| 王发,王莉,李继,赵婷.伊曲康唑颗粒溶出度测定及与生产工艺相关性探讨[J].中国药事,2018,32(7):927-931 |
| 伊曲康唑颗粒溶出度测定及与生产工艺相关性探讨 |
| Determination of Itraconazole Granules's Dissolution and Its Correlation with Production Process |
| 投稿时间：2017-06-20 |
| DOI：10.16153/j.1002-7777.2018.07.014 |
| 中文关键词: 抗真菌药 伊曲康唑颗粒 溶出度测定 生产工艺 质量分析 高效液相色谱法 |
| 英文关键词: antifungal drugs itraconazole granules determination of dissolution production process quality analysis HPLC |
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| 中文摘要: |
| 目的：建立伊曲康唑颗粒溶出度测定方法，并探讨溶出曲线与生产工艺的相关性。方法：采用浆法和高效液相色谱法，以0.5%十二烷基硫酸钠的0.1 mol·L-1盐酸溶液1000 mL为溶出介质，转速75 r·min-1，HPLC法测定，色谱柱：Agilent C18（250 mm×4.6 mm，5μm），流动相：甲醇-0.065 mol·L-1醋酸铵-乙醚（70：20：6），流速：1.0 mL·min-1，柱温：35℃，检测波长：261 nm。结果：经方法学验证，伊曲康唑在0.02014~0.1208 mg·mL-1的质量浓度范围内线性关系良好（r=0.9995），加样回收率为98.3%，精密度为0.6%。该方法可以对伊曲康唑颗粒的体外释放过程进行有效评价。结论：本法经方法学验证可用于伊曲康唑颗粒溶出度测定和工艺质量控制。 |
| 英文摘要: |
| Objective:To establish a method for the determination of itraconazole granules's dissolution and to discuss the correlation between dissolution curve and production process. Methods:Paddle and HPLC methods were applied. 0.5% sodium dodecyl sulfate in 0.1 mol·L-1 hydrochloric acid solution (1000 mL) was used as the dissolution medium and the rotation speed was kept at 75 r·min-1. The analysis was carried out by using the method of HPLC. Chromatographic column was Agilent C18 (250 mm×4.6 mm, 5μm) and methanol, 0.065 mol·L-1 ammonium acetate and ether (70:20:6) were used as mobile phase at the flow rate of 1.0 mL·min-1. The temperature of column was 35℃ and the detection wavelength was at 261 nm. Results:It was verified by methodology that calibration cures were linear in the range of 0.02014-0.1208 mg·mL-1 (r=0.9995), the average recovery rate was 98.3% and RSD was 0.6%. The method could be used to evaluate the release process of itraconazole granules in vitro. Conclusion:This method was validated by methodology and can be used for the determination of dissolution and the control of itraconazole granules's process quality. |
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