CN106176595A - 一种更昔洛韦注射液及其制备工艺 - Google Patents
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Abstract
本发明属于药物制备技术领域，具体来说，涉及到一种更昔洛韦注射液及其制备工艺。所述更昔洛韦注射液包括更昔洛韦和pH调节剂；所述更昔洛韦注射液以注射用水为溶剂，以塑料安瓿为直接接触更昔洛韦注射液的内包装容器。通过对更昔洛韦注射液易出现浑浊沉淀的机理进行了深入地分析研究，找到了易出现可见异物不合格、不溶性微粒增多的本质原因。与现有技术相比，本发明所述更昔洛韦注射液在制备时对塑料容器包装材料进行选择，使药液与包材均呈现良好的相容性，从而使可见异物和不溶性微粒均显著下降。
Description
技术领域
本发明属于药物制备技术领域，具体来说，涉及到一种更昔洛韦注射液及其制备工艺。
背景技术
更昔洛韦是英国syntex制药公司开发的第2代核苷类抗病毒药。该药进入细胞后由病毒的激酶诱导生成三磷酸化物，竞争性抑制病毒的DNA聚合酶而终止病毒DNA链增长。近年来随着临床应用的不断深入，更昔洛韦在各类疾病中得到广泛应用。但更昔洛韦水中溶解性较差，微溶于水，但随着pH值增高溶解度增加，目前上市的更昔洛韦注射液pH值为10.5～11.5之间，玻璃安瓿盛装。但是玻璃安瓿在容纳的药液经常会引起玻璃薄片特别是其碱性薄片溶解的问题。首先玻璃安瓿在使用时需掰断安瓿，因玻璃的易碎性，使在掰断安瓿同时带出大量玻璃碎屑，使玻璃碎屑直接进入药物中，人眼对微粒分辨是50微米以上，因人体毛细血管直径仅有7微米左右，大量不可视玻璃微粒随药品输入人体，具有“隐匿性微粒污染”威海，而这种微粒危害具有潜在性和持久性。
发明内容
为解决上述技术问题，本发明提供了一种能延缓可见异物不合格和不溶性微粒增加的更昔洛韦注射液及其制备工艺。
本发明所述的一种更昔洛韦注射液，所述更昔洛韦注射液包括更昔洛韦和pH调节剂；所述更昔洛韦注射液以注射用水为溶剂，以塑料安瓿为直接接触更昔洛韦注射液的内包装容器。
本发明所述的一种更昔洛韦注射液，所述pH调节剂选自氢氧化钠、碳酸氢钠、碳酸钠、柠檬酸钠、柠檬酸钾、枸橼酸钠、乳酸钠、磷酸钠、磷酸氢钠或磷酸二氢钠中的一种或多种。
本发明所述的一种更昔洛韦注射液，所述塑料安瓿的材料选自聚乙烯(PE)塑料、聚酯(PET和PBT)塑料、聚丙烯(PP)塑料或聚氯乙烯(PVC)塑料的一种。
本发明所述的一种更昔洛韦注射液，所述塑料安瓿的材料选自聚丙烯塑料；所述pH调节剂为氢氧化钠。
本发明所述的一种更昔洛韦注射液，所述更昔洛韦注射液规格为每支5ml,含更昔洛韦0.25g。
本发明所述的一种更昔洛韦注射液，所述更昔洛韦注射液还包括益母草叠烯酸酯A。
本发明所述的更昔洛韦注射液的制备工艺，所述制备工艺具体步骤为：1)注射用水搅拌下加入1/10更昔洛韦量的氢氧化钠，搅拌使溶解，将处方量的更昔洛韦慢慢倒入，搅拌使完全溶解；用氢氧化钠调节pH值至11.2；2)加入0.3％(w/v)的活性炭搅拌10分钟，不加注射用水至全量，过滤循环15分钟，取样检测含量、pH值合格后，用三合一设备制塑料PP安瓿、灌装、封口；于115℃灭菌30分钟，灯检合格后包装，检验。
通过对更昔洛韦注射液易出现浑浊沉淀的机理进行了深入地分析研究，找到了易出现可见异物不合格、不溶性微粒增多的本质原因。更昔洛韦注射液出现可见异物不合格、不溶性微粒增多的本质原因为：当用玻璃安瓿盛装更昔洛韦注射液时，由于更昔洛韦注射液为碱性溶液，在高温灭菌条件下或者贮藏过程中，药液经常会侵蚀玻璃，引起玻璃薄片特别是其碱性薄片溶解，导致可见异物不合格、不溶性微粒逐渐增加。然后，从直接接触药液的内包装材料入手解决了更昔洛韦注射液出现可见异物不合格、不溶性微粒增多的技术难题。与现有技术相比，本发明所述更昔洛韦注射液在制备时对塑料容器包装材料进行选择，使药液与包材均呈现良好的相容性，从而使可见异物和不溶性微粒均显著下降。
具体实施方式
下面结合具体的实施例对本发明所述更昔洛韦注射液及其制备工艺做进一步说明，但是本发明的保护范围并不限于此。
实施例1
处方：
工艺过程：
其制备方法为：
(1)注射用水搅拌下加入1/10更昔洛韦量的氢氧化钠，搅拌使溶解，将处方量的更昔洛韦慢慢倒入，搅拌使完全溶解。用氢氧化钠调节pH值至11.2。
(2)加入0.3％(w/v)的活性炭搅拌10分钟，不加注射用水至全量，过滤循环15分钟，取样检测含量、pH值合格后，用三合一设备制塑料PP安瓿、灌装、封口。于115℃灭菌30分钟。灯检合格后包装，检验。
实施例2
处方：
其制备方法为：
(1)注射用水搅拌下加入处方量的氢氧化钠，搅拌使溶解，将处方量的更昔洛韦慢慢倒入，搅拌使完全溶解。用碳酸钠调节pH值至11.2。
(2)加入0.3％(w/v)的活性炭搅拌10分钟，不加注射用水至全量，过滤循环15分钟，取样检测含量、pH值合格后，用三合一设备制塑料PP安瓿、灌装、封口。于115℃灭菌30分钟。灯检合格后包装，检验。
实施例3
处方：
其制备方法为：
(1)注射用水搅拌下加入处方量的氢氧化钠，搅拌使溶解，将处方量的更昔洛韦和益母草叠烯酸酯A慢慢倒入，搅拌使完全溶解。用碳酸钠调节pH值至11.2。
(2)加入0.3％(w/v)的活性炭搅拌10分钟，不加注射用水至全量，过滤循环15分钟，取样检测含量、pH值合格后，用三合一设备制塑料PP安瓿、灌装、封口。于115℃灭菌30分钟。灯检合格后包装，检验。
对照实施例
处方：
(1)注射用水搅拌下加入1/10更昔洛韦量的氢氧化钠，搅拌使溶解，将处方量的更昔洛韦慢慢倒入，搅拌使完全溶解。用氢氧化钠调节pH值至11.2。
(2)加入0.3％(w/v)的活性炭搅拌10分钟，不加注射用水至全量，过滤循环15分钟，取样检测含量、pH值合格后，灌封于常规工艺洗净的玻璃安瓿内，于115℃灭菌30分钟。灯检合格后包装，检验。
效果验证
选择可见异物和不溶性微粒为指标对本发明进行进一步详细描述。检测方法参照当前版药典附录可见异物和不溶性微粒检测方法。取实施例1～3和对照实施例进行性状、pH值、可见异物和不溶性微粒的检测，结果如表1所示。
表1各种样品性状、pH值、可见异物和不溶性微粒的测定结果
Claims (7)
1.一种更昔洛韦注射液，其特征在于，所述更昔洛韦注射液包括更昔洛韦和pH调节剂；所述更昔洛韦注射液以注射用水为溶剂，以塑料安瓿为直接接触更昔洛韦注射液的内包装容器。
2.根据权利要求1所述的一种更昔洛韦注射液，其特征在于，所述pH调节剂选自氢氧化钠、碳酸氢钠、碳酸钠、柠檬酸钠、柠檬酸钾、枸橼酸钠、乳酸钠、磷酸钠、磷酸氢钠或磷酸二氢钠中的一种或多种。
3.根据权利要求1所述的一种更昔洛韦注射液，其特征在于，所述塑料安瓿的材料选自聚乙烯塑料、聚酯塑料、聚丙烯塑料或聚氯乙烯塑料的一种。
4.根据权利要求1所述的一种更昔洛韦注射液，其特征在于，所述塑料安瓿的材料选自聚丙烯塑料；所述pH调节剂为氢氧化钠。
5.根据权利要求1所述的一种更昔洛韦注射液，其特征在于，所述更昔洛韦注射液规格为每支5ml,含更昔洛韦0.25g。
6.根据权利要求1所述的一种更昔洛韦注射液，其特征在于，所述更昔洛韦注射液还包括益母草叠烯酸酯A。
7.根据权利要求5所述的更昔洛韦注射液的制备工艺，其特征在于，所述制备工艺具体步骤为：1)注射用水搅拌下加入1/10更昔洛韦量的氢氧化钠，搅拌使溶解，将处方量的更昔洛韦慢慢倒入，搅拌使完全溶解；用氢氧化钠调节pH值至11.2；2)加入0.3％(w/v)的活性炭搅拌10分钟，补加注射用水至全量，过滤循环15分钟，取样检测含量、pH值合格后，用三合一设备制塑料PP安瓿、灌装、封口；于115℃灭菌30分钟，灯检合格后包装，检验。
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