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目的:研究中药安慰剂对胃肠动力和镇痛抗炎是否有药效学作用。方法:采用小鼠小肠推进和新斯的明亢进实验来观察中药安慰剂是否对胃肠动力有影响;采用小鼠热板镇痛法和二甲苯致小鼠耳肿胀实验来观察中药安慰剂是否有镇痛抗炎作用。结果:安慰剂、含5%原药加辅料组、含10%原药加辅料组与正常组比较均无统计学意义(P>0.05),阳性对照药与正常组比较有显著的统计学意义。结论:安慰剂、含5%原药加辅料、含10%原药加辅料对胃肠动力没有影响,并没有镇痛抗炎作用,提示本课题含有临床中药试验药低浓度(5%和10%)经以上实验结果表明没有药效学作用,从而起到了作为中药安慰剂对照的作用,为临床中药安慰剂的制作提供了实验依据,亦为本课题(中德合作中医药治疗腹泻型肠易激综合征的临床研究)中所采用含有5%试验药成分作为临床中药安慰剂对照提供实验依据。
OBJECTIVE: To study whether Chinese medicine placebo has pharmacodynamic effects on gastrointestinal motility and analgesic and anti-inflammatory effects. METHODS: Mouse small intestine advancing and Neostigmine augmentation experiment were used to observe whether placebo of Chinese medicine had influence on gastrointestinal motility; mouse hot plate analgesia and xylene induced ear swelling test were used to observe whether placebo was Has analgesic and anti-inflammatory effects. Results: There was no statistically significant difference between placebo, 5% original drug plus excipient group, and 10% original drug plus excipient group compared with normal group (P>0.05). Positive control drug had significant statistical significance with normal group. . Conclusions: Placebo, 5% of original drugs plus excipients, and 10% of original drugs plus excipients have no effect on gastrointestinal motility, and have no analgesic and anti-inflammatory effects, suggesting that this subject contains low concentration of clinical Chinese medicine test drugs (5% and 10%). The above experimental results show that there is no pharmacodynamic effect, which has played a role as a placebo control of traditional Chinese medicine, provides experimental basis for the production of traditional Chinese medicine placebo, also for this topic (Chinese and German cooperation Chinese medicine treatment of diarrhea type bowel Clinical study of irritable bowel syndrome provides experimental basis for using 5% test drug ingredients as placebo control for clinical Chinese medicine.