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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。
Objective To investigate the influence of butyl rubber stopper on the insoluble particles in the liquid after being treated by different methods. Methods The butyl rubber plug was treated by four methods of filtration purification water washing, ultrasonic cleaning, water boiling and acid-base treatment, and sterilized at 115 ℃ for 30 min, and the visible foreign matter and the insoluble particles were measured . Results The butyl rubber stopper was treated by four methods. The purified water rinsing method was filtered, the ultrasonic cleaning method was used, and the foreign matters were more visible in the water-boiling method. The number of insoluble particles was also significantly higher than that of the acid-base treatment method. Conclusion Acid-base treatment is an ideal treatment method, ultrasonic cleaning method is a good way.