乳酸环丙沙星壳聚糖滴鼻剂的制备及质量控制.docVIP

乳酸环丙沙星壳聚糖滴鼻剂的制备及质量控制 王艳, 王涛,赵国东（1.徐州医学院附属医院药剂科 2.徐州医学院04级实习生 江苏 徐州 221002） 摘要　目的：研制乳酸环丙沙星壳聚糖滴鼻剂并建立其质量控制方法。 方法：以壳聚糖为增稠剂、增效剂，乳酸环丙沙星为主药制备滴鼻剂。采用反相高效液相色谱法（RP-HPLC）测主药含量，并对其稳定性进行考察。 结果：所制备的制剂为无色、微粘、澄明液体, 其鉴别符合2005版《中国药典》中的相关规定；乳酸环丙沙星在10～200μg.mL-1范围内线性关系良好（r =0.9999, n=6）。平均回收率为99.19％，RSD为0.94% 。日内RSD为0.53 %, 日间RSD为0. 68 % 。结论：本制剂制备工艺简单可行，质量稳定、可靠，控制方法灵敏、准确。 关键词 乳酸环丙沙星；壳聚糖；制备；质量控制 [中图分类号] R943　　[文献标识码] A　 Preparation and quality control of ciprofloxacin lactate chitosan nasal drop Ji Huaixue(Ji HX), Wang Yan(Wang Y)，Wang Tao(Wang T)，et al (Short for Department of Pharmacy，affiliated Hospital of Xuzhou Medical College, Xuzhou 221002) ABSTRACT OBJECTIVE:　To prepare ciprofloxacin lactate chitosan nasal drop and establish its quality control method. METHODS: The nasal drop was prepared using chitosan as thicken agent and synergist with ciprofloxacin as principal agent. The content of ciprofloxacin was determined by RP-HPLC. The stability of the preparation was investigated as well. RESULTS: The prepared nose drop was colorless transparent glutinous limpid liquid with its identification items all up to the relate standards stipulated in Chinese Pharmacopoeia (2005 edition). The linear range of ciprofloxacin was 10～200μg.mL-1, r =0.9999 ( n=6 ）. The average recover was 99.19％, RSD was 0. 94 %. The average RSD of intra-day and inter-day was 0.49%, 1.50%. CONCLUSIONS: The preparation technology is simple and feasible. The quality of preparation is stable and controllable. The method of quality control is rapid and accurate. KEY WORDS: ciprofloxacin lactate, chitosan, creparation, quality control 环丙沙星是第三代氟喹诺酮类抗生素，体外抗菌活性在目前在临床应用的氟喹诺酮类抗生素中最强。具有抗菌谱广，抗菌活性强, 对革兰阴性阳性菌、支原体及厌氧菌等 [作者简介]　王艳,女,硕士,主管药师,电话:0516有较好抗菌活性, 几乎没有潜在的光毒性等优点。该药作用于细菌DNA回旋酶及拓朴异构酶干扰病原微生物核酸的复制、翻译发挥杀菌作用[1]。目前外用制剂品种包括滴眼剂、滴眼剂、凝胶剂等[2]。壳聚糖是目前药用制剂中较好的媒介，既可增加生物利用度又可减少药物对皮肤粘膜的刺激，迅速缓解感染，同时促进鼻咽部创伤的愈合[3]。鉴于两药以上特点，我们试制了乳酸环丙沙星壳聚糖滴鼻剂，并建立其质量控制方法，旨在为临床提供更优良的制剂。 1 仪器与试剂 Waters高效液相色谱仪（美国，包括515输液泵、2487紫外分光监视器、717自动进样器、