复方止痒喷雾剂成型工艺研究及药效评价*

作者：沈家燕1，林 涛2，童 瑛1，张 颜1，向亚津晶1，贺怡凡1，吴康利1，刘 葭1，吴 清1

单位：1.北京中医药大学中药学院，北京 102488； 2.北京中医药大学科技园管理办公室，北京 102488

引用：引用：沈家燕，林涛，童瑛，张颜，向亚津晶，贺怡凡，吴康利，刘葭，吴清.复方止痒喷雾剂成型工艺研究及药效评价[J].中医药导报,2026,32(4):82-87.

DOI：10.13862/j.cn43-1446/r.2026.04.013

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摘要：目的：将止痒方研制成溶液型喷雾剂，并对其进行初步药效学评价。方法：以表观评价、透光率、离心稳定性和耐寒耐热稳定性为指标，采用单因素考察法确定喷雾剂处方，并通过2,4-二硝基氯苯诱导的小鼠慢性瘙痒模型对制剂进行初步药效学评价。结果：最终确定喷雾剂处方工艺为取对应处方量的水提取纯化浓缩药液[2 g/mL（以生药计）]，添加1.5%（V/V）吐温80、1.0%（m/V）泊洛沙姆188、5.0%（V/V）丙二醇，配制后添加0.2%（m/V）山梨酸钾，用对应处方量的蒸馏液配制后加水补齐至全方总量即得，其能够有效缓解小鼠瘙痒模型产生的病理状态。结论：所确定的复方止痒喷雾剂的成型工艺稳定可行，经考察具有较好的止痒药效，可为该制剂的后续研究与应用提供参考。

关键词：复方止痒喷雾剂；瘙痒；成型工艺；药效评价；中药制剂

Abstract：

Objective: To develop the Anti-itch Formula into a solution-type spray and conduct a preliminary pharmacodynamic evaluation on it. Methods: With appearance evaluation, light transmittance, centrifugal stability, and cold/heat resistance stability as the indicators, the spray formulation was determined by the single-factor investigation method. The preliminary pharmacodynamic evaluation was carried out on the preparation using a chronic pruritus mouse model induced by 2,4-dinitrochlorobenzene. Results: The finalized formulation process was as follows: take the water-extracted, purified and concentrated medicinal solution of the corresponding prescription dose (2 g/mL calculated by crude drug), add 1.5% (V/V) Tween 80, 1.0% (m/V) Poloxamer 188 and 5.0% (V/V) propylene glycol for preparation, then add 0.2% (m/V) potassium sorbate, prepare the mixture with distilled water of the corresponding prescription dose, and finally add water to make up the total volume of the whole prescription. This formulation could effectively alleviate the pathological changes in mice with pruritus model. Conclusion: The established formulation process of the compound antipruritic spray is stable and feasible, and it exhibits satisfactory anti-itch efficacy through investigation, which provides a reference for the subsequent research and application of this preparation.

Key words：Compound Antipruritic Spray; pruritus; formulation process; pharmacodynamic evaluation; traditional Chinese medicine (TCM) preparation

发布时间：2026-04-26

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