基于“药辅合一”制备艾天羊肌肉关节通络膏Ⅱ并评价药效

Preparation of Aitianyang Muscle and Joint Collaterals-dredging CreamⅡwith Medicinal Excipient

目的:发挥“药辅合一”的优势,将艾天羊肌肉关节通络膏(ATY乳膏)油相的中链脂肪酸更换为薄荷油,优化处方工艺,得到ATY乳膏Ⅱ,并对2种通络膏进行药效学比较研究。方法:以油/水相质量比、促透剂、添加剂量和药液与基质质量比为考察因素,采用Box-Behnken响应面法优化ATY乳膏Ⅱ制备工艺。通过热板实验,研究比较2种通络膏对小鼠痛阈值的影响;通过小鼠耳肿胀实验,研究比较2种通络膏抗炎的作用;通过醋酸扭体实验,观察2种通络膏对化学刺激引起的疼痛的影响。结果:ATY乳膏Ⅱ的优化工艺处方为油/水相质量比35∶65,促透剂添加剂量8%,药液与基质质量比1∶10。药效实验中,改进后的ATY乳膏Ⅱ组与模型组比较,可显著提高小鼠痛阈值(P<0.01),抑制二甲苯致小鼠耳肿胀的程度(P<0.01),对化学刺激引起的疼痛具有一定的镇痛作用(P<0.01);且上述作用ATY乳膏Ⅱ优于ATY乳膏。结论:改进后的ATY乳膏Ⅱ的工艺简单、可行,稳定性良好,且具有活血化瘀、抗炎镇痛作用。

Objective:Following the principle of unifying medicine with excipient,this paper aims to replace the medium-chain fatty acids in the oil phase of Aitianyang muscle and joint collaterals-dredging Cream(hereinafter referred to as ATY Cream)with peppermint oil,optimize the prescription process to yield ATY CreamⅡ,and compare the effects of ATY Cream and ATY CreamⅡ.Methods:Box-Behnken design was employed to optimize the oil-water phase mass ratio,the amount of penetration enhancer,and medicinal extract for the preparation of ATY CreamⅡ.The hot-plate test was used to investigate the effect of the two creams on the pain threshold of mice,mouse ear swelling test the anti-inflammatory effect,and acetic acid-induced writhing test the effect on chemical stimulus-induced pain.Results:The optimized preparation process for ATY CreamⅡis as follows∶oil-water phase mass ratio of 35∶65,8%penetration enhancer,and medicinal extract-matrix mass ratio of 1∶10.The two creams can significantly increase the pain threshold of mice(P<0.01),alleviate xylene-induced ear swelling(P<0.01),and relieve the pain induced by chemical stimulus(P<0.01)compared with the model group,particularly the ATY CreamⅡ.Conclusion:The improved ATY CreamⅡ,featuring simple preparation and high stability,has blood-activating and stasis-resolving,anti-inflammatory,and analgesic effects.