复方硼酸含漱液局部用药的毒性研究

Topical Toxicity of Compound Boric Acid Gargle

目的探讨复方硼酸含漱液局部用药的毒性作用。方法选用SD大鼠和白色豚鼠,分别进行复方硼酸含漱液的局部口腔黏膜刺激试验和过敏试验。口腔黏膜刺激试验分为复方硼酸含漱液组和生理盐水对照组,观察记录给药后24h～7dSD大鼠的全身状况及口腔黏膜反应情况。过敏试验除复方硼酸含濑液组外,另设空白对照组(生理盐水组)和阳性对照组(2,4-二硝基氯苯组),激发接触试验6、24、48、72h观察皮肤过敏反应及全身反应情况。结果SD大鼠口腔给予复方硼酸含漱液,未发现口腔黏膜组织异常,证明复方硼酸含漱剂对口腔黏膜无刺激性;豚鼠过敏实验结果显示复方硼酸含漱液皮肤用药,未出现过敏反应。结论复方硼酸含漱液局部用药毒性试验显示其无口腔黏膜刺激性和致敏性,提示复方硼酸含漱液作为口腔外用含漱液临床用药安全。

Objective In order to provide evidence for clinical use,the topical toxicity tests of compound boric acid gargle （CBAG） were done on rats and guinea pigs.Methods According to Drug Registration Regulations and the related regulatory requirements,the local oral mucosa irritation tests and allergy tests of CBAG were done on s rats and guinea pigs,respectively.Normal saline was used as placebo in the oral mucosal irritation test.For allergy testing,2,4-Dinitrochlorobenzene was added as positive control.Results After rinsed orally with a dose of CBAG in rats,no abnormal oral mucosa was found,proving that CBAG has no irritation on rat oral mucosa.Meanwhile,the guinea pig allergy test results showed that CBAG do not cause allergic reactions when adminstrated on skin.Conclusion The clinical application of CBAG is external use as mouth wash or rinse.The topical toxicity tests showed that no oral mucosa irritation and skin allegy were related to the use of CBAG,suggesting that the clinical use of CBAG in human being is safe.