Study On Hypodermic Osmotic Pump Controlled Injection Instrument Of Ceftriaxone Sodium Based On Osmotic Pump

In the process of the hospital service,earthquake relief,battle field rescue,weoften need continuous drug delivery in order to achieve the purpose of the rescue andthe medical treatment. Therefore,the quantitative drug infusion into the body by aspecific way quantitatively and slowly, maintains a relatively stable plasmaconcentration, which has always been the research focus of the healthcareorganizations and scientific research departments. In this subject,we develop a newtype of hypodermic osmotic pump controlled injection patch based on osmotic pump,by designing and developing the hypodermic osmotic pump controlled injection patch,and the study of the prescription and preparation process of ceftriaxone sodium as thetarget drug.Objective: The aim of the present study was to design and develop the hypodermicosmotic pump controlled injection patch,and study the prescription and preparationprocess of ceftriaxone sodium as the target drug,as the foundation for the furtherdevelopment of the device and the expansion of the application.Methods:1. Design and manufacture the instrument model by using kinds of CAD software.2. Select and optimize the core tablet and coating formula of the part of ceftriaxonesodium osmotic pump by the single factor test, and confine the preliminaryprescription and production progress.3. Use orthogonal design to select the optimal formulation and process parameters,and prepare the osmotic pump system by using the selected formulation. Subsequently,evaluate the characterization of drug release of in vitro.4. Establish the methods for the contents and the accumulative drug release amount incompound osmotic pump tablets by HPLC,that contains the specificity,linearity,sensitivity,etc.5. Study the multiple produce repeatability by similarity factor,and investigate the release stability of the hypodermic osmotic pump controlled injection patch ofceftriaxone sodium.Results:1. The results show that the hypodermic osmotic pump controlled injection patchdesigned here are strong enough to guarantee safe injection through skin,and theyhave the following characteristics,such as novel design,reasonable structure,easy touse,ingenious production and low-cost.2. In vitro,the drug of hypodermic osmotic pump controlled injection patch ofceftriaxone sodium released constantly and simultaneously between0~6h accordingto zero-order kinetics. The single factor test results showed different kinds of osmoticagents and PEG,the amounts of glucose and PEG1500,the coating weight of themembrane had marked effects on the Ts,and the Te and the drugs release； on otherhand,the orifice size and the hardness showed no marked effects. Besides,increasethe amount of osmotic agents and PEG could shorten the Ts and prolong the Te; withthe DEP and the coating weight increased,the Ts and the Te lengthened.3. The selected formula was300mg glucose,1.5g PEG1500,0.5ml DEP and11%weight gain of coat by using orthogonal design,and the cumulative release of the drugin the selected formula of osmotic pump tablet could up to95%. The simulativeequation between the time and the cumulative release percent of hypodermic osmoticpump controlled injection patch of ceftriaxone sodium wasY=14.736*X+3.6418(R~2=0.9955),which showed constant release of the drug.4. The contents and the accumulative drug release amount in compound osmoticpump tablets were detected by HPLC method,and the specificity,linearity,sensitivity,and precision of the methodology fulfil the requirements of the study.5. In this paper,the study of multiple produce showed good repeatability by similarityfactor,which built a fine foundation for engineering production. In addition,theresults of stability experiments indicated that the compound osmotic pump tabletswere sensitive to high temperature and humidity,which should be stored in a cool dryplace.Conclusions: Until now,reports about formulation and arts of hypodermic osmoticpump controlled injection patch of ceftriaxone sodium still were not beheld in china and abroad. In the present study,the effects of formulations of core tablet and coatingmembrane,arts of preparation and process parameters on the drug release behaviorwere investigated using single factor test. Then the optimal formulation was selectedby orthogonal design,and the ceftriaxone sodium osmotic pump tablets of theselected formula released linearly according to zero order kinetics.The contents and the accumulative drug release amount in compound osmoticpump tablets were detected by HPLC method,which demonstrated high selectivity,good accuracy and high sensitivity.In conclusion,the development of the hypodermic osmotic pump controlledinjection patch of ceftriaxone sodium provides a new approach for the transdermaldrug delivery,and creates a new method for clinical establishment of injection. Theresearch results solve the problem of difficulty to maintain steady-state plasmaconcentration of clinical injection drug,and were particularly suitable for patients toself-administration,or to achieve rapid drug delivery and desire therapeutic effectunder extreme conditions. The design of the device was ingenious,convenient andpractical,and the prescription was simple,stable,and had good repeatability,qualitycontrol. The new dosage form was very suitable for different drugs,and provided anew way to achieve controlled release drug delivery for clinical treatment.