CN102657623A - 一种炎琥宁注射剂的组合物及其制备方法 - Google Patents
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Abstract
本发明属于药物制剂技术领域，具体涉及一种稳定的炎琥宁药物组合物，该组合物为冻干粉针剂，其特征在于冻干粉针剂加入了右旋糖酐和氯化钠的冻干填充剂组合；本发明制备得到的冻干粉针剂具有更好的稳定性，长期放置过程中有关物质变化小。
Description
技术领域
本发明属于药物技术领域，具体涉及一种稳定的注射用炎琥宁组合物，其剂型为冻干粉针剂。
背景技术
炎琥宁系植物穿心莲提取物—穿心莲内酯经酯化、脱水、成盐精制而成的脱水穿心莲内酯琥珀酸半酯钾钠盐，与穿琥宁在体内活性代谢物为同一物质(穿琥宁为穿心莲内酯半酯单钾盐)。有清热解毒及抗病毒作用，主要用于病毒性肺炎和病毒性上呼吸道感染。临床药理研究表明：(1)本品对细菌内毒素引起发热的家兔有较强的解热作用，能促进发热的消退，作用迅速并维持4小时以上；(2)本品能对抗二甲苯或组织胺所引起毛细血管壁通透性增高；(3)本品能缩短戊巴比妥钠引起的小白鼠睡眠潜伏期，延长其睡眠时间，还能加强阈下量的戊巴比妥钠作用，引起小白鼠睡眠，该实验结果提示本品有明显的镇静作用；(4)本品能明显地促进大白鼠肾上腺皮质功能，增加机体对病原体感染的应急能力；(5)临床病原学诊断实验和组织培养灭活实验显示本品体外对流感病毒甲I型、甲III型、肺炎腺病毒(Adv)III型、IV型，肠合胞病毒及呼吸道合胞病毒(Rsv)均有一定灭活作用。
目前已有上市注射用炎琥宁(冻干粉针剂)，但炎琥宁本身结构稳定性差，一般认为主要是pH的变化对其结构稳定性的影响比较大，而制剂放置过程中特别是时间长以后pH通常会发生变化，目前一般通过加入抗氧化剂、缓冲盐等手段来解决，也有通过超滤工艺来制备冻干粉针，但该工艺增加了生产的复杂性和成本。
发明内容
本申请的目的解决炎琥宁组合物(冻干粉针剂)的稳定性问题，即减少药物储存过程中的降解。
申请人在研究中发现，本发明的组合物在不加入其它抗氧化剂或缓冲盐等组分时，采用常规的冻干制剂制备工艺也能显著提高制剂的稳定性，使药物在长期放置过程中有关物质增加很少，避免了活性物质的降解，具有重要的实际意义。
本发明提供一种炎琥宁药物组合物，其特征在于由下列组分制成：
所述组合物为冻干粉针剂。
其特征在于炎琥宁的含量为80mg/瓶。
本发明还提供一种炎琥宁药物组合物，其特征在于由下列组分制成：
所述组合物为冻干粉针剂。
其特征在于炎琥宁的含量为200mg/瓶。
上述药物组合物的制备方法，其特征为包括以下步骤：
称取炎琥宁，加入注射用水至全量的80％搅拌使溶解，加入0.1％(g/ml)的活性炭，搅拌吸附30分钟，脱炭，调pH值至6.0-8.0之间，加注射用水至全量，中间体含量测定确定装量后，除菌过滤(0.15μm微孔滤膜)，分装，冷冻干燥，包装，检验，入库。
本申请使用的pH调节剂没有特别要求，根据需要，常用的如氢氧化钠溶液或盐酸溶液以及其它常规pH调节剂等都可以。
本申请与现有技术比较没有加入抗氧化成分、缓冲盐或者现有技术的提高稳定性成分，但申请人发现使用本申请的两种常用冻干制剂填充剂能显著提高制剂的稳定性，而单用时并未发现上述效果，由于药物和辅料之间的相互关系较为复杂，目前还不清楚其提高制剂稳定性的原因，但特定的药物和特定辅料组合具有更好稳定性的现象在药物制剂中也是普遍存在的，充分说明了药物制剂是一门实验科学。
制备实施例
实施例1炎琥宁冻干粉针剂
制备方法：
称取炎琥宁、右旋糖酐、氯化钠，加入注射用水至全量的80％搅拌使溶解，加入0.1％(g/ml)的活性炭，搅拌吸附30分钟，脱炭，用氢氧化钠溶液调pH值至6.0-8.0之间，加注射用水至全量，中间体含量测定确定装量后，除菌过滤(0.15μm微孔滤膜)，分装，冷冻干燥，包装，检验，入库。
实施例2炎琥宁冻干粉针剂
制备方法：
称取炎琥宁、右旋糖酐、氯化钠，加入注射用水至全量的80％搅拌使溶解，加入0.1％(g/ml)的活性炭，搅拌吸附30分钟，脱炭，氢氧化钠溶液调pH值至6.0-8.0之间，加注射用水至全量，中间体含量测定确定装量后，除菌过滤(0.15μm微孔滤膜)，分装，冷冻干燥，包装，检验，入库。
比较例1炎琥宁冻干粉针剂
制备方法：参照实施例1的方法制备。
比较例2炎琥宁冻干粉针剂
制备方法：参照实施例1的方法制备。
比较例3炎琥宁冻干粉针剂
制备方法：参照实施例1的方法制备。
比较例4炎琥宁冻干粉针剂
制备方法：参照实施例1的方法制备。
比较例5炎琥宁冻干粉针剂
制备方法：参照实施例1的方法制备。
比较例6炎琥宁冻干粉针剂
制备方法：参照实施例1的方法制备。
比较例7炎琥宁冻干粉针剂
制备方法：参照实施例1的方法制备。
实施例和比较实施例长期放置有关物质实验结果
为了反映制剂的真实有关物质变化情况，本发明研究中取实施例样品和对比实施例样品进行了长期稳定性研究。
参照中国药典药物稳定性试验指导原则。
考察项目：性状、有关物质。考察时间：30个月。
有关物质的测定方法按照现有技术的方法进行测定。结果表明放置过程中本发明制剂及对比例制剂的性状、溶解后澄明度均未发生显著改变，符合冻干制剂的相关质量要求，上述试验样品测定得到的有关物质结果见下表。
长期稳定性实验有关物质测定结果(％)
长期稳定性结果表明本发明制剂的稳定性显著提高，在放置30个月后本发明制剂的有关物质变化很小，依然符合质量要求，而对比实施例制剂在长期稳定性实验18个月后有关物质就接近或超出了质量标准的规定(1％)，24个月和30个月的有关物质则明显超出标准规定。
炎琥宁由于其本身结构的不稳定性，因此控制其降解是保证制剂安全的重要方法，现有研究认为控制pH是控制制剂稳定的重要因素，而本发明的研究结果表明通过选择右旋糖酐和氯化钠的组合作为冻干填充剂使用也能提高制剂中活性成分的稳定性，即本发明选择的特定冻干填充剂组合对于提高制剂稳定，避免储藏过程有关物质的增加有重要作用，与本发明组合物比较，对比例稳定性显著较差，本发明的效果根据现有技术无法预料，属于预料不到的技术效果。
Claims (5)
1.一种炎琥宁药物组合物，其特征在于由下列组分制成：
所述组合物为冻干粉针剂。
2.一种炎琥宁药物组合物，其特征在于由下列组分制成：
所述组合物为冻干粉针剂。
3.根据权利要求1的炎琥宁药物组合物，其特征在于炎琥宁的含量为80mg/瓶。
4.根据权利要求2的炎琥宁药物组合物，其特征在于炎琥宁的含量为200mg/瓶。
5.根据权利要求1至4任意一项的药物组合物的制备方法，其特征为包括以下步骤：
称取炎琥宁，加入注射用水至全量的80％搅拌使溶解，加入0.1％(g/ml)的活性炭，搅拌吸附30分钟，脱炭，调pH值至6.0-8.0之间，加注射用水至全量， 中间体含量测定确定装量后，除菌过滤(0.15μm微孔滤膜)，分装，冷冻干燥，包装，检验，入库。
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|---|---|---|---|---|
| CN107281143A (zh) * | 2017-07-27 | 2017-10-24 | 哈尔滨松鹤制药有限公司 | 一种注射用炎琥宁冻干粉针剂及其制备方法 |
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| CN102657623B (zh) | 2013-07-17 |
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