The observed biological activity in two New Zealand Myrsine species has been shown to be due to the presence of triterpene saponins. From Myrsine australis a series of eight oleanane-type saponins was obtained, with compounds 1-4 and 7 and 8 being novel. Also isolated were ardisiacrispin A [5] and ardisiacrispin B [6]. The structures of the new compounds were determined by chemical and spectroscopic techniques. Extracts of Myrsine salicina yielded only one saponin, 5. Saponins 1-8 were shown to be combinations of four oleanane triterpenes bonded to beta-D-xylp(1-->2)-beta-D-glcp(1-->4)-[beta-D-glcp(1-->2)]-alpha-L -arap (compounds 1, 3, 5, 7) and this same tetrasaccharide with alpha-L-rhap replacing the beta-D-xylp unit (compounds 2, 4, 6, 8).
Objective:
This study compared the pharmacokinetics (PK), safety, and immunogenicity of the biosimilar TAB008 monoclonal antibody to bevacizumab (Avastin
®
) in normal healthy Chinese male volunteers.
Methods:
In this randomized, double-blind, parallel controlled study, a total of 100 healthy Chinese male subjects were randomized (1:1) to receive a single 1 mg/kg intravenous dose of TAB008 or Avastin
®
over a 90-min infusion. The subjects were followed for 99 days after drug administration. Primary endpoints were bioequivalence of major pharmacokinetic parameters (AUC
0-t
and AUC
0-∞
) and maximum observed serum concentration (C
max
). Secondary endpoints included safety and immunogenicity parameters.
Results:
The two groups of test subjects (49 subjects in the TAB008 group and 50 subjects in the Avastin
®
group) were well matched in regards to all demographic and baseline characteristics. The treatment group ratios of LS geometric means for the three primary PK parameters were fully contained within the bioequivalence limits of 80.00–125.00% (90% CI was 103.66–118.33% for C
max
, 94.32–111.72% for AUC
0-t
, and 94.69–112.23% for AUC
0-∞
). Treatment-emergent adverse events (TEAEs) were reported for 24 (49.0%) subjects in the TAB008 group and 22 (44.0%) subjects in the Avastin
®
group. TEAEs related to the study drug were reported for 19 (38.8%) subjects in the TAB008 group and 19 (38.0%) subjects in the Avastin
®
group. National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade 3 TEAEs were reported for 1 (2.0%) subject in the TAB008 group and 3 (6.0%) subjects in the Avastin
®
group. There were no Grade 4 or 5 TEAEs or serious adverse events (SAEs) during the study. Anti-drug antibody generation was reported once only in each group, and neutralizing antibody (Nab) analysis was negative upon follow-up.
Conclusion:
TAB008 attained pharmacokinetic similarity to bevacizumab, and was safe and well tolerated.
The
sustainable separation process for the recovery of acetonitrile
from wastewater is essential to achieve the circular economy and environmental
protection. In this work, we demonstrate systematically a methodology
to develop an energy-efficient extractive distillation process for
separating the acetonitrile and water azeotrope. First, the separation
performances of candidate entrainers, i.e., ionic liquids (ILs) and
ethylene glycol (EG), were determined using the residue curve maps.
Second, the boundaries of decision variables for optimization procedures
were obtained via the sensitivity analysis, and the nonsorting genetic
algorithm (NSGA-II) was applied to get the optimal operating parameters
of conventional and heat-integrated schemes using EG and three ILs.
Third, three indicators including the total annual cost, gas emissions,
and thermodynamic efficiency were used to evaluate the economic, environmental,
and energy efficiency performances of conventional and intensified
schemes. Using the conventional EG process as a basis, the heat-integrated
scheme using [EMIM][OAC] shows the best performance as it gives the
reductions of 26.3% and 22.1% in the total annual cost and gas emissions,
respectively, and an absolute increase of 0.44 in the second-law efficiency.
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