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氯诺昔康干混悬剂的制备及其质量考察

Study on the preparation methodology and quality of lornoxicam dry suspension
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摘要 目的制备氯诺昔康干混悬剂并对其质量进行考察。方法通过单因素试验,考察不同辅料对氯诺昔康干混悬剂沉降体积比及再分散性的影响,再运用正交试验优选出最优处方工艺;采用高效液相色谱法测定干混悬剂中氯诺昔康的质量分数,并对其溶出度及稳定性进行考察。结果最佳处方工艺为:以质量分数8%的CMC-Na和5%的黄原胶共同作为助悬剂,15%的微晶纤维素为崩解剂,15%的聚乙烯吡咯烷酮K30为黏合剂;3批样品标示质量分数平均值为98.7%;p H 7.4磷酸盐缓冲液作为溶出介质时,氯诺昔康溶出速度快且较平缓;稳定性试验显示制剂的各项检测指标均无明显变化。结论优化后的处方工艺简单、可行、稳定性可控、重复性好,所制备的制剂符合干混悬剂质量要求。 Objective To study the preparation and quality of lornoxicam dry suspension. Methods The sedimentation rate and dispersion of lornoxicam dry suspension were investigated by single factor study. The prescription methodology was optimized by orthogonal design. HPLC method was used for determining the content of lornoxicam dry suspension. The dissolution behavior and stability of lornoxicam dry suspension were also been investigated. Results The optimal prescription methodology for lornoxicam dry suspension was as follows: CMC-Na (8%) and xanthan gun (5%) as the suspending agents, MCC (15%) as the disintegrant, and 15% PVP( in 50% ethanol solution) as the adhesive. The average labeled content of 3 batches of samples was 98.7%. The pH 7.4 phosphate buffer was the optimal dissolution media with fast dissolution rate and relatively smooth. The each index of suspension displayed no significant change by the stability test. Conclusion The optimized formulation process is simple, feasible, stable and repeatable. The preparation is in accordance with the quality requirements of dry suspension.
出处 《广东药学院学报》 CAS 2016年第3期275-278,290,共5页 Academic Journal of Guangdong College of Pharmacy
基金 湖北省自然科学基金项目(2015CKB757)
关键词 氯诺昔康 干混悬剂 处方工艺 高效液相色谱法 稳定性 lornoxiea dry suspension preparation methodology HPLC stability
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