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@#Objective To analyze the trend of the hemagglutinin(HA) and ovalbumin contents in the lot release of influenza virus split vaccines in 2021,and evaluate the quality and quality control level of the vaccines.Methods The HA and ovalbumin content data of influenza virus split vaccines from two domestic enterprises in 2021 were collected and collated. The mean value and standard deviation were calculated according to the first 40 batches of data of the enterprise in the year,and the warning limit and action limit were established. The trend analysis of the above indexes was carried out to evaluate the stability and consistency of the product quality of the enterprise. Statistical data comparison and consistency analysis were made between the test results of the batch inspected by the lot release institution and the results of the enterprise.Results Through the retrospective data analysis of quadrivalent influenza virus split vaccines from two vaccine enterprises A and B,it was found that the content of H1N1 subtype HA and ovalbumin in the two enterprises and the content of Bv HA in the B enterprise had out of trend(OOT)situations,while the trend of other items was stable. The results of paired student's t test or Wilcoxon signed-rank test of the samples inspected by the lot release institution showed that except Bv subtype HA(t = 1. 094 and 0. 742 respectively)and ovalbumin(w =-64 and 36 respectively)contents showed no statistically significant difference(P > 0. 05),the HA contents of H1N1(t = 3. 862,w = 232),H3N2(t = 8. 225 and3. 473 respectively)and By(t = 5. 616 and 4. 934 respectively)of the two enterprises had significant differences(P <0. 05). The results of enterprises were generally higher than the lot release institution. Bland-Altman test analysis found that the consistency between the test data of enterprise A's HA content and the data of the lot release institution was better than that of enterprise B.Conclusion The stability and consistency of data trends of active ingredients and main impurity ingredients of quadrivalent influenza virus split vaccine batches in 2021 were generally good. The trend analysis can identify potential problems in vaccine production,and enterprises should carefully implement trend analysis and effectively monitor the product quality of vaccines.
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Objective To study the adjuvant effect of Epimedium polysaccharide co-immunized with H1N1 influenza virus split vaccine. Methods BALB/c mice were intramuscularly injected H1N1 virus lysate premixed with Epimedium polysaccharide G1, G4 and saline, respectively. The titer of serum antibody of mice was determined by ELISA two weeks after the initial immunization. The proliferation of T lymphocytes was measured by MTT assay and the levels of lymphocyte cytokines IFN-γ and IL-4 were determined by ELISA. CD4 +, CD8 +, CD3 + and CD19+ lymphocyte populations were determined by flow cytometry. Results Epimedium polysaccharides, G1 and G4, could rapidly induce the production of high levels of serum antibody against H1N1 in mice. The polysaccharides could significantly promote lymphocytes proliferation and IFN-γ secretion. The contents of CD4 +, CD8 + and CD3 +, the ratio of CD3 + and CD19+ (CD3+/CD19+) were promoted in the polysaccharides groups. Conclusion These polysaccharides could induce significant immune response against H1N1 in mice without observable toxicity. They should be further evaluated as a useful adduvant candidate for H1N1 influenza virus split vaccine.