丁基橡胶输液瓶塞的处理方法研究

A Study on the Process of the Butyl Rubber Stopper of Infusion Bottle

关键词:  丁基胶塞  不溶性微粒  可见异物  输液剂

Key words:  butyl rubber stopper  insoluble particle  visible foreign body  infusion solution

摘要:

目的考察丁基胶塞经过不同方法处理后对药液中不溶性微粒的影响。方法采用滤过纯化水冲洗法、超声波清洗法、水煮法、酸碱处理法四种方法对丁基胶塞进行处理， 115 ℃热压灭菌30 min，进行可见异物检查和不溶性微粒数测定。结果丁基胶塞经过四种方法处理，滤过纯化水冲洗法、超声波清洗法、水煮法可见异物较多，不溶性微粒数也明显高于酸碱处理法。结论酸碱处理法是比较理想的处理方法，超声波清洗法也不失为一种较好的方法。

Abstract:

OBJECTIVE The influence of the butyl rubber bottle stopper on insoluble particles in solution by different processing methods was discussed. METHODS Filtered purification water washing, ultrasonic wave washing, boiling water washing and acid and alkali processing method are used to wash butyl rubber bottle stopper and then sterilized by 115 ℃ high pressure steam for 30 minutes. Then the visible foreign bodies and the number of insoluble particles were checked. RESULTS The solution in the bottles disposed by acid and alkali processing had the least visible foreign bodies and insoluble particles comparing with other methods. CONCLUSION Acid and alkali processing is an ideal method, and ultrasonic wave washing is another useful alternative.