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Xue Y.,Eliving Pharmaceutical Company Ltd of Shenyang | Sun X.-D.,The Blood Station of 208th Hospital of PLA | Wang D.,Eliving Pharmaceutical Company Ltd of Shenyang | Liu T.-L.,Eliving Pharmaceutical Company Ltd of Shenyang | And 2 more authors.
Chinese Journal of New Drugs | Year: 2012

Objective: To develop a high-performance liquid chromatography coupled to tandem mass spectrometry (HPLC-MS/MS) method for quantification of meptazinol in human plasma. Methods: After a simple liquid-liquid extraction, meptazinol and the internal standard paracetamol were separated on a Inertsil CN (150 mm×4.6 mm, 3.5 μm) column and detected by tandem mass spectrometry. The mobile phase consisted of 10 mmol·L-1 ammonium acetate (including 0.5% formic acid water)-acetonitrile (70:30). A mass spectrometer equipped with electrospray ionization source was used as detector operated in the positive ion mode. Multiple reaction monitoring (MRM) mode was used with the trasitions of m/z 234.2→107.0 for meptazinol and m/z 152.0→110.0 for the internal standard, respectively. Results: The linear calibration curve was obtained in the concentration range of 0.20~508.00 μg·L-1. The limit of quantification was 0.20 μg·L-1. The extraction recoveries of the three concentrations were 68.1%, 67.0% and 65.6%, respectively. Conclusion: This method is proved to be suitable for the clinical investigation of meptazinol pharmacokinetics, which offers the advantages of specificity, speed and greater sensitivity compared with the reported methods.


Huang Z.-B.,Liaoning Institute of Science and Technology | Xue Y.,E living Pharmaceutical company Ltd of Shenyang | Yu F.-X.,E living Pharmaceutical company Ltd of Shenyang | Liu Y.,E living Pharmaceutical company Ltd of Shenyang
Chinese Journal of New Drugs | Year: 2012

Objective: To develop a LC-MS/MS assay for determination of benidipine in the plasma of healthy human. Methods: Healthy male volunteers (n=19) were orally administrated with a single dose of benidipine 4 mg. Benidipine and the internal standard (azelnidipine) were extracted from plasma with methyl tert-butyl ether. The mobile phase consisted of 5 mmol · L -1 ammonium acetate-acetonitrile. A mass spectrometer equipped with electrospray ionization source and multiple reaction monitoring mode were used as detector operated in the positive ion mode. The plasma concentration-time curves as well as pharmacokinetics were analyzed using WinNonlin 6.0 software. Results: Calibration curve of benidipine was linear in the range of 0.020 4~3.066 0 ng · mL -1 and LLOQ was 0.020 4 ng · mL -1. The extraction recovery was in the range of 75.%~83.6%. The main pharmacokinetic parameters of benidipine were as follows: t 1/2 was (1.86 ± 0.69) h, C max was (1.4961 ± 0.479 5) ng · mL -1, T max was (0.58 ± 0.31) h, and AUC 0~t was (1.79 ± 0.81) ng · h · mL -1. Conclusion: The method is sensitive and convenient, and can be used in investigation of benidipine in human plasma.


Wei X.-M.,E Living Pharmaceutical Co. of Shenyang | Zhao N.,E Living Pharmaceutical Co. of Shenyang | Song D.-M.,E Living Pharmaceutical Co. of Shenyang | Zhang X.,E Living Pharmaceutical Co. of Shenyang | And 4 more authors.
Chinese Journal of New Drugs | Year: 2010

Objective: To evaluate the pharmacokinetics and bioequivalence of two preparations of fudosteine. Methods: In a randomized, crossover and self-control study, 20 healthy male volunteers were given a single oral dose (400 mg) of test (granules) and reference (tables) prepatations. Serial plasma samples were analyzed by HPLC-MS/MS. Pharmacokinetic parameters were calculated and compared statistically to evaluated bioequivalence between the two preparations using DAS 2.1 program. Results: The major pharmacokinetic parameters of the reference and test preparations were as follows: Cmax (10.89±3.45) and (10.99±3.01) μg·mL-1, Tmax(0.43± 0.09) and (0.38±0.14) h, t1/2(3.46±0.72) and (3.19±0.70) h, AUC0-t,(23.17±7.47) and (23.17± 6.64) μg·h·mL-1, AUC0-∞ (25.13±7.63) and (24.97±6.94) μg·h·mL -1. The relative bioavailability of two preparations was (101.5±11.2) %. No significant differeneces between the two preparations were found in Cmax, Tmax and AUC. Conclusion: The test and reference preparations of fudosteine are bioequivalent.


Zhao N.,E living Pharmaceutical Company Ltd of Shenyang | Liu X.-S.,Liaoning University of Traditional Chinese Medicine | Yan D.,E living Pharmaceutical Company Ltd of Shenyang | Zhao C.-Y.,Liaoning University of Traditional Chinese Medicine | And 2 more authors.
Chinese Journal of New Drugs | Year: 2011

Objective: To develop an HPLC-MS-MS method for determination of topiramate in human plasma. Methods: Plasma samples were extracted using methyl tertiary butyl ether, and separated on a Hypersil ODS C 18 column (150 mm×4.6 mm, 5 μm) with aqueous solution (5 mmol-L -1 ammonium acetate buffer)-methanol (25:75) as mobile phase with a isocratic mode, and at a flow rate of 0.5 mL-min -1. ESI was used as the ion source, and diclofenac sodium as the internal standard. The target compounds topiramate and diclofenac sodium were quantified with m/z 338.1 [M-H] - → 78.0 and 294.1→ 249.7, respectively. Results: Calibration curve was obtained in the range of 10.00~3 600.00 ng-mL -1(n=7), r>0.999. The inter- and intra-day precisions (RSD) were within 8.9%. The extraction recoveries of topiramate at low, middle, high level were (75.5±3.1)%, (77.0±1.6)% and (72.8±1.5)%, respectively; the internal standard the extraction recovery was (76.1±3.5)%. Matrix effect of topiramate at low, middle, high level were (99.2±5.6)%, (98.9±4.2)% and (99.4±3.8)%, respectively; the internal standard the matrix effect was (100.4±1.3)%. Conclusion: The method is accurate, sensitive and simple for determination of topiramate in human plasma.


Zhang X.,E living Pharmaceutical Company Ltd of Shenyang | Xie X.-Q.,E living Pharmaceutical Company Ltd of Shenyang | Liu T.-L.,E living Pharmaceutical Company Ltd of Shenyang | Song D.-M.,E living Pharmaceutical Company Ltd of Shenyang
Chinese Journal of New Drugs | Year: 2011

The quantitative determination of endogenous compounds in biological samples is more complicated and difficult in aspects of both analytical methods and the validation. The literature of the domestic and overseas was investigated, analyzed and summarized. In this paper, we reviewed in detail the quantitative determination methods of endogenous compounds in biological samples, study design and assessment of the bioequivalence of endogenous drugs. A number of different strategies had been employed to overcome the corresponding inherent bias. Considerations and methods are very meaningful to promote bioanalysis of the endogenous compounds and the evaluation of bioequivalence of endogenous drugs.


Jiang C.-M.,Liaoning University of Traditional Chinese Medicine | Liu Y.,E living Pharmaceutical Company Ltd of Shenyang | Wang J.-J.,E living Pharmaceutical Company Ltd of Shenyang | Zhang Q.,E living Pharmaceutical Company Ltd of Shenyang | Kang B.-X.,E living Pharmaceutical Company Ltd of Shenyang
Chinese Journal of New Drugs | Year: 2011

Fidaxomicin (edarbi) is the antibiotic with a novel structure of macrolides for the treatment of clostridium difficile-associated diarrhea (CDAD). Literature was searched from FDA database with the key word edarbi. The pharmacology, pharmacokinetics, clinical evaluation, safety evaluation and drug interactions of fidaxomicin were reviewed.


Zhai N.-N.,Shenyang Pharmaceutical University | Xu H.-Y.,Shenyang Pharmaceutical University | Song D.-M.,E Living Pharmaceutical Company Ltd of Shenyang | Jiang X.,Shenyang Pharmaceutical University | And 2 more authors.
Chinese Journal of New Drugs | Year: 2011

Objective: To develop a LC-MS/MS method to determine the concentration of leuprolide in human serum. Methods: After extracted from serum by protein precipitation, leuprolide and paracetamol (internal standard) were separated by an Agela Venusil ASB C 18 column(150 mm × 4.6 mm, 5 μm). Acetonitrile-ammonium acetate (5 mmol - L -1)-formic acid (30 70:0.1) were used as the mobile phase. The multiple reaction monitoring (MRM) was used for quantitative determination in positive mode. The transitions were m/z: 605.6 → 248.9, 220.9 for leuprolide ([M+2H] 2+) and m/z: 151.8 → 110.1 for paracetamol ([M+H] +). Results: No significant interferences for the detection of leuprolide from endogenous substances in serum were observed in the present study. The calibration curve was linear over the range of 0.1~10.0 ng - mL -1. The lowest limit of quantitation of leuprolide was 0.1 ng - mL -1. The accuracy was in the range of 88.5%~111.5% and the inter-day and intra-day precisions were less than 15%. Conclusion: The LC/MS/MS method is simple, rapid and sensitive enough for the pharmacokinetic study of leuprolide in human.


Song D.-M.,E Living Pharmaceutical Company Ltd of Shenyang | Zhang X.,E Living Pharmaceutical Company Ltd of Shenyang | Liu T.-L.,E Living Pharmaceutical Company Ltd of Shenyang | Guo Z.,The Affiliated Hospital of Mongolia Medical College | And 2 more authors.
Chinese Journal of New Drugs | Year: 2011

Objective: To develop an HPLC-MS-MS assay for determination of clemastine in human plasma, and estimate the bioequivalence of clemastine in paracetamol, clemastine fumarate and pseudoephedrine hydrochloride capsule in healthy volunteers. Methods: An open, randomized, two-periods, two-treatment, two-sequence, and crossover clinical trial was performed in 19 healthy male volunteers. They were orally administrated with a single dose of clemastine fumarate 0.67 mg. The plasma concentration of clemastine was determined by LC-MS-MS using nifedipine as an internal standard and methyl tert-butyl ether as an extraction solvent. The plasma concentration-time curves as well as pharmacokinetics of both test and reference formulations were analyzed using WinNonlin 6.0 software. Results: Calibration curve of clemastine was linear in the range of 5.09~407.20 ng-L -1 and LLOQ was 5.09 ng-L -1. Absolute recovery and matrix effect were in the range of 79.7%~80.6% and 101.0%~103.6%, respectively. Accuracy and precision (intra-run and inter-run) were conformed to the requirement. The main pharmacokinetic parameters of clemastine in the test and reference formulations were as follows: t 1/2 were (20.67±3.56) and (20.83±4.94) h, C max were (142.07±65.69) and (146.55±60.16) ng-L -1, T max were (4.21±1.23) and (4.13±1.27) h, and AUC 0-t were (2829±1681) and (2839±1560) ng-h-L -1. The relative bioavailability of clemastine in the test formulation was (101.7±23.4)% as estimated by AUC 0-t. Conclusion: HPLC-MS-MS method is sensitive and accurate for determination of clemastine, and the two formulations of clemastine are bioequivalent.


Wang D.,E.Living Pharmaceutical Company Ltd of Shenyang | Gao Y.,E.Living Pharmaceutical Company Ltd of Shenyang | Liu T.-L.,E.Living Pharmaceutical Company Ltd of Shenyang | Wang X.-X.,E.Living Pharmaceutical Company Ltd of Shenyang | Xue Y.,E.Living Pharmaceutical Company Ltd of Shenyang
Chinese Journal of New Drugs | Year: 2012

Retigabine is a neuronal potassium channel opener. Retigabine is a new antiepileptic drug for adjunctive treatment of partial-onset seizures in adult patients with a novel mechanism of action. The mechanism, pharmacodynamics, pharmacokinetics, drug interaction, clinical evaluation, and safety of retigabine were reviewed.


Liu X.-S.,Liaoning University of Traditional Chinese Medicine | Liu B.-Y.,E.Living Pharmaceutical Company Ltd of Shenyang | Wang J.-J.,E.Living Pharmaceutical Company Ltd of Shenyang | Song D.-M.,E.Living Pharmaceutical Company Ltd of Shenyang
Chinese Journal of New Drugs | Year: 2012

Icatibant is a potent bradykinin B 2 receptor antagonist for the treatment of acute attacks of hereditary angioedema (HAE) in 18-years-old and older adults. It is convenient for patients to self-administering icatibant upon recognition of HAE attack symptoms after training. References of in vitro and in vivo studies evaluating icatibant were obtained from MEDLINE to review the action mechanism, pharmacodynamics, pharmacokinetics, clinical evaluation, and safety of icatibant in the treatment of HAE. The key terms used in database searches were icatibant, bradykinin B 2 receptor antagonist, hereditary angioedema and HAE. Icatibant is effective and generally well tolerated in patients with acute HAE attacks. However, more research is required to solidify icatibant therapy.

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