Hemolytic test in medical package

Hemolytic examination in medical packaging a method of detecting hemolysis in vitro by measuring the amount of hemoglobin released by red blood cells in contact with the blood.

100ml COP vials

Prior to the test, unless otherwise specified, fresh blood from the heart of healthy rabbits was collected into the anticoagulant vessels. The common anticoagulants were 3.2% sodium citrate or 2% potassium oxalate. 8ml fresh anticoagulant rabbit blood was taken and diluted with 10ml 0.9% sodium chloride injection.

The preparation of the test product shall be divided into three parts, 5g for each part, and generally cut into strips of 0.5cmx2cm, unless otherwise specified. Due to the potential difference in extraction performance between the complete surface and the cut surface, the integrity of the test product can be maintained when necessary.

Except as otherwise provided for in inspection. 3 test tubes in the test group, 5g of test tube and 10ml of 0.9% sodium chloride injection were added to each tube. Negative control group 3 test tubes, each tube added 0.9% sodium chloride injection 10ml; In the positive control group, add 10ml purified water to each tube. After all the test tubes were placed in a constant temperature water bath at (37±1) degrees for 30 minutes, 0.2ml of diluted rabbit blood was added to each test tube, which was then gently mixed and kept warm for 60 minutes in a water bath at (37±1) degrees. Pour out the tube and centrifuge the liquid for 5 minutes (800g). The absorbance was measured at the wavelength of 545nm by spectrophotometry (Chinese pharmacopoeia 4 general rule 0401).