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Thirteen-Week Study of PM014 Subchronic Oral Toxicity in Rats
Hwan-Suck Chung1, Hyunil Lee1, Hyunsu Bae1
1Department of Physiology, College of Korean Medicine, Kyung Hee University, No. 1 Hoeki-Dong, Dongdaemoon-gu, Seoul 130-701, Republic of Korea.
Abstract:
PM014 is a modified herbal formula based on Chung-Sang-Bo-Ha-Tang, which is a well-known prescription drug used for curing various inflammatory pulmonary diseases. We previously showed that PM014 attenuated lung inflammation in a murine model of chronic obstructive pulmonary disease (COPD). The objective of the present study was to evaluate the chronic oral toxicity of PM014 in rats. PM014 was administered to rats orally once daily at doses of 0, 750, 1500, and 3000 mg/kg/day for 13 weeks. The PM014 treatment did not result in any toxicologically significant changes between the control and treatment groups in body weight, clinical signs, food consumption, dermatological and serum biochemical parameters, organ weight ratio, or histopathology. We concluded that no PM014-related toxicity was detected even at the highest doses investigated in this repeated dose oral toxicity study. Based on our results, the no-observed-adverse-effect level (NOAEL) of PM014 was 3000 mg/kg/day in both genders. These results might provide supportive evidence of the safety of PM014 to develop a new drug.
Insights
This study found that PM014, a modified herbal formula, showed no significant toxicity in rats after 13 weeks of oral administration. The no-observed-adverse-effect level (NOAEL) was determined to be 3000 mg/kg/day, supporting its potential safety for drug development.
Area of Science:
- Pharmacology and Toxicology
- Herbal Medicine Research
- Pulmonary Disease Therapeutics
Background:
- PM014 is a modified herbal formula derived from Chung-Sang-Bo-Ha-Tang, known for treating inflammatory pulmonary diseases.
- Previous research demonstrated PM014's efficacy in reducing lung inflammation in a murine model of chronic obstructive pulmonary disease (COPD).
Purpose of the Study:
- To evaluate the chronic oral toxicity of PM014 in a rat model.
- To establish the safety profile of PM014 for potential therapeutic applications.
Main Methods:
- Rats were administered PM014 orally once daily for 13 weeks at doses of 0, 750, 1500, and 3000 mg/kg/day.
- Comprehensive toxicological assessments included body weight, clinical signs, food consumption, biochemical parameters, organ weights, and histopathology.
Main Results:
- No toxicologically significant differences were observed between the control and PM014 treatment groups across all measured parameters.
- No PM014-related toxicity was detected, even at the highest dose of 3000 mg/kg/day.
- The no-observed-adverse-effect level (NOAEL) for PM014 was established at 3000 mg/kg/day in both male and female rats.
Conclusions:
- PM014 demonstrates a favorable safety profile with no observed adverse effects at the highest tested dose in a 13-week oral toxicity study in rats.
- These findings provide crucial supportive evidence for the safety of PM014, facilitating its further development as a potential therapeutic agent for pulmonary conditions.
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