摘要
目的对羟乙基淀粉类代血浆注射液的制备工艺进行研究，确定切实可行的生产工艺。方法分析影响羟乙基淀粉类代血浆注射液成品质量的因素，采用单因素方法，以成品的含量、可见异物的合格率及成品率为评价指标，考察了不同因素对注射液质量的影响。结果溶液温度、过滤温度、煮沸时间、药液pH值、活性炭用量及灭菌条件等因素对注射液的质量均有影响。最佳生产工艺条件为：在80℃以上溶解原料，加入0．1％的活性炭，煮沸30min，将药液pH值调至3．5～5．5，采用121℃，12min灭菌，即能得到质量可靠稳定的产品。结论该生产工艺设计合理，切实可行，代血浆类注射液质量稳定。
OBJECTIVE Intensive efforts had been made to establish a practical preparation technique suitable for the preparation of Blood Substitue Injection. METHODS We had investigated the impact of different factors on the quality of parenteral solution, employing the single factor method, with content and yield of the finished product, the passing rate of the visible foreign matter as the evaluation indexes. RESULTS Many factors influenced the injection quality,such as dissolving temperature,filtering temperature, boilling time, pH value of the injection, active charcoal consumption and sterilization conditions, etc.. To obtain the products with reliable and steady quality, the production process should be conducted under the conditions as follows idissolving raw materials at 80℃ ,adding 0.1% active charcoal, boilling 30 minutes,adjusting the pH value of the injection to 3.5-5.5,and sterilized at 121℃ for 12 minutes. CONCLUSION With regard to Blood Substitue Injection, the developed production technique is reasonable and realistic.
出处
《齐鲁药事》
2009年第7期431-433,共3页
qilu pharmaceutical affairs
关键词
代血浆
羟乙基淀粉注射液
生产工艺
PH值
可见异物
Blood Substitue Injection
Hydroxyethylstarch Injection
production technigue
pH
clarity
