Preparation Of The Root Of Mallotus Apelta Formula Granules Of Zhuang Medicine

Objective: According to the guidance of TCM theory and combined with modern pharmaceutical technology,root of Mallotus apelta decoction was developed into formula granules.Exploring the forming process of formulation granules,the quality standard and stability in vitro bacteriostasis test of the formula granules were studied comprehensively and deeply,in order to provide reference for the rational development and clinical application of the root of Mallotus apelta formula granules.Methods:1 Studies on the preparation processStudy of extraction process,the content of total flavonoids as the evaluation index,the concentration of ethanol,the ratio of material to liquid and the time of extraction were used as the investigation factors.An orthogonal experiment was used to optimize the ethanol extraction process of the root of Mallotus apelta,and the ethanol extraction process is tested.The water extraction process is optimized by adding the amount of water,extraction time and extraction times.The standard decoction of white back leaf root was prepared according to the decoction method of clinical decoction.Study on dtying process,the appearance of the dried material is used as an inspection indicator,and the parameters such as inlet temperature,relative density and material flow rate of spray drying process were investigated tooptimize spray drying process.Molding process research,the dry powder obtained by spray drting is used as raw material,ang the granules is granulated by dry method.Enlarge pilot,according to the established process flow,six batches of amplification pilot production.2 Study on quality standard and stabilityAccording to the method of “Chinese Pharmacopoeia”,the differences in particle size,moisture,solvency,and loading capacity of the root of Mallotus apelta formula granules were examined.TLC identification method was used to study the thin layer identification of the root of Mallotus apelta formula granules.The determination method of total flavonoids is established by ultraviolet spectrophotometry.The fingerprint method was established by HPLC.After studying the wavelength,extraction solvent,extraction time and mobile phase,the chromatographic condition of HPLC was finally determined.Review of stability,the influence factor test,accelerated test and long-term test the root of Mallotus apelta formula granules were carried out.3 Study on the antibacterial activity of the root of Mallotus apelta formula granules in vitroIn this experiment,the gradient dilution method was used to investigate the minimum inhibitory concentration(MIC)of the root of Mallotus apelta formula granules for staphylococcus aureus,staphylococcus aureus,escherichia coli,enterococcus faecalis,pseudomonas aeruginosa,and multi drug resistant acinetobacter baumannii(Bauman).1 Studies on the preparation processFinally,the optimized ethanol extraction process is: the ethanol concentration is 65%,the ratio of the material to liquid is 1:8,the extraction time is 1h,and the extraction time is twice.Water extraction process is:for the first time,we add 9 times of water,and then add 7 times water for the second time,and extract 30 min each time.The spray drying process parameters are: the relative density of liquids1.12(70℃);inlet air temperature182℃;exhaust temperature 120℃;material flow rate: 17 rmp.The molding process is: dry granulation process parameters are : the roller pressure is 0.5 bar,the feeding speed is 4.5 rpm,the grain speed is 35.2rpm,and the roller speed is 18 rpm.The sample of the six batch conforms to the relevant provisions under the granule.2 The study results of quality standard and stabilityGranularity,moisture,solubility and quantity difference of the samples in the six batches are all in accordance with the relevant provisions under the granule.A TLC identification method for the root of Mallotus apelta formula granules has good identification,strong specificity,clear spots and negative interference.A method for content determination by UV spectrophotometry.Methodological investigation shows that the concentration of rutin has a good linear relationship in the range of 3.5-20.9μg/ml.The standard curve equation is: y=-0.0099+0.0450 x,r=0.999492.Precision test RSD0.138%,repeatability test RSD 1.52%,the average recovery rate is 98.29%,and RSD is 0.80%.The results of fingerprint : the detection wavelength was 254 nm,theResults:column temperature was 35℃,the flow rate was 0.8ml/min,the sample size was 10 ul,and acetonitrile(A)-0.1% phosphoric acid water(B)gradient elution.There are six characteristic peaks in the eight batches of samples,a total of one active ingredient was identified and peak six was epigallocatechin gallate.After six consecutive months of quality stability,the grain size,water,solubility,flavonoids content and other indexes of the six batches of the root of Mallotus apelta formula granules were not significantly changed.3 Comparison of formula granules and traditional decoctionThe total flavonoid transfer rate of the ethanol extract formula was91.05%.the transfer rate of standard decoction was 89.95%.The transfer rate of water-mentioned formula granules was 87.54%.Number and peak height of the formula granule and traditional decoction are similar.Compared with the water extract formula granule and standard decoction,the ethanol extract granule was obviously deficient.4 Study on the antibacterial activity of the root of Mallotus apelta formula granules in vitroThe minimum inhibitory concentration(MIC)of ethanol extract the root of Mallotus apelta formula granules to staphylococcus aureus,staphylococcus aureus,escherichia coli,enterococcus faecalis,pseudomonas aeruginosa,multi drug resistant acinetobacter baumannii(MIC)are: 15.63、15.63 、 62.50 、 12.50 、 15.63 、 15.63mg/ml;The minimum inhibitory concentration(MIC)of water extract the root of Mallotus apelta formula granules to staphylococcus aureus,staphylococcus aureus,escherichia coli,enterococcus faecalis,pseudomonas aeruginosa,multi drug resistant acinetobacter baumannii(MIC)are : 31.25、15.63、62.50、250.00、62.50、31.25 15.63mg/ml;and the minimum inhibitory concentration(MIC)of thestandard decoction to staphylococcus aureus,staphylococcus aureus,escherichia coli,enterococcus faecalis,pseudomonas aeruginosa,multi drug resistant acinetobacter baumannii(MIC)are: 31.25、31.25、12.50、250.00、62.50、31.25 mg/ml.Conclusion: The process parameters of the root of Mallotus apelta formula granules are clear and preparation technology is reasonable.The quality could accurately perform the qualitative and quantitative analysis and effectively control the quality of product.The antibacterial effect of ethanol extract the root of Mallotus apelta formula granules is better than that of water extraction granule and standard decoction.There is no significant difference in antibacterial effect between water extract granule and standard decoction.