The Research Progarm Of Preparation Technology And Quality Standard Of Jintudi Uric Acid-lowering Particles

The source of Jintudi uric acid-lowering particles was new clinical prescription that summarized and created by Shurong Liu,chief physician of Jilin Provincial Academy of Traditional Chinese Medicine.After more than 5 years of clinical application,the prescription was proved to be effective.The prescription and production process were all from Jilin Jilin Provincial Academy of Traditional Chinese Medicine.The Academy has developed its own products.It does not involve the infringement of the property rights and interests of others.The prescription of Jintudi uric acid-lowering particles consists of Smilacis glabrae rhizoma,Lysimachiae herba,Pheretima,Rhei radixetrhizoma,Achyranthis bidentatae radix,Atractylodis rhizoma,Phellodenpri chinensis corte,Glycyeehizae radix et rhizoma praeparata cum mella.It has the advantages of heat dissipation,dehumidification and collaterals.It reduces the excretion of uric acid in the kidney by reducing the synthesis of uric acid in the body and has a significant effect on hyperuricemia.In order to ensure the effectiveness of the clinical preparation of this preparation and the stability of quality in the large-scale production process,this article has conducted in-depth research on its preparation process and quality standards,and established and improved the preparation process and quality standards program of Jintudi uric acid-lowering particles.The design of this program contains two parts.First of all,the main content of the production process is the selection of extraction process and molding process.Based on the clinical decoction administration method of this agent,the decoction extraction method was used in the extraction process,and the influencing factors of the extraction process,such as the amount of water added,the time of extraction,and the number of extraction,were investigated by orthogonal experiments.The rate and the content of astilbin are two indexes for the selection and optimization of the extraction process;the design of the molding process is based on the basic principle of the choice of dosage form,and the selection of the granule dosage form is determined by the clinical efficacy,the stability of the drug preparation and the facilitation of achievement conversion.The conditions of molding process were examined,and the preparation process of Jintudi uric acid-lowering particles was established.Secondly,in the program of quality standards,Smilacis glabrae rhizoma,Rhei radixetrhizoma,Achyranthis bidentatae radix,Phellodenpri chinensis corte,Glycyeehizae radix et rhizoma praeparata cum mella were used to carry on thin layer identification experiments;according to the "Chinese Pharmacopoeia"(2015 Edition),four general rules 0104 particle formulation effects.Under the inspection requirements,the preparation was examined;the aspirin was used as the index component in this preparation,and the HPLC determination technique was established;According to the principle of stability inspection,the granules were investigated for accelerated stability and room temperature stability for a period of 6 months.According to the research program,the results of the production process program:1 Extraction process use 15 times the amount of water boiling 3 times,2 hours each time;2 Molding process use extract powder and dextrin mixed by 1:1.25,85%ethanol is granulated as a wetting agent.The average particle angle of repose was 34.97°,the moisture absorption was small,and the amount of sweetener added was 1.5%in the inspection of the molding process,the results are meet the requirements.The results of the implementation of the quality standard research program:1 The TLC identification techniques for the medicinal materials of Smilacis glabrae rhizoma,Rhei radixetrhizoma,Achyranthis bidentatae radix,Phellodenpri chinensis corte,Glycyeehizae radix et rhizoma praeparata cum mella in this preparation were established;2 The differences in particle size,moisture,solvency,content uniformity were examined for the effect of the formulation,the results are meet the requirements of the four general rules of the Chinese Pharmacopoeia(2015 edition).3 HPLC determination technology of astilbin in Jintudi uric acid-lowering particles was established.The chromatographic conditions were established.Shimadzu VP-ODS(4.6x 150mm,5μm)was selected as the chromatographic column,and methanol:0.1%glacial acetic acid(32:68).Equivalent elution for the mobile phase,flow rate 1.0 mL/min,detection wavelength 291 nm,column temperature 30℃,detector is SPD-20A UV detector,the oretical plate number not less than 5000.The methodological evaluation showed a linear relationship between astilbin in the range of 0.04-0.64μg.The regression equation was Y=3×106X-6302.1,r=0.9999,the average recovery was 97.61%,and RSD was 1.57%(n=6).The content of astilbin in three batches of samples was determined,and the content limit was set to not less than 1.60 mg per bag.4 The results of the stability investigation meet the requirements of the"Chinese Pharmacopoeia"(2015 edition).5 The drafting of the draft quality standard for Jintudi uric acid-lowering granules was completed.Through the implementation of this research program,the Jintudi reduced uric acid was developed into a granule form from clinical traditional decoctions,which effectively improved the compliance of the patients in clinical treatment,and the convenience of carrying and storage.The implementation of this program ensures the feasibility of the production,preparation process of Jintudi uric acid-lowering granules and the controllability of product quality.This research has effectively explored the deep development and quality standardization of traditional experience.