ABSTRACT
A simple, rapid, and sensitive gas chromatography-mass spectrometry (GC-MS) method was developed and validated for the simultaneous determination of two fatty acids, methyl hexadecanoate (MH) and methyl stearate (MS), to allow the evaluation of packaging-drug compatibility. The two migrants were quantified in selective ion-monitoring (SIM) mode, with limits of detection (LOD) of 0.0030 μg/mL and 0.0121 μg/mL. Linear calibration curves for MH and MS were obtained in the concentration ranges of 0.1011–5.0570 μg/mL and 0.2015–10.0740 μg/mL, respectively. The developed method was successfully applied to estimate the safety of the injection of recombinant antitumor-antivirus protein (RAAP). The results showed that the possible maximum daily intake was 3.0 ng and 12.1 ng for MH and MS, re-spectively. As these values were both below the permitted daily exposure, the migrants can be con-sidered as having low safety risk and do not affect the quality of the injection.
ABSTRACT
A simple method was established for the determination of β-propiolactone (BPL) in human inactivated rabies vaccine by gas chromatography-mass spectrometry (GC-MS). The determination was performed on an Agilent HP-INNOWAX (30m × 0.32mm i.d., 0.25 μm) capillary column at the temperature of 80 °C. Electrospray ionization (ESI) was used by selective ion detection at m/z 42. The temperature for ESI source and inlet was set at 230 °C and 200 °C, respectively. Helium was used as the carrier gas at a flow rate of 25.1 mL/min. The total run time was 8 min. Acetonitrile and other components in the sample did not interfere with the determination of BPL. The results showed good linearity of BPL in the range of 0.50–10.01 μg/mL, with the limit of detection and the limit of quantification of 0.015 μg/mL and 0.050 μg/mL, respectively. Satisfactory precision was achieved for the current developed method. The method was applied to detect 6 batches of vaccine samples, and the results indicated that the target analyte BPL was present in three batches of unpurified samples, but was not detected in the purified samples, indicating the test samples were qualified. The established method was proved to be simple, versatile and sensitive, which can meet the requirements of quality control of BPL in human inactivated rabies vaccine.
ABSTRACT
OBJECTIVE:To screen and identify endophytic fungi from Schisandra chinensis with antioxidant activity. METH-ODS:The tissue isolation skill was used to isolate endophytic fungi from roots,leaves,stems and fruits of S. chinensis. And anti-oxidant activity of endophytic fungi were screened by DPPH radical scavenging assay and hydroxyl radical scavenging assay. The to-tal DNA were extracted;the 18S rDNA ITS were amplified and sequenced with primer ITS1 and ITS4;the results of sequencing were analyzed comparatively based on homology to confirm the classification of active strains. RESULTS:23 strains were isolated from S. chinensis. GSR-12,isolated from roots of S. chinensis,had strong antioxidant activities. The scavenging rate on DPPH and the hydroxyl radical were 87.96% and 82.31% respectively. GSR-12 strain was identified as Clonostachys rosea by analyzed com-paratively. CONCLUSIONS:1 strain of C. rosea,isolated from roots of S. chinensis,has strong antioxidant activity.