OBJECTIVE: To assess the safety and effectiveness of Dengzhanxixin injection(DZI) extracted from Dengzhanxixin(Herba Erigerontis Breviscapi) and identify its potential risks.METHODS: A series of studies were conducted...OBJECTIVE: To assess the safety and effectiveness of Dengzhanxixin injection(DZI) extracted from Dengzhanxixin(Herba Erigerontis Breviscapi) and identify its potential risks.METHODS: A series of studies were conducted on the production process, quality standards, and pharmacology. Postmarketing clinical studies and literature reviews including adverse reactions(ADR),adverse events(ADE), case analysis and systematic reviews were also conducted. Data from the hospital information system and spontaneous reporting system were analyzed.RESULTS: The acute toxicity test indicated that the Lethal Dose 50 test( LD 50) dosage was 250 times more than the clinical maximum daily dosage(6mg/kg). In long-term toxicity tests, rats experi-enced renal tubular damage at 480 mg/kg. However, the dose of 120 mg/kg is safe and non-toxic,which is 40 times above the clinical daily maximum. Beagles had increased serum creatinine at160 mg/kg. In a prospective study, 15 962 cases experienced 16 ADR/ADE. The rate of ADR/ADE was0.1002%. ADR symptoms included rash(16.00%),chills(16.00%), and fever(16.00%).CONCLUSION: There is significant evidence that DZI is safe and effective in a clinical setting.展开更多
OBJECTIVE: To examine the acute toxicity of an aqueous extract of Aspidopterys obcordata(A. obcordata) in Sprague Dawley rats.METHODS: The rats were orally administered a dose of 5000 mg/kg body weight and observed co...OBJECTIVE: To examine the acute toxicity of an aqueous extract of Aspidopterys obcordata(A. obcordata) in Sprague Dawley rats.METHODS: The rats were orally administered a dose of 5000 mg/kg body weight and observed continuously for 6 h and then daily for 14 days. Control rats were administered distilled water. The effect of the extract on general behavior, body weight, and food and water intake were measured.After 14 days, the rats were sacrificed and their organs(liver, heart, spleen, lungs, kidney, adrenal glands, ovaries, and testes) were removed for macroscopic examination. The body and organ weights in addition to hematology(e.g., hemoglobin and white blood cell counts) and clinical blood biochemistry(e.g., albumin and bilirubin) were also examined.RESULTS: There were no deaths recorded, and the rats treated with A. obcordata showed no signs of toxicity. All measured parameters in rats treated with A. obcordata were unaffected when compared with those in control rats. The acute toxicity(LD_(50))was estimated to be > 5000 mg/kg body weight.CONCLUSION: Our results demonstrate the safety of an acute oral administration of an aqueous extract of A. obcordata in rats and indicate that future subacute and long-term toxicity testing of A. obcordata is warranted.展开更多
基金Supported by National Science and Technology Major Projects for"Major New Drugs Innovation and Development":Study on Key Technologies of Postmarketing Evaluation for Chinese Medicine(No.2009ZX09502-030)
文摘OBJECTIVE: To assess the safety and effectiveness of Dengzhanxixin injection(DZI) extracted from Dengzhanxixin(Herba Erigerontis Breviscapi) and identify its potential risks.METHODS: A series of studies were conducted on the production process, quality standards, and pharmacology. Postmarketing clinical studies and literature reviews including adverse reactions(ADR),adverse events(ADE), case analysis and systematic reviews were also conducted. Data from the hospital information system and spontaneous reporting system were analyzed.RESULTS: The acute toxicity test indicated that the Lethal Dose 50 test( LD 50) dosage was 250 times more than the clinical maximum daily dosage(6mg/kg). In long-term toxicity tests, rats experi-enced renal tubular damage at 480 mg/kg. However, the dose of 120 mg/kg is safe and non-toxic,which is 40 times above the clinical daily maximum. Beagles had increased serum creatinine at160 mg/kg. In a prospective study, 15 962 cases experienced 16 ADR/ADE. The rate of ADR/ADE was0.1002%. ADR symptoms included rash(16.00%),chills(16.00%), and fever(16.00%).CONCLUSION: There is significant evidence that DZI is safe and effective in a clinical setting.
基金National Natural Science Foundation of China(Transport Characters and Mechanism Research of Multiplicity Ingredient TCM Utilizing Sensitive Bioactivity in Caco-2 Cell Model,No.81173645)Program for Innovative Research Team in IMPLAD(Discovery and foundation of new drug of TCM)+2 种基金a grant from the Basic Scientific Research Special of the Central Public Welfare Research Institutes of IMPLAD(Research on the Kidney Stone Activities and Preliminary Mechanisms of Aspidopterys Obcordata,No.YZYN-15-06)PUMC Youth Fund(Study of Anti-Tumor Activities of Pegylation Artemisinin Prodrugs Based on PK-PD Binding Model,No.33320140076)Beijing Municipal Natural Science Foundation(Preparation of Silica-Based Nanoparticles/PDMS Hybrid Membranes for Pervaporation of Ethanol/Water Mixtures,No.2132010)
文摘OBJECTIVE: To examine the acute toxicity of an aqueous extract of Aspidopterys obcordata(A. obcordata) in Sprague Dawley rats.METHODS: The rats were orally administered a dose of 5000 mg/kg body weight and observed continuously for 6 h and then daily for 14 days. Control rats were administered distilled water. The effect of the extract on general behavior, body weight, and food and water intake were measured.After 14 days, the rats were sacrificed and their organs(liver, heart, spleen, lungs, kidney, adrenal glands, ovaries, and testes) were removed for macroscopic examination. The body and organ weights in addition to hematology(e.g., hemoglobin and white blood cell counts) and clinical blood biochemistry(e.g., albumin and bilirubin) were also examined.RESULTS: There were no deaths recorded, and the rats treated with A. obcordata showed no signs of toxicity. All measured parameters in rats treated with A. obcordata were unaffected when compared with those in control rats. The acute toxicity(LD_(50))was estimated to be > 5000 mg/kg body weight.CONCLUSION: Our results demonstrate the safety of an acute oral administration of an aqueous extract of A. obcordata in rats and indicate that future subacute and long-term toxicity testing of A. obcordata is warranted.
