Study On The Production Technology And Quality Control Of Ultrafine Powder Of Rhodiolae Crenulatae Radix Et Rhizoma

Rhodiolae Crenulatae Radix et Rhizoma is the dry root and rhizome of the large flower Rhodiolae Crenulatae Radix et Rhizoma of the genus Sedum.Rhodiolae Crenulatae Radix et Rhizoma has the name of “plateau ginseng” because the main component of Rhodiolae Crenulatae Radix et Rhizoma,salidroside,has anti-hypoxia function and can increase blood oxygen content,so Rhodiolae Crenulatae Radix et Rhizoma can relieve altitude sickness very well.Rhodiolae Crenulatae Radix et Rhizoma not only has anti-hypoxia function,but also anti-radiation,anti-aging,anti-tumor,and improve memory.This paper mainly studies the production technology of Rhodiolae Crenulatae Radix et Rhizoma ultrafine powder,and carries on the quality research,formulates the draft quality standard of Rhodiolae Crenulatae Radix et Rhizoma ultrafine powder.The main contents and results are as follows:1.The production process of Rhodiolae Crenulatae Radix et Rhizoma ultrafine powderTaking the particle size as the index,the process parameters of pre-drying time and pre-drying time of Rhodiolae Crenulatae Radix et Rhizoma were investigated.The results showed that the original medicinal materials were coarsely crushed and dried at 80℃ for 2.5 h and vibrated mill for 30 min.2.Quality control of Rhodiolae Crenulatae Radix et Rhizoma ultrafine powder(1)According to the Chinese Pharmacopoeia 2015 edition of the second Rhodiolae Crenulatae Radix et Rhizoma ultrafine powder standard and the four general rules for the traits,identification(microscopic identification,thin layer identification),inspection(moisture,total ash,acid-insoluble ash,sulfur dioxide residue,relative dissolutionthe,minimum amount of the sample)and the extract were measured.As a result,the product was a taupe powder.Aroma,slightly bitter,and sweet;compared with the control,the spots of the same color,and the blank does not interfere;moisture ≤ 12.0%,total ash ≤ 8.0%;acid insoluble ash ≤ 2.0%;relative dissolution ≥ 85.0%;sulfur dioxide residue ≤ 150 mg/kg;leachate ≤ 22.0%.(2)The content was determined by high performance liquid phase method.The chromatographic conditions were: Agilent 1100 high performance liquid phase system,the column was Welch Yuexu UltimateXB-C18 [column length: 250 mm,inner diameter: 4.6 mm,particle size: 5 μm ],the mobile phase was methanol-water(19:81),the flow rate was 1.0 mL/min,the injection volume was 10 μL,and the detection wavelength was 275 nm.Methodological verification results: accuracy(92% to 105%),precision(RSD: ≤ 2%),system suitability(separation 30.0,number of plates 15874),durability,specificity,linear relationship [Y(Peak area)=-1110000.0 + 40174800.0 × X(mg / ml)(r = 0.9998,n = 5)] are good,in line with the requirements(3)Taking salidroside as an indicator,HPLC method was used to compare and determine the content of salidroside in traditional tablets of Rhodiolae Crenulatae Radix et Rhizoma and Rhodiolae Crenulatae Radix et Rhizoma ultrafine powder.According to the ratio of migration,the dosage of Rhodiolae Crenulatae Radix et Rhizoma ultrafine powder was determined.It is 1/3 of the amount of traditional decoction pieces(ie 1~2 g);the water temperature(40℃,60℃,80℃,100℃)and the brewing time(5 min,10 min,15 min,20 min)The investigation confirmed that the salidroside powder could be brewed in warm water for 20 min;The dissolution curve of salidroside in different dissolution media(pH 1.2 hydrochloric acid solution,pH 4.5 phosphate buffer,pH 6.8 phosphate buffer)was determined by simulating the pre-meal meal and the meal.The product can be taken at any time without being affected by the meal or not.This project aims to solve the dilemma that Rhodiolae Crenulatae Radix et Rhizoma can not be taken safely during the practical application of altitude sickness.Through the research on the parameters of ultrafine grinding process,the suitable production process was determined,and the quality standard of Rhodiolae Crenulatae Radix et Rhizoma ultrafine powder was researched and formulated,which provided the research foundation for the future research of Rhodiolae Crenulatae Radix et Rhizoma ultrafine powder.