CN114917187A - 一种盐酸胺碘酮注射液的制备方法 - Google Patents
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Abstract
本发明公开一种盐酸胺碘酮注射液的制备方法，包括：将增溶剂、稳定剂加入配液罐中加热，然后加入盐酸胺碘酮，搅拌待固体全部溶解后加入注射用水，之后药液经氮气除氧后经除菌过滤后进入灌封工序，灌封工序将除菌后的药液灌封制得半成品，所述半成品经灯检、高压放电检漏合格后包装制得成品。该制备方法操作简易，工艺安全性好，无菌保障能力高，产品质量稳定，绿色环保无污染。
Description
技术领域
本发明属于医药技术领域，具体涉及一种盐酸胺碘酮注射液的制备方法。
背景技术
盐酸胺碘酮注射液主要成分为盐酸胺碘酮，其化学名为2-丁基-3-苯并呋喃基4-[2-（二乙氨基）乙氧基]-3,5-二碘苯基甲酮盐酸盐，可用于治疗严重的心律失常，尤其适用于房性心律失常伴快速室性心律；W-P-W综合征的心动过速；严重的室性心律失常；体外电除颤无效的室颤相关心脏停搏的心肺复苏。
心脑血管疾病已经是全球发病率最高的一类疾病，且发病迅速，病情恶化快，临床死亡率居高不下，特别是肥胖、老年人群发病率较高，注射液解决了老年人或者临床表现严重患者无法吞咽口服制剂的缺陷，同时也解决了口服制剂起效慢得缺点。
发明内容
因盐酸胺碘酮原料药本身在水中溶解性差，且其对氧、紫外光、高温等因素质量不稳定，本发明通过使用适量的增溶剂、稳定剂及一定的工艺条件下生产出了无菌保障能力高、产品质量稳定的盐酸胺碘酮注射液。
为实现上述目的，本发明采用如下的技术方案：
一种盐酸胺碘酮注射液的制备方法，包括：将增溶剂、稳定剂加入配液罐中加热，然后加入盐酸胺碘酮，搅拌待固体全部溶解后加入注射用水，之后药液经氮气除氧后经除菌过滤后进入灌封工序，灌封工序将除菌后的药液灌封制得半成品，所述半成品经灯检、高压放电检漏合格后包装制得成品。
进一步的，所述增溶剂为聚山梨酯80，所述稳定剂为苯甲醇。
进一步的，所述注射液中聚山梨酯80的含量为100mg/ml，苯甲醇含量为20mg/ml，盐酸胺碘酮含量为50ml/ml。
进一步的，所述的加热的温度为55~65℃。
进一步的，所述的搅拌的速度为150~180r/m。
进一步的，所述的氮气的压力为0.1~0.3Mpa，所述除氧的时间为30分钟。经除氧后，氧含量小于0.5mg/L。
进一步的，所述的过滤为经0.45um滤芯过滤后再经过两级0.22um除菌滤芯过滤。
进一步的，所述的灌封为将除菌后的药液灌入经高温灭菌的中硼硅玻璃安瓿中进行熔封。
本发明所采用的盐酸胺碘酮注射液的制备方法，该制备方法操作简易，工艺安全性好，无菌保障能力高，产品质量稳定，绿色环保无污染。
以聚山梨酯80作为增溶剂，苯甲醇作为稳定剂，注射用水作为溶剂，通过简单的溶解、过滤及除菌过滤后灌装熔封，熔封后的半成品经灯检、高压放电检漏、包装得成品，整个工艺过程简单易操作，工艺安全性好，无菌保障能力高，产品质量稳定，绿色环保无污染。
具体实施方式
实施例1
在配液罐中加入36kg聚山梨酯80，然后加入7.2kg苯甲醇，开启搅拌，转速设定为120r/m，升温加热至60℃，然后加入18kg盐酸胺碘酮，加完将搅拌转速设定为180r/m搅拌30分钟，观察固体全部溶解后将搅拌速度调至120r/m，然后加入200kg注射用水，通入氮气除氧30分钟，检测氧含量小于0.5mg/L后，加注射用水定容至368kg，定容后药液继续搅拌15分钟后降温至30℃以下，然后将药液通过0.45um滤芯过滤至储液罐中，储液罐中药液经2级0.22um除菌滤芯过滤后灌装入经高温灭菌的5ml中性硼硅玻璃安瓿中进行灌装熔封，熔封后的半成品高压灯检、放电检漏、包装得成品。
实施例2
在配液罐中加入36kg聚山梨酯80，然后加入7.2kg苯甲醇，开启搅拌，转速设定为130r/m，升温加热至62℃，然后加入18kg盐酸胺碘酮，加完将搅拌转速设定为160r/m搅拌45分钟，观察固体全部溶解后将搅拌速度调至130r/m，然后加入220kg注射用水，通入氮气除氧45分钟，检测氧含量小于0.5mg/L后，加注射用水定容至368kg，定容后药液继续搅拌15分钟后降温至30℃以下，然后将药液通过0.45um滤芯过滤至储液罐中，储液罐中药液经2级0.22um除菌滤芯过滤后灌装入经高温灭菌的5ml中性硼硅玻璃安瓿中进行灌装熔封，熔封后的半成品高压灯检、放电检漏、包装得成品。
Claims (8)
1.一种盐酸胺碘酮注射液的制备方法，其特征在于，包括：将增溶剂、稳定剂加入配液罐中加热，然后加入盐酸胺碘酮，搅拌待固体全部溶解后加入注射用水，之后药液经氮气除氧后经除菌过滤后进入灌封工序，灌封工序将除菌后的药液灌封制得半成品，所述半成品经灯检、高压放电检漏合格后包装制得成品。
2.根据权利要求1所述的制备方法，其特征在于，所述增溶剂为聚山梨酯80，所述稳定剂为苯甲醇。
3.根据权利要求1所述的制备方法，其特征在于，所述注射液中聚山梨酯80的含量为100mg/ml，苯甲醇含量为20mg/ml，盐酸胺碘酮含量为50ml/ml。
4.根据权利要求1所述的制备方法，其特征在于，所述的加热的温度为55~65℃。
5.根据权利要求1所述的制备方法，其特征在于，所述的搅拌的速度为150~180r/m。
6.根据权利要求1所述的制备方法，其特征在于，所述的氮气的压力为0.1~0.3Mpa，所述除氧的时间为30分钟。
7.根据权利要求1所述的制备方法，其特征在于，所述的过滤为经0.45um滤芯过滤后再经过两级0.22um除菌滤芯过滤。
8.根据权利要求1所述的制备方法，其特征在于，所述的灌封为将除菌后的药液灌入经高温灭菌的中硼硅玻璃安瓿中进行熔封。
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