【摘要】：目的:建立測(cè)定鹽酸表阿霉素-索拉非尼聚乳酸-羥基乙酸聚合物(PLGA)栓塞微球載藥量和包封產(chǎn)率的方法。方法:采用高效液相色譜法測(cè)定該制劑中鹽酸表阿霉素和索拉非尼的含量,再通過公式計(jì)算載藥量和包封產(chǎn)率。色譜柱為Phenomenex Luna 5u C8(2)100A,流動(dòng)相為甲醇-[水(含0.05%三氟乙酸和0.14%十二烷基硫酸鈉)](75∶25,V/V),流速為1.0 mL/min,檢測(cè)波長(zhǎng)為252 nm,柱溫為25℃,進(jìn)樣量為10μL。結(jié)果:鹽酸表阿霉素和索拉非尼檢測(cè)質(zhì)量濃度線性范圍分別為2.020~101.00μg/mL(r=0.999 8)、2.048~102.40μg/mL(r=0.999 7);定量限分別為3.297 0、2.546 8μg/mL;檢測(cè)限分別為0.989 1、0.764 1μg/mL;精密度、穩(wěn)定性、重復(fù)性試驗(yàn)的RSD2.0%;回收率分別為96.41%~101.80%(RSD=1.64%,n=9)、99.46%~101.45%(RSD=0.70%,n=9)。3批樣品中兩種成分的載藥量≥1.17%,包封產(chǎn)率≥58%。結(jié)論:該方法操作簡(jiǎn)單、結(jié)果準(zhǔn)確,可用于測(cè)定鹽酸表阿霉素-索拉非尼PLGA栓塞微球的載藥量和包封產(chǎn)率。
[Abstract]:Aim: to establish a method for the determination of drug loading and encapsulation yield of epirubicin-Solafenil-poly (lactic acid)-glycolic acid polymer (PLGA) for embolization of microspheres. Methods: the contents of epirubicin hydrochloride and sorafenil in the preparation were determined by HPLC, and the drug loading and encapsulation yield were calculated by formula. The chromatographic column was Phenomenex Luna 5u C8 (2) 100A, the mobile phase was methanol-water (containing 0.05% trifluoroacetic acid and 0.14% sodium dodecyl sulfate) (75: 25 V / V), the flow rate was 1.0 mL/min, the detection wavelength was 252UC8 (2) 100A, and the sample size was 10 渭 L at 25 鈩，

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