咳喘六味合剂质量标准提高研究
投稿时间:2018-07-02  修订日期:2018-09-10  点此下载全文
引用本文:杨帆平,李国文,奚燕.咳喘六味合剂质量标准提高研究[J].药学实践杂志,2019,37(1):55~58,85
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杨帆平 上海中医药大学附属普陀医院药物临床试验机构办公室, 上海 200062  
李国文 上海中医药大学附属上海市中西医结合医院药剂科, 上海 200082  
奚燕 上海中医药大学附属龙华医院药剂科, 上海 200032 xiyan363700@126.com 
基金项目:上海市浦东新区中医药专项课题项目(PDYNZJ2015-17)
中文摘要:目的 完善龙华医院院内制剂咳喘六味合剂的质量控制标准。方法 应用TLC法对咳喘六味合剂中的黄芩、细辛进行定性鉴别;应用HPLC法对麻黄、黄芩进行含量测定。采用Welch-C18柱(4.6 mm×250 mm,5 μm);以乙腈-0.1%磷酸溶液(4∶96)及甲醇-0.1%磷酸溶液(47∶53)为流动相;检测波长分别为206、278 nm;流速为1.0 ml/min。结果 TLC法显示与黄芩、细辛药材特征荧光斑点相符合的斑点,且阴性对照溶液无干扰。盐酸麻黄碱在12.04~301.00 μg/ml范围内线性关系良好(r=1.000 0),平均回收率为101.7%,RSD为1.5%;盐酸伪麻黄碱在7.98~199.40 μg/ml范围内线性关系良好(r=1.000 0),平均回收率为101.6%,RSD为2.4%。黄芩苷在5.18~129.50 μg/ml范围内与峰面积呈良好线性关系(r=0.999 9),平均回收率为101.0%,RSD为0.3%。结论 本实验建立的定性鉴别和含量测定方法简单可行,可以作为咳喘六味合剂的质量控制标准。
中文关键词:咳喘六味合剂  质量标准  薄层色谱
 
Study on improvement of quality standard for Kechuan Liuwei oral liquid
Abstract:Objective To improve the quality control standard of the hospital preparation Kechuan Liuwei oral liquid in Longhua Hospital. Methods TLC was used for qualitative identification of Scutellaria baicalensis Georgi and Asarum sieboldi Mig in the Kechuan Liuwei oral liquid. Ephedrine and Baicalin content in ephedra and Scutellaria were determined by HPLC with Welch-C18 column (4.6mm×250mm, 5 μm). Acetonitrile-0.1% phosphoric acid solution (4:96) and methanol-0.1% phosphoric acid solution (47:53) were used as mobile phase. The detection wavelengths were 206 nm and 278 nm respectively. The flow rate was 1.0 ml/min. Results The TLC spots of Scutellaria baicalensis Georgi and asarum were clear without interference of the negative control. The linear range of Ephedrine hydrochloride was within 12.04-301.00 μg/ml (r=0.999 9). The average recovery was 101.7% (RSD=1.5%). The linear range of Pseudoephedrine hydrochloride was within 7.98-199.40 μg/ml (r=0.999 9). The average recovery was 101.6% (RSD=2.4%). The linear range of Baicalin was within 5.18-129.50 μg/ml (r=0.999 9). The average recovery was 101.0% (RSD=0.3%). Conclusion The qualitative identification and the active ingredient assay method established in this experiment were simple and feasible. Those methods can be used as the quality control standard for Kechuan Liuwei oral liquid.
keywords:Kechuan Liuwei oral liquid  quality standard  TLC
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