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    Home > Chemicals Industry > Chemical Technology > Safety inspection of traditional Chinese medicine injections (2)

    Safety inspection of traditional Chinese medicine injections (2)

    • Last Update: 2022-06-24
    • Source: Internet
    • Author: User
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    (2) Allergic reaction inspection method

    1.
    Brief introduction This method is a systemic active allergic reaction test for injection administration.
    A certain amount of the test solution is injected into the guinea pigs, and the test solution is injected intravenously after a certain period of time to attack, and observe the animal's allergic reaction.
    , In order to determine whether the test product causes an animal's systemic allergic reaction

    .

    2.
    Test conditions

    (1) Equipment: a syringe (sterile), typically 1ml; small beaker flask and the like
    .
    Balance (for animal weighing and reagent weighing)

    .

    (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
    .
    Before the test and during the observation period of the test, the animals should be raised in accordance with the national requirements for the breeding conditions of experimental animals

    .
    Animals that have undergone this experiment must not be reused

    .

    3.
    Unless otherwise specified, the test solution should be prepared according to the specified concentration under each category to prepare the test solution

    .
    Pay attention to aseptic operation in the process of preparing the test solution

    .

    4.
    Inspection method

    (1) Sensitization: Unless otherwise specified, take 6 guinea pigs mentioned above and inject 0.
    5ml of the test substance solution into the intraperitoneal cavity every other day for a total of 3 times for sensitization

    .

    (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.
    Attack with 1ml, and observe the symptoms within 30 minutes after intravenous 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.
    Judgment of results Unless otherwise specified, allergic reactions should not occur within 30 minutes after intravenous injection of the test solution

    .
    If there are two or more of the phenomena such as vertical hair, trembling, retching, 3 consecutive sneezing, 3 consecutive coughing, purple chancre, and difficulty breathing on the same animal, or incontinence or gait Those who are unstable or fall to the ground, convulsions, shock, or death will be judged that the test product does not meet the requirements

    .

    (3) Pyrogen inspection method

    1.
    Brief description of this method is to inject a certain dose of the test substance into rabbits intravenously, and observe the increase in the rabbit's body temperature within a specified period of time to determine whether the limit of the pyrogen contained in the test substance meets Regulations

    .

    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)

     

     

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