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。Abstract: 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 cap- sule 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 Sar- candrae 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.
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Key words:
- Changtai capsules /
- UV /
- TLC /
- Radix Pulsatillae /
- Hedyotis difusa /
- Herba Sarcandrae
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