CN113144209A - 狂犬病疫苗冻干保护剂 - Google Patents
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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Abstract
一种狂犬病疫苗冻干保护剂,包括柠檬酸、钠盐、蔗糖和人血白蛋白等。本发明提供的冻干保护剂,实现了狂犬疫苗冻干制剂的快速复溶,大幅缩短的产品制备时间,有效提高安全了,降低了免疫原性。
Description
技术领域
本发明涉及一种用于生物制品的组合物,尤其涉及一种用于疫苗冻干的保护剂,不使用生物原型的物质,提高安全性。
背景技术
为保护疫苗在冻干过程中生物组分的稳定性及保证制品的赋型效果,制品在冻干过程中 通常会使用不同类别的冻干保护剂。现阶段,国内大多数疫苗企业通常选择含有不同比例的 明胶作为冻干保护剂组分,虽然冻干效果达到要求,但明胶作为动物源性成分使冻干制品存 在一定安全性问题,并可能与疫苗接种后出现的过敏反应相关。随着人们对疫苗安全性认识 不断提高,促使人们在疫苗选择上越来越倾向于无明胶组分的疫苗制剂。
CN105497904A公开了一种伪狂犬病病毒疫苗耐热冻干保护剂,水解明胶2~6%、乳糖 0.2~4%、蔗糖2~5%、植物多糖0.1~0.5%、山梨醇1~3%、L-谷氨酸1~1.5%、L-组氨酸0.1~1%、 维生素C 0.2~0.5%、维生素E 0.1~0.3%、无水磷酸二氢钾1~2%、叔丁醇0.5~1%、人血清白 蛋白0.1~1%,余量为注射用水。
发明内容
本发明的一个目的在于提供一种狂犬病疫苗冻干保护剂,以利于制剂使用时复溶, 缩短制备时间。
本发明的另一个目的在于提供一种狂犬病疫苗冻干保护剂,以利于制剂使用时复溶,降低免疫原型。
本发明的另一个目的在于提供一种狂犬病疫苗冻干保护剂,保持疫苗的效价。
一种狂犬病疫苗冻干保护剂,包括柠檬酸、钠盐、蔗糖和人血白蛋白。
柠檬酸用量为20g/L~30g/L。
蔗糖用量为10.5g/L。
人血白蛋白用量为8.5g/L。
钠盐如:柠檬酸钠、氯化钠和谷氨酸钠等,这些物质单独或组合应用于本发明。
具体的,20.5g/L柠檬酸钠,0.5g/L柠檬酸;1.5g/L谷氨酸钠;2.5g/L氯化钠等之一种或几种。
另一种狂犬病疫苗冻干保护剂,还包括右旋糖酐、甘氨酸和水。比如:2.5g/L右 旋糖酐和0.75g/L甘氨酸。
另一种狂犬病疫苗冻干保护剂,包括:
氯化钠、柠檬酸、柠檬酸钠、蔗糖、右旋糖酐、人血白蛋白、谷氨酸钠、甘氨酸 和水。
另一种狂犬病疫苗冻干保护剂,包括:
2.5g/L氯化钠、0.5g/L柠檬酸、20.5g/L柠檬酸钠、10.5g/L蔗糖、2.5g/L右旋糖酐、8.5g/L人血白蛋白、1.5g/L谷氨酸钠、0.75g/L甘氨酸和水。
本发明的技术方案在选择合适的冻干保护剂组分过程中考虑狂犬病疫苗分子结构及生产制备工艺特点,适当增加了多糖含量及人血白蛋白组分,其可以阻止冻干过 程中蛋白质结构发生改变,提高疫苗组分稳定性,使用该冻干保护剂可在冻干过程中 保证冻干制品良好的外观,同时能够使冻干制品保持良好的免疫原性。
本发明的技术方案还实现了狂犬疫苗冻干制剂的快速复溶,大幅缩短的产品制备时间,有效提高安全了,降低了免疫原性。
具体实施方式
以下详细描述本发明的技术方案。本发明实施例仅用以说明本发明的技术方案而非限制,尽管参照较佳实施例对本发明进行了详细说明,本领域的普通技术人员应当 理解,可以对发明的技术方案进行修改或者等同替换,而不脱离本发明技术方案的精 神和范围,其均应涵盖在本发明的权利要求范围中。
本实施例所用基础仪器设备如下表1所示,所用主要试剂如下表2所示。
表1
表2
冻干保护剂的组分按如下表3所示,制取步骤如下:
先将纯化液按上述配方加入相应物质至终浓度,混匀。
然后,将配制完成的原液按1ml/支分装至2ml西林瓶中,并标注配方信息,半盖 塞后转至冻干机中。
接着,打开冻干机电源,设置冻干参数,进行冻干。
冻干完成后,进行压塞,取出冻干制品,进行轧盖,分别取样按《中国药典》2020 版进行外观、水分、复溶时间以及效价检查。
另从三组样品中分别进行取样,将样品放置37℃生化培养箱放置28天、35天, 并按《中国药典》2020版进行热稳定性试验。
连续进行3次冻干实验,最终确定合适配方的冻干保护剂。
表3
由表3可知,使用不同配比的冻干保护剂冻干的制品,冻干外观效果均为白色疏松体, 复溶后为澄明液体,无异物。但各配方冻干制品复溶时间存在差异,配方2、配方4三次实 验复溶时间较配方1、配方3及对照组复溶时间大幅缩短。各组冻干制品水分结果均符合《中 国药典》2020版要求。制品使用冻干配方3、冻干配方4冻干后效价较其他组低,在热稳定 性实验中,同样存在配方3、配方4效价降低情况较对照组更明显。而配方1、配方2在热稳定性实验中结果与对照组使用明胶组分结果相当。结合疫苗复溶以及效价变化情况综合评价 得出配方2为合适的不含明胶的狂犬病疫苗冻干保护剂。
Claims (10)
1.一种狂犬病疫苗冻干保护剂,其特征在于包括柠檬酸、钠盐、蔗糖和人血白蛋白。
2.根据权利要求1所述的狂犬病疫苗冻干保护剂,其特征在于所述的钠盐选自于柠檬酸钠、氯化钠和谷氨酸钠之一种或几种。
3.根据权利要求1所述的狂犬病疫苗冻干保护剂,其特征在于所述的蔗糖用量为10.5g/L。
4.根据权利要求1所述的狂犬病疫苗冻干保护剂,其特征在于所述的人血白蛋白用量为8.5g/L。
5.根据权利要求1所述的狂犬病疫苗冻干保护剂,其特征在于柠檬酸钠用量为20.5g/L,所述的柠檬酸用量为0.5g/L。
6.根据权利要求1所述的狂犬病疫苗冻干保护剂,其特征在于还包括1.5g/L谷氨酸钠。
7.根据权利要求1所述的狂犬病疫苗冻干保护剂,其特征在于还包括2.5g/L氯化钠。
8.根据权利要求1所述的狂犬病疫苗冻干保护剂,其特征在于还包括2.5g/L右旋糖酐。
9.根据权利要求1所述的狂犬病疫苗冻干保护剂,其特征在于还包括0.75g/L甘氨酸。
10.根据权利要求1所述的狂犬病疫苗冻干保护剂,其特征在于包括:
2.5g/L氯化钠、0.5g/L柠檬酸、20.5g/L柠檬酸钠、10.5g/L蔗糖、2.5g/L右旋糖酐、8.5g/L人血白蛋白、1.5g/L谷氨酸钠、0.75g/L甘氨酸和水。
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CN115040656A (zh) * | 2022-07-05 | 2022-09-13 | 吉林惠康生物药业有限公司 | 狂犬疫苗冻干保护剂、应用和疫苗及其制备方法 |
CN115040656B (zh) * | 2022-07-05 | 2024-04-26 | 吉林惠康生物药业有限公司 | 狂犬疫苗冻干保护剂、应用和疫苗及其制备方法 |
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