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注射用赖氨洛芬的研制及其质量控制 被引量:1

Preparation and Quality Controll of Ibuprofen Lysine Sterilized powder for Injection
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摘要 目的:研制注射用赖氨洛芬,为临床提供一种高效、低毒、速效的布洛芬新制剂奠定基础。方法:合成并精制赖氨洛芬原料,用HPLC法检测其纯度后,制成无菌粉末,对其性状、澄明度、含量、稳定性、肌注刺激性等进行了检测。结果:本制剂质量稳定,肌注刺激性小。结论:本制剂适合肌注给药,可做进一步临床考察。 Objective: To study the preparing technology of ibuprofen lysine sterilized powder for injection in order to provide a new type of ibuprofen with higher effect, less irritation, and rapid action for clinic. Methods: The materials of ibuprofen lysine, of which concentration was deternined by HPLC, were synthesized and purified. The quality of the preparation such as char- acteristics, clearance degree, stability, irritation to muscles, were also determined. Results: The quality of preparation was stable with less irritation. Conclusion: The preparation an be used as injection and is valuable to further study on clinic effect.
出处 《中国药师》 CAS 2000年第4期213-214,共2页 China Pharmacist
关键词 赖氨洛芬 质量控制 注射剂 Ibuprofen lysine sterilized powder for injection Quality controll
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