Yamamoto T, Maitani Y, Isowa K, Nagai T
Department of Pharmaceutics, Hoshi University, Tokyo, Japan.
Biol Pharm Bull. 1995 Jun;18(6):887-90. doi: 10.1248/bpb.18.887.
Soybean-derived sterylglucoside mixture (SG) is a potentially effective absorption enhancer for the nasal absorption of insulin. Insulin is a peanut oil suspension dosage form and in a powder dosage form with SG were administered into the rabbit nasal cavity. After 0.5 or 1 h, nasal mucosa was taken from the nasal cavity and side effects were examined by an optiphoto light microscope. The insulin in the peanut oil suspension produced a histological change in the nasal epithelium mucosae, as well as mucodermal phlogistic cellular infiltration. The peanut oil suspension with SG showed side effects slightly stronger than without SG. SG alone and the insulin powder dosage form with SG produced no signs of inflammation, erosion or squamous metaplasia. The results from this study indicate that SG can be considered safe.
大豆衍生的甾醇糖苷混合物(SG)是一种对胰岛素鼻腔吸收具有潜在有效作用的吸收增强剂。胰岛素分别以花生油混悬剂型和与SG混合的粉末剂型经鼻腔给予家兔。给药0.5小时或1小时后,从鼻腔取出鼻黏膜,用光学显微镜检查副作用。花生油混悬液中的胰岛素导致鼻上皮黏膜出现组织学变化以及黏膜皮肤炎性细胞浸润。含SG的花生油混悬液显示出的副作用略强于不含SG的混悬液。单独的SG以及含SG的胰岛素粉末剂型均未出现炎症、糜烂或鳞状化生迹象。本研究结果表明SG可被认为是安全的。