RESUMO
OBJECTIVE: To establish methods for screening of macromolecules in traditional Chinese medicine injections by molecular exclusion chromatography (SEC). METHODS: The separation was carried out by SEC with Phenomenon BioSep-SEC-s2000 (7.8 mm×300 mm, 8 μm) column. The mobile phase was 0.05 mol·L-1 Na2SO4, and differential detector was used when dextran was used as the reference standard. When proteins were used as reference standards, the mobile phase was the mixture of 0.1% trifluoroacetic acid and acetonitrile (70-30), and UV detector was selected. RESULTS: With the differential detector, the molecular weight range of dextran was 7100-133800, and the limit of detection was 0.0979 μg; with the UV detector, the molecular weight range of the proteins was 1638-13700, and the limit of detection was 0.00358 μg. No macromolecules were detected in the selected traditional Chinese medicine injections. CONCLUSION: The proposed method can be used for the screening of macromolecules in traditional Chinese medicine injections.