摘要:A near infrared(NIR) spectral database for pharmaceutical powders of Chinese medicine oral solid dosage forms was established,and the application of NIR spectral data in material classification and material properties prediction was studied by pattern recognition method.NIR diffuse reflectance spectra for 149 batches of pharmaceutical powders were rapidly measured with portable near infrared spectrometer,and the NIR spectral data were input into the intelligent traditional Chinese medicine(iTCM) database.Principal component analysis(PCA) method was used to explore the classification ability of NIR spectral data for materials with known structures.Partial least squares(PLS) method was used to study the prediction ability of NIR spectra on the material properties of pharmaceutical powders and tablet properties in direct compression.The NIR spectra pretreated by standard normal variable transformation(SNV)+Savitzky-Golay(SG) smoothing+first derivative exhibited a good discrimination ability for five kinds of excipients,i.e.microcrystalline cellulose,lactose,ethyl cellulose,polyvinylpolypyrrolidone and hydroxypropyl methylcellulose.NIR spectra had a strong correlation with particle size,density and hygroscopicity.NIR spectral information could be used as a supplement for the material properties,which could improve the performance of the prediction model for tablet properties in direct compression.Meanwhile,NIR spectral data were also a kind of supplement for the material properties data of iTCM database.The combination of material properties and NIR spectral data could be used to comprehensively characterize the properties of pharmaceutical excipients.
关键词:near infrared spectroscopy;database;material characterization;pattern recognition;pharmaceutical excipients;Chinese medicine extract powders
摘要:A quantitative analysis method of chemical markers coupled with pattern recognition algorithms was established for the rapid discrimination of Lao-Xiang-Huang preserved in different years.A ultra performance liquid chromatography-tandem mass spectrometry(UPLC-MS/MS) method was developed for the analysis of 21 chemical markers related to Lao-Xiang-Huang and the internal standard kaempferol-3-O-rutinoside.The developed method was applied to the distinguishing of different preserving years of Lao-Xiang-Huang with good linearity,high sensitivity and strong specificity.According to the amounts of 15 detected chemical markers and combining analysis of principal component analysis(PCA),hierarchical cluster analysis(HCA) and orthogonal partial least squares discriminant analysis(OPLS-DA),six differential chemical markers were identified significantly in contributing to the discrimination.Results showed that the chemical marker 5,7-dimethoxycoumarin was the uppermost contributor in distinguishing the preserving year of Lao-Xiang-Huang,which amounts were(47.465±1.987)μg/g in the 0th year,(17.069±0.542)μg/g in the 3rd year,(11.073±1.862)μg/g in the 5th year,(41.905±2.240)μg/g in the 8th year,(21.079±2.270)μg/g in the 10th year,(43.267±2.432)μg/g in the 15th year and(51.711±1.439)μg/g in the 20th year.The amount of 5,7-dimethoxycoumarin could reflect the preserving year of Lao-Xiang-Huang in a certain extent.To verify the reliability of the developed method,the proficiency test was carried out,and the calibrated year was in line with that provided by the manufacturer.This study provides a rapid and reliable method for the quality identification and control of Lao-Xiang-Huang in the market.
关键词:Lao-Xiang-Huang;ultra performance liquid chromatography-tandem mass spectrometry(UPLC-MS/MS);pattern recognition;chemical marker;quality control
摘要:An ultra high liquid chromatography-quadrupole orbitrap mass spectrometry(UHPLC/Q-Orbitrap-MS) combined with chemometrics was developed for the rapid analysis of absorbed components of Ziziphi Spinosae Semen in rat serum.A model for insomnia rat was established by intraperitoneal injection of para-chlorophenylalanine(PCPA).After intragastric administration of Ziziphi Spinosae Semen aqueous extract for five successive days,the serum samples from the model group and the Ziziphi Spinosae Semen aqueous extract treatment group were collected.The protein was removed using Oasis PRIME HLB 96-well plates.The data was acquired by UHPLC/Q-Orbitrap-MS,and analyzed by chemometrics including principal component analysis(PCA),orthogonal partial least-squares discriminant analysis(OPLS-DA) and variable importance in the projection(VIP) to screen different prototype compounds and metabolites.A total of 20 components were identified,including 11 prototype components and 9 metabolites.The developed method provides a basis for further study on the effective substances of Ziziphi Spinosae Semen for insomnia improvement.
关键词:Ziziphi Spinosae Semen;absorbed components in rat serum;ultra high liquid chromatography;high resolution mass spectrometry;chemometrics
摘要:In this work,an orthogonal separation method was developed for the separation of lycopene isomers based on the combination of low temperature(L-T) C18 column and C30 column.As the temperature decreased to -20 ℃,the resolution for the separation of lycopene isomers on a normal C18 column was greatly improved.After investigating the relation of solubility and resolution,seven kinds of lycopene isomers were finally prepared by the orthogonal separation method with their purities all higher than 97%.The loading capacity and purification effect of the orthogonal method for lycopene were much higher than that of the method only based on L-T C18 or C30 column.Then,the obtained all trans lycopene were dissolved in walnuts oil,black seed oil,almonds oil,grape seed oil,pumpkin seed oil and peach kernel oil,respectively,and heated at 120 ℃ to study their isomerization.Grape seed oil was regarded as the most valuable solvent for developing lycopene product due to its highest cis/all trans ratio of lycopene isomers after heating.Finally,the stability of cis isomers at 4 ℃ in edible oils was investigated by taking walnut oil as the example.Both the isomerization and degradation of these isomers happened with the increase of storage time.All trans lycopene and(13Z)lycopene were found as the preferential conformations in walnut oil.The obtained results were expected to provide some beneficial information for the development of lycopene product.
关键词:lycopene;low temperature preparation;isomerization;degradation;edible oils
摘要:Aiming at the current situation of long time and cumbersome operation in precise screening of macroporous resins with high selective separation performance for polysaccharides of traditional Chinese medicine,a predictive model for the rapid screening of macroporous resins was constructed in this paper.A multi source information model for the parameters of a macroporous adsorption resin,the molecular weight of glucan and the adsorption capacity was established by using R language,which was used to quickly predict and screen the type of macroporous adsorption resin with the optimal adsorption effect for polysaccharides of traditional Chinese medicine.The correlation coefficient(r2) of the established multi source information model is 0.901 2,the P value is 0.000 782 and the root mean square error(RMSE) is 19.89,which was verified with lycium barbarum polysaccharide,and was used to predict the adsorption effects of LX-T19,LX-T81,LX-20,LX-1180 and D101 type macroporous adsorption resins on lycium barbarum polysaccharides.Results showed that LX-20 is the best macroporous adsorption resin,with its adsorption capacity of 117.40 mg·g-1,while its actual adsorption capacity by the verification experiment is 111.23 mg·g-1.The established multi source information prediction model is accurate and reliable,and has a reference value for the precise and rapid screening of macroporous adsorption resins used for purification of polysaccharides in Chinese medicine.
关键词:macroporous adsorption resin;glucan;R language;multi source information model
摘要:To study the quality markers of Danhe granule for treatment of hyperlipidemia,the network of “hyperlipidemia-common target-components of Danhe granules in vivo” was constructed by Cytoscape software based on the results of in vivo component analysis.To determine the key target and component,the biological process,pathway enrichment and network topology of the common target were analyzed by DAVID and String database,respectively.Then HepG2 cells induced by oleic acid(OA) were selected to establish a lipid accumulation cell model to verify the lipid-lowering efficacy of the key components.Finally,combined with the content,stability and characteristics of the related components in the preparation,the quality markers were determined.Result showed that components of Danhe granule in vivo act on 10 disease targets of hyperlipidemia,including CES1,ADORA2A,ADORA1,APOB,LDLR,PPARA,PPARG,INSR,ESR2 and ESR1,which mainly regulated the process of lipid metabolism and the signal pathways of PPAR and cAMP.It was found that LDLR,PPARA and PPARG may be the key targets for the lipid-lowering effect of Danhe granules,while the components interacted with the key targets were resveratrol and naringenin.Futhermore,resveratrol or naringenin could not only reduce the number of intracellular lipid droplets,improve the severity of lipid accumulation in HepG2 cells,but also significantly reduce the content of intracellular triglyceride which may be the key components.Considering that the resveratrol and naringenin in vivo come from polydatin and naringin in preparation,while polydatin and naringin are rich and stable in preparation with obvious characteristics,they thus could be used as the quality markers of Danhe granules in the treatment of hyperlipidemia.This study provides a reasonable candidate quality control index for the establishment of the quality standard of Danhe granules.
关键词:Danhe granules;quality marker;quality control index;network pharmacology;hyperlipidemia
摘要:As a traditional prescription of Tibetan drug,Sanweidoukou decoction could be made from boiling herbal medicine cardamom,cumin,piper longum with yak milk together.It is reported to possess therapeutic efficacies against various diseases including Alzheimer′s disease(AD).However,its composition is still unclear due to its complex constituents with different polarities and volatilities.The principal objective of this research is to investigate the chemical constituents of the decoction.Considering different physicochemical properties of various components,gas chromatography tandem mass spectrometry(GC-MS) and ultra performance liquid chromatography coupled with high resolution mass spectrometry(UPLC-HRMS/MS) analysis were performed.As a result,99 compounds were identified and confirmed as monoterpenes or oxygenated monoterpenes from cardamom and cumin,such as eucalyptol,and alkaloids from piper longum such as piperine,as well as lipids from yak milk like triglycerides,etc.The results obtained provide a good support for further insight into Sanweidoukou decoctions pharmacological mechanism study in AD treatment.
关键词:Sanweidoukou decoction;Alzheimer′s disease;gas chromatography mass spectrometry(GC-MS);ultra performance liquid chromatography coupled with high resolution tandem mass spectrometry(UPLC-HRMS/MS);chemical composition
摘要:A rapid method was established for the nondestructive determination of multi marker components in Aconiti Lateralis Radix Praeparata by near infrared spectroscopy(NIRS) combined with partial least squares(PLS) and least square-support vetor machine(LS-SVM).A total of 38 batches of samples were selected for the determination of six alkaloids,ie.benzoylmesaconine,benzoylaconine,benzoylhypaconine,meaconitine,hypaconitine and aconitin in Aconiti Lateralis Radix Praeparata by high performance liquid chromatography(HPLC),and their NIR spectra were further collected.Two determination calibration models between the six components and NIRS were established by PLS and LS-SVM methods,respectively.The relative prediction deviations(RPDs) for the six components the total of monoester type alkaloids and the total of diester type alkaloid were 3.3,3.2,4.1,7.7,8.8,7.6,4.0 and 8.6,while the rpre for the 8 types were 0.948 6,0.947 5,0.966 8,0.990 9,0.994 6,0.996 9,0.966 9 and 0.992 7,respectively.Results showed that the LS-SVM model was better than PLS model,indicating that a good nonlinear relation existed between the predicted values of NIRS model and the measured values of HPLC.The established NIRS combined with LS-SVM could be applied to the rapid determination of six alkaloids in Aconiti Lateralis Radix Praeparata,and even to the prediction of the total of monoester type alkaloids and the total of diester type alkaloid,which is beneficial for the quality control of the Aconiti Lateralis Radix Praeparata.
关键词:near infrared spectroscopy(NIRS);Aconiti Lateralis Radix Praeparata;least square-support vetor machine(LS-SVM);partial least squares(PLS);monoester type alkaloids;diester type alkaloids附子(Aconiti Lateralis Radix Praeparata)
摘要:The near infrared spectra for the outer skin and inner capsule of citri reticulatae pericarpium from different habitats were collected.Different spectral pretreatment methods were used and the best method was selected. The identification model of citri reticulatae pericarpium origin was established by principal component analysis.It was found that there were obvious baseline drift and background interference in the raw spectra.The interferences could be eliminated to a certain extent by using single spectral pretreatment method.After using pretreatments of standard normal variate transform,multivariate scattering correction,first derivative,second derivative and continuous wavelet transform,the best identification results for the inner capsule data could be obtained,with an accuracy of 91.67%,while the optimal identification results for the outer skin data could be obtained by the maximum and minimum normalization pretreatment with an accuracy of 70.83%.A 100% of identification accuracy could be obtained by 9 combinations of two pretreatment methods for the outer skin data,and the optimal pretreatment combination for the inner capsule data was de-trending+maximum-minimum normalization,with an accuracy of 95.83%.However,the accuracies for three pretreatment combinations were lower than those for two pretreatment combinations,which indicated that useful information might be deducted if too many kinds of pretreatments were used.Results showed the nondestructive identification on citri reticulatae pericarpium of different origins could be achieved based on the combination of near infrared spectroscopy and spectral pretreatments,in which a 100% accuracy could be realized by using the outer skin data to optimizing combination of spectral pretreatment.
摘要:A fingerprint analysis method was developed for the quality control of Citrus aurantium by high performance liquid chromatography(HPLC).The separation was carried out on a Waters Tnature-ACCHROM C18(4.6 mm×250 mm,5 μm) column,using acetonitrile-05% formic acid water as mobile phase by gradient elution,and the common peaks in the fingerprint of Citrus aurantium were identified by high performance liquid chromatography-quadrupole time of flight-mass spectrometry(HPLC-QTOF-MS).Similaritity evaluation,cluster analysis(CA) ,principal component analysis(PCA) and orthogonal partial least square discriminant analysis(OPLS-DA) were used for the data analysis and quality evaluation on 22 batches of Citrus aurantium.Results showed that 12 common peaks were defined by the fingerprint,and 11 components were identified by HPLC-QTOF-MS.The similarities for 22 batches of Citrus aurantium samples were more than 0.9.The results obtained from CA,PCA and OPLS-DA were consistent,among which,the samples from Jiangxi Province were clustered into one group,while the samples from Hunan Province and Fujian Province were clustered into another group,and three quality differential markers were screened out as hesperidin,neohesperidin and naringin by OPLS-DA.The HPLC fingerprint for Citrus aurantium is stable and reliable,and could be used to provide a reference for its quality control.
摘要:This study introduced the three parameters of comprehensive linear qualitative similarity Sl, comprehensive linear quantitative similarity Pl% and fingerprint variation coefficient α to establish a novel method comprehensive linear fingerprinting method(CLFM),which comprehensively evaluated the overall quality of traditional Chinese medicine from a qualitative and quantitative perspective.The fingerprints for Tuire Jiedu injection(TJI) samples at 210,254,265,330 and 360 nm wavelengths were collected by high performance liquid chromatography with diode array detection(HPLC/DAD),and followed by the data fusion.Meanwhile,four index components,including chlorogenic acid(CHA),forsythin A(FA),paeonol(PA) and saikosaponin D(SD) were quantitatively analyzed.The quality of the samples was identified by CLFM.Results showed that 10 batches of injection samples were divided into 5 levels,and 10 batches of intermediate samples were divided into 4 levels.The quantitative analysis results of the four index components were highly correlated with the quantitative similarity Pl% of the fingerprint,indicating that the CLFM could be used to replace the standard substance for sample quantitative analysis.This method provides a new idea for the overall quality control of traditional Chinese medicine.
摘要:A high coverage matrix assisted laser desorption/ionization mass spectrometry imaging(MALDI-MSI) method was developed to visualize the spatial locations of a wide spectrum of metabolites in lotus seed in this paper,in which the spatial locations of alkaloids,flavonoids,amino acids,fatty acids,organic acids,cholines and phospholipids in lotus seed were successfully imaged.Results suggested that the alkaloids are mainly distributed in the lotus seed germ,the flavones are mainly located in the lotus seed germ and lotus seed skin,the levels of amino acids in lotus seed cotyledon are significantly higher than that in the lotus seed embryo,there are few distribution differences of fatty acids in different tissues of lotus seed,the levels of choline in the lotus seed germ and the bottom of the lotus seed cotyledon are higher than those in other tissue regions,glycerophosphocholine mainly distributes in the apex of the lotus seed cotyledon,and the levels of organic acids and most phospholipids in the lotus seed cotyledon are higher than that in the lotus seed embryo.This study provides a new way to investigate the drug quality and the metabolic networks of lotus seed.
关键词:lotus seed;metabolites;matrix assisted laser desorption/ionization mass spectrometry imaging(MALDI-MSI);tissue distribution
摘要:In this paper,a chemiluminescence aptasensor for the highly sensitive detection of aflatoxin B1 (AFB1) was constructed based on the strategy of enzyme assisted target recycling amplification.The label free aptamer probe H1-S1 and hairpin probe H2 were well designed using G-quadruplex/hemin DNAzyme as the signal molecule.The aptamer probe bound to the target AFB1,which triggered the target recycling amplification reaction with the help of exonuclease I to generate hairpin H1.The hairpin H1 was hybridized with H2,releasing the complete G-quadruplex sequence.The G quadruplex sequence combined with hemin to form G quadruplex/hemin DNAzyme,which catalyzed the oxidation of luminol-H2O2 chemiluminescence system to generate chemiluminescence signals to achieve the amplified detection of AFB1.Under the optimal experimental conditions,the chemiluminescence intensity exhibited a good linear relationship(r2=0.995 5) with the logarithm of AFB1 concentration in the range of 0.001-100 ng/mL.The detection limit was 0.93 pg/mL,and the recoveries were in the range of 93.7%-107%.With the advantages of simple operation,high sensitivity and good specificity,this aptasensor has a good application prospect in the detection of aflatoxin contamination.
关键词:aflatoxin B1(AFB1);chemiluminescence;target recycling;G quadruplex;DNAzyme;traditional Chinese medicine
摘要:A method of ultra high performance liquid chromatography(UPLC) was developed for the quantitative determination of 10 active components in Yinlai decoction,which was subsequently used for the quality evaluation of Yinlai decoction.The chromatographic separation was performed on a Waters ACQUITY UPLC HSS T3 column(2.1 mm×100 mm,1.8 μm) by gradient elution with 0.1% formic acid water and 0.1% formic acid acetonitrile as mobile phases.The detection wavelength was firstly set at 320 nm for neochlorogenic acid,chlorogenic acid,cryptochlorogenic acid,sinapine thiocyanate,forsythoside I in the first 10 min,then switched to 350 nm for forsythoside A,quercitrin from 10 to 16 min,and finally switched to 320 nm for baicalin,oroxylin A-7-O-β-D-glucuronide,wogonoside from 16 to 30 min.Results showed that the method completed the baseline separation for 10 active components in Yinlai decoction within 30 min.There were good linear relationships for 10 components in the certain concentration ranges with their correlation coefficients(r) not less than 0.999 2.The limits of detection and limits of quantitation were in the ranges of 0.018 8-0.075 0 μg·mL-1 and 0.062 5-0.250 μg·mL-1,respectively.The content range for 10 components ranged from 0.204 to 38.129 mg·g-1,in which baicalin was the highest,while quercitrin was the lowest.The method was used in the detection of three batches of sample,and it was found that the contents of the measured components were stable and consistent.The established analytical indexes are relatively comprehensive,reasonable and feasible,and could be used for better characterization and evaluation of the quality of Yinlai decoction.
关键词:Yinlai decoction;ultra high performance liquid chromatography;wavelengths switching;quantitative analysis;quality evaluation
摘要:A novel universal method based on artificial intelligence with fingerprints on multi elements and multi data was established for the identification of varieties of Chinese medicines.Firstly,the same medicinal material was treated by different methods to acquire the information of chemical substances with different properties.A universal liquid phase method,including reversed phase chromatography,hydrophilic chromatography and molecular exclusion chromatography was used to collect the chemical information.The three liquid phase methods were complementary to each other to fully characterize the small polar molecules,large polar molecules and macromolecular compounds in the medicinal material.Then,a model with the fingerprints on multi elements and multi data was established by convolutional neural network to identify the varieties of Chinese medicines.In addition,all the fingerprints were treated by a standard process.Finally,a model with a test set accuracy of 92% was obtained.This method could be applied to the rapid,accurate and efficient identification of Chinese medicines,overcoming the subjective consciousness in the variety identification of traditional Chinese medicines,and giving therefore the identification results more objective and accurate.
摘要:Several methods were employed to explore the composition of Mongolian medicine magnetite.Fourier transform infrared spectroscopy(FTIR) and X ray diffraction(XRD) were used to determine the spectra of 10 batches of sample from different manufacturers,while elements in magnetite were quantified by inductively coupled plasma mass spectrometry(ICP-MS).Therefore,seven characteristic peaks were found in the infrared spectra for the magnetite,and the characteristic absorption peaks for quartz and Fe3O4 were at 468 cm-1 and 526 cm-1,respectively.Nine characteristic peaks were detected in XRD experiment.The data of peak 5,7,8 and 9 in the spectrum for magnetite were consistent with those of Fe3O4,while the data of the peak 3 and 4 were consistent with those of SiO2.Meanwhile,ICP-MS was used to quantify 24 elements in magnetite.Results showed that the content of Fe was found to be the highest,and other heavy metals and harmful elements were also detected.FTIR,XRD and ICP-MS could be used to identify the structure of magnetite,which lays a foundation for the quality analysis of magnetite.
摘要:The volatile oils of Radix Bupleuri extracted under decompression and atmospheric pressure were compared in terms of composition,content and efficacy to investigate the quality of the volatile oil and optimize the extraction method.Gas chromatography-mass spectrometry(GC-MS) was used to analyze the constituents of volatile oils and their relative contents.Meanwhile,a method of gas chromatography(GC) was established for the determination of hexanal,heptanal,octanal and trans 2,4 decadienal in the volatile oils,and the contents of active components in volatile oil extracted under different pressures were determined.A rat fever model was reproduced by subcutaneous injection of yeast suspension on the back,the volatile oils extracted from Radix Bupleuri under atmospheric pressure and decompression were dissolved in 1% Tween 80 and injected intraperitoneally.The temperature changes of rats at different time points were measured,and single factor analysis of variance was used for intergroup comparison.The composition and content of the volatile oil extracted under decompression conditions were different from those extracted under atmospheric pressure,the extraction rates of hexanal,heptanal,octanal and trans 2,4 decadienal were higher,and the effect of the volatile oil on the fever caused by dry yeast was more significant.Results showed that decompression could effectively reduce the damage of heat sensitive components and improve the extraction efficiency of effective components.The volatile oil of Radix Bupleuri extracted by this method has a more significant medicinal effect,and its quality is better than that extracted under atmospheric pressure.
关键词:essential oil of Bupleurum Chinense;decompression extraction;gas chromatography-mass spectrometry(GC-MS);antipyretic experiment
摘要:A high performance liquid chromatography(HPLC) for quantitative analysis of multi components with a single marker(QAMS) was established for the quality control of Shuganyipi granules.Meanwhile,the applicability and accuracy of the method in quality control were also verified.Three main effective components,i.e.schisandrol,deoxyschisandrin and schisandrin B in Shuganyipi granules were simultaneously separated by HPLC.With schisandrol as the internal reference,the relative correction factors(RCFs) fs/k for other two components were set up and calculated to achieve QAMS.In a certain linear range,the RCFs(fs/k) for deoxyschisandrin and schisandrin B were calculated by multipoint correction method to be 0.94 and 0.95,respectively,with good repeatability under the experimental conditions such as different instruments and chromatographic columns.Moreover,the results of QAMS were compared with those obtained by the external standard method,and there were no significant differences existed.Therefore,the QAMS method is simple,reliable and accurate,and could be used for the simultaneous detection of contents of three components in Shuganyipi granules and the effective control of the quality of Shuganyipi granules.
关键词:multi-component with a single marker;Shuganyipi granules;relative correction factor;schisandrol;deoxyschisandrin;schisandrin B
摘要:In view of current situation for the quality evaluation system of traditional Chinese medicine(TCM),the key scientific problems for TCM quality evaluation are summarized.The methods for quality evaluation of TCM based on “discovery” and “control” effective ingredients are mainly discussed in this paper.Combined with the author′s years of experience in quality analysis and research of TCM,the research contents,means and application scopes of three quality evaluation and detection methods are analyzed,including “spectrum effect” relationship research,multi wavelength fusion fingerprint and biological activity determination,so as to provide a reference for enriching and improving the quality control methods and quality standard system of TCM.
关键词:quality detection of traditional Chinese medicine;“spectrum-effect” relationship research;full time isometric multiwavelength fusion fingerprint;bioactivity determination
摘要:Traditional Chinese medicine(TCM) powders are important intermediates or products of oral solid preparations of traditional Chinese medicines.The physical properties of the powders not only affect the formation techniques,but also impact the quality of the products directly or indirectly.There are many types of traditional Chinese medicine powders with different scales.Physical fingerprints,as a complementary method for the content determination of traditional Chinese medicine powders or HPLC fingerprint evaluation,are used to evaluate the quality of traditional Chinese medicine powders from the physical properties,which provide a new way for the overall quality control of traditional Chinese medicine powders.A standardized establishment method of the physical fingerprints for traditional Chinese medicine powders is systematically described in this paper,including design of the index system,test or calculation of the secondary indexes,and standardized processing and map display of the secondary indexes.Application of physical fingerprints in the whole process quality evaluation of Chinese medicine wall broken powders,Chinese medicine extract powders,Chinese medicine granules,pharmaceutical excipients,dosage forming process and formulation design is summarized.Carrying out physical fingerprints and physical property analysis method verification to ensure the reliability of the data of the physical fingerprints,combining pattern recognition with artificial intelligence methods to expand the application scenarios of physical fingerprints,supporting the quality consistency evaluation and the design and continuous improvement of the prescription and process of Chinese medicine preparations are the main directions of the future research.
关键词:traditional Chinese medicine powders;physical fingerprint;physical characterization;quality consistency evaluation;quality by design
摘要:The issue of pesticide residues in Chinese medicinal materials has always been a focus of attention.As an important rapid analysis technique with strong specificity and high sensitivity,immunoassay plays an important role in the rapid screening of pesticide residues in Chinese herbal medicine.Combined with the relevant research progress on immunoassay in recent years,the application,technical advantages and limitations of different immunoassay techniques in pesticide residue analysis in Chinese herbal medicine are analyzed and summarized in this review,and the prospect for the development of immunoassay technique is also forecasted.This review has an important instructive to the application of immunoassay in pesticide residue analysis and the safety evaluation of traditional Chinese medicines.