摘要
目的:筛选盐酸利多卡因凝胶最佳基质处方,并考察成品稳定性,制备适合电子肠镜检查的麻醉辅助制剂。方法:以卡波姆-940、甘油、三乙醇胺为可变因素,以盐酸利多卡因凝胶的性状均匀性、润滑性、黏附力、含量、pH值为考察指标,通过均匀设计试验优化处方,并考察凝胶成品的稳定性,特别是黏附力的变化情况。结果:盐酸利多卡因凝胶主要成分最优处方:卡波姆-940为1.3%,甘油40%,三乙醇胺1.8%。除了凝胶黏附力受温度影响明显外,其他性质稳定性较好。结论:盐酸利多卡因凝胶制备工艺简便,外观细腻均匀,润滑性黏附力好,含量稳定,符合临床应用要求。
OBJECTIVE To optimize formula for lidocaine bydrochloride gel and study the stability of its finished products which may be used in enteroscopy. METHODS Carbopol 940,glycerol, triethanolamine were selected as variable factors, while character and homogeneity, unctuosity,adhesive force,content,pH value were taken as indexes to conduct the uniform design. Initial stability of lidocaine hydrochloride gel was detailed investigated, especially adhesive force. RESULTS The optimum preparation is established as： Carbopol 9401.30%, glycerol 40%, triethanolamine 1.8%. The quality of lidocaine hydrochloride gel was stable except that adhesive force of gel was influenced obviously by temperature. CONCLUSION The Lidocaine hydrochlo- ride gel has a simple preparation fine and smooth, appearance good adhesive, force and stable quality for clinical application.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2010年第7期547-551,共5页
Chinese Journal of Hospital Pharmacy
