Study On Preparation Process Of Xia Kangjian Powders Of The Chinese Medcine’s New Product

Objective:Through studying on preformulation,Prescription screening,Preparation process,verification via pilot magnification,Intermediate Characteristics with its quality standards established,selecting the best preparation process of Xia Kangjian powders.To control more effectively the quality of the Xia Kangjian powders provides a scientific basis,guaranteeing its effectiveness in shrimp farming applications.Methods:1.Preformulation Research:According to the current standard of Chinese Pharmacopoeia of 2015 version,a review of the relevant literature and the existing experimental basis,prescription analysis to determine the appropriate dosage.2.Prescription Screening Research:With survival ratio,body length and weight as the main investigation index,regular feeding and multiple prescription’s aqueous extract add to feeding will be observed on effect of white shrimp of growing and survival ratio by comparison;than selecting the best prescription.3.Detection methods for the determination of emodin and chlorogenic acid of extract of Xia Kangjian by high performance liquid(HPLC):Referring to detection method of related medicines under the Chinese Pharmacopoeia of 2015 version to establish an appropriate method of chromatographic conditions.4.Preparation process Research:With emodin and chlorogenic acid content and dry extract ratio as the indexes of quantification,determiningextraction solvent,combining single factor and orthogonal test to investigate the number three factors of the amount of solvent,extraction time and times on effect of the extraction process,optimizing extraction process of Xia Kangjian.With emodin and chlorogenic acid’s content and its corresponding retention rate as indexes,comparing two kinds of ways of the atmospheric concentration and concentrated under reduced pressure to determine the concentration process.With emodin and chlorogenic acid’s content and its corresponding retention rate as indexes,comparing three kinds of ways of Oven drying,vacuum drying and spray drying to determine the drying process.With situation of sticky wall,moisture conditions,the melting of performance as indexes,the type and amount of materials will be screened to establish molding process.5.Study on pilot scale : In GMP pharmaceutical amplified test,the small best technology will be verified.6.Study on intermediate product characteristics : Xia Kangjian prowders’ intermediates of pilot production will be studied about relevant characteristics.According to pilot process to produce product.Referring to the general powders Inspection of Chinese Pharmacopoeia of 2015 version and China Veterinary Pharmacopoeia of 2010 edition,experiment will study intermediates of Xia Kangjian of traits,moisture,particle size,melting of the angle of repose,critical relative humidity(CRH),qualitative and quantitative analysist and microbial limit.7.Study on intermediate product’s quality standards.Results:1.Preformulation Research:.this subject used herbs are in line with the 2015 edition of Chinese Pharmacopoeia under the relevant provisions,the dosage form determine powder.2.Prescription Screening Research:Compared with the control groupA,group B,C,D,E and F survival rates have improved by 14%,24%,22%,10%,22%,the lowest survival rate of the control group A has only 26%.Relative growth rate and relative growth rate of group C was 1962.86%and 190.8%,which are the highest in several groups,and its survival ratio has a significant difference with group A while its high survival rate surpasses D group,so choosing prescription group C as the best prescription which named Xia Kangjian.3.Detection methods for the determination of emodin and chlorogenic acid of extract of Xia Kangjian by high performance liquid(HPLC):The mobile phase was methanol-0.1% phosphoric acid(80:20).In which the ratio of the mobile phase,the emodin sample peak can be baseline separated.The mobile phase was A acetonitrile-B0.4%phosphoric,gradient elution(0-15 min,10% A;15-40 min,100% A;40-50 min,60% A;50-60 min,10% A;60-75 min,10% A).In which the ratio of the mobile phase,the chlorogenic acid sample peak can be baseline separated.4.Preparation process Research:Determining extraction is solvent 60% ethanol.The best extraction technology is that medicinal material extracted threetimes,9 times amount of the 60% ethanol added in everytime,extract-ed for 60 min in everytime.Concentrated liquid use spray-dried(inlet temperature=220℃,outlet temperature=105℃,peristaltic pumps=50ml/min).The type of accessories is dextrin,and Usage amount is 80% of dry extractrate.5.Study on pilot scale:After the pilot process to produce,an average yield is 85.0% in the test product.6.Study on intermediate product characteristics:Xia Kangjian powders’ intermediates trait can be defined as a tan to brown powder,gas aro-matic,bitter and slightly astringent.The average moisture content of 1.34%.The average particle size of percentage 98.03%.Melting observation Show dissolved fully and no turbidity.Repose angle of granules is 26oand CRH is 62%.In mangosteen TLC figure of intermediate products,the test sample and the reference drug corresponding position is the same color spots and negative control chromatography in the corresponding position is without spots.The average content of emodin and chlorogenic acid is0.4304mg/g and 2.2182mg/g respectively.Microbial limit test bacteria between 290~310cfu/g,mold and yeast between 50~60 cfu/g,which escherichia coli is not detected.7.Study on intermediate product’s quality standards:establish quality standards of Xia Kangjian,,which test items include:character,identification,inspection(moisture,particle size,melting properties),determination content.Conclusion:1.the best preparation process by Xia Kangjian Powders was as follows:medicinal ma-terial extracted three times,9 times amount of the 60% ethanol added in everytime,extracted for 60 min in everytime,filtering by 300 mesh filter cloth,recovered of ethanol under the reduced pressure and concentrated filtrate to a relative density ρ=1.15(20℃),and Usage amount is 80% of dry extractrate,joining dextrin mixed together,placed in spray drying(inlet temperature=220 ℃,outlet temperature=105℃,peristaltic pumps=50ml/min),the dry extract powder pass 100 mesh sieve,examination,the particles are distributed into300g/bottle.Medicinal plastic bottles need to sealed and placed in a cool dry place.2.Intermediate quality control standards can effectively control the powder mass before packaging,to provide protection for its productquality control.3.In the middle test,we know that Xia Kangjian powders’ preparation process is stable and reliable,and it can promiss the stability of Chinese medicine products.In addition,it is also Suitable for industrial mass production.