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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 technology of Guanxin Suhe Capsule and to develop a method for determination of its content. Methods: Gas chromatography was adopted (appendix VI E of 2010 edition of Pharmacopoeia of People’s Republic of China); Column: HP20M 30 m × 0.32 mm × 1.0 μm (PEG20M); Column temperature: 140 ℃; Gasification temperature: 280 ° C; detector temperature: 300 ° C; carrier gas: nitrogen (chromatographic purity); flow rate: 35.5 m L / min; split ratio: 40: 1; injection volume: 1 μL. Optimize the process of drying temperature and accessories dosage. Results: The content of borneol in Guanxin Suhe capsule showed a good linear relationship in the range of 1.85-11.13 mg with an average recovery rate of 97.71% -101.24% and a RSD of 1.35% (n = 6), in line with the relevant regulations. Other Methodological tests are in line with the relevant provisions. Drying process temperature below 50 ℃, the amount of accessories appropriate. Conclusion: This method is fast, simple and easy to operate, with good precision, repeatability and stability. After optimization, each index of Guanxin Suhe capsule conforms to Pharmacopoeia regulations, and has good process repeatability and is suitable for large-scale production.