采用颗粒包衣改善盐酸甲氯芬酯胶囊的稳定性
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摘 要 目的：改善盐酸甲氯芬酯胶囊的稳定性。方法：在不改变盐酸甲氯芬酯胶囊规格的前提下，筛选适宜的辅料及工艺，制成的胶囊剂以外观性状、含量、有关物质和溶出度为指标，考察其稳定性。结果：改进后的盐酸甲氯芬酯胶囊质量稳定，其各项指标符合质量标准。结论：本方法较好地解决了盐酸甲氯芬酯胶囊的吸湿性问题，提高了产品稳定性。
关键词 盐酸甲氯芬酯胶囊 乙基纤维素 稳定性
中图分类号：R917 文献标识码：B 文章编号：1006-1533(2008)10-0461-03
To improve the stability of meclofenoxate hydrochloride capsules by using granule-coating
Shi Huiqin，Liu Xiao
(Shanghai Xudong Haipu Pharmaceutical Co., Ltd，Shanghai,201206)
ABSTRACT Objective:To improve the stability of meclofenoxate hydrochloride capsules. Methods: Under the premise of unchanged drug specifications,suitable excipients and preparing process were screened, the stability of prepared capsules was studied by appearance, content, related substances and dissolubility. Results: After being improved, the quality of meclofenoxate hydrochloride capsules was stable, its various indexes conformed to the quality standard. Conclusion: The method may solve the hygroscopicity of meclofenoxate hydrochloride capsules, and its stability can be improved. ......
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