There has never been so many high ranked officials punished for corruption as those during the reign of Emperor Qianlong. Among the main sewers of corruption were there purpresture upon false accounts and receipts, enrichment unjustly by their official power, and defalcation in their own business etc. The corruption was chiefly characterized by crime in mobs, refuge in the illegal local customs, committing by their family members or aides, and embezzlement by low ranked petty officials etc.
Objective
To analyze the influence of different agitation systems on the molecular size distribution of human tetanus immunoglobulin (HTIG) during the ultrafiltration and formulation process.
Methods
Five batches of HTIG each were ultrafiltered and formulated using mechanical agitation system (A system) or magnetic agitation system (B system), and the molecular size distributions of HTIG at different production stages were compared.
Results
The molecular size distributions of HTIG for production with A or B system all met the requirements of Chinese pharmacopoeia (2015 edition, volume Ⅲ ), and the difference had no statistical significance (t=-0.95, P=0.398 ). During the ultrafiltration and formulation process, the effect of A system was less than that of B system on the molecular size distribution at the ultrafiltration and concentration stage, the difference had statistical significance (t=2.31, P=0.038). The molecular size distributions of HTIG at different production stages were further compared in the same agitation system.The results showed that A system had no effect on the molecule size distribution of HTIG at different production stages. When HTIG was produced using B system, the molecular size distributions of HTIG had significant difference at the ultrafiltration and concentration stage ( t=20.57, P=0.000 ) and the pH adjustment stage (t=-4.15, P=0.006) as compared with those at the previous production stage respectively.
Conclusion
During the ultrafiltration and formulation process, the effect of A system is less than that of B system on the molecular size distribution.
Key words:
Ultrafiltration; Immunoglobulins; Mechanical agitation; Magnetic agitation; Molecular size distribution
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