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复方莪术油脂质体的制备及质量评价
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| 篇名： | 复方莪术油脂质体的制备及质量评价 |
| TITLE： | |
| 摘要： | 目的：制备复方莪术油脂质体（ZTOC-LPS）并对其质量进行评价。方法：以复方莪术油中莪术油（以吉马酮表征）和维A酸的包封率及载药量等为考察指标，筛选ZTOC-LPS的制备方法及处方中大豆卵磷脂（SPC）的加入量、脂质中SPC-胆固醇（CH）质量比、莪术油-脂质质量比、维A酸-脂质质量比、水浴温度；并对最优处方制备工艺所制脂质体进行质量评价和初步稳定性考察。结果：优选的制备方法为乙醇注入法；最优处方制备工艺为每1 mL脂质体中SPC 4 mg、SPC-CH质量比3 ∶ 1、莪术油-脂质质量比1 ∶ 9、维A酸-脂质质量比1 ∶ 70、水浴温度55 ℃。所制3批脂质体中莪术油和维A酸的平均包封率分别为（64.63±1.00）％和（90.33±0.72）％，载药量分别为（9.09±0.14）％和（1.43±0.02）％，粒径为（257.41±7.58） nm，Zeta电位为（－38.77±0.81） mV，多分散系数为 0.10±0.04；离心加速试验结果显示脂质体具有良好的物理稳定性；脂质体样品在（4±2） ℃条件下放置 1 个月时各项考察指标均未发生明显变化。结论：建立的制备方法简单可行，所制脂质体质量符合要求，可为后续复方莪术油新剂型的研究提供参考。 |
| ABSTRACT： | OBJECTIVE： To prepare zedoary turmeric oil compound liposomes （ZTOC-LPS） and evaluate its quality. METHODS： The preparation method of liposome， the addition amount of soybean phosphatidylcholine （SPC）， ratio of SPC to cholesterol （CH） in lipid， drug-lipid ratio of zedoary turmeric oil （ZTO）， drug-lipid ratio of tretinoin in formulation， and water bath temperature were screened using encapsulation efficiency and drug-loading amount of ZTO （represented by germacrone） and tretinoin as investigation indexes. Quality evaluation and primary stability investigation were conducted for liposomes prepared by optimal preparation technology. RESULTS： The optimal preparation method was ethanol injection method； The optimal preparation technology were SPC 4 mg in 1 mL lipid， the mass ratio of SPC to CH 3 ∶ 1， the ratio of ZTO to lipid 1 ∶ 9 ， the ratio of tretinoin to lipid 1 ∶ 70， water bath temperature of 55 ℃. Encapsulation efficiencies of ZTO and tretinoin were （64.63±1.00）％ and （90.33±0.72）％ in 3 batches of ZTOC-LPS， respectively. Drug-loading amount of ZTO and tretinoin were （9.09±0.14）％ and （1.43±0.02）％， respectively. Particle size was （257.41±7.58） nm， Zeta potential was （－38.77±0.81） mV， PDI was 0.10±0.04； the results of centrifugal acceleration test showed that the liposomes had good physical stability. No obvious change was found in each investigation index of ZTOC-LPS that stored at （4±2） ℃ for 1 month. CONCLUSIONS： Established preparation technology is simple and feasible， the quality of the prepared ZTOC-LPS conforms to the requirements， and it can provide reference for the following research of ZTOC-LPS. |
| 期刊： | 2018年第29卷第5期 |
| 作者： | 陈积，赵小倩，胡姗姗，马彦巧，刘燕，谭丹枫，陈泽慧，田应彪 |
| AUTHORS： | CHEN Ji，ZHAO Xiaoqian，HU Shanshan，MA Yanqiao，LIU Yan，TAN Danfeng，CHEN Zehui，TIAN Yingbiao |
| 关键字： | 莪术油；维A酸；脂质体；包封率；载药量；制备工艺；质量评价 |
| KEYWORDS： | Zedoary turmeric oil； Tretinoin； Liposomes； Encapsulation efficiency； Drug-loading amount； Preparation technology； Quality evaluation |
| 阅读数： | 328 次 |
| 本月下载数： | 5 次 |
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