右旋糖酐铁糖衣片改为薄膜衣片生产工艺探讨

Iron dextran sugar pill instead of film-coated tablet production technology

目的提高右旋糖酐铁糖衣片的溶出度和防潮性能,使其在有效期内能够保持质量稳定,符合中国药典规定。方法将右旋糖酐铁片由糖衣片改为薄膜衣片。结果薄膜衣片溶出度和防潮性能明显提高,在留样考察期内,薄膜衣片溶出度和防潮性能无明显改变,产品在有效期内质量始终满足中国药典要求。结论按该工艺生产的右旋糖酐铁片质量稳定可靠,改进的薄膜包衣工艺适合大生产要求。

Objective Improve the dissolution of iron dextran sugar pill and moistureproof property;in the period of validity can maintain stable quality, conform to the requirement of Chinese pharmacopoeia. Methods The dextran iron film- coated tablet instead of it. Results Film-coated tablet dissolution and moistureproof performance has improved significantly, in the period of retention samples inspection, film-coated tablet dissolution and moistureproof performance has no obvious change, quality of products in the period of validity meet the requirements of pharmacopoeia. Conclusions is always Chinese According to the production of the dextran iron quality stable reliable, the improvement of film coating process is suitable for mass production requirements.