Study On The Production Technology And Quality Control Of Salviae Miltiorrhizae ET Rhizoma Ultrafine Powder

Salviae miltiorrhizae et rhizoma ultrafine is the dried root and rhizome of salviae miltiorrhizae et rhizoma ultrafine.The results showed that lipid soluble tanshinone and water soluble phenolic acid were the main pharmacodynamic components of salvia miltiorrhiza.In this paper,a new Chinese herbal medicine decoction form-salviae miltiorrhizae et rhizoma ultrafine powder,will be proposed,namely salviae miltiorrhizae et rhizoma ultrafine powdered into ultrafine powder.The process was adjusted by the effect of particle size,and based on the content of tanshinone and salvianolic acid B which was determined by HPLC to study the quality contral and dosage of salviae miltiorrhizae et rhizoma ultrafine.The main research contents and results are as follows:1.Production technology of salviae miltiorrhizae et rhizoma ultrafine powder.The raw materials were crushed by ultra-fine grinding technology,and the influencing factors in the pulverization process were investigated with the particle size determination results of ultra-fine powder.The results showed that the raw materials needed to be dried for 2 hours before pulverization,and the ultra-fine grinding time was 45 minutes.2.Quality control of salviae miltiorrhizae et rhizoma ultrafine powder.?1?The traits,identification,examination and extract of this salviae miltiorrhizae et rhizoma ultrafine powder were determined in accordance with the relevant methods Shandong Province Chinese Herbal Medicine Standard 2012 edition.The results showed that the characters of salviae miltiorrhizae et rhizoma ultrafine powder were reddish-brown powder with slight smelling,bitter and astringent taste.There was no complete cell morphology,but yellow-brown and broken cell walls were visible by microscopic identification.Water was only 13.0%,total ash was 7.0%,acid-insoluble ash was only 3.0%.And sulfur dioxide residue was only 150 mg/kg.Among the heavy metal,lead was no more than 5 mg/kg,cadmium was no more than 0.3 mg/kg,arsenic was no more than 2 mg/kg,mercury was no more than0.2mg/kg,and copper was no more than 20 mg/kg.Water-soluble extract was not less than 35.0%,and alcohol-soluble extract was not less than 15.0%.The relative dissolution of tanshinones was not less than70.0%.?2?The content's determination of tanshinones and salvianolic acid B by HPLC.The chromatographic conditions for the determination of tanshinones were Agilent 1100 high performance liquid system,and the column was Welch Lunxu UltimateXB-C18?4.6*250 mm,5?m?with acetonitrile as mobile phase A and 0.02%phosphoric acid solution as mobile phase B to gradient elution.The flow rate was of 1.2 ml/min,detection wavelength of 286 nm,and column temperature of 20?.The chromatographic conditions for the determination of salvianolic acid B were Agilent 1100 high performance liquid system,and the column was Welch Moon Xu UltimateXB-C18?4.6*250 mm,5?m?,but the mobile phase of acetonitrile set-0.1%phosphoric acid solution?22:78?.The flow rate was of 1.2ml/min,detection wavelength of 286 nm,and column temperature of 20?.The total contents,according to the results of determination of tanshinone II_A(C₁₉H₁₈O₃),cryptotanshinone(C₁₉H₂₀O₃)and tanshinone I(C₁₈H₁₂O₃)was not less than 0.25%,and salvianolic acid B(C₃₆H₃₀O₁₆)was not less than 3.0%.?3?The methodology for the determination of tanshinone and salvianolic acid B was vertified,and the results showed that this method had good and available accuracy,linearity and range,specificity,system applicablity,precision and durability,which proved the feasibility of the method.?4?Usage and dosage of salviae miltiorrhizae et rhizoma ultrafine powder.Dissolution of tanshinones and salvianolic acid B by measuring the salviae miltiorrhizae et rhizoma ultrafine powder brewing at different water temperatures?50?,80?,100??for 10 minutes,15minutes,20 minutes.Dissolution of tanshinones and salvianolic acid B was determined by measuring the salviae miltiorrhizae et rhizoma ultrafine powder in different dissolved media?pH1.2 hydrochloric acid solution,pH4.5 phosphate buffer and pH6.8 phosphate buffer?;The extraction and transfer of tanshinones and salvianolic acid B were compared by salviae miltiorrhizae et rhizoma ultrafine powder and decoction the traditional pieces of salviae miltiorrhizae et rhizoma ultrafine,according to the clinical prescription dosage of traditional pieces and according to the principle of active ingredients?tanshinones and salvianolic acid B?,the dosage of salviae miltiorrhizae et rhizoma ultrafine powder was calculated.About 2/3 of the amount of traditional decoction pieces?ie 6¹0 g?,the usage is“blown,served or taken with the formula granules”,and it is recommended to brew with hot water and take it after meals.This topic provides a theoretical basis for the clinical application of this product through theinvestigation of the ultrafine pulverization process of salviae miltiorrhizae et rhizoma ultrafine,the determination and verification of the main quality control items,and the exploratory research on the usage and dosage of salviae miltiorrhizae et rhizoma ultrafine?superfine?powder.And provides a feasible idea for the research and development of ultrafine powder.