CN111388429B - 一种广谱抗病毒药物Triazavirin的冻干粉针剂及其制备方法 - Google Patents

一种广谱抗病毒药物Triazavirin的冻干粉针剂及其制备方法 Download PDF

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CN111388429B
CN111388429B CN202010298567.7A CN202010298567A CN111388429B CN 111388429 B CN111388429 B CN 111388429B CN 202010298567 A CN202010298567 A CN 202010298567A CN 111388429 B CN111388429 B CN 111388429B
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杨文茂
王勇
余翔
唐磊
马龙
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Abstract

本发明公开了一种广谱抗病毒药物Triazavirin新型冻干粉针剂，以及该冻干粉针剂的制备方法。新型冻干粉针剂由广谱抗病毒药物Triazavirin、β‑环糊精、低分子右旋糖酐、EDTA、pH调节剂和渗透压调节剂组成。本发明提供的方法是将β‑环糊精加入注射用水中，溶解后加入适量的EDTA，再加入适量广谱抗病毒药物Triazavirin和低分子左旋糖酐搅拌使其主药完全溶解，经活性炭处理后，加入渗透压调节剂，再用pH调节剂调pH＝7.5‑8.5，最后灌装于安瓿中，冻干，密封得广谱抗病毒药物Triazavirin的冻干粉针剂。采用本发明制备的广谱抗病毒Triazavirin冻干粉针剂具有水分低、外观好、相关杂质低等优点，适用于长期储存。

Description

一种广谱抗病毒药物Triazavirin的冻干粉针剂及其制备 方法
技术领域
本发明属于医药领域，具体涉及一种广谱抗病毒药物Triazavirin的冻干粉针剂及制备方法。
背景技术
Triazavirin是2014年由俄罗斯乌拉尔国立大学化学技术研究所研制的新型广谱抗病毒药物，此药物有助于延迟治疗急性呼吸道病毒感染和流感，在第一天改善健康状况，降低并发症的可能性，迅速停止冠状病毒感染的临床症状，防止疾病恶化，有效对抗RNA病毒感染。
目前，Triazavirin作为俄罗斯政府提供的防疫支援物资在中国开展临床试验(特力阿扎维林治疗2019新型冠状病毒肺炎(COVID-19)患者有效性和安全性的多中心、随机、双盲、安慰剂对照临床研究)。
目前该药物市场上主要以片剂和胶囊为主，但由于该药物水溶性非常好，所以进入人体后代谢非常快，以至于该药的服用剂量很大才能有效抑制病毒。
针对目前国内外新冠病毒大量蔓延，重症及病死率不断增加，因此将广谱抗病毒药Triazavirin做成具有使用剂量小、服药次数少、起效快、毒副作用低的粉状针剂就显得非常必要和紧迫。
发明内容
为了克服上述技术缺陷，针对现有市场并无影响粉针剂特点，本发明公开了一种广谱抗病毒药物Triazavirin的新型冻干粉针剂以及广谱抗病毒药物Triazavirin新型冻干粉针剂的制备方法。
本发明第一个目的，提供了一种广谱抗病毒药物Triazavirin的新型冻干粉针剂，包括如下组分：Triazavirin、稳定剂、赋形剂、络合剂、pH调节剂、渗透压调节剂、水。
进一步地，在上述技术方案中，所述稳定剂为β-环糊精或/和甲基环糊精；或/和赋形剂为甘露醇或/和低分子右旋糖酐；或/和水为无菌注射用水。
进一步地，在上述技术方案中，所述pH值调节剂为无机酸或/和无机碱。
进一步地，在上述技术方案中，所述pH值调节剂为柠檬酸、盐酸、磷酸、氢氧化钠、磷酸氢二钠、磷酸二氢钠中的一种或多种；加入pH调节剂为粉剂长期保存的关键因素之一，通常pH值在7.5-8.5，优选pH＝8.0-8.1。
进一步地，在上述技术方案中，所述渗透压调节剂为一种或多种药学可接受辅料，该辅料可促使溶液与血液相容。渗透压调节剂选自甘露醇、甘油、乳糖、葡萄糖、氯化钠或山梨醇。
在一些实施方式中，选用pH调节剂补偿渗透压调节剂，在溶液中提供相似的离子。例如，当使用氯化钠作为渗透压调节剂时，可以使用盐酸和/或氢氧化钠，作为pH调节剂。
进一步地，在上述技术方案中，所述渗透压调节剂为甘露醇、乳糖、氯化钠或山梨醇；优选氯化钠。
进一步地，在上述技术方案中，该冻干粉剂还进一步添加药学可接受辅料、稀释剂、缓冲剂或防腐剂中的一种或多种。
进一步地，在上述技术方案中，该冻干粉剂优选以下组分方案构成，稳定剂为β-环糊精，赋形剂为低分子右旋糖酐，络合剂为EDTA，pH调节剂为磷酸氢二钠，渗透压调节剂为氯化钠。
进一步地，在上述技术方案中，该冻干粉剂由以下具体组分组成：Triazavirin 1份、β-环糊精1-2份、右旋糖酐10-30份、EDTA 0.05-0.1份、磷酸氢二钠以调节pH＝7.5-8.5份、氯化钠0.5-1份、无菌注射用水100-200份。
本发明的第二个目的为提供了一种广谱抗病毒药物Triazavirin的冻干粉针剂的制备方法，包括如下步骤：
将稳定剂加入注射用水中，溶解后加入络合剂，再加入广谱抗病毒药物Triazavirin和赋形剂搅拌至完全溶解，加活性炭吸附过滤后，加入渗透压调节剂，接着加入pH调节剂，最后经膜过滤除菌后灌装于安瓿中，冻干密封得广谱抗病毒药物Triazavirin的冻干粉针剂。
进一步地，在上述技术方案中，稳定剂选自β-环糊精，络合剂选自EDTA，赋形剂选自低分子右旋糖酐，渗透压调节剂选自氯化钠，pH调节剂选自磷酸氢二钠。
进一步地，在上述技术方案中，所述加入pH调节剂调至pH＝7.5-8.5；过滤所述膜为0.1-0.25μm。
发明有益效果
本发明制备的广谱抗病毒Triazavirin冻干粉针剂具有水分低，外观好，有关物质低，适用于长期储存等优点。
申请人经过大量试验研究发现：广谱抗病毒药物Triazavirin性质不稳定，制备为注射剂后，在长期稳定性试验中外观、可见异物、不溶微粒等检测指标常常不达标。本申请中通过调整溶液pH值进行改善，发现溶液pH值调整在合适范围时，Triazavirin粉针剂外观、可见异物、不溶微粒等指标可以达标准要求。
具体实施例
实施例1：
准确称取β-环糊精1.0g，加入100mL注射用水中，超声溶解后再加入EDTA 0.05g，广谱抗病毒药Triazavirin 1.0g，超声溶解后加入低分子右旋糖酐20g搅拌使其溶解完全，之后加入活性炭2.0g，搅拌脱色吸附45min过滤，滤液加入氯化钠0.5g，溶解后用磷酸氢二钠调节pH＝7.5，待15min后复测pH稳定在7.5后，用0.2μm膜过滤除菌，滤液分别罐装于2mL安瓿瓶中，其罐装量为1mL/瓶，装好后将其放于冻干机中冻干，36h后取出密封，得到广谱抗病毒药Triazavirin冻干粉针剂。
实施例2
广谱抗病毒药Triazavirin冻干粉针剂各组分配比如下，其制备过程如实施例1，具体配比如下：
Figure BDA0002453125540000041
Figure BDA0002453125540000051
实施例3
广谱抗病毒药Triazavirin冻干粉针剂各组分配比如下，其制备过程如实施例1，具体配比如下：
Figure BDA0002453125540000052
实施例4
广谱抗病毒药Triazavirin冻干粉针剂各组分配比如下，其制备过程如实施例1，具体配比如下：
Figure BDA0002453125540000053
Figure BDA0002453125540000061
实施例5
广谱抗病毒药Triazavirin冻干粉针剂各组分配比如下，其制备过程如实施例1，具体配比如下：
Figure BDA0002453125540000062
实施例6
广谱抗病毒药Triazavirin冻干粉针剂各组分配比如下，其制备过程如实施例1，具体配比如下：
Figure BDA0002453125540000063
实施例7
广谱抗病毒药Triazavirin冻干粉针剂各组分配比如下，其制备过程如实施例1，具体配比如下：
Figure BDA0002453125540000071
实施例8
广谱抗病毒药Triazavirin冻干粉针剂各组分配比如下，其制备过程如实施例1，具体配比如下：
Figure BDA0002453125540000072
实施例9
本发明实施例1-8广谱抗病毒药Triazavirin冻干粉针剂稳定性试验。
本发明中实例1-8冻干粉针剂稳定性试验测定依据《中国药典》2015版中药物稳定性的考察项目进行，其中稳定性考察的项目指标为：pH值、澄清度、可见异物、不溶性微粒、水分和含量等6项。
加速试验是在温度40℃±1℃的条件下放置6个月，在试验期间分别于0个月及第1个月、2个月、3个月、6个月末取样，并记录其各项指标与0月进行比较得出的结果如表1。
表1：加速试验结果
Figure BDA0002453125540000081
Figure BDA0002453125540000091
长期试验在温度25℃±1℃的条件下放置12个月，在试验期间分别于0个月、3个月、6个月、9个月、12个月末取样，并记录其各项指标与0月进行比较得出的结果如表2。
表2：加速试验结果
Figure BDA0002453125540000092
Figure BDA0002453125540000101
以上实施例描述了本发明的基本原理、主要特征及优点。本行业的技术人员应该了解，本发明不受上述实施例的限制，上述实施例和说明书中描述的只是说明本发明的原理，在不脱离本发明原理的范围下，本发明还会有各种变化和改进，这些变化和改进均落入本发明保护的范围内。

Claims (2)

1.一种广谱抗病毒药物Triazavirin的冻干粉针剂，其特征在于，由如下组分制备：Triazavirin 1份、β-环糊精1-2份、右旋糖酐10-30份、EDTA 0.05-0.1份、磷酸氢二钠以调节pH＝7.5-8.5、氯化钠0.5-1份、无菌注射用水100-200份。
2.如权利要求1所述广谱抗病毒药物Triazavirin的冻干粉针剂的制备方法，其特征在于，包括如下步骤：将稳定剂加入注射用水中，溶解后加入络合剂，再加入广谱抗病毒药物Triazavirin和赋形剂搅拌至完全溶解，加活性炭吸附过滤后，加入渗透压调节剂，接着加入pH调节剂，最后经膜过滤除菌后灌装于安瓿中，冻干密封得广谱抗病毒药物Triazavirin的冻干粉针剂；其中，稳定剂选自β-环糊精，络合剂选自EDTA，赋形剂选自右旋糖酐，渗透压调节剂选自氯化钠，pH调节剂选自磷酸氢二钠；加入pH调节剂调至pH＝7.5-8.5；过滤所述膜为0.1-0.25μm。
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