Research on Removing Sudden Pyrogen Contamination in Baicalin Injection

OBJECTIVE To optimize the pyrogen removing process of sudden contamination in injections containing baicalin. METHODS The bacterial endotoxin (BE) and effective composition contents in baicalin solution were detected by kinetic turbidity method and HPLC before and after using different concentrations of activated carbon and different molecular weight cut off (MWCO) ultrafiltration membranes to calculate the removal rate of BE and baicalin recovery rate， respectively. RESULTS Under the condition of pyrogen sudden pollution， BE removal rate in baicalin solution were 80.2%， 91.7% and 95.6% when using 0.10%， 0.50% and 1.00% activated carbon， and recovery rate of baicalin were 90.8%， 73.1% and 51.3%. BE removal rate in baicalin solution were nearly 100% when using 5 and 10 kDa MWCO ultrafiltration membrane， the recovery rate of baicalin were 52.6%， 94.3%. CONCLUSION The experiments confirmed that different concentrations of activated carbon cannot effectively remove the pyrogen of baicalin solution， and the adsorption rate of baicalin was high; while ultrafiltration showed better results in pyrogen removal with high recovery rate， thus providing the basis for the production of Chinese medical injections.