冠心苏合胶囊工艺优化及含量测定研究

Process Optimization and Determination of Guanxin Suhe Capsule

目的：优化冠心苏合胶囊工艺,制定其含量测定方法。方法：采用气相色谱法（《中华人民共和国药典》2010年版一部附录VI E）测定;色谱柱：HP20M 30 m×0.32 mm×1.0μm（PEG20M）;柱温：140℃;气化温度：280℃;检测器温度：300℃;载气：氮气（色谱纯）;流速：35.5 m L/min;分流比：40∶1;进样量：1μL。优化工艺中的干燥温度和辅料用量。结果：冠心苏合胶囊中冰片称样量在1.85~11.13 mg范围内呈良好的线性关系,平均回收率在97.71%~101.24%,RSD为1.35%（n=6）,符合有关规定,其他方法学考查均符合有关规定。工艺中干燥温度50℃以下,辅料用量适量。结论：本法操作快速、简便、易行,精密度、重复性、稳定性好。经过优化后制备的冠心苏合胶囊各项指标符合药典规定,工艺重复性好,适于规模化生产。

Objective：To optimize the Guanxin Suhe capsule technology,to establish the determination method for the content. Method：The gas chromatography（China Pharmacopoeia 2010 VI E）determination;chromatographic column：HP20M 30 m×0.32 mm×1 μm（PEG20M）;column temperature：140 ℃;gasification temperature：280 ℃;detector temperature：300 ℃;carrier gas：nitrogen（chromatographic purity）;flow rate：35.5 m L/min;split ratio：40：1;sample size：1 μL. Optimization of the process of drying temperature and dosage of adjuvant. Results：Borneol in Guanxin Suhe capsules sample weight in the range of 1.85~11.13 mg showed a good linear relationship,the average rate of recovery was 97.71%~101.24%,RSD was 1.35%（n=6）,in accordance with the relevant provisions,other methods of study are in conformity with the relevant provisions. In the process of drying temperature is below 50 ℃,the amount of excipients. Conclusion：The method is rapid,simple,and convenient operation,precision,repeatability,stability. After optimization of the preparation of Guanxin Suhe capsules meets the Pharmacopoeia,good technique repeatability,and is suitable for large-scale production.