Study on Pilot Process and Acute Toxicity of Compound Zhajin Granules
Author(s): LI Zhaoyi, SHI Junpin, XU Jing, JIANG Xiaoqin, JI Qian, TIAN Jing, Xixi Hospital of Hangzhou, The Affiliated Hospital of Hangzhou Normal University
Pages: 1972-1974+2069-2070
Year: 2015 Issue: 8
Journal: Chinese Archives of Traditional Chinese Medicine
Keyword: Compound Zhajin Granules; pilot process; acute toxicity; maximum dose;
Abstract: Objective: To establish the extraction process and quality indicators of Compound Zhajin Granules in the trial and to clear the acute toxicity and make the safety evaluation to guide its clinical drug safety. Methods: To assess the key technical parameters of extraction,concentration and drying process,with dry extract rate and chlorogenic acid content as assessment indicators. The acute toxicity test was operated by the maximum dose of test,with Compound Zhajin Granules extract in pilot test. The appearance,activity,diet,excretion,body weight and death in mice after medication and within14 days were observed. The changes in vital organs( heart,liver,spleen,lung,kidney,stomach and intestines,etc.) were observed after anatomy. Results: The dry extract rate of Compound Zhajin Granules was 11. 06% and the chlorogenic acid content was 0. 0170%. No mortality was found within 14 days. The general feature and main organs in testing and control groups showed no obvious change and there was no statistically significant difference in body weight( P > 0. 05). The median lethal dose of Compound Zhajin Granules was not determined. The maximum dose was 280. 0 g / kg body weight,157 times the clinical dose and toxic reactions were not observed. Conclusion: The pilot test is reliable and the equipment and its performance are stable. The Compound Zhajin Granules is safe when the dose is 150 times larger than the draft clinical dosage.
Pages: 1972-1974+2069-2070
Year: 2015 Issue: 8
Journal: Chinese Archives of Traditional Chinese Medicine
Keyword: Compound Zhajin Granules; pilot process; acute toxicity; maximum dose;
Abstract: Objective: To establish the extraction process and quality indicators of Compound Zhajin Granules in the trial and to clear the acute toxicity and make the safety evaluation to guide its clinical drug safety. Methods: To assess the key technical parameters of extraction,concentration and drying process,with dry extract rate and chlorogenic acid content as assessment indicators. The acute toxicity test was operated by the maximum dose of test,with Compound Zhajin Granules extract in pilot test. The appearance,activity,diet,excretion,body weight and death in mice after medication and within14 days were observed. The changes in vital organs( heart,liver,spleen,lung,kidney,stomach and intestines,etc.) were observed after anatomy. Results: The dry extract rate of Compound Zhajin Granules was 11. 06% and the chlorogenic acid content was 0. 0170%. No mortality was found within 14 days. The general feature and main organs in testing and control groups showed no obvious change and there was no statistically significant difference in body weight( P > 0. 05). The median lethal dose of Compound Zhajin Granules was not determined. The maximum dose was 280. 0 g / kg body weight,157 times the clinical dose and toxic reactions were not observed. Conclusion: The pilot test is reliable and the equipment and its performance are stable. The Compound Zhajin Granules is safe when the dose is 150 times larger than the draft clinical dosage.
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