The Study On Preparation Process And Quality Standard Of JIE-du-chu-shi Concentrated Pills

Objective: To study the extraction,molding process and establish quality standards of Jie-du-chu-shi concentrated pills.Methods:(1)Using single factors experiment with central comosite design-response surface method,the components of Matrin e,Verbascoside,total polysaccharides and extraction rate as index.The extracting times,independent variables,immersion time and water addition times were investigated to optimizing the extraction process of Astragali radix and other medicinal materials.(2)Confirm the optimal molding process of Jie-du-chu-shi concentrated pills.(3)Using thin-layer chromatography technique distinguish all Chinese medicinal materials of Jie-du-chu-shi concentrated pills.(4)Using high performance liquid chro matography methods to ensure the component of Obacunone,fraxinellone,Tanshinone ⅡA and Matrine.The methodology was investigated and the quality standards was established.Result:(1)The optimum extraction conditions of Jie-du-chu-shi concentrated pills were soak for 45 minutes for two times with 12 fold water and 120 minutes per time.(2)The optimum molding process Jie-du-chu-shi concentrated pill s were as follows: Dictamni cortex,Phellodenderi Amurensis cortex were crushed into fine power.The aqueous extract was concentrated to a thick paste with a relative density of 1.20(70℃).(3)A thin-layer chromatography method for the identification of Jie-du-chu-shi concentrated pills in Dictamni cortex,Phellodenderi Amurens is cortex,Salvia miltiorrhizae radix,Atraaylodes macrocephale Rhizoma was Established.(4)The high performance liquid chromatography method for determining the content of Obacunone,fraxinellone,Tanshinone ⅡA and Matrine.The chromatographic conditions of Obacunone,fraxinellone,Tanshinone ⅡA were as follows: the mobile phase was [0-20 min methanol-acetonitrile-water(2:43:55);20-25 min acetonitrilewater(65:35);30-50 min acetonitrile-water(65:35)],the flow rate was 1ml/min.the detection wavelength of UV detector was 236 nm and 276 nm.The chromatographic conditions of Matrine: the mobile phase was methanol-acetonitrile-Phosphate buffer-triethylamine(7:15:78:0.1),the detection wavelength of UV detector was 220 nm,the column temperature was 30℃,the flow rate was 1ml/min respectively.Conclusion:The preparation process of Jie-du-chu-shi concentrated pills was reasonable and feasible;the quality standards establishment was simple,reliable and stable that can control the quality of the preparation effectively.