Study On Eucommia Sustained Release Tablets And Quality Standards

Eucommia Sustained-Release Tablets is a sustained-release preparation made of Eucommia ulmoides as the main raw material.This preparation can slowly release the blood concentration of the drug to the peak,reduce the number of administrations and improve the safety of drug use.It can reduce the risk of medication for patients,reduce adverse drug reactions,reduce the burden of liver and kidney drugs and improve patient compliance.First,extract the effective ingredient pinoresinol diglucoside in Eucommia ulmoides,and use single factor experiment to screen the extraction method,determine to use ultrasonic-assisted extraction method to extract it;then investigate the medicinal material crushing particle size,ethanol concentration,extraction times and soaking time.the best extraction process was determined to be 70℃,75%ethanol,25 times the volume,3 extractions,and the extraction time was 4 h each time;in order to achieve the requirements of formulation design,the purification process was investigated The best process is the macroporous resin purification method.As a result,the content of the crude extract is increased from 4.5%to 17.14%.Then,the preparation process of Eucommia ulmoides depressurized sustained release tablets was screened.The sustained release tablets were prepared by direct powder pressing method,high speed shear granulation method and fluidized bed granulation method,and finally the fluidized bed granulation method was determined.by investigating the impact of HPMC model and dosage on the release of sustained-release tablets,the final formulation was determined:Eucommia extract:469.4 mg,HPMC k15:210 mg,sodium lauryl sulfate:15 mg,polyvinylpyrrolidone k90:90 mg,magnesium stearate:3.92 mg.The specification is 80 mg(calculated as pinoresinol diglucoside).Finally,the quality standard of Eucommia Sustained-Release Tablets was established,at the same time,its stability was investigated.Sustained-release tablets are brown oval tablets with slight gas and bitter taste.The release quality standard is 15%release at 1h,65%release at 6 h,and 95%release at 12 h.In the stability study,the properties,moisture,content,and release impact of sustained-release tablets as the inspection indicators.We investigated different indicators,such as influencing factors,accelerated experiments and long-term experiments,the conclution show that the sustained-release tablets have good stability under high temperature,high humidity and light conditions.At the same time,the results of accelerated experiments and long-term experiments show that there is no significant change in the content after accelerating for 1,2,3,and 6 months and after 3 months and 6 months of storage.Conclusion:The extraction and purification process of Eucommia ulmoides extract is simple and feasible.The preparation process of Eucommia ulmoides sustained release tablets is mature and stable,with comprehensive quality standards and good stability,It can release 95%within 12 hours.The research of Eucommia sustained-release tablets is of great significance in reducing adverse drug reactions,reducing the burden of liver and kidney drugs,and improving patient compliance.