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Application of fingerprint of traditional Chinese MedicineLv Chunping1,Guan Ming2 (1. School of public health of Jilin University, Changchun 130021; 2 Jilin University School of medicine in Changchun, 130021) abstract the fingerprint of traditional Chinese medicine used for quality control of Chinese herbal medicine has been recognized at home and abroad. Methods to establish the fingerprint of traditional Chinese medicine, prospect of application problems and application prospects. Keywords Chinese medicine, traditional Chinese medicine fingerprint quality control, classification number: R927.1 document code: A Article No.1006-5687()02-0058-05 ApplicationoffingerprintoftraditionalChinesemedicine LChunping1,GuanMing2 (1.SchoolofPublicHealth,JilinUniversity,Changchun130021,China;2.SchoolofPharmacy,JilinUniversity,Changchun130021,China) ABSTRACTThispaperreviewedtheapplicationoffingerprintoftraditionalChinesemedicinetothequalitycontrol.Italsoreviewedthemethodestablishment,themainproblemspresentedandtheprospectivefutureinapplicationoffingerprintoftraditionalChinesemedicine. KEYWORDStraditionalChinesemedicine(TCM),fingerprint,qualitycontrol Restricting the modernization of traditional Chinese medicine industry, internationalization is the intrinsic quality of instability, poor controllability, resulting in clinical instability, not even sure, it was rejected by the guidance of theory of Western medicine in the international market. The quality standard of Chinese traditional medicine is based on Western medicine quality standard model to a great extent, that is to control the Chinese medicine through qualitative, one or several effective components of quantitative quality. The quality standard of easy operation, can be repeatedly, has certain practicability. But it is ignored in traditional Chinese medicine is a multi-component, multi-channel, multi-target synergy effect, single component content can not represent the quality of traditional Chinese medicine. But for many components of quality evaluation of traditional Chinese medicine is a common ingredient of traditional Chinese medicine,For example, ginseng, American ginseng, three seven contain ginseng saponin, ginsenoside standards so as not to be distinguished. Research shows that, ginsenoside content of Panax quinquefolium, flower buds was higher than that of American ginseng root, but its physiological activity is not as good as American ginseng root, indicating the role is not only the ginseng saponin, and other components of 1,2. Therefore, from the comprehensive analysis of macroscopic overall quality control of traditional Chinese medicine. At present, the United States Food and Drug Administration (FDA) guidelines for the evaluation of medicinal plant products industry guide, WHO herbs have pointed out, if the active ingredients can not be identified, herbal medicine, can through the fingerprint (fingerprintspectrum) certificate of product quality consistency. The EC in herbal quality guidelines note also points out, Chinese herbal medicine and its preparation is as effective as a whole material, therefore, effective components of herbs on quality stability determination of known is not enough, should show the various components of the contained by fingerprint. India Herbal Pharmacopoeia, British Herbal Pharmacopoeia, the German Association of Canada medicinal plants, medicinal and aromatic plants Association, also accept fingerprint to ensure the effective component of unknown herbal product quality consistency. Chinas State Drug Administration requirements by the end of , all the application Chinese medicine injection should be related to the fingerprint data, including traditional Chinese medicine raw materials, extract, 3 maps, 3 kinds of spectra peak shape must have great relevance, otherwise it will not be accepted.The 1.1 concepts of TCM fingerprint concept and significance of the 1 fingerprint of traditional Chinese medicine with Chinese medicine is obtained from the spectral and chromatographic technique (mainly plant medicine) secondary metabolic chemical spectra or chromatograms, it is a comprehensive, quantitative identification methods for the identification of Chinese herbal medicines, authenticity. Is the quality control mode of current TCM characteristics evaluation of Chinese medicinal materials, intermediate and finished product quality consistency, stability. Its basic characteristics are integral and fuzzy. Should meet the specificity, reproducibility and practicality of the technical requirements of 3. The 1.2 meaning of fingerprint of traditional Chinese medicine is from the macro to grasp the overall quality of the traditional Chinese medicine, rather than the single, small components. The quality evaluation of traditional Chinese medicine more scientific, standardization. Through the fingerprint identification of samples can be compared. Establishment of fingerprint has certain directive significance to the research of traditional Chinese medicine, to confirm the signal characteristic of fingerprint, characterization of chemical composition, the correlation between further study component and efficacy, so as to elucidate the action mechanism of traditional Chinese medicine. To establish the fingerprint of traditional Chinese medicine and stable sources of raw materials must be standardized, so the fingerprint of traditional Chinese medicine on the cultivation of Chinese medicine GAP implementation plays a guiding role in supervision. 2 the fingerprint classification of 2.1 according to the application object classification of traditional Chinese medicine fingerprint can be used for quality control of traditional Chinese medicine research, production of Chinese traditional medicine, Chinese herbal medicine planting, harvesting, according to the classification of the application object, can be divided into the fingerprint of traditional Chinese medicine fingerprint, raw materials, intermediate products, traditional Chinese medicine fingerprint fingerprint. According to the analysis of 2.2 measurement means classification according to the determination by different can be divided into, biological fingerprint and the fingerprint of Chinese medicine of traditional Chinese medicine. Chinese biological fingerprint including herbs DNA fingerprints, fingerprint of traditional Chinese medicine traditional Chinese medicine genomics, proteomic fingerprints.Fingerprint of Chinese medicine can be divided into traditional Chinese medicine fingerprint spectrum (such as IR, UV, X- ray diffraction), chromatographic fingerprint (such as TLC, GC, HPLC, CE etc.), spectral fingerprint (such as MS, NMR etc.), and using many kinds of modern analysis instrument combined with the multi-dimensional characteristics spectrum (characteristicfingerprintofmultrdimensionandmultrdata), such as HPLC/MS, HPLC/MS/MS, GC/MS, CE/MS etc. 3 the fingerprint spectrum of action in the application of fingerprint of traditional Chinese medicine in the fingerprint has certain limitations, infrared spectroscopy is hard to quantify, UV peak less difficult to qualitative, therefore, the State Drug Administration recommended the use of chromatographic fingerprint of traditional Chinese medicine in technology. 3.1 thin layer chromatographic fingerprint (TLCfingerprintspectrum) thin layer chromatography (TLC) because of its characteristics of fast speed, convenient operation, economy, the visual image, wide application range, and is widely applied. TLC as a method for identification of major by multinational plant pharmacopoeia. Chinese Pharmacopoeia in edition of a TLC method for identification of varieties has reached 602, accounting for the load of traditional Chinese medicine 60%. In recent years, study on TLC fingerprint of more also 4, Xie intervention 5,6 against ginseng, ginseng, three seven,TLC fluorescence color image is obtained under the optimized operation conditions, in the same plate to visually compare the similarities and differences between the 3 samples. Yan Yuzhen 7 fingerprint of Rhizoma Coptidis on TLC is found, the fluorescence and UV scanning contour maps can be used to identify Rhizoma coptidis. Li Caijun and 8 were studied by thin layer chromatography fingerprint of flavonoids in Alpinia officinarum Hance, can effectively identify Alpinia officinarum hance. Thin layer chromatography can also identify a plurality of 59 Tianjin Pharmaceutical Tianjin Pharmacy in April sixteenth volume second samples, but also has low efficiency, poor sensitivity. The chromatographic system is an open system, in order to get the stable, reproducible patterns, must be strictly controlled experimental conditions. The limited information available, for the traditional Chinese medicine and its compound preparation of complex, difficult to use TLC fingerprint identification and quality evaluation. Fingerprints of 3.2 high performance liquid chromatography (HPLCfingerprintspectrum) and high performance liquid chromatography (HPLC) with high separation efficiency, analysis of the characteristics of fast speed, high sensitivity, high selectivity. Compared with the thin layer chromatography, it is a closed system of chromatography, less influenced by outside factors, chromatography, stability, good reproducibility, the separation, identification ability is much higher than that of thin layer chromatography. High performance liquid chromatography fingerprint of most of fingerprint in traditional Chinese medicine. Study on fingerprint of traditional Chinese medicine injection technology requirements of the National Drug Administration (Provisional) medicine and preparation of traditional Chinese medicine injections have been approved and declaration of new traditional Chinese medicine injections mostly by HPLC fingerprint. Su Xiaoli 9 using the HPLC fingerprint method is toxic ingredients of Chinese medicine podophyllotoxin were analyzed, and points out that using HPLC fingerprint of podophyllotoxin can identify podophyllotoxin (table seven), gentian, clematis. High gain equal 10 with ginsenoside Rg1 as the control, the HPLC fingerprints of three seven herbs is established. Zhai Weimin 11 to establish the HPLC fingerprint of ginseng, American ginseng and three seven is used to distinguish the three. HPLC/DAD by Zou Zhongmei 12,(Gradient elution, the 10 batch of paeoniflorin, were measured the results showed that, total glucosides of paeony fingerprint characteristics and strong specificity, combined with the determination of content can be used for the quality control of total glucosides of paeony. 3.3 gas chromatographic fingerprint (GCfingerprintspectrum) gas chromatography analysis for pharmaceutical ingredients volatile, practical application often associated with mass spectrometry. Ling Dakui 13 retention index of components of volatile oil from Amomum villosum, angelica, Atractylodes, bupleurum root, Ligusticum and Cyperus rotundus GC was determined by chromatographic separation conditions of Standardization (GCRI), using GC-MS and GC- Fu Liye transform infrared spectroscopy (FTIR) of the main components of the qualitative identification. Methods such as Qian Haoquan 14 by using GC-MS, identification of Alpinia officinarum Hance and their relatives, they found the fingerprint feature is obviously different, chromatogram have unique characters of representative. 3.4 NMR fingerprint (1HNMRfingerprintspectrum) based on nuclear magnetic resonance spectrum absorption peak position and intensity, can obtain compounds by chemical displacement, the number of protons, coupling relationship between the information structure. 1 HNMR map has good reproducibility and suitable for traditional Chinese medicine characteristic, identification of the species identification and characteristics of total extract of Chinese medicine. Qin Hailin 15,16 of ginseng, Gastrodia elata, Coptis, Polygonum cuspidatum, he Shou Wu characteristics such as total extract 1 HNMR fingerprints were studied, results showed that, 1HNMR fingerprint of various plant research has characteristic of height and good reproducibility, the same species of different origin samples of 1 HNMR fingerprint has good consistency. 3.5 ms fingerprintMSfingerprientspectrum) (Traditional Chinese medicine ingredients, mass spectra of the fragment peaks are also different, so it can be used for the identification of traditional Chinese medicine. Yuan Xianglin 17 by matrix assisted laser desorption ionization time of flight mass spectrometry was used to identify Radix Astragali and its adulterants. Yu Wenjia 18 using high resolution electrospray ionization time of flight mass spectrometry directly without separation analysis of Salvia lipid soluble extract, and high performance liquid chromatography electrospray single quadrupole mass spectrometry were compared, the conclusion is high resolution electrospray ionization time of flight mass spectrometry method for the determination of fast, accurate, stable, simple, research fingerprint of traditional Chinese medicine for. 3.6 capillary electrophoresis fingerprint (capillaryelectrophoresisfingerprintspectrum) has a high column efficiency, fast speed, less sample, sample pretreatment is simple, we can not only analyze the small molecule acid, alkali, salt and neutral molecules, but also can analyze large biological molecules (nucleic acid, polypeptide and protein etc.). Chinese Pharmacopoeia version has the statutory qualitative and quantitative methods. Difference between Sun Yuqing 19 of Cordyceps sinensis and Cordyceps, Cordyceps militaris, counterfeit and substandard products by capillary electrophoresis fingerprint. 3.7 high-speed counter-current chromatography fingerprintHSCCCfingerprintspectrum) HSCCC is the separation of samples by using dynamic liquid-liquid distribution principle, the degree of separation and repeatability and is similar to HPLC, but the simple sample preparation. Shen Ping 20 application of separation, analysis of HSCCC herbs in. 3.8 X- X-ray diffraction fingerprint when a substance for diffraction analysis, the substance is X ray diffraction phenomenon in different degrees and produce. Composition, crystal, molecular substances in bonding, molecular structure, determines the material produces a diffraction pattern characteristic. If the substance is a mixture, the diffraction pattern is the superposition of each diffraction effect. As long as the composition of the mixture is constant, the diffraction pattern can be used as a fingerprint of the mixture. As the composition of various herbs each are not identical, diffraction patterns they have characteristics, which can be used in Chinese medicine identification. Wang Shuchun 21 by X ray diffraction Fourier spectral analysis method to identify comparisons of natural bear bile, bile drainage bear gall and adulterants, established a new method for identification of bear gall. Zhang Lili 22 were studied by powder X ray diffraction Fourier fingerprint for the identification of Herba hedyotidis. Multiple information characteristic spectrum of the multidimensional 3.9 multi-dimensional refers to using a variety of analytical instrument coupled model, the so-called multiple information refers to traditional Chinese medicine characteristic spectrum should include two aspects of chemical and medical information. A single analysis method is difficult to reflect the complexity of TCM, in recent years, using many kinds of modern analysis instrument combined with the way the multi-dimensional characteristics spectrum used in increasing. For example: GC/MS, LC/MS, HPLC/MS, HPLC/NMR, CE/MS combined application of fingerprint of traditional Chinese medicine to use technology to provide a lot of information. At present, the most commonly used is a high performance liquid chromatography (or capillary electrophoresis) / photodiode array detector / mass spectrometry / mass spectrometry method (HPLC or CE/DAD/MS/MS) is refers to the map.Yu Jing 23 using the HPLC/UV/MS method of Acanthopanax senticosus Harms of water-soluble and fat-soluble components carried out the research of fingerprints, get resolution and reproducibility of the HPLC/UV and HPLC/MS fingerprints, and can be used for quality control. Zhang Haixia 24 by headspace gas chromatography - mass spectrometry (HSGC-MS) 60 Tianjin Pharmaceutical Tianjin Pharmacy April sixteenth volume second issue is hyphenated techniques, can effectively identify the cinnamon, cinnamon, adulterants Chai GUI, the method is rapid, accurate, simple operation and without extraction separation of samples. Chen Zhong 25 of HPLC/NMR on-line coupled method for quality control of traditional Chinese medicine technology. Cai Luxin 26 of CE/NMR technology application in the analysis of complex mixtures. Interpretation of the fingerprints of 4 fingerprint provides a large amount of chemical information, its function is to reflect the intrinsic quality of traditional Chinese medicine and its preparation, homogeneity and stability, therefore, Xie Pei hill that 27, the analysis emphasizes chromatographic fingerprint is accurate recognition (accuraterecognition) instead of precise calculation (precisecalculation); comparative map that is similar but not the same (similarity) (identical). Study on fingerprint of traditional Chinese medicine injections of the technical requirements of the State Drug Administration issued (Provisional) in the provisions of the technical parameters of fingerprint, including calibration common fingerprint peaks, ratio of common peaks area, not the common peaks area requirements. Evaluation of fingerprint can be used as the index of similarity, similarity of the requirements of qualified goods in 0.9 1, traditional Chinese medicine fingerprint Computer Aided Similarity Evaluation Software recommendation available national pharmacopoeia committee (CASE) to calculate similarity. In addition, Su Weiwei 28 by computer using fuzzy information analysis method, artificial neural network method, the grey clustering method, analysis of Scutellaria TLC, Kudingcha HPLC fingerprint, asarum gas chromatography - mass spectrometry and X ray fingerprint.Miao Aidong 29 by data processing of MicrosoftOffice office software in the EXCEL series of function, achieve the peaks of fingerprint matching and similarity computing. Stability of chemical composition of traditional Chinese medicine fingerprint quality of 5.1 Chinese herbal medicine there are 5 problems in application of fingerprint of traditional Chinese medicine is the determination of plant secondary metabolites. There are resources experts point out that, for the same seed, ecological environment, different cultivation conditions, chemical products are not the same. Study on fingerprint of traditional Chinese medicine injections technical requirements, therefore the State Drug Administration issued (Provisional) of Chinese medicine name, source, sample preparation, determination, fingerprint and technical parameters of the detailed provisions. But because the traditional Chinese medicine production, sales area at present is still not standardized, different sources of medicinal plants is difficult to establish fingerprint stable. Therefore the establishment of fingerprint of traditional Chinese medicine, must grasp the quality of the crude drug, such as fixed origin, fixed planting technology, fixed species, fixed harvesting time and processing methods, the implementation of medicinal plant of GAP, to establish production base of Chinese herbal medicine. 5.2 operating procedures standardization to establish the fingerprint of different samples, first separation, separation and extraction method, the components are not the same, not the same fingerprint. Therefore must be standard operating procedure. The 5.3 test conditions standardized fingerprint only with good s
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