The Pharmaceutical Research On Cuqu Tablets

The incidence of cardiovascular diseases caused by hyperlipidemia has been increasing in recent years.It causes stasis of the blood vessel wall,which is very likely to cause acute coronary heart disease and atherosclerotic cardiovascular disease.In order to reduce the occurrence of cardiovascular diseases,hypolipidemic treatment and prevention is imperative.In recent years,natural source hypolipidemic products have attracted much attention.Cuqu tablets which are used to hypolipidemic are composed of vinegar powder,red yeast and aloe vera.It has definite effect and good safety.In the preparation,vinegar powder and red yeast was used as powder,and aloe was concentrated by alcohol and dried.First of all,the extraction process of aloe was studied.The ethanol reflux extraction method was used.The ethanol concentration,extraction time,and liquid-to-material ratio was selected with absorbance value of flavonoids（R₁）and extract yield（R₂）as evaluation indicators.The response surface method was used to optimize the extraction process of total flavonoids in aloe,and the best extraction process as follows:65%ethanol was used as extraction solvent,the liquid-to-material ratio was 20:1,reflux extraction for 4 h.The ethanol in the extract was recovered,and the concentrate was dried in oven at 60°C.The preparation of Cuqu tablet cores are carried out by wet granulation and compression.Through single factor investigation,it was found that the amount of disintegrant,ethanol concentration and drying temperature have great influence on the quality of the tablet cores.Therefore,the above three variables as inspection factors.The comprehensive scores including disintegration time,hardness,appearance and angle of repose of the granules before tableting as evaluation indicators to optimize the molding process.The orthogonal test design was used to select the amount of disintegrant,wetting agent concentration and drying time.The optimal tablet cores（1000 tablets）prescriptions were determined as:vinegar powder（470 g）,red yeast（200 g）,aloe（280 g）,pregelatinized starch（75 g）,polyvinylpyrrolidone（25 g）,85%ethanol solution（appropriate amount）,talcum powder（10 g）.Cuqu tablets contain volatile and hygroscopic ingredients,so the tablets are film coated.Coating temperature,coating fluid supply rate and coating weight was selected with the pass rate and disintegration time of coated tablets as evaluation indicators.The Box-Behnken test design scheme was used to optimize the best coating process which as follows:dissolve an appropriate amount of film coating premix in purified water to get tablet coating liquid with solid content was 12%,the coating temperature at 45℃,and the coating liquid supply rate was 4 mL/min,the coating weight was 3%.In this study,the quality standards of Cuqu tablets were established:qualitative identification of red yeast in Cuqu tablets by microscopic identification and thin layer chromatography,and qualitative identification of aloe in Cuqu tablets by thin layer chromatography.All the above materials were detected and the characteristics were obvious.The content of total lovastatin in Cuqu tablets was determined by high-performance liquid chromatography.After verification by methodology,all indicators were in compliance with relevant regulations.The qualitative and quantitative methods established by the study are accurate and reliable.This paper established the best preparation process of Cuqu tablets,which is proved to be stable and feasible by pilot test.The content of total lovastatin is high,and has significant effect on hypolipidemic.Therefore,total lovastatin is used as the quality control index.By influencing factor test,accelerated test and long-term test,the results show that the Cuqu tablets are stability.