indexes representing commonness and speciality of Ginkgo biloba L.leaf.The four characteristic indexes can reflect the quality of Ginkgo biloba L.leaf,and the intermal relations between them are significant.The contents of other compounds could define the quantity relation with characteristic markers.It simplified the approach of quality control,and provided a basis for quality control of Ginkgo biloba L.