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发明公开
CN101926763A 一种前列地尔脂肪乳剂灭菌制剂的制备方法 无效 - 撤回

一种前列地尔脂肪乳剂灭菌制剂的制备方法
摘要：
本发明的目的是提供一种前列地尔脂肪乳剂的灭菌制剂的制备方法。首次将旋转灭菌法应用在前列地尔乳剂的制备工艺。灭菌工艺采用旋转灭菌法，对已灌封的前列地尔脂肪乳剂西林瓶灭菌，灭菌过程中温度维持在128℃一134℃之间，压力维持在165-210kPa之间，时间维持300-600秒范围内。本发明可有效避免前列地尔脂肪乳剂因传统蒸气灭菌工艺而造成的主药降解，达到产品无菌要求。
摘要（英）：

The invention provides a method for preparing lipoalprostadil sterile preparation. The rotating sterilization technique is applied to the method for preparing lipoalprostadil for the first time. The method comprises the steps of using the rotating sterilization technique to sterilize an encapsulated lipoalprostadil Cillin-glass bottle, and in the process of sterilization, keeping the sterilizing temperature between 128 and 134 DEG C, maintaining the pressure between 165 and 210 kPa, and keeping for 300 to 600 seconds. The method of the invention can efficiently prevent the basic drug of the lipoalprostadil from degrading caused by traditional steam sterilization technique so as to meet the demand of sterilization.

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