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目的:建立痛风灵胶囊的质量标准。方法:采用照薄层色谱鉴别法,鉴别痛风灵胶囊中秦艽、防己及延胡索是否为阴性,判断药品中是否含有上述成分。采用高效液相色谱法检验药品中各成分的含量。结果:痛风灵胶囊中,秦艽、防己及延胡索照薄层色谱鉴别结果均为阳性。采用高效液相色谱法检验痛风灵胶囊的质量较为适用。当进样量处于1.00-13.15μg范围内时,具有良好的线性关系。精密度试验峰面积数值为0.23%,稳定性试验峰面积数值为0.85%,批次1延胡索含量35.100μg/粒、偏差0.45%,批次2延胡索含量41.269μg/粒、偏差2.13%,批次1延胡索含量42.985μg/粒、偏差0.71%。结论:痛风灵胶囊含有秦艽、防己及延胡索3种成分,不考虑其他成分的情况下,延胡索含量需居于35.100μg/粒-42.985μg/粒间,方可符合质量检验要求。
Objective: To establish the quality standard of Gout Capsule. Methods: According to thin layer chromatography identification method, the identification of Tongfengling capsule Gentiana, antigens and Corydalis is negative, to determine whether the drug contains the above ingredients. Using high performance liquid chromatography to test the content of each component in medicine. Results: Tongfengling capsule, Gentiana, tetrandrine and Corydalis thin layer chromatography identification results were positive. The use of high performance liquid chromatography Tongling Ling capsule quality is more applicable. When the injection volume in the range of 1.00-13.15μg, has a good linear relationship. The peak area of the precision test was 0.23%, the peak area value of the stability test was 0.85%, the content of Corydalis marquise 1 was 35.100μg / g, the deviation was 0.45%, the content of Corydalis marquiseus Catch 41.269μg / g, deviation of 2.13% 1 Corydalis content 42.985μg / grain, deviation 0.71%. Conclusion: Tongfengling Capsule contains Gentiana straminea, Rhizoma Coptidis and Corydalis Rhizoma, and its content should be within the range of 35.100μg / grain-42.985μg / grain regardless of other ingredients before it meets the quality inspection requirements.