Pharmaceutical Evaluation Of Needle-free Injector With Injection Effect

Needle-free Injection was also called jet injection, refered to the use of mechanical device (such as high pressure gas or spring) produces the moment of high pressure, promoting agents (liquid or freeze-dried) through a very fine nozzle, form high pressure jet, high speed through the skin and directly disperse to skin or muscle tissue. The speed of the jet was extremely high, typical values for150-300m/s, and the depth into the body was limited,nerve endings stimulation was small, so didn’t have obvious tingling as traditional needle syringe.This article through the polyacrylamide gel simulating skin test, preliminarily evaluates injection effect in vitro with homemade needle-free injection、import YiJie needle-free injection and traditional needle syringe, research the distribution of absorption, metabolism, discharge and pharmacokinetic law respectively injecting drug by three syringe in the body; And give the corresponding discussion to rat skin irritation. We choose the two typical drugs (hemostatic medicine carbazochrome sodium sulfonate and atropine), using high performance liquid chromatography,compared pharmacokinetic characteristics with three different forms of injection in the rabbit, and contrast the advantages and disadvantages of three kinds of injection way, so as to evaluate the performance of the homemade needle-free injection, get the following results:1.The injection effect of three kinds of syringe in vitro preliminary comparison:acrylamide gel elastomer simulated skin tissue properties, the three kinds of injection modes injection ink to examine L ink further general, D ink spread diameter, d deep hole length, preliminary compared the injection effect with group A homemade needle-free injection, group B YiJie needle-free injection and traditional needle syringe of group C. With the increasing doses, L, D, d value of three groups were increased.for the same dose,as spring stiffness coefficient increases, L, D, d value were increased for A group,A group of4kinds of spring stiffness coefficient (k=2.2,4.0,4.4,5.3kg·cm-1),k was4.0kg·cm-1had same injection effect with group B, and the group B spring stiffness coefficient was consistent.2.The pharmacokinetic of carbazochrome sodium sulfonate:the blood drug concentration and the time data fit by DAS2.1.1pharmacokinetic analysis software, needle-free inject and needle syringe pharmacokinetic process which conform to the single room model,the major pharmacokinetic parameters of homemade needle-free injection group AUC (0-t), Tmax, Cmax and T1/2respectively:(162.43±17.09) μg·mL-1·min、(5.00±1.41) min、(5.93±0.02)μg·mL-1、(23.54±3.89)min; YiJie needle-free injection group:(183.35±15.26) μg·mL-1·min、(5.00±1.52) min、(6.25±0.16)μg·mL-1、(24.11±5.00)min; needle syringe injection muscle group:(180.82±15.29) μg·mL-1·min、(23.00±2.01) min、(5.09±0.29) μg·mL-1、(18.28±2.47) min. Compared with the traditional needle injection, needle-free injection could make the peak time significantly in advance, increasing concentration of peak, other major pharmacokinetic after statistics processing parameters have no significant differences, showing needle-free injection could achieve similar injection effect with needle syringe injection.3. Three syringes to human skin evaluation:use A homemade needle-free injection, B YiJie needle-free injection and C traditional needle syringe all injected physical saline water in rats on both sides of the thigh, respectively, in0.5,1,4,24,48and72hours macroscopic observation to medicine without erythema and edema, part indicate that the0.5h, group C compared AB group needle generally small, but the high incidence of bruised and swollen, group B and bruises rate slightly better than the group A,48h group C when basic recovery, only a very small group AB not completely restored. Three groups were not found erythema phenomenon. Biopsy found that did not have apparent tissue damage, fat, muscle structure continuous complete, no muscle enlargement phenomenon. Needle-free injection did not cause irreversible influence to the skin and was relatively safe.The peak concentration and peak time were all obviously superior to the traditional needle syringe; the injection site after a biopsy found no obvious skin and muscle damage reflected on the safety of the needle-free injection. Under special conditions for emergency treatment such as battlefield, unexpected disaster (such as earthquake, flood) and long term injected drug such as insulin needle-free injection had remarkable advantage.