鼻渊通窍颗粒质量标准的改进

目的：提高鼻渊通窍颗粒检测质量标准：增加两味药的TLC鉴别，主成分麻黄含量测定以盐酸麻黄碱和盐酸伪麻黄碱总量（C10H25NO·HCl）计]由UV法改为HPLC法。方法：采用薄层色谱法增加对处方中辛夷、丹参的定性鉴别；采用高效液相色谱法测定样品中麻黄的含量，色谱条件为：Lichrospher C18色谱柱（250mm×4．6mm，5μm）；以磷酸二氢钾溶液（取磷酸二氢钾6．8g，加水1000ml溶解后，加三乙胺1．0ml，用磷酸调pH至3．0）-乙腈（96：4）为流动相；检测波长为210nm。结果：薄层色谱法鉴别方法专属性好，阴性对照无干扰；含量测定结果表明，盐酸麻黄碱和盐酸伪麻黄碱分别在3～30μg·ml^-1和1—10μg·ml^-1浓度范围内与其峰面积呈良好的线性关系（r均为0．9998），平均回收率分别为100．6％和98．7％，RSD分别为1．13％（n=6）和1．05％（n=6）。结论：本方法灵敏、准确、可靠，专属性强、准确度高，可更好地用于鼻渊通窍颗粒的质量控制与检测。

Study on improving the quality criteria for Biyuan Tongqiao Granules

Objective ： To improve the quality criteria for biyuan tongqiao granules ： Add the TLC identification for two types of chinese crude drug and set up a new method of determination on chinese ephedra herb based on the total amount of the ephedrine hydrochloride and pseudoephedrine hydrochloride with HPLC instead of UV method. Method ： Biod Magnolia Flower Bud and Danshen Root in recipe were identified by TLC. The content of Chinese Ephedra Herb in samples was determined by HPLC. HPLC conditions were as follows：The Lichrospher C18 column （250 mm × 4. 6 mm ,5 μm）was served and the mobile phase was potassium dihydrogen phosphate solution （ weighted the potassium dihydrogen phosphate 6. 8 g, dissolved in 1 000 ml water and added 1.0 ml triethylamine, adjusted to pH 3.0 with phosphoric acid） -acetonitrile （96：4 ）. The detection wavelength was 210nm. Result： Biod Magnolia Flower Bud and Dan- shen Root could be identified by TLC respectively. Both of the ephedrine hydroehloride and pseudoephedrine hydroehloride had good linearity with the response value of peak area in the concentration range of 3-30 μg·ml^-1 and 1-10μg·ml^-1 respectively （both of the r were 0. 9998 ）. The average recoveries of ephedrine hydroehloride and pseudoephedrine hydrochloride were 100. 6% and 98. 7% , and the RSD were 1.13% （ n = 6） and 1.05% （ n = 6 ） respectively. Conclusion ： The method is sensitive, accurate, reliable, specific and more suitable for the quality control of Biyuan Tongqiao granules.