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目的:优选枇杷花叶含片(LFLBT)的处方工艺并通过药效学试验验证其祛痰、止咳及抗炎的药理活性。方法:以口感和崩解时限为综合评价指标,通过正交试验考察微晶纤维素、甘露醇、阿斯巴甜、柠檬酸用量对LFLBT处方工艺的影响;采用酚红排泌法、浓氨水喷雾引咳法和二甲苯致小鼠耳肿胀法验证LFLBT的祛痰、止咳及抗炎活性。结果:最佳处方工艺为每30 g枇杷花叶提取物中加入微晶纤维素70 g和甘露醇5 g,另加入0.5%阿斯巴甜和1%柠檬酸,以95%乙醇为黏合剂制粒。与空白组相比,LFLBT高剂量组能明显增加小鼠的酚红排泌量;LFLBT中剂量组和高剂量组能延长浓氨水所致的小鼠咳嗽潜伏期并减少小鼠3 min内的咳嗽次数;LFLBT高剂量组能明显抑制二甲苯引起的小鼠耳肿胀。结论:优选的处方工艺简单可行,制备的LFLBT具备一定的清咽利喉活性。
Objective: To optimize the prescription of loquat mosaic leaf tablets (LFLBT) and to verify its expectorant, cough and anti-inflammatory pharmacological activity by pharmacodynamic test. Methods: The effects of microcrystalline cellulose, mannitol, aspartame and citric acid on the formulation of LFLBT were investigated by orthogonal test with the mouthfeel and disintegration time as the comprehensive evaluation indexes. The effects of phenol red excretion, concentrated ammonia Anti-phlegm, cough-relieving and anti-inflammatory activity of LFLBT was verified by spray cough-inducing method and xylene-induced ear swelling in mice. Results: The optimal prescription was adding microcrystalline cellulose 70 g and mannitol 5 g to 30 g loquat mosaic extract, adding 0.5% aspartame and 1% citric acid, 95% ethanol as binder Granulation. Compared with the blank group, LFLBT high-dose group can significantly increase phenol red secretion in mice; LFLBT middle-dose group and high-dose group can prolong the incubation period of mice caused by concentrated ammonia water cough and cough within 3 min Frequency; LFLBT high-dose group can significantly inhibit xylene-induced mouse ear swelling. Conclusion: The preferred prescription process is simple and feasible, the preparation of LFLBT has a certain Qingre throat activity.