最新刊期
卷 32 ， 期 14 ， 2021
- 摘要：OBJECTIVE：To pr ovide reference for improving extended clinical trial system in China. METHODS ：The implementation experience of the international extended clinical trial system was introduced from three aspects ： system development，application scope and principles ，application and approval ；the evolution and challenges of the system in China were further analyzed ，and relative suggestions were put forward. RESULTS & CONCLUSIONS ：The development of international extended clinical trial system in the United States ，the United Kingdom ，Australia and the European Union had been relatively mature. The specific system had not formally been established in China ，and the implementation of the system faced many challenges，such as the ethical problems caused by drug use risk ，the sponsor dilemma caused by the difficult balance between the resistance of initiating application and the benefits ，the difficulty of review caused by the unknown responsible party of risk assessment and the urgent time of approval. It can be dealt with by the following measures ：improving the existing laws and regulations，strengthen information disclosure and risk prevention work ，make clear the division of responsibilities in the process of system operation. Meanwhile ，based on the existing international model ，the management system of the expanded clinical trials in China is established. Corresponding application paths are set up for different application types such as “single patient emergency ”， “single patient non emergency ”and“two or more patients group ”，and all parties should be mobilized to supervise so as to promote the improvement and implementation of the extended clinical trial system.关键词：Extended clinical trial;Compassionate use;Status;Challenge;Enlightenment
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To systematically evaluate the research and development status quo of respiratory inhalation preparations. METHODS ：Related literatures or data about R&D status quo of domestic and foreign respiratory inhalation preparations were retrieved from 5 databases（PubMed，Embase，CNKI，Wanfang database and VIP ），4 clinical trial registration platforms，15 national/regional drug administration platforms and yaozhi.com . The status quo of related studies was analyzed by descriptive analysis. RESULTS & CONCLUSIONS ：A total of 27 second literatures were included. The information of respiratory inhalation preparations approved by European Union ，the United States ，Canada，Japan and China was collected ，and the information of related drugs under registration and approval in China was also collected. The market situation of respiratory inhalation preparations was analyzed from the perspective of dosage form ：powder aerosols accounted for 46％，aerosols account ed for 32％，and atomized inhalation solutions accounted for 22％ in the global consumption sum of each dosage form. From the perspective of market share ，companies such as AstraZeneca in the UK ，Boehringer Ingelheim in Germany and GlaxoSmithKline in the UK had a total market share of about 70％. At present ，there were 39 kinds of respiratory inhalation preparations on the market in European Union ，121 kinds in the United States ，111 kinds in Canada ，37 kinds in Japan ，69 kinds of domestic inhalation preparations and 80 kinds of imported inhalation preparations in China. Respiratory inhalation preparations were undergoing clinical trials with 511 cases abroad and 69 cases in China. The barriers to the imitation of respiratory inhalation preparations mainly included research and development ，clinical trial ，approval and production barriers. At present ，the support is provided for 0035） domestic drug innovation and localization of medical devices in China through a series of policies ，which is helpful to promote the localization research and development of inha led preparations. Future research and development can pay more cn attention to combination ，indication，dosage and device of inhalation preparation.关键词：Respiratory system;Inhalation preparations;Research and development of medicine;Status quo;Systematic
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To p rovide policy suggestions for the development and supervision of online drugstores in China. METHODS：By literature review ，the relevant literatures and policy documents about the development of online drugstores were searched，screened and sorted out to summarize the development process of China ’s internet drug trading mode and policy ，analyze the development status of China ’s online drugstores ；on the basis of the development experience of some developed countries ，the suggestions were put forward for China ’s relevant policies. RESULTS & CONCLUSIONS ：China’s medical e-commerce started relatively late ，and the policies related to online drug trading were basically released during last 20 years. The number of online drugstores showed a growing trend. The online drugstores were geographically allocated widely but unevenly. They sold many varieties，and policies on selling prescription medicines were gradually liberalized. These online drugstores provided diverse payment and delivery choices ，but their pharmaceutical service needed to be improved. The development models of online drugstores in the United Kingdom ，the United States and Germany could be referred. According to the current situation of online drugstores in China ， combined with the development mode and operation strategy in foreign countries ，it is suggested to improve relevant laws and regulations，and strengthen legal support ；strengthen the government supervision to ensure drug safety ；use the industrial power to standardize medicine operation behavior ；set up the third part trading platform to promote medical insurance payment.关键词：Online drugstores;Regulatory policies;Situation;Literature analysis;Suggestion
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To investigate the improvement effect of Tiarella polyphylla ethanol extract （TPME）on CCl 4-induced hepatic fibrosis in mice ，and to explore its possible mechanism preliminarily. METHODS ：Totally 60 male Kunming mice were randomly divided into normal group ，model group ，positive control group （colchicine 0.1 mg/kg），TPME low-dose ，medium-dose and high-dose groups （250，500，1 000 mg/kg）according to body weight ，with 10 mice in each group. Except for normal group ， other groups were given 20％ CCl4 olive oil solution intraperitoneally to induce hepatic fibrosis ，twice a week ，for consecutive 8 weeks. From the fifth week after modeling ，administration groups were given relevant medicine intragastrically ，normal group and model group were given constant volume of normal saline intragastrically ，once a day ，for consecutive 4 weeks. Twelve hours after last administration ，the liver weight of mice in each group was measured and the liver index was calculated. The serum contents of ALT，AST，SOD，MDA，PC-Ⅲ，C-Ⅳ，LN，TNF-α and IL- 6 were determined. Western blot assay was used to detect the protein expression of α-SMA，TGF-β1 and Smad 3 in liver tissue. HE and Masson staining were used to observe the pathological changes of hepatic tissue. RESULTS ：Compared with normal group ，the liver index ，the activities of ALT and AST and the contents of MDA ， LN，PC- Ⅲ ，C- Ⅳ ，LN，TNF-α and IL- 6 in serum were increased significantly ， while the activity of SOD was 6011） decreased significantly in model group （P＜0.01）；the protein expression of α-SMA，TGF-β1 and Smad 3 in liver tissues were hfjsznd8@126.com increased significantly （P＜0.01）. Obvious fibrosis lesions was observed in liver tissue. Compared with model group ，the live indexes ，the activities of ALT and AST ，the contents of MDA，PC-Ⅲ，C-Ⅳ，LN，TNF-α and IL-6 in serum were decreased significantly in positive control group and TPME groups ， while the activities of SOD were increased significantly （P＜0.05 or P＜0.01）. The protein expression of α-SMA，TGF-β1 and Smad3 in liver tissue were decreased significantly （P＜0.05 or P＜0.01），and liver fibrosis was improved to different extent. Compared with TPME low-dose group ，the contents of PC- Ⅲ，LN and IL- 6 in serum ，protein expression of TGF-β1 and Smad 3 in liver tissue were decreased significantly in TPME high-dose group （P＜0.05）. CONCLUSIONS ：TPME can improve hepatic fibrosis induced by CCl 4 in mice ，the mechanism of which may be associated with the inhibition of collagen synthesis and oxidative stress，the reduction of inflammatory factors ，and the down-regulation of the expression α-SMA and relative proteins of TGF-β1/ Smad signal pathway.关键词：Tiarella polyphylla;Hepatic fibrosis;Inflammation response;Oxidative stress;TGF-β1/Smad signal pathway;Mice
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To analyze the mass spectrometry fragmentation regularity of bicyclol ，bifendate and schisandrin C ， and to identify the impurities of bicyclol raw material. METHODS ：UHPLC-ESI-Q-TOF-MS method was adopted. Using electrospray ionization source ，in positive ion mode ，the excimer ion and characteristic fragments of bicyclol ，bifendate and schisandrin C were analyzed by means of TOF-MS. According to the mass change of fragments ，the possible fragmentation pathways were speculated ，and the fragmentation regularity were analyzed and summarized. Bicyclol raw material sample was first separated by liquid chromatography to find the impurity peaks in it ，and then the impurity peaks were analyzed by mass spectrometer；the impurity identification was conducted by combining with the fragmentation regularity. RESULTS ：The 3 compounds all produced [M+H] + excimer ion in the positive ion mode. After collision-induced dissociation ，the C-O bond ，the simple rupture of the C-C bond and the ring-opening cleavage of the oxygen ring occurred ；with the loss of neutral fragments ， mainly CH 2O，supplemented by CO 2，CO and CHO ，the dissociation was concentrated in the middle and high quality regions. C-C and C-O bonds of 3 compounds were simply broken only in the branched chain structure and/or oxygen ring structure ，but the structure of the biphenyl parent nucleus remained unchanged. Among them ，the bicyclol contained a benzyl alcohol structure ，so under acidic mobile phase conditions ，it would exist stably in the form of [M+H －H2O]+. Because schisandrin C contained 8-membered ring structure，ring opening first occurred under collision voltage ，and then neutral fragment loss occurred. The secondary mass spectra of impurity in bicyclol raw material were consistent with the mass spectra fragmentation of secondary fragments of bifendate. CONCLUSIONS：The study summarized mass spectrometry fragmentation regularity of 3 schisandrin derivatives. The impurity in bicyclol raw material may be bifendate.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To opt imize the extraction technology of phenolic acid from Amomum tsaoko . METHODS ：The extraction technology of phenolic acid from A. tsaoko was optimized by using Box-Behnken design-response surface methodology with ethanol volume fraction ，liquid-solid ratio and extraction time as factors ，using the total contents of protocatechuic acid and vanillic acid as response value. The optimizd extraction technology was vlidated. RESULTS ：The optimal extraction technology was as follows ：ethanol volume fraction 65％，liquid-solid ratio 4∶1（mL/g），extraction time 2.5 h. After 3 times of validation tests ， average total content of protocatechuic acid and vanillic acid were 12.32 mg/g（RSD＝0.26 ％，n＝3），average relative error of which with predicted value （12.63 mg/g）was 2.45％. CONCLUSIONS ：The optimal technology is stable and feasible .
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To study the i mprovement effects of α-lipoic acid on glucose metabolism disorder of insulin resistant HepG2 cells. METHODS ：The effects of 25-1 000 µmol/L α-lipoic acid on survival rate of human hepatoma cell HepG2 were determined by MTT assay so as to determine the concentration of α-lipoic acid. Negative control group ，insulin resistance group （1× 10－7 mol/L insulin ），combination resistance group （30 µmol/L sodium arsenite+ 1×10－8 mol/L insulin ），α-lipoic acid low- concentration，medium-concentration and high-concentration groups were set up. HepG 2 cells were treated with α-lipoic acid for 12 h and then cultured with corresponding concentration of sodium arsenite or/and insulin for 24 h. The glucose oxidase method was used to detect the glucose consumption ，colorimetric method was used to detect hexokinase activity and pyruvate kinase activity ， and anthrone method was used to detect glycogen content. Western blot assay was used to detect the protein expression of GLUT 4， p-GSK3β and GSK3β as well as the ratio of p-Akt/Akt and p-GSK3β/GSK3β. RESULTS：25，50，100 µmol/L α-lipoic acid had no significant effect on the survival rates of HepG 2 cells（P＞0.05），and survival rates of H epG2 cells were higher than 96％，so they were used as the low ，medium and high concentration for follow-up study. Compared with negative control group ，glucose consumption，the activities of hexokinase and pyruvate kinase ，glycogen content ，protein expression of GLUT 4 and p-GSK 3β，the ratio of p-Akt/Akt and p-GSK 3β/GSK3β were decreased significantly in insulin resistance group and combined resistance group， while the protein expression of GSK 3β was increased significantly（P＜0.05）. Compared with combination resistance group ，the glucose consumption （except for α-lipoic acid low- concentration group ），the activities of h exokinase（except for α-lipoic acid low-concentration and medium-concentration groups ） andpyruvate kinase （except for α-lipoic acid low-concentration com and medium-concentration groups ）， glycogen contents ， protein expression of GLUT 4 （except for α-lipoic acid mail：bliang163@163.com low-concentration group ）and p-GSK3β，the ratio of p-Akt/ Akt（except for α-lipoic acid low-concentration and medium-concentration groups ）and p-GSK 3β/GSK3β（except for α-lipoic acid low-concentration groups ）were increased significantly in α-lipoic acid groups ，while protein expression of GSK 3β（except for α-lipoic acid low-concentration and medium-concentration groups ） was decreased significantly （P＜0.05）；glycogen content ， protein expression of GLUT 4 and the ratio of p-GSK 3β/GSK3β in α-lipoic acid high-concentration group as well as the protein expression of p-GSK 3β in α-lipoic acid medium-concentration and high-concentration groups were improved significantly （P＜0.05）. CONCLUSIONS：α-lipoic acid can improve the disorder of glucose metabolism in insulin resistant HepG 2 cells，the mechanism of which may be associated with the increase of glucose consumption ，the activities of glucose metabolism related enzymes and glycogen content ，and expression up-regulation of the phosphorylation levels of Akt and GSK 3β protein，the expression of GLUT 4 and p-GSK 3β proteins，down-regulation of the expression of GSK 3β protein.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To establish a method for simultaneous determination of 12 components including naringin ， hesperidin，neohesperidin，aloe emodin ，rhein，notopterol，emodin，honokiol，isoimperatorin，magnolol，chrysophanol and physcion in classical formula Sanhua tang. METHODS ： HPLC-multi-wavelength switching technology was adopted. The determination was performed on COSMOSIL C 18 with mobile phase consisted of acetonitrile- 0.1％ phosphoric acid （gradient elution）at the flow rate of 1.0 mL/min. The detection wavelength was 280 nm（naringin，hesperidin，neohesperidin），254 nm （aloe emodin ，rhein，chrysophanol，emodin methyl ether ），310 nm（notopterol，emodin，honokiol，isoimperatorin，magnolol）. The column temperature was set at 30 ℃，and the sample size was 10 μL. RESULTS：A total of 12 components were well separated without negative interference. The linear range of naringin ，hesperidin，neohesperidin，aloe emodin ，rhein，notopterol， emodin，honokiol，isoimperatorin，magnolol，chrysophanol and physcion were 55.4-5 540，3.8-380，45.6-4 560，1.2-120， 2.1-210，2.2-220，2-200，2.4-240，0.8-80，1.2-120，1.7-170，1.1-110 μg/mL（R 2≥0.999 6），respectively. The detection limits were 0.064，0.024，0.053，0.018，0.020，0.041，0.050，0.091，0.030，0.180，0.028 and 0.083 μg/mL，respectively. The limits of quantitation were 0.213，0.075，0.174，0.060，0.063，0.138， 0.166，0.323，0.130，0.600，0.094 and 0.275 μ g/mL，respec- 9721004） tively. RSDs of precision ，stability （24 h） and repeatability 2633531778@qq.com tests were all lower than 2％（n＝6）. Average recoveries were 99.54％，99.69％，100.01％，99.93％，100.36％，99.65％， 100.03％，100.47％，99.97％，100.68％，99.90％，100.17％ （all RSDs were lower than 2％，n＝6），respectively. CONCLUSIONS ：Established HPLC-multi- wavelength switching technology is simple ，specific and stable ，which could be used for the simultaneous determination of 12 components in Sanhua tang as naringin，hesperidin，neohesperidin.关键词：Sanhua tang;Classic formula;Content determination;HPLC;Multi-wavelength switching
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To e valuate the correlation between processing time ，color and chemical composition content in the wine-fried process of Salvia miltiorrhiza . METHODS ：Wine-fried S. miltiorrhiza with different processing time （7-15 min）was prepared by yellow rice wine. The contents of salvianolic acid B ，tanshinone ⅡA and 5-HMF in raw and wine-fried S. miltiorrhiza were determined by HPLC. The colorimeter was used to determine their chromatic values [red-green axis component （a*）， yellow-blue axis component （b*），lightness（L*）] and calculate the total color difference value （ΔE）. Spearman ’s rho and Kendall ’s Tau-b test were adopted to validate the correlation between processing time ，chromatic value and chemical composition content. RESULTS：The contents of salvianolic acid B ，tanshinone ⅡA and 5-HMF were 17.9-70.6，2.3-3.1，0 mg/g in S. miltiorrhiza decoction pieces ；the contents of them were 14.8-68.4，1.1-3.9，0.7-34.4 mg/g in wine-fried S. miltiorrhiza . The content of salvianolic acid B at first decreased and then increased ，reaching the peak at about 9，11 min，and then gradually decreased ；the content of tanshinone ⅡA increased at first ，reached its peak about 7 min，and then gradually decreased；the content of 5-HMF increased sharply after frying 13 min. The measurement results of chromaticity values were ΔL* －5.369-2.553，Δa* －1.098-0.321， Δb* －1.471- 2.355，ΔE 0.217-5.397. Results of Spearman ’s rho and Kendall ’s Tau-b test showed that ΔE was positively correlated with processing time （the correlation coefficient were 0.517，0.389 respectively）and 5-HMF content （the correlation coefficient were 0.549，0.405 respectively）（both P＜0.01）. The content of tanshinone ⅡA was negatively correlated with Δb（* the correlation coefficient were －0.509，－0.391 respectively），processing time （the corr elation coefficient were －0.556，－0.420 respectively） and 5-HMF content （the correlation coefficient were －0.545，－0.392 respectively）（both P＜0.01）. The content of 5-HMF was positively correlated with the processing time （the correlation coefficient were 0.957，0.870 respectively）（both P＜0.01）. CONCLUSIONS ：The contents of tanshinone ⅡA and 5-HMF in the process of wine-fried process are significantly related to the time and color. With the increase of processing time and temperature ，its color changes from red 话：0553-3844333。E-mail：liulj1@126.com yellow to yellow green ，and tends to be black in black and white；the content of tanshinone ⅡA is decreased and the content of 5-HMF is increased.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To i nvestigate the spectrum-effect relationship of analgesic and anti-inflammatory effects of ethyl acetate extract from Zhuang medicine Stahlianthus involucratus from different habitats. METHODS ：Ten batches of S. involucratus from different habitats were used as samples to investigate the anti-inflammatory and analgesic activities of ethyl acetate extracts by xylene induced ear swelling test and acetic acid induced writhing test in mice. HPLC fingerprints of 10 batches of ethyl acetate extract from S. involucratus were established and their similarity was evaluated by using Similarity Evaluation System of TCM Chromatogram Fingerprint （2012 edition），and the common peaks were identified by comparison with the control. The spectrum-effect relationship of anti-inflammatory and analgesic effects of ethyl acetate extract from S. involucratus were analyzed on the basis of Pearson correlation coefficient （auricle swelling degree and writhing times in 15 min as pharmacodynamic indexes ）and Grey relational analysis （inhibition rate of ear swelling and analgesic rate as pharmacodynamic indexes ）. RESULTS ： batches of ethyl acetate extract from S. involucratus had obvious anti-inflammatory and analgesic effects ； inhibition rates of ear swelling in mice were 46.43％-55.16％，and the analgesic rates of mice were 45.56％-52.72％. A total of 18 common peaks were identified in 10 batches of samples ，andthe similarity between them and the control fingerprint was 0.994-0.997. Compared with substance control ，the pea ks 1，2 and 4 were identified as protocatechuic acid ， p-hydroxy- 0771-4953513。E-mail：liangjie1101@126.com benzoic acid and p-hydroxybenzaldehyde，respectively. Results of Pearson correlation analysis showed that peak 10 and peak 18 were significantly negative correlated with auricle swelling degree and writhing times in 15 min（r were values －0.853，－0.738，P values were 0.002，0.015，respectively）. Results of Gray correlation degree analysis showed that the correlation degree of 18 common peaks with inhibition rate of ear swelling and analgesic rate were all greater than 0.65；among them ，peaks 14，1（protocatechuic acid ），17，9，4（p-hydroxybenzaldehyde），2（p-hydroxybenzoic acid ）， 16，7 and 6 showed the relatively high correlation degree （correlation degree ＞0.7）；peak 1（protocatechuic acid ），17，14，9，16，2 （p-hydroxybenzoic acid ）and 4（p-hydroxybenzaldehyde）showed the relatively high correlation degree （correlation degree ＞0.7）. CONCLUSIONS：The ethyl acetate extract of S. involucratus show good anti-inflammatory and analgesic effects. Peak 1 （protocatechuic acid ），2（p-hydroxybenzoic acid ），10，14，17，18 may be its main active ingredients.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To establish the method for determining protein binding rate of dipeptidyl peptidase- 4 inhibitor LGT- 6 in different species of plasma ，and to compare their difference. METHODS ：By equilibrium dialysis ，LGT-6（3，30，300，3 000 nmol/L）was equilibrated in rat ，monkey and human plasma （i. e. internal dialysis solution ）for 48 h，using phosphate buffer as the external dialysis solution. The concentration of LGT- 6 in internal and external dialysis solution was determined by UPLC-MS/MS using tolbutamide as internal standard ，and the plasma protein binding rate was calculated. The determination was performed on ACQUITY UPLC HSS T 3 column with water （containing 0.01％ formic acid ）-acetonitrile（containing 0.01％ formic acid ）as mobile phase at the flow rate of 0.6 mL/min. The column temperature was 40 ℃，and the sample size was 2 μL. The ion source was electrospray ion source ，and the multiple ion monitoring mode was used to carry out positive ionization scanning. The ion pairs for quantitative analysis were m/z 487.0→434.3（LGT-6），m/z 271.1→172.0（internal standard ），respectively. RESULTS ：At the concentrations of 3，30，300，and 3 000 nmol/L，the protein binding rates of LGT- 6 in rat plasma were （96.25±0.97）％，（84.16± 1.24）％，（78.25±0.61）％，（66.63±0.95）％；the protein protein binding rates in monkey plasma were （98.54±0.58）％，（87.27± 1.01）％，（79.35±0.86）％，（66.69±0.54）％；the protein binding rates in human plasma were （99.40±1.03）％，（84.48± 1.15）％，（77.62±0.77）％，（66.93±0.48）％. At the same concentration ，the protein binding rates of LGT- 6 in rat ，monkey and human plasma had no significant difference （P＞0.05）. In the same species of plasma ，there were significant differences in the plasma protein binding rates of different concentration of LGT-6 among those groups （P＜0.05），and it decreased with 才〔2016〕4015） the increase of drug concentration. CONCLUSIONS ： The method for the determination of plasma protein binding rate of LGT-6 is successfully established. The data revealed that the protein binding rate of LGT- 6 is concentration-dependent ， there was no obvious spec ies difference on protein binding rates of LGT- 6 in rat ，monkey and human plasma under the same concentration.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To optimize the inclusion technology of volatile oil from Ganmao qingre granules. METHODS ： Guided by the concept of “quality by design ”，taking volatile oil inclusion rate and inclusion complex yield as key quality attribute，comprehensive score of above two indexes after weighting as response value ，inclusion temperature ，inclusion time ，the ratio of β-CD to volatile oil as key technology parameters ，Box-Burman response surface design was adopted to establish the design space of key technology parameters and key quality attributes. The design space was optimized and verified by 95％ confidence interval. The stability of inclusion complex was investigated preliminarily. RESULTS ：The optimal design space ，i. e. the optimal technology parameters rang ，included inclusion temperature 35-40 ℃，inclusion time 1.8-2.0 h，the ratio of β-CD to volatile oil 9.5∶1- 10∶1（g/mL）. The results of 3 validation tests showed that the volatile oil inclusion rates were all over 62％，the yields of inclusion complex were all over 75％，and the comprehensive scores were all over 80 point. The results of preliminary stability showed that the inclusion rate of volatile oil ，the yield of inclusion complex and the comprehensive score did not change significantly. The difference in evaluation indicators within 7 days was within 5％. CONCLUSIONS ：The optimized inclusion technology is feasible ， and the obtained inclusion complex is stable.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To provide reference f or the qualit y sta ndard establishment of Amaranthus retroflexus. METHODS ： Taking 7 batches of A. retroflexus medicinal materials as the research object ，the appearance properties of the medicinal materials were investigated ，and the microscopic characteristics of the medicinal powders were observed. TLC method was adopted to qualitatively identify rutin ，valine and leucine in A. retroflexus medicinal materials. According to the relevant methods of the 2015 edition of Chinese Pharmacopoeia （part Ⅳ），water content ，total ash content ，acid-insoluble ash content and water-soluble extract content were determined. HPLC method was used to determine the content of rutin in the medicinal material of A. retroflexus . The determination was performed on Agilent 5 TC-C18（2）column with mobile phase consisted of methanol- 0.3％ phosphoric acid solution（40∶60，V/V），at the flow rate of 1.0 mL/min. The detection wavelength was set at 358 nm，and the column temperature was 30 ℃. The sample size was 10 μL. RESULTS：The appearance and microstructure characteristics of the medicinal materials were consistent with the existing description. The identification results of TLC meth od showed that 7 batches of medicinal materials and each reference substance （rutin，valine，leucine）showed spots of the same color at the same position. The moisture content of 7 batches of A. retroflexus medicinal materials was 7.43％-8.72％，the total ash content was 11.82％-13.78％，the acid-insoluble ash content was 0.15％-0.55％，and the water-soluble extract content was 17.27％-24.74％. The linear range of rutin was 10-200 μg/mL（R 2＝1.000 0）. RSDs of precision test ，stability test （24 h）and repeatability test were all less than 2.0％ （n＝6）. The average recovery rates of rutin were 99.14％，97.98％ and 98.80％ in low ，medium and high concentration of samples，and RSDs were 0.97％，0.95％，0.96％（n＝3）. The contents of rutin in 7 batches of A. retrophylla were 0.314-1.102 mg/g. CONCLUSIONS：In this study ，character observation ，microscopic identification ，moisture content ，total ash content ，acid- insoluble ash content and water-soluble extract content of A. retroflexus are investigated ；TLC method was established for qualitative identification of leucine ，valine and rutin in A. retroflexus ，and the HPLC method was established for content determination of rutin. It provides reference for the quality standard establishment of A. retroflexus .
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To establish the fingerprint of Bombyx mori and the method for the content determination of multi- components，and to provide reference for comprehensive quality evaluation of B. mori . METHODS ：Using 18 batches of B. mori from different producing areas as samples ，HPLC method was used. The column was Shiseido CAPCELL PAK C 18 AQ S 5 with mobile phase consisted of methanol- 0.05 mol/L potassium dihydrogen phosphate solution （gradient elution ）at the flow rate of 1.0 mL/min. The detection wavelength was 260 nm，and column temperature was set at 30 ℃. The sample size was 10 μL. HPLC fingerprint analysis and similarity evaluation were performed by using TCM Chromatogram Fingerprint Similarity Evaluation System（2012 edition），and the chromatographic peak was identified by comparing with the chromatogram of reference substance. The contents of 4 nucleosides as uracil ，guanine，xanthine，uridine were determined . RESULTS ：A total of 16 common peaks were identified in HPLC fingerprint for 18 batches of B. mori ，and peaks 3，6 ，7 and 8 were identified as uracil ，guanine，xanthine and uridine. The similarity of sample chromatogram with control fingerprint were 0.912-1.000. The linear range of uracil ，guanine， xanthine and uridine were 5.34-534，5.28-528，5.06-506，5.195-519.5 μg/mL（r≥0.999 8）. The limits of detection were 0.032 4， 0.032 0，0.030 7，0.031 2 μg/mL，and the limits of quantitation were 0.106 8，0.105 6，0.101 2，0.103 0 μg/mL. RSDs of precision，reproducibility and stability tests （24 h）were all lower than 1.00％（n＝6）. Average recoveries were 100.15％-102.95％， and RSD s were all lower than 2.00％（n＝9）. The content determination results showed that the content of uracil ，guanine， xanthine and uridine of B. mori from different producing areas were 0.41％-2.46％，0.37％-1.98％，0.72％-2.63％，0.94％-3.67％， respectively. CONCLUSIONS ：Established HPLC fingerprint and content determination method of 4 nucleosides were specific ， accurate and reliable ，which can be used for the quality evaluation and control of B. mori .关键词：Bombyx mori;HPLC;Fingerprint;Content determination;Nucleosides
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To provide referenc e for selectin g antitumor drugs economic evaluation models and improving the quality of evidence for antitumor drugs economics evaluation in China. METHODS ：A systematic search of the antitumor drug health technology evaluation （pCODR）reports were conducted on the official website of the Canadian Agency for Drugs and Technologies in Health （CADTH）. The search time was limited to Jan. 1st，2015 to Sep. 6th，2020. The basic information ，model types and structure ，and key limitations were extracted and summarized. RESULTS & CONCLUSIONS ：A total of 185 pCODR reports were finally retrieved ，involving 114 types of tumor indications and 98 types of antitumor drugs. The number of CADTH antitumor drugs economics evaluations in the past 5 years had shown an increasing trend. Among 137 pCODR reports with final economic guidance report ，98 reports（71.5％）adopted the PartSA model ，21 reports（15.3％）used the Markov model ，and some reports（6 reports，4.3％）used both PartSA and Markov models to explore the uncertainty of the model structure. In terms of model health status setting ，86 reports（62.8％）used three-state models to evaluate the economy of different anti tumor drugs ，and 16 reports（11.7％）used no less than four health states to simulate the outcome of disease state. However ，there were still some problems in CADTH models ，such as the unreasonable choice of research time limit ，the unreasonable extrapolation method or uncertain extrapolation results of efficacy （survival）data，the uncertainty of efficacy data obtained by indirect comparison ，and some assumptions or parameter settings did not conform to the actual diagnosis and treatment environment. In view of the advantages of PartSA model ，it is suggested that PartSA model or Markov model combined with PartSA model should be used first to verify the uncertainty of model structure in the future economic evaluation of antitumor drugs ；reasonable settings of key model parameters should be considered to improve the quality of evidence for antitumor drugs economics evaluation in China.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To investigate the effects of d exmedetomidine on postoperative delirium （POD） in liver tumor resection elderly patients with sleep disorder （SD）. METHODS ：Totally 80 patients undergoing liver tumor resection with preoperative Pittsburgh sleep quality index （PSQI）score ≥7 were selected from the Affiliated Cancer Hospital of Zhengzhou University from Jan. 1st，2020 to Oct. 31st，2020. They were randomly divided into group SD and group Dex according random number table ，with 40 cases in each group. At the same time ，40 patients with preoperative PSQI score ＜7 were selected as group C. Thirty min before anesthesia induction ，Dexmedetomidine hydrochloride injection 0.4 μg/kg was injected intravenously in group Dex. Etomidate emulsion injection ，Sufentanil citrate injection and Rocuronium bromide injection were used for anesthesia induction in 3 groups，and Ropofol medium/long chain fat emulsion injection + Remifentanil hydrochloride for injection was used to maintain anesthesia. The drug use ，operation time ，PACU stay time and postoperative hospital stay were recorded in 3 groups. The cognitive function was evaluated 2 h before operation and 1，3，5，7 days after operation. The occurrence of POD was observed. The plasma levels of IL- 6 and S 100β were measured 2 h before operation ，2 h after operation ，1，3，5 days after operation. The occurrence of ADR was recorded. RESULTS ：There was no statisti cal significance in intraoperativ e drug use and operation time among 3 groups （P＞0.05）. The PACU stay time ， the incidence of POD and the duration of POD in group SD an d lixxi18@126.com group Dex were significantly higher or longer than group C ， while the Dex group was significantly lower or shorter thangroup SD （P＜0.05）. The postoperative hospitalization stay ofgroup SD was significantly longer than group C and group Dex （P＜0.05），and there was no statistical significance between group Dex and group C （P＞0.05）. Before operation ，there was no statistical significance in MMSE scores or plasma levels of IL- 6 and S100β among 3 groups（P＞0.05）. MMSE scores of group C 1，3 days after operation ，those of group SD and group Dex 1，3，5 and 7 days after operation were significantly lower than those before operation. MMSE scores of group SD and group Dex 1，3，5 and 7 days after operation were significantly lower than group C at corresponding period ；the group Dex was significantly higher than the group SD at corresponding period （P＜0.05）. The plasma levels of IL- 6 and S 100 β at different time points were significantly higher than before operation ，and the group SD and group Dex were significantly higher than the group C ，and the group Dex was significantly lower than group SD at corresponding period （P＜0.05）. There was no statistical significance in the total incidence of ADR among 3 groups（P＞0.05）. CONCLUSIONS ：SD can promote the occurrence of POD in liver tumor resection elderly patients. Dexmetomidine can reduce the incidence of POD in elderly patients with preoperative SD ，the mechanism of which may be associated with the inhibition of IL- 6 and S 100β expression and the alleviation of brain injury with good safety.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To excavate the ADR signals of rivaroxaban and provide reference for its safe and rational use in clinic. METHODS ：Based on FDA adverse event reporting system （FAERS），the ADRs of rivaroxaban reported from September 2008 to December 2020 in FDA ’s Open Data Program were mined using ratio of reports to odds （ROR）and proportional report ratio （PRR）. The related ADRs were analyzed ，and the corresponding system organ classification （SOC）was mapped. At the same time，the basic information such as gender ，age and indications of the patients were statistically reported. RESULTS & CONCLUSIONS：Among 9 373 236 ADR reports extracted ，102 027 ADR reports with rivaroxaban as concomitant and suspected drug were obtained ；883 ADR signals were mined ，involving 27 systems. Among 102 027 reports，the proportion of female patients （41 294 cases，40.47％）was similar to that of male patients （41 071 cases，40.26％）. The patients were mainly ＞50 to 75 years old（29 261 cases，28.68％）and ＞75 years old （21 470 cases，21.04％）. The reporting year was mainly in 2018（18 446 cases， 18.08％）；main reporting country was the United States （75 390 cases，73.89％）；there were 35 046 cases（34.35％）of severe ADR reports ，mainly involving hospital or prolonged hospital stay. The SOC of rivaroxaban ADR singal mainly focused on diseases of the blood and lymphatic system ，vascular diseases ，various types of examination and nervous system diseases. Among top 20 preferred terms of ADRs with the highest frequency ，except for pulmonary embolism ，acute kidney injury and atrial fibrillation ，the rest were mainly bleeding related ADRs ，of which intracranial hemorrhage was the more seriou s ADR. Intracranial hemorrhage may occur when rivaroxaban is used for the prevention of atrial fibrillation and cerebrovascular accidents ， and pulmonary embolism may occur when rivaroxaban is used for the prevention of pulmonary embolism ，（deep）venous thrombosis and thrombosis. Great importance should be paid on it.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To systematic ally ev aluate the efficacy and safety of benralizumab in the treatment of severe eosinophilic asthma ，and to provide evidenced-based reference for clinical treatment. METHODS ：Retrieved from PubMed ， Embase，Cochrane Library ，ClinicalTrials.gov，CNKI，VIP and Wanfang database ，randomized controlled trials （RCTs）about benralizumab+routine treatment （trial group ）versus placebo+routine treatment （control group ）were collected during the inception to Dec. 2020. The relevant references were also retrieved manually. After data extraction ，the quality of included literatures was evaluated with bias risk evaluation tool 2.0 recommended by Cochrane systematic evaluator manual 6.1. Meta-analysis was conducted by using Rev Man 5.4 software. RESULTS ：Totally 5 studies involving 2 646 patients were included. Results of Meta-analysis showed that acute exacerbation rate of asthma [RR ＝0.67，95％ CI（0.61，0.74），P＜0.000 01]，asthma control questionnaire score [MD ＝－0.29，95％CI（－0.37，－0.21），P＜0.000 01] and the incidence of severe adverse event [RR ＝0.67，95％CI （0.53，0.84），P＝0.000 6] in trial group were significantly lower than control group. FEV 1[MD＝0.13，95％CI（0.09，0.17），P＜0.000 01] and asthma quality of life questionnaire score [MD ＝0.23，95％CI（0.13，0.33），P＜0.000 01] in trial group were significantly higher than control group. There was no statistical significance in the incidence of adverse event between 2 groups [RR ＝0.97，95％CI （0.92，1.02），P＝0.28]. CONCLUSIONS ：Benralizumab is effective and safe in the treatment of severe eosinophilic asthma. Due to the relatively limited data ，this conclusion needs to be confirmed by more studies.关键词：Benralizumab;Eosinophilic asthma;Efficacy;Safety;Meta-analysis
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To investigate the role of clinical pharmacists in the diagnosis and treatment of liposome-induced hand-food syndrome （HFS），and to provide reference for rational use of liposome preparation in clinic. METHODS ：One case of elderly female patient with breast cancer ，admitted to our hospital suffered from HFS （grade 2）after treated with Doxorubicin hydrochloride liposome ；after successful therapy ，the patient had skin symptoms （grade 3）again due to Paclitaxel liposome ，and clinical pharmacist judged the recurrence of HFS. For symptomatic treatment ，stopping the treatment and external use of hormone was suggested ，and whole-process pharmaceutical care was provided. The pathogenesis ，differential diagnosis ，risk factors and therapeutic drugs of HFS were summarized based on literature review and 2 case reports in the database. RESULTS ：The physicians adopted the suggestion of clinical pharmacists ；the patient ’s symptoms improved significantly on the third day and disappeared after 1 week. Combined with literature analysis and 2 case reports ，doxorubicin liposome metabolized more slowly than non liposomes in palms and soles of feet ，resulting in accumulation of doxorubicin in sweat duct and stratum corneum ，aggravating skin damage and leading to HFS. Sequential paclitaxel in liposome form may also lead to the accumulation in eccrine duct ，further caused skin damage and induced HFS. CONCLUSIONS ：Clinical pharmacists actively participate in the diagnosis and treatment of ADR ， which is conducive to the rehabilitation of patients. At same time ，combination or sequential of Paclitaxel liposome with PLD should be avoided ，as it can lead to ADR as HFS.关键词：Doxorubicin liposome;Paclitaxel liposome;Hand-food syndrome;ADR;Recurrence;Clinical pharmacists
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To evaluate the application effects of wh ole process intelligent dispensing mode in the inpatient pharmacy of our hospital ，and to provide reference for the intelligent construction of pharmacy department. METHODS ：Combined with the working situation of inpatient pharmacy in our hospital ，the application of automated drug unit-dose dispensing machine （ADDM），intelligent tablet dispensing table （ITDT），medication detection machine （MDM）were introduced. The improvement of work efficiency and the error rate were compared with before and after the implementation of intelligent dispensing mode. The satisfaction survey of intelligent mode was carried out. RESULTS ：Under the dispensing linkage mode of ADDM+ITDT+MDM ， the time of oral drug dispensing was shortened by about 1.5 h per person ；pharmacists reduced by 2 persons；with the help of ADDM image database and image printing technology of drug bag ，the visual inspection method and the efficiency of drug check could be improved ；the introduction of ITDT standardized the management of dismounted drug ，and the work efficiency of dispensing dismounted drug by ITDT （daily dispensing back-up time as index ）were improved 23.29％-38.93％，compared with manual dispensing. The introduction of MDM improved the efficiency of intelligent check ，all drug information could be traced ， and the work efficiency [daily （total）check time as index] were 65.64％-74.78％ higher than that of manual check ；the error rate of three machine dispensing linkage mode was 70.32％ lower than that of ADDM+manual check and dispensing mode ，52.44％ lower than that of ADDM+MDM linkage mode ，and the overall satisfaction of nu rsing staff was 97.97％. CONCLUSIONS ： ADDM+ITDT+MDM linkage mode shortens dispensing time ， ＊副主任药师 。研究方向 ：医院药学 。电话：0571-56007192。 E-mail：61012796@qq.com improves work efficiency and decreases error rate. # 通信作者 ：副主任药师 。研究方向 ：医院药学 。电话：0571-
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发布时间：2022-06-21
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