ABSTRACT
Objective To evaluate the antibody titer distributions after primary vaccination by different sequential schedules of Sabin strain-based inactivated poliovirus vaccine(sIPV) and bivalent oral attenuated live poliomyelitis vaccine against types 1 and 3 (bOPV) in Drug Candy(DC) form or liquid dosage form. Methods Eligible infants of 2 months old selected in Liuzhou were assigned randomly in a ratio of 1:1:1:1 to 4 groups as following: sIPV+2bOPV(DC), sIPV+2bOPV(liquid), 2sIPV+bOPV(DC), 2sIPV+bOPV(liquid), and were vaccinated at 0, 28, 56 days. Polio neutralizing antibody titers against poliovirus types 1, 2 and 3 were tested prior to Dose 1 and at 28 days after Dose 3. Results The antibody titer distribution for type 1 was statistically different between sIPV+2bOPV(DC) and sIPV+2bOPV(liquid) (Z=-2.589, P=0.010) while no significant differences were detected between the two groups for type 2(Z=-0.331, P=0.741) and type 3(Z=-1.556, P=0.120). There were no significant differences between 2sIPV +bOPV(DC) and 2sIPV+bOPV(liquid) for the distributions(All P>0.05) (type 1: Z=-1.249, P=0.212; type 2: Z=-1.658, P=0.097; type 3: Z=-1.436, P=0.151). In the same dosage forms with different sequential schedules, the antibody titer distributions were significantly different between 2 doses sIPV and 1 dose sIPV groups(All P<0.05)(sIPV+2bOPV(liquid) vs 2sIPV+bOPV(liquid): type 1: Z=-2.766, P=0.006; type 2: Z=-9.137, P<0.001; type 3: Z=-5.529, P<0.001. sIPV+2bOPV(DC) vs 2sIPV+bOPV(DC): type 1: Z=-3.748, P<0.001; type 2: Z=-7.660, P<0.001; type 3: Z=-6.030, P<0.001). Conclusions Different dosage forms have similar immune effects, so appropriate dosage forms should be selected for vaccination according to the effectiveness, characteristics of subjects and the population density. In the case of sufficient supply of sIPV, 2 doses sIPV sequential program should be the first choice to complete the primary immunization.
ABSTRACT
Regulatory science of food and drug is a cutting-edge science in recent years.The development of regulatory science and management communities attach importance.The regulatory science is not only research and control the development of pharmaceutical innovation products,but also is useful for regulatory policies,regulatory laws and regulations to build methods,product innovation and technical strategies and various innovative product standards,and R&D assessment of pharmaceutical innovation product safety,effectiveness,quality and performance and scientific regulation are great significance.Especially in the pharmaceutical product development and evaluation and product development,production,circulation supervision has important scientific significance and application value.This paper analyzes the development of international food and drug regulatory science.This article describes the development of the international drug regulatory and regulatory science,and it hopes to benefit researchers and managers from emerging disciplines.
ABSTRACT
Regulatory science of food and drug is a cutting-edge science in recent years.The development of regulatory science and management communities attach importance.The regulatory science is not only research and control the development of pharmaceutical innovation products,but also is useful for regulatory policies,regulatory laws and regulations to build methods,product innovation and technical strategies and various innovative product standards,and R&D assessment of pharmaceutical innovation product safety,effectiveness,quality and performance and scientific regulation are great significance.Especially in the pharmaceutical product development and evaluation and product development,production,circulation supervision has important scientific significance and application value.This paper analyzes the development of international food and drug regulatory science.This article describes the development of the international drug regulatory and regulatory science,and it hopes to benefit researchers and managers from emerging disciplines.
ABSTRACT
<p><b>OBJECTIVE</b>To investigate the effect of balsalazide on intestinal mucosal permeability of experimental colitis induced by dextran sulfate sodium(DSS) in a mouse model and its possible mechanism.</p><p><b>METHODS</b>Forty-five C57BL/6J mice were randomly divided into five groups. Normal group was only fed with distilled water, DSS group and Balsalazide groups at doses of 42,141,423 mg/kg were fed with 5% DSS. Balsalazide was given by intragastric administration. DAI was evaluated daily. At the end of the experiment, colon tissue was collected for assessment of histological changes, MDA content, MPO, SOD and GSH-PX activity. Small intestinal mucosa was collected for assessment of transmission electron microscope(TEM), and detection of permeability by Evans blue.</p><p><b>RESULTS</b>Compared with normal group, DSS group mice all manifested severe weight loss associated with hematochezia and diarrhea with significant increase of DAI and HI score(P<0.01). MDA content and MPO activity was increased with the reverse result of SOD and GSH-PX(P<0.01) in DSS group. Intestinal mucosa showed a focal reduction in thinning of microvillous carpet and even a total disarrangement of epithelial surface, with decurtated and broaden junctional complex and enlarged intercellular space under TEM observations in DSS group. The amount of Evans blue permeated into intestinal wall was obvious in DSS group. Compared with DSS group, balsalazide improved gross findings, decreased MPO activity and MDA content, but increased the activity of SOD and GSH-PX(P<0.05). The amount of Evans blue permeated into intestinal wall was less(P<0.05). Ileal microvillous carpet was ameliorated in dose-dependent manner by balsalazide.</p><p><b>CONCLUSIONS</b>Intestinal mucosal permeability is increased in DSS group. Balsalazide can significantly ameliorate intestinal mucosal permeability in colitis model.</p>