| Objective: As other autoimmune disease, lymphocytes directly or indirectly part in the cause of immune eye disease, So ring spore A is usually applied in local or whole body clinically to limit lymphocyte mediated immune response. But blood-ocular barrier cause drug to enter the eye difficultly,pursuit of efficacy,incrasing drug dosage will increase adverse drug reactions. This study will discuss an eye patch that is a local medication,takes advantage of the transdermal properties of babu ointment and the pharmacological characteristics,nano scale microemulsion,lymphatic targeting characteristics of ring spore A.Inspect its potential value to cure immune eye disease. Methods: This study is devided into three parts,the first part is the preparation of ring spore A microemulsion papua cream eye patch: add proper humectants,filler,crosslinking agent,crossing regulator,chelant into water soluble polymer to make good air permeability and comfortable ring spore A microemulsion papua cream. Adhesion experiment is used to optimize formulation process,and determine paste content. The second part is in vitro transdermal experiment of papua cream eye patch:Take abdomen skin of mouse,use evolutionary Franze diffusion device and High Performance Liquid Chromatography(HPLC) to determine 2,5,8,12,24 hour’s sample concentration of ring spore A. Observe percutaneous permeability Of papua cream,study percutaneous absorption and simply discussed on percutaneous mechanism of ring spore A microemulsion. The third part is skin irritation and allergic test:Cavia porcellus is the experimental animal.observe the effect of single dosing and multiple dosing to intact skin and damaged skin.observe the acute allergic reaction and delayer hypersensitivity reaction after administration.Using SPSS 18.0,statistical software analysis,P<0.05 show difference with statistical significance.Results: 1.The result determines the papua cream which prescription is sodium polyacrylate( NAPA) :polyvinylpyrolidone(PVP):glutin:kaolin:titanium pigment:calmogastrin:tartaric acid:natrium adetate(EDTA-2Na):nipagin ester:propylparaben:tween-80:glycerol:purifier water: ring spore A microemulsion is30:10: 7.5:10:2.5:0.75:1.0:0.25:0.125:0.125:1.5:75:500:0.5 is preferably(the content of ring spore A microemulsion is 10mg/slice,the concentration is 1mg/ml).The anchoring strength is 3steel ball. The property of ring spore A microemulsion papua cream eye patch is stable,and fits the emplastrum sets of the 2005 edition(Chinese Pharmacopoeia).2.The percutaneous concentration of ring spore A microemulsion increase over time, 24 hour,s cumulative transdermal concentration is 0.4881mg/ml.The ring spore A microemulsion papua cream has a good transdermal effect. Through the experiment that observe the effect of single dosing and multiple dosing to intact skin and damaged ski of cavia porcellus,the result shows that the skin irritation and toxicity of ring spore A microemulsion papua cream is small,and observe the allergic experiment,the cutaneous anaphylaxis of cavia porcellus such as erythema or edema is not seen.Conclusion: Babu ointment is applited to the preparation of eye paste for the first time,Its transdermal properties,adhesion property and skin comfortn are fine.We choose ring spore A because of its efficacy ability of acting on lymphocytes,and ring spore A dose not increase the chances of infection.The medication of cyclosporine eye drops clinically can be used for reference, safety and efficacy of ring spore A microemulsion papua cream eye patch.Local external use is different from the systemic delivery of oral or intravenous injection,etc.it is easily accepted by patients,increase patient compliance. Except this eye patch can improve the clinical curative effect in the future treatment of autoimmune eye disease such as hyperthyroidism sex eye disease. |
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