Study On The Preparation And Quality Standard Of YIQING Sustained-release Tablet

Yiqing sustained-release tablet are composed of extracts of Coptidis Rhizoma,Rhubarb,and Radix Astragali.The efficacy is heat-reducing and fire-fighting,swelling of the gums,pain,toothache,throat,and dry mouth.Based on the theory of traditional Chinese medicine,this study studied the preparation process of Yiqing sustained-release tablet,the study of quality standards and the preliminary stability study.This subject is based on the chemical properties and pharmacological effects of the active ingredients of Sanwei Chinese herbal medicines in the compound,combined with the features of their functional indications,to retain the active ingredients of each medicinal material to the maximum,and to apply orthogonal test methods to determine the optimal test proportion through multiple tests.By consulting literature and pharmacopoeia,Huanglian,rhubarb,and Huangqi are all extracted by water decoction.This is also a traditional and safe method for traditional Chinese medicines.Therefore,we use water decoction method to extract.According to the characteristics of this product,we use orthogonal design to select the key indicators that affect the water extraction effect as the object of the study.Baicalin content is used as the index,and the extraction process is finally determined as medicinal material plus eight times of water,extracted three times,and each time boiling three hours.In the study of preparation of a sustained-release tablet,the experiment examined the type of filler,the type and amount of the binder,the type of retarder,the type of wetting agent,the type of disintegrant,the type of lubricant,and the release force of the tablet.The influence of such factors on the formability.The final lactose was a filler,50%HPMC-K4M was a binder,ethylcellulose retarder was 60%ethanol wetting agent,stearic acid was a magnesium lubricant,and the tableting force was 80-90N.In the study of quality standards,thin layer identification was performed on the three-flavored Chinese herbal medicines in a sustained-release tablet.At the same time,the main effective baicalin was determined by high performance liquid chromatography.The average baicalin content was 21 mg/g.The test results of weight difference,microbiological limit check,heavy metal,etc.were all in compliance with relevant regulations.In addition,the methodological investigation of baicalin was established and the experimental results of the determination of baicalin content were established.The results showed that the method for determination of baicalin content was simple and feasible,scientific and controllable,and the effectiveness and safety of its particles could be effectively detected to achieve the purpose of quality control.It also established strict quality standards for the medicinal materials used and the finished product sustained-release tablets,and improved the quality control standards of the product during the entire process.A preliminary investigation of the stability of the three batches of a sustained-release tablet showed that the tablets all met the requirements of the "Chinese Pharmacopoeia" tablet,and there were no significant changes in the indicators.The research results of this project indicate that the preparation process of Yiqing Sustained-release Tablets is stable,the quality standards are comprehensive,the stability results are good,the science is feasible,and it is capable of supporting large-scale production.