青藤堿聚乳酸羥基乙酸共聚物-水溶性維生素E納米粒的質(zhì)量評價
發(fā)布時間:2018-01-22 02:24
本文關(guān)鍵詞: 青藤堿 聚乳酸羥基乙酸共聚物-水溶性維生素E 納米粒 質(zhì)量評價 體外釋放度 穩(wěn)定性 出處:《中國藥房》2015年07期 論文類型:期刊論文
【摘要】:目的:對青藤堿聚乳酸羥基乙酸共聚物-水溶性維生素E(PLGA-TPGS)納米粒(SPTN)的質(zhì)量進(jìn)行評價。方法:以PLGATPGS為載體,采用超聲乳化-溶劑揮發(fā)法制備SPTN;另以PLGA為載體制備青藤堿PLGA納米粒(SPN)作為對照。采用激光粒度儀測定2種納米粒的粒徑和Zeta電位;采用高效液相色譜法測定2種納米粒中藥物含量,計算其載藥量、包封率、體外釋放度和考察SPTN的體外穩(wěn)定性,色譜柱為Hypersil C18,流動相為甲醇-10 mmol/L磷酸二氫鈉(38∶62,V/V),流速為1.0 ml/min,檢測波長為262 nm,進(jìn)樣量為20μl。結(jié)果:SPTN和SPN的平均粒徑分別為(194.6±2.8)、(382.4±3.2)nm,Zeta電位分別為(-21.3±1.7)、(-13.9±2.3)m V;載藥量分別為(9.5±0.7)%、(6.2±0.8)%,包封率分別為(41.3±1.6)%、(32.8±1.8)%;體外藥物釋放二者均呈兩相釋放,30 d時累積釋放度分別為92.8%、71.3%;與0 d時比較,高溫(40℃)、強(qiáng)光[(4 500±500)lx]、高濕[(90±5)%]條件下10 d內(nèi)SPTN的外觀性狀、粒徑、載藥量均無明顯變化,6個月的加速試驗(yàn)和12個月的長期試驗(yàn)中SPTN的外觀性狀、粒徑、載藥量也均無明顯變化。結(jié)論:SPTN具有比SPN更小的粒徑、更大的載藥量和包封率,體外釋放更完全,具有明顯的緩釋作用,體外穩(wěn)定性好。
[Abstract]:Objective: to evaluate the quality of sinomenine poly (lactic acid glycolic acid) copolymers, water-soluble vitamin E (PLGA-TPGS) nanoparticles. Methods: PLGATPGS was used as the carrier. SPTNs were prepared by phacoemulsification and solvent volatilization. In addition, sinomenine PLGA nanoparticles were prepared with PLGA as the carrier. The particle size and Zeta potential of the two kinds of nanoparticles were measured by laser particle size analyzer. High performance liquid chromatography (HPLC) was used to determine the drug content in the two nanoparticles. The drug loading, encapsulation efficiency, release in vitro and the stability of SPTN in vitro were calculated. The chromatographic column was Hypersil C18. The mobile phase consisted of methanol-10 mmol/L sodium dihydrogen phosphate (38: 62 V / V), the flow rate was 1.0 ml / min, and the detection wavelength was 262 nm. Results the average particle size of SPN was 194.6 鹵2.8 渭 l and 382.4 鹵3.2 nm, respectively. The Zeta potentials were -21.3 鹵1.7mV and 13.9 鹵2.3mV, respectively. The drug loading rate was 9.5 鹵0.7 and the entrapment rate was 41.3 鹵1.6 and 32.8 鹵1.8 respectively. The cumulative release rates of both drugs in vitro were 92.8% and 71.3% respectively at 30 days after release. Compared with 0 d, high temperature 40 鈩,
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