左氧氟沙星聚乙烯醇微粒胶囊的制备及稳定性研究

Studies on Preparation and Stability of Levofloxacin Polyvinyl Alcohol Micro-particles Capsules

目的制备左氧氟沙星聚乙烯醇微粒胶囊并考察其稳定性。方法以聚乙烯醇为载体,采用喷雾干燥法制备左氧氟沙星聚乙烯醇微粒和分装胶囊,采用HPLC法测定左氧氟沙星含量,通过高温、高湿、强光,加速试验及长期试验分别进行稳定性考察。结果聚乙烯醇对左氧氟沙星HPLC法测定无干扰,HPLC测定误差≤0.9%,每粒胶囊平均含量为(100.55±1.11)%,胶囊70min体外溶出度约为(95.11±1.76)%,微粒中左氧氟沙星遇强光易分解,分装胶囊塑料瓶密封包装后,加速试验和长期试验检测指标变化不大,主药含量与体外溶出度基本保持不变。结论制剂制备及含量测定方法简便准确,稳定性良好,符合左氧氟沙星用药要求。

OBJECTIVE To prepare levofloxacin polyvinyl alcohol micro-particle （ LFX-PVA-MP ） capsules, and investigate its stability.METHODS LFX-PVA-MP and the sub-packing capsules were prepared by spray-dr-ying method with PVA as carrier.The content of levofloxacin was determined by HPLC.The stability was investigated by high temperature,high moisture,strong light,acceleration test and long-term test respectively.RESULTS The polyvinyl alcohol did not disturb the determination of levofloxacin via HPLC.The error of HPLC determination was≤0.9%,and the average content of each capsule was （100.55＋1.11）%.In vitro dissolution rate of the capsule was about （ 95.11 ＋1.76 ）% within 70min.Levofloxacin in the micro-particle was easily decomposed in strong light.After the packing and sealing of plastic bottles of sub-packing capsules,the test index had no significant change under acceleration test and long-term test.The content and in vitro dissolution rate of main medicine basically re-mained unchanged.CONCLUSION Preparation and content determination methods are simple and accurate with good stability,which conforms to the medication demand of levofloxacin.