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Zhang B.-H.,Shanxi Institute for Food and Drug Control | Wang F.,Shanxi Institute for Food and Drug Control | Meng X.-F.,Shanxi Institute for Food and Drug Control | Xu C.-G.,Shanxi Institute for Food and Drug Control | And 3 more authors.
Chinese Pharmaceutical Journal | Year: 2013

OBJECTIVE: To establish the determination method of the related substances in ibuprofen raw materials, tablets and capsules. METHODS: High performance liquid chromatography (HPLC) was used for the determination of 2-(4-isobutyl phenyl) propanoic acid, 4-isobutyl benzoic acid, sodium methyl hydroxybenzoate(provided by national institutes for food and drug control), 4′-isobutyl acetophenone (known impurities of JP), the relative substance A, J, N (known impurities of EP), and the unknown impurities. A Kromasil C18 column (4.6 mm × 250 mm, 5 μm) was used as the analytical column, acetonitrile-water (pH adjusted to 3.0 by phosphoric acid) (45:55) were used as the mobile phase, the flowing rate was 1.0 mL · min-1, the detection wavelength was set at 254 nm, and the column temperature was 35°C. RESULTS: The relative substances detected in ibuprofen raw materials and its preparations were mainly 4-isobutyl benzoic acid and 4′-isobutyl acetophenone. The contents of unknown impurities were also high in the preparations of some manufacturers. CONCLUSION: The method can be used for the analysis of the related substances in ibuprofen raw materials and its preparations.


Xie J.-S.,Peking Union Medical College | Xie J.-S.,Northwest University, China | Wen J.,Chinese Pharmaceutical Association | Wang X.-F.,Peking Union Medical College | And 6 more authors.
Molecules | Year: 2015

Using potassium hexacyanoferrate (III)-sodium acetate as oxidant, the oxidative coupling reaction of isorhapontigenin and resveratrol in aqueous acetone resulted in the isolation of three new indane dimers 4, 6, and 7, together with six known stilbene dimers. Indane dimer 5 was obtained for the first time by direct transformation from isorhapontigenin. The structures and relative configurations of the dimers were elucidated using spectral analysis, and their possible formation mechanisms were discussed. The results indicate that this reaction could be used as a convenient method for the semi-synthesis of indane dimers because of the mild conditions and simple reaction products. © 2015 by The Authors.


Zhang Q.,National Institute of Food and Drug Control | Wang A.,National Institute of Food and Drug Control | Meng Y.,National Institute of Food and Drug Control | Ning T.,National Institute of Food and Drug Control | And 4 more authors.
Analytical Chemistry | Year: 2015

13C NMR spectroscopic integration employing short relaxation delays and a 30° pulse width was evaluated as a quantitative tool for analyzing the components of polysorbate 80. 13C NMR analysis revealed that commercial polysorbate 80 formulations are a complex oligomeric mixture of sorbitan polyethoxylate esters and other intermediates, such as isosorbide polyethoxylate esters and poly(ethylene glycol) (PEG) esters. This novel approach facilitates the quantification of the component ratios. In this study, the ratios of the three major oligomers in polysorbate 80 were measured and the PEG series was found to be the major component of commercial polysorbate 80. The degree of polymerization of -CH2CH2O- groups and the ratio of free to bonded -CH2CH2O- end groups, which correlate with the hydrophilic/hydrophobic nature of the polymer, were analyzed, and were suggested to be key factors for assessing the likelihood of adverse biological reactions to polysorbate 80. The 13C NMR data suggest that the feed ratio of raw materials and reaction conditions in the production of polysorbate 80 are not well controlled. Our results demonstrate that 13C NMR is a universal, powerful tool for polysorbate analysis. Such analysis is crucial for the synthesis of a high-quality product, and is difficult to obtain by other methods. © 2015 American Chemical Society.


Chen B.,Chinese Pharmaceutical Association | Yang Y.-X.,China Pharmaceutical University
Chinese Journal of New Drugs | Year: 2014

The question whether the pioneer drug labeling subject to the Author's Right Law protection in China had been raised again since the ruling of the Changsha People's Court in the case Xiangbei Welman Pharm. Co. vs. Suzhou Erye Pharm. Co. was published. Arguments are mostly focused on whether an Author's Right exists on a pioneer drug product's labeling. To establish the right, the labeling should be approved as original intellectual creations, and the rulings of the US court in Computer Association International, Inc. v. Altai, Inc. could be a good test to the originality. Further questions remain not solved, because the conflicts between the new drug originator's copyright on the labeling and the privilege the competent authority invested to the generic manufacturers. Similar dilemma had also embarrassed the US government and the industry before. The right solution is to give propriety to the generic drug regulations than the copyright of the pioneer drug labeling so that to encourage generic penetration, and in turn to guarantee the public affordability of medicines. Suggestions to the Chinese legislation, regulation and pharmaceutical industry are also proposed.


Pu R.,Peking University | Geng X.-N.,Chinese Pharmaceutical Association | Yu F.,Peking University | Liang H.-G.,East Carolina University | Shi L.-W.,Peking University
Chinese Journal of Integrative Medicine | Year: 2013

Objective: To perform meta-analyses evaluating the efficacy of adding Liuwei Dihuang Pills (LDP) to Western medicine in improving treatment outcomes for type 2 diabetes. Methods: Medline, PubMed, Cochrane Library, and Chinese databases, including the Chinese National Knowledge Infrastructure were searched to identify eligible studies; i.e., if the study involved a randomized clinical trial in which the experimental group combined LDP with Western drugs and the control group used the corresponding Western drugs alone to treat type 2 diabetes. Outcomes were measured in terms of fasting blood glucose (FBG), postprandial blood glucose (2hPG) and HbA1c level. Efficacy was also measured by using control and response rates. The combined odds ratio (OR), mean difference (MD), and 95% confidence intervals (95% CI) were calculated. Results: Studies included in the analysis were less adequate than expected in terms of methodological quality. A total of 1,609 patients from 18 studies were included. We found that adding LDP can lower patients' FBG (MD=0.54 mmol/L, 95% CI [0.15, 0.93], P=0.007), 2hPG (MD=1.05 mmol/L, 95% CI [0.29, 1.81], P<0.01) and HbA1c (MD=0.23, 95% CI [0.02, 0.45], P=0.008). There were also improvements in treatment response rates (OR=3.41, 95% CI [2.38, 4.90], P<0.01) and control rates (OR=2.47, 95% CI [1.91, 3.20], P<0.01). Conclusion: Adding LDP to Western medicine might improve treatment outcomes of diabetes, including FBG, 2hPG, response rates and control rates. © 2013 Chinese Association of the Integration of Traditional and Western Medicine and Springer-Verlag Berlin Heidelberg.

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