制川乌配方颗粒与标准煎剂对二甲苯致小鼠耳肿胀抑制作用的比较研究

目的 对制川乌配方颗粒与标准煎剂抗炎药效等效性进行研究。方法 应用二甲苯致小鼠耳肿胀法比较制川乌标准煎剂及配方颗粒对其抑制作用。结果 在抗炎药效等效性研究中，在小鼠耳廓肿胀抑制率22.51%～38.65%共同效应范围内，1/2、1、2倍临床等效剂量（195.00、390.00、780.00 mg/kg）制川乌标准煎剂等效于0.07、0.20、0.46倍临床等效剂量（27.36、77.67、178.29 mg/kg）制川乌配方颗粒所产生的抗炎效应，制川乌配方颗粒等效剂量DEE_{制川乌配方颗粒}=-22.950＋0.258× DEE_{制川乌标准煎剂}（R²=0.958，r=0.979，P<0.01），回归系数b₀=-22.950，95% CI为（4.549，41.351），与总体均值0相比，差异有显著性（P<0.05），常数项b₁=0.258，95% CI为（-0.218，0.299），与总体均值1相比，差异有显著性（P<0.05）。制川乌配方颗粒与制川乌标准煎剂药剂量在1/8～1倍临床等效应剂量范围内（48.75～390.00 mg/kg）具有可比性，制川乌配方颗粒的等剂量效应EED_{制川乌配方颗粒}=2.963＋1.573×EED_{制川乌标准煎剂}（R²=0.923，r=0.961，P<0.01），回归系数b₀=2.963，95% CI为（-5.373，11.300），与总体0比较差异有显著性（P<0.05），常数项b₁=1.573，95% CI为（1.230，1.915），与总体均值1相比差异有显著性（P<0.05）。结论 在抗炎方面制川乌配方颗粒和制川乌标准煎剂的等效应剂量不具有等效性，制川乌配方颗粒等效应剂量较制川乌标准煎剂小。在抗炎方面制川乌配方颗粒和制川乌标准煎剂的等剂量效应不具有等效性，制川乌配方颗粒等剂量效应较制川乌标准煎剂大。

Comparison on inhibition between Aconiti Radix Cocta formula granule and standard decoction on ear swelling of mice induced by dimethyl benzene

Objective To study the anti-inflammatory pharmacodynamics between Aconiti Radix Cocta formula granule and standard decoction. Methods To study the inhibition of Aconiti Radix Cocta formula granule and standard decoction on the ear swelling of mice induced by dimethyl benzene. Results During the auricular inflammation test, when the inhibitory rate on ear swelling of mice was between 22.51% ~ 38.65%, the effect of 1/2, 1, and 2 times of the clinical equivalent dose (195, 390, and 780 mg/kg) are equal to 0.07, 0.20, and 0.46 times of Aconiti Radix Cocta formula granule (27.36, 77.67, and 178.29 mg/kg), the dose of equivalent effects (DEE)_{formula granule} (mg/kg)=-22.950+0.258 × DEE_{traditional form} (mg/kg) (r=0.979, P < 0.01), b₀=-22.950, 95% confidence interval is (4.549 and 41.351) (P < 0.05), b₁=0.258, 95% confidence interval is (-0.218 and 0.299) (P < 0.05). Hence, the DEE of Aconiti Radix Cocta formula granule is less than the traditional form. When the clinical equivalent dose of 1/8 ~ 1 times, the effects of equivalent dose (EED)_{formula granule} (%)=2.963+1.573 × EED_{traditional form} (%) (r=0.961, P < 0.01), b₀=2.963, 95% confidence interval is (-5.373 and 11.300) (P < 0.05), b₁=1.573, 95% confidence interval is (1.230 and 1.915) (P < 0.05). Conclusion The dose of the equivalent effects of Aconiti Radix Cocta formula granule is smaller than that in the traditional form. The effects of the equivalent dose of Aconiti Radix Cocta formula granule is stronger than that in the traditional form.