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兽用吡喹酮-聚乳酸-羟基乙酸缓释植入棒含量测定及释放度考察
马丽霞
0
(山东省医疗器械研究所)
摘要:
建立了吡喹酮-聚乳酸-羟基乙酸(吡喹酮-PLGA)缓释植入棒含量测定的HPLC法,并对其释放度进行了考察。以甲醇-水(100:40,V/V)为流动相,采用Grace C18反相色谱柱( 4.6mm?250mm,5μm),流速1.0mL/min,紫外检测波长263nm,在此试验条件下,吡喹酮在10~200μg/mL范围内与峰面积线性关系良好,r=0.9999;平均回收率为99.48%,RSD 为0.53%(n=9)。三批样品的含量分别为98.96%、98.67%和98.81%,该方法简单、快捷、辅料无干扰、准确度高,适于吡喹酮-PLGA植入棒的含量测定。吡喹酮-PLGA植入棒以骨架溶蚀释放机制缓慢释放,释药期可达三周,释放度高于300μg/d。
关键词:  吡喹酮  PLGA  缓释植入棒  含量测定  HPLC  释放度
DOI:
投稿时间:2012-11-20修订日期:2013-03-19
基金项目:
Determination and Release rate of Veterinary Sustained-release Praziquantel-PLGA Implants
(Shandong Provincial Key Laboratory of Biomedical Polymers,Shandong Institute of Medical Instrumens)
Abstract:
The paper estabalisted an HPLC method for determination of the praziquantel-PLGA implants, and investigate release rate. The diamonsil C18 column was used, the mobile phase consisted of methanol and ultrafiltrated water (100:40, v/v), the flow rate was 1.0mL/min, the detection wavelength was at 263nm. Praziquanel has a good linearity at the range of 10μg/mL~200μg/mL(r=0.9999), and the average recovery was 99.48% with RSD 0.53%(n=9). The determinations of three lots samples are 98.96%, 98.67% and 98.81%, respectively. Praziquantel can be slowly released from the implant to three weeks and release rate is more than 300μg/d. The method is simple, rapid and accurate without excipients interference, and suitable for the determination of the praziquantel-PLGA implants. Praziquantel can be slowly released with the frame-erosion mechanism.
Key words:  praziquantel  PLGA  sustained-release implant  determination  HPLC  release rate

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