基于多动物模型药效评价体系研究羚羊感冒口服液儿童用药剂量

doi:10.19803/j.1672-8629.20230388

摘要/Abstract

摘要： 目的确定羚羊感冒口服液儿童用药的有效性和最佳剂量范围,增加其儿童用法用量,为儿童临床应用提供参考。方法基于多动物模型药效评价体系,采用反映主要功能主治的5种相应幼龄动物模型,包括甲型H1N1流感病毒感染致小鼠肺炎模型;冰醋酸致小鼠腹腔毛细血管通透性增加急性炎症模型;氨水雾化致小鼠咳嗽模型;冰醋酸致小鼠疼痛模型;脂多糖（LPS）致家兔发热模型,分别观察羚羊感冒口服液的人用剂量（儿童）0.1、0.2、0.4、0.6、0.8、1.0 mL·kg^-1·d^-1 6个剂量组抗病毒、抗炎、止咳、镇痛及解热的有效性,按体表面积换算公式换算为动物用量：小鼠用量分别为1、2、4、6、8、10 mL·kg^-1·d^-1;家兔用量分别为0.3、0.6、1.2、1.8、2.4、3.0 mL·kg^-1·d^-1。最终根据结果确定儿童最佳剂量范围。结果羚羊感冒口服液在所试剂量范围内均可在一定程度上降低小鼠肺指数、抑制小鼠毛细血管通透性、减少小鼠咳嗽次数及扭体次数、降低家兔体温,其中发挥稳定药效的剂量范围分别为4.0~8.0 mL·kg^-1·d^-1和1.2~2.4 mL·kg^-1·d^-1,相当于人用剂量0.4~0.8 mL·kg^-1·d^-1。结论羚羊感冒口服液在0.4~0.8 mL·kg^-1·d^-1剂量范围内产生稳定有效的抗病毒、抗炎、止咳、镇痛及解热作用,换算成不同年龄小儿临床推荐用量为1~3岁：每次5 mL、每日1~2次;4~6岁：每次5 mL、每日1~3次;7~12岁：每次5 mL、每日2~4次。

关键词: 羚羊感冒口服液, 儿童, 抗病毒, 抗炎, 镇痛, 止咳, 解热, 多动物模型, 小鼠, 家兔

Abstract: Objective To determine the effectiveness and range of optimal dosages of Lingyang Ganmao oral liquid for children, and to provide reference for medication in children. Methods Based on multi-animal models, five corresponding young animal models that targeted the major properties were used, including the mouse pneumonia model caused by influenza A (H1N1) virus infection, the mouse acute inflammation model for increased permeability of abdominal capillaries caused by glacial acetic acid, the mouse cough model caused by ammonia nebulization, the mouse pain model caused by glacial acetic acid and the rabbit fever model caused by lipopolysaccharide (LPS). To observe the antiviral, anti-inflammatory, antitussive, analgesic and antipyretic efficacy of Lingyang Ganmao oral liquid in six dosage groups, namely 0.1, 0.2, 0.4, 0.6, 0.8 and 1.0 mL·kg^-1·d^-1 for human use (children's dosage).The animal dosages were calculated using the body surface area conversion formula, based on the human dose. For mice, the dosages were 1, 2, 4, 6, 8, and 10 mL·kg^-1·d^-1, while for rabbits, the dosages were 0.3, 0.6, 1.2, 1.8, 2.4, and 3.0 mL·kg^-1·d^-1. The results are used to determine the optimal dose range for children. Results Lingyang Ganmao oral liquid could reduce lung indexes, inhibit capillary permeability, reduce the number of times mice coughed and writhed and help lower the body temperature of rabbits. The doses of stable efficacy ranged from 4.0 to 8.0 mL·kg^-1·d^-1 and from 1.2 to 2.4 mL·kg^-1·d^-1, respectively, which were equivalent to 0.4-0.8 mL·kg^-1·d^-1 for human use. Conclusion Lingyang Ganmao oral liquid produces stable and effective antiviral, anti-inflammatory, anti-cough, analgesic and antipyretic effects within the dose range of 0.4 to 0.8 mL·kg^-1·d^-1. The recommended dosage is 5mL each time and 1-2 times daily for children ages 1 to 3, 5mL each time and 1-3 times daily for those ages 4 to 6, and 5mL each time and 2-4 times daily for those between 7 and 12.

Key words: Lingyang Ganmao oral liquid, children, antiviral, anti-inflammatory, analgesia, antitussive, antipyretic, multi-animal, mouse, rabbit

中图分类号:

孙绮悦, 赵荣华, 包蕾, 郭姗姗, 耿子涵, 李舒冉, 徐英莉, 张敬升, 崔晓兰, 孙静. 基于多动物模型药效评价体系研究羚羊感冒口服液儿童用药剂量[J]. 中国药物警戒, 2024, 21(2): 121-126.

SUN Qiyue, ZHAO Ronghua, BAO Lei, GUO Shanshan, GENG Zihan, LI Shuran, XU Yingli, ZHANG Jingsheng, CUI Xiaolan, SUN Jing. Safe doses of Lingyang Ganmao oral liquid for children based on the multi-animal model[J]. Chinese Journal of Pharmacovigilance, 2024, 21(2): 121-126.

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