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Journal of Zhejiang University SCIENCE B
ISSN 1673-1581(Print), 1862-1783(Online), Monthly
2014 Vol.15 No.10 P.888-899
Needle-free injection of insulin powder: delivery efficiency and skin irritation assessment
Abstract: 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.
Key words: Powder needleless injection, Insulin, Transdermal drug delivery, Skin irritation
创新要点:首次报道了胰岛素粉末无针注射给药方法,有望为糖尿病患者长期自我给药提供便捷。
研究方法:自主设计便携式自动无针粉末注射给药装置,采用计算机辅助方法计算给药装置的主要空气动力学参数;采用家兔评价无针粉末注射对皮肤的刺激性,并分析与空气动力学参数的相关性;采用四氧嘧啶诱导家兔糖尿病模型,评价不同无机盐载药的胰岛素粉末的无针注射给药降糖效果。
重要结论:采用自主设计便携式自动无针粉末注射给药装置,递送以无机盐为载体的胰岛素粉末具有显著的降血糖作用,而递送胰岛素原料药粉末无降血糖作用,说明无机盐载体对胰岛素粉末无针注射给药效果具有重要作用。皮肤刺激性实验表明,储气室气压、容积以及喷管与皮肤的间距三个参数显著影响无针粉末注射装置的皮肤损伤程度,优化后的注射条件对皮肤几乎没有损伤。优化给药条件下以磷酸盐载体的胰岛素粉末无针注射给药,相对给药效率为72.25%。研究结果表明无针粉末注射技术用于胰岛素或其它生物制品的无针给药具有良好应用前景。
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<1>
2014-11-07 22:04:30
I am doing something related to this,so want to download and make a consideration
DOI:
10.1631/jzus.B1400065
CLC number:
R944.9
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On-line Access:
2014-10-08
Received:
2014-03-05
Revision Accepted:
2014-07-09
Crosschecked:
2014-09-24