小儿止哮平喘颗粒质量标准的研究  

Quality standard study of Xiao’er Zhixiao Pingchuan Granules

作　　者：王迪磊 钟琳瑛 白洁[1] 张翼[1] 樊箫雨 彭警 彭征屏[2] 杜守颖[1] WANG Di-lei;ZHNG Lin-ying;BAI Jie;ZHANG Yil;FAN Xiao-yu;PENG Jing;PENG Zheng-ping;DU Shou-ying(Beijing University of Chinese Medicine,Beijing 102488,China;Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China)

机构地区：[1]北京中医药大学,北京102488 [2]中国中医科学院西苑医院,北京100091

出　　处：《中国新药杂志》2022年第7期685-692,共8页Chinese Journal of New Drugs

基　　金：北京市科技计划资助项目(G42044678)。

摘　　要：目的:建立小儿止哮平喘颗粒的药品质量标准,更好地控制产品质量。方法:建立处方药味蜜麻黄、黄芩、地骨皮、赤芍、丹参的TLC鉴别法;建立盐酸麻黄碱、盐酸伪麻黄碱、黄芩苷含量测定的HPLC法,盐酸麻黄碱、盐酸伪麻黄碱含量以乙腈-0.1%磷酸水(4∶96)为流动相;检测波长为210 nm;柱温为30℃;黄芩苷含量以甲醇-0.1%磷酸水(45∶55)为流动相;检测波长为280 nm;柱温为30℃。结果:建立的TLC图谱与相应的对照药材在相同位置上显现相同颜色的斑点,阴性样品无干扰。HPLC法测定盐酸麻黄碱、盐酸伪麻黄碱、黄芩苷含量,进样量分别在0.026 9~1.721 6,0.010 5~0.670 7,0.102 4~0.768 0μg范围内线性关系良好(r为0.999 9~1.000 0);平均加样回收率分别为96.8%,96.1%,100.31%,RSD均小于3%。结论:实验建立的TLC鉴别法和HPLC含量测定法专属性强、重现性好,可用于小儿止哮平喘颗粒的质量控制。Objective: To establish the quality standard for Xiao’er Zhixiao Pingchuan Granule, in order to further control the product quality. Methods: TLC method was established for the identification of braised Ephedra with honey, Scutellariae Radix, Lycii Cortex, Moutan Cortex and Salviae miltiorrhizea Radix et rhizoma. HPLC method for the determination of ephedrine hydrochloride, pseudoephedrine hydrochloride and baicalin was established. The content of ephedrine hydrochloride and pseudoephedrine hydrochloride was determined, using acetonitrile-0.1% phosphate water(4∶96) as mobile phase. The detection wavelength was set at 210 nm, and the column temperature was 30 ℃. The content of baicalin was determined using methanol-0.1% phosphate water(45∶55) as mobile phase. The detection wavelength was set at 280 nm and the column temperature was 30 ℃. Results: The TLC chromatography showed the same color spots in the same position of the corresponding control drugs, and the negative samples showed no interference. The linear ranges of ephedrine hydrochloride, pseudoephedrine hydrochloride and baicalin were 0.026 9~1.721 6, 0.010 5~0.670 7 and 0.102 4~0.768 0 μg, respectively(r=0.999 9~1.000 0). The average recoveries were 96.8%, 96.1% and 100.31%, respectively, with RSDs less than 3%. Conclusion: The TLC identification method and HPLC method for the purpose of content determination were established in this study, which have strong specificity and good reproducibility. They can be used for the quality control of Xiao’er Zhixiao Pingchuan Granules.

关 键 词：小儿止哮平喘颗粒 TLC法 HPLC法 质量标准 

分 类 号：R917[医药卫生—药物分析学]