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目的:优选芳冰鼻吸剂的处方工艺。方法:以大鼠睡眠持续时间和入睡潜伏期的综合评分为评价指标,采用L9(34)正交试验考察薄荷脑、芳樟醇、冰片用量对芳冰鼻吸剂处方工艺的影响。以冰片、薄荷脑的溶解性及鼻吸剂气味为指标,通过单因素试验考察乙醇不同体积对该制剂释药速率的影响;以薄荷脑、芳樟醇、冰片的体外释放度为指标,结合睡眠剥夺药效验证,确定芳冰鼻吸剂的最佳处方。结果:最佳处方为冰片0.15 g,芳樟醇0.4 mL,薄荷脑0.070 9 g,90%药用乙醇0.1mL;潜伏期(13.26±1.51)min,睡眠持续时间(43.58±1.94)min。结论:芳冰鼻吸剂处方设计合理,药味芳香宜人,为中药肺部给药制剂的开发提供启发。
OBJECTIVE: To optimize the prescription of Fang Bing Ni inhalation. Methods: Based on the comprehensive score of sleep duration and sleep latency in rats, the effects of menthol, linalool and borneol on the prescription of Fang Bing Ni inhalation were investigated by L9 (34) orthogonal test. Taking the solubility of borneol, menthol and nasal odor as indexes, the effects of different volumes of ethanol on drug release rate were investigated by single factor test. In vitro release of menthol, linalool and borneol were used as indexes, Sleep deprivation efficacy verification, to determine the best prescription Fang Bingni inhaler. Results: The optimal prescription was 0.15 g of borneol, 0.4 mL of linalool, 0.070 9 g of menthol and 0.1 mL of 90% ethanol. The incubation period was (13.26 ± 1.51) min and the duration of sleep was (43.58 ± 1.94) min. Conclusion: Fang Bing nasal inhalation prescription design is reasonable, fragrant aroma, for the development of Chinese medicine pulmonary formulations provide inspiration.