Safety inspection of traditional Chinese medicine injections (4)

(4) Abnormal toxicity inspection method

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2.

(1) Equipment: a syringe (sterile), the accuracy of 0.

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

(3) Experimental animals: They should be healthy and qualified.

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4.

(1) Administration: For non-biological products, unless otherwise specified, take 5 mice and give each mouse 0.

(2) Intravenous injection

1) Put the mouse into the regulator and expose the tail of the mouse

2) Wipe the mouse tail injection site with a 75% ethanol cotton ball to make the vein clear

3) Insert the needle of the syringe sucking the test solution into the tail vein of the mouse, fix the syringe with one hand, and inject the test solution at a constant speed while pushing slowly with the other

4) After the injection, pull out the needle and press the injection site to prevent bleeding and leakage of the test solution

5) After hemostasis at the injection site, put the mouse in the mouse box and observe the immediate reaction

6) If the inserted needle does not accurately enter the vein and the test solution is not lost, it can be appropriately moved from the tip of the tail to the root of the tail and re-inserted; if the test solution is lost, the mouse is invalid, and another mouse should be taken.

(3) Intraperitoneal injection

1) Hold the mouse in one hand and fix it so that it cannot struggle

2) Wipe the injection site of the mouse abdomen with a cotton ball of 75% ethanol

3) Insert the syringe needle with the test solution into the abdomen subcutaneously, and insert it into the abdominal cavity of the mouse after about 5mm under the skin, and gently inject the test solution at a uniform speed
.

4) After the injection is completed, pull out the needle and lightly press the injection site to prevent leakage of the test solution
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5) Put the mouse in the mouse box and observe the immediate reaction
.

(4) Subcutaneous injection

1) Hold the mouse in one hand and fix it so that it cannot struggle
.

2) Wipe the injection site on the abdomen or back of the mouse with a cotton ball of 75% ethanol
.

3) Insert the syringe needle sucking the test solution into the subcutaneous, and after moving forward at least 5mm under the skin, gently push and inject the test solution at a constant speed
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4) After the injection is completed, pull out the needle and lightly press the injection site to prevent leakage of the test solution
.

5) Put the mouse in the mouse box and observe the immediate reaction
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(5) Oral administration

1) Hold the mouse in one hand and fix it so that it cannot struggle
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2) The syringe is connected to the gavage needle, and the test solution is sucked
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3) Slowly insert the gavage needle into the mouse's oral cavity, gently change the angle to make it enter the esophagus, and gently push to inject the test solution at a uniform speed
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4) After the administration, gently pull out the gavage needle, put the mouse into the mouse box, and observe the immediate response
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(6) Observation during the observation period: After the injection of the drug and within the specified time, the mice should be raised normally and closely observed to determine whether there are toxic reactions and deaths
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Non-biological products are generally observed 48 hours after administration
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Biological products are generally observed 7 days after administration
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5.
Judgment of Results

(1) Non-biological products: Unless otherwise specified, all mice shall not die within 48 hours after administration, and those without death shall be judged to meet the requirements
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In case of death, another 10 mice weighing 19-21g should be taken for retest
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In the retest of 10 mice, there was no death within 48 hours, and it was judged to meet the requirements
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In the retest of 10 mice, animal deaths occurred within 48 hours and were judged as non-compliant
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(2) Biological products: Unless otherwise specified, all animals should be alive without showing unhealthy status.
When the animal's weight should increase when it expires, it is judged as qualified
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Otherwise, 10 mice of 19-21g can be used for the re-test, or 4 guinea pigs of 250-350g can be used for the re-test.
The judgment criteria are the same as before
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Related Links: Safety Inspection of Traditional Chinese Medicine Injections (3)