Determination of Endotoxin in Chuan Hu Ning Iinjection with Kinetic Turbidimetry Limulus Test / 中药新药与临床药理

ABSTRACT

Objective: The dynamic turbidimetry Limulus test was used to assay endotoxin content in Chuan Hu Ning injection. Methods: When the standardized endotoxin added in Chuan Hu Ning injection sample (Lot.No.000409) and in its 40-fold dilution, 80-fold dilution, 120-fold dilution and 200-fold dilution , the recovery was 0 %, 21.18 %, 76.69 %, 101.1 %and 117.8 %and as the standardized endotoxin added in the three batches of 200-fold dilution of Chuan Hu Ning injection (Lot.No.000408?000409?001023), the recovery was 110.5 %, 124.4 %and 87.98 %. Results: As standardized endotoxin concentration being 5.00, 0.500, 0.0500Eu/mL , the 200-fold dilution of Chuan Hu Ning injection is effective to eliminate the interference in the test. Conclusion: The dynamic turbidimetry Limulus test provides a new way for the determination of endotoxin in Chuan Hu Ning injection.