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A quantitative analysis of multi-components by single marker method (QAMS) was established for simultaneous determination of gallic acid, protocatechuic acid, catechin, epicatechin, p-coumaric acid, ferulic acid and phloridzin in Cynomorium songaricum Rupr. The analysis was performed on a ChromCore Polae C18 column (250 mm×4.6 mm, 5 μm) , with a mobile phase consisting of acetonitrile-0.3% phosphoric acid aqueous solution for gradient elution. The volume flow rate, column temperature and sample injection volume were set at 1.0 mL·min-1, 25 ℃, and 40 µL, respectively. The relative correction factors of gallic acid and protocatechuic acid, catechin, epicatechin, p-coumaric acid, ferulic acid and phloridzin were calculated and the durability was also investigated. The contents of these seven compounds in fourteen batches of Cynomorium songaricum Rupr. from different producing areas or batches were determined by external standard method (ESM) and quantitative analysis of multi-components with a single-marker method (QAMS), respectively. SPSS and Origin Pro software were employed for principal components assay, similarity evaluation and cluster analysis. The specificity, precision, repeatability, stability and linear range (R2 > 0.999 0) of the seven components were all good. The average recovery was 96.89%-103.16% and RSD was 0.55%-2.76%. Then gallic acid was chosen as internal reference for calculation the correction factors for the other six components, the average relative correction factors of protocatechuic acid, catechin, epicatechin, p-coumaric acid, ferulic acid and phloridzin were 1.141 5, 0.200 5, 0.208 0, 2.361 9, 1.867 7, 0.204 6, respectively. Student's test results showed that there was no significant difference between the data analyzed by ESM and the data obtained from QAMS method. Through data visualization analysis, the contents of gallic acid, protocatechuic acid, catechin and epicatechin in different samples were significantly different, indicating that these four components might be the main quality markers of Cynomorium songaricum Rupr. for gaving more contributes to the principal components. The cluster analysis showed that samples from Xinjiang and samples from Inner Mongolia were clustered in significantly different categories, meaning that the quality of Cynomorium songaricum Rupr. had great relation with producing areas. The method of QAMS established in this study is a simple, economical and practical method with scientific and applicable charactistics for evaluating the quality of Cynomorium songaricum Rupr. efficiently and scientifically.
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OBJECTIVE：To provide reference for improving the operation efficiency of drug quality sampling and inspection in China . METHODS ：Starting from the application and management situation of inspection standards/methods in provincial inspection institutions ，the problems existing in the application and management of inspection standards/methods in provincial inspection institutions were analyzed ；the inspection standards/methods database of provincial inspection institutions is attempted to build，combining with the relevant experience and practices of FDA. RESULTS & CONCLUSIONS ：The inspection methods involved in drug sampling and inspection could be divided into official standards and non-standard methods. Official standards were the main standards for drug sampling and inspection ，and were mainly used for routine inspection. Such kind of standards could be classified according to the characteristics of compiled ，single-page and later-issued supplementary ；an electronic catalogue should be established for unified management. Non-standard methods were only used for sample preliminary screening ，verification of official inspection results ，quality evaluation and inspection of unknown or suspicious samples in emergency inspection. Its tracking，collection and management mechanisms were not yet complete. It is recommended to draw on the experience of drug sampling and inspection in the United States so as to establish method database hierarchically. For the mature method established in drug supervision system ，an electronic catalog and document content database should be established and the method should be confirmed before use ；for national standards and the recommended methods published by authoritative institutions in other industries，and mature methods published in scientific and technological literature ，the retrieval channels should be listed ，the methods should be verified ，reviewed and approved before use ，and an electronic catalogue should be established and recorded in time after use. The electronic catalogue format of non-standard methods generally include controlled number ，applicable variety name，method name ，inspection items ，etc.
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OBJECTIVE: To establish a method of quantitative analysis of multi-components by single marker (QAMS) for determining four essential oils (cinnamaldehyde, cinnamyl alcohol, cinnamic acid, 2-methoxy cinnamaldehyde) in Cinnamomum cassia, and provide the experimental base for establishing the quality standard of Cinnamomum cassia. METHODS: Cinnamaldehyde was used as the internal reference standard, and the relative correction factors (RCF) of cinnamyl alcohol, cinnamic acid, and 2-methoxy cinnamaldehyde in Cinnamomum cassia were calculated. The contents of the four components were determined by both external standard method and QAMS. The validity of the QAMS method was evaluated by comparison of the quantitative results of both methods. RESULTS: The RCFs had good reproducibility, relative correction factor 0.673, 0.605 and 1.943, with RSDs of 0.529%, 0.373%, and 0.759%, respectively. No significant differences were found in the quantitative analysis results of cinnamyl alcohol, cinnamic acid, 2-methoxy cinnamaldehyde by using RCF and ESM. CONCLUSION: In the absence of reference substance, the content determination of the four essential oils in Cinnamomum cassia can be realized by QAMS, and this method can be used in the multi-index evaluation of Cinnamomum cassia essential oil constituents. It is suggested that the standard for cinnamaldehyde content be increased to 2.5%, and the contents of total cinnamyl alcohol, cinnamic acid and 2-methoxy cinnamaldehyde be not less than 0.2%.
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In order to make the national standard method of "General Test Method in Salt Industry-Determination of Iodine" (GB/T 13025.7-2012) more standardized and strict,basing on work experience,literatures and books,the authors listed the details needed to be amended and completed,including method principle,writingof chemical equations,preparation and calibration of standard titration solution,blank tests,sample weighing and result calculation,starch indicator,etc.At the same time,we gave out our opinions and suggestions aiming to provide reference for standard methodologist in revising and updating the standard method.
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To reveal the extraction regularity of volatile oil from galangal by GC-MS analysis. The volatile oil in galangal was extracted by steam distillation. The extract was collected every 30 min, the oil part and the water part were separated. GC-MS was used to analyze the extraction liquid collected at different time periods. A total of 140 volatile components were obtained by GC-MS analysis. Among them, the main components were eucalyptus oil alcohol, alpha-pine oil alcohol and 4-terpene alcohol; 22 special components were dissolved in water, 77 special components were dissolved in oil and 41 components were dissolved in both oil and water. With the increase of specific components in water, the content of Eucalyptus in water increased in a linear manner. The increase of eucalyptus oil further promoted the dissolution or dispersion of alpha PN in water, and the change of specific components in oil was positively correlated with the content of Eucalyptus and alpha-terpilenol in oil. The results of principal component analysis show that the physical and chemical properties of the compounds were important factors affecting the distribution of components. PC1 (molecular weight, melting point, boiling point positive correlation), PC2 (negative correlation of refractive index) and PC3 (positive correlation of water solubility) were the main components that lead to the differences in composition distribution. The process of extracting volatile oil from galangal through steam distillation was affected by the physical and chemical properties of volatile components. Some components were specifically distributed in the fragrance and volatile oil system. The endemic components of aromatic water increased the content of the main components in the water system, which may lead to the "emulsification", reduction of the yield and low quality of the volatile oil.
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Distillation , Gas Chromatography-Mass Spectrometry , Kinetics , Oils, Volatile , Plant Oils , Steam , Zingiberaceae , ChemistryABSTRACT
Objective To reveal the dissolution rule of volatile oil in the extraction processfrom Foeniculum vulgare by GC-MS analysis. Methods The volatile oil of F. vulgare was extracted by steam distillation; The volatile oil/perfume system was collected at fixed time interval (30 min); The volatile oil part and perfume part were separated. Using N-docosane and methyl myrisate as double internal standard, GC-MS was selected for analysis and quantification. The main components were extracted by thermography, and the distribution regularity of components was definited. The principal components with the impact on the composition distribution were investigated according to the physical and chemical properties of the molecular weight, melting point, boiling point, and density of the compounds. Results The GC-MS analysis results concluded 123 volatile components. The main components were estragole, anethole, and (R)-(+)-limonene. There were 60 and 27 endemic components in aromatic aqueous solution and volatile oil, respectively, in which 27were common composition. The content of anethole in water was positively related to the endemic components in aromatic water, and even had a positive correlation with anethole artemisia content and (R)-(+)-limonene content. The specific components in the oil were positively related to the content of the main components (R)-(+)-limonene in the volatile oil. The principal component analysis showed that the physical and chemical properties of the compounds were important factors affecting the distribution of components; PC1 (molecular weight and positive correlation of melting point), PC2 (refractive index positive correlation), and PC3 (water-soluble negative correlation) were the principal components that lead to differences in component distribution. Conclusion In the process of extracting volatile oil from F. vulgare, steam distillation is affected by the physical and chemical properties of volatile components. Some components are specifically distributed in aromatic perfume and volatile oil system. The endemic components of aromatic water increase the content of the main components in the water system, which may lead to theproduction of "emulsification" during the extraction process of volatile oil and reduce the yield and quality of volatile oil.
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The laboratories of National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, have developed a series of experimental method . These method have unique advantages over the national standard method and industry standard method . How to make these method become public products through legal procedures to serve disease prevention and control more extensively is an obligatory task for national virological laboratories. This article explores the establishment, verification, validation, and examination of virological non-standard method under laboratory certification and accreditation conditions through empirical research on the " RT-RAA method for detecting EV71/CA16 and other viruses" .
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To develop the HPLC method for simultaneous determination of febrifugine and isofebrifugine in Dichroa febrifuga root, and on the basis of this, the feasibility of quantitative analysis of multi-component by a single-marker (QAMS) model for the determination of the two alkaloids was investigated. The chromatographic separation was performed on an octadecyl bonded silica gel column with mixed solvent consisting of acetonitrile-water-glacial acetic acid-triethylamine (9∶91∶0.36∶0.745) as mobile phase at a flow rate of 1.0 mL•min⁻¹. The detection wavelength was set at 225 nm, and the column temperature was set at 30 ℃. The linear range of febrifugine and isofebrifugine were 10.7-426 ng and 10.6-424 ng, respectively. Their average recovery were 98.33% (RSD 2.7%) and 100.4% (RSD 1.8%), respectively. On the basis of this established method, febrifugine was used as the internal reference substance to calculate the relative correction factors (RCF) and the relative retention values (RRV) of isofebrifugine to febrifugine. Through a series of methodology evaluations, the two alkaloids were simultaneously assayed only by quantitative determination of febrifugine. This result played the part of demonstration role for the application of QAMS model in the determination of isomers.
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Objective To establish a method for the determination of 8 heavy metal elements of Pb,Cd,As,Hg,Co,V,Se,Mo in iron dextran by inductively coupled plasma optical emission spectrometry (ICP-OES).Method Through selection of detection wavelengths,optimization of instrument parameters,verification of matrix effect interference and investigation of internal standard for correction of matrix effect interference,the 8 heavy metal elements were analyzed by ICP-OES.Results The recovery rate of the detected elements were increased from 83％-90％ to 94％-100％,after correction of matrix effect interference by internal standard method.The accuracy of the method were good.The spiked recoveries of the detected elements were from 94.3％ to 101.5％.The precision of the method were good (RSD ＜ 3.5％,n =6).The linearities of the detected elements were good,and the correlation coefficients were all greater than 0.999.The detection limits were from 0.22 to 8.54 ng/mL.The quantization limits were from 0.68 to 25.73 ng/mL.Conclusion The established method was accurate,sensitivity,rapid and reliable,which can be applied to the determination of contents of 8 heavy metal elements in iron dextran.
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Objective To compare the differences between external standard method and relative correction factor method for determination of the flavonoids from Sorbus tianschanica Rupr.Methods Using HPLC external standard method for determination of hyperoside,rutin,isoquercitrin,quercetin-3-O-(6″-O-malonyl)-β-D-glucoside,astragalin and Kaempferol-3-O-(6″-O-malonyl)-β-D-glucopyranoside in Sorbus tianschanica Rupr.,HPLC relative correction factor method was adopted to establish relative correction factor of the other five flavonoids above with hyperoside as reference.The difference was evaluated by comparing the external standard method with the relative correction factor method.Results There was no significant difference between the T test external standard method and relative correction factor method(P>0.05).Conclusion External standard method and relative correction factor method can be used for determination of the flavonoids from Sorbus tianschanica Rupr.,but in the case of lack of reference substance or mass detection,using the relative correction factor method for determination of rutin,hyperoside isoquercitrin,quercetin-3-O-(6″-O-malonyl)-β-D-glucoside,astragalin and kaempferol-3-O-(6″-O-malonyl)-β-D-glucopyranoside in Sorbus tianschanica Rupr.It was more feasible and it can be used as a new quality evaluation method in determination of flavonoid components from Sorbus tianschanica Rupr.
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Objective:To develop a method of quantitative analysis of multi-components by single marker( QAMS) for nine kinds of alkaloids in Xiaohuoluo pills. Methods: An HPLC-QTOF-MS method with an Agilent ZORBAX Extend-C18 RRHT(2. 1 mm × 50 mm,1. 8 μm) column was applied. The flow rate was 0. 21 ml·min-1 . The column temperature was 30 ℃. The mobile phase was methanol (A)-water (B;containing 0. 1％ formic acid and 2. 5 mmol·L-1 ammonium acetate) with gradient elution. The aconitine was used as the internal standard, and the relative correction factor ( RCFs) of hypaconitine, mesaconitine, benzoylaconine, benzoyl-hypaconine, benzoylmesaconine, aconine, hypaconine and mesaconine was respectively established, and the reproducibility inspection on the RCF was performed. The contents of the other 8 kinds of aconitum alkaloids were calculated according to the RCF. At the same time, an external standard method ( ESM) was performed for the content determination of the nine alkaloids. The results of the two methods were compared. The feasibility and accuracy of the QAMS method were verified. Results:Within a certain range,the RCF of hypacontine,mesacontine, benzoylaconine, benzoylhypaconine, benzoyl mesaconine, aconine, hypaconine and mesaconine to aconitine was 1. 736,1. 979,1. 0471,0. 9242,1. 2901,1. 3078,1. 2859,and 1. 0948,respectively. The QAMS method was established for determi-ning alkaloids. There were no significant differences between the results of the QAMS method and those of the external standard method ( ESM) . Conclusion:With the validation of methodology, the method established in our study can be used for the content determina-tion of aconitine, hypaconitine, mesaconitine, benzoylaconine, benzoylhypaconine, benzoylmesaconine, aconine, hypaconine and mesaconine in xiaohuoluo pills.
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OBJECTIVE:To establish the method for simultaneous determination of 5 saponins in Lonicerae Flos. METHODS:Using macranthoidin B as a reference,HPLC method was adopted to calculate the relative correction factor(RCF)of it to macran-thoidin A,dipsacoside B,macranthoside A and macranthoside B. The contents of above 4 saponins were calculated through RCF. Using the contents of saponins determined by external standard method as measured value,the calculated value was compared with measured value. RESULTS:The linear ranges of macranthoidin A,macranthoidin B,dipsacoside B,macranthoside A and macran-thoside B were 0.316-6.32 μg(r=0.9973),0.453-9.06 μg(r=0.9982),0.231-4.62 μg(r=0.9996),0.342-6.84 μg(r=0.9984) and 0.147-2.94 μg(r=0.9961),respectively. RSDs of precision,stability and reproducibility tests were all lower than 2.0%. The recoveries were 97.74%-104.51%(RSD=2.37%,n=6)、96.70%-103.20%(RSD=2.37%,n=6)、96.12%-103.61%(RSD=2.45%, n=6)、98.80%-104.70%(RSD=2.32%,n=6)、99.21%-102.92%(RSD=1.39%,n=6),respectively. There was no statistical sig-nificance between calculated value and measured value(P>0.05). CONCLUSIONS:The method is simple,precise,stable and re-producible. It can be used for the determination of saponins in Lonicerae Flos.
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Objective: To establish a GC determination method for the content and dissolution of magnesium valproate tablets. Methods:Magnesium valproate tablets were detected by a GC internal standard method. The samples were dissolved in 0. 1 mol·L-1 hydrochloric acid solution, and then extracted by dichloromethane. Eicosane was used as the internal standard. The dissolution was de-termined by the first method described in ChP 2015 edition. The dissolution medium was 0. 1 mol·L-1 hydrochloric acid solution and the rotation speed was 100 r·min-1 with the sampling time at 45 min. The samples were extracted by dichiormethane, and eicosane was used as the internal standard as well. Results: The dissolution of magnesium valproate tablets showed good linearity within the range of 0. 005-1. 000 mg·ml-1(r=0. 9999). The recovery was 99. 2% (RSD=0. 5%, n=9). The dissolution curve showed that magnesium valproate released above 80% in 45 minutes. Conclusion:The method has good specificity and high accuracy, and can be used for the content determination and dissolution detection of magnesium valproate tablets.
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Objective To establish a method for the determination of 8 heavy metal elements of Pb,Cd,As,Hg,Co,V,Se,Mo in iron dextran by inductively coupled plasma optical emission spectrometry (ICP-OES).Method Through selection of detection wavelengths,optimization of instrument parameters,verification of matrix effect interference and investigation of internal standard for correction of matrix effect interference,the 8 heavy metal elements were analyzed by ICP-OES.Results The recovery rate of the detected elements were increased from 83％-90％ to 94％-100％,after correction of matrix effect interference by internal standard method.The accuracy of the method were good.The spiked recoveries of the detected elements were from 94.3％ to 101.5％.The precision of the method were good (RSD ＜ 3.5％,n =6).The linearities of the detected elements were good,and the correlation coefficients were all greater than 0.999.The detection limits were from 0.22 to 8.54 ng/mL.The quantization limits were from 0.68 to 25.73 ng/mL.Conclusion The established method was accurate,sensitivity,rapid and reliable,which can be applied to the determination of contents of 8 heavy metal elements in iron dextran.
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Objective: To establish a method of quantitative analysis of multi-components by single marker (QAMS) for determining the flavonoids in Epimedii Herba and improve the level of quality control of Epimedii Herba by applying multi-index components control. Methods: To detect a relative correction factor (RCF) of epimendin A, epimendin B, epimendin C, and icariin at detection wavelength of 270 nm by HPLC in the range of a linear, to investigate the reproducibility of RCF in different chromatographic columns and different instruments as well, to consider icariin as an internal standard, to calculate the contents of epimendin A, epimendin B, and epimendin C in Epimedii Herba by using RCF; Meanwhile, to analyze the content of the four components in 100 Epimedii Herba by external standard method (ESM) and verify the accuracy and scientificalness of QAMS. Results: The RCF had a good reproducibility, which were 1.352, 1.384, and 1.340. The values of RSD were less than 5%; No significant differences were found in the quantitative results of epimendin A, epimendin B, and epimendin C determined by using RCF and ESM. Conclusion: This method could be accurate and reliable, simple and feasible, which could save the reference and costs of testing. It further validates that this approach can be used as a quality control method for the determination of multi-component index in Epimedii Herba.
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Objective: To establish a quantitative analysis method for determining the contents of artemisinin, quercetin, isorhamnetin, Ginkgo esters, and lactones a, b, c in Shuxuening Injection by using multi-components with a single marker (QAMS), and set up methodological evaluation model of the above experiment. Methods: With artemisinin and Ginkgo esters as indexes, the relative correction factor (fk/s) between artemisinin and the other two total flavonoids and the fk/s between Ginkgo esters and lactones a, b, c were established. The contents of artemisinin and Ginkgo esters in Shuxuening Injection were determined by external standard method, the contents of other five components in Shuxuening Injection were calculated by the relative correction factor. The results of the content of five batches of Shuxuening Injection determined by QAMS and tested by external standard method were carried out by t test. Results: The fk/s of quercetin and isorhamnetin with reference to artemisinin were 1.873 and 0.324, the fk/s of ginkgolide A, B, C with reference to Ginkgo esters were 2.280, 1.659, and 1.429. And the repeatability was good under different experimental conditions. There were no significant differences between the calculated value and estimated value on QAMS and external standard method of five batches of Shuxuening Injection, and the results showed that fk/s was authentic. Conclusion: The established correction factor has good repeatability, and could be used for quantitative analysis and quality evaluation of multiple components in Shuxuening Injection.
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OBJECTIVE: To establish a1 H-NMR internal standard method for measurement of glucosamine hydrochloride in glucosamine hydrochloride capsules. METHODS: For the HPLC-UV method, a China national drug tentative standard (No. YBH11442006) was employed. For the H-NMR analysis, the optimal determination conditions were selected as follows; the pulse sequence was zgpr, hydrogen spectral width was 6 009 Hz, pulse width was 11. 95μs, delay time was 6.50μs, the temperature was 27℃ and the number of scans was 32. RESULTS: The peak of δ 3.05 ppm of the glucosamine hydrochloride and the peak of δ 0 ppm of TSP were selected as quantitative peak and internal standard peak, respectively, and the concentration of the internal standard TSP was 1.02 mmol·L-1. A good linear relationship was obtained with a regression equation as Y = 2.717 IX +0.149 9(r =0.9998) in the concentration range of 2.0-12.0 mg·mL-1. The average recovery rate and the RSD of glucosamine hydrochloride capsules were 103.59% and 1.09% (n = 9), respectively. CONCLUSION: With simple pretreatment, high sensitivity, good repeatability and short analysis time, the NMR-based method could be applied to the measurement of glucosamine hydrochloride in glucosamine hydrochloride capsules.
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Objective:To establish a quantitative analysis of multi-components by single marker ( QAMS) method for the determi-nation of six components ( phillyrin, schizandrol, schisandra ester, deoxyschizandrin, schisandrin B and schisandrin C ) in Liuwei Wuling tablets,and verify the accuracy and feasibility of the method applied in the preparation. Methods:The relative correction factor ( f) of schisandrin B, schisandrin C, schisandra ester, schizandrol, phillyrin and deoxyschizandrin was detected by HPLC at the detec-tion wavelength of 230nm, and the contents of the components in Liuwei Wuling tablets were calculated to achieve the multi evaluation. Meanwhile, the contents of the six components were analyzed by an external standard method and the relative error between the calcula-tion of QAMS method ( Wf ) and the result of the external standard method ( Ws ) was calculated to verify the accuracy of QAMS. The reproducibility of the method was also investigated. Results:The QAMS method was established to determine the contents of 6 compo-nents in Liuwei Wuling tablets, and the components in 10 batches of Liuwei Wuling tablets were determined. The differences between the calculated values and the measured values were small ( RSD < 5%) . Conclusion:The QAMS method is simple, effective and ac-curate in determining the contents of 6 effective components in Liuwei Wuling tablets. The quality evaluation model of QAMS for Liuwei Wuling tablets is validated, which can be used for the quality control of Liuwei Wuling tablets and provide reference for the further study.
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Objective To establish a kind of simple ,rapid ,accurate and reliable method to determine the phenobarbital in the biomaterial .Methods We pre‐treated biomaterial by the method that the reagent of acetone∶water (v/v 8∶2) was firstly used to soak the biomaterial ,and then we took use of ethyl acetate as reagent to extract the phenobarbital of the biomaterial in the present of pH=3-4 .We finally employed GC‐MS to determine these samples .On the one hand ,we not only took advantage of the reten‐tion time of the phenobarbital in total ion current (TIC) but also took advantage of the characteristic fragment ions of phenobarbital in mass spectrogram as qualitative basis .On the other hand ,we took advantage of the external standard method as quantitative ba‐sis .Results The method had the characteristics of the simple and easy operation .There was hardly background interference and there was good separation effect in the method .The method also had the characteristics of fast analytical speed such as the retention time of the phenobarbital was 8 .385 min .The characteristic fragment ions of phenobarbital was m/z 204 and m/z 232 .The charac‐teristic fragment ions of m/z 204 was served as quantitative ion fragments and we employed the external standard method to quanti‐fy in the method .In short ,the average recovery rate of the method was 87 .35% .Relative standard deviation (RSD) was 5 .43% in the method .The lowest limit of detection (LLOD) was 0 .005 mg/mL .Conclusion The method showes satisfactory result that it could be applied to determine the phenobarbital of the biomaterial of forensic toxicological analysis .
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Objective To establish QAMS method to determine the contents of three alkaloids in bile processed Coptidis Rhizoma; To compare the results of QAMS with those from external standard method; To prove the feasibility of QAMS.Methods An HPLC method was developed. Berberine hydrochloride was selected as the internal reference substance. 2 relative correction factors (RCF) of berberine hydrochloride to palmatine hydrochloride and to jatrorrhizine hydrochloride were established. Obtained RCFs were used to conduct content calculation (calculated value) to complete QAMS method. At the same time, the contents (measured value) of the three components were also determined by external standard method. Calculated value and measured value were compared.Results The analysis results showed that there was no significant difference between the calculated values and the measured values of the three alkaloids in 10 batches of bile processed Coptidis Rhizoma.Conclusion The QAMS method can be applied in the determination of alkaloids in bile processed Coptidis Rhizoma.