| Chinese traditional formula granule is new dosage form for clinical use,which is based on traditional Chinese medicine theory,using pharmacopoeia standardized traditional Chinese medicine decoction pieces as ingredient and is on the basis of modern extraction process.It has the advantages of simple route of administration,high medicine utilization efficiency,convenient carrying and storage,adding and subtracting according to symptoms,accurate measurement,etc.However,it is still a big controversy regarding whether there is a difference in chemical composition and content between formula granules and traditional decoction,whether the method of administration needs to be improved to melt and then decoction,and whether it can replace traditional decoction pieces in clinical practice among different researchers.Therefore,this article compares the chemical composition and content of the formula granule decoction solution,formula granule dissolving solution and traditional decoction of Zhishi Xiebai Guizhi decoction,and compares the formula granules of different manufacturers,hoping to be a traditional Chinese medicine formula.The particle quality control and the rationality and safety of clinical use provide a reference basis.In this study,the author is going to use high performance liquid chromatography(HPLC)and high resolution mass spectrometry(MS)to study Zhishi Xiebai Guizhi decoction formula granules and traditional decoctions from two aspects,qualitatively and quantitatively,and establish analytical methods to lay the foundation for the quality research and clinical use of formula granules.The author is also going to adopt the analytical methods which can create the foundation for quality research and clinical use of formula granules.This dissertation was divided into five parts:Part one:literature reviewIn this study,the author will introduce the present situation,advantages and disadvantages of the researches on Chinese herbal formula granule,as well as doing the comparative studies on the chemical composition,pharmacological action and clinical curative effect between Chinese herbal formula granule and traditional decoction pieces.The author will also illustrate the recent researches on the chemical composition,pharmacological action and clinical curative effect of the traditional prescription Zhishi Xiebai Guizhi decoction.Therefore,this article chooses the classic prescription Zhishi Xiebai Guizhi decoction with large clinical dosage and definite curative effect as the research carrier,and uses chemical analysis technology to compare traditional decoctions and formula granules to analyze the differences between them.Part Two:The difference among Zhishi Xiebai Guizhi decoction granule,simple dissolved decoction solution and traditional decoctionIn order to figure out the differences between the Zhishi Xiebai Guizhi decoction granule and simple dissolved decoction solution,the author will melt the formula particles first and then do the decoction.In order to determine the formula granule decoction time,the author will use high performance liquid chromatography(HPLC)method to decoct the Zhishi Xiebai Guizhi decoction formula granules solution for 2 mins,5 mins,and 10 mins.The author will also do the measurement separately.The chromatographic Column will be carried out on Waters Symmetry (?) C18(4.6 x 250 mm Column)with gradient elution consisted of acetonitrile(A)and 0.3%phosphoric acid(B)as mobile phase at A flow rate of 1.0 mLˇmin-1.The Column temperature will be set at 30? and the detection wavelength will be set at 283 nm.The comparison will be made by using the similarity evaluation system of traditional Chinese medicine chromatographic fingerprint(2012.130723 version).After doing all the testing,the results showed that there was no difference in the similarity of the formula particles under the three different period,and all the results are over all of 0.95.The separately dissolved formula particles and combined decoction have high similarities,but decocting for 2 mins is in line with the characteristics of convenient taking of formula granules.By comparing different samples from the same batch,we can draw the following conclusions:the similarities between the two and the traditional decoction were low.Part Three:Qualitative and quantitative comparison between Zhishi Xiebai Guizhi decoction granule and traditional decoctionAccording to the established high performance liquid chromatography method,the qualitative and quantitative analysis of the formula granules of Zhishi Xiebai Guizhi decoction and the traditional decoction of A manufacturer are carried out,and the creaming rate of the two is compared,and the result shows that the formula particles are the creaming rate,the content of 5-HMF,magnolol,honokiol,and adenosine are all higher than that of traditional decoction(P<0.05).It can be seen that there are certain differences in the content of ingredients of formula granules and traditional decoction.Part Four:Comparative analysis of index components of Zhishi Xiebai Guizhi decoction granules from different manufacturersIn this part,the author will do different testing on formula particles produced by different enterprises with the help of high performance liquid chromatography(HPLC)method,analyze the similarities and differences of formula granule decoction solution and melt solution which are produced by the same enterprises,compare the chemical component and contents of formula particles among different manufactures.The results indicated that the difference between formula granule decoction solution and thawing solution was not statistically significant(P>0.1),and the content of index components of formula granules varies greatly among different manufacturers.It can be seen that the chemical composition content of the formula particles varies among different manufacturers.Part Five:Comparative analysis of the composition between Zhishi Xiebai Guizhi decoction granule and traditional decoctionIn order to further analyze the different dosage forms of Zhishi Xiebai Guizhi decoction,in this chapter,the author will use liquid chromatography-time-of flight mass(HPLC-TOF-MS)spectrometry to do testing on the decoction solution,dissolved solution and traditional decoction of Zhishi Xiebai Guizhi decoction granules.The chromatographic column was Eclipse Plus C18(4.6 × 250 mm,5 ?m),and the mobile phase consisted of acetonitrile(A)-water(B)gradient elution at the flow rate of 1.0 mLˇmin-1.The author has used Electrospray ion source(ESI)and conducted detection in positive and negative ion modes.The composition analysis between the granule and the traditional decoction showed that there were some differences in the composition. |
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