Study On The Preparation And Quality Standard Of The Extract Of Flos Trollii And Radix Puerariae

Extract of traditional Chinese medicine (TCM) as a new product is being given increasing attention. With definite material basis of pharmacodynamical effect and rigorous quality standard, extract of TCM is extracted from Chinese medicinal materials or compound prescription by adopting advanced technology, which can be used as a new type of "Decoction Pieces" as well as the raw materials of the preparation of TCM. Extract of TCM reflects the advance of this industry and its demand of modernization, and takes the advantage of raw materials, extraction process, quality control, TCM clinical, etc.Extract of TCM can be divided into three categories: single-medicine extract, compound prescription extract and purified extract, and the single-medicine is studied most. This paper taking flos trollii and radix puerariae as research object, gets the extract of the two materials separately.After obtained the extract, this paper also carried out the quality standard research. At the present time, the most popular method used for quality control of TCM is chromatographic fingerprint. TCM fingerprints obtain from the proper processing and afterwards analyzing with certain instrument, which display the mark peaks. The common means are: high performance liquid chromatography (HPLC), thin layer chromatography, gas chromatography, and capillary electrophoretic, etc. To a certain extent, they are able to reflect the total conditions of TCM, making the indicator of quality control from the former single component determination to test of the entire internal quality. The fingerprints have achieved comprehensive evaluation of internal quality and the overall control of all the materials, making the quality of TCM stabilized and controllable and ensuring the stability of the clinical efficacy of TCM.Flos trollii is the special product of Chengde City, has the effect of heat-clearing and detoxifying, antibacterial and anti-inflammatory, which can be used on the treatment of tonsillitis, acute otitis media and other inflammatory. Peoples also have the habit of drinking Flos trollii. Today there are a variety of formulations of the Flos trollii, such as tablets, oral solution etc. Radix puerariae has been used for a long history as TCM, with the effect of expelling pathogenic factors from the muscles and skin and reducing fever, promoting the production of the body fluid, promoting eruption, elevating yang, and mainly for the fever and headache due to exopathy, rigidity of the neck, thirst, emaciation and thirst, loosing stools and diarrhea, high blood pressure, and so on. At present, Chinese Pharmacopoeia of 2005 version has the collection of Yufengningxin Tablets, which is the extract of Radix puerariae and has a good effect on the treatment of high blood pressure.Objective:1 Using appropriate extraction method get extract from flos trollii and radix puerariae.2 Studying the quality standard of the extract of flos trollii and radix puerariae.3 Finding out the difference between the different spcies of flos trollii and different extraction processes on the extracts. Comparing the correlation between the herbal, extract and related preparation.Methods:1 Taking the transfer rate of the main active ingredient in flos trollii and radix puerariae, orientin and puerarin, according to the importance of the influence factors, optimizing the extraction process by single factor and orthogonal experimental study separately, through the range analysis, connecting the actual production, determined the optimum extraction method of the two herbs.2 Adopting HPLC fingerprint to identificate, and to determine the active ingredients, ultravialet spectrophotometry (UV) to determine the content of the flavonoids of the extract. And through method validation, setting up the system of quality evaluation of the two extract about flos trollii and radix puerariae.3 Adopting the HPLC system to identificate the different spcies of flos trollii, and determine the content of the active ingredients, finding out the difference of the flos trollii. Comparing the fingerprint of extracts from different extraction methods to find their overall impact on the extracts. Comparing the fingerprint of the medicinal herbs, extracts and corresponding preparations, finding out the correlation.Results:1 The extraction process of flos trollii: checking the medicinal herbs to 30 times the amount of boiling water decocted for 0.5 h, separating the dregs by centrifugal, concentrating the solution, and drying. The extraction process of radix puerariae: checking the strip-line of the medicinal herbs to 10 times the amount of 30% alcohol, stirring at 40℃for 1 h, separating the dregs by centrifugal, concentrating the solution, and drying.2 The fingerprint of the extract trollii gets 16 peaks in 2 h, which the 4^th and 7^th peak is orientin and vitexin. The content of orientin in the extract is 2.47%, and vitexin is 0.46%, and the total flavonoids are 15.94%. The fingerprint of the extract puerariae gets 12 peaks in 40 min, which the 2^nd is puerarin, the 5^th is daidzin, and the 12^th is daidzein. The content of puerarin in the extract is 12.63%, daidzin is 3.24%, daidzein is 1.23%, and the total flavonoids are 36.00%.3 After the experiment, finding out the significant differences between the three types of flos trollii which the most is the content of the 1^st peak, and in Trollius macropetalus Fr. Schmidt, the the peak height ratio of the 1^st to 4^th is 1 : 2, in Trollius chinensis Bunge, there is none of the 1^st peak, and in Trollius ledebouri Reichb., the ratio is 1 : 1. In Trollius chinensis Bunge, except for the 1^st peak, the 2^nd, 3^rd, 10^th, 11^th, 12^th are not evident, the relative peak height of these peaks are very low. Extracts made by the same herbs but different preparation method, compared with HPLC fingerprint, for extracts trollii, except the content of the active ingredients with a lightly difference, there is no significant difference between the extracts from two preparation method. But for extracts puerariae, because of larger changes, not only the content of active ingredients, but also the relative content of daidzin and daidzein, have larger changes.There are good correlation between the medicinal herbs and their extracts of different preparations, and because of this, tracing the medicinal varieties of the extract or the preparation.Conclusion:1 Comparing with the traditional extraction method, this paper has the obvious advantage of the active ingredient in the extract of the content is relatively higher, and the consumption of the solvent, the time of extracting and concentrating decreased significantly, besides the transfer rate of the active ingredients has no evident difference. Therefore, the new method saves the cost and simplifies the operation.2 Comparing with the original standards of the relative preparation, this paper reflects the the integrity of the efficacy, improves the quality standard.3 After the comparison of the three types of flos trollii, come to the conclusion: there are obvious differences between the three flos trolliis in the type and content of the ingredients, and proposing for the further study. From the comprison of the fingerprints of different preparation methods, fingerprints can be on the overall quality of products, shows the changes in the preparation process. The fingerprint can be used to trace the origin of the extract or the preparation.