硫酸长春新碱缓释药膜的制备及稳定性初步研究  

Study on preparation and stability of collagen-chitosan complex film loaded with vincristine sulfate

作　　者：陈汉[1] 陈红丽[1] 莫丽都尔[1] 张其清[1] 

机构地区：[1]中国医学科学院中国协和医科大学生物医学工程研究所天津市生物医学材料重点实验室,天津300192

出　　处：《生物医学工程与临床》2007年第5期341-343,共3页Biomedical Engineering and Clinical Medicine

摘　　要：目的制备出载硫酸长春新碱微球的胶原-壳聚糖缓释药膜,并考察该制剂的稳定性。方法采用W/O/O溶剂挥发法制备载硫酸长春新碱的聚乳酸/聚羟基乙酸共聚物(PLGA)微球,后把微球与壳聚糖、胶原溶液共混及二次冻干,制备出载硫酸长春新碱微球的胶原-壳聚糖药膜。对微球和药膜表面形态进行了电镜观察,测定了微球和药膜的包封率、载药量及药物释放,药物含量采用高效液相法检测。此外,还初步考察了缓释药膜的稳定性。结果制备的微球包封率达到79.0%±1.0%,微球药物的突释为27.2%±1.2%,制备成药膜后降低到18.0%±1.1%,采用该工艺流程制备出来的缓释药膜,药物突释明显减少。稳定性实验显示,该药膜在40℃条件下放置3个月药物含量下降到97.9%±0.1%,而高湿度或光照环境下放置10 d药物含量下降到91.4%±0.3%和91.2%±0.4%。结论药物包囊制成微球后与胶原、壳聚糖共混制备出的缓释药膜具有较好的释放特性和稳定性,有望成为一种实用的新型缓释抗肿瘤制剂。　Objective To investigate the preparation and stability of collagen-chitosan complex film loaded with vincristine sulfate（VCR）.Methods A water-in-oil-in-oil double-emulsion /solvent evaporation method was performed to prepare VCR-loaded poly（lactide-co-glycolide）（PLGA） microspheres,then microspheres were mixed with collagen and chitosan swelling solution,and lyophilized.Encapsulation efficiency and release kinetics of VCR microspheres were determined,as well as the release kinetics of the complex film.The rate of VCR release from the film and the microspheres submerged in PBS（pH 6.8） were assayed by high-performance liquid chromatography（HPLC）.The stability of the film under the conditions of high temperature（40 ℃ ± 1 ℃）,high humidity（75 % ± 5 %） and illumination were determined.Results The initial burst release value of the drug released from the film was significantly lower than the drug from the microspheres,with the former 18.0 % ± 1.1 % and the later 27.2 % ± 1.2 %.At the end of stability test,the residue content of the films in the heat,humidity and photo stability tests were 97.9 % ± 0.1 %,91.4 % ± 0.3 % and 91.2 % ± 0.4 %,respectively.Conclusion The films made of collagen,chitosan and PLGA is a promising preparation in treating some cancers.

关 键 词：硫酸长春新碱 聚乳酸/聚羟基乙酸共聚物 胶原 膜剂 稳定性 

分 类 号：R94[医药卫生—药剂学]