Preparation Technology And Quality Standard Of Changyanning Enteric-Coated Tablets

Objective:Enteritis ning enteric-coated metformin hydrochloride dosing method is superior to the traditional ordinary tablets,proper positions in the gut to be able to stay for a long time,locating release of certain drugs,so as to achieve the increasing local therapeutic effect and specific effective absorption of drug absorption parts,overcome the enteritis ning in gastric juice consumption,improve the effective drug concentration,avoid drug degradation in the stomach or gastric stimulation,at the same time improve the therapeutic efficacy of drugs,the drug play a best treatment effect,improved the patients with special medication suitability,increased the drug crowd.Methods:In this paper,through the experiment screened enteric-coated metformin hydrochloride preparations of disintegrating agents,adhesives,fillers,lubricants,such as the type and dosage of pharmaceutical excipients,for the prescription of particles liquidity,pressure resistance,hardness,brittle broken degree,disintegration time limit,and so on and so forth to examine the feasibility of the prescription,optimizing the best prescription composition ratio.Examines the preparation condition of coating raw materials compatibility and groping,choose the appropriate disintegrating agent,lubricant and adhesives,finally identified the best prescription enteritis ning enteric-coated metformin hydrochloride and the best preparation process,at the same time on the properties and the degree of release,content determination methodology validation,the results show that the test method of high specificity,high accuracy,good durability,can be applied to the product quality inspection requirements,thus the qualitative quantitative studies on preparation quality,improve the quality of the preparation.Results:according to the compatibility of different materials to determine the raw materials,compatibility and consistency,through the process of the material prescription dosage were determined,the test sample results show that a feasible parameters of the research laboratory and quality research,this study aimed at the identification of Changyanning enteric coated tablets properties,moisture,content and release rate were investigated,according to the identification results,characters,the determination of water will check methods to establish quality standards for water to be lower than the limit value is equal to 5%,the release of the main needle to inspect its degree in the 4 medium dissolution,results in 4 kinds of Changyanning tablets media release behavior consistent observation found that the release curve of high similarity,this method validation results meet the requirements,establish a method for determining the release The quality standard is set in and the method of content determination is verified by methodology.The results show that the established quality research method is feasible.The stability of the tested products was investigated.The influencing factors were 60,90%,5%,and the intensity was 50001x.The setting conditions of the samples were removed for packaging.The results showed that the samples were stable under the influence factors,and the selected materials were feasible.Accelerated conditions for 40-2 Deg.C,long-term conditions for 25-2 Deg.C,placing the sample with packing conditions for placement,acceleration and 6 months long-term test results show that the sample properties,within 6 months of release,and the water content had no obvious change,indicate that the sample has good stability,according to the stable qualitative investigation results will be tested can temporarily product is valid for 24 months.Conclusion:Research results show that the process stability is feasible and reasonable products meet quality requirements.