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Impurity of thrombin preparations for clinical use
Journal of Clinical and Hospital Pharmacy
|June 1, 1985
Summary
Thrombin preparations for gastro-intestinal bleeding contain impurities. Purer thrombin formulations are needed for effective and safe treatment, as current products show varied biological activities and contaminants.
Area of Science:
- Biochemistry
- Pharmacology
- Gastroenterology
Background:
- Thrombin preparations are increasingly used for upper gastro-intestinal bleeding.
- Assessing the purity and activity of these preparations is crucial for clinical application.
Purpose of the Study:
- To evaluate the purity and biological activities of thrombin preparations from different pharmaceutical companies.
- To identify potential impurities and their impact on therapeutic efficacy.
Main Methods:
- Immunological methods
- Biological assays (e.g., amidolytic activity, dimer production, fibrin production, fibrinopeptide A release, anti-stretch activity)
- Sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE)
Main Results:
- All examined thrombin preparations contained proteins other than thrombin.
- Immunological studies indicated at least two types of contaminating proteins in each preparation.
- Significant variations in biological activities (e.g., fibrinolytic, platelet-aggregating) were observed.
- Preparation A exhibited the highest overall activity but also the strongest binding to antithrombin III.
- Preparation B showed the least contamination, while Preparation C had the highest fibrinolytic and platelet-aggregating activity.
Conclusions:
- Thrombin preparations for upper gastro-intestinal bleeding treatment exhibit varying degrees of impurity.
- Purer thrombin preparations are necessary for safe and effective local administration in treating gastro-intestinal bleeding.