發(fā)布時(shí)間：2018-04-21 21:02

  本文選題：克拉霉素 + 微丸��； 參考：《中國抗生素雜志》2017年10期

【摘要】：目的研究一種新的工藝制備克拉霉素掩味顆粒并評(píng)價(jià)制劑質(zhì)量。方法利用流化床包衣技術(shù),在空白丸芯上依次噴涂主藥層和樹脂層,制成克拉霉素微丸,所得微丸與其他輔料混合,制粒得到克拉霉素掩味顆粒。結(jié)果該方法制備的克拉霉素掩味顆�？诟辛己脽o苦味,在p H為7.0的磷酸鹽緩沖液中45min累積釋放率大于85%,平均收率大于88.3%。結(jié)論通過影響因素試驗(yàn)初步評(píng)價(jià)了其穩(wěn)定性,在強(qiáng)光、高溫和高濕度條件下放置10d,性狀、含量及有關(guān)物質(zhì)符合2015版《中華人民共和國藥典》和《美國藥典》有關(guān)克拉霉素掩味顆粒質(zhì)量要求。
[Abstract]:Objective to study a new process for preparing clarithromycin flavor granules and evaluate the quality of the preparation. Methods Clarithromycin pellets were prepared by using fluidized bed coating technique. Clarithromycin pellets were prepared by spraying the main and resin layers on the blank pellets in turn. The pellets were mixed with other excipients to produce clarithromycin mask granules. Results the clarithromycin granules prepared by this method had a good taste without bitter taste. The cumulative release rate of 45min in phosphate buffer solution with pH = 7.0 was more than 85 and the average yield was more than 88.3. Conclusion the stability was evaluated preliminarily by the influence factor test, and the stability was evaluated under the condition of strong light, high temperature and high humidity for 10 days. The content of Clarithromycin and its related substances were in accordance with the quality requirements of the 2015 edition of the Pharmacopoeia of the people's Republic of China and the American Pharmacopoeia of Clarithromycin.
【作者單位】： 湖北工業(yè)大學(xué)生物工程與食品學(xué)院;武昌工學(xué)院食品工程學(xué)院;
【分類號(hào)】：R943
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本文編號(hào)：1784080