摘要
目的 :改进原部颁质量标准生产的蛋氨酸片片重过大的工艺缺陷 ,制备片重适宜的新的蛋氨酸片 ,为该药部颁新标准的制定提供资料。方法 :在不改变原有规格的前提下 ,筛选适宜的辅料种类及用量 ,然后制粒、压片 ,进行质量检测。结果 :新的蛋氨酸片片重减轻了 2 1.4% ,且各项指标符合质量标准。结论 :改进的蛋氨酸片制备工艺合理 ,能满足各项质量要求。
Objectives:To improve the original procedure included in Ministerial Standards of Drugs for obtaining tablets with appropriate weight.Methods:With the pre-request of maintaining the original specifications ,suitable auxiliary materials and quantities used were selected,then tablets were prepared by mixing,granulating and compressing.Finally they were analyzed according to specifications.Results:Tablets thus obtained completely conform to the specifications and their weight reduced by 21.4%.Conclusions:A reasonable procedure for preparation of methionine tablets with appropriate weight is obtained.
出处
《中国新药杂志》
CAS
CSCD
2000年第8期543-544,共2页
Chinese Journal of New Drugs
关键词
蛋氨酸片
片重
质量控制
制备
methionine tablets
tablet-weight
quality control
