目的:观察复方乌头微乳长期连续经皮肤给药对SD大鼠的毒性作用。方法:将100只SD大鼠随机分为5组,分别为生理盐水对照组、空白微乳对照组、低剂量微乳组、中剂量微乳组、高剂量微乳组,每组各20只,雌雄各半。生理盐水对照组背部涂生理盐水...目的:观察复方乌头微乳长期连续经皮肤给药对SD大鼠的毒性作用。方法:将100只SD大鼠随机分为5组,分别为生理盐水对照组、空白微乳对照组、低剂量微乳组、中剂量微乳组、高剂量微乳组,每组各20只,雌雄各半。生理盐水对照组背部涂生理盐水0.3 m L·d-1,空白微乳对照组背部涂空白微乳0.3 m L·d-1,低剂量微乳组背部涂复方乌头微乳0.3 m L·d-1,中剂量微乳组背部涂复方乌头微乳0.6 m L·d-1,高剂量微乳组背部涂复方乌头微乳0.9 m L·d-1,涂药后用胶布固定,每日1次,连用45 d,停药后再观察15 d。用药期间及停药后观察大鼠的一般性状,最后心脏采血,检测血常规及血液生化指标。结果:生理盐水对照组、空白微乳对照组、低剂量微乳组、中剂量微乳组各组大鼠在给药期(45 d)和恢复期(15 d)内,所有大鼠饮食、大小便、活动情况、精神状态、排泄物、行为等均无明显异常;高剂量微乳组有3只大鼠于给药第40天出现便溏,精神差,停药5 d内,3只大鼠大便恢复正常,其余大鼠均无异常变化。各组大鼠主要血常规指标、血生化指标组间比较,差异均无统计学意义(P>0.05)。结论:复方乌头微乳长期连续经皮肤给药对实验大鼠无毒性反应,可在临床安全使用。展开更多
Insulin is widely used in treating diabetes, but still needs to be administered by needle injection. This study investigated a new needle-free approach for insulin delivery. A portable powder needleless injection（PNI...Insulin is widely used in treating diabetes, but still needs to be administered by needle injection. This study investigated a new needle-free approach for insulin delivery. A portable powder needleless injection（PNI） device with an automatic mechanical unit was designed. Its efficiency in delivering insulin was evaluated in alloxan-induced diabetic rabbits. The skin irritation caused by the device was investigated and the results were analyzed in relation to aerodynamic parameters. Inorganic salt-carried insulin powders had hypoglycemic effects, while raw insulin powders were not effective when delivered by PNI, indicating that salt carriers play an important role in the delivery of insulin via PNI. The relative delivery efficiency of phosphate-carried insulin powder using the PNI device was 72.25%. A safety assessment test showed that three key factors（gas pressure, cylinder volume, and nozzle distance） were related to the amount of skin irritation caused by the PNI device. Optimized injection conditions caused minimal skin lesions and are safe to use in practice. The results suggest that PNI has promising prospects as a novel technology for delivering insulin and other biological drugs.展开更多
文摘目的:观察复方乌头微乳长期连续经皮肤给药对SD大鼠的毒性作用。方法:将100只SD大鼠随机分为5组,分别为生理盐水对照组、空白微乳对照组、低剂量微乳组、中剂量微乳组、高剂量微乳组,每组各20只,雌雄各半。生理盐水对照组背部涂生理盐水0.3 m L·d-1,空白微乳对照组背部涂空白微乳0.3 m L·d-1,低剂量微乳组背部涂复方乌头微乳0.3 m L·d-1,中剂量微乳组背部涂复方乌头微乳0.6 m L·d-1,高剂量微乳组背部涂复方乌头微乳0.9 m L·d-1,涂药后用胶布固定,每日1次,连用45 d,停药后再观察15 d。用药期间及停药后观察大鼠的一般性状,最后心脏采血,检测血常规及血液生化指标。结果:生理盐水对照组、空白微乳对照组、低剂量微乳组、中剂量微乳组各组大鼠在给药期(45 d)和恢复期(15 d)内,所有大鼠饮食、大小便、活动情况、精神状态、排泄物、行为等均无明显异常;高剂量微乳组有3只大鼠于给药第40天出现便溏,精神差,停药5 d内,3只大鼠大便恢复正常,其余大鼠均无异常变化。各组大鼠主要血常规指标、血生化指标组间比较,差异均无统计学意义(P>0.05)。结论:复方乌头微乳长期连续经皮肤给药对实验大鼠无毒性反应,可在临床安全使用。
基金Project supported by the National Key Technologies R&D Program of China(Nos.2008ZXJ09014-004 and 2012ZX10005010-002-002)
文摘Insulin is widely used in treating diabetes, but still needs to be administered by needle injection. This study investigated a new needle-free approach for insulin delivery. A portable powder needleless injection（PNI） device with an automatic mechanical unit was designed. Its efficiency in delivering insulin was evaluated in alloxan-induced diabetic rabbits. The skin irritation caused by the device was investigated and the results were analyzed in relation to aerodynamic parameters. Inorganic salt-carried insulin powders had hypoglycemic effects, while raw insulin powders were not effective when delivered by PNI, indicating that salt carriers play an important role in the delivery of insulin via PNI. The relative delivery efficiency of phosphate-carried insulin powder using the PNI device was 72.25%. A safety assessment test showed that three key factors（gas pressure, cylinder volume, and nozzle distance） were related to the amount of skin irritation caused by the PNI device. Optimized injection conditions caused minimal skin lesions and are safe to use in practice. The results suggest that PNI has promising prospects as a novel technology for delivering insulin and other biological drugs.
