複方莪朮油脂質體的製備及質量評價

2022-12-31 02:45:05 字數 2472 閱讀 7847

作者:陳積趙小倩胡姍姍馬彥巧劉燕譚丹楓陳澤慧田應彪**:《中國藥房》2023年第05期

中圖分類號 r283 文獻標誌碼 a 文章編號 1001-0408(2018)05-0615-06

doi 10.6039/

摘要目的:製備複方莪朮油脂質體(ztoc-lps)並對其質量進行評價。方法:

以複方莪朮油中莪朮油(以吉馬酮表徵)和維a酸的包封率及載藥量等為考察指標,篩選ztoc-lps的製備方法及處方中大豆卵磷脂(spc)的加入量、脂質中spc-膽固醇(ch)質量比、莪朮油-脂質質量比、維a酸-脂質質量比、水浴溫度;並對最優處方製備工藝所製脂質體進行質量評價和初步穩定性考察。結果:優選的製備方法為乙醇注入法;最優處方製備工藝為每1 ml脂質體中spc 4 mg、spc-ch質量比3 ∶ 1、莪朮油-脂質質量比1 ∶ 9、維a酸-脂質質量比1 ∶ 70、水浴溫度55 ℃。

所製3批脂質體中莪朮油和維a酸的平均包封率分別為(64.63±1.00)%和(90.

33±0.72)%,載藥量分別為(9.09±0.

14)%和(1.43±0.02)%,粒徑為(257.

41±7.58) nm,zeta電位為(-38.77±0.

81) mv,多分散係數為 0.10±0.04;離心加速試驗結果顯示脂質體具有良好的物理穩定性;脂質體樣品在(4±2) ℃條件下放置 1 個月時各項考察指標均未發生明顯變化。

結論:建立的製備方法簡單可行,所製脂質體質量符合要求,可為後續複方莪朮油新劑型的研究提供參考。

關鍵詞莪朮油;維a酸;脂質體;包封率;載藥量;製備工藝;質量評價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 ****** 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.