| Objective:this topic to the fabrication technique of three different types of scientific evaluation on the joint quality of plaster,on a hot melt rubber paste,solvent type rubber paste,pressure sensitive adhesive patch,the advantages and disadvantages of three kinds of preparations for the future provide a scientific basis for the improvement of production and quality.Choose the good curative effect,stable raw material sources,moderate viscosity,small skin irritation,allergic,good comfort,little environmental pollution and production cost is relatively low production technology of joint plaster;On the premise of guarantee the quality of drugs,and discusses the main effective components of release.Methods:(1)preparation preparation:according to Ling Rui pharmaceutical co.,LTD.,the existing workshop production process for solvent rubber paste solvent method of joint plaster sample preparation,according to the Ling Rui pharmaceutical co.,LTD.,the existing method of hot pressing workshop production technology for rubber paste joint plaster sample preparation,according to the research of Ling Rui pharmaceutical co.,LTD.,type of pressure sensitive adhesive preparation technology of emplastrum preparation type pressure sensitive adhesive patch joint plaster sample preparation.The investigation of the characteristics of(2)preparation:according to the 2015 edition of《Chinese pharmacopoeia》the fourth emplastrum under regulation,the observed by naked eye observation method in paste material coating uniformity;The surface gloss cream;Have to take off the cream,loss of adhesion phenomenon;Whether level off,clean,the phenomenon such as leakage paste on the back.(3)preparation of adhesive inspection:according to the 2015 edition of 《 Chinese pharmacopoeia》in the fourth under emplastrum adhesion force measurement method;1,the moisture determination:at the beginning of the emplastrum was evaluated by rolling the ball stop ramp method at the beginning of the adhesion force.2,the determination of peel strength:180°peel test is used to determine the sticky patch together.3,the determination of adhesion,adhesion is on the《Chinese pharmacopoeia》2015version of emplastrum adhesion performance of the new inspection method,the adhesion of the rubber paste suggested in3000~6000m N.(4)preparation of chemical component content determination:TLC method for preparation of atropine sulfate,diphenhydramine hydrochloride for qualitative identification.Preparation were determined by HPLC method;In preparation for using GC method,the content of camphor,menthol,methyl salicylate,(5)release study,transdermal absorption test:release device and modified Franz device were used respectively to three types of joints,the release of acetanilide experimental research,using HPLC method for determining the content of diphenhydramine hydrochloride 、atropine 、capsaicine in accept liquid,calculation of diphenhydramine hydrochloride in three kinds of release degree of the condition of leakage,by contrast,select release degree of the largest tank leakage conditions.Determination of camphor 、 menthol and salicylic acid methyl salicylate by GC.(6)Skin irritation 、 irritability test:the greatest irritant,the lowest hot pressing method.(7)Skin irritation experiments:choose healthy adult male white hairs guinea pigs as subjects,using its own about correlation method,for seven days in a row,observation of1,24,48,72 h animal skin irritation,record data and statistics.All landowners skin allergic experiment:choose healthy adult male white hairs guinea pigs as subjects,for a group to group,using their own side so correlation method,in 1d,7d and14 d respectively,and in the last 14 d after the treatment to stimulate,observe 0,24,48,72 h animal allergenic.Results:(1)preparation: three different preparation process of joint plaster,hot melt type joint acetanilide plaster(hot pressing method)and solvent joint(solvent)to choose the main substrate compositions of natural rubber for prescription,type pressure sensitive adhesive joints plaster(hot melt glue)to choose the major component of matrix SIS for prescription.Solvent method and hot pressing method comparison,natural rubber part due to contain a variety of protein is easy to produce allergic phenomenon,the solvent used in the production process of solvent oil,hard to avoid a small amount of residual drying process,considering the production preparation process,the solvent method due to the use of solvent oil,increased production equipment,and security costs,hot-pressing law relative to environmental protection,safety,hot melt adhesive method to shorten the whole production line,the operation is simple and easy.The investigation of the characteristics of(2)preparation: compared to the three;Solvent method and the method of hot melt adhesive colloid glossiness good,more comfortable,hot-pressing method technology to produce gel hardness is larger,the skin to follow sex difference,gloss is less than the first two(3)preparation of adhesive performance review: solvent method used in the process of solvent oil production technology,mixing fully,at the beginning of cohesion,adhesion and peel strength,adhesive performance is best;Heating hot pressing method directly on the natural rubber,gel hardness,skin to follow and comfort as solvent method,minimum adhesion performance,hot melt adhesive method in solvent method and hot pressing method,adhesion performance center.(4)preparation of release:through diffusion pool and blade disc method two kinds of methods of diphenhydramine hydrochloride investigation concluded that blade disc method release rate is better,the result is relatively stable,30% ethanol-and PBS7.4 saline solution,30%ethanol-saline solution and PBS 7.4 experiment contrast,the former is better.(5)preparations in vitro transdermal absorption through preliminary experimental investigation,Liquid to 20% ethanol-saline for acceptance,measuring camphor,The highest rate is hot-melt adhesive,second solvent method,hot pressing method were compared with the previous two relatively lower.Conclusion:through three different matrix and preparation process of joint plaster contrast,three kinds of prescription matrix are stable,through the quality standard of validation,preparation of three kinds of quality is controllable,diphenhydramine hydrochloride release degree study,blade disc method of 30% ethanol-saline accept liquid type hot melt adhesive joints acetanilide 24 h to release the highest degree,in vitro transdermal comparison research,three different preparation technology of joint plaster 24 h in vitro through rate difference is not very big,hot melt adhesive is relative taller;Skin irritation,allergic experiment,the biggest stimulus on guinea pig solvent method,allergy rate is higher. |
