摘要
目的:建立心灵丸(蟾酥、人工麝香、冰片、体外培植牛黄、熊胆、人参、三七等)的质量标准。方法:采用显微鉴别处方中的珍珠;采用GC及TLC分别对处方中的人工麝香、冰片等进行定性鉴别;采用HPLC法测定华蟾酥毒基和脂蟾毒配基的含量。结果:在GC图谱中可检测到与麝香酮对照品相同保留时间的色谱峰;在TLC图谱中可检出人参、三七等药材的特征斑点;华蟾酥毒基在0.0398～0.4776μg之间线性关系良好,r=0.9998,精密度试验RSD=0.3%(n=6),平均回收率为100.18%,(RSD=0.5%,n=6);脂蟾毒配基在0.0419～0.5026μg之间线性关系良好,r=0.9998,精密度试验RSD=0.6%(n=6),平均回收率为97.00%,(RSD=0.9%,n=6)。结论:所采用的方法准确、可靠,可行性及重复性良好,能有效控制该制剂的质量。
Objective：To establish the method for control of Xinling Pill（ Venenum Bufonis, Calculus Bovis Moschus, Borneolum Syntheficum, Calculus Bovis Sativus, Radix et Rhizoma Ginseng, Radix et Rhizoma Notoginseng etc）. Methods：Margarita in Xinling Pill was identified by microscope; Calculus Bovis Moschus in Xinling Pill was identified by GC; Borneolum Syntheticum, Calculus Bovis Sativus, Radix et Rhizoma Ginseng and Radix et Rhizoma Notoginseng in Xinling Pill was identified by TLC ,and the content of Cinobufagin and Recibufogenin were determined by HPLC. Results：The same Relative migration time of Muscone was identified by GC ; Radix et Rhizoma Ginseng and Radix et Rhizoma Notoginseng were identified by TLC ; Cinobufagin showed a good liner relationship at the range of 0. 039 8 - 0. 477 6 μg, r = 0. 999 8. The RSD of measurement precision test was 0, 3% （ n = 6）, The average recovery was 100. 18%, （RSD = 0, 5% , n = 6） ; Recibufogenin showed a good liner relationship at the range of 0. 041 9 -0. 502 6 μg, r = 0. 999 8, The RSD of measurement precision test was 0. 6% （ n =6） ,The average recovery was 97.00%, （ RSD =0. 9%, n =6）. Conclusion：The method is accurate,reliable and available with a reproducibility and can be used to control the quality of this ointment effectively.
出处
《中国药品标准》
CAS
2008年第4期263-267,共5页
Drug Standards of China
