RESUMO
Objective:To study the safety factors of Fuyanyu mixture. Methods: The contents of antiseptic and residual ethanol were determined by HPLC and GC, respectively, and those of heavy metals and harmful elements were detected by ICP-MS. Results:The contents of benzoic acid in 6 batches of samples were less than 0. 3%. In two thirds of samples, ethanol residue was more than 0. 5%. The total mercury exceeded 15μg/day in one of the samples, and the contents of Pb, Ge, Gr, As, Ni and Cu met the limits described in USP<232> in all of the last samples. Conclusion: The methods are accurate and reliable. It is urgent to improve the preparation process so as to reduce the residual amount of ethanol according to the detection results. It is recommended to increase the testing items that affect the safety of the preparation so as to control the preparation quality strictly.
RESUMO
Objective:To study the safety factors of Fuyanyu mixture. Methods: The contents of antiseptic and residual ethanol were determined by HPLC and GC, respectively, and those of heavy metals and harmful elements were detected by ICP-MS. Results:The contents of benzoic acid in 6 batches of samples were less than 0. 3%. In two thirds of samples, ethanol residue was more than 0. 5%. The total mercury exceeded 15μg/day in one of the samples, and the contents of Pb, Ge, Gr, As, Ni and Cu met the limits described in USP<232> in all of the last samples. Conclusion: The methods are accurate and reliable. It is urgent to improve the preparation process so as to reduce the residual amount of ethanol according to the detection results. It is recommended to increase the testing items that affect the safety of the preparation so as to control the preparation quality strictly.