目的 對制川烏配方顆粒與標(biāo)準(zhǔn)煎劑抗炎藥效等效性進(jìn)行研究。方法 應(yīng)用二甲苯致小鼠耳腫脹法比較制川烏標(biāo)準(zhǔn)煎劑及配方顆粒對其抑制作用。結(jié)果 在抗炎藥效等效性研究中，在小鼠耳廓腫脹抑制率22.51%～38.65%共同效應(yīng)范圍內(nèi)，1/2、1、2倍臨床等效劑量（195.00、390.00、780.00 mg/kg）制川烏標(biāo)準(zhǔn)煎劑等效于0.07、0.20、0.46倍臨床等效劑量（27.36、77.67、178.29 mg/kg）制川烏配方顆粒所產(chǎn)生的抗炎效應(yīng)，制川烏配方顆粒等效劑量DEE_{制川烏配方顆粒}=-22.950＋0.258× DEE_{制川烏標(biāo)準(zhǔn)煎劑}（R²=0.958，r=0.979，P<0.01），回歸系數(shù)b₀=-22.950，95% CI為（4.549，41.351），與總體均值0相比，差異有顯著性（P<0.05），常數(shù)項(xiàng)b₁=0.258，95% CI為（-0.218，0.299），與總體均值1相比，差異有顯著性（P<0.05）。制川烏配方顆粒與制川烏標(biāo)準(zhǔn)煎劑藥劑量在1/8～1倍臨床等效應(yīng)劑量范圍內(nèi)（48.75～390.00 mg/kg）具有可比性，制川烏配方顆粒的等劑量效應(yīng)EED_{制川烏配方顆粒}=2.963＋1.573×EED_{制川烏標(biāo)準(zhǔn)煎劑}（R²=0.923，r=0.961，P<0.01），回歸系數(shù)b₀=2.963，95% CI為（-5.373，11.300），與總體0比較差異有顯著性（P<0.05），常數(shù)項(xiàng)b₁=1.573，95% CI為（1.230，1.915），與總體均值1相比差異有顯著性（P<0.05）。結(jié)論 在抗炎方面制川烏配方顆粒和制川烏標(biāo)準(zhǔn)煎劑的等效應(yīng)劑量不具有等效性，制川烏配方顆粒等效應(yīng)劑量較制川烏標(biāo)準(zhǔn)煎劑小。在抗炎方面制川烏配方顆粒和制川烏標(biāo)準(zhǔn)煎劑的等劑量效應(yīng)不具有等效性，制川烏配方顆粒等劑量效應(yīng)較制川烏標(biāo)準(zhǔn)煎劑大。

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.

廣東省中醫(yī)藥局科研課題（20121241）；廣州市科技攻關(guān)專項(xiàng)（201300000153）