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纸质出版:2014
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曾钰,韩宪忠,金蜀蓉.复方芩苍鼻喷雾剂药效及安全性的初步评价[J].陆军军医大学学报(原第三军医大学学报),2014,36(17):1833-1836.
Zeng Yu,Han Xianzhong,Jin Shurong.Primary evaluation for efficacy and safety of compound Qincang nasal spray in treatment of allergic rhinitis in guinea pigs[J].J Amry Med Univ (J Third Mil Med Univ),2014,36(17):1833-1836.
曾钰,韩宪忠,金蜀蓉.复方芩苍鼻喷雾剂药效及安全性的初步评价[J].陆军军医大学学报(原第三军医大学学报),2014,36(17):1833-1836. DOI:
Zeng Yu,Han Xianzhong,Jin Shurong.Primary evaluation for efficacy and safety of compound Qincang nasal spray in treatment of allergic rhinitis in guinea pigs[J].J Amry Med Univ (J Third Mil Med Univ),2014,36(17):1833-1836. DOI:
目的 评价复方芩苍鼻喷雾剂对变应性鼻炎模型的药效及对局部、全身产生的急性毒性反应和局部刺激性,考察该药的安全性。 方法 药效实验:选取豚鼠40只,分为正常对照组、模型组(采用卵蛋白致敏法建模)、给药组[低剂量组(黄芩苷含量8.21 mg/mL)、常规剂量组(黄芩苷含量24.63 mg/mL)],鼻腔喷予复方芩苍鼻喷雾剂5 d,根据过敏症状评分对药效进行评价。急性毒性实验、局部刺激实验:均参照中药新药研究指导原则,分别选取健康新西兰兔30只,分为空白对照组、给药组[低剂量组(黄芩苷含量8.21 mg/mL)、常规剂量组(黄芩苷含量24.63 mg/mL)],连续鼻腔给药7 d。分别评价急性毒性反应和局部刺激性反应,并结合鼻黏膜病理组织学检查,综合判断复方芩苍鼻喷雾剂的安全性和局部刺激性。 结果 药效实验结果显示,给药组豚鼠鼻痒、喷嚏、流涕、呼吸等症状评分明显低于模型组(P0.01)。急性毒性实验及局部刺激性实验结果显示,所有动物未发生全身性反应及死亡,给药组与空白对照组差异无统计学意义(P0.05),表明并无明显的急性毒性反应和局部刺激性。处死的动物组织病理学检查未见异常。 结论 复方芩苍鼻喷雾剂能改善变应性鼻炎症状,同时对新西兰兔无明显的急性毒性反应和局部刺激性,动物实验表明其安全性较高。
Objective To determine the effects of compound Qincang nasal spray (containing bacalin as its active ingredient) on the guinea pig model of allergic rhinitis
and on the local and systemic toxicity as well as local irritation
and to evaluate the safety of this medicine. Methods Efficacy experiment: 40 healthy guinea pigs were selected and then divided into 4 groups
that is
normal control group
allergic rhinitis model group (established by ovalbumin sensitization) and administration groups including low dose group (bacalin 8.21 mg/mL) and conventional dose group (baicalin 24.63 mg/mL). After the animals were given compound Qincang nasal spray for 5 d
the effect was evaluated by allergic symptom scoring. Acute toxicity experiment and local irritation experiment: according to the guidance on the research of new Chinese traditional medicines
30 healthy New Zealand rabbits were divided into 3 groups: blank control group and administration groups including low dose group (baicalin 8.21 mg/mL) and conventional dose group (baicalin 24.63 mg/mL). After drugs were administrated with nasal mode in 7 continuous days
the acute toxicity and local irritation were evaluated
and the safety and local irritant effect were comprehensively evaluated with the nasal mucosa pathological examination. Results Efficacy experiments showed that the symptom scores (nasal itching
sneezing
rhinorrhea
and dyspnea) were significant lower in the compound Qincang nasal spray administration groups than the model group (P0.01). Acute toxicity experiment and local irritation experiment indicated there was no systemic reaction or death
or no statistical difference between administration groups and blank control group (P0.05). The compound Qincang nasal spray showed neither obvious acute toxicity reaction nor local irritation
and no pathological abnormality in killed animals. Conclusion Qincang nasal spray significantly improves the symptoms of allergies
and at the same time
has no obvious acute toxicity reaction or local irritant effect
which is considered to be safe in laboratory practice.
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