CN117598994A - 一种具有光动力作用的脂质体制剂及其制备方法和应用 - Google Patents
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Abstract
本发明提供了一种具有光动力作用的脂质体制剂,其包括脂质体、化疗药物和光敏剂‑替莫泊芬;其中,化疗药物和光敏剂‑替莫泊芬包裹在该脂质体内。本发明同时采用脂质体给药系统和光动力疗法,并与传统的化疗结合,提高了对肿瘤的靶向性,增加了药效,可以减轻不良反应,为治疗肿瘤提供了新的策略。
Description
技术领域
本发明涉及生物医药技术领域,具体涉及一种具有光动力作用的脂质体制剂及其制备方法和应用。
背景技术
肿瘤作为一种严重威胁人们生命的疾病,其治疗方法已成为众多科研工作者致力研究的课题,多种抗癌药物被开发出并应用于化疗,但常常会引起患者的不良副作用,导致身体和精神上的疼痛,且治疗效率很低。目前临床上常用的化疗药物包括紫杉醇、阿霉素、伊立替康、10-羟基喜树碱等等。各种新剂型和疗法也逐渐应用到这一领域当中,如脂质体等纳米给药系统和光动力疗法(Photodynamic therapy,简称PDT)。
脂质体纳米药物制剂是一种被脂双分子层囊泡结构包裹的具有纳米尺度的新型药物制剂。脂质体作为药物递送载体,具备生物相容性良好、在体内可被生物降解以及定位靶向性强等优点。应用脂质体纳米药物递送系统,可在一定程度上改善某些药物在人体内的药代动力学行为及药效,减轻不良反应。
光动力疗法是一种应用于实体肿瘤治疗的新方法,通过氧化损伤作用破坏靶部位细胞的结构和功能,引起靶细胞的凋亡和坏死,在临床上被接受作为一种治疗癌症的缓解疗法。
目前,单一疗法治疗肿瘤无法达到令人满意的效果,多种手段联合治疗可以克服单一疗法的缺点,是一种具有广阔前景的肿瘤治疗策略。采用多模式治疗肿瘤,可以结合不同治疗模式的优势,利用不同的作用机制协同抑制肿瘤生长,提高疗效,降低副作用。本发明拟结合脂质体给药系统和光动力疗法提供一种结合多种治疗模式的脂质体制剂。
发明内容
为了克服现有技术中的缺陷,本发明提供了一种具有光动力作用的脂质体制剂及其制备方法和在制备治疗肿瘤的药物中的应用。
为实现上述目的,本发明采用如下技术方案:
本发明的第一方面是提供一种具有光动力作用的脂质体制剂,其包括脂质体、化疗药物和光敏剂-替莫泊芬;其中,化疗药物和光敏剂-替莫泊芬包裹在该脂质体内。
进一步地,化疗药物选自紫杉醇、阿霉素、伊立替康、10-羟基喜树碱中的一种或多种。
本发明的第二方面是提供上述脂质体制剂的制备方法,包括如下步骤:
步骤一,将大豆卵磷脂、二硬脂酰基磷脂酰乙醇胺-聚乙二醇2000、胆固醇和化疗药物按照一定的质量比完全溶解于有机溶剂中;
步骤二,完全溶解后,采用旋转蒸发仪将上述含有多种原料的有机溶剂减压蒸发成膜,真空干燥过夜;将膜加入磷酸盐缓冲液中使薄膜脱落溶解;反复冻融4次,得到溶液;
步骤三,上述溶液经高压匀质机乳匀制备成不同粒径的脂质体混悬液。
进一步地,上述大豆卵磷脂和二硬脂酰基磷脂酰乙醇胺-聚乙二醇的质量比为2~10:1。
进一步地,胆固醇的质量与大豆卵磷脂和二硬脂酰基磷脂酰乙醇胺-聚乙二醇的质量和的比为1:10~20。
进一步地,胆固醇、替莫泊芬和化疗药物的质量比为4~6:1:0.5~2。
进一步地,上述有机溶剂为氯仿或乙醇。
进一步地,在步骤一中,各个原料在氮气的保护状态下,完全溶解于有机溶剂中。
进一步地,在步骤二中,真空干燥过夜的条件是30~40℃。
进一步地,上述磷酸盐缓冲液的pH为7~7.6。
进一步地,乳匀的压力为10~600bar。
本发明的第三方面是提供上述脂质体制剂在制备治疗肿瘤药物中的应用。
本发明采用以上技术方案,与现有技术相比,具有如下技术效果:
本发明同时采用脂质体给药系统和光动力疗法,并与传统的化疗结合,提高了对肿瘤的靶向性,增加了药效,可以减轻不良反应,为治疗肿瘤提供了新的策略。
具体实施方式
本发明提供了一种具有光动力作用的脂质体制剂及其制备方法和在制备治疗肿瘤的药物中的应用。下面通过具体实施例对本发明进行详细和具体的介绍,以使更好的理解本发明,但是下述实施例并不限制本发明范围。
实施例中方法如无特殊说明的采用常规方法,使用的试剂如无特殊说明的使用常规市售试剂或按常规方法配制的试剂。
实施例1
本实施例提供了一种具有光动力作用的脂质体制剂,其制备方法包括如下步骤:
步骤一,将大豆卵磷脂60mg、二硬脂酰基磷脂酰乙醇胺-聚乙二醇2000(DSPE-PEG-2k)20mg、胆固醇5mg、替莫泊芬1mg和紫杉醇1mg在氮气保护的状态下,用30ml氯仿溶解;完全溶解后,采用旋转蒸发仪减压蒸发成膜,在37℃下真空干燥过夜。将膜加入30ml,pH=7.4的1×磷酸盐缓冲液中使薄膜脱落溶解。反复冻融4次,得到溶液。
步骤二,上述溶液经高压匀质机乳匀(乳匀压力:10bar、60bar、1200bar、500bar)制备成不同粒径的脂质体混悬液。
实施例2
本实施例提供了一种具有光动力作用的脂质体制剂,其制备方法包括如下步骤:
步骤一,将大豆卵磷脂90mg、二硬脂酰基磷脂酰乙醇胺-聚乙二醇2000(DSPE-PEG-2k)25mg、胆固醇8mg、替莫泊芬2mg和紫杉醇3mg在氮气保护的状态下,用50ml氯仿溶解;完全溶解后,采用旋转蒸发仪减压蒸发成膜,在37℃下真空干燥过夜。将膜加入50ml,pH=7.4的1×磷酸盐缓冲液中使薄膜脱落溶解。反复冻融4次,得到溶液。
步骤二,上述溶液经高压匀质机乳匀(乳匀压力:10bar、60bar、1200bar、500bar)制备成不同粒径的脂质体混悬液。
实施例3
本实施例提供了一种具有光动力作用的脂质体制剂,其制备方法包括如下步骤:
步骤一,将大豆卵磷脂70mg、二硬脂酰基磷脂酰乙醇胺-聚乙二醇2000(DSPE-PEG-2k)15mg、胆固醇7mg、替莫泊芬1.5mg和紫杉醇2mg在氮气保护的状态下,用40ml氯仿溶解;完全溶解后,采用旋转蒸发仪减压蒸发成膜,在37℃下真空干燥过夜。将膜加入40ml,pH=7.4的1×磷酸盐缓冲液中使薄膜脱落溶解。反复冻融4次,得到溶液。
步骤二,上述溶液经高压匀质机乳匀(乳匀压力:10bar、60bar、1200bar、500bar)制备成不同粒径的脂质体混悬液。
实施例4
本实施例对上述实施例1提供的脂质体制剂进行性质的表征,粒径和Zeta电位的测定方法是将脂质体稀释合适浓度后,使用马尔文激光粒度仪nano ZS90进行脂质体的粒径和Zeta电位的测定;包封率的测定则采用超滤离心法,方法如下:
将超滤离心后的滤液,经15000rpm离心后注入HPLC,进行未包埋的药物含量测定。包封率(%)=(投药量-未包埋药物含量)/投药量*100%。
结果如下表1所示,实施例1提供的脂质体制剂汇中紫杉醇和替莫泊芬有很高的包封率。
表1脂质体制剂的性能测试数据
粒径(nm) | Zeta电位(MV) | 紫杉醇包封率(%) | 替莫泊芬包封率(%) |
135.89 | 3.08±0.32 | 91% | 89% |
以上对本发明的具体实施例进行了详细描述,但其只作为范例,本发明并不限制于以上描述的具体实施例。对于本领域技术人员而言,任何对本发明进行等同修改和替代也都在本发明的范畴之中。因此,在不脱离本发明精神和范围下所作的均等变换和修改,都应涵盖在本发明的范围内。
Claims (10)
1.一种具有光动力作用的脂质体制剂,其特征在于,包括脂质体、化疗药物和光敏剂-替莫泊芬;其中,化疗药物和光敏剂-替莫泊芬包裹在所述脂质体内。
2.根据权利要求1所述的脂质体制剂,其特征在于,所述化疗药物选自紫杉醇、阿霉素、伊立替康、10-羟基喜树碱中的一种或多种。
3.如权利要求1或2所述脂质体制剂的制备方法,其特征在于,包括如下步骤:
步骤一,将大豆卵磷脂、二硬脂酰基磷脂酰乙醇胺-聚乙二醇2000、胆固醇和化疗药物按照一定的质量比完全溶解于有机溶剂中;
步骤二,完全溶解后,采用旋转蒸发仪将所述含有多种原料的有机溶剂减压蒸发成膜,真空干燥过夜;将膜加入磷酸盐缓冲液中使薄膜脱落溶解;反复冻融4次,得到溶液;
步骤三,所述溶液经高压匀质机乳匀制备成不同粒径的脂质体混悬液。
4.根据权利要求3所述的制备方法,其特征在于,大豆卵磷脂和二硬脂酰基磷脂酰乙醇胺-聚乙二醇的质量比为2~10:1;胆固醇的质量与大豆卵磷脂和二硬脂酰基磷脂酰乙醇胺-聚乙二醇的质量和的比为1:10~20;胆固醇、替莫泊芬和化疗药物的质量比为4~6:1:0.5~2。
5.根据权利要求3所述的制备方法,其特征在于,所述有机溶剂为氯仿或乙醇。
6.根据权利要求3所述的制备方法,其特征在于,在步骤一中,各个原料在氮气的保护状态下,完全溶解于有机溶剂中。
7.根据权利要求3所述的制备方法,其特征在于,在步骤二中,真空干燥过夜的条件是30~40℃。
8.根据权利要求3所述的制备方法,其特征在于,所述磷酸盐缓冲液的pH为7~7.6。
9.根据权利要求3所述的制备方法,其特征在于,乳匀的压力为10~600bar。
10.如权利要求1或2所述的脂质体制剂在制备治疗肿瘤药物中的应用。
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