本文關(guān)鍵詞： 亞微乳 苯丁酸氮芥鈉 高壓均質(zhì)法 包封率 穩(wěn)定性 Freundlich方程　出處：《沈陽(yáng)藥科大學(xué)學(xué)報(bào)》2017年11期 　論文類型：期刊論文

【摘要】：目的以大豆油為藥物載體及乳滴基本成分,大豆磷脂為乳化劑,制備苯丁酸氮芥鈉亞微乳,考察水相pH,油酸,吐溫-80等因素對(duì)藥物包封率、粒徑穩(wěn)定性的影響,并考察藥物的釋放行為。方法采用高速剪切法制備粗乳,磷酸調(diào)節(jié)粗乳外水相pH值,高壓均質(zhì)法制備亞微乳,密封高溫高壓滅菌得最終產(chǎn)品。激光動(dòng)態(tài)光散射法測(cè)定乳滴粒徑,酸度計(jì)測(cè)定乳劑的pH,考察兩個(gè)時(shí)間段的儲(chǔ)存期后的乳滴粒徑、ζ電位和乳劑pH的變化。低溫高速離心分離油水兩相,高效液相色譜-紫外分光光度法測(cè)定水相及全乳的藥物含量并得到包封率,正滲透膜透析法考察乳劑中苯丁酸氮芥鈉在pH7.4的磷酸緩沖鹽中的釋放行為并對(duì)釋放曲線進(jìn)行擬合。結(jié)果粗乳pH值越低,苯丁酸氮芥鈉在最終產(chǎn)品乳滴中的包封率越高,油酸和Tween-80有助于包封率和ζ電位絕對(duì)值的提高。所得乳劑在儲(chǔ)存30、60 d后,均出現(xiàn)pH降低的現(xiàn)象。油酸防止了粒徑的增長(zhǎng)和ζ電位絕對(duì)值的降低,Tween-80未有此作用。藥物有明顯的突釋相,突釋相過(guò)后呈現(xiàn)緩釋相,包封率越低突釋率越高。藥物的釋放符合Freundlich方程。結(jié)論調(diào)節(jié)合適的pH,選用合適的助乳化劑,有助于得到包封率較高、穩(wěn)定性較好、呈現(xiàn)特定緩釋行為的苯丁酸氮芥鈉乳劑。
[Abstract]:Objective to study the effects of pH of aqueous phase, oleic acid and Tween-80 on encapsulation efficiency and particle size stability of nitromustard sodium phenylbutyrate, using soybean oil as drug carrier and milk droplet as basic component and soybean phospholipid as emulsifier. Methods crude emulsion was prepared by high speed shear method, pH value of external water phase was adjusted by phosphoric acid, sub-microemulsion was prepared by high pressure homogenization method, the final product was obtained by sealing high temperature and high pressure sterilization, and the particle size of emulsion was determined by laser dynamic light scattering method. The pH of emulsion was determined by acidometer, and the changes of particle size, 味 potential and pH of emulsion after storage period were investigated. The oil-water phase was separated by centrifugation at low temperature and high speed. High performance liquid chromatography-ultraviolet spectrophotometry was used to determine the drug content in aqueous phase and whole milk, and the encapsulation efficiency was obtained. The release behavior of nitrogen mustard phenylbutyrate in phosphate buffer salt of pH7.4 was investigated by normal permeation membrane dialysis and the release curve was fitted. Results the lower the pH value of crude emulsion, the higher the entrapment efficiency of nitrogen mustard phenylbutyrate sodium in the final product. Oleic acid and Tween-80 can increase the entrapment efficiency and the absolute value of 味 potential. Oleic acid prevented the increase of particle size and the decrease of the absolute value of 味 potential. Tween-80 had no such effect. The lower the encapsulation efficiency, the higher the sudden release rate. The drug release accords with the Freundlich equation. Conclusion adjusting the appropriate pH and selecting the appropriate co-emulsifier can help to obtain the sodium butyrate emulsion with higher entrapment efficiency and better stability, showing a specific slow-release behavior.
【作者單位】： 錦州醫(yī)科大學(xué)藥學(xué)院;遼寧省藥物作用與質(zhì)量評(píng)價(jià)工程技術(shù)研究中心;錦州醫(yī)科大學(xué)公共基礎(chǔ)學(xué)院;
【基金】：國(guó)家自然科學(xué)基金資助項(xiàng)目(511021178) 遼寧省科技廳資助項(xiàng)目(2014022041) 中國(guó)博士后基金資助項(xiàng)目(2014M561187)
【分類號(hào)】：R943

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