Preparation And Drug Release Properties Of Hydroxypropyl Methyl Cellulose/Pullulan Blend Films

Membrane agent is a kind of membrane preparation made from drugs and suitable film-forming materials.At present,the product of this preparation is not only for local infection,but also for oral treatment.Considering that some drugs need to be administered many times in clinic,the preparation of sustained-release membrane has become a trend.Montmorillonite is a non-metallic mineral,which is capable of ion exchange and adsorption.It has been considered by many scholars as a good carrier for sustained/controlled release preparations.Objective:the aim of this study was to screen and determine the optimal film formulation,to establish the preparation technology and quality control method of the membrane agent,and to prepare ornidazole,lysozyme and chlorhexidine acetate membrane agent,and to explore the effect of these drug membranes on the release after adding montmorillonite and which drugs are slow by montmorillonite.Content:using hydroxypropyl methyl cellulose and Pullulan as the main film-forming materials,ornidazole membrane agent was prepared,and lysozyme membrane agent and chlorhexidine acetate membrane agent were prepared on the basis of its optimal basic prescription.The inhibitory effect of Ornidazole membrane on Escherichia coli was also studied.Methods:the dosage of ornidazole oral membrane was screened by L9(3~4)orthogonal experiment.The optimal formulation was determined by evaluating the appearance of the membrane,the drug content per unit area,the tensile strength and the breaking-up rate.Then,the optimum technological conditions were determined by evaluating the appearance,film thickness and mechanical strength.Referring Chinese Pharmacopoeia method,the content uniformity and drug content of the membrane were determined,and the cumulative release rate of drugs in drug film was determined.Bacteriostatic test was used to inspect the bacteriostatic effect of Ornidazole membrane on Escherichia coli before and after adding montmorillonite.Results:the optimal formulation was determined by L9(3~4)orthogonal experiment:the dosage of HPMC E5,Pullulan,glycerol,mannitol and mannitol were 3.75g,1.25g,0.25g,0.15g and 50g,respectively.The active component contentof the three drugs were 0.45mg/cm~2ornidazole,0.50mg/cm~2 lysozyme and 0.16mg/cm~2 chlorhexidine acetate,respectively,and the dosage of montmorillonite was determined according to the specific drug and preparation process.When montmorillonite was added,the cumulative release rate of ornidazole membrane was more than 90%at 5h,and the cumulative release rate of lysozyme membrane was more than 85%at 12h,regardless of whether the preparation process was improved or not,and the cumulative release rate of ornidazole membrane was over 90%at 5h,and the cumulative release rate of lysozyme membrane was over85%at 12h after adding montmorillonite.After adding montmorillonite,the cumulative release rate of chlorhexidine acetate film reached more than 50%at 24h.The bacteriostatic effect of ornidazole membrane agent added montmorillonite was slightly enhanced.Conclusion:the dissolution test of ornidazole membrane in vitro shows that the dissolution of ornidazole membrane does not meet the release requirements of sustained-release membrane.Both lysozyme membrane agent and chlorhexidine acetate membrane agent with montmorillonite showed sustained release effect in different degrees,which indicated that montmorillonite had no adsorption effect on ornidazole,and had different degree of adsorption effect on lysozyme and chlorhexidine acetate,which indicated that montmorillonite had no adsorption effect on ornidazole and lysozyme and chlorhexidine acetate in varying degrees.Montmorillonite can increase the bacteriostatic effect of ornidazole.