本文關(guān)鍵詞： 阿奇霉素 掩味 干乳 二氧化硅 腸黏膜刺激　出處：《藥學(xué)學(xué)報》2017年05期 　論文類型：期刊論文

【摘要】：研制阿奇霉素兒科用掩味口服制劑,采用脂質(zhì)納米反膠束技術(shù)掩蔽藥物的苦味,再以膠態(tài)二氧化硅固化含藥油溶液制備掩味干乳。通過染色實驗證明了干乳處方中油相均勻分散,進一步結(jié)合掃描電鏡對其進行評價。采用X-射線粉末衍射及掃描電鏡測定固體粉末中藥物的結(jié)晶狀態(tài),激光粒度測定儀和透射電鏡考察再分散乳滴的粒徑大小及其形態(tài)特征。通過口腔模擬釋放實驗和志愿者口嘗對制劑掩味效果進行評價,并對制劑進行腸黏膜刺激性評價。結(jié)果表明,制備的掩味干乳再分散乳滴平均粒徑為530.1 nm,混懸后再分散性良好,混懸液外觀均一。與上市制劑希舒美相比,相同劑量下掩味效果相近且腸黏膜刺激性較小,具有很好的發(fā)展前景。
[Abstract]:Azithromycin Pediatric Mask Oral preparation was prepared, and the bitter taste of the drug was masked by lipid nanometer reverse micelle technique. Then the dry milk was prepared by curing the medicated oil solution with colloidal silica. The dyeing experiment proved that the oil phase was evenly dispersed in the formulation of dry milk. X-ray powder diffraction and scanning electron microscopy were used to determine the crystalline state of the drug in the solid powder. The particle size and morphological characteristics of redispersed emulsion droplets were investigated by laser particle size analyzer and transmission electron microscope. Oral simulated release test and oral taste of volunteers were used to evaluate the effectiveness of the preparation. The results showed that the average diameter of the prepared dry milk was 530.1 nm, the dispersion of the suspension was good, the appearance of the suspension was uniform. At the same dose, the effect of taste masking is similar and the irritation of intestinal mucosa is small, so it has a good prospect of development.
【作者單位】： 天津中醫(yī)藥大學(xué)實驗教學(xué)部;軍事醫(yī)學(xué)科學(xué)院毒物藥物研究所;
【基金】：“十二五”國家重大新藥創(chuàng)制資助項目(2015ZX09J15104-003)
【分類號】：R943

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本文編號：1538296