Safety inspection of traditional Chinese medicine injections (1)

(1) Hemolysis and Coagulation Test Method

1.

2.

(1) Equipment: clean tube, glass beads, flasks, pipettes, flasks, centrifuge, centrifuge tubes, syringes, water bath, a microscope, ultraviolet-visible spectrophotometer

(2) Reagent: 75% ethanol, distilled water, 0.

(3) Experimental animals: rabbits, weighing more than 2kg, should be healthy and qualified, both male and female

3.

4.

(1) Preparation of 2% erythrocyte suspension: Take healthy rabbits above 2kg, after fixation, use a syringe to take blood 20ml-30ml from the heart, and quickly put it into an Erlenmeyer flask with glass beads (or stir the blood with a glass rod), Immediately start shaking for 10 minutes to remove fibrinogen and make defibrinated blood

(2) Add test solution: Unless otherwise specified, take 5 clean test tubes, numbered, tubes 1 and 2 are test sample tubes, add test solution, tube 3 is red blood cell negative control tube, No.

Table 15-29 Preparation table for adding liquid to warm bath test tube for hemolysis and agglutination inspection

(3) Warm bath and observation: After adding the liquid, gently shake and mix, and immediately put it in a 37℃±0.

Table 15-30 Record Form of Hemolysis and Coagulation Inspection Results

(4) Judgment of hemolysis: ①The solution in the test tube (No.

Hemolysis rate (%)=(A-A5)/(A4-A5)×100%.

In the formula, A is the average value of absorbance of No.

(5) Judgment of red blood cell aggregation: ①There is brown-red or red-brown flocculent precipitate in the test tube (No.

5.
Judgment of results Unless otherwise specified, when the negative control tube has no hemolysis and aggregation, and the positive control tube (No.
4) has hemolysis, the test is established; if the two test tubes do not have hemolysis within 3 hours If there is hemolysis and (or) agglomeration within 3 hours of 1 test product tube, 4 test product tubes should be set up for retesting, and 4 test product tubes should be used for retesting.
Hemolysis and (or) agglomeration shall not occur within 3 hours, otherwise it is determined that the test product does not meet the requirements
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