肾衰宁片中黄连6种生物碱类成分含量测定研究  

Determination of Six Alkaloids in Coptidis Rhizoma in Shenshuaining Tablets

作　　者：王健 孙菡 白洁 王钰宁 周亚楠 WANG Jian;SUN Han;BAI Jie;WANG Yu-ning;ZHOU Ya-nan(Qinhuangdao Food and Drug Inspection Center,Qinhuangdao 066000,China;Hebei Institute for Drug and Medical Equipment Control,Shijiazhuang 050000,China)

机构地区：[1]秦皇岛市食品药品检验中心,河北秦皇岛066000 [2]河北省药品医疗器械检验研究院,河北石家庄050000

出　　处：《食品与药品》2022年第3期250-255,共6页Food and Drug

摘　　要：目的建立同时测定肾衰宁片中黄连药材中盐酸药根碱、非洲防己碱、表小檗碱、盐酸黄连碱、盐酸巴马汀和盐酸小檗碱6种黄连类生物碱成分含量的方法。方法采用高效液相色谱法(HPLC),色谱柱为Shimadzu MGⅡC_(18)(250 mm×4.6 mm,5μm),流动相为乙腈-0.06 mol/L碳酸氢铵溶液,梯度洗脱;流速1.0 ml/min;柱温30℃;检测波长345 nm,进样量10μl。结果盐酸药根碱、非洲防己碱、表小檗碱、盐酸黄连碱、盐酸巴马汀和盐酸小檗碱6种成分在各自范围内线性关系良好(r>0.9995),平均加样回收率97.9%~103.7%,RSD为1.5%~2.3%。测定4家生产企业的22批肾衰宁片中6种生物碱的含量结果表明,不同企业及不同批次样品间各成分含量均存在明显差异。结论该方法准确可靠,可应用于肾衰宁片中黄连药材中盐酸药根碱、非洲防己碱、表小檗碱、盐酸黄连碱、盐酸巴马汀和盐酸小檗碱6种生物碱成分的质量控制,进而全面有效地评价肾衰宁片的质量,为提高该制剂的质量标准提供依据。Objective To establish on HPLC method for the simultaneous determination of six kinds of Coptis alkaloids in Shenshuaining Tablets,such as jatrorrhizine hydrochloride,tetrandrine,epiberberine,coptisine hydrochloride,palmatine hydrochloride and berberine hydrochloride.Methods The quantitative analysis was performed by HPLC.A Shimadzu MGⅡC_(18) column(250 mm×4.6 mm,3.5μm)was used with a mobile phase of acetonitrile-0.06 mol/L ammonium bicarbonate by gradient elution.The flow rate was 1.0 ml/min,the column temperature was 30℃,the detection wavelength was 345 nm and the injection volume was 10μl.Results The linear relationships of jatrorrhizine hydrochloride,tetrandrine,epiberberine,coptisine hydrochloride,palmatine hydrochloride and berberine hydrochloride were well(r>0.9995).The average recoveries were 97.9%-103.7%with RSDs of 1.5%-2.3%.The contents of six components in Shenshuaining Tablets from 22 batches of 4 production enterprises in China were determined by the external standard method.The results showed there were significant differences in the content of each component from different enterprises and different batches of samples.Conclusion The method of multi-component quantitative analysis established in this study is accurate and suitable for the quality control of Shenshuaining Tablets.This study also provides basis for the improvement of the quality standard.

关 键 词：肾衰宁片 含量测定 黄连 盐酸药根碱 非洲防己碱 表小檗碱 盐酸黄连碱 盐酸巴马汀 盐酸小檗碱 

分 类 号：R927.1[医药卫生—药学]