AI Article Synopsis
- A new analysis method combining biological and chemical techniques was established to enhance the quality control of propylene glycol alginate sodium sulfate (PSS), a sulfated polysaccharide used in medication.
- Allergic and anticoagulant tests indicated that PSS with higher molecular weight (Mw) and a lower mannose to galactose (M/G) ratio could increase the risk of allergic reactions and bleeding.
- The study recommends that PSS with high purity, an M/G ratio above 1.5, an Mw around 9kD, and a degree of substitution (DS) between 9.0-13.0% is optimal for clinical effectiveness and minimizing adverse side effects.
Article Abstract
The combination of biological and chemical analysis methods was developed to improve quality control of propylene glycol alginate sodium sulfate (PSS), a sulfated polysaccharide drug. The allergic and anticoagulant assays revealed that PSS fractions with higher Mw and lower M/G ratio may have allergic response and bleeding risks. HPLC with pre-column derivatization, HPGPC and IC methods were combined to analyze 10 batches of PSS samples from different manufacturers. The results showed that the quality of these PSSs varied greatly which in turn led to the unstable anticoagulant activity and side effects. The study indicated that PSS with high purity, M/G ratio above 1.5, Mw of ∼9kD and DS of 9.0-13.0% can ensure clinical efficacy and low incidence of adverse drug reactions. In conclusion, the combined methods would be in favor of guiding manufacture and quality control of PSS to guarantee its effectiveness and safety.
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| http://dx.doi.org/10.1016/j.carbpol.2016.03.001 | DOI Listing |
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