17味超临界CO2萃取中药配方颗粒急性毒性研究

目的对比观察17味同批次中药饮片所制备的标准煎剂、膏粉（水提物）、超临界CO2萃取技术制备的中药配方颗粒和超临界CO2萃取物等四种制剂的急性毒性,明确超临界CO2萃取技术制备配方颗粒的安全剂量范围。方法将药物制成最大可溶浓度的水溶液,小鼠按照0.4 ml/10 g体重灌胃给药,空白对照组以同样容积的去离子水灌胃,24 h内给药3次,连续观察14 d动物出现的反应。结果在观察的14 d内,动物均未出现任何异常行为变化;体重未有减轻现象,与对照组相比,无显著差异;也无任何动物死亡;17味中药饮片不同工艺的最大给药量的临床用药剂量倍数在75.39～2 629.05倍之间。结论 17味同批次中药饮片所制备的标准煎剂、膏粉剂、超萃物和配方颗粒,均为无毒性药物,超临界萃取中药配方颗粒临床可安全使用。

Toxicity Study of 17 kinds Chinese Medicinal Dispensing Granule Made by Supercritical CO2 Extraction

Objective To compare the acute toxicity difference of 17 kinds Chinese medicine including the prepared standard decoction,cream powder（water extract）,the supercritical CO2 extraction and Chinese medicinal dispensing granule.To decide the safe dose range of Chinese medicinal dispensing granule made by supercritical CO2 extraction.Methods After preparation of the largest dissolved concentration of the Chinese medicine,the mice were given by intragastric administration in accordance with 0.4 ml/10 g body weight tid.At the same time,the control group animals were given by deionized water tid.The response of animals was observed for 14 d.Results During 14 d,animals did not display any toxicity reaction.Body weight did not reduce.Compared with the control group,no significant differences occurred.No animals died.The maximum administration doses of 31 different herbs were 75.39~2 629.05 times than clinical doses.Conclusion The 17 kinds of Chinese herbal medicine from the same batch by the different technology preparations are non-toxic.Chinese medicinal dispensing granules by supercritical CO2 extraction can be used safely in clinical.