In order to combat the counterfeiting of drugs, adapted HPLC analytical USP methods were applied to evaluate the quality of the amoxicillin (with or without potassium clavulanate) powder for suspension sold in some Co...In order to combat the counterfeiting of drugs, adapted HPLC analytical USP methods were applied to evaluate the quality of the amoxicillin (with or without potassium clavulanate) powder for suspension sold in some Congolese markets. The adaptation has been done by modifying the column dimensions and adjusting the flow rate. According to the intended deployment of these methods in Democratic Republic of Congo (DRC), 3 factors (analyst, day and equipment) were involved in the validation step while applying the classic total error measurement approach with an accuracy profile as decision tool. Since adequate results were obtained in terms of selectivity, precision, trueness and accuracy (tolerance limits of life expectancy: ?6.0% and 3.8%) for levels of interest concentration, the methods have been considered for routine use on several samples from different provenances and collected in 4 major DRC cities. Out of 278 samples collected, 200 were eligible for analysis from which 28% were found under standards with several figures: pH failure, out of specification for amoxicillin content, absence of potassium clavulanate, physical modifications of the powders. As evidenced by these findings, medicines of low-quality continue to be a major public health problem requiring appropriate action to effectively address this problem.展开更多
In the framework of fighting against the poor quality medicines sold in developing countries using classical analytical methods easily accessible in those countries, four UV-Visible spectrophotometric methods for one ...In the framework of fighting against the poor quality medicines sold in developing countries using classical analytical methods easily accessible in those countries, four UV-Visible spectrophotometric methods for one antimalarial (quinine) and two antibiotics (amoxicillin and metronidazole) have been developed and validated according to the total error strategy using the accuracy profiles as a decision tool. The dosing range was 2 - 10 μg/mL (for quinine sulfate in tablet), 4 - 12 μg/mL (for quinine bichlorhydrate in oral drop-metronidazole benzaote in oral suspension) and 15 - 35 μg/mL (for amoxicillin trihydrate in capsule). The validated methods were then applied in determining the content of some analogous medicines sold in the Democratic Republic of Congo. Thus, the proposed UV-Visible spectrophotometric methods are simple and suitable to quantify quinine, amoxicillin and metronidazole in different pharmaceutical forms.展开更多
As an important representative of the modernization of the Chinese medicine industry,traditional Chinese medicine(TCM)compound preparations are an indispensable part of the development of TCM.The complex ingredients a...As an important representative of the modernization of the Chinese medicine industry,traditional Chinese medicine(TCM)compound preparations are an indispensable part of the development of TCM.The complex ingredients and unclear action mechanism of TCM compound preparations restrict the development of TCM.In line with this problem,the modern TCM research has made extensive remarkable achievements.From the single indicator in the past to multiple indicator,the research on the combination of TCM fingerprints and pharmacodynamics also has made great progress.The introduction of quality evaluation methods such as the"quantitative analysis of multi-components by a single marker","dose-effect"indicator,"Bioactive Equivalent Combinatorial Components"(BECCs)and TCM quality markers have brought new ideas for quality control of TCM compound preparations.展开更多
A high-performance liquid chromatographic method was applied to the determination of stachydrine hydrochloride concentration in TJF granule (Chinese name: Tiao-Jing-Fang), using a mobile phase of methanol-acetonitrile...A high-performance liquid chromatographic method was applied to the determination of stachydrine hydrochloride concentration in TJF granule (Chinese name: Tiao-Jing-Fang), using a mobile phase of methanol-acetonitrile (50:50, v/v) by the Agilent Kromasi NH2 column (250 mm × 4.6 mm, 5 μm, S/N: 22N25110). Detection wavelength was 201 nm. The result revealed good linearity of stachydrine hydrochloride and was obtained within the range of 0.20 - 1.98 μg/mL (R = 0.9995). The average recovery was 97.01%;the relative standard deviation (RSD) was 0.19%. To the best of our knowledge, this is the first report dedicated to the determination of stachydrine hydrochloride by the evaporative light scattering detector-high-performance liquid chromatographic (ELSD-HPLC) method.展开更多
Due to the continuous development of information technology, people's perception of real life is more based on the information acquired on the real environment with the help of various media, rather than intuition...Due to the continuous development of information technology, people's perception of real life is more based on the information acquired on the real environment with the help of various media, rather than intuition. Based on priority evaluation data obtained from dianping.com(Liaoning Province), and the established criteria for assessing pseudo habitat environment quality, this study uses the entropy method to calculate and rank the comprehensive score of each merchant's word-of-mouth evaluation. It analyzes the spatial pattern and differentiation characteristics of pseudo environment quality, as well. Results show that:(1) The overall quality scores of the pseudo living environment in southern, central, and northern Liaoning are higher than those in eastern and western area. The pseudo habitat environment quality score of coastal cities is relatively higher than that of inland cities; and that of cities with high resource depletion is lower.(2) Parent-child activity, learning and training, and sports & health have significant impact, whereas hotels and peripheral tours have less impact on the pseudo habitat environment quality in Liaoning province. The overall pseudo habitat environment quality score of a city is inversely proportional to the total scores of various indicators in the city.(3) The spatial distribution of pseudo habitat quality in Liaoning Province shows a "saddle" structure. The spatial heterogeneity of the pseudo habitat environment in central and northern Liaoning areas is larger than that in eastern, western, and southern areas of Liaoning. The degree of quality of the pseudo habitat environment is proportional to the size of its spatial differentiation degree in total.展开更多
With the rapid development and wide application of traditional Chinese medicine injection(TCMI), a number of adverse events of some TCMIs have incessantly been reported and have drawn broad attention in recent years. ...With the rapid development and wide application of traditional Chinese medicine injection(TCMI), a number of adverse events of some TCMIs have incessantly been reported and have drawn broad attention in recent years. Establishing effective and practical analytical methods for safety evaluation and quality control of TCMI can help to improve the safety of TCMIs in clinical applications. In this study, a sensitive and rapid high-performance liquid chromatography–tandem mass spectrometry(HPLC–MS/MS)method has been developed and validated for the quantitative determination of potentially harmful substance5,5′-oxydimethylenebis(2-furfural, OMBF) in TCMI samples. Chromatographic separation was performed on a C18 reversed-phase column(150 mm × 2.1 mm, 5 μm) by gradient elution, using methanol–water containing 0.1% formic acid as mobile phase at the flow rate of 0.3 m L/min. MS/MS detection was performed on a triple quadrupole mass spectrometer with positive electrospray ionization in the multiple reaction-monitoring mode. The method was sensitive with a limit of quantification of 0.3 ng/m L and linear over the range of 0.3–30 ng/m L(r = 0.9998). Intra-and inter-day precision for analyte was o9.52% RSD withrecoveries in the range 88.0–109.67% at three concentration levels. The validated method was successfully applied to quantitatively determine the compound OMBF in TCMIs and glucose injections. Our study indicates that this method is simple, sensitive, practicable and reliable, and could be applied for safety evaluation and quality control of TCMIs and glucose injections.展开更多
文摘In order to combat the counterfeiting of drugs, adapted HPLC analytical USP methods were applied to evaluate the quality of the amoxicillin (with or without potassium clavulanate) powder for suspension sold in some Congolese markets. The adaptation has been done by modifying the column dimensions and adjusting the flow rate. According to the intended deployment of these methods in Democratic Republic of Congo (DRC), 3 factors (analyst, day and equipment) were involved in the validation step while applying the classic total error measurement approach with an accuracy profile as decision tool. Since adequate results were obtained in terms of selectivity, precision, trueness and accuracy (tolerance limits of life expectancy: ?6.0% and 3.8%) for levels of interest concentration, the methods have been considered for routine use on several samples from different provenances and collected in 4 major DRC cities. Out of 278 samples collected, 200 were eligible for analysis from which 28% were found under standards with several figures: pH failure, out of specification for amoxicillin content, absence of potassium clavulanate, physical modifications of the powders. As evidenced by these findings, medicines of low-quality continue to be a major public health problem requiring appropriate action to effectively address this problem.
文摘In the framework of fighting against the poor quality medicines sold in developing countries using classical analytical methods easily accessible in those countries, four UV-Visible spectrophotometric methods for one antimalarial (quinine) and two antibiotics (amoxicillin and metronidazole) have been developed and validated according to the total error strategy using the accuracy profiles as a decision tool. The dosing range was 2 - 10 μg/mL (for quinine sulfate in tablet), 4 - 12 μg/mL (for quinine bichlorhydrate in oral drop-metronidazole benzaote in oral suspension) and 15 - 35 μg/mL (for amoxicillin trihydrate in capsule). The validated methods were then applied in determining the content of some analogous medicines sold in the Democratic Republic of Congo. Thus, the proposed UV-Visible spectrophotometric methods are simple and suitable to quantify quinine, amoxicillin and metronidazole in different pharmaceutical forms.
基金Supported by Project of National Natural Science Foundation of China(81560691)Special Fund Project for Innovation Driven Development of Guangxi(Gui Ke AA17202046)+8 种基金Program of Scientific Research Third-level Laboratory"Chinese(Zhuang)Medicine Chemical and Quality Analysis Laboratory"of State Administration of Traditional Chinese Medicine(Guo Zhong Yi Yao Fa 2009[21])Program of Key Laboratory for Purification and Quality Analysis of TCM Extraction in Guangxi Universities(Gui Jiao Ke Yan[2014]No.6)Program of Collaborative Innovation Center of Zhuang and Yao Medicine(Gui Jiao Ke Yan:2013 No.20)Program of Key Laboratory of Zhuang and Yao Medicine[Gui Ke Ji Zi:2014 No.32]Bagui Scholar Program of Key Discipline of Guangxi"Study on Innovation Theory and Efficacy of Traditional Chinese Medicine"[Gui Ke Zheng Zi:2013 No.25]High-level Talent Team Cultivation Program of"Qihuang Project"of Guangxi University of Chinese Medicine(2018002)Open Program for Construction of TCM Pharmacy Doctor Station in Guangxi University of Chinese Medicine(201410-06)High Level Innovation Team and Excellent Scholar Program of Guangxi Universities(Gui Jiao Shi Fan 2019 No.52)Guangxi One Thousand Young and Middle-aged College and University Backbone Teachers Cultivation Program(Gui Jiao Ren2019 No.5).
文摘As an important representative of the modernization of the Chinese medicine industry,traditional Chinese medicine(TCM)compound preparations are an indispensable part of the development of TCM.The complex ingredients and unclear action mechanism of TCM compound preparations restrict the development of TCM.In line with this problem,the modern TCM research has made extensive remarkable achievements.From the single indicator in the past to multiple indicator,the research on the combination of TCM fingerprints and pharmacodynamics also has made great progress.The introduction of quality evaluation methods such as the"quantitative analysis of multi-components by a single marker","dose-effect"indicator,"Bioactive Equivalent Combinatorial Components"(BECCs)and TCM quality markers have brought new ideas for quality control of TCM compound preparations.
文摘A high-performance liquid chromatographic method was applied to the determination of stachydrine hydrochloride concentration in TJF granule (Chinese name: Tiao-Jing-Fang), using a mobile phase of methanol-acetonitrile (50:50, v/v) by the Agilent Kromasi NH2 column (250 mm × 4.6 mm, 5 μm, S/N: 22N25110). Detection wavelength was 201 nm. The result revealed good linearity of stachydrine hydrochloride and was obtained within the range of 0.20 - 1.98 μg/mL (R = 0.9995). The average recovery was 97.01%;the relative standard deviation (RSD) was 0.19%. To the best of our knowledge, this is the first report dedicated to the determination of stachydrine hydrochloride by the evaporative light scattering detector-high-performance liquid chromatographic (ELSD-HPLC) method.
基金Sponsored by National Nature Science Foundation of China(41671158)Ph.D.Programs Foundation of Ministry of Education(20132136110001)Program for Liaoning Excellent Talents in University(LR2013050)
文摘Due to the continuous development of information technology, people's perception of real life is more based on the information acquired on the real environment with the help of various media, rather than intuition. Based on priority evaluation data obtained from dianping.com(Liaoning Province), and the established criteria for assessing pseudo habitat environment quality, this study uses the entropy method to calculate and rank the comprehensive score of each merchant's word-of-mouth evaluation. It analyzes the spatial pattern and differentiation characteristics of pseudo environment quality, as well. Results show that:(1) The overall quality scores of the pseudo living environment in southern, central, and northern Liaoning are higher than those in eastern and western area. The pseudo habitat environment quality score of coastal cities is relatively higher than that of inland cities; and that of cities with high resource depletion is lower.(2) Parent-child activity, learning and training, and sports & health have significant impact, whereas hotels and peripheral tours have less impact on the pseudo habitat environment quality in Liaoning province. The overall pseudo habitat environment quality score of a city is inversely proportional to the total scores of various indicators in the city.(3) The spatial distribution of pseudo habitat quality in Liaoning Province shows a "saddle" structure. The spatial heterogeneity of the pseudo habitat environment in central and northern Liaoning areas is larger than that in eastern, western, and southern areas of Liaoning. The degree of quality of the pseudo habitat environment is proportional to the size of its spatial differentiation degree in total.
基金supported by Chinese Academy of Medical Science (CAMS) Innovation Fund for Medical Sciences (Grant Nos. 2016-I2M-1–009 and 2016-I2M-3–010)National Scientific and Technological Major Project for New Drugs (Grant No. 2017ZX09101003-002-004)
文摘With the rapid development and wide application of traditional Chinese medicine injection(TCMI), a number of adverse events of some TCMIs have incessantly been reported and have drawn broad attention in recent years. Establishing effective and practical analytical methods for safety evaluation and quality control of TCMI can help to improve the safety of TCMIs in clinical applications. In this study, a sensitive and rapid high-performance liquid chromatography–tandem mass spectrometry(HPLC–MS/MS)method has been developed and validated for the quantitative determination of potentially harmful substance5,5′-oxydimethylenebis(2-furfural, OMBF) in TCMI samples. Chromatographic separation was performed on a C18 reversed-phase column(150 mm × 2.1 mm, 5 μm) by gradient elution, using methanol–water containing 0.1% formic acid as mobile phase at the flow rate of 0.3 m L/min. MS/MS detection was performed on a triple quadrupole mass spectrometer with positive electrospray ionization in the multiple reaction-monitoring mode. The method was sensitive with a limit of quantification of 0.3 ng/m L and linear over the range of 0.3–30 ng/m L(r = 0.9998). Intra-and inter-day precision for analyte was o9.52% RSD withrecoveries in the range 88.0–109.67% at three concentration levels. The validated method was successfully applied to quantitatively determine the compound OMBF in TCMIs and glucose injections. Our study indicates that this method is simple, sensitive, practicable and reliable, and could be applied for safety evaluation and quality control of TCMIs and glucose injections.
