The anaphylaxis test method for the determination of finished pharmaceutical and biological products is used to inject experimental animals with a test solution, which is then used to observe the vital state of the animals after treatment with the test solution and to compare with the animals injected with the standard solution. At present, there is one main type of test used for the determination of finished pharmaceutical and biological products by the allergy reaction check method: the allergy reaction check method.

Operation method

anaphylaxis

Materials and Instruments

Reagent:
① Solution of the test article.
Laboratory animals:
① Clean grade guinea pig weighing 250~350 g.

Move

The basic procedure of the allergic reaction test method can be divided into the following steps:
A. Preparation of the test solution. Prepare according to the specified concentration of each species.
B. Animal selection. Take 6 clean-grade guinea pigs weighing 250~350 g. The females should be non-pregnant; Note: The guinea pigs that have been used for this test should not be reused.
C. Animal Disposal.
(1) Weighing: weigh each guinea pig and record its weight.
(2) Grouping: Divide 6 guinea pigs into 2 groups of 3 guinea pigs each.
(3) Sensitization: Every other day, each guinea pig is injected intraperitoneally with 0.5 mL of the test solution for 3 times for sensitization.
(4) Sensitization: On the 14th and 21st day after the first sensitization injection, 1 mL of the test solution was injected intravenously for sensitization. Observe whether the guinea pigs have any symptoms of allergic reaction within 30 minutes after sensitization.

Caveat

A. If no allergic reaction occurs within 30 minutes of intravenous injection of the test material, the test material is judged to be in compliance.B. If one of the following symptoms occurs, the test article is considered non-compliant：

（1） Two or more of the following symptoms occur in the same guinea pig: raised hair, shivering, dry heaving, three consecutive sneezes, three consecutive coughs, cyanosis, and respiratory distress.(2) One of incontinence, unsteady gait, collapse, convulsion, or death by shock.

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