关于明胶空心胶囊标准中脆碎度检查的建议

Suggestions of Friability Examination about Vacant Gelatin Capsules

目的:对明胶空心胶囊标准中的脆碎度检查项目提出修改建议。方法:对明胶空心胶囊的脆碎度检查的历版标准(1989～2010年,共5版)内容进行比较、分析并辅以实际试验进行佐证。结果:经比较分析及实际试验操作发现,历版标准中明胶空心胶囊的脆碎度检查存在相对湿度控制不量化、硝酸镁饱和溶液制备无依据、检验器具不明确等方面的不足。结论:建议相关部门重视并最终确定明胶空心胶囊的脆碎度检查的各项条件,使之更具可操作性,使建立的标准发挥应有的指导作用。

OBJECTIVE：To put forward suggestions for friability examination about vacant gelatin capsules.METHODS：The contents of 5 editions of friability examination criteria（1989-2010）about vacant gelatin capsules were compared and analyzed,and identified by experimental experiences.RESULTS：After comparative analysis and experimental operation,there were some deficiencies in those criteria,such as in friability examination relative humidity control hadn＇t been quantized;the preparation of magnesium nitrate saturated solution was short of evidence;inspection instruments was not clear.CONCLUSIONS：It is suggested to strengthen and determine the final conditions for vacant gelatin capsules friability examination so as to own maneuverability and play the deserved guiding role of criteria.