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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 investigate the quality and stability of fenugreek total saponin film-coated tablets, providing a scientific basis for the formulation and packaging and storage of its quality standards. Methods: According to the standard of Chinese Pharmacopoeia, the quality control of fenugreek saponins film-coated tablets was carried out. Influencing factors and accelerated tests were conducted to investigate the changes of traits, water content, disintegration time and content. Results: Three batches of samples met the requirements of the Pharmacopoeia for tablets and were stable under the commercial package. Conclusion: Fenugreek total saponins film-coated tablets have stable quality but are sensitive to light and humidity, and should be stored in shading, airtight and dry place.