张 甜, 王成润, 沈 松, 金 一, 戈延茹. 克拉霉素肠溶掩味颗粒的制备与评价J. 药学学报, 2011,46(12): 1520-1525.
引用本文: 张 甜, 王成润, 沈 松, 金 一, 戈延茹. 克拉霉素肠溶掩味颗粒的制备与评价J. 药学学报, 2011,46(12): 1520-1525.
ZHANG Tian, WANG Cheng-run, SHEN Song, JIN Yi, GE Yan-ru. Preparation and evaluation of enteric-coated and taste masking clarithromycin granulesJ. 药学学报, 2011,46(12): 1520-1525.
Citation: ZHANG Tian, WANG Cheng-run, SHEN Song, JIN Yi, GE Yan-ru. Preparation and evaluation of enteric-coated and taste masking clarithromycin granulesJ. 药学学报, 2011,46(12): 1520-1525.

克拉霉素肠溶掩味颗粒的制备与评价

Preparation and evaluation of enteric-coated and taste masking clarithromycin granules

  • 摘要:

    采用熔融法和流化床包衣技术制备克拉霉素肠溶掩味颗粒, 将克拉霉素与药用辅料基质在一定温度下熔融后制成颗粒, 再进行流化床包衣。分别用X-射线粉末衍射法 (X-ray) 和扫描电镜法 (SEM) 研究药物存在形式和载药颗粒的形态, 并考察其体外释放情况。结果表明, 载药颗粒的粒径范围为0.20.6 mm; 颗粒中克拉霉素的晶型未发生变化; 肠溶颗粒在0.1 mol·L−1盐酸中2 h累积释放百分数 < 10%, pH 6.8磷酸缓冲液中1 h累积释放百分数 > 80%。所制备的克拉霉素颗粒不仅有较好的掩味效果, 还有较好的释放, 有望更好地应用于临床。

     

    Abstract:

    The study is to prepare taste masking and enteric-coated clarithromycin granules by melting and fluid bed coating technology.  Clarithromycin and matrix materials were melted at a certain temperature, and then made into particles by fluidized bed coating.  X-ray powder diffraction and scanning electron microscopy were used to identify the crystal and morphology of drug loading granules.  In vitro dissolution method was used for the observation of the drug release behavior.  The results showed that the drug particles size range was 0.2 − 0.6 mm; the crystal form of clarithromycin in the granule did not change; enteric-coated granules accumulated release in 0.1 mol·L−1 hydrochloric acid in 2 h was less than 10%, while in pH 6.8 phosphate buffer in 1 h was more than 80%.  The taste masking and enteric-coated clarithromycin granules not only have good taste masking effect, but also have a good release behavior.  It is expected to have better clinical application.

     

/

返回文章
返回