氟比洛芬脂质体凝胶的制备及质量控制
Preparation and quality control of flurbiprofen liposomal gel
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摘要: 目的: 制备氟比洛芬脂质体凝胶,并建立其质量控制方法。 方法: 采用乙醇注入法制备脂质体、研和法制备脂质体凝胶;HPLC法测定氟比洛芬含量;离心法测定脂质体的包封率。 结果: 氟比洛芬含量测定方法的平均回收率为(98.62±2.22)%,脂质体的包封率为(58.44±3.05)%,脂质体凝胶剂的pH值为6.0～7. 0,其稳定性良好。 结论: 本制备工艺简单,性质稳定,质量可控,适于作为医院制剂开发。Abstract: Objective: To prepare flurbiprofen liposomal gel and to establish its quality control method. Methods: The liposome was prepared by ethanol injection method and the liposomal gel was prepared using mixing method.The content of flurbiprofen was de termined by HPLC.The entrapment efficiency of flurbiprofen liposome was determined by centrifugation. Results: The average recovery of flurbiprofen was(98.62±2.22)%.The entrapment efficiency of the liposome was(58.44±3.05)%.The pH vaule of the liposo- mal gel was between 6.0 and 7.0.The stability of the liposomal gel was good. Conclusion: This gel is feasible in preparation tech- nique,stable in quality,convenient and reliable in quality control method.
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Key words:
- flurbiprofen /
- liposomal gel /
- preparation /
- quality control
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