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Zou L.,China Pharmaceutical University | Li X.,China Pharmaceutical University | Shi Q.,Jiangsu Institute for Food and Drug Control | Feng F.,China Pharmaceutical University
Analytical Methods | Year: 2014

Zhi-Zi-Da-Huang decoction (ZZDHD) is an effective formula to treat alcoholic liver disease in China for nearly 2000 years. However, compounds in the formula are still not clear due to the complexity of the coexisting constituents. In this study, a sensitive integrated method based on HPLC-DAD-ESI-MS (TOF) and HPLC-DAD-ESI-MS/MS (QqQ) was developed and 85 chemical compounds in ZZDHD were identified. By TOF/MS, the quasi-molecular ions of the constituents were deduced according to the accurate mass of corresponding positive and negative ions, and product ion scan was then carried out using QqQ/MS. The fragments of each compound were observed by TOF/MS and/or QqQ/MS. Compounds with different chemical structures and concentration levels were tentatively identified according to their chromatographic retention time, UV absorption and MS data. Fragmentation patterns of six types were proposed to verify the identification results. It was found that at TOF/MS mode, a retro diels-alder (RDA) reaction occurred at bonds 1 and 3 in C-ring of flavanone 7-O-diglycosides when 4′-OH exists at B-ring. While the reaction was not observed if a methoxyl group appeared at the same site of flavanone skeleton. Another important phenomenon was noticed that 3-sinapoyl-5-caffeoylquinic acid, 4-sinapoyl-3-caffeoylquinic acid, and sinapylglucoside were detected only in ZZDHD while they were not found in four component herb extracts. The phenomenon revealed that changes of compounds happened when the component herbs were decocted together. The results in the paper are favorable of the clinic dosage and have laid a foundation for the subsequent research of ZZDHD in vivo. © 2014 the Partner Organisations.

Zhang Z.-H.,Jiangsu Province Academy of Traditional Chinese Medicine | Sun Y.-S.,Shanghai University of Traditional Chinese Medicine | Pang H.,Jiangsu Institute for Food and Drug Control | Munyendo W.L.L.,China Pharmaceutical University | And 2 more authors.
Molecules | Year: 2011

The purpose of this research was to prepare floating calcium alginate beads of berberine for targeting the gastric mucosa and prolonging their gastric residence time. The floating beads were prepared by suspending octodecanol and berberine in sodium alginate (SA) solution. The suspension was then dripped into a solution of calcium chloride. The hydrophobic and low-density octodecanol enhanced the sustained-release properties and floating ability of the beads. The bead formulation was optimized for different weight ratios of octodecanol and SA and evaluated in terms of diameter, floating ability and drug loading, entrapment and release. In vitro release studies showed that the floating and sustained release time were effectively increased in gastric media by addition of octodecanol. In vivo studies with rats showed that a significant increase in gastric residence time of beads had been achieved. © 2011 by the authors; licensee MDPI, Basel, Switzerland.

An L.,China Pharmaceutical University | Shi Q.,Jiangsu Institute for Food and Drug Control | Feng F.,China Pharmaceutical University
RSC Advances | Year: 2015

Zhi-Zi-Da-Huang decoction (ZZDHD), a Traditional Chinese Medicine (TCM) formula, has been widely used for the treatment of alcohol-induced liver injury for many years. To comprehensively explore the possible mechanism of the hepatoprotective effects of ZZDHD, a nuclear magnetic resonance (NMR)-based metabolomics study, 1H NMR spectra combined with pattern recognition methods including PCA and OPLS-DA, was applied to identify potential plasma and liver biomarkers responsible for the positive effects of ZZDHD on alcohol-induced liver injury in rats. PCA gave a global overview of control, alcohol and ZZDHD group rats. Potential plasma and liver biomarkers that were obtained from OPLS-DA loading plots combined with the corresponding VIP values reflected the hepatoprotective effects of ZZDHD associated with alcohol-induced liver injury. The results suggested that 9 potential plasma biomarkers including, lipoprotein, leucine, valine, dihydrothymine, 3-d-hydroxybutyrate, lactate, alanine, acetate and glucose, and 8 potential liver biomarkers, triglyceride, lactate, alanine, acetate, glutamine, glucose, xanthine and hypoxanthine were identified. Related metabolic pathway analysis found that ZZDHD significantly alleviated the disturbance in energy metabolism, glucose metabolism, amino acid metabolism, lipid metabolism, nucleic acid metabolism, ameliorating lipid peroxidation and permeability change of membrane, and oxidative stress induced by alcohol. The results indicated that ZZDHD could achieve remarkable effects on alcoholic hepatic injury through partially preventing or regulating the perturbed metabolic pathways. The study also demonstrated that NMR-based metabolomics was a useful tool for screening potential biomarkers, further helping to explain the therapeutic mechanism of TCM formula on a comprehensive scale. © 2015 Royal Society of Chemistry.

Deng X.,Catholic University of Leuven | Yuan Y.,Jiangsu Institute for Food and Drug Control | Adams E.,Catholic University of Leuven | Van Schepdael A.,Catholic University of Leuven
Talanta | Year: 2013

A fast and sensitive chiral capillary electrophoresis method has been developed to determine levornidazole and its enantiomeric impurity at a 0.05% level in levornidazole injection solution. Several chemical and instrumental parameters which have an effect on chiral separation were investigated, including chiral selectors, buffer composition and pH, applied voltage, capillary length, temperature and rinsing procedure. After optimizing all the effective parameters, the ideal separation conditions were 20 mM Tris phosphate buffer at pH 2.1, containing 2.0% (w/v) sulfated-α-cyclodextrin with short end injection at 0.5 psi for 5.0 s. Online UV detection was performed at 277 nm. A voltage of 30 kV was applied and the capillary temperature was kept at 25 °C. 2,4,6-triaminopyrimidine was chosen as internal standard to improve the injection precision. The total analysis time is less than 7 min, which is faster than the existing chiral HPLC method (65 min). The validation of the method was performed in terms of factorial analysis, stability of the solution, different cyclodextrin batches study, selectivity, linearity (from 2.5 μg/mL to 6000 μg/mL, y=0.0015 x+0.0304; R2=0.9999 and the residuals were randomly scattered around 0), LOD and LOQ (0.3 and 1.0 μg/mL, respectively), precision and accuracy. The proposed method was then applied to the enantiomeric purity control of the starting material and injection solution of levornidazole (0.5 mg/100 mL). © 2012 Elsevier B.V.

Zhang L.,Jiangsu Institute for Food and Drug Control | Zhang L.,Nanjing University | Shang C.,Nanjing University | Sun C.,Nanjing University
Chinese Journal of Chromatography (Se Pu) | Year: 2014

Phthalate esters (PAEs) are commonly used for plastic products as plasticizer. Once taken in by human, PAEs will cause diseases, such as endocrine disorders, cancer, etc. Shengmaiyin is a kind of Chinese medicine oral fluid whose packaging materials may include phthalate esters. If the phthalate esters migrated into the solution, it would lead to serious problem on the safety of drugs. In this study, a method of gas chromatography coupled to triple quadrupole mass spectrometry (GC-QQQ-MS) was developed for the simultaneous determination of 17 phthalate esters in Shengmaiyin samples. The samples were extracted with n-hexane by liquid-liquid extraction method before analysis. The separation was performed on an HP-5MS capillary column (30 m×0. 25 mm×O. 25 μm) with temperature programming. The MS/MS detection was performed under electron impact source (EI) in multi-reaction monitoring (MRM) mode. The good linear relationships were obtained in the range of 0. 5-20 mg/L for all the target analytes. The average recoveries of the 15 PAEs were in the range of 91. 8% -117. 2%, except dimethyl phthalate and diethyl phthalate which were about 51. 9% and 77. 2%, respectively, and all the RSDs were in the range of 0. 5%-5. 4% (n = 6). The limits of detection ranged from 0. 04 to 16. 76 μg/L. The developed GC-MS method is simple, accurate, sensitive, proprietary, and can be applied in the detection of the phthalate ester residues in Shengmaiyin.

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