Study On The Preparation Technology And Quality Standard Of Yiqijiangzhi Granule

Hyperlipidemia,one of the important risk factors for cardiovascular and cerebrovascular diseases,is a symptom of elevated serum lipid and lipoprotein levels caused by abnormal lipid metabolism.It is common among elders.However,with the increase of social pressure,the imbalance of dietary nutritional status and the growth of alcohol consumption and smoking,the prevalence of hyperlipidemia is rising steadily.The success of research and development of effective hyperlipidemia treatment drugs have a great contribution to the development of human health.On the basis of the overview of the effective ingredients,prescription and traditional Chinese medicine preparations we summarized,which have the effect of regulating lipid metabolism,the preparation process and preliminary quality standard of the Yiqi Jiangzhi granules were studied,which is a new Chinese medicine preparation.Objective:Yiqi Jiangzhi granules,consisting of ten ingredients:Ginseng,Jiang Huang,Tangerine Peel,Pollen Cattail,Lotus Leaf,Hawthorn,Bran,Rhizoma Atractylodis Macrocephalae,Rhizoma Alisma,Laminaria and Cassia Seed,has the effect of Invigorating Qi and invigorating the spleen,activating blood and removing blood stasis,and good therapeutic effect on hyperlipidemia.This research is based on the prescription of traditional Chinese medicine,combined with modern Chinese medicine preparation technology.After the extraction and purification,we made the extract into granuless.Then we conducted a preliminary study on the quality standard of the preparation,striving to provide safe,effective and convenient traditional Chinese medicine preparation for the hyperlipidemia.Method:This study mainly includes the preparation of Yiqi Jiangzhi granules and the preliminary study of the quality standard.The main methods are as follows:(1)Curcuma:The curcumin ethanol immersion extraction rate as index,orthogonal test design,soaking process study of Curcuma ethanol.(2)Ginseng,and dried tangerine:Established a HPLC method for the determination of alcohol extract of peel of ginsenoside Rg1,ginsenoside Re and ginsenoside Rb1 and hesperidin.Ginsenoside Rg1,ginsenoside Re and ginsenoside Rb1 and hesperidin extraction rate as the index,optimize the process by using orthogonal test.(3)Pollen Typhae and other water extracts:Established a HPLC method for determination of water extracts of pollen Typhae typhaneoside and isorhamnetin-3-Pneohesperidin,aurantio obtusin-6-O-glucoside.Taking typhaneoside and isorhamnetin-3-Oneohesperidin,aurantio obtusin-6-O-glucoside extraction rate as index,we investigated the extraction of pollen with the single factor and orthogonal experiment.(4)Moulding:Granuless was the prescription formulation.Making granules fluidity,moisture rate,particle forming rate,soft material properties as parameters.We also studied the the critical relative humidity of granuless to provide reference for control of environmental humidity in the process of granules preparation.(5)Identification:We set up a TLC method for qualitative identification of Yiqi Jiangzhi granules ginseng,Jiang Huang,tangerine peel,cassia seed,pollen,lotus leaf,hawthorn,and bran fried atractylodes;and we make use of the test tube reaction to the Yiqi Jiangzhi granules for qualitative identification of kelp.(6)Determination:We used UPLC-MS/MS technology to determine ginsenoside Rg1,ginsenoside Re,ginsenoside Rb1,typhaneoside,hesperidin,isorhamnetin-3-O-neohesperidin,aurantio obtusin-6-O-glucoside,curcumin.(7)Examination:According to the 2015 edition of China Pharmacopoeia,the related items of Yiqi Jiangzhi granules were investigated.Result:(1)Curcuma:The soaking optimum was B1 times the amount of A2 extracted for D2 times,C1 hours each time.(2)Ginseng,and dried tangerine:The linearity,stability,precision and accuracy of the HPLC method are all in accordance with the requirements.The optimum extraction technology of ginseng and Pericarpium Citri reticulata is:F3 times,E2,H3 times of reflux,G1 hours each time,and there is little difference between the three parallel experiments,which shows that the process is stable and feasible.(3)Pollen Typhae and other water extracts:The linearity,stability,precision and accuracy of the HPLC method are all in accordance with the requirements.The optimal process for the extraction of pollen Typhae separately as I3 times the amount of water,reflux extraction J times,K3 h each time,with water extract and concentrated to the relative density of L3(60℃),the concentration of ethanol is M2,let rest N3 h.(4)Moulding:Wet granulation,dextrin as excipient,P as a supplement,uniform mixing,T ethanol as wetting agent,soft material,sieving and granulation,drying at 60 degrees,and whole grain.The relative humidity of the environment should be controlled below V during the whole particle preparation process.(5)Identification:The qualitative identification of the ginseng,Jiang Huang,tangerine peel,cassia seed,pollen,lotus leaf,hawthorn,bran fried Atractylodes,Rhizoma alismatis,kelp has strong specificity.Control samples in the corresponding position of material had the same color spots with good separation,while negative control without interference.(6)Determination:Regression equations of ginsenoside Rg1,ginsenoside Re,ginsenoside Rb1,typhaneoside,isorhamnetin-3-O-neohesperidin,hesperidin,aurantio obtusin-6-O-glucoside,curcumin were Y=35.5467 X-41.0527(r=0.9998)、Y=21.2182 X-83.5767(r=0.9996)、Y=58.6352 X-130.663(r=0.9996)、Y=1027.01 X+956.703(r=0.9993)、Y=1695.25 X+5538.88(r=0.9990)、Y=1392.21 X+45380.2(r=0.9990)、Y=3947.57 X-9292.51(r=0.9999)、Y=446.023 X+17976.6(r=0.9991),respectively.And they showed good linear relationship in the range of 13.08～104.64、11.88～118.80、14.74～132.65、47.47～414.72、35.14～351.36、492.80～4928.00、15.92～159.20、161.60～1454.40 ng/mL,respectively.The specificity,stability,precision and accuracy of the method are all up to the requirements.(7)Examination:the appearance,granularity,moisture and solubility of Yiqi Jiangzhi granuless were in accordance with the relevant provisions of the 2015 edition of China Pharmacopoeia.Conclusion:In order to guarantee the quality of the preparation,we studied the extraction,purification and preparation process of Yiqi Jiangzhi granuless,and established a stable and feasible preparation process,and prepared qualified granuless.And the qualitative identification and content determination method of Yiqi Jiangzhi granules were established by relevant research on its quality standard.In all,this study has achieved the intended purpose of experimental research.