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肠泰胶囊的质量控制研究

Study on the quality control of Changtai capsules
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摘要 目的:建立肠泰胶囊的质量控制方法。方法:采用了白花蛇舌草、肿节风的薄层色谱,白头翁的紫外可见分光光度法进行定性鉴别;并采用醇浸出物测定法进行含量测定,装量差异、水分、崩解时限及微生物限量检测。结果:白头翁对照药材提取液与供试品提取液均在(201±1)nm波长处有最大吸收,紫外吸收光谱基本一致,白花蛇舌草、肿节风的提取物的TLC结果与对照品一致,样品的醇溶性浸出物平均含量为38.8 mg/ g,装量差异、水分、崩解时限及微生物限量检测均符合药典规定。结论:该质控方法简便,可靠。 Objective:To establish a quality control method for Changtai capsules. Methods:Qualitative analysis of Hedyotis difusa Willd and Herba Sarcandrae were carried out by TLC,Radix Pulsatillae was tested by UV. Ethanol-soluble extractive of Changtai capsule was determined by Chinese Pharmacopoeia. Results :The extracting solution of the Radix Pulsatillae and it's masculine comparison have the biggest absorption in (201± 1 ) nm, and have the same UV -spectrum. The extractive of Hedyotis difusa Willd and Herba Sarcandrae were assayed by TLC. The results were consistent with the controles. The average content of ethanol-soluble extractive of the samples was 38.8 mg/g. The weight variation, water content, disintegration time, microbiological timiting, test conformed with Chinese pharmacopoeia. Conclusion:This method is simple, accurate, and can be used as the quality control of Changtai capsules.
出处 《药学实践杂志》 CAS 2007年第4期224-226,共3页 Journal of Pharmaceutical Practice
关键词 肠泰胶囊 紫外分光光度法 薄层色谱法 白头翁 白花蛇舌草 肿节风 Changtai capsules UV TLC Radix PulsatiUae Hedyotis difusa Herba Sarcandrae
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