最新刊期
卷 32 ， 期 4 ， 2021
- 摘要：OBJECTIVE：To provide reference for pharmaceutical enterprises to better fulfill their social responsibilities . METHODS：Taking the pharmaceutical enterprises listed in Shanghai and Shenzhen stock markets as the research objects ，the social responsibility texts and environmental protection texts of the included enterprises from 2017 to 2019 were classified and analyzed according to the three dimensions of time ，ownership and drug production type by using ROST Content Mining 6.0 software. The semantic network and node centrality were analyzed. RESULTS ：From the social responsibility texts of the included enterprises，it could be seen that from the perspective of time dimension ，the included enterprises paid more attention to “employees”，“social responsibility ”and“development”in 2017-2019，and the high-frequency words in the three years were relatively stable. From the perspective of ownership ，state-owned holding enterprises paid more attention to “development”and “targeted poverty reduction ”，while private holding enterprises paid more attention to “employees”，and collective holding enterprises paid more attention to “social responsibility ”. From the perspective of drug production type ，the word frequency of “targeted poverty reduction ”of TCM pharmaceutical enterprises was higher. From the environmental protection texts of the included enterprises，it could be seen that from the time dimension ，the included enterprises paid more and more attention to environmental protection in recent years ，and the description of environmental protection in the texts was more detailed. From the perspective of ownership，private holding enterprises paid more attention to environmental protection than collective holding enterprises and state-owned enterprises. From the perspective of drug production type ，due to the different types of drugs ，chemical drugs ，TCM， biological drugs and active pharmaceutical ingredients enterprises had their own characteristics in pollutants and their treatment processes. The results of semantic network and node centrality analysis showed that ，“development”，“protection” and “targeted poverty reduction ”were three high-frequency words with high centrality in the semantic analysis network of social responsibility text ，the middle centrality was 5.555，1.695，1.521 respectively；“emission”and“testing”were two key words with high centrality in the semantic analysis network of environmental protection texts ，the middle centrality was 3.856， 1.914 respectively，which further reflected that the included enterprises paid more attention to the above issues in terms of social responsibility performance and environmental protection. CONCLUSIONS ：The listed pharmaceutical enterprises have a broad consensus on social responsibility in China ，and have well fulfilled their social responsibility ，which is well combined with the current social hot spots. For environmental protection ，as a high pollution industry ，the pharmaceutical enterprises also performs the responsibility of environmental protection.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To furt her standardize and improve the drug instructions of Chinese patent medicine ，and to promote its clinical safe and rational use. METHODS ：The varieties of Chinese patent medicines with clear content revision issued by the website of the State Drug Administration from January 2010 to June 2020 were inquired. The revised contents ，characteristics and deficiencies were summarized and analyzed to put forward the revision suggestions. RESULTS & CONCLUSIONS ：Among 107 Chinese patent medicine varieties the instruction content of which were revised clearly ，safety items were the focus of revision ；106 types（99.07％）were revised in terms of “contraindications”，103 types（96.26％）were revised in terms of “precautions”，102 types（95.33％）were revised in terms of “ADR”，49 types（45.79％）were revised in terms of “warning words ”，etc. The main dosage forms involved in the revision were oral preparations ，followed by injections and a small amount of external/rectal/vaginal dosage forms. The revised content highlighted the TCM syndrome types applicable to Chinese patent medicine ，emphasized the precautions for the use of Chinese patent medicine containing toxic and chemical components and detailed the medication precautions for special groups. However ，there were still some problems ，such as lack of quantitative expression ，lack of systematic and comprehensive drug interaction tips ，and other related items that had not been revised needed to be improved. In order to promote the safe and rational use of Chinese patent medicine ，it is suggested that the revision of Chinese patent medicine instructions should focus on safe drug use ，provide clear ADR monitoring data ，clear and specific medication attention and systematic and comprehensive drug interaction.关键词：Chinese patent medicin e;Drug instructions;Rational drug use;Revision;Analysis
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To evaluate the current situation and implementation effect of the pilot project of electronic prescription and remote pharmaceutical care in social pharmacy from the perspective of consumers ，and to provide reference for improving and optimizating the electronic prescription and remote pharmaceutical care in social pharmacy. METHODS ：Totally 264 consumers in 6 counties and 36 drugstores of Chengdu were randomly selected for the questionnaire survey. Descriptive statistics were conducted by using SPSS 23.0 software. Compare the distribution and differences of various. The influential factors in consumer satisfaction based on χ2 test and ordinal multiple Logistic regression analysis. Consumers were randomly selected for semi-structured interviews. Text analysis was conducted by Nvivo 12.0 software to refine the problem of this service . RESULTS ：A total of 271 questionnaires were distributed to consumers in various districts of Chengdu ，and 264 valid questionnaires were collected，with an effective recovery rate of 97.4％. Among 264 respondents，178（67.9％）knew about electronic prescription and remote pharmaceutical care ；197（74.6％）received electronic prescription and remote pharmaceutical care service in pharmacies ； 202（76.5％）said they needed this service ，and 63（23.9％）expressed that they would like to pay for it. Of the 197 respondents who had received the service ，163（82.2％）were satisfied or very satisfied with the service ，and only one （0.5％）was dissatisfied with the service. Waiting time ，satisfaction of drug demand ，staff attitude ，service platform configuration ，the qualifications of tele-practice pharmacists and service quality were the main influential factors of satisfaction ；while the service also suffered from difficulties in electronic prescription circulation ，inadequate service monitoring measures ，insufficient certification of physicians and pharmacists，cultural lag ，and irregular service processes. CONCLUSIONS ：Electronic prescription and remote pharmaceutical care service in social pharmacy is inadequate in terms of technical level ，institutional design and social acceptance. It is recommended that relevant departments implement incentive policies ，optimize technology ；follow up supporting policies in time ，strengthen supervision；and increase social publicity and supervision ，so as to promote the continuous improvement and long-term development of electronic prescription and remote pharmaceutical care in social pharmacy.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To provide reference for constructing and improving the pharmacovigilance signal management sys - tem in China by comparing signal management system among the European Union （EU），the United States （U. S. ）and Japan. METHODS：Literature analysis method was used to systematically compare the similarities and differences on definitions ，sources， detection methods and management process of pharmacovigilance signals among EU ，U. S. and Japan. Some suggestions were put forward for pharmacovigilance management in China. RESULTS & CONCLUSIONS ：Regulatory authorities of the EU ，U. S. and Japan did not have a uniform definition on signals ；EU drug administration adopted the definition of the eighth working group of Council for International Organizations of Medical Sciences ，FDA adopted its own definition ，while the Japanese regulatory agency had no clear definition. Currently ，post-marketing surveillance still relied mainly on spontaneous reporting systems ；EU，U. S. and Japan had carried out the signal detection based on the spontaneous reporting system ；EU mainly adopted the proportional reporting ratio method ，U. S. mainly adopts the multiple gamma Poisson Shrinker ，and Japan mainly adopted the reporting ratio method. EU had special guidelines for signal management process ，while the U. S. and Japan did not. It is recommended to accelerate the deve- lopment of the legal and regulatory framework on pharmacovigilance in China ，draw up guidelines on pharmacovigilance practices ， strengthen the active ADR surveillance and promote the application of data mining techniques in signal detection field ，for accelerat - ing the standardization and internationalization of China ’s pharmacovigilance work.关键词：European Union;The United States;Japan;Pharmacovigilance;Signal;Active surveillance;Data mining;En-
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To study the effects of rat intestinal flora on the pharmacokinetic parameters of pyrazinamide and its active metabolite pyrazinoic acid. METHODS ：Totally 16 SD rats were randomly divided into trial group and control group ，with 8 rats in each group. Trial group was given mixed antibiotics （streptomycin sulfate+neomycin sulfate ）intragastrically to construct pseudoaseptic rat model. After modeling ，both groups were given pyrazinamide intragastrically （150 mg/kg）. Before and 0.167， 0.333，0.667，1，1.5，2，3，4，6，9 h after administration ，0.1 mL blood sample was collected from orbital venous plexus ，and 0.3 mL blood sample was collected from orbital venous plexus 12，24 h after administration. Using phenacetin as internal standard ， LC-MS/MS method was adopted to determine the plasma concentration of pyrazinamide and pyrazinoic acid. The determination was performed on Agilent ZORBAX SB-Aq column with mobile phase consisted of 0.2％ formic acid （containing 8 mmol/L ammonium acetate）-methanol（gradient elution ）at the flow rate of 1 mL/min. The column temperature was set at 30 ℃，and sample size was 10 μL. The ion source was ESI and the temperature of ion source was 500 ℃. The collision gas was nitrogen and the pressure was 10 psi. The temperature of mass transfer interface was 100 ℃. The mass spectrum monitoring mode was multi reaction monitoring ， and the collection mode was positive ion mode. The monitoring transition ion-pairs were m/z 124.0→79.0（pyrazinamide），m/z 125.1→79.1（pyrazinic acid ）and m/z 180.0→110.2（internal standard ）. The de-clustering potential and collision voltage were 55， 26 and 85 V，24，23 and 28 V，respectively. The pharmacokinetic parameters were calculated and compared by using DAS 2.1.1 software. RESULTS ：The linear ranges of pyrazinamide and pyrazinoic acid were 25-5 000 ng/mL（r＝0.997 6）and 100-12 500 ng/mL（r＝0.999 0）. The lower limits of quantification were 25 and 100 ng/mL，respectively. Intra-batch and inter-batch accuracy were 92.93％-100.50％，and RSDs of intra-batch and inter-batch precision and matrix effect tests were all lower than or equal to 8.42％（n＝6 or n＝3）. Compared with control group ，tmax of pyrazinamide in trial group was prolonged significantly （P＜0.01）； there was no statistical significance in other pharmacokinetic parameters between 2 groups（P＞0.05）. CONCLUSIONS ：The absorption of single dose pyrazinamide is delayed with the change of intestinal flora in rats.关键词：Pyrazinamide;Pyrazinoic acid;Rat;Intestinal flora;Pharmacokinetics;LC-MS/MS
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发布时间：2022-06-21 - 摘要：OBJECTIVE： To study the effects of Atractylodes macrocephala ethanol extract （AM） on life span of Caenorhabditis elegans（called N 2 nematode for short ），and to investigate its mechanism based on transcription factor SKN- 1/ nuclear factor E 2 related factor 2（Nrf2）. METHODS ：N2 nematode were divided into blank control group ，positive control group （100 μ mol/L curcumin，similarly hereinafter ），AM low-dose ，medium-dose and high-dose groups （100，200，300 μ g/mL， similarly hereinafter ）. The effects of AM on the life span （by average survival time ）of N 2 nematode under normal condition and oxidant stress condition （40 mmol/L H 2O2）as well as its effects on reproductive capability （by the number of filial generation ）of N2 nematode under normal condition were investigated . 700 μmol/L H2O2 was used to establish neuroblastoma cells N 2a oxidant stress model. Effects of positive control ，low-dose，medium-dose and high-dose of AM on the survival rate of model cells were detected by MTT method. After human embryonic renalepithelial cells 293T were transfected with Nrf 2-ARE plasmid ， the effects of positive control and AM on luciferase activity of Nrf2-ARE were detected by luciferase reporter gene method at low，medium and high dose for 24 h and at medium dose for 12，18 and 24 h. RT-PCR was used to detect the effects ofpositive control ，low-dose，medium-dose and high-dose of AM on the mRNA expression of downstream genes NQO- 1 and HO- 1 of Nrf 2 in N 2a cells as well as mRN A expression of en@hactcm.edu.cn downstream genes GCS- 1，GST-7，GST-10，HSP-60，HSP- 16.2 and SOD- 3 of SKN- 1 in N 2 nematode. RESULTS ：Compared with blank control group ，average survival time of N 2 nematode under normal and oxidant stress condition was significantly prolonged in positive control group and AM groups ；the number of filial generation on the first day （except for AM high-dose group ），the number of filial generation on the second day （except for AM low-dose group ） and the total number of filial generation （except for AM low-dose group ） were increased significantly（P＜0.05 or P＜0.01）. The survival rate of N 2a cells in positive control group ，AM medium-dose and high-dose groups were significantly higher than that of model group （P＜0.05 or P＜0.01）. Compared with blank control group ，Nrf2-ARE luciferase relative activity of 293T cells in positive control group and AM groups as well as Nrf 2-ARE luciferase relative activity of 293T cells in AM medium-dose group after different time of treatment were increased significantly （P＜0.01），in dose-dependent and time-dependent trend. Compared with blank control group ，mRNA relative expression of HO- 1 and NQO- 1（except for positive control group ），GCS-1（except for AM low-dose group ），GST-7（except for positive control group and AM low-dose group ）， GST-10 and HSP- 60（except for AM low-dose group ），HSP-16.2（except for positive control group and AM low-dose group ）and SOD-3 （except for positive control group and AM low-dose group ） were increased significantly （P＜0.05 or P＜0.01）. CONCLUSIONS：AM can prolong the life span of N 2 nematode under normal and oxidant stress condition and improve the its reproductive capacity ，the mechanism of which may be associated with the activation of SKN- 1/Nrf2 signaling pathway.关键词：Atractylodes macrocephala;Ethanol extract;Caenorhabditis elegans;Life span;Oxidant stress;Nrf2;SKN-1
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To predict the pot ential target and mechanism of Xintong Changluo Method carrier-Compund Shensu Ⅱ couplet medicine of Bupleurum falcatum-Scutellaria baicalensis intervening in podocyte lesion ，and to provide reference for the development of sequential clinical and basic research of Xintong Changluo Method in the prevention and treatment of podocyte lesion. METHODS ：Based on TCMSP database ，chemical components and target protein of B. falcatum and S. baicalensis were retrieved，and Cytoscape 3.2.1 software was used to draw a “TCM-component-target”network. The targets related to podocyte lesion were searched from OMIM database ，DrugBank database and Digsee online text ，and the intersection genes of above targets and“B. falcatum -S. baicalensis ”target were obtained by Venny 2.1.0 online mapping tool. The protein-protein interaction （PPI） network was constructed by STRING database ，and the core targets were obtained by topology analysis of the network by using CytoNCA plug-in Cytospace 3.2.1 software. With the help of DAVID database ，the fu nction of Gene Ontology （GO）was annotated and KEGG pathway was enriched ；and the enrichment results were visualized through OmicShare Tools online mapping platform. RESULTS ：Based on retrieval results of TCMSP database，44 active components were obtained ，involving 13 com of B. falcatum and 32 of S. baicalensis ； stigmasterol is common component of B. falcatum and S. baicalensis Quercetin，kaempferol and wogonin were the compounds withmain potential targets. T he target proteins wi th high node degree were prostaglandin endoperoxide synthase 2（PTGS2），PTGS1， nuclear receptor coactivator 2 and heat shock protein 90α，which were associated with 37，30，25 and 25 active components respectively. Twenty genes were obtained from the interaction between “B. falcatum -S. baicalensis ”and podocyte lesion related targets，including PTGS2，VEGFA，MMP9，TNF and IL6. PPI network diagram of the above intersection genes contained 20 nodes and 110 lines，with MMP9，VEGFA，IL6 and other genes at the core. The results of GO analysis showed that a total of 154 biological information items were obtained （P＜0.05），including 139 biological process items ，8 cell composition items and 7 molecular function items. Among them ，biological processes mainly involved in the positive regulation of NO biosynthesis process ， inflammatory response ，immune response. Cell composition mainly involved in extracellular space ，extracellular region ，external side of plasma membrane ，etc.，and molecular function mainly involved in protein binding ，cytokine activity ，growth factor activity，etc. At the same time ，47 KEGG pathways were obtained （P＜0.05），mainly including cytokine-cytokine receptor interaction，rheumatoid arthritis ，malaria，cancer signaling pathways. CONCLUSIONS ：The active components of Compund Shensu Ⅱ couplet medicine of “B. falcatum -S. baicalensis ”may act on MMP9，VEGFA，IL6，TNF and other targets through cytokine-cytokine receptor interaction ，rheumatoid arthritis ，malaria，cancer signal pathway ，so as to play its intervention effect on podocyte lesion.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To isolate and purify the polysaccharides from Cucumis satiuus ，and to investigate its in vitro antioxidant activity. METHODS ：The crude polysaccharides （CCL）were extracted from C. satiuus by water extraction and alcohol precipitation. CCL was separated and purified on Amberlite FPA 90Cl anion and Amberlite FPC 3500H cation exchange resin column and DEAE cellulose 52 column，so as to obtain 3 kinds of polysaccharides as CCL-M 2，CCL-M3，CCL-M6. The purity ， molecular weight ，structure and monosaccharide composition of 3 kinds of polysaccharides were analyzed by HPLC-ELSD ， UPLC-QTOF/MS，UV and IR. Using vitamin C （VC）as positive control ，the scavenging activity of CCL-M 2，CCL-M3 and CCL-M6（0.4，0.8，1.2，1.6，2.0 mg/mL）to 1，1-dibenzene-2-trinitrobenzene free radicals （DPPH·），hydroxyl free radicals （·OH） and superoxycyclic anion free radicals （O2－·）were investigated ，and IC50 was calculated. RESULTS ：CCL-M2，CCL-M3 and CCL-M6 were homogeneous polysaccharides in the form of pyranose ，with molecular weights of 9.614×106，2.024×107 and 3.343× 107 Da，respectively. CCL-M 2 monosaccharides were composed of rhamnose ，semi-lactose aldehyde acid ，glucose， semi-lactose and arabic sugar ，with a molar ratio of 5.1∶2.6∶1.7∶1.4∶31.6. CCL-M 3 and CCL-M 6 monosaccharides were composed of mannose， rhamnose，glucose，semi-lactose，arabic sugar ，with a molar ratio of 1.7 ∶ 3.8 ∶ 6.4 ∶ 3.3 ∶ 1.3 and 1.3 ∶ 3.0 ∶ 3.2 ∶ 4.4 ∶ 8.9. The results of antioxidant activity in vitro showed that 3 kinds of homogeneous polysaccharides had certain scavenging activity on DPPH ·，·OH and O 2－·；the order of scavenging activity to DPPH ·was VC ＞CCL-M2＞CCL-M3＞CCL-M6（IC50 was 0.309， 1.240， 1.489 and 1.713 mg/mL）； the order of scavenging activity to ·OH was VC ＞CCL-M2＞CCL-M6＞CCL-M3（IC50 was 0.968，1.032，1.233，1.356 mg/mL）；the order of scavenging activity to O 2 －· was VC ＞CCL-M2＞CCL-M3＞CCL-M6 （IC50 was 0.335， 0.379， 0.812， 1.662 mg/mL）. CONCLUSIONS：3 kinds of monosaccharides in the form of pyranose are isolated from C. satiuus ，and all of them have antioxidant activity in vitro ，and CCL-M 2 is the best.关键词：Cucumis satiuus;Homogeneous polysaccharides;Separation;Purification;Antioxidant activity
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To study the effects of paeonol combined with cisplatin on the proliferation and apoptosis of human osteosarcoma cell MG- 63 and its possible mechanism. METHODS ：MG-63 cells in logarithmic growth phase were divided into blank control group ，cisplatin group （4 µmol/L），paeonol group （50 mg/L），and low ，medium，high concentration combined groups （50，100，200 mg/L paeonol+ 4 µmol/L cisplatin ）. CCK- 8 method was used to detect the cell proliferation rate at 24，48，and 72 hours of treatment. Annexin Ⅴ-FITC/PI double staining method was used to detect the cell apoptosis rate at 24 hours of treatment. The relative expression of PI 3KCA，Akt，mTOR，P-gp and PTEN mRNA in cells were detected by qRT-PCR. RESULTS ：Compared with blank control group ，the cell proliferation rate at each time point ，and the relative expression of PI 3KCA，Akt and mTOR mRNA in cells were significantly reduced and the apoptosis rate and the relative expression of P-gp and PTEN mRNA in the cells were increased significantly （P＜0.05 or P＜0.01）. Compared with cisplatin group and paeonol group ，cell proliferation rate at each time point and the relative expression of PI 3KCA，Akt and mTOR mRNA in cells were decreased significantly in the high concentration combination group ，while the relative expression of P-gp and PTEN mRNA in the cells were significantly increased （P＜0.01）；there were statistical significance in some of the above indicators in the medium and low concentration combination groups（P＜0.05 or P＜0.01）. CONCLUSIONS ：The combination of paeonol and cisplatin could inhibit the proliferation of MG- 63 cells and promote their apoptosis ，which may be related to the down-regulation of PI 3KCA，Akt and mTOR mRNA expression ，and the up-regulation of P-gp and PTEN mRNA expression.关键词：Paeonol;Cisplatin;Osteosarcoma;PI3K/Akt/mTOR signaling pathway;Proliferation;Apoptosis
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To identif y and analyze the flavonoids and coumarins in Radix Ardisiae from different sources. METHODS：UPLC-QE-HF-MS/MS was adopted. The determination was performed on Zorbax Eclipse-C 18 column with mobile phase consisted of acetonitrile- 0.1％ formic acid solution （gradient elution ）at the flow rate of 0.3 mL/min. The column temperature was 30 ℃，and the temperature of injector was 4 ℃. The sample size was 2 µL；ESI source was applied in negative and positive scanning ion mode ，the heater temperature was 325 ℃，the sheath gas pressure was 45 arb，the auxiliary gas pressure was 15 arb，the purge gas pressure was 1 arb，the electrospray voltage was 3.5 kV，the capillary temperature was 330 ℃， S-lens RF level was 55％，scan mode was first-order full sca m/z 100-1 500，data-dependent secondary mass spectrometry scanning （dd-MS2，Top N ＝10），the resolution was 70 000 （first mass spectrometry ） ， 17 500 （secondary mass spectrometry），the collision mode was high-energy collision dissociation. Through retrieving foreign and domestic databases as ChemSpider ，mzCloud，mzVault，PubChem，the structure of the compound was identified on the basis of related literatures and reference data ，and the conten ts were compared. RESULTS & CONCLUSIONS：A total of 47 components were separated from Radix Ardisiae of 3 kinds of sources as Ardisia crenata Sims，A. crispa（Thunb.）A. DC. ，A. crenata Sims var . bicolor （Walk）C. Y. Wu et C. Chen. A total of 17 flavonoids were identified ，including 9 flavonols （quercetin 3-O-rhamnoside-7-O-glucoside， myricetin， rutin， mauritanin， kaempferol， quercetin， isorhamnetin， quercetin，mearnsitrin），3 flavan-3-ols [（-）-epigallocatechin，catechin，epigallocatechin gallate ）2 dihydroflavonoids [fustin ， eriodictyol] and 3 other types [ 3-（2，3-dihydro-benzo[1，4]dioxin-6-yl）-7-hydroxy-2-trifluoromethyl-chromen-4-one，methadone， oriciacridone F] ，10 coumarins {bergenin ，（[ 7-hydroxy-4-methyl-2-oxo-2H-chromen-6-yl）oxy]acetic acid ，[7-（carboxymethoxy）- 4-methyl-2-oxo-2hydroxychromo-3-yl]acetic acid ，4，9-dihydroxy-7H-furo[3，2-g]chromen-7-one，6，7-dihydroxy-4-methylcoumarin， esculetin，fraxetin，7，8-dihydroxy-4-methylcoumarin，4-methylumbelliferyl glucuronide ，scoparone}. Results of content analysis showed that in flavonoids and coumarins ，there were 5 common components in Radix Ardisiae from 3 kinds of sources ，i.e. bergenin（peak 2），[7-（carboxymethoxy）-4-methyl-2-oxo-2-hydroxychromo-3-yl] acetic acid （peak 5），methadone（peak 16）， quercetin（peak 18），oriciacridone F （peak 26）；the contents of common components were significantly different. In addition to 5 common components ，there were 22 different chemical components ，which were compounds corresponding to peaks 1，3，4， 6-15，17，19-25 and 27，respectively. Among them ，compounds corresponding to peaks 3，6，8 and 23 were only found in A. crenata Sims var. bicolor（Walk）C. Y. Wu et C. Chen ；compounds corresponding to peaks 12-15，19 were only found in A. crispa （Thunb.）A. DC. UPLC-QE-HF-MS/MS method can efficiently ，accurately and quickly identify the flavonoids and coumarins in Radix Ardisiae from different sources.关键词：Radix Ardisiae;UPLC-QE-HF-MS/MS;Flavonoids;Coumarins;Structure identification;Content
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To establish fingerprint of Tibetan medicine Ershi wuwei luxue pills ，and determine the contents of 5 components，and to conduct chemical pattern recognition. METHODS ：HPLC method was adopted. Using aesculetin as reference ， HPLC fingerprint of 10 batches of Tibetan medicine Ershi wuwei luxue pills were drawn. The similarity evaluation was conducted by using Evaluation System of TCM Chromatogram Fingerprint Similarity （2012 edition），and the common peaks were determined. Same HPLC method was adopted to determine the contents of 5 components in Tibetan medicine Ershi wuwei luxue pills. The cluster analysis and principle component analysis were performed by using SPSS 19.0 software. RESULTS ：Totally 11 common peaks were calibrated ，and the similarity was higher than 0.98. Five common peaks were identified ，as aesculetin ，orientin， isovitexin，isoscoparin and ellagic acid. The linear range of aesculetin ，orientin，isovitexin，isoscoparin and ellagic acid were 1.232-11.092 μg/mL（r＝0.999 6），2.766-24.893 μg/mL（r＝0.999 5），1.400-12.600 μg/mL（r＝0.999 8），0.600-5.400 μg/mL（r＝ 0.999 5），49.447-445.025 μg/mL（r＝0.999 4），respectively. RSDs of precision ，stability（24 h）and reproducibility tests were all lower than 2％. The average recoveries were 101.29％（RSD＝2.33％，n＝3），91.39％（RSD＝1.22％，n＝3），90.28％（RSD＝ 1.88％，n＝3），98.76％（RSD＝2.53％，n＝3），101.45％（RSD＝2.84％，n＝3），100.44％（RSD＝1.38％，n＝3），100.91％ （RSD＝1.73％，n＝3），97.78％（RSD＝2.07％，n＝3），99.15％（RSD＝1.28％，n＝3），100.27％（RSD＝1.81％，n＝3），98.38％ （RSD＝1.89％ ，n＝3），101.92％（RSD＝1.17％ ，n＝3），95.50％（RSD＝0.67％ ，n＝3），99.89％（RSD＝0.38％ ，n＝3）， 100.10％（RSD＝0.65％，n＝3），respectively. Their contents were 0.175-0.310， 0.351-0.632， 0.274-0.395， 0.186-0.278， 61932600 6.956-8.636 mg/g，respectively. Cluster analysis showed that 10 batches of Tibetan medicine Ershi wuwei luxue pills were clustered into two category ，with S1-S4 as one category and S5-S10 as one category. Principal component analysis showed that accumulative contribution rate of two principle components was 89.178％. CONCLUSIONS ：Established fingerprint is stable and feasible ，and the method of content determination is simple ， accurate and reproducible. They combined with chemical pattern recognition can be used for the quality control of the Tibetan medicine Ershiwuwei luxue pills.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To study the anti-inflammatory effects of Yuyang capsule on bacterial dermatitis model rats and its effect on TLR/NF-κ B pathway. METHODS：Minimum inhibition concentration （MIC）and minimal bactericidal concentration （MBC）of Yuyang capsule against Staphylococcus aureus were determined by microdilution test. Totally 50 SD rats were randomly divided into model group ，positive control group （amoxicillin and clavulanate potassium ，120 mg/kg as amoxicillin ），Yuyang capsules high-dose ，medium-dose and low-dose groups （according to MIC ），with 10 rats in each group. The model of bacterial dermatitis was established by using the burned skin of rats infected with S. aureus . 24 h after modeling ，administration groups were intragastrically given the corresponding drug ，and model group was intragastrically given the same amount of normal saline ，once a day，for consecutive 7 days. The skin healing rate was calculated on the 1st，3rd，5th and 7th day of administration ，and the scab formation，decrustation and healing were recorded. The contents of IL- 1β，IL-6，IL-10，TNF-α，hydroxyproline（HYP），collagen Ⅰ（Col Ⅰ）and Col Ⅲ in skin tissue were detected by ELISA. Morphology changes of skin tissues were observed by HE staining. The ultrastructure was observed by transmission electron microscope. Protein expression of TLR 2，TLR4 and p-NF-κB p65 were detected by Western blotting assay. RESULTS ：MIC and MBC of Yuyang capsule were 25 mg/mL and 50 mg/mL，respectively. Dose of Yuyang capsules high-dose ，medium-dose and low-dose groups were set at 600，300，150 mg/kg. Compared with model group，scab appeared on the injured skin 3 days after administration in Yuyang capsule high-dose and medium-dose groups ，and decrustation appeared on the injured skin of part mice 5-7 days after administration ；the skin healing rate of the positive control group，Yuyang capsule high-dose and medium-dose groups were all significantly increased at each time point. The contents of IL- 1 β，IL-6，IL-10 and TNF-α，pathological score ，protein expression of TLR 2，TLR4 and p-NF-κB p65 were decreased significantly （P＜0.05 or P＜0.01）；the pathological changes such as inflammatory cell infiltration in skin tissue were improved. The contents of HYP，Col Ⅰ and Col Ⅲ were increased significantly in positive control group and Yuyang capsule high-dose group （P＜0.05 or P＜0.01）. There was no statistical significance in most above indexes in positive control group ，Yuyang capsule high-dose and medium-dose groups （P＞0.05）. CONCLUSIONS ：Yuyang capsule can promote skin healing of bacterial dermatitis model rats and shows certain anti-inflammatory effects ；the mechanism may be related to inhibiting TLR/NF-κB signaling pathway and reducing inflammatory response.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To study t he effects of bro mophenylcurcumin（GL63）on the apoptosis ，migration and invasion of human cholangiocarcinoma RBE cells ，and to investigate its mechanism based on JAK/STAT signaling pathway. METHODS ：MTT assay was used to detect the effects of different concentrations of GL 63 [0（blank control ，similarly hereinafter ），1.25，2.5，5，10， 20，40 μ mol/L] on the proliferation of RBE cells after 48 h treatment ；the IC 50 was calculated. The effects of different concentrations of GL 63（0，5，10，20 μmol/L）on colony formation were detected by crystal violet staining after 48 h treatment. Flow cytometry ，Hoechst 33342 staining，cell scratch test and Transwell chamber invasion test were used to detect the effects of different concentrations of GL 63（0，5，10，20 μmol/L）on cell cycle distribution ，apoptosis，migration and invasion ability after 24 h treatment. Western blotting assay was adopted to detect the effects of different concentration of GL 63（0，5，10，20 μmol/L） on the expression of JAK 2/STAT3 signal pathway associated proteins. RESULTS ：The proliferation inhibition rates of RBE cells in different concentrations of GL 63 groups（1.25-40 μmol/L）were significantly increase d，compared with blank control group （P＜ 0.01），and showed a dose-dependent trend ，with IC 50 of （8.46±1.30）μmol/L. Compared with blank control group， 85917439。E-mail：zhaoji-an-88@163.com inhibition rates of RBE cell colony formation were significantly decreased in different concentrations （5，10，20 μmol/L）of GL 63 groups（P＜0.01）. The percentage of RBE cells at G 0/G1 phase increased significantly ，while that at S phase decreased significantly （P＜0.01）. The apoptotic rate increased significantly（P＜0.01），and the nucleus showed dense pyknosis and apoptotic bodies. The rate of cell migration and healing was significantly decreased （P＜0.01），and the number of invasive cells through basement membrane was significantly decreased （P＜ 0.01）. The protein expression of p-JAK 2， p-STAT3， Bcl-2， MMP-2， MMP-9， Pro-caspase-9 and P ro-caspase-3 were down-regulated significantly while the expression of Bax ，Cyt-c，Cleaved-caspase-9 and Cleaved-caspase- 3 were up-regulated significantly（P＜0.01）. CONCLUSIONS ：GL63 may inhibit the proliferation ，migration and invasion of RBE cells and promote its apoptosis by inhibiting JAK 2/STAT3 signal pathway.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To investigate the occurrence and characteristics of new adverse drug reactions （ADR）in Shandong province，so as to provide reference for the safety of drug use in the clinic. METHODS ：The data of new ADR reports were collected from Spontaneous Reporting System of Shandong ADR Monitoring Center during Oct. 2019 to Mar. 2020. Those reports were analyzed statistically in respects of report types ，reporting institution ，reporters’occupation，gender and age of patients ，drug type ，organs/ systems involved ，clinical manifestations. RESULTS & CONCLUSIONS ：A total of 8 566 new ADR reports were screened out ， accounting for 10.81％ of the effective ADRs. Among them ，there were 7 961 new and general ADR （92.94％）and 605 new and serious ADRs （7.06％）. For the new ADR ，the reporting institutions were mainly medical institutions （98.42％），and the reporters ’ occupation were mainly doctors （78.44％）. Female （4 860 cases）was slightly more than male （3 698 cases）；most of them were 45 years old and above （70.00％），and intravenous drip （47.67％）was the main route of administration. The top five ADR suspected drugs were TCM preparations （34.50％），anti-microbials（13.75％），circulatory system drugs （11.41％），nervous system drugs （6.39％）and blood system drugs （4.81％），involving 517，91，64，53，50 types，respectively，among which Levofloxacin injection caused the most serious ADR （24 cases）. The new and general ADR mainly involved gastrointestinal system ，skin and its appendant ； their clinical manifestations were nausea ，vomiting，rash，etc. New and serious ADR mainly caused systemic damage ；their clinical manifestations were anaphylactic shock ，chest tightness and shivering ，etc. It is suggested to strengthen the ADR monitoring of TCM preparations，anti-microbials，circulatory system drugs and other drugs ，so as to ensure the safety of clinical drug use.关键词：Shandong province;New;Adverse drug reactions;Report analysis;Safety of drug u se
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To establish the method for simultaneous determination of 5-fluorouracil（5-FU）and its metabolites 5-fluoro-5，6-dihydrouracil （5-FUH2） in human plasma ，and apply it in the clinic. METHODS ：After plasma samples were processed twice by ethyl acetate ，UPLC-MS/MS method was adopted using 5-bromouracil （5-Bru） as internal standard. The determination was performed on Acquity UPLC HSS T 3 column with mobile phase consisted of methanol-water （30 ∶ 70，V/V）at the flow rate of 0.3 mL/min. The column temperature was 20 ℃，and sample size was 5 μL. An electrospray ion source was used to carry out negative ion scanning with multiple reaction monitoring. The capillary voltage was 1.5 kV；the taper hole voltage was 20 V；the desolvent temperature was 450 ℃；the desolvent air flow was 850 L/h；the cone hole gas velocity was 50 L/h. The ion transitions for quantitative analysis were m/z 129.00→41.90（5-FU），m/z 130.87→82.92（5-FUH2），m/z 189.00→42.10（5-Bru）， respectively. From Aug. to Oct. 2020，10 patients with advanced colorectal cancer were treated with continuous intravenous drip of 5-FU for 46 hours were collected from Harbin Medicinal University Cancer Hospital. Steady-state plasma concentration of 5-FU and plasma concentration of 5-FUH2 were determined at 18-30 h of continuous intravenous drip. The area under the curve （AUC）for 5-FU and concentration ratio of 5-FUH2/5-FU were calculated. RESULTS ：The linear range of 5-FU and 5-FUH2 were 20 to 1 000 μg/mL（R 2＞0.990）. The quantification limits were 20 ng/mL. RSDs of precision test were all lower than 20％，and relative error ranged ±10％. The extraction recovery and matrix effects didn ’t affect the determination of substance to be measured. Among 10 patients with advanced colorectal cancer ，the steady-state concentration of 5-FU were 180.04-622.83 ng/mL，and AUC of 5-FU ranged from 8.28 to 28.65 mg·h/L. The concentration of 5-FUH2 ranged 336.48-948.43 ng/mL，and concentration ratio of 5-FUH2/ 5-FU ranged 0.93-4.21. AUC of 5-FU in 10 patients had about 3-4 fold individual differences. CONCLUSIONS ：The established method has good precision and accuracy ，high sensitivity ，and simple operation. It can be used for plasma monitoring of 5-FU in patients with advanced colorectal cancer.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To compare the eff icacy and safety of rivaroxaban versus enoxaparin in the treatment of malignant tumor complicated with venous thromboembolism （VTE），and to provide evidence-based reference to the clinic. METHODS ： Retrieved from PubMed ，Embase，Cochrane Library ，Clinical Trials ，CNKI，CBM and VIP ，clinical trials or observational studies about rivaroxaban versus enoxaparin were collected during the inception to Apr. 2020. After literature screening and data extraction ， the quality of included literatures were evaluated by Newcastle Ottawa scale ；Stata 15.0 software was used to conduct Meta-analysis，sensitivity analysis and publication bias analysis. RESULTS ：A total of 5 observational clinical cohort studies were retrieved，including 4 retrospective cohort studies and one prospective cohort study. Totally 997 patients were included ，among which 625 patients received enoxaparin and 372 patients received rivaroxaban. Results of Meta-analysis showed that there was no statistical significance in recurrence rate of VTE at 3 months follow-up [RR ＝0.91，95％CI（0.50，1.66），P＝0.760] and 6 months follow-up [RR ＝0.53，95％CI（0.24，1.15），P＝0.106] as well as the incidence of massive hemorrhage at 3 months follow-up [RR ＝ 1.22 ，95％CI（0.66，2.25），P＝0.530] and 6 months follow-up [RR ＝1.30，95％CI（0.73，2.33），P＝0.368]. The results of sensitivity analysis showed that the results of above Meta-analysis were stable ；the results of publication bias analysis showed that there was less possibility of publication bias in this study. CONCLUSIONS ：Rivaroxaban is as effective and safe as enoxaparin in the treatment of malignant tumor with VTE.关键词：Rivaroxaban;Enoxaparin;Malignant cancer;Venous thromboembolism;Efficacy;Safety;Meta-analysis
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To explore refined management mode of outpatient pharmacy ，and to improve the efficiency and quality of outpatient pharmacy service. METHODS ：From the hospital information and big data center of our hospital ，the outpatient pharmacy prescription data under the traditional management mode were collected ；fish bone analysis was used to find out the factors that may affect the waiting time of patients ，the work efficiency and quality of pharmacy ；4M1E method was adopted to improve the related problems and implement refined management. The prescription data of 10 working days before improvement，stage 1 and stage 2 of refined management were selected. The work efficiency of pharmacists ，average waiting time of patients ，dispensing errors and inventory errors before and after the improvement were compared and analyzed to evaluate the effects of refined management. RESULTS ：By fishbone diagram ，the factors influencing the waiting time of patients ，the work efficiency and quality of outpatient pharmacy service in our hospital included personnel factors ，machine factors ，material factors ， method factors ，environmental factors ，such as the number of personel and time alloction was unreasonable ，the machine was aging，etc. After the implementation of refined management ，the outpatient pharmacy of our hospital had taken a variety of measures，such as adjusting the staff working time and refining the performance rew ard scheme ，maintaining the automatic dispensing machine and updating the prescription scanning equipment，setting up temporary drug containers and opti- mizing the location number ，strengthening drug management and relevant personnel training ， openning the window ofcharacteristic single variety dispensing. The statistical results com showed that in the first stage of fine management ，the number of dispensing prescriptions and the number of p rescription items in the outpatient pharmacy of our hospital increased slightly in 10 working days. Due to the decrease of the number of on-the-job staff and the change of the number and time of open windows ，the cumulative working hours of on-the-job staff decreased from 1 680 hours to 1 440 hours；the number of dispensing prescriptions and prescription items per hour per capita increased from 52.0 pieces，58.7 to 65.1 pieces，69.6（P＜0.05）；the number of dispensing errors decreased from 30 to 5；there was no significant change in waiting time of patients and inventory errors. In the second stage of fine management ，when the amount of dispensing prescriptions in outpatient pharmacy of our hospital was similar ，the number of dispensing prescriptions and the number of prescription items per hour per capita increased from 52.0 pieces，58.7 to 59.9 pieces，67.3，respectively（P＜0.05）；the average waiting time of patients decreased from 9.30 min to 7.32 min（P＜0.05）. After further refining the error data collection method and adjusting the performance incentive scheme ，the number of dispensing errors in outpatient pharmacy increased to 75，and the number of inventory errors decreased from 5 to 0. CONCLUSIONS ：By 4M1E method，outpatient pharmacy of our hospital carry out refined management ，to achieve the improvement of work efficiency and quality，shorten the waiting time of patients关键词：Outpatient pharm acy;Refined management;4M1E method;Effect evaluation;Work efficiency
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To provide reference for improving the level of pharmaceutical care in hospitals and promoting the continuous transformation and upgrading of O 2O pharmaceutical care mode in medical institutions in China. METHODS ：Using “Internet”“Network”“O2O”“Pharmaceutical care ”“Medication education ”“Chronic disease management ”“Medication consultation ” “Science popularization and education ”as keywords ，related literatures were collected from CNKI ，VIP，Wanfang and other Chinese databases during Jan. 2012-Mar. 2020. The development process ，characteristics，service content ，advantages and disadvantages of O 2O pharmaceutical care mode in China were analyzed and summarized ，and relevant suggestions were put forward. RESULTS & CONCLUSIONS ：O2O pharmaceutical care in Chinese hospitals covers prescription review and dispensing ， drug distribution ，medication consultation after visiting ，medication education ，chronic disease management ，science popularization and education ，pharmacy clinic ，etc.，realizing the whole process of closed-loop management. At present ，O2O pharmaceutical care in Chinese hospital had gradually moved from stage 1.0 to stage 2.0. Artificial intelligence technology has also been widely integrated into all aspects of pharmaceutical care ，assisting hospital pharmacists to better practice the “patient-centered”service concept，not only improving the quality and value of pharmacists ’pharmaceutical care more efficiently and accurately ，but also promoting the sinking of high-quality pharmaceutical resources and serving the grassroots. O2O pharmaceutical care shows the advantage of optimizing the allocation of pharmaceutical care resources ，expanding the scope of pharmaceutical care ，improving the relationship between doctors and patients ，diverting patients with different needs ，and promote hierarchical diagnosis and treatment. However，there are still some problems ，such as the failure to effectively cover rural patients ，the risk of patient privacy leakage ， and the lack of special quality management standards ，which hinder the further development and improvement of scale advantage of O2O pharmaceutical care. It is suggested to further improve the pharmaceutical care function of the platform ，expand the consumer population，promulgate relevant laws and regulations as soon as possible ，carry out continuing education and training for pharmacists according to the needs of patients in grassroots areas ，establish and improve relevant laws and regulations ，and improve O 2O pharmaceutical care quality management standards， so as to promote the development of O 2O pharmaceutical care mode in the hospital in China.
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发布时间：2022-06-21
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