Study On The Technology And Quality Standard Of Yiwei Granules

Based on Yiwei Decoction,Yiwei Decoction Granules as Research Objects,Study on the best preparation process of Yiwei Granules,Establish quality standards for the formulation,And compare the fingerprint of Yiweitang standard decoction and Yiweitang compound granules,Exploring the similarities and differences between the two,providing experimental basis for the development of new drugs.Using ultra-high performance liquid chromatography(UPLC),the extraction amount and the creaming rate of verbascoside and ruthenium saponin as indicators.Taking the amount of water added,boiling time and boiling times as the influencing factors,the L9(34)orthogonal test method was used to optimize the optimal water extraction process of Yiwei Granules.Investigate concentration pressure and temperature And freeze-drying pre-freezing time and Main drying time,The best concentrated drying process of Yiwei Granule is preferred.Taking the formability,melting property and hygroscopicity of the particles as an indicator.The amount of auxiliary materials,the proportion of excipients,and the concentration of ethanol are the influencing factors.L9(34)orthogonal test method is selected,and the optimal preparation process of Yiwei Granule is preferred.According to the provisions of the Chinese Pharmacopoeia 2015 granules.Study on the properties,inspection,thin layer and content of Yiwei Granules.Preparation of 15 batches of Yiwei Granules and Yiwei Standard Decoction.Measuring the chromatogram with UPLC,Import data into Chinese medicine chromatographic fingerprint similarity evaluation system software(2012A)and automatically generate control map,Establishing the fingerprint of Yiwei Standard Decoction and Yiwei Granule,Compare the comparison maps of the two,The similarity was evaluated and the attribution peak was analyzed.After screening,Determination of the preparation process of Yiweitang compound granule,Add 12 times the amount of water,decoct 1 time,each time for 2 hour,then concentrate under reduced pressure(80?),Freeze-drying(pre-freezing temperature:-80?,pre-freezing time:12h,separator temperature:5?,vacuum:1.030 mba,drying time:48h),Add 50%excipients,The ratio of dextrin to lactose is 1:1,The concentration of ethanol is 85%,and the stomach is made of Yiwei Granules.In the quality standard study,the traits of Yiwei Granules are brown granules,and the color was all dry,no moisture absorption and no deblocking.The average moisture content in the inspection is 5.47%,which is less than the specified 8.0%;The average value of the sum that cannot pass through the No.1 sieve and the pass No.5 sieve is 7.10%,less than 15%;After the sample was added with water 200ml and stirred for 5 minutes,all three batches were completely melted,and the batch was slightly turbid,which met the requirements;The average extract content was 61.38,?50.0;the average loss on drying was 0.40%,less than 2.0%.The thin layer is identified in the chromatogram of the test sample,and the same color spot is displayed at the position corresponding to the chromatogram of the reference substance.The content of verbascoside in the content determination was 0.292 mg·g-1,and the content of saponin was 4.448 mg·g-1.The average creaming rate of the standard decoction in the creaming rate is 20.13%.The average creaming rate of Yiwei Granules was 24.77%.The rate of transfer rate is 123%.The yield of the intermediate prepared is within the specified range.Among the index component transfer rates,the average content of Yiwei standard decoction verbascoside is 6.486mg/L.The average content of the musk granules of Yiwei Granules is 7.907 mg/L.The transfer rate of Yiwei Standard Decoction to Yiwei Intermediate is 122%.The average content of total saponins in standard decoction is 113.1 mg/L.The average content of total saponins in Yiwei Granules was 119.52mg/L.The rate of gra:in transfer from Yiwei Standard Decoction to Yiwei Intermediate is 106%.The intermediate transfer rate obtained is within the specified range.Fingerprint comparison,Established fingerprints of 15 batches of Yiwei standard decoction,and identified 16 common peaks.The similarity between the 15 batches of standard decoction fingerprints is greater than 0.900,And use the similarity evaluation software to generate a control fingerprint of Yiwei standard decoction.Establish a fingerprint of Yiwei Granule and identify 16 common peaks,The similarity between the control fingerprint of the Yiwei Granule fingerprint and the standard decoction fingerprint was 0.912.It indicates that the similarity is good and is within the acceptable range of fingerprint similarity.In the analysis of the attribution peak,the peaks 1,2,3,5,6,and 8 are the exclusive peaks of Rehmannia,And the peak of the 6th is the Verbascoside.Peaks 9,14,15,and 16 are the exclusive peaks of Ophiopogon japonicus.And the peak No.9 is saponin D,No.15 peak is methyl amylose flavonoid A.Peaks 4,10 and 11 are the exclusive peaks of Radix.7,12,13 are the exclusive peaks of Polygonatum.The preparation process of Yiwei Granules screened in this paper is simple and stable,the quality standard method is simple,the specificity is strong,the result is accurate,and the quality can be controlled comprehensively and effectively.Through the comparison of Yiwei standard decoction on the creaming rate,index component and fingerprint of Yiwei Granule,the results show that the designed Yiwei Granule meets the principle of quality consistency and can be used as the quality standard of Yiwei Granule.