Application of Isolated Guinea Pig Ileum Method for Detection of Histamine Substances in Osteopeptide Injections

Abstract

ObjectiveTo evaluate the detection of the histamine substances in osteopeptide injections by the isolated guinea pig ileum method, and to explore the feasibility of replacing cat depressor substances method.MethodsAccording to the 2020 edition of Chinese Pharmacopoeia, the histamine substances in 7 batches of osteopeptide injections were detected from 5 enterprises by isolated guinea pig ileum method. The results were compared with the test method of cat depressor substances.ResultsBy the isolated guinea pig ileum method, the histamine substances in 3 batches of preparations were negative, which was consistent with the results of the test method of cat depressor substances. The results of the other 4 batches of preparations were suspicious; while the examination results of depressor substances in cat were 3 batches suspicious and 1 batch positive. The overall consistency rate of the two methods was 85.7% (6/7).ConclusionThe results of isolated guinea pig ileum method is almost the same as the test of cat depressor substances, which can be used for the screening and study of histamines in osteopeptide injections. It is suggested to add the inspection items of the test of depressor substances or histamines in the standard of osteopeptide injections.

Keywords

• isolated guinea pig ileum method
• osteopeptide injections
• histamine substances test
• test of cat depressor substances