Comparison of Histamine and Antihypertensive Substances in Compound Amino Acid Injection(18AA)
Objective:To explore the possibility of substituting histamine test for antihypertensive test in safety test of compound amino acid injection(18AA).Methods:Three batches of compound amino acid injection(18AA)were examined for antihypertensive sub-stances and histamine substances according to the stipulations of antihypertensive substances and histamine substances in Chinese pharma-copoeia(2020 edition),compare the results of the two methods.Results:According to Pharmacopoeia Standard,3 batches of compound amino acid injection(18AA)passed the method and the results of antihypertensive substances and histamine substances were in accord-ance with the regulations.Conclusion:The histamine test for compound amino acid injection(18AA)can be used as a supplement to the antihypertensive substance test.The sensitivity of the histamine test remains to be determined.
Compound Amino acid Injection(18AA)Antihypertensive substance testHistamine substance test
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