Journal of ethnopharmacology · 2026
Safety assessment of Zhibo Qingliang extract derived from a clinical experience formula: Single and 13-week repeated-dose studies in rats.
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Huang Ting, Yang Yang, Yan Jianyan, Yu Lining, Mao Xiaoyan, Chen Lifen, Xu Li, Zhang Junfang, Sun Yijie, Chong Liming, Zeng Jia
Аннотация
ETHNOPHARMACOLOGICAL RELEVANCE: Zhibo Qingliang (ZBQL) formula, a clinically validated traditional Chinese medicine (TCM) comprising sixteen herbs, has been used for over two decades to treat chronic glomerulonephritis (CGN), particularly in cases presenting with proteinuria due to damp-heat retention and declining healthy energy. Despite its extensive clinical application, the preclinical safety profile of the modernized ZBQL granule remained unestablished.
AIM OF THE STUDY: This study aimed to evaluate the safety of ZBQL dry extract through single- and repeated-dose oral toxicity studies in Sprague Dawley (SD) rats, including the determination of the maximum tolerated dose (MTD) and no-observed-adverse-effect level (NOAEL).
MATERIALS AND METHODS: A single-dose study was conducted by the administration of 30.0 g/kg ZBQL extract (43.3 × human dose) to SD rats, followed by 14-day observation. A 13-week repeated-dose study with a 4-week recovery period was performed at daily doses of 6.0, 12.0, and 15.0 g/kg (equivalent to 8.7, 17.3, and 21.6 × human dose), with an administration volume of 30 mL/kg. Parameters included clinical signs, body weight, food consumption, hematology, coagulation, blood biochemistry, urinalysis, organ weights (absolute and relative), and histopathology.
RESULTS: The single-dose MTD was ≥30.0 g/kg, with only transient diarrhea observed. In the repeated-dose study, the NOAEL was 12.0 g/kg. Dose-dependent reductions in body weight and food intake were observed in both male and female rats, attributed to the high viscosity. Reversible, non-adverse changes included mild hematological shifts, biochemical alterations consistent with reduced nutritional intake, and adaptive histopathological findings such as centrilobular hepatocyte hypertrophy and alveolar macrophage aggregation at the high dose. All changes resolved following the recovery period.
CONCLUSIONS: ZBQL extract demonstrated a wide safety margin in rats, with no evidence of direct organ toxicity. Observed effects were reversible and consistent with exaggerated pharmacological activity or adaptive responses. These findings support the continued clinical development of ZBQL granule as a safe and effective TCM-based therapeutic.
AIM OF THE STUDY: This study aimed to evaluate the safety of ZBQL dry extract through single- and repeated-dose oral toxicity studies in Sprague Dawley (SD) rats, including the determination of the maximum tolerated dose (MTD) and no-observed-adverse-effect level (NOAEL).
MATERIALS AND METHODS: A single-dose study was conducted by the administration of 30.0 g/kg ZBQL extract (43.3 × human dose) to SD rats, followed by 14-day observation. A 13-week repeated-dose study with a 4-week recovery period was performed at daily doses of 6.0, 12.0, and 15.0 g/kg (equivalent to 8.7, 17.3, and 21.6 × human dose), with an administration volume of 30 mL/kg. Parameters included clinical signs, body weight, food consumption, hematology, coagulation, blood biochemistry, urinalysis, organ weights (absolute and relative), and histopathology.
RESULTS: The single-dose MTD was ≥30.0 g/kg, with only transient diarrhea observed. In the repeated-dose study, the NOAEL was 12.0 g/kg. Dose-dependent reductions in body weight and food intake were observed in both male and female rats, attributed to the high viscosity. Reversible, non-adverse changes included mild hematological shifts, biochemical alterations consistent with reduced nutritional intake, and adaptive histopathological findings such as centrilobular hepatocyte hypertrophy and alveolar macrophage aggregation at the high dose. All changes resolved following the recovery period.
CONCLUSIONS: ZBQL extract demonstrated a wide safety margin in rats, with no evidence of direct organ toxicity. Observed effects were reversible and consistent with exaggerated pharmacological activity or adaptive responses. These findings support the continued clinical development of ZBQL granule as a safe and effective TCM-based therapeutic.