中药胡芦巴片的质量及稳定性研究

Research on the Quality and Stability of Huluba Tablet

目的:考察胡芦巴总皂苷薄膜衣片的质量及稳定性,为其质量标准的制定及包装、贮存提供科学依据。方法:按中国药典标准,对胡芦巴总皂苷薄膜衣片进行质量检测;并进行影响因素试验和加速试验,重点考察性状、水分、崩解时限和含量的变化。结果:三批样品符合药典对片剂的要求,且在市售包装下样品稳定。结论:胡芦巴总皂苷薄膜衣片质量稳定,但对光和湿较敏感,应在遮光、密闭、干燥处保存。

Objective： To evaluate the quality and stability of Huluba total saponin film coating tablet,and provide scientific guidance for its quality standard setting,packing and storage.Methods： According to the requirements of Chinese Pharmacopeia, the quality of the Huluba total saponin film coating tablet was assayed.The changes of character,moisture,disintegration time and content were studied by influence factor test and accelerated test.Results： The results indicated that the 3 batches of samples accorded with the tablet requirements of Chinese Pharmacopeia,and they were stable in the commercial packing.Conclusion： The quality of Huluba total saponin film coating tablet was proved to be stable.Since Huluba total saponin film coating tablet was sensitive to light and humidity,it should be preserved in a dark,sealed and dry condition.