苏氏伤痛宁软膏质量控制研究  

Study on quality control of Sushi Shangtongning ointment

作　　者：刘栋 段立鸣 郝哲 张建帮 屈俊 王丽军 李明春 LIU Dong;DUAN Li-ming;HAO Zhe(Department of Pharmacy,No.988 Hospital of PLA,Zhengzhou,Henan 450042,China;不详)

机构地区：[1]解放军第988医院药剂科,河南郑州450042 [2]解放军海军第971医院药剂科,山东青岛266071

出　　处：《实用医药杂志》2021年第5期450-453,共4页Practical Journal of Medicine & Pharmacy

基　　金：军队医疗机构制剂标准提高科研专项课题(14ZJZ02)。

摘　　要：目的完善苏氏伤痛宁软膏的质量控制标准。方法采用薄层色谱法(TLC)对苏氏伤痛宁软膏中的黄连、当归、冰片进行定性鉴别。采用高效液相色谱法(HPLC)测定制剂中盐酸小檗碱的含量,色谱柱为Wondasil C18(250 mm×4.6 mm,5μm),流动相为乙腈-0.05 mol/L磷酸二氢钾溶液(用磷酸调pH值至3.0)(30∶70),检测波长349 nm;流速1.0 ml/min;柱温30℃;进样量10μl。结果TLC色谱图斑点清晰,阴性无干扰;盐酸小檗碱在1.02~10.17μg/ml范围内线性关系良好(r=0.9999),回收率平均值为98.46%,RSD为1.07%。结论该方法快速简便,准确可靠,能更好地用于苏氏伤痛宁软膏的质量控制。Objective To perfect the quality control standard of Sushi Shangtongning ointment.Methods Thin layer chromatography(TLC)was used for qualitatively identify Rhizoma Coptidis,Angelicae Sinensis Radix and Borneolum Syntheticum in Sushi Shangtongning ointment.High-performance liquid chromatography(HPLC)was used to determine the content of berberine hydrochloride in preparation.It was performed on column of Wondasil C18(250mm×4.6mm,5μm)with mobile phase consisted of acetonitrile-0.05mol/L potassium dihydrogen phosphate solution(adjusting pH to 3.0 with phosphoric acid)(30∶70)at the flow rate of 1.0ml/min,the detection wavelength of 349nm,the column temperature of 30℃and the volume of 10μl.Results TLC chromatographic spots were clear without interference of the negative control.There was a good linear relationship in the range of 1.02~10.17μg/ml(r=0.9999).The average recovery rate was 98.46%(RSD=1.07%).Conclusion The method is simple,accurate and reliable,and can be better used for quality control of Sushi Shangtongning ointment.

关 键 词：苏氏伤痛宁软膏 HPLC TLC 盐酸小檗碱 质量标准 

分 类 号：R286.0[医药卫生—中药学]