Safety inspection of traditional Chinese medicine injections (2)

(2) Allergic reaction inspection method

1.

2.

(1) Equipment: a syringe (sterile), typically 1ml; small beaker flask and the like

(2) Reagents: 75% ethanol , water for injection, sodium chloride injection or other prescribed solvents

(3) Experimental animals: Guinea pigs, weighing 250g～350g, should be healthy and qualified, both male and female, female mice are not pregnant

3.

4.

(1) Sensitization: Unless otherwise specified, take 6 guinea pigs mentioned above and inject 0.

(2) Attack: Unless otherwise specified, the 6 sensitized guinea pigs were divided into 2 groups, 3 in each group, and the test solution was injected intravenously on the 14th and 21st day after the first injection.

(3) Observation

1) The weight of each animal should be measured and recorded before the first sensitization and challenge

2) During the experiment, the behavior and physical signs of each animal should be observed daily

3) Observation of symptoms after attack

Unless otherwise specified, within 30 minutes of intravenous injection of the test solution, observe whether the animal has the symptoms listed in Table 15-31 or other symptoms, and make a record

Table 15-31 Symptoms or other symptoms

5.

(3) Pyrogen inspection method

1.

2.
Experimental materials and utensils

(1) The accuracy of the balance: 0.
01mg or 0.
1mg (for the weighing of the test product), 0.
1mg or 1mg (for the weighing of the reagent), 10g (for the weighing of the rabbit)
.

(2) Electric heating drying box
.

(3) Constant temperature water bath
.

(4) Pyrogen thermometer or anal thermometer, with an accuracy of 0.
1℃
.

(5) Rabbit fixed box: There are vents on both sides of the box
.

(6) Experimental equipment: syringes, beakers, triangular flasks, large weighing bottles, straws, pipettes, watch glasses, glass rods, wide-mouth reagent bottles, straight tweezers, metal sealers (all need to remove the pyrogen), Clock, absorbent cotton or soft toilet paper
.

(7) Reagents: 75% ethanol , petrolatum or 50% glycerin , normal saline, sterile water for injection (tested by bacterial endotoxin, the bacterial endotoxin is less than 0.
25 EU/ml), pyrogen-free sodium chloride (after 250 ℃ 30 minutes other suitable methods to remove pyrogen)
.

3.
Solution preparation

(1) API

1) Precisely weigh an appropriate amount and place it in a beaker, triangular flask or weighing bottle
.

2) Add a precise amount of sterile water for injection or physiological saline according to the specified concentration, and stir to dissolve
.

(2) Injection

1) Disinfect the neck of the ampoule with 75% ethanol cotton ball, and cut the ampoule
.

2) Precisely measure a certain amount of liquid medicine
.

3) Add a precise amount of sterile water for injection or physiological saline according to the specified concentration, and mix well
.

(3) Powder injection

1) Use 75% ethanol cotton ball to disinfect the neck of Ambu or bottle stopper
.

2) Add a certain amount of solvent to make the required concentration
.

Related links: Safety inspection of traditional Chinese medicine injections (1)