麝香保心丸中3种有效成分的体外溶出度测定

Study on dissolution of three active components in Shexiang Baoxin Pill

目的:建立人参皂苷Rb1、肉桂酸、冰片3种有效成分的测定方法,考察市售麝香保心丸(麝香、人参提取物、人工牛黄、肉桂、苏合香、蟾酥、冰片)中该3种成分的体外溶出度。方法:采用小杯法进行体外溶出度的研究,采用高效液相色谱法测定人参皂苷Rb1与肉桂酸的体外溶出度,采用气相色谱法测定冰片的体外溶出度。结果:所建立的指标成分测定方法简单易行,专一性、精密度、准确度、稳定性等均能满足试验要求;人参皂苷Rb1、肉桂酸、冰片的T50分别为30.90min、29.73min和42.38min,Td分别为33.79min、37.11min和48.51min。结论:麝香保心丸中三种有效成分的溶出较快,所建立的溶出度测定方法可用于该制剂的质量评价。

AIM： To study the dissolution of ginsenoside Rb1,cinnamic acid and borneol in traditional Chinese medicine Shexiang Baoxin Pill（Moschus,extract of Radix et Rhizoma ginseng,Calculus Bovis artifactus,Cortex Cinnamomi,Styrax,Venenum Bufonis and Borneolum syntheticum）. METHODS： The in vitro dissolution of active components in Shexiang Baoxin Pill was performed with paddle method. HPLC was used for determination of ginsenoside Rb1 and cinnamic acid,and GC for borneol. RESULTS： The analytic method above was easy to carry out,the requirement of the specificity,accuracy,precision and stability could meet the needs of experiment well; the dissolution time T50 and Td of ginsenoside Rb1,cinnamic acid and borneol were 30. 90,33. 79 min,29. 73, 37. 11 min and 42. 38,48. 51 min respectively. CONCLUSION： The dissolution rate of three active components from Shexiang Baoxin Pills was fast and the analytic methods established in this study could be used to evaluate the quality of the preparation.