摘要
目的对脑立清片的质量标准进行增修提高。方法对脑立清片中牛膝、珍珠母和清半夏进行显微鉴定,对赭石、磁石进行了理化鉴别,建立了脑立清片中牛膝、猪胆汁及冰片的薄层色谱鉴别方法,采用原子吸收分光光度法测定脑立清片中的铁含量,采用气相色谱法测定脑立清片中冰片和薄荷脑的含量。结果显微鉴别操作简单,效果佳,理化鉴别反应专属性强。薄层色谱中特征斑点清晰,分离度好。薄荷脑和龙脑分别在0.0598~0.9970和0.0616~1.0280mg·mL^-1线性关系良好,平均回收率分别为102.70%和101.40%,RSD分别为1.26%和0.92%。采用原子吸收分光光度法测定铁含量在0.5~10.0mg·mL^-1的浓度范围内线性关系良好,平均回收率为100.83%,RSD为1.46%。结论该方法专属性强,稳定性好,重复性好,能够有效评价与控制脑立清片的质量。
Objective To improve the quality standard for Naoliqing tablets.Methods The microscopic identification of Achyranthis Bidentatae Radix,Margaritifera Concha and Pinelliae Rhizoma Praeparatum cum Alumine m were adopted.Thephysical and chemical identification was used for the identification of Haematitum and Magnetitum in Naoliqing tablets.The qualitative analysis of Achyranthis Bidentatae Radix,Fel Suillus and Borneolum Syntheticum in Naoliqing tablets were performed by thin layer chromatography(TLC).The iron element in Naoliqing tablets was determined by atomic absorption spectrophotometry(AAS).The content determination of borneol andmenthol in the drug were conducted by gas chromatography(GC).Results The microscopic identification method could be performed simply with good specificity.The physical and chemical identification had strong specificity.TLC spots were clear and well separated.GC analysis indicated that the calibration curves were linear in the ranges of 0.059 8 to 0.997 0 mg·mL^-1 and 0.061 6 to 1.028 0 mg·mL^-1 for menthol and borneol respectively.The average recoveries of menthol and borneol were 102.70%and 101.40%with RSDs of 1.26%and 0.92%,respectively.The results of AAS analysis showed that there was a good linear relationship of iron within the range of 0.5-10.0 mg·mL^-1,the recovery of iron was 100.83%with RSD of 1.46%.Conclusion The established methods are highly specific,stable and reproducible which can be used in the evaluation and control of the quality of Naoliqing tablets.
作者
陈晓颙
辜明
CHEN Xiaoyong;GU Ming(Hubei Institute for Drug Control,Wuhan 430075,China;Department of Pharmacy,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430022,China)
出处
《医药导报》
CAS
北大核心
2019年第9期1212-1217,共6页
Herald of Medicine
关键词
脑立清片
色谱法
薄层
色谱法
气相
分光光度法
原子吸收
质量标准
Naoliqing tablets
Chromatography,thin layer
Chromatography,gas
Spectrophotometry,atomic absorption
Quality standard
