复方益心酮口崩片的质量控制研究  

Study on Quality Control of Compound Yixintong Orally Disintegrating Tablets

作　　者：曾媛 方松 郝林 许宁宁 王晓玲 ZENG Yuan;FANG Song;HAO Lin;XU Ningning;WANG Xiaoling(Medical Support Center,General Hospital of Central Theater Command,Wuhan Hubei 430070,China)

机构地区：[1]中部战区总医院医疗保障中心,湖北武汉430070 [2]临潼康复疗养中心健康管理部药剂科

出　　处：《联勤军事医学》2024年第7期559-562,共4页Military Medicine of Joint Logistics

摘　　要：目的 建立复方益心酮口崩片主要有效成分山楂叶提取物指标性成分牡荆素葡萄糖苷(pectin glucoside,PG)、牡荆素鼠李糖苷(pectin rhamnoside,PR)的含量测定方法。方法 采用高效液相色谱(high-performance liquid chromatography,HPLC)法,对山楂叶提取物PG、PR进行含量测定,色谱柱使用Diamonsil C18,四氢呋喃-乙腈-甲醇-醋酸-水(38∶3∶3∶4∶152)为流动相,检测波长为330 nm,柱温为30℃,进样量为20μl。结果 PG在0.40~8.00μg/ml浓度范围内线性关系良好(r=0.999),PR在1.50~30.00μg/ml浓度范围内线性关系良好(r=0.999);精密度、重复性、稳定性试验,相对标准偏差(relative standard deviation,RSD)均小于2.00%;PG平均回收率为99.40%,RSD为1.21%(n=6),PR平均回收率为99.61%,RSD为0.52%(n=6)。结论 本研究所建立的HPLC法专属性强,重现性良好,结果准确,可用于复方益心酮口崩片的质量控制。Objective To establish a method to determine the content of the main active ingredient,pectin glucoside(PG) and pectin rhamnoside(PR),in hawthorn leaf extract in compound Yixintong orally disintegrating tablets.Methods The contents of PG and PR in hawthorn leaf extract were determined by high-performance liquid chromatography(HPLC),the chromatographic column used Diamonsil C18,and the mobile phase was tetrahydrofuran-acetonitrile-methanol-acetate-water(38∶3∶3∶4∶152),the detection wavelength was 330nm,the column temperature was 30℃,and the injection amount was 20 μL.Results PG had a good linear relationship in the concentration range of 0.40-8.00 μg/ml(r=0.999),PR had a good linear relationship in the concentration range of 1.50-30.00 μg/ml(r=0.999);the relative standard deviation(RSD) of precision,repeatability and stability test results were all less than 2.00%;the average recovery rate of PG was 99.40%,RSD was 1.21%(n=6),and the average recovery rate of PR was 99.61%,RSD was 0.52%(n=6).Conclusion The HPLC method in this study has strong specificity,good reproducibility and accurate results,which can be used for quality control of compound Yixintong orally disintegrating tablets.

关 键 词：益心酮 口崩片 牡荆素葡萄糖苷 牡荆素鼠李糖苷 

分 类 号：R943[医药卫生—药剂学]