Liaoning Institute for Food and Drug Control

Shenyang, China

Liaoning Institute for Food and Drug Control

Shenyang, China
SEARCH FILTERS
Time filter
Source Type

Yao L.,Liaoning Institute for Food and Drug Control | Liu Y.,Liaoning Institute for Food and Drug Control | Zhang Y.-J.,Liaoning Institute for Food and Drug Control
Chinese Journal of Antibiotics | Year: 2014

Objective: To establish a GC method for the determination of propylene oxide and diethylene glycol in rifamycin sodium injection. Methods: The GC was equipped with hydrogen flame-ionazition detector, the detector temperature was 250°C, the inlet temperature was 230°C. Temperature programming and the capillary chromatographic column coated with polyethylene glycol was used in the test, the carrier gas was nitrogen, the column flow was 1.1mL/min; and the split ratio was 20:1. Results: The 2 kinds of impurities had a good linear relation in the range of 0.00166~0.0332mg/mL, r=0.9982 (propylene oxide) and 0.00215~0.04300mg/mL, r=0.9999 (diethylene glycol). The everage recovery was 100.3% and 98.2% and the quantitative limits were 0.376 and 2.12μg/mL, respectively. Conclusion: The method was accurate and reliable, suitable for determination of impurities of propylene oxide and diethylene glycol in rifamycin sodium injection.


Yi D.-W.,Liaoning Institute for Food and Drug Control | Ma L.,Liaoning Institute for Food and Drug Control | Zhang Y.-J.,Liaoning Institute for Food and Drug Control
Chinese Pharmaceutical Journal | Year: 2014

OBJECTIVE: To develop an HPLC method for simultaneous determination of thimerosal and phenylmercuric compounds in chloramphenicol eye drops. METHODS: The analysis was performed on a phenyl-column with an ion-suppress mobile phase system consisting of 0.05 mol·L-1 potassium dihydrogen phosphate solution(pH adjusted to 5.5 with triethylamine)/acetonitrile(82:18, V/V)at a flow rate of 1.2 mL·min-1 at 220 nm. RESULTS: The established method had good linearity within the concentration range of 2.0-100 μg·mL-1(r>0.9990) for thimerosal and phenylmercuric acetate, with average recoveries of ≥96.9% for thimerosal and ≥99.1% for phenylmercuric acetate. CONCLUSION: The method is simple, accurate and specific for determination of thimerosal and phenylmercuric compounds in chloramphenicol eye drops.


Fu Q.,Shenyang Pharmaceutical University | Sun J.,Shenyang Pharmaceutical University | Ai X.,Shenyang Pharmaceutical University | Zhang P.,Shenyang Pharmaceutical University | And 11 more authors.
International Journal of Pharmaceutics | Year: 2013

Purpose: We had conducted a comprehensive study on preparation, characterization and pharmacokinetics of nimodipine nanocrystals for oral administration previously, and nimodipine nanocrystals displayed lower dissolution profiles but higher bioavailability than Nimotop®. In this study, we aimed at elucidating the reasons of unfavorable in vitro in vivo correlation for NMD nanocrystals and Nimotop® with a hypothesis that special oral absorption mechanism was involved in the absorption of nimodipine nanocrystals. Methods: Investigations of oral absorption mechanism of the nanocrystals were performed on everted gut sac models, lymphatically (mesenteric lymph duct) cannulated SD rats, Caco-2 cell monolayers and chylomicron flow blocking rats, respectively. Results: The permeability of nanocrystals in duodenum, ileum and colon was not superior to that of Nimotop®, suggestive of special absorption mechanisms involved. Exudates of nanocrystals from enterocytes were detected in mesenteric lymphatic fluids using a transmission electron microscope, and the bioavailability was only about half of the control after the mesenteric lymph was blocked. The nanocrystals were taken up by enterocytes via macropinocytosis and caveolin-mediated endocytosis pathways. Conclusions: It was impossible to establish a favorable in vitro in vivo correlation for NMD nanocrystals and Nimotop®, because portions of the nanocrystals underwent macropinocytosis and caveolin-mediated endocytosis by enterocytes as intact nanocrystal forms, then bypassed the liver first-pass metabolism. © 2013 Elsevier B.V.


Guo Z.,Shenyang Pharmaceutical University | Ma M.,Liaoning Institute for Food and Drug Control | Hao Y.,Shenyang B. Braun Pharmaceutical Co. | Jiang T.,Shenyang Pharmaceutical University | Wang S.,Shenyang Pharmaceutical University
Journal of Pharmacy and Pharmacology | Year: 2011

Objectives The aim of this study was to investigate the correlation between the growth behaviour and in-vitro dissolution rate of water-insoluble drugs prepared with high-shear wet granulation. Methods Granules containing nimodipine, microcrystalline cellulose, low-substituted hydroxypropylcellulose and aqueous solution of hydroxypropylcellulose were prepared and the effects of independent process variables, including impeller speed and liquid-to-solid ratio were taken into consideration. The mean granule size, granule-size distribution (GSD), porosity and surface properties were monitored at different kneading times to identify the granule-growth mechanisms simultaneously. A computer-based method was applied to simulate the dissolution behaviour of polydisperse granules based on the GSD data. Key findings The in-vitro dissolution rate of drug was high for the early stages of granulation and sharply decreased when coalescence and consolidation of granules started, approaching a flat and low level when granules were sufficiently consolidated. The simulated dissolution results were in agreement with experimental observations and were significantly affected by the GSD, porosity and surface properties of granules during the granulation process. Moreover the GSD was directly related to the granule-growth behaviour and mechanisms. Conclusions In general, it was concluded that the dissolution properties of nimodipine basically correlated with the growth behaviour of granules in a high-shear mixer. The simulation method based on GSD can be used as a convenient and rapid way to predict the dissolution properties for formulation development and granulation optimization. © 2011 The Authors. JPP © 2011 Royal Pharmaceutical Society.


PubMed | Nanjing University, Liaoning Institute for Food and Drug Control, Shanghai AB Sciex Analytical Instrument Trading Co. and China Medicine Corporation
Type: | Journal: Journal of chromatography. B, Analytical technologies in the biomedical and life sciences | Year: 2015

Fangji Huangqi Tang (FHT) is a classical formula widely used in Chinese clinical application. In this paper, a novel and advanced strategy has been developed for the multiple constituent identification of FHT in rats, which was basing on an ultra-high performance liquid chromatography equipped with electrospray ionization quadrupole time-of-flight mass spectrometry (UHPLC-ESI-Q-TOF-MS) method combined with dynamic background subtract (DBS) data acquisition and enhance peak list (EPL) data processing techniques. Firstly, a total of 58 potential bioactive compounds including alkaloids, flavonoids, saponins, saccharides and terpenoids were detected from FHT. Their chemical structures were identified by comparing the retention time and mass spectrometry data, as well as retrieving the reference literatures. Based on the same instrumental conditions, 33 compounds were found in rat serum after oral administration of FHT. After a considerate comparison with the former chemical identification results of FHT, 33 compounds were found, which turned out to be 8 original compounds of FHT as well as 25 metabolites, including 20 phase I and 5 phase II metabolites. The results indicated that the metabolic reactions included hydroxylation, hydrogenation, demethylation, tarine conjugation and acetylation. This study firstly reported the metabolism description of fangchinoline and tetrandrine in vivo, which could be very useful for further pharmacological and clinical studies of FHT. Meanwhile, it provided a practical strategy for rapid screening and identifying of multiple constituents and their metabolites of complex traditional Chinese medicine in biological matrix.


Lu J.,Liaoning Institute for Food and Drug Control | Pang Y.,Liaoning Institute for Food and Drug Control | Li Y.,Liaoning Institute for Food and Drug Control | Wang C.,Liaoning Institute for Food and Drug Control
Chinese Journal of Chromatography (Se Pu) | Year: 2012

An analytical method for the simultaneous determination of 6 antibiotics minocycline, oxytetracycline, tetracycline hydrochloride, chlorotetracycline hydrochloride, doxycyc-line hydrochloride and chloramphenicol and metronidazole in acne removal products of cosmetic was established using high performance liquid chromatography, HPLClz, The drugs in the sample were extracted with methanol. The separation was performed on an Agilent ZORBAX SB-C18 column, 250 mm × 4.6 mm, 5 μm, at 20 °C with methanol; acetonitrile and 0.002 mol/L oxalic acid solution as mobile phases with gradient elution at a flow rate of 0. 8 mL/min. The detection was performed by a diode array detector, DAD at 268 nm. The injection volume was 10 μL. The quantification was performed by external standard method. The calibration curves showed good linearity within the range of 1-30 mg/L with the correlation coefficients no less than 0 997 0. The detecticm limits were in the range of 1.1-1.2 μg/g. The recoveries were between 91.9% and 107.7% in three spiked levels of 5, 10 and 20 mg/L with the relative standard deviations RSDs of 0.13%-1. 74%. The method was used in the analysis of acne removal products, and metronidazole was found in 15% of the total test samples. The method is rapid, sensitive, accurate, effective in separation, and can be used in the determination of the six antibiotics and metronidazole in acne removal products. © 2010 Editorial Office of Chinese Journal of Chromatography, Dalian Institute of Chemical Physics, CAS.


Zhao F.,Liaoning Institute for Food and Drug Control | Gao G.,Liaoning Institute for Food and Drug Control | Na H.,Liaoning Institute for Food and Drug Control | Ma D.,Liaoning Institute for Food and Drug Control | Wang X.,Liaoning Institute for Food and Drug Control
Se pu = Chinese journal of chromatography / Zhongguo hua xue hui | Year: 2013

A method for the simultaneous determination of saccharin sodium and synthetic colours in flavourings by solid phase extraction (SPE) and high performance liquid chromatography with variable wavelengths was established. After degreased with petroleum ether, extracted, purified with SPE, and concentrated, the sample was separated on a C18 column with a gradient elution of 0.02 mol/L ammonium acetate and methanol, and detected at 230, 510, 484 and 510 nm, separately. The saccharin sodium and synthetic colours were separated with this method. The recoveries were 88.6% - 97.1% with the RSD < 5%. The limit of detection was 0.05 mg/kg for all the analytes. The proposed method is simple, reliable and reproducible, and especially suitable for a lot of sample detections of saccharin sodium and synthetic colours in flavourings.


Tian Y.,Shenyang Pharmaceutical University | Wang X.,Shenyang Pharmaceutical University | Wang X.,210th Hospital of Peoples Liberation Army | Xi R.,Shenyang Pharmaceutical University | And 7 more authors.
International Journal of Nanomedicine | Year: 2014

Realgar is a poorly water-soluble compound that exhibits poor bioavailability. To improve this, the authors reduced the particle size of realgar to nanoscale by high-energy ball milling and optimized the preparation process under which (realgar weight 40g, milling time 9 hours, milling speed 38Hz, milling temperature -20°C) realgar nanoparticles (NPs) with an average size of 78±8.3nm were prepared. The average particle size of realgar was characterized by laser scattering, and its apparent shape was observed by transmission electron microscopy and scanning electron microscopy. The solubility of realgar was enhanced after milling until the particles were in the nanoscale region without altering its properties, as confirmed by a scanning electron microscopy energy-dispersive spectrometer. Realgar NPs had higher cytotoxicity on the selected cell lines, namely human breast cancer (MCF7), human hepatoma (HepG2), and human lung cancer (A549) cell lines, than coarse realgar. In addition, a pharmacokinetics study performed in rats indicated that the relative bioavailability of realgar NPs was 216.9% compared with coarse realgar; a biodistribution study performed in mice showed that after intragastric administration of realgar NPs, higher arsenic concentration was reached in the tumor, heart, liver, spleen, lung, and kidney compared with the administration of coarse realgar, as confirmed by inductively coupled plasma mass spectrometry to determine the concentration of arsenic. This study indicated that high-energy ball milling is an effective way to reduce the average particle size of realgar, and compared with coarse realgar, the cytotoxicity and bioavailability of realgar NPs were significantly improved. © 2014 Tian et al.


Fu Q.,Shenyang Pharmaceutical University | Sun J.,Shenyang Pharmaceutical University | Sun J.,Tianjin Institute of Pharmaceutical Research | Zhang D.,Shenyang Pharmaceutical University | And 13 more authors.
Colloids and Surfaces B: Biointerfaces | Year: 2013

This study intended to develop nimodipine (NMD) nanocrystals with different sizes for oral administration and to investigate the relationship between dissolution and pharmacokinetics for NMD nanocrystals and Nimotop®. NMD nanocrystals were prepared by combination of microprecipitation and high pressure homogenization and were further lyophilized. The particle size, morphology and aqueous solubility of the NMD nanocrystals were determined. With Nimotop® as the control, the dissolution rate was evaluated and the pharmacokinetic study was undertaken in beagle dogs. NMD nanocrystals with mean diameters of about 159.0, 503.0 and 833.3nm were prepared, respectively. The lyophilization didn't affect the particle sizes of the redispersed nanocrystals. The aqueous solubility was significantly improved and displayed a size-dependent manner. The nanocrystals exhibited lower dissolution patterns than Nimotop® under non-sink condition, but bioavailability of the two nanocrystals (159.0 and 833.3nm) was equivalent, about 2.6-fold higher than Nimotop®. In conclusion, oral nanocrystal drug delivery system was a promising strategy in improving the oral bioavailability of poorly soluble or insoluble drugs. But we could not establish a favorable in vitro in vivo correlation for NMD nanocrystals and Nimotop® and thus the oral absorption mechanism of the NMD nanocrystals required further study. © 2013 Elsevier B.V.


PubMed | Liaoning Institute for Food and Drug Control
Type: Journal Article | Journal: Se pu = Chinese journal of chromatography | Year: 2013

A method for the simultaneous determination of saccharin sodium and synthetic colours in flavourings by solid phase extraction (SPE) and high performance liquid chromatography with variable wavelengths was established. After degreased with petroleum ether, extracted, purified with SPE, and concentrated, the sample was separated on a C18 column with a gradient elution of 0.02 mol/L ammonium acetate and methanol, and detected at 230, 510, 484 and 510 nm, separately. The saccharin sodium and synthetic colours were separated with this method. The recoveries were 88.6% - 97.1% with the RSD < 5%. The limit of detection was 0.05 mg/kg for all the analytes. The proposed method is simple, reliable and reproducible, and especially suitable for a lot of sample detections of saccharin sodium and synthetic colours in flavourings.

Loading Liaoning Institute for Food and Drug Control collaborators
Loading Liaoning Institute for Food and Drug Control collaborators