Quality evaluation of osmotic pressure offreeze-dried rabies vaccine for human use
Objective To understand the quality control status of osmotic pressure molar concentration of freeze-dried human rabies vaccine and explore the main vaccine components that affect osmotic pressure molar concentration,so as to provide data support for the quality evaluation of freeze-dried human rabies vaccine.Methods The osmotic pressure molar concentration determination method in the third volume of the Chinese Pharmacopoeia was used to determine 80 batches of freeze-dried human rabies vaccine from 8 domestic companies.In order to understand the osmotic pressure molar concentra-tion of the main components of freeze-dried human rabies vaccine,the osmotic pressure molar concentration of the main ex-cipients used in the vaccine,such as human serum albumin,dextran,sucrose,maltose and gelatin,was determined;And the osmotic pressure molar concentration of the vaccine solvent phosphate buffer was determined.The trend analysis of the os-motic pressure molar concentration test data of multiple batches of a domestic company was carried out to understand the batch-to-batch variability of this project in vaccine production.Results The quality control limit standards of osmotic pres-sure molar concentration of freeze-dried human rabies vaccine from different companies in my country are not uniform,ran-ging from 200 to 600 mOsmol·kg-1.For freeze-dried human rabies vaccine,the content of vaccine stabilizer in the excipient is related to the osmotic pressure molar concentration result,and the factors with greater influencing factors are sucrose and maltose.The osmotic pressure molar concentration of vaccine solvent phosphate buffer is relatively high because it contains NaCl and KCl.The osmotic pressure molar concentration of different companies is between 238 and 325 mOsmol·kg-1.The trend analysis results of 184 batches of products from a domestic company showed that the average detection value was(386.0±19.3)mOsmol·kg-1,which was within the action limit and had good batch consistency.Conclusion The osmotic pressure molar concentration limit standards of freeze-dried human rabies vaccine for different companies are different,and the main influencing factors are phosphate buffer,sucrose and maltose.The osmotic pressure molar concentration is related to the safety of freeze-dried human rabies vaccine.This study will provide technical support for the standardization of this pro-ject and has guiding significance for the quality evaluation of freeze-dried human rabies vaccine.
Rabies vaccineQuality controlOsmotic pressure determinationEvaluation and analysis
万方数据
