青霉素V钾片中水分和有关物质的相关性研究

目的 对青霉素V钾中的水分和有关物质进行相关性研究,以考察青霉素V钾片有关物质存在差异的原因.方法 采用《中国药典》2010年版中青霉素V的有关物质的测定方法测定制剂中总杂质含量,采用卡氏水分法测定制剂中水分,采用干燥失重法测定制剂减失重量.结果 水分和有关物质的总杂质含量成正相关,平均片重大时水分有增大的趋势.结论 有必要对青霉素V钾片的水分进行控制,限度可拟定为含水分不得过2.0％.

Study on the Correlation of Water Content and Related Substances in Phenoxymethylpenicillin Potassium Tablets

Objective To conduct a correlation study on the water content and related substances in Phenoxymethylpenicillin Potassium Tablets so as to investigate the reasons for the differences of related substances in Phenoxymethylpenicillin Potassium Tablets. Methods The total impurity quantity of Phenoxymethylpenicillin Potassium was measured by the determination method of related substances in Penicillin V described in ChP 2010. The water content and weight loss of Phenoxymethylpenicillin Potassium were measured by the Karl Fischer titrator and the weightlessness method respectively. Results There was positive correlation of the water content and the total impurity quantity. The water content had an increasing trend when the average tablet weight was heavier. Conclusion It is necessary to control the water content of Phenoxymethylpenicillin Potassium Tablets. The limit for the water content may be set at 2.0%.