摘要
目的探讨复方氯已定含漱液局部用药的毒性作用。方法选用Wistar大鼠和白色豚鼠,分别进行复方氯已定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氯已定合漱液组和生理盐水对照组,观察记录给药后24—144h大鼠的全身状况及口腔黏膜反应情况。过敏试验除复方氯已定含濑液组外,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)。6、24、48、72h观察激发接触试验皮肤过敏反应及全身反应情况。结果大鼠口腔给予复方氯已定含漱液未发现口腔黏膜组织异常;白色豚鼠过敏实验结果显示复方氯已定含漱液皮肤用药未出现过敏反应。结论复方氯已定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,提示复方氯已定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 chlorhexidine were done on rats and guineapigs. Methods According to Drug Registration Regulations and the related regulatory requirements, the local oralmucosa irritationtests and allergy tests of compound ehlorhexidine were done on rats and guineapigs, respectively. Normal saline was used as placebo in the oralmucosal irritation test. For allergy testing, 2, 4 - Dinitrochlorobenzene was added as positive control. Results After rinsed orallywith a dose of compound chlorhexidine in rats, no abnormal oralmucosa was found, Meanwhile, the white guinea pig allergy test resuhsshowed that compound chlorhexidine do not cause allergic reactions when adminstrated on skin. Conclusion The clinical application of compound chlorhexidine is external use asmouth wash or rinse. The topical toxicity tests showed that no oralmucosa irritation and skin allegy were related to the use of compound chlorhexidine , suggesting that the clinical use of compound chlorhexidine in human being is safe.
出处
《青海医学院学报》
CAS
2010年第4期262-264,共3页
Journal of Qinghai Medical College