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BioReagent,无菌 级 ,适用于对基线干扰要求严格的色谱和分析工作流程。
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在色谱分析、有机合成和交叉偶联反应领域已被 0 篇同行评审文献引用。
双组分脂质体佐剂B是基于3-O-脱酰基化-4’-单磷酰基脂A (3D-MPLA)与皂树皂苷QS-21组分的脂质体佐剂系统,其通过双分子层脂质体实现双佐剂的协同递送,有效增强免疫反应和疫苗效应。采用薄膜分散法+脂质体挤出技术,脂质体粒径均一 (PDI < 0.2),粒径大小为95 nm~120 nm。它呈泛乳光的无色到浅褐色液体,是即用型溶液,可直接与抗原混合 (适用于冻干疫苗复溶)。
二、技术参数
| 项目 | 规格 |
| 成分 | 3D-MPLA+QS-21组分 |
| 粒径分布 | 80-120 nm (PDI<0.2) |
| pH值 | 5.8-6.4 |
| 有效期 | 2年 (2-8℃避光保存) |

图1 粒径结果示意图

图2 透射电镜照片
三、产品信息
1. 成分:采用明尼苏达沙门氏菌R595发酵生产的3D-MPLA及南美皂皮树提取的QS-21组分 (纯度≥95%)作为核心原料。所有原料符合NMPA佐剂技术指南要求。
2. 生产与检测:每项成分均经过检测,以确保符合严格的内部标准 (包括成分鉴定与批次一致性)。 该佐剂在GMP级超净车间通过严格控制的脂质体生产工艺 (批次一致性CV值<5%)制备而成。生产过程中采用0.22 μm除菌过滤确保无菌性,并通过加速试验 (25℃/75% RH,6个月)验证其稳定性,活性成分保留率>95%,粒径变化<10%。
3. 免疫应答:通过TLR4/TRIF与CD2双通路激活免疫系统。其MPL成分经TLR4/MD-2受体激活TRIF信号,诱导树突状细胞成熟并促进IL-12分泌;同时,QS-21组分通过结合T细胞表面CD2受体直接激活ZAP-70激酶,增强IFN-γ产生。此外,脂质体载体可显著增强抗原呈递细胞 (APC)的摄取效率,从而协同激发强大的体液与细胞免疫应答。
4. 已验证应用场景:带状疱疹疫苗;RSV疫苗;疟疾疫苗
5. 不同抗原与双组分脂质体佐剂B脂质体佐剂的配伍比例:
| 疫苗类型 | 抗原 | 抗原: 双组分脂质体佐剂B |
| 重组带状疱疹疫苗 | gE蛋白 | 50 μg: 50 μg (1:1) |
| 疟疾疫苗 | RST, S | 25 μg: 25 μg (1:1) |
| HIV疫苗 | gp120蛋白 | 20-50 μg: 50 μg (0.5~1:1) |
| RSV疫苗 | Pre F3 | 50 μg: 50 μg (1:1) |
注:双组分脂质体佐剂B的浓度为100 μg/mL
6. 推荐剂量:
实验室动物各注射部位抗原/佐剂混合物的推荐注射量
| 物种 | 用量 |
| 小鼠 | 50 μL |
| 大鼠 | 100 μL |
| 豚鼠 | 200 μL |
| 家兔 | 200 μL |
| 人 | 500 μL |
Two-Component Liposomal Adjuvant B is a liposomal adjuvant system based on 3-O-deacylated-4'-monophosphoryl lipid A (3D-MPLA) and Quillaja saponin QS-21 fraction. It achieves synergistic delivery of the two adjuvants via bilayer liposomes, effectively enhancing immune responses and vaccine efficacy.Prepared by the thin-film dispersion method combined with liposome extrusion technology, the liposomes feature uniform particle size (PDI < 0.2) ranging from 95 nm to 120 nm. It is a ready-to-use solution appearing as an opalescent, colorless to light brown liquid, which can be directly mixed with antigens (suitable for reconstitution of lyophilized vaccines).
II. Technical Parameters
| Item | Specification |
| Components | 3D-MPLA + QS-21 fraction |
| Particle size distribution | 80–120 nm (PDI < 0.2) |
| pH value | 5.8–6.4 |
| Shelf life | 2 years (stored at 2–8 °C, protected from light |
Figure 1 Schematic diagram of particle size results
| Item | Average | Standard Deviation | Relative Standard Deviation | Minimum | Maximum |
| Z-Average (nm) | 100.8 | - | - | 100.8 | 100.8 |
| Polydispersity Index (PI) | 0.02836 | - | - | 0.02836 | 0.02836 |
| Area Mean Diameter of Volume-weighted Distribution (nm) | 106.2 | - | - | 106.2 | 106.2 |
| Intercept | 0.9801 | - | - | 0.9801 | 0.9801 |
| Polydispersity | 0.001341 | - | - | 0.001341 | 0.001341 |

Figure 2 Transmission electron microscopy (TEM) image
III. Product Information
1. ComponentsCore raw materials consist of 3D-MPLA produced by fermentation of Salmonella minnesota R595 and QS-21 fraction (purity ≥95%) extracted from Quillaja saponaria. All materials comply with the adjuvant technical guidelines of NMPA.
2. Manufacturing and TestingEach component is tested to meet strict internal standards, including component identification and batch consistency.The adjuvant is manufactured in a GMP-grade cleanroom via a tightly controlled liposome production process, with batch-to-batch consistency CV < 5%.Sterility is ensured by 0.22 μm sterile filtration during production. Stability is verified by accelerated testing (25 °C / 75% RH, 6 months), with active ingredient retention >95% and particle size variation <10%.
3. Immune ResponseThe adjuvant activates the immune system through dual TLR4/TRIF and CD2 pathways.The MPL component activates TRIF signaling via the TLR4/MD-2 receptor, inducing dendritic cell maturation and promoting IL-12 secretion. Meanwhile, the QS-21 fraction directly activates ZAP-70 kinase by binding to the CD2 receptor on T cells, enhancing IFN-γ production.In addition, the liposomal carrier significantly improves the uptake efficiency of antigen-presenting cells (APCs), thereby synergistically eliciting robust humoral and cellular immune responses.
4. Verified Application ScenariosHerpes zoster vaccine; RSV vaccine; Malaria vaccine
5. Compatibility Ratios of Different Antigens with Two-Component Liposomal Adjuvant B
| Vaccine Type | Antigen | Antigen : Two-Component Liposomal Adjuvant B |
| Recombinant zoster vaccine | gE protein | 50 μg : 50 μg (1:1) |
| Malaria vaccine | RST, S | 25 μg : 25 μg (1:1) |
| HIV vaccine | gp120 protein | 20–50 μg : 50 μg (0.5~1:1) |
| RSV vaccine | Pre F3 | 50 μg : 50 μg (1:1) |
Note: The concentration of Two-Component Liposomal Adjuvant B is 100 μg/mL.
6. Recommended Dosage
Recommended injection volume of antigen/adjuvant mixture at different administration sites in laboratory animals
| Species | Dosage |
| Mouse | 50 μL |
| Rat | 100 μL |
| Guinea pig | 200 μL |
| Rabbit | 200 μL |
| Human | 500 μL |
| pH | 5.8-6.4 |
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| 批号(Lot Number) | 证书类型 | 货号 |
|---|---|---|
| 分析证书 | L1520830 |