Other drug testing method for the determination of finished pharmaceutical and biological products is the use of different drug supplies to treat experimental animals, which is subsequently used to observe the life state of animals after treatment with different kinds of drug supplies and to compare with the animals injected with drug standards. At present, there are two main types of tests used for the determination of finished pharmaceutical and biological products by other drug testing methods: antimony sodium gluconate toxicity test and digitalis biochemical testing method.

Operation method

Antimony sodium gluconate toxicity test

Materials and Instruments

Reagents:
① Sodium antimony gluconate standard.
Laboratory animals:
① Mice weighing 17~25 g, clean grade.

Move

The basic process of antimony sodium gluconate toxicity check method can be divided into the following steps:
A. Preparation of standard solution.
(1) Precisely weigh the appropriate amount of antimony sodium gluconate standard, calculated according to the amount of antimony contained, add the appropriate amount of warm water and stir to dissolve.
(2) Heating (about 70 ° C, 15 minutes), make up enough water to a certain amount, heating at a constant temperature of 50 ° C for 30 minutes (to avoid evaporation of water), cooling to room temperature.
(3) Inject 0.02 mL of the standard solution into the tail vein of each 1 g of body weight of mice with the following specifications, adjust the concentration so that about half of the mice die, and 20%~80% of the mortality rate is the appropriate concentration.
B. Preparation of the test solution.
(1) As powder, follow the preparation method of the standard solution.
(2) For injections, dilute with water, warm at a constant temperature of 50 °C for 30 minutes (to avoid evaporation of water), cool to room temperature, and the concentration of the test solution should be 83% of that of the standard solution.
C. Animal selection. Take 40 or 20 clean-grade mice weighing 17~25 g. The weight difference between mice for each test should not exceed 3 g.
D. Animal disposal.
(1) Animal grouping: Randomly divide the mice into two groups of 20 or 10 mice each, one group being the standard group and the other group being the test article group.
(2) Injection: Inject 0.02 mL of standard solution or test solution into the tail vein for every 1 g of body weight of the mice, and the injection should be completed within 4~5 seconds.
(3) Observation: Observe the mice immediately for 15 minutes and record the number of deaths.

Caveat

A. Examination with 40 mice.(1) If the number of deaths of mice in the test group is less than the number of deaths of mice in the standard group, or if the number of deaths of mice in both groups is the same, the toxicity of the test article is judged to be in compliance with the regulations.(2) If the number of deaths of mice in the test group is higher than that of mice in the standard group, the toxicity of the test article is judged to be non-compliant.B. Examination with 20 mice.(1) If the number of deaths of mice in the test group is 2 or more less than the number of deaths of mice in the standard group, the toxicity of the test article is judged to be in compliance.(2) If the number of deaths of mice in the test group is 2 or more than the number of deaths of mice in the standard group, the toxicity of the test article is judged to be non-compliant.C. If the number of deaths in the two groups is the same or differs by only 1 mouse, 20 mice shall be taken for retesting, and the results of the two tests shall be combined and processed in the same way as the above judgment method using 40 mice.

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