CN116570560A - 一种***磷酸钠注射液及其制备方法 - Google Patents
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- PLCQGRYPOISRTQ-FCJDYXGNSA-L dexamethasone sodium phosphate Chemical compound [Na+].[Na+].C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@@H](C)[C@@](C(=O)COP([O-])([O-])=O)(O)[C@@]1(C)C[C@@H]2O PLCQGRYPOISRTQ-FCJDYXGNSA-L 0.000 title claims abstract description 34
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Abstract
本发明公开了一种***磷酸钠注射液及其制备方法,包括以下步骤:称量:按处方量称量***磷酸钠原料药、渗透压调节剂、螯合剂、pH值调节剂;配药:将80%处方量的注射用水加入至容器具中,配制过程中需充加氮气保护,依次将渗透压调节剂、螯合剂、原料药、加入注射用水中,搅拌溶解,使用pH值调节剂调节pH,加注射用水定容,搅拌混合至均匀;除菌过滤:将所述药液经0.22μm除菌滤芯过滤;灌封:按照装量灌装于中硼硅玻璃安瓿中,封口,灌封过程中,充加氮气保护。本发明通过保证***磷酸钠注射液有效性的前提下,提高了***磷酸钠注射液产品的稳定性、安全性。
Description
技术领域
本发明涉及医药技术领域,尤其涉及一种***磷酸钠注射液及其制备方法。
背景技术
***磷酸钠为白色至微黄色粉末、无臭、有引湿性。***是一种类固醇药物,皮质类固醇是天然存在于人体内的激素,可帮助保持健康状况。当注射到静脉或肌肉中时,***可减少炎症并抑制免疫***,是一种治疗与体内炎症有关的各种疾病的有效方法。
目前上市的产品中,为提高产品稳定性,常添加有机溶剂丙二醇,但经研究表明其具有溶血性,不宜用于静脉注射。
发明内容
本发明的目的是为了解决现有技术中存在的缺点,而提出的一种***磷酸钠注射液及其制备方法,保证***磷酸钠注射液有效性的前提下,提高***磷酸钠注射液产品的稳定性、安全性。
为了实现上述目的,本发明采用了如下技术方案:
一种***磷酸钠注射液,包括:***磷酸钠原料、药学上可接受的辅料;
所述药学上可接受的辅料包括渗透压调节剂、螯合剂、pH值调节剂、注射用水。
优选地,所述渗透压调节剂由氯化钠、甘油、葡萄糖、甘露醇的一种或几种组成。
优选地,所述螯合剂为依地酸二钠。
优选地,所述pH值调节剂由氢氧化钠、盐酸、磷酸的一种或几种组成。
本发明还提供了一种***磷酸钠注射液的制备方法,包括以下步骤:
(1)称量:按处方量称量***磷酸钠原料药、渗透压调节剂、螯合剂、pH值调节剂;
(2)配药:将80%处方量的注射用水加入至容器具中,配制过程中需充加氮气保护,依次将渗透压调节剂、螯合剂、原料药、加入注射用水中,搅拌溶解,使用pH值调节剂调节pH,加注射用水定容,搅拌混合至均匀;
(3)除菌过滤:将所述药液经0.22μm除菌滤芯过滤;
(4)灌封:按照装量灌装于中硼硅玻璃安瓿中,封口,灌封过程中,充加氮气保护。
优选地,所述***磷酸钠原料药、渗透压调节剂、螯合剂的质量比为5:9:10。
优选地,所述配制过程温度为40℃以下。
优选地,所述pH值调节至7.0~8.5。
本发明技术方案,具有如下优点:
1、本发明的***磷酸钠注射液通过渗透压调节剂、螯合剂、pH值调节剂和***磷酸钠原料的协同作用,有效增加了***磷酸钠注射液的稳定性;
2、本发明的***磷酸钠注射液的制备方法简单,易于控制,在加入有效组分配药后经过除菌、并通过氮气保护灌封,在保证***磷酸钠注射液有效性的前提下,提高了***磷酸钠注射液产品的稳定性、安全性。
具体实施方式
下面将对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。
实施例1
所述制备工艺包括以下步骤
(1)按照处方用量依次称量所需原辅料。
(2)量取80%配制量的注射用水于容器具中,将配药温度控制在40℃以下,加入处方量的氯化钠,搅拌至溶解;加入处方量的原料药,搅拌至溶解;然后使用pH值调节剂将药液pH值调节至7.0~8.5,加注射用水定容,搅拌混合至均匀。
(3)使用0.22μm的除菌滤芯将所述药液除菌过滤。
(4)使用中硼硅玻璃安瓿,灌封即得。
实施例2
所述制备工艺包括以下步骤
(1)按照处方用量依次称量所需原辅料。
(2)量取80%配制量的注射用水于容器具中,将配药温度控制在40℃以下,加入处方量的氯化钠、依地酸二钠,搅拌至溶解;加入处方量的原料药,搅拌至溶解;然后使用pH值调节剂将药液pH值调节至7.0~8.5,加注射用水定容,搅拌混合至均匀。
(3)使用0.22μm的除菌滤芯将所述药液除菌过滤。
(4)使用中硼硅玻璃安瓿,灌封即得。
实施例3
所述制备工艺包括以下步骤
(1)按照处方用量依次称量所需原辅料。
(2)量取80%配制量的注射用水于容器具中,将配药温度控制在40℃以下,加入处方量的氯化钠、依地酸二钠,搅拌至溶解;加入处方量的原料药,搅拌至溶解;然后使用pH值调节剂将药液pH值调节至7.0~8.5,加注射用水定容,搅拌混合至均匀。
(3)使用0.22μm的除菌滤芯将所述药液除菌过滤。
(4)使用中硼硅玻璃安瓿,灌封过程中,充加氮气保护,即得。
将实施例1~3中所制备的样品,放置于高温40℃条件下,分别于0天、5天、10天、30天取样,进行性状、pH值、有关物质检测,得到的数据如表1所示。
表1实施例1~3的检测数据
注:NA表示未进行检测。
结论:按照实施例3制得的成品在高温40℃的条件下进行考察,稳定性较其他实施例显著提高,说明在制备***磷酸钠注射液时加入螯合剂,并在制备过程中充加氮气,可显著提高产品稳定性。
以上所述,仅为本发明较佳的具体实施方式,但本发明的保护范围并不局限于此,任何熟悉本技术领域的技术人员在本发明揭露的技术范围内,根据本发明的技术方案及其发明构思加以等同替换或改变,都应涵盖在本发明的保护范围之内。
Claims (8)
1.一种***磷酸钠注射液,其特征在于,包括:***磷酸钠原料、药学上可接受的辅料;
所述药学上可接受的辅料包括渗透压调节剂、螯合剂、pH值调节剂、注射用水。
2.根据权利要求1所述的***磷酸钠注射液,其特征在于,所述渗透压调节剂由氯化钠、甘油、葡萄糖、甘露醇的一种或几种组成。
3.根据权利要求1所述的***磷酸钠注射液,其特征在于,所述螯合剂为依地酸二钠。
4.根据权利要求1所述的***磷酸钠注射液,其特征在于,所述pH值调节剂由氢氧化钠、盐酸、磷酸的一种或几种组成。
5.根据权利要求1~4任一项所述的***磷酸钠注射液的制备方法,其特征在于,包括以下步骤:
(1)称量:按处方量称量***磷酸钠原料药、渗透压调节剂、螯合剂、pH值调节剂;
(2)配药:将80%处方量的注射用水加入至容器具中,配制过程中需充加氮气保护,依次将渗透压调节剂、螯合剂、原料药、加入注射用水中,搅拌溶解,使用pH值调节剂调节pH,加注射用水定容,搅拌混合至均匀;
(3)除菌过滤:将所述药液经0.22μm除菌滤芯过滤;
(4)灌封:按照装量灌装于中硼硅玻璃安瓿中,封口,灌封过程中,充加氮气保护。
6.根据权利要求5所述的***磷酸钠注射液的制备方法,其特征在于,所述***磷酸钠原料药、渗透压调节剂、螯合剂的质量比为5:9:10。
7.根据权利要求5所述的***磷酸钠注射液的制备方法,其特征在于,所述配制过程温度为40℃以下。
8.根据权利要求5所述的***磷酸钠注射液的制备方法,其特征在于,所述pH值调节至7.0~8.5。
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