CN112957330A - 一种多肽介导的雷公藤内酯醇纳米脂质体及制备方法 - Google Patents
一种多肽介导的雷公藤内酯醇纳米脂质体及制备方法 Download PDFInfo
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Abstract
本发明提供一种多肽介导的雷公藤内酯醇纳米脂质体及制备方法,所述雷公藤内酯醇纳米脂质体包含以下成分:雷公藤内酯醇:25‑75mg、肿瘤靶向性多肽:100‑200mg、脂类混合基质4‑8g、DSPE‑PEG2000:0.5‑1g、乳化剂泊洛沙姆188:2‑4g、共乳化剂丙三醇:2‑3g、超纯水:100 g。本发明是将中药雷公藤中的二萜内酯类单体成分雷公藤内酯醇包载于一种肿瘤靶向小肽修饰的纳米脂质载体中,工艺简单,制剂性质稳定,生物利用度高,具有低刺激性和致敏性,可通过靶向性多肽调节细胞的摄取率,增强肿瘤靶向性。
Description
技术领域
本发明属于中药制剂领域,涉及一种多肽修饰的雷公藤内酯醇纳米脂质载体及其制备方法,是将中药雷公藤中的二萜内酯类单体成分雷公藤内酯醇包载于一种肿瘤靶向小肽修饰的纳米脂质载体中。
背景技术
雷公藤内酯醇(Triptolide)是从卫矛科植物雷公藤中提纯分离到的二萜内酯结构化合物,大量体内和体外研究证明,本品对多种癌症如白血病、乳腺癌、胰腺癌及肺癌等均有良好的抗肿瘤活性,雷公藤内酯醇分子式:C20H24O6,分子量:360.4,熔点226~227℃,结构式如下。
雷公藤内酯醇难溶于水,溶于甲醇、乙酸乙酯、氯仿等。体内和体外研究证明雷公藤内酯醇具有良好的抗肿瘤活性,对多种癌症如白血病、乳腺癌、胰腺癌及肺癌等均有较好的抑制作用。虽然雷公藤内酯醇有较好的免疫抑制、抗炎与抗肿瘤作用,但是由于溶解度小,加上治疗有效剂量与毒性剂量十分接近,雷公藤内酯醇的应用受到了极大的限制。
发明内容
本发明的目的在于提供一种具有肿瘤靶向性的雷公藤内酯醇纳米脂质体,解决了雷公藤内酯醇在水中溶解度小、生物利用度低,发挥效应剂量与毒性剂量十分接近等问题。
为实现上述目的,本发明采用如下技术方案:
所述雷公藤内酯醇纳米脂质体包含以下成分:雷公藤内酯醇:25-75mg、肿瘤靶向性多肽:100-200mg、脂类混合基质:4-8g、DSPE-PEG2000 :0.5-1g、乳化剂泊洛沙姆188:2-4g、共乳化剂丙三醇:2-3g、超纯水: 100 g。
优选的,所述雷公藤内酯醇纳米脂质体包含以下成分:雷公藤内酯醇:50mg、肿瘤靶向性多肽:50mg、脂类混合基质6g、DSPE-PEG2000 1g、乳化剂泊洛沙姆188:3g、共乳化剂丙三醇:2.5g、超纯水:100g。
所述脂类混合基质为胆固醇和大豆卵磷脂的混合基质,胆固醇和大豆卵磷脂两种基质的质量比例1:4-1:10。
多肽介导的雷公藤内酯醇纳米脂质体的制备方法,所述方法包括以下步骤:
(1)脂类基质用10ml二氯甲烷溶解成溶液状态,雷公藤内酯醇用5ml甲醇完全溶解,两种溶液混合,制备油相;
(2)肿瘤靶向性多肽和DSPE-PEG2000用5倍质量的超纯水溶胀,溶解成混悬液;
(3)(1)和(2)两种溶液混合,旋转蒸发仪薄膜分散,低温回收溶剂,制备雷公藤内酯醇固体分散薄膜;
(4)共乳化剂丙三醇用超纯水配制成2-3%的溶液;
(5)乳化剂泊洛沙姆188用2-3%的丙三醇溶液溶解,恒温40℃,制备水相;
(6)将水相溶液加入第(3)步所得的薄膜中,40℃超声溶胀,制备初乳;
(7)将上述初乳加入高压均质机乳匀、复合,即得多肽介导的雷公藤内酯醇纳米脂质体。
本发明的优点在于:
本发明工艺简单,制剂性质稳定,生物利用度高,具有低刺激性和致敏性,可通过多肽的肿瘤靶向调节细胞的摄取率,增强肿瘤靶向性。
肿瘤细胞比较容易摄取带有生化小分子的多肽,多肽比抗体小,无毒性与抗原性。DSPE-PEG-SP94,分子量4085,属于小分子多肽,与肝脏肿瘤细胞具有亲和性,通过与雷公藤内酯醇复合形成粒径小于200nm的脂质体,增加肝肿瘤细胞对雷公藤内酯醇的摄取率,减少雷公藤内酯醇的剂量,增强抗肝肿瘤的活性。
具体实施方式
实施例1
所述雷公藤内酯醇纳米脂质体包含以下成分:雷公藤内酯醇:50mg、肿瘤靶向多肽(多肽是DSPE-PEG-SP94):50mg、脂类混合基质6g、DSPE-PEG2000 1g、乳化剂泊洛沙姆1883g、共乳化剂丙三醇 2.5g、超纯水:100g。
所述脂类混合基质为胆固醇和大豆卵磷脂(质量比1:3)的混合基质。
多肽介导的雷公藤内酯醇纳米脂质体的制备方法,所述方法包括以下步骤:
(1)脂类混合基质用10ml二氯甲烷溶解成溶液状态,雷公藤内酯醇用5ml甲醇完全溶解,两种溶液混合,制备油相;
(2)肿瘤靶向多肽和DSPE-PEG2000用5倍质量的超纯水溶胀,溶解成混悬液;
(3)(1)和(2)两种溶液混合,旋转蒸发仪薄膜分散,低温回收溶剂,制备雷公藤内酯醇固体分散薄膜;
(4)2.5克共乳化剂丙三醇用超纯水溶解成2.5%的溶液;
(5)泊洛沙姆188用2.5%的丙三醇溶液溶解,恒温40℃,制备水相;
(6)将水相溶液加入第(3)步所得的薄膜中,超声溶胀,制备初乳;
(7)将上述初乳加入高压均质机乳匀、复合,即得多肽介导的雷公藤内酯醇纳米脂质体。
按实施例1方案实施制备的脂质体粒径为134.8nm,Zeta电位30.51mv,雷公藤内酯醇的包封率为84.3%。
实施例2
所述雷公藤内酯醇纳米脂质体包含以下成分:雷公藤内酯醇:25mg、肿瘤靶向多肽DSPE-PEG-SP94:100mg、脂类混合基质4g、DSPE-PEG2000 0.5g、乳化剂泊洛沙姆188 2.5g、共乳化剂丙三醇3g、超纯水:100 g。
所述脂类混合基质为胆固醇和大豆卵磷脂(质量比1:6)的混合基质。
多肽介导的雷公藤内酯醇纳米脂质体的制备方法,所述方法包括以下步骤:
(1)脂类基质用10ml二氯甲烷溶解成溶液状态,雷公藤内酯醇用5ml甲醇完全溶解,两种溶液混合,制备油相;
(2)靶向多肽和DSPE-PEG2000用5倍质量的超纯水溶胀,溶解成混悬液;
(3)(1)和(2)两种溶液混合,旋转蒸发仪薄膜分散,低温回收溶剂,制备雷公藤内酯醇固体分散薄膜;
(4)3克共乳化剂丙三醇用超纯水溶解成3%的溶液;
(5)泊洛沙姆188用3%的丙三醇溶液溶解,恒温40℃,制备水相;
(6)将水相溶液加入第(3)步所得的薄膜中,40℃超声溶胀,制备初乳;
(7)将上述初乳加入高压均质机乳匀、复合,即得多肽介导的雷公藤内酯醇纳米脂质体。
按实施例2方案制备的脂质体粒径为96.7nm,Zeta电位24.73mv,雷公藤内酯醇的包封率为76.3%。
实施例3
所述雷公藤内酯醇纳米脂质体包含以下成分:雷公藤内酯醇:75mg、肿瘤靶向多肽DSPE-PEG-SP94:200mg、脂类混合基质8g、DSPE-PEG2000 1g、乳化剂泊洛沙姆188 4g、共乳化剂丙三醇3g、超纯水:100g。
所述脂类混合基质为胆固醇和大豆卵磷脂(质量比1:9)的混合基质,
多肽介导的雷公藤内酯醇纳米脂质体的制备方法,所述方法包括以下步骤:
(1)脂类基质用10ml二氯甲烷溶解成溶液状态,雷公藤内酯醇用5ml甲醇完全溶解,两种溶液混合,制备油相;
(2)靶向多肽和DSPE-PEG2000用5倍质量的超纯水溶胀,溶解成混悬液;
(3)(1)和(2)两种溶液混合,旋转蒸发仪薄膜分散,低温回收溶剂,制备雷公藤内酯醇固体分散薄膜;
(4)3克共乳化剂丙三醇用超纯水溶解成3%的溶液;
(4)泊洛沙姆188用3%丙三醇溶液溶解,恒温40℃,制备水相;
(5)将水相溶液加入第(3)步所得的薄膜中,40℃超声溶胀,制备初乳;
(6)将上述初乳加入高压均质机乳匀、复合,即得多肽介导的雷公藤内酯醇纳米脂质体。
按实施例3方案制备的脂质体粒径为151.2nm,Zeta电位32.85mv,雷公藤内酯醇的包封率为90.9%。
以上所述仅为本发明的较佳实施例,凡依本发明申请专利范围所做的均等变化与修饰,皆应属本发明的涵盖范围。
Claims (5)
1.一种多肽介导的雷公藤内酯醇纳米脂质体,其特征在于:所述雷公藤内酯醇纳米脂质体包含以下成分:雷公藤内酯醇:25-75mg、肿瘤靶向性多肽DSPE-PEG-SP94:100-200mg、脂类混合基质4-8g、DSPE-PEG2000 0.5-1g、乳化剂泊洛沙姆188:2-4g、共乳化剂丙三醇:2-3g、超纯水: 100 g。
2.根据权利要求1所述的一种多肽介导的雷公藤内酯醇纳米脂质体,其特征在于:所述雷公藤内酯醇纳米脂质体包含以下成分:雷公藤内酯醇:50mg、肿瘤靶向性多肽:50mg、脂类混合基质6g、DSPE-PEG2000 1g、乳化剂3g、共乳化剂2.5g、超纯水:100g。
3.根据权利要求1所述的一种多肽介导的雷公藤内酯醇纳米脂质体,其特征在于:所述脂类混合基质为胆固醇和大豆卵磷脂基质,其中胆固醇和大豆卵磷脂两种基质的质量比例1:4-1:10。
4.根据权利要求1所述的一种多肽介导的雷公藤内酯醇纳米脂质体,其特征在于:所述乳化剂为泊洛沙姆188,共乳化剂为丙三醇。
5.如权利要求1所述的一种多肽介导的雷公藤内酯醇纳米脂质体的制备方法,其特征在于:所述方法包括以下步骤:
(1)脂类混合基质用10ml二氯甲烷溶解成溶液状态,雷公藤内酯醇用5ml甲醇完全溶解,两种溶液混合,制备油相;
(2)肿瘤靶向性多肽和DSPE-PEG2000用5倍质量的超纯水溶胀,溶解成混悬液;
(3)(1)和(2)两种溶液混合,旋转蒸发仪薄膜分散,低温回收溶剂,制备雷公藤内酯醇固体分散薄膜;
(4)共乳化剂丙三醇用超纯水配制成2-3%的溶液;
(5)乳化剂泊洛沙姆188用2-3%的丙三醇溶液溶解,恒温40℃,制备水相;
(6)将水相溶液加入第(3)步所得的薄膜中,40℃超声溶胀,制备初乳;
(7)将上述初乳加入高压均质机乳匀、复合,即得多肽介导的雷公藤内酯醇纳米脂质体。
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CN114209853A (zh) * | 2022-01-14 | 2022-03-22 | 广西大学 | 一种双配体修饰的肝癌靶向脂质体的制备及应用 |
CN114569554A (zh) * | 2022-03-01 | 2022-06-03 | 福建省医学科学研究院 | 一种肿瘤靶向性雷公藤内酯醇乳液及其制备方法 |
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