ABSTRACT
BACKGROUND:Traditional bone cement in the treatment of osteoporotic vertebral compression fracture easily induces heat dissipation effect, leakage, big difference in mechanical strength with the surrounding tissue, which greatly affects treatment effect of osteoporotic vertebral compression fracture. This prospective self-controled open-label clinical trial is designed to analyze the effectiveness of a novel high viscosity bone cement for osteoporotic vertebral compression fractures. METHODS/DESIGN:This prospective self-controled open-label clinical trial wil be performed in the Yixing Hospital Affiliated to Jiangsu University of China. High viscosity bone cement wil be implanted in patients with osteoporotic vertebral compression fractures by percutaneous vertebroplasty. Immediate outcomes: Pain symptom of patients before and after implantation of high viscosity bone cement, and Visual Analogue Scale score. Middle- and long-term outcomes: The recovery of spinal function, Oswestry dysfunction index questionnaire, vertebral body height, bone cement leakage rate, Barthel index and SF-36 quality of life scale score. DISCUSSION: This trial wil provide a clinical basis for the treatment of osteoporotic vertebral compression fractures with high viscosity bone cement. ETHICS APPROVAL: This trial has been approved by the Medical Ethics Committee, Yixing Hospital Affiliated to Jiangsu University (Approval number 0136). Patients and their family members have signed the informed consent.
ABSTRACT
A method was developed for determining residual dexamethasone and betamethasone in swine liver by HPLC-MS/MS with isotope dilution. The samples were digested by β-glucuronidase/aryl sulfatase, and extracted) with acetonitrile. Further cleanup was performed on C_(18)) cartridge and liquid-liquid extraction with sodium) carbonate solution. Then the supernatant was dried under nitrogen and residues were dissolved in mobile) phase. The samples were analyzed by HPLC-MS/MS on a Hypercarb C_(18)) column with a mixture of acetonitrile-water-formic acid as the mobile phase. The samples were quantified with the internal standard calibration curve method using isotope dilution. The limit of detection for dexamethasone and betamethasone in swine liver was 0.12 μg/kg and 0.14 μg/kg, respectively. The limits of quantification were 0.42 μg/kg and0.47 μg/kg), respectively. The average recoveries were 97.3%-111.0%, the intra-assay relative standard deviations were 1.85%-5.65% and the inter-assay relative standard deviations were 2.8%-8.0% at spiked levels of 0.75-2.00 μg/kg. There was a good linear correlation (the correlation coefficient is above 0.9997) between the ratio of peak areas of quantitative ion-pair to internal standard and concentration of analyte) in the range of 10-500 μg/L.
ABSTRACT
A method was developed for determining residual narasin in chicken tissues by HPLC with post-column derivatization. The samples were extracted with iso-octane. Further cleanup was performed on LC-si cartridge after centrifugation. Then the eluent was dried by nitrogen and residues were dissolved in methanol, water mixture (90∶ 10 v/v). The samples were analyzed on an Inertsil ODS-3 C18 column with a mixture of methanol-acetic acid-water as the mobile phase and vanillin as the derivatization reagent. The detection wavelength was 520 nm. The samples were quantified with the external standard calibration curve method. The limit of detection and the limit of quantification for narasin in chicken tissues were 6.0 μg/kg and 20 μg/kg, respectively. The average recoveries of narasin in chicken tissues were 76.4 %-93.1 %, the intra-assay relative standard deviations were 2.6 %-8.9% and the inter-assay relative standard deviations were 4.7%-9.7% at spiked levels of 20-1800 μg/kg. There was a good linear correlation (the calibration coefficient is above 0.9993) between the peak areas and concentration of narasin in the range of 70-10000 μg/L.