本文選題：注射用醋酸亮丙瑞林微球 + 粒徑及其分布��； 參考：《中國新藥雜志》2017年08期

【摘要】：目的:對(duì)影響注射用醋酸亮丙瑞林微球粒徑測(cè)定的關(guān)鍵因素進(jìn)行探討,建立微球粒徑測(cè)量的最優(yōu)方法。方法:分別考察攪拌速度、攪拌時(shí)間、超聲時(shí)間、樣品取樣量和助懸劑對(duì)微球制劑粒徑及其分布測(cè)定的影響,確定最適實(shí)驗(yàn)條件。取醋酸亮丙瑞林微球樣品20 mg,加入助懸劑1 mL,輕輕振搖至形成均勻混懸液,然后將混懸液傾倒至已加水的樣品池中,攪拌轉(zhuǎn)速為2 200 r·min~(-1),超聲1 min,重復(fù)測(cè)定。結(jié)果:超聲、攪拌時(shí)間、轉(zhuǎn)速對(duì)微球粒徑測(cè)定結(jié)果具有顯著影響;對(duì)3家企業(yè)的注射用醋酸亮丙瑞林微球的粒徑及其分布進(jìn)行了測(cè)定,企業(yè)A和B微球制劑粒徑及其分布比較一致,與企業(yè)C微球制劑差異較大。結(jié)論:通過確定激光散射法測(cè)定粒徑及其分布的最優(yōu)條件,可有效對(duì)注射用亮丙瑞林微球的粒度進(jìn)行控制。
[Abstract]:Aim: to study the key factors influencing the determination of the particle size of Leuprorelin acetate microspheres for injection, and to establish an optimal method for measuring the particle size of the microspheres. Methods: the effects of stirring speed, stirring time, ultrasonic time, sample sampling amount and suspension aid on the determination of particle size and distribution of microspheres were investigated, and the optimum experimental conditions were determined. The sample of brilliant proprilline acetate microsphere was 20 mg, then the suspension was 1 mL, and the suspension was shaken gently to form a uniform suspension. Then the suspension was poured into the water filled sample tank. The stirring speed was 2 200 r min-1, the ultrasonic time was 1 min, and the measurement was repeated for 1 minute. Results: ultrasound, stirring time and rotating speed had a significant effect on the particle size of the microspheres, and the particle size and distribution of the brilliant propraline acetate microspheres for injection in three enterprises were determined. The particle size and distribution of A and B microspheres were the same as those of C microspheres. Conclusion: by determining the optimal conditions for the determination of particle size and its distribution by laser scattering, the particle size of brilliant propraline microspheres for injection can be effectively controlled.
【作者單位】： 中國食品藥品檢定研究院;葛蘭素史克(中國)投資有限公司;
【基金】：國家“重大新藥創(chuàng)制”科技重大專項(xiàng)資助項(xiàng)目(2015ZX09303001)
【分類號(hào)】：R927

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