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目的:建立扶正胶囊的质量标准.方法:采用 TLC 法对扶正胶囊中黄芪、甘草进行定性鉴别;采用中国药典2015年版进行扶正胶囊微生物限度检查的方法学验证;采用HPLC法测定淫羊藿中淫羊藿苷的含量,色谱柱:Agilent TC-C18(2) (250 mm×4. 6 mm, 5 μm),以乙腈-水(30 : 70)为流动相,流速:1. 0 ml·min-1,检测波长:270 nm,进样量:5 μl.结果:薄层色谱斑点清晰,在与对照品色谱相应的位置上,显相同颜色的斑点,阴性样品无干扰;可采用平皿法和直接接种法进行扶正胶囊微生物限度检查;淫羊藿中淫羊藿苷在0. 101~1. 008 μg范围内线性关系良好(r=0. 999 7),平均回收率为99. 36% ,RSD为0. 81% (n=6).结论:本方法操作简便,专属性高、重复性好,可作为扶正胶囊的质量控制方法.“,”Objective: To establish the quality standard for Fuzheng capsules. Methods: TLC was adopted to identify Astragali Radix and Glycyrrhiza uralensis. The method validation for Fuzheng capsules was conducted by microbial limit test as described in the appendixes of Chinese Pharmacopeia (2015 edition). The content of epimedii in Epimedium brevicornu was determined by HPLC. The chromatographic separation was carried out on an Agilent TC-C18(2) (250 mm×4. 6 mm, 5 μm) column. The mobile phase consis-ted of acetonitrile-water( 30: 70) with gradient elution at a flow rate of 1. 0 ml·min-1,and the injection volume was 5 μl. The detec-tion wavelength was 270 nm. Results: The spots in TLC were clear without any interference. The methods of plating and direct inocu-lation could be used for the microbial limit test. The linear range was 0.101-1.008 μg (r =0.999 7). The average recovery was 99. 36% with the RSD of 0. 81% (n=6). Conclusion: The method is simple with high specificity and good repeatability, which can be used as the quality control method for Fuzheng capsules.