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儿科用剂型的开发研究(V)仓鼠颊囊中药用软糖的口腔黏膜刺激性研究

Studies on development of dosage forms for pediatric use (V) oral mucosal irritation study of gummi drugs in hamster cheek pouch.

作者信息

Namiki N, Takagi N, Yuasa H, Kanaya Y

机构信息

Department of Pharmacy, The Jikei University School of Medicine Daisan Hospital, Komae-city, Tokyo, Japan.

出版信息

Biol Pharm Bull. 1998 Jan;21(1):87-9. doi: 10.1248/bpb.21.87.

DOI:10.1248/bpb.21.87
PMID:9477177
Abstract

In the present study we investigated irritation of the oral mucosa and the safety of gummi drugs containing acetaminophen (AAP). The oral mucosae of hamsters were macroscopically examined for any evidence of irritation after gummi drugs were inserted into the cheek pouch and left there for 1 h. The cheek pouch tissue was also macroscopically and microscopically examined 24 h after gummi drugs were withdrawn from the cheek pouch. As a result, no evidence of irritation was found macroscopically 1 h after insertion, or macroscopically and microscopically 24 h after the withdrawal of the gummi drugs or placebos as compared with negative controls (saline). Considering these results, the gummi drugs administered in the present study produced no irritation to the oral mucosa.

摘要

在本研究中,我们调查了含对乙酰氨基酚(AAP)的软糖药物对口腔黏膜的刺激性及安全性。将软糖药物插入仓鼠颊囊并放置1小时后,对仓鼠口腔黏膜进行宏观检查,以寻找任何刺激迹象。从颊囊中取出软糖药物24小时后,对颊囊组织进行宏观和微观检查。结果显示,与阴性对照(生理盐水)相比,插入软糖药物1小时后未发现宏观刺激迹象,取出软糖药物或安慰剂24小时后,在宏观和微观上均未发现刺激迹象。基于这些结果,本研究中使用的软糖药物对口腔黏膜未产生刺激。

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