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Abstract:
Acute toxicity of Immunol to mice was carried out according to the principel of traditional Chinese medicine study. The maximum tolerance dosage (MTD) of Immunol was measured because it was impossible to find its LD50. Accumulated dosage was eqal to 1000 times of the clinical dosage. Adverse drug reaction (ADR) and death were not found in the end.
Objective:
To investigate the acute toxic reaction and death resulting from Immunol tablets in mice.
Materials:
Test Drug:Immunol tablets supplied by Hamida Pharma, Inc. in the United States.
Identification No.: IM-1010.
Maximum concentration: Immunol tablets were made into 25% suspension with 1% CMC-Na.
Animals: Species: Swiss Mouse.
Source: Experimental Animal Center of Jilin University.
Certificate: 10-5107.
Sex: Male and Female.
Age: No particular age was prescribed for this study.
Body Weight Range: 24-26 grams.
Acclimation Period: 1-2 days.
Number of Animals: 30.
Methods: Animal Management:
Husbandry: Conditions conformed to Standard Operating Procedures which are based on the "Guide for the Care and Use of Laboratory Animals".
Food: NIH-07 Rodent diet was provided daily.
Water: Freely available, municipal water was delivered through an automatic watering system.
Contaminants: Resonably expected contaminants in food or water supplies did not have the potential to influence the outcome of this test.
Housing: Animals were housed in groups of 10 per extract in stainless steel cages identified by a card indicating the animal numbers, test code, sex, animal code and date dosed.
Enviromental: The room temperature was monitored daily. The temperature range for the room was within a range of 20-26'C. The room humidity was monitored daily. The humidity range for the room was 40-70%. The light cycle was controlled using an automatic timer (12 hours light, 12 hours dark).
Facility: Pharmacology Lab of Basic School of Medical Science, Jilin University is registered with the Ministry of Public Health of PRC and conforms to GLP standards.
Personnel: Associates involved were appropriately qualified and trained.
Selection: Only healthy, previously unused animals were selected.
Pretest:
Immunol was made into 25% suspension which is the maximum concentration and was administered to ten mice with maximum volume (0.4ml/10g, i g). No animal was dead during the subsequent seven days.
Test:
The maximum tolerance dosage (MTD) of Immunol was measured because it was impossible to find its LD50. 20 mice were fast for 16 hours. 25% Immunol suspension was administered three times to the animals within 24 hours (0.4ml/10g body weight) and then the animals' gloss of fur, free activity, breath, diet, body weight, and death were observed for seven days.
Results:
20 mice hadn't obvious ADR and no animal was dead. Common condition was normal. Body weight increased a little (Table 1). Accumulated dosage was 30g/kg which was equal to 1000 times of clinical dosage (1.8g/60kg).
Conclusion:
Accumulated dosage of Immunol tablet (ig) was 30g/kg which was equal to 1000 times of clinical dosage. No ADR and death were observed during 7 days.
Record Storage:
All original data pertaining to this study and a copy of the final report are to be retained in Dept. of Pharmacology, Basic School of Medical Science, Jilin University of China. |
