小儿咳喘灵颗粒质量标准优化  

Improved Quality Standard for Xiao'er Kechuanling Granules

作　　者：杨群 肖文涛 李韦 YANG Qun;XIAO Wentao;LI Wei(Drug Subbranch of Jiujiang Test Center,Jiujiang Jiangxi 332000,China)

机构地区：[1]九江市检验检测认证中心药品分中心,江西九江332000

出　　处：《药品评价》2022年第4期209-212,共4页Drug Evaluation

基　　金：江西省药品监督管理局科技计划(2020JS14)。

摘　　要：目的:对小儿咳喘灵颗粒的质量标准进行提升。方法:用薄层色谱法(TCL)对瓜蒌、甘草进行定性鉴别,用高效液相色谱法(HPLC)同时测定盐酸麻黄碱和绿原酸含量。色谱柱为Venusil MP C18(4.6 mm×250 mm,5μm);流动相为乙腈(A)-0.1%磷酸(B),0~10 min,5%A,10~25 min,5%~25%A,25~30 min,25%~5%A,30~40 min,5%A;流速:1.0 mL/min;检测波长:0~15 min,207 nm,15~25 min,327 nm,25~40 min,207 nm。结果:对瓜蒌、甘草的薄层色谱特征鉴别方法专属性强、斑点清晰、阴性对照无干扰。绿原酸线性范围为18.3~366μg/mL,相关系数(r)为0.999,检出限为0.00036μg/mL,平均回收率为93.9%,精密度及稳定性良好;盐酸麻黄碱线性范围为6.3~126μg/mL(r=0.999),检出限为0.0063μg/mL,平均回收率为92.2%,精密度及稳定性良好。结论:该方法专属性高,定量和定性方法准确无干扰,能够对小儿咳喘灵颗粒检测质量标准进行优化。Objective:To improve the quality standard of xiao'er kechuanling granules.Methods:TLC was used to identify trichosanthes kirilowii and liquorice.HPLC was used to determine the ephedrine hydrochloride and chlorogenic acid.The column was Venusil MP C18(4.6 mm×250 mm,5μm);the mobile phases were acetonitrile(A)and 0.1%phosphoric acid(B),0-10 min,5%A,10-25 min,5%-25%A,25-30 min,25%-5%A,30-40 min,5%A;the flow rate:1.0 mL/min;the detection wavelength:0-15 min,207 nm,15-25 min,327 nm,25-40 min,207 nm.Results:Thin layer chromatography of trichosanthes kirilowii and liquorice featured strong specificity,clear identification spots,negative control without interference.The linear range of chlorogenic acid was 18.3-366μg/mL,the relative was 0.999,the detection limit was 0.00036μg/mL,the average recovery was 93.9%,it also had good precision and stability.The linear range of ephedrine hydrochloride was 6.3-126μg/mL(r=0.999),the detection limit was 0.0063μg/mL,the average recovery was 92.2%,it also had good precision and stability.Conclusion:The method is highly exclusive and can be used for the accurate quantitative and qualitative analysis without interference,which can effectively improve the xiao'er kechuanling granules internal testing standard.

关 键 词：质量控制 小儿咳喘灵颗粒 瓜蒌 甘草 盐酸麻黄碱 绿原酸 薄层色谱 高效液相色谱 

分 类 号：R286.0[医药卫生—中药学]