Shandong Key laboratory of Polymorphic Drugs

Tengzhou, China

Shandong Key laboratory of Polymorphic Drugs

Tengzhou, China
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Gong N.,Peking Union Medical College | Jin G.,Peking Union Medical College | Gao Z.,Shandong Key laboratory of Polymorphic Drugs | Du G.,Peking Union Medical College | And 2 more authors.
Current Analytical Chemistry | Year: 2016

Objective: The aim of this study was to prepare and certify a new Certified Reference Material (CRM) of quercetin for the quality control of quercetin and related functional foods and botanical supplements. Methods: Three different methods, including coloumetric titration (CT), differential scanning calorimetry (DSC) and mass balance (MB) methods were used in the purity determining process. Results: The purity results determined by the three methods were consistent, and the CT has the highest accuracy and the smallest uncertainty. Conclusion: CT and DSC methods were established for purity determination of quercetin for the first time. The purity of quercetin CRM, after validation and evaluation, was 99.3% ± 0.4% (k = 2, P = 0.95). The new CRM can be widely used to quantitatively analyse quercetin and other related functional foods and botanical supplements. © 2016 Bentham Science Publishers.


Yang S.,Peking Union Medical College | Yang D.,Peking Union Medical College | Hu K.,Peking Union Medical College | Zhou H.,Peking Union Medical College | And 4 more authors.
Analytical and Bioanalytical Chemistry | Year: 2015

Honokiol is the most important active pharmaceutical ingredient in Magnolia officinalis, which is a famous traditional Chinese medicine and commonly used in clinical practice. In order to control the quality of honokiol and related pharmaceuticals, a new certified reference material (CRM) of honokiol was developed. The studies of sample preparation, homogeneity, stability, value assignment, and uncertainty evaluation were accomplished in this paper. Three different methods, including differential scanning calorimetry (DSC), mass balance method (MB), and coulometric titration (CT), were employed to determine the purity of honokiol. Specifically, the DSC and CT methods for purity determination of honokiol were established for the first time. The purity of honokiol CRM, after validation and evaluation, was found to be 99.3 %, with an expanded uncertainty of 0.5 % (k = 2). © 2015 Springer-Verlag Berlin Heidelberg


Gong N.,Peking Union Medical College | Zhang B.,Peking Union Medical College | Yang D.,Peking Union Medical College | Gao Z.,Shandong Key laboratory of Polymorphic Drugs | And 3 more authors.
Journal of the Science of Food and Agriculture | Year: 2015

BACKGROUND: Neohesperidin is an important natural flavanone glycoside distributed in several citrus species. This compound is widely used as a raw material for food additives in the food industry. The request for certified reference materials (CRMs) in dietary supplements was stipulated by the National Administrative Committee for CRMs and was underpinned by the need to improve the accuracy and comparability of measurement data and to establish metrological traceability of analytical results. RESULTS: This paper reports the sample preparation methodology, homogeneity and stability studies, value assignment and uncertainty estimation of a new certified reference material of neohesperidin (GBW09522). Differential scanning calorimetry, coulometric titration and mass balance methods proved to be sufficiently reliable and accurate for certification purposes. The certified value of neohesperidin CRM is 994 g kg-1 with an expanded uncertainty of 4 g kg-1 (k = 2). The reference material described above was homogeneous and stable for 12 months at a storage temperature of 25 °C. CONCLUSION: The new CRM of neohesperidin can be used to validate analytical methods and improve the accuracy of measurement data as well as quality control of neohesperidin-related dietary supplements, foods, traditional herbs and pharmaceutical formulations. © 2014 Society of Chemical Industry.


Gong N.,Peking Union Medical College | Wang X.,Peking Union Medical College | Zhang B.,Peking Union Medical College | Gao Z.,Shandong Key laboratory of Polymorphic Drugs | And 3 more authors.
Journal of Pharmaceutical and Biomedical Analysis | Year: 2014

A new certified reference material (CRM) of baicalein was developed aiming to control the quality of baicalein and relative pharmaceuticals. Sample preparation, homogeneity, stability, value assignment, and uncertainty of a new certified reference material (CRM) of baicalein were presented in this paper. Characterization of the material relied on three different methods, which were differential scanning calorimetry (DSC), coulometric titration method (CT) and mass balance method. DSC and CT were used for purity determination of baicalein firstly. The certified value of baicalein CRM is 99.72% with an expanded uncertainty of 0.25% (k= 2). The new CRM of baicalein can be used to validate analytical methods, improve the accuracy of measurement data as well as establish meteorological traceability of analytical results. © 2013 Elsevier B.V.


Yang S.,Peking Union Medical College | Yang D.,Peking Union Medical College | Gong N.,Peking Union Medical College | Xu W.,Peking Union Medical College | And 4 more authors.
Accreditation and Quality Assurance | Year: 2016

Chrysin, a naturally occurring flavone, extracted from traditional Chinese herbs and abundantly found in propolis has been known to exhibit a wide range of biological activities, such as antioxidant, anti-inflammatory, hypolipidemic, anti-hypertensive, anti-diabetic, and anti-tumour activities. Among this, its anticancer effects make chrysin promising to be a candidate drug. The objective of this study was to develop a new certified reference material (CRM) for the quality control of traditional Chinese medicine, chrysin, and the related pharmaceuticals. The studies of sample preparation, homogeneity, stability, value assignment, and uncertainty evaluation were accomplished in this paper. Two different methods, namely differential scanning calorimetry and coulometric titration, were utilized for the first time to determine the purity of chrysin. The purity of the high-purity chrysin CRM, after validation and evaluation, was certified to be (0.996 ± 0.015) g/g (k = 2). © 2016 Springer-Verlag Berlin Heidelberg


Gong N.,Chinese Academy of Sciences | Liu S.,Chinese Academy of Sciences | Xu W.,Chinese Academy of Sciences | Shi Y.,Shandong Key Laboratory of Polymorphic Drugs | And 3 more authors.
Analytical Methods | Year: 2013

A reliable, sensitive, and rapid coulometric titration (CT) method was developed for the purity determination of luteolin reference material candidates. The results obtained from the proposed CT method were compared with those obtained from differential scanning calorimetry (DSC) and mass balance method. The performance of the CT method was comparable, and the quantitative results of the proposed methods were in good agreement with those of DSC and mass balance methods. CT has the advantages of minimal sample requirement, rapid measurement, high accuracy, good reproducibility, and no corresponding reference standard requirement. This method can be used for luteolin purity assays and related production quality control. This journal is © The Royal Society of Chemistry 2013.


PubMed | Shandong Key laboratory of Polymorphic Drugs and Peking Union Medical College
Type: Journal Article | Journal: Journal of the science of food and agriculture | Year: 2015

Neohesperidin is an important natural flavanone glycoside distributed in several citrus species. This compound is widely used as a raw material for food additives in the food industry. The request for certified reference materials (CRMs) in dietary supplements was stipulated by the National Administrative Committee for CRMs and was underpinned by the need to improve the accuracy and comparability of measurement data and to establish metrological traceability of analytical results.This paper reports the sample preparation methodology, homogeneity and stability studies, value assignment and uncertainty estimation of a new certified reference material of neohesperidin (GBW09522). Differential scanning calorimetry, coulometric titration and mass balance methods proved to be sufficiently reliable and accurate for certification purposes. The certified value of neohesperidin CRM is 994 g kg(-1) with an expanded uncertainty of 4 g kg(-1) (k = 2). The reference material described above was homogeneous and stable for 12 months at a storage temperature of 25 C.The new CRM of neohesperidin can be used to validate analytical methods and improve the accuracy of measurement data as well as quality control of neohesperidin-related dietary supplements, foods, traditional herbs and pharmaceutical formulations.


PubMed | Shandong Key laboratory of Polymorphic Drugs and Peking Union Medical College
Type: | Journal: Journal of pharmaceutical and biomedical analysis | Year: 2013

A new certified reference material (CRM) of baicalein was developed aiming to control the quality of baicalein and relative pharmaceuticals. Sample preparation, homogeneity, stability, value assignment, and uncertainty of a new certified reference material (CRM) of baicalein were presented in this paper. Characterization of the material relied on three different methods, which were differential scanning calorimetry (DSC), coulometric titration method (CT) and mass balance method. DSC and CT were used for purity determination of baicalein firstly. The certified value of baicalein CRM is 99.72% with an expanded uncertainty of 0.25% (k=2). The new CRM of baicalein can be used to validate analytical methods, improve the accuracy of measurement data as well as establish meteorological traceability of analytical results.

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