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目的研究全水型薄膜包衣技术在复方丹参片生产中的应用,提高复方丹参片的质量稳定性。方法进行加速试验,比较复方丹参片全水型薄膜衣片与醇溶性薄膜衣片的综合质量和稳定性。结果全水型薄膜包衣片外观明显优于醇溶性薄膜衣片,在稳定性考察过程中含量测定和崩解时限均无明显变化。结论全水型薄膜包衣预混剂可用于复方丹参片的包衣生产。
Objective To study the application of water-based film coating technology in compound Danshen tablets and improve the quality stability of compound Danshen tablets. Methods Accelerated tests were carried out to compare the overall quality and stability of the compound Danshen tablets with water-soluble film-coated tablets and water-soluble film-coated tablets. Results The appearance of water-based film-coated tablets was significantly better than that of alcohol-soluble film-coated tablets. There was no significant change in the determination of content and disintegration time during the course of the stability study. Conclusion The water-based film coating premix can be used for the coating production of compound Danshen tablets.