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目的:考察基于药理学评价的中药质量控制的可行性及应用条件。方法:以含雷公藤类、乌头类、马钱子和青风藤等有毒药材为主药的十一种祛风除湿类药物,检测其对DNFB所致小鼠迟发型超敏反应和鸡红细胞诱导的血清溶血素生成的影响,以评估功能主治类似的药物对此二指标反应的差异性;比较毒效成分含量不同的同一药物对上述指标的影响及其急性毒性的差异,以评估主要药效成分含量、药效学指标及毒性反应的相关性。结果:含雷公藤类药材的五种药物可显著抑制正常小鼠的体液免疫和/或细胞免疫,但含乌头类、青风藤、马钱子等药材的药物中,除含乌头类的麝香风湿胶囊对DNFB所致迟发型超敏反应有明显作用外,其他药物作用甚微;风湿平及狼疮平两种受试药物对特异性免疫的抑制作用和急性毒性均随药物中昆明山海棠的含量降低而降低,呈明显的含量-药效-毒性相关性。结论:采用祛风除湿类中药对鸡红细胞所致小鼠溶血素抗体生成和DNFB所致小鼠耳肿胀试验以及小鼠急性毒性试验,可作为质量控制的药理学评价主要指标之一。
Objective: To investigate the feasibility and application conditions of quality control of traditional Chinese medicine based on pharmacological evaluation. Methods: Thirteen kinds of expelling and damp-removing and dehumidification-type drugs were used as the main drugs, including poisonous herbs such as Tripterygium wilfordii, Aconitum, Strychnos vines, and Cyperus alba, to detect their delayed type hypersensitivity reaction in mice induced by DNFB and chicken Erythrocyte-induced serum hemolysin production in order to assess the function of similar drugs on the two indicators of the difference in response; the same drug content of different toxic components compared to the above indicators and their acute toxicity differences to assess the main The content of pharmacodynamics, pharmacodynamics and the relativity of toxic reaction. Results: Five drugs containing Tripterygium wilfordii could significantly inhibit the humoral and / or cellular immunity of normal mice. However, among the drugs containing aconite, aconite and strychnos, Of musk rheumatism capsule on DNFB-induced delayed-type hypersensitivity has a significant effect, other drugs have little effect; rheumatism and lupus two kinds of test drugs on specific immune suppression and acute toxicity with the drug in Kunming Mountain Begonia content decreased and decreased, showed a significant content - efficacy - toxicity-related. CONCLUSION: Qufengchushi can be used as one of the main indexes of pharmacological evaluation of quality control for hemolysin antibody production by mouse erythrocytes and mouse ear edema induced by DNFB and acute toxicity test in mice.