Study On The Preparation Technology And Quality Control Of The Pellets

Objective This study was initiated to improve Penyanjing’s clinical compliance and quality, to screen the optimum preparation technique for Penyanjing film-coated tablet and choose eligible method in use of its quality control.Methods Orthogonal experiment, parallel control experiments were used to investigate the parameters that included the extraction time, the amount of water added, the frequency of extraction, alcohol concentration of physic liquor during alcohol precipitation, relative density of physic liquor, and best optimization of extraction and alcohol precipitation conditions based on the yield of strong liquor and extracted peoniflorin, and selection trial was performed for concentration and drying conditions. In the molding process of film-coated tablet, hygroscopicity was used as an indicator, the type and amount of adjuvant, and molding methods were studied. Use thin-layer chromatography to discriminate Caulis Lonicerae, dandelion, Rhizoma Cibotii and active ingredient paeoniflorin, the heavy metal, arsenic salt and other relevant items of tablet were checked referring to official method. High performance liquid chromatography (HPLC) was used for contents determination; the methodology for determination of active ingredient paeoniflorin was investigated.Results The best extraction condition is to extract twice, imbitition amount is ten times, eight times and extract time is two hours; the best alcohol precipitation condition is the relative density of physic liquor is 1.25, alcohol concentration is 65%; the best drying condition is decompression concentration and vacuum drying at 60 to 70℃. The optimal molding process is:silica powder, microcrystalline cellulose and starch are mixed in the ratio of 3:3:8 as adjuvants, then underwent pelletization and tabletting. Each tablet weighs 0.65g. Environmental humidity of tabletting should be controlled at below 66%. HPLC was performed for the determination of paeoniflorin, the average recovery was 97.88%, RSD=0.80%.Conclusion Optimal process parameters in accordance with Penyanjing film-coated tablet can set the maximum to ensure the clinical efficacy of this compound, in line with the quality control of the relevant provisions. The process is reasonable, workable, stable, and can be used to quality standards, stability, efficacy, toxicology, clinical research. Quantitative and qualitative analysis methods is rapid, accurate, reliable and can be uaed to process and stability syudies.