摘要
目的制备羟苯磺酸钙胶囊并建立其质量控制方法。方法选用微晶纤维素为填充剂,硬脂酸镁为润滑剂进行粉末直接填充,并对其性状、鉴别、干燥失重、崩解时限、有关物质、含量等进行检查。结果制得的羟苯磺酸钙胶囊符合2010年版《中国药典》质量要求。结论本制剂工艺简单,稳定性好,质量可控。
Objective To prepare calcium dobesitate capsules and establish the quality control method. Methods The microcrystalline cellulose was selected as fillers, and magnesium stearate as lubricants. The characteristics, distin- guishability, loss on drying, disintegration time limit, the related substances and contents were tested. Results The capsules was accorded with the quality requirements of the Chinese Pharmacopoeia (2010 edition). Conclusion The preparation process of the calcium dobesilate capsules is easy and stable, and has controllable quality.
出处
《华南国防医学杂志》
CAS
2016年第2期125-127,共3页
Military Medical Journal of South China
关键词
羟苯磺酸钙
胶囊
制备
质量控制
Calcium dobesilate
Capsules
Preparation
Quality control