The Research And Development Of Wuzhuyu Decoction Compound Granules

Objective:To optimize extraction process and establish the quality standard of Wuzhuyu decoction compound Granules.Moreover,to compare the content of index component and the fingerprint from compound granules,formula granule and tradition decoction in the Wuzhuyu decoction.Which provide a reference for rational development and clinical application of Wuzhuyu decoction compound Granules.Methods:1.Evodia rutaecarpa,zinger officinale roscoe,Ginseng Radix et Rhizom and Zizyphus jujuba were determined according to the requirements from Pharmacopoeia of People's Republic of China,which make sure the quality of the raw materials.2.Taking evodiamine,rutaecarpine,ginsenoside Re,ginsenoside Rb1 and dry extract rate as indexes,L9(34)orthogonal test was adopted to investigate effects of the amount of water,boiling time and decocting times on water extraction process.Contents of evodiamine,rutaecarpine,ginsenoside Re,ginsenoside Rb1 were determined by HPLC.3.TLC was used for the qualitative identification of Evodia rutaecarpa,zinger officinale roscoe and Ginseng Radix et Rhizom.HPLC was used to simultaneously determine the contents of evodiamine,rutaecarpine,ginsenoside Re and ginsenoside Rb1.4.The content of evodiamine,rutaecarpine,ginsenoside Re and ginsenoside Rb1 in the three forms of Wuzhuyu decoction was determined and compared.5.A method was established to analyze and compare the fingerprint from compound granules,formula granule and tradition decoction in the Wuzhuyu decoction by HPLC.The common chromatographic peaks were determined based on their fingerprint,and the similarity results of three forms of Wuzhuyu decoction were analyzed and compared.Results:1.The testing result of Evodia rutaecarpa,zinger officinale roscoe,Ginseng Radix et Rhizom and Zizyphus jujuba were in accordance with the requirements from Pharmacopoeia of People's Republic of China.2.Optimum extraction conditions were as follow:soaked in water for 1h,and decocted triple with 12 times the volume of water.1h per time.Moreover,the vacuum concentration(80?),spray drying(Inlet air temperature of 152? and outlet air temperature of 80?)and pelletizing were taked to prepara the Wuzhuyu decoction compound Granules.3.TLC spots were clear and well-separated without negative interference.HPLC experiment showed that the average content of evodiamine,rutaecarpine,ginsenoside Re and ginsenoside Rb1 of Wuzhuyu decoction compound granule were 0.319 ?0.341?1.246?2.388mg·g-1,and the method to determine content was established by HPLC.4.The total content of evodiamine and rutaecarpine from compound granules and formula granule were 47.32,13.49 mg·L-1,was 3.75 times and 1.07 times higher than tradition decoction that was 12.60 mg·L-1,and the total content of ginsenoside Re and ginsenoside Rb1 from compound granules and formula granule were 335.23,345.28mg·L-1,was 1.09 times and 1.12 times higher than tradition decoction that was 307.39mg·L-1.5.A method was established to analyze and compare the fingerprint from compound granules,formula granule and tradition decoction in the Wuzhuyu decoction by HPLC.32,35,34 common Chromatographic peaks were determined based on their fingerprint in the three forms of Wuzhuyu decoction by using Similarity Evaluation System for Chromatographic Fingerprint of TCM(2012A).The similarity results of three forms of Wuzhuyu decoction were analyzed and compared,and the results showed that the similarity was all higher than 0.9.The species diversity of the chemical composition was smaller,and the content of the chemical composition exist a certain differences.Conclusion:Optimized extraction process of Wuzhuyu decoction compound Granules is stable,simple and feasible.The method,to establish the quality standard for Wuzhuyu decoction compound Granules,is simple,accurate and reliable with good precision.It can be used for the quality comprehensive control of Wuzhuyu decoction compound Granules.By the comparison of the content of index component and the fingerprint between three forms of Wuzhuyu decoction,the results show that the similarity is high,and the species diversity of the chemical composition was smaller,however,the content of the chemical composition exist a certain differences.In a word,the comprehensive research on Wuzhuyu decoction compound Granules can provide the reference and significant guiding for rational development and clinical application of Wuzhuyu decoction compound Granules.