关键词: font-size:medium, ">泊沙康唑；细菌内毒素；动态显色法；不溶于水；原料药；鲎试剂

Abstract: Objective： To establish a kinetic chromogenic method for the quantification of bacterial endotoxin in water-insoluble active pharmaceutical ingredients(API) of posaconazole. Methods：Based on the clinical dosage of posaconazole injection， a strict limit of 0.25 EU·mg-1 for the posaconazole API was formulated. The posaconazole API was dissolved with a diluent (dimethyl sulfoxide: RIPA strong lysis solution=1∶1) as a solvent， and kinetic chromogenic limulus amebocyte lysate reagents from two manufacturers were used. According to method 2(photometry) in the general rule 1143 in the Chinese Pharmacopoeia(2020 Edition，Volume Ⅳ)， the mass concentration range of the sample was determined using the kinetic chromogenic assay . Finally， the bacterial endotoxin of three batches of samples was quantitatively detected. Results：The absolute correlation coefficients of the standard curves of limulus amebocyte lysate from two manufacturers were greater than 0.980. When the sample mass concentration was ≤0.02 mg·mL-1， the recoveries of bacterial endotoxin were in the range ； The quantitative detection results of bacterial endotoxin in three batches of samples all met the requirements. Conclusion：With a limit of 0.25 EU·mg-1， the kinetic chromogenic assay is feasible and controllable for the quantitative determination of bacterial endotoxin in water insoluble posaconazole API.

Key words: font-size:medium, ">Posaconazole； Bacterial Endotoxin； Kinetic Chromogenic Assay； Insoluble； Active Pharmaceutical Ingredients； Limulus Amebocyte Lysate