| 王一行,赵峡,吴健,等.藻酸双酯钠缓释片的制备及体外释放特性研究[J].中国海洋药物,2014,33(6):59-64. |
| 藻酸双酯钠缓释片的制备及体外释放特性研究 |
| Preparation of Propylene glycol aginate sodium sulfate sustained-release tablets and evaluation of its drug release in vitro |
| 投稿时间：2014-03-05 修订日期：2014-03-13 |
| DOI： |
| 中文关键词: 藻酸双酯钠 缓释片 制备 柱前衍生高效液相色谱 释放度 |
| English Keywords:Propylene glycol alginate sodium sulfate (PSS) Sustained-release tablets Preparation Precolumn derivatization high performance liquid chromatography realease rate |
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| 中文摘要: |
| 目的 制备藻酸双酯钠(PSS)的缓释片；建立PSS缓释片体外药物释放度的测定方法,并对其体外释放特性进行考察。方法 以羟丙基甲基纤维素(HPMC)、羧甲基纤维素钠(CMC-Na)和十八醇为骨架材料,采用熔融制粒法制备PSS缓释片,并采用正交设计优化PSS缓释片的处方；采用高效液相色谱法测定PSS缓释片的体外释放度。结果 建立了测定PSS缓释片药物释放度的柱前衍生高效液相色谱法,在0.3~12 mg/mL浓度范围内与峰面积呈现良好的线性关系(R2=0.9983),各辅料不影响PSS的含量测定。在低,中,高三个浓度下的加样回收率分别为103.6%,93.3%,104.8%,平均RSD为2.1%(n=6),精密度RSD为1.4%(n=5),重复性RSD为3.4%(n=5),24 h内稳定性良好,RSD为1.92%。采用正交设计确定了制备PSS缓释片的最优处方为：HPMC、CMC-Na和十八醇的用量分别为片重的15%,10%和10%,在最适条件下制备的PSS缓释片在2 h、6 h、12 h内可分别释放药物30.3%,70.9%和95.5%,体外药物释放行为符合一级模型,ln(1-Q)=-0.2756t 4.8141,r=0.9888。 结论 建立的柱前衍生高效液相色谱法具有专属性强,精密度和重现性好的特点,可用于PSS缓释片体外释放度的测定。采用熔融制粒法制备的PSS缓释片体外释放特性良好。 |
| English Summary: |
| Objective To prepare PSS sustained-release tablets and establish a chromatography method for release rate determination, and evaluate its release characteristics in vitro. Method PSS sustained-release tablets were prepared by melting granulation method using HPMC,CMC-Na and octadecanol as matrix materials.The release rate of PSS sustained-release tablets in vitro was determined by a precolumn derivatization high performance liquid chromatography (PC-HPLC) method ,and the prescription was optimized by an orthogonal design. Result A PC-HPLC method was successfully established to the determination of release rate in vitro of PSS sustained-release tablets. There was a good linear relationship between peak area ratio and concentration in the range of 0.3~12 mg/mL (R2=0.9983),All excipients did not disturb the determination of release rate of PSS. The sample recovery rates at low,medium and high concentration were 103.6%,93.3%,104.8%, respectively, with an average RSD of 2.1%(n=6). The RSD of precision test was 1.4%(n=5),and the RSD of repeatability test was 3.4%(n=5). The RSD of stability test within 24 h was 1.92%. The optimum prescription was determined by orthogonal design as follows: the weight percents of HPMC, CMC-Na, and octadecanolin PSS sustained-release tablets were 15%,10%,10%, respectively.The release rates of PSS sustained-release tablets were 30.3%,70.9% and 95.5% within 2 h,6 h,12 h, respectively.The release characteristics of PSS was conformed to the first-order kinetics equation of (ln(1-Q)=-0.2756t 4.8141,r=0.9888). Conclusion The PC-HPLC method is suitable to determine the release rate in vitro of PSS sustained-release tablets with good specificity precision and reproducibility.The release characteristics in vitro of PSS sustained-release tablets is satisfactory. |
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