最新刊期
卷 33 ， 期 4 ， 2022
- 摘要：OBJECTIVE To provide reference for the safety of drug use in children and the rational drug use management strategies by health administration departments. METHODS A self-designed questionnaire was used to investigate the cognition of antibiotics and the parents ’behavior of children ’s use of antibiotics ，using online and offline questionnaires. Univariate analysis was carried out on the scores of respondents ’cognition，and multivariate Logistic regression analysis was carried out on the factors affecting parents ’behavior of children ’s use of antibiotics. RESULTS A total of 1 068 questionnaires were distributed ，and 993 valid questionnaires were recovered ，with the effective recovery rate of 93.0％. Among the respondents ，43.2％ of the parents ’ behavior of children ’s use of antibiotics in the past 6 months. The score of respondents ’cognition，high treatment cost and cumbersome treatment procedures ，easy access to antibiotics ，certain medication experience ，the recommendation of pharmacists in drug store ，the recommendation of relatives and friends and the publicity of mass media were positively correlated with parents ’ behavior of children ’s use of antibiotics （P＜0.05）. CONCLUSIONS The rate of the parents ’in Sichuan-Chongqing area is high ， which is the result of a combination of several factors. Reducing the risk of behavior of children ’s use of antibiotics requires the joint efforts of the government ，medical institutions and the public. The parents ’cognition towards antibiotics should be improved ，and the acquisition of antibiotics should be standardized so as to reduce unreasonable use of antibiotics.关键词：Children;Parents;Antibiotics;Sichuan-Chongqing area;Cognition;Behavior
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发布时间：2022-06-21 - 摘要：OBJECT IVE To provide reference for relevant decision-makers to formulate policies to guide the transfer of pharmaceutical industry. METHODS Using the statistical data from 2000 to 2019，taking industrial transfer index as index ，on the basis of 4 regions，our country was divided into 8 comprehensive economic areas ：the eastern coastal area ，the southern coastal area，the northern coastal area ，the middle reaches of the Yellow River area ，the middle reaches of the Yangtze River area ，the northeast area ，the southwest area and the northwest area. The regional characteristics and regularity of China ’s pharmaceutical industrial transfer were discussed in terms of space and time. RESULTS & CONCLUSIONS From 2004 to 2019，among the 31 provinces，pharmaceutical industry was transferred in 19 provinces，including Jilin ，Shandong，Henan and Gansu ，accounting for 61.3％；pharmaceutical industry was transferred out in 12 provinces，including Hebei ，Beijing，Xinjiang and Hubei ，accounting for 38.7％. There were 12 provinces whose absolute average values of industrial transfer index were greater than 0.2，indicating that China’s pharmaceutical industry had undergone large-scale migration among provinces ，and the scale of pharmaceutical industrial transfer varied significantly among provinces. From the perspective of regional distribution ，4 pharmaceutical industrial transfer-in centers had been formed in China ，the eastern coastal area ，the northeast area ，the middle reaches of the Yangtze River area and the southern coastal area ；industrial transfer followed the location selection mode from within areas to between areas. From the perspective of time change trend ，there was a phenomenon of gradient deviation in the transfer of pharmaceutical industry in various areas of China ，and there are 5 evolution types ，mainly including “up and down fluctuation ”，“first decrease and then increase”，“first increase and then decrease ”；the transfer of pharmaceutical industry was active in most areas ，and the transfer path remained relatively stable. In some areas ，the roles of transfer-out place and transfer-in place had been exchanged. According to the scale and trend of industrial transfer ，each area should formulate guiding policies to realize the coordinated development of inter-regional pharmaceutical industry.关键词：Pharmaceutical industry;industrial transfer;transfer characteristics;transfer regular ity;empirical analysis
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发布时间：2022-06-21 - 摘要：OBJECTIVE To provi de reference for standardizing the distribution behavior of drug wholesale enterprises and improving the supervision level of drug supervision departments. METHODS The defective items found in the on-site inspection of 570 drug wholesale enterprises in Hunan province in 2020 were summarized ，the main risks were analyzed to put forward countermeasures and suggestions. RESULTS & CONCLUSIONS The provincial drug regulatory departments conducted daily supervision and inspection among 192 drug wholesale enterprises ，of which 168 enterprises（87.50％）were ordered to make corrections；a total of 1 804 defective items were found ，involving 11 serious defects ，806 major defects and 987 general defects. The provincial drug regulatory departments conducted special inspections among 20 wholesale enterprises of narcotic drugs and psychotropic drugs ，of which 18 enterprises（90.00％）were ordered to make corrections ；a total of 48 defective items were found ， involving 33 major defects and 15 general defects ，and no serious defective items were found. The drug regulatory departments of all cities （autonomous prefectures ）inspected 358 drug wholesale enterprises ，of which 290 enterprises（81.00％）were ordered to make corrections ；a total of 1 499 defective items were found ，including 665 main defects and 834 general defects ，and no serious defective items were found. According to the statistics of occurrence frequency ，defective items of drug wholesale enterprises in Hunan province were mainly concentrated in storage and maintenance （687 items，20.50％），facilities and equipments （608 items， 18.14％），personnel and training （579 items，17.28％），receipt and acceptance （272 items，8.12％）and quality management system documents （260 items，7.76％），which together accounted for 71.80％ of the total defects. The main risks of drug wholesale enterprises included weak enterprise risk awareness ，high frequency of quality risks in drug marketing ，imperfect enterprise quality management system documents ，and fraud in enterprise business behavior. It is recommended that drug wholesale enterprises should establish quality risk management institutions ，evaluation standards and management systems ，improve the operation quality management system ，strengthen the management of drug storage ，standardize the operation and management of enterprises，strengthen personnel training and standardize procurement behavior ，so as to j ointly maintain the safety and efficacy of drugs and controllable quality.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To improve th e quality standard for Gerbera piloselloides. METHODS The properties of G. piloselloides were observed and microscopic identification was conducted for powder. The moisture ，total ash ，acid-insoluble ash and ethanol-soluble extract were detected according to the method stated in 2020 edition of Chinese Pharmacopoeia （part Ⅳ）. The contents of nodakenin，luteolin-7-O-β-D-lutinoside，luteoloside，apigenin-7-O-β-D-lutinoside，apigenin-7-O-β-D-glucopyranoside and marmesin were determined by high performance liquid chromatography method. RESULTS G. piloselloides were shrunken ，densely covered with thick white cotton wool ，with many fibrous roots ；the surface was taupe or gray-brown ；its texture was brittle and easy to break ；the cross section was yellow-white ，and there was an obvious small wooden heart in the center. Its powder was tan ， and non-glandular hairs ，stone cells ，calcium oxalate cubes ，ducts，fibers could be seen unde r microscope. The measured values of moisture，total ash ，acid-insoluble ash and alcohol-soluble extract ， for 15 batches of samples were 8.63％-11.34％，10.39％-14.93％， 3.29％-6.37％ and 9.03％-15.02％，respectively；average values were 10.01％，12.26％，4.61％，12.36％. The linear ranges of nodakenin，luteolin-7-O-β-D-rutinoside，luteoloside，apigenin- 7-O-β-D-lutinoside，apigenin-7-O-β-D-glucopyranoside and marmesin we re 3.87-154.88，1.64-65.41，1.60-64.00，1.92-76.96， 1.27-50.93，0.40-15.89 μg/mL，respectively（r≥0.999 1）. RSDs of precision ，stability（24 h）and repeatability tests were all less than 3％. The average recoveries were 101.88％，100.89％，102.64％，95.75％，96.71％ and 103.48％，respectively；RSDs were 0.55％，0.43％，0.34％，0.49％，0.47％ and 0.37％，respectively（n＝6）；the contents of above 6 components were 0.152 7-0.852 2， 0.084 5-0.669 7，0.136 7-0.961 0，0.126 0-1.193 2，0.128 8-1.102 2，0.046 9-0.678 0 mg/g. CONCLUSIONS The established method can be used for the quality control of G. piloselloides . It is preliminarily proposed that the moisture in G. piloselloides is not more than 12.0％；the total ash is not more than 15.0％，the acid-insoluble ash is not more than 6.0％，the alcohol-soluble extract is not less than 9.0％；the contents of luteoloside and apigenin- 7-O-β-D-glucopyranoside are not less than 0.016％.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To prepare Leonurine hydrochloride tablets and evaluate the quality. METHODS The wet granulation technology was adopted ；leonurine hydrochloride was used as the crude drug ，and the types of fillers ，disintegrants，binders and lubricants were screened by single-factor experiments. Combined with orthogonal experiments ，using the cumulative dissolution rate within 15 minutes（using water as dissolution media ）as index ，the proportion of disintegrants ，the mass fraction of binder solution，and the proportion of lubricants were screened and verified. The in vitro dissolution behavior of the prepared Leonurine hydrochloride tablets （dissolution media were hydrochloric acid solution of pH 1.2，acetic acid-sodium acetate solution of pH 4.5， phosphate buffer solution of pH 6.8，water），tablet appearance ，hardness，friability and content uniformity were tested according to the general principles in 2020 edition of Chinese Pharmacopoeia （part Ⅳ）. RESULTS The optimal formulation of Leonurine hydrochloride tablets included leonurine hydrochloride crude drug of 500 mg，dextrin of 9 250 mg，crosslinking polyving y- pyrrolidone of 200 mg，magnesium stearate of 50 mg，1％ hydroxypropyl methyl cellulose solution of 4 mL. The average 15-minute cumulative dissolution rate of the three batches of tablets was 81.25％（RSD＝1.12％，n＝3）. In above 4 dissolution media，the dissolution equilibrium of prepared tablets could be reached within 30 minutes，and the cumulative dissolution rates exceeded 85％. The prepared tablets had uniform beige in color ，smooth surface ，complete edge ，no mottle ，spot，foreign matter ， etc.，hardness of 57.3 N（n＝6），weight loss rate of 0.15％. The content uniformity was in accordance with relevant provisions in 2020 edition of Chinese Pharmacopoeia （part Ⅳ）. CONCLUSIONS Leonurine hydrochloride tablets are successfully prepared ， and the quality comply with relevant regulations.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To study the nephrotoxicity of the extracts from different parts o f Miao medicine Wikstroemia indica in healthy rats ，and to provide reference for the study of its toxicity mechanism and clinical drug use. METHODS Using 70％ ethanol as solvent ，total ethanol extract of W. indica was extracted with diacolation method. After dispersing the above extract with water，the fractions of corresponding fractions were obtained with petroleum ether ，ethyl acetate and n-butanol，and the rest was the extract of water fraction. SD rats were randomly divided into total ethanol extract group ，petroleum ether fraction group ，ethyl acetate fraction group ，n-butanol fraction group ，water fraction group and blank group ，with 12 rats in each group （half male and half female ）. The rats in the administration groups were given the corresponding dose of drug solution intragastrically （total ethanol extract 317.520 mg/kg，petroleum ether fraction 7.875 mg/kg，ethyl acetate fraction 78.435 mg/kg，n-butanol fraction 53.865 mg/kg and water fraction 76.545 mg/kg），once a day ，for conse- cutive 2 weeks，and then stopped taking drug for 2 weeks； rats in the blank group were given equal volume of 1.0％ . sodium carboxymethyl cellulose solution intragastrically. Duringthe experiment ，the general conditions of rats were observed. The samples of urine （on the 14th and 28th day ），serum and bilateral renal tissues （on the 15th and 29th day ）were taken respectively，the renal index was calculated ，the levels of @qq.com renal function indexes in serum and urine were detected ，and the pathomorphological changes of renal tissues were observed. RESULTS During administration ，compared with blank group ，the rats in the total ethanol extract group and ethyl acetate fraction group showed poisoning behavior and activity characteristics such as mental depression ，decreased activity and diet ，thin stool and decreased body mass. The mental state of the rats in the petroleum ether fraction group ，n-butanol fraction group and water fraction group were slightly worse than that in blank group，and slightly decreased activity and diet as well as thin stool ，and slowly increased body mass were found ；however，there was no significant difference in anal temperature in each group. After 2 weeks of administration ，the renal index in total ethanol extract group ，the serum levels of N-acetylglucosaminidase（NAG），urea nitrogen （BUN）and creatinine （Cr）in total ethanol extract group and ethyl acetate fraction group ，serum level of NAG in n-butanol fraction group and serum level of Cr in water fraction group ，as while as NAG levels in urine of rats in total ethanol extract group and petroleum ether fraction group ，NAG and urinary protein levels in urine of rats in ethyl acetate fraction group were increased significantly （P＜0.05 or P＜0.01）. In the pathomorphological observation ，renal tubules showed different degrees of unclear structure ，cell swelling and a few cell necrosis in the total ethanol extract group ，petroleum ether fraction group and ethyl acetate fraction group ，accompanying by glomerular pyknosis，renal tubular sclerosis and inflammatory cell infiltration ，compared with blank group. After drug withdrawal ，the mental state of rats in the administration groups were significantly improved ，the amount of activity and diet increased ，and the stool tended to be normal. Two weeks after drug withdrawal and recovery ，the levels of above indexes in serum and urine of rats in administration groups returned to be close to that in blank group （P＞0.05）；the glomerular structure of rats in each administration group gradually recovered clearly ，and cell swelling and inflammatory cell infiltration were rare in total ethanol extract group ， petroleum ether fraction group and ethyl acetate fraction group. CONCLUSIONS The total ethanol extract ，petroleum ether fraction and ethyl acetate fraction of Miao medicine W. indica have certain nephrotoxicity and reversibility. The toxic component may
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发布时间：2022-06-21 - 摘要：OBJECTIVE To determi ne the contents of total fla vonoids i n Scutellaria barbata standard decoction ，evaluate in vitro antioxidant activity ，establish the fingerprint and conduct chemical pattern recognition analysis. METHODS The contents of total flavonoids in S. barbata standard decoction （calculated by scutellarein ）were determined by ultraviet-visible spectrophotometry. In vitro antioxidant activity of S. barbata standard decoction was investigated by free radical scavenging tests of 1，1-diphenyl- 2-trinitrophenylhydrazine（DPPH）and 2，2′-azino-bis（3-ethylbenzothiazoline-6-sulfonic acid ）ammonium salt （ABTS）；HPLC method was adopted. Using scutellarin as reference ，the fingerprints of 16 batches of S. barbata standard decoction were drawn and evaluated by Similarity Evaluation System of TCM Chromatogram Fingerprint （2004 A edition ），and the common peaks were determined；Pearson correlation analysis was carried out by using SPSS 24.0 software to screen substances with in vitro antioxidant activity. Taking them as variables ，cluster analysis and principal component analysis were carried out by using SPSS 24.0 and SIMCA 14.1 software. RESULTS The linear range of total flavonoids were 2.106-21.06 μg/mL（R2＝0.999 3）；RSDs of precision ， reproducibility and stability tests （120 min）were all lower than 2％；the recovery was 100.62％（RSD＝0.55％，n＝6）；the contents of total flavonoids were 0.634-1.053 mg/mL. Median inhibitory concentration （IC50） of DPPH radical scavenging experiment ranged 1.120-3.602 mg/mL，and IC 50 of ABTS radical scavenging e xperiment range d 0.684-1.327 mg/mL. The results of correlation analysis showed that the content of total flavonoids Δ 基金项目 ：河北省高校省级重点学科建设项目 （No.冀教 in S. barbata standard decoction was negatively correlated 高〔2013〕4号）；承德医学院自然科学研究计划项目（No.201824） ＊讲师，硕士。研究方向：中药质量控制 。电话：0314-2291186。 with the IC 50 of DPPH free radical and ABTS free radical E-mail：duyilongww@sina.com scavenging experiment ，and the correlation coefficients were # 通信作者 ：教授，硕士。研究方向 ：中药质量控制 。电话： －0.976 and －0.940 respectively（P＜0.01）. There were 18 0314-2291186。E-mail：phf2301@163.com common peaks in the fin gerprints of 16 batches of S. barbata 中国药房 2022年第33卷第4期 China Pharmacy 2022Vol. 33 No. 4 ·425· standard decoction ；the s imilarities were 0.964-0.997. A total of 4 common peaks were identified ，such as scutellarin （peak 8）， scutellarein（peak 14），luteolin（peak 15），apigenin（peak 17）.In the HPLC fingerprints of S. barbata standard decoction ，the peak areas of peak 3-4，8-9，12-15 and 17 were significantly negatively correlated with the IC 50 of DPPH free radical and ABTS free radical scavenging experiment （P＜0.05）. The results of cluster analysis showed that 16 batches of S. barbata standard decoction could be clustered into two categories ，of which S 2，S7-S8 and S 14-S16 were clustered into one category ，S1，S3-S6 and S 9-S13 were clustered into one category. By principal component analysis ，16 batches of S. barbata standard decoction were divided into two categories ，of which S 2，S4，S7 and S 14-S16 were clustered into one category ，and S 1，S3，S5-S6 and S 8-S13 were clustered into one. The comprehensive scores were high in the samples of S 4，S13，S15. CONCLUSIONS Established HPLC fingerprint and chemical pattern recognition analysis method can be used to evaluate the quality of S. barbata standard decoction ； peak 3-4，8-9，12-15 and 17 and total flavonoids are the potential material basis for S. barbata standard decoction to scavenge DPPH free radical and ABTS free radical.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To compare the phar macokinetics o f ligustrazine hydrochlori de，salvianic acid and rosemarinic acid from Shenxiong glucose injection （SGI）in normal and acute myocardial ischemia （AMI）rats. METHODS Male SD rats were randomly divided into normal group and model group ，with 9 rats in each group. AMI model was established by isoproterenol hydrochloride modeling method. Three rats in each group were selected for model verification. The remaining 6 rats in each group were given SGI （1.2 mL/kg）or equal volum of normal saline via tail vein ；0.3 mL blood was collected through orbital venous bush 0.083，0.167，0.333，0.5，0.75，1，1.5，2，3，5 h after administration. Using luteoloside as internal standard ，the plasma concentrations of ligustrazine hydrochloride ，salvianic acid and rosemarinic acid were determined by ultra performance liquid chromatography-tandem mass spectrometry. Pharmacokinetic parameters were fitted by WinNonlin 8.1 software，and statistical analysis was performed by SPSS 18.0 software. RESULTS The linear ranges of ligustrazine hydrochloride ，salvianic acid and rosmarinic acid were 0.06-29.96，0.01-5.15 and 0.006-3.09 μ g/mL（all r＞0.99），respectively. The results of methodological investigation were all in line with the requirements of Chinese Pharmacopoeia （2020 edition）. Compared with normal rats ，CLz of ligustrazine hydrochloride in AMI model rats was significantly increased （P＜0.05）；t1/2 and Vz of salvianic acid were significantly prolonged or increased （P＜0.05）；but the cmax and AUC 0－5 h were significantly decreased （P＜0.05）；AUC0－5 h of rosmarinic acid was significantly decreased （P＜0.05）. CONCLUSIONS The exposure levels of salvianic acid and rosmarinic acid in SGI are lower in AMI model rats than in normal rats ，and the elimination of ligustrazine hydrochloride in AMI model rats is stronger than that in normal rats.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To establish the fingerprint of Zhuang medicine Jinmu granules and carry out chemometric analysis ， and determine the contents of three components . METHODS High performance liquid chromatography （HPLC） method was adopted. Using rutin as the reference ，HPLC fingerprints of 10 batches of Jinmu granules were drawn and similarity evaluation was performed by Similarity Evaluation of Chromatographic Fingerprint of Traditional Chinese Medicine （2012 edition）；the common peak was determined by comparing with mixed control ；SPSS 21.0 software was used for cluster analysis ，and SIMCA 14.1 software was used for principal component analysis and orthogonal partial least squares-discriminant analysis. The differential components affecting the quality of Jinmu granules were screened by taking the variable importance in projection （VIP）value ＞1 as the standard ；the HPLC method was used to determine the contents of astilbin ，polydatin and berberine hydrochloride in Jinmu granules. RESULTS There were 22 common peaks in 10 batches of Jinmu granules ，and the similarities were 0.962-0.997；five common peaks were identified ，namely gallic acid （peak 2），polydatin（peak 9），rutin（peak 11），astilbin（peak 13）and kaempferol （peak 20）. The results of cluster analysis showed that 10 batches of Jinmu granules could be clustered into 3 categories：S1 and S 3-S4 were grouped into one category ；S5-S6 and S 9 were grouped into one category ；S2，S7-S8 and S 10 were grouped into one category. The results of principal component analysis showed that the parameter of model interpretation was 0.951 and that of prediction ability was 0.723. The classification results were basically consistent with cluster analysis. The classifica tion results of orthogonal partial least squares- com discriminant analysis were also ba sically consistent with clus- ter analysis. The common peaks with VIP value ＞1 in the order were peak 7＞peak 11（rutin）＞peak 17＞peak 13（astilbin）＞ peak 3＞peak 8＞peak 6＞peak 16 respectively. The linear ranges of astilbin ，polydatin and berberine hydrochloride were 0.012 6- 1.225 0，0.010 8-1.052 5 and 0.020 0-1.562 5 mg/mL，respectively（all R 2＝0.999 9）. RSDs of precision ，stability（24 h）and repeatability tests were all less than 3％. The average recoveries were 99.48％（RSD＝2.67％，n＝9），98.57％（RSD＝1.77％，n＝ 9）and 100.84％（RSD＝2.49％，n＝9）. The contents were 1.221 0-7.011 6，2.251 1-4.462 9，1.252 4-3.328 7 mg/g，respectively. CONCLUSIONS Established fingerprint and the method of content determination are accurate ，stable and simple. Combined with chemometric analysis ，it can be used for the quality control and evaluation of Zhuang medicine Jinmu granules.
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发布时间：2022-06-21 - 摘要：OB JECTIVE To investigate the component characteristics and anti-infla mmatory activities of the low polarity parts from Sabia campanulata ，S. discolor and S. parviflora . METHODS Gas chromatography-mass spectrometry was used to analyze the components of low polarity parts eluted by petroleum ether from petroleum ether extract of dried stems and leaves of S. campanulata，S. discolor and S. parviflora . The chromatographic peaks were retrieved by both NIST 17 and Wiley 275 database， and their structures of each compound were compared and identified manually. The relative percentage content of each component was calculated by peak area normalization method. With indomethacin as positive control and the inhibition rate of nitric oxide （NO）production as the index ，the effects of the low polarity parts of the above three species of Sabia genus on the production of NO in lipopolysaccharide-induced human rheumatoid arthritis fibroblast-like synoviocytes （RA-FLS） and mouse mononuclear macrophage RAW 264.7 were compared ；the half inhibitory concentration （IC50）was calculated. RESULTS Totally 70，40 and 33 chemical components were identified respectively from the low polarity parts of S. campanulata ，S. discolor and S. parviflora ， including long-chain fatty hydrocarbons ，long-chain alcohol/aldehyde/ester ，monoterpenes；but there were only 5 common components in the three species ，such as dodecane and docosane，etc. S. campanulata contained abundant terpenoids （40.89％）； the relative percentage content of triterpenoids was high in S. discolor （30.29％）；the relative percentage content of long-chain fatty hydrocarbons was high in S. parviflora （87.70％）. The values of IC 50 of the low polarity parts of the above three species of Sabia genus to the production of NO in RA-FLS cells were 2.22，1.69 and 4.15 μg/mL，respectively. The values of IC 50 of them to the production of NO in RAW 264.7 cells were 1.23，4.02 and 3.05 μg/mL respectively，and all of them were lower than indomethacin （12.97，10.66 μg/mL）. CONCLUSIONS The components of the low polarity parts fr om the above three species of Sabia genus are mainly long-chain fatty hydrocarbons ， monoterpenes and long-chain alcohol/aldehyde/ester ， and all of them have certain anti-inflammatory activities.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To establish the fing erprint of Temurin- 5 powder，conduct chemical pattern recognition analysis ，and determine the contents of 4 components simultaneously. METHODS The fingerprints of 10 batches of Temurin- 5 powder were established and similarity evaluation was performed by using high performance liquid chromatography （HPLC）combined with the Similarity Evaluation System of Chromatographic Fingerprints of Traditional Chinese Medicine （2012 edition）；common peaks were identified by comparing with mixed substance control. The common peaks were analyzed by systematic cluster analysis and principal component analysis with SPSS 26.0 software. The HPLC method was used to determine the contents of gallic acid ， geniposide，chlorogenic acid and ellagic acid in 10 batches of samples. RESULTS A total of 15 common peaks were identified from the fingerprints of 10 batches of Temurin-5 powder，and the similarity was 0.997-0.999. It was identified that peak 1 was gallic acid ，peak 3 was geniposide ，peak 5 was chlorogenic acid and peak 12 was ellagic acid. Among the 10 batches of samples ， S4 and S 9 were grouped into one category ，S6-S8 were grouped into one category ，and the other batches of samples were grouped into one category. The accumulative variance contribution rate of first three principal components was 89.245％. The linear ranges of gallic acid ，geniposide，chlorogenic acid and ellagic acid were 5.55-177.5，15.98-511.5，2.56-82.0 and 13.48-431.5 μg/mL， respectively. RSDs of precision ，stability（24 h）and repeatability tests were all less than 2％（n＝6 or n＝7）. The average recoveries were 101.56％，102.21％，98.60％ and 96.62％，respectively，RSDs were 1.90％，1.61％，1.58％ and 1.73％（n＝6）. Average contents of above components were 5.03-5.64，10.38-12.16，1.40-1.69，6.47-7.11 mg/g，respectively. CONCLUSIONS The established fingerprint is stable and feasible ，and the content determination method meets the relevant regulations. Combined with chemical pattern recognition analysis ，it can be used for the quality control of Temurin- 5 powder.关键词：Temurin-5 powders;Fingerprint;systematic cluster analysis;Principal component analysis;Content determination
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发布时间：2022-06-21 - 摘要：O BJECTIVE To prepare Neuritic acid oral emulsion ，to optimize its formulation and preparation technology ，and to investigate its stability. METHODS Neuritic acid oral emulsion was prepared by mechanical method. On the basis of single factor experiment ，the appearance ，centrifugal stability ，centrifugal stability constant （Ke）and particle size of the emulsion as indexes，the formulation was optimized by orthogonal design ，taking the dosage of oleic acid ，octylphenol polyoxyethylene ether-10 and propylene glycol as factors ，the preparation technology was optimized by taking emulsification temperature ，shear time，pressure of high-pressure homogenization and cycle times of high-pressure homogenization as factors. The content of neuritic acid was determined by high performance liquid chromatography. The stability of Neuritic acid oral emulsion was investigated by high temperature test ，accelerated test and long-term test. RESULTS The optimal formulation and preparation technology were as follows：neuritic acid of 1 g，oleic acid of 5％ ，octylphenol polyoxyethylene ether- 10 of 4％ ，propylene glycol of 2％ ， emulsification temperature of 60 ℃ ，shear time of 2 min，homogenization pressure of 40 MPa and cycle times of twice. After three experiments ，the average particle size of Neuritic acid oral emulsion was 158.05 nm（RSD＝1.58％，n＝3），the average Ke was 0.39（RSD＝1.49％，n＝3），and the appearance was uniform milky white ，there was no stratification. The results of high temperature test showed that Neuritic acid oral emulsion was prone to stratification in high temperature environment ，and the content of neuritic acid increased. The results of accelerated test and long-term test showed that there was no significant change in the appearance or the content of neuritic acid when Neuritic acid oral emulsion was placed at room temperature for 6 months. CONCLUSIONS The formulation and preparation technology are stable and feasible ，and can be used for the preparation of Neuritic acid oral emulsion. Neuritic acid oral emulsion should not be placed in high temperature environment. It has good stability at room temperature for 6 months.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To study the metabolites of four diterpenoids of Euphorbia fischeriana in liver microsomes of rats and to investigate its metabolic regularity. METHODS In vitro incubation system of liver microsomes of rats was built. The jolkinolide A，jolkinolide B ，17-hydroxyl jolkinolide A and 17-hydroxyl jolkinolide B were added into incubation system of liver microsomes in rats activated by reduced nicotinamide adenine dinucleotide phosphate ，incubated at 37 ℃ for 30 min，and then terminated the reaction with acetonitrile. Taking the negative group （adding acetonitrile firstly and then starting incubation for 30 min）as the reference，the ultra-high performance liquid chromatography-quadrupole time-of-flight mass spectrometry was used ；Anaylyst®TF 1.7.1、PeakView® 2.2，MetabolitePilot 1.5 and MasterView 1.2 software were used to speculate and identify the fragmentation law of mass spectrometry and metabolites. RESULTS Four diterpenoids were easy to lose neutral fragments such as H 2O and CO in secondary mass spectrometry. Jolkinolide A and 17-hydroxyl jolkinolide A showed similar metabolism pathway ，including dihydroxylation，dehydrogenation，and monohydroxylation ；six and five metabolites were identified respectively. Jolkinolide B and 17-hydroxyl jolkinolide B showed similar metabolism pathway ，including monohydroxylation ，hydration and isomerization. Five metabolites were identified. CONCLUSIONS Both jolkinolide A and 17-hydroxyl jolkinolide A produce the metabolites of hydroxylation and dehydrogenation in liver microsomes of rats ；both jolkinolide B and 17-hydroxyl jolkinolide B produce the metabolites of hydroxylation ，hydration and isomerization in liver microsomes of rats. The metabolites of four diterpenoids are phase Ⅰ metabolites.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To study in vitro inhibitory effects of realgar nanoparticles on breast cancer stem cells. METHODS Human breast cancer MCF- 7 parent cells were selected as subjects and cultured by serum-free culture to obtain breast cancer stem cells. Using adriamycin （1 mg/L）as positive control ，same concentration of water-processed realgar as reference ，the effects of realgar nanoparticles on the proliferation of MCF- 7 parent cells and stem cells were detected by CCK- 8 method. The effects of realgar nanoparticles on the formation of mammosphere ，the ability of differentiation ，migration and invasion ，the proportion of CD44+/CD24－ subgroup in breast cancer stem cells were detected by mammosphere formation and differentiation experiment ， scratch experiment ，Transwell invasion experiment and flow cytometry. Western blot assay was used to detect the expression of proteins related to epithelial mesenchymal transformation pathway （E-cadherin and vimentin ） in breast cancer stem cells. RESULTS The survival rates of MCF- 7 parent cells and stem cells （except for breast cancer stem cells in both 1 mg/mL groups ）in 1，5，10，40，60，80 mg/L groups of water-processed realgar and realgar nanoparticles were significantly lower than blank control group（P＜0.01）. The number of mammosphere （＞20 stem cells ）in 1，2.5，5，10 mg/L groups of water-processed realgar and realgar nanoparticles was significantly lower than blank control group （P＜0.01）；the volume of mammosphere decreased and the differentiated adherent cells decreased ；the healing rate of wound ，relative invasion rate （except for water-processed realgar 1 mg/L group）and the proportion of CD 44+/CD24－ subgroup were significantly lower than blank control group （P＜0.01）. The expressions of E-cadherin in 2.5，10 mg/L groups of water-processed realgar and realgar nanoparticles was significantly higher than blank control group ，and the expressions of vimentin was significantly lower than those in blank control group （P＜0.01）. The above effects of realgar nanoparticles were generally better than those of water-processed realgar with the same mass concentration （P＜ 0.01）. CONCLUSIONS Compared with water-processed realgar with the same mass concentration ，realgar nanoparti cles can significantly inhibit the proliferation of breast cancer stem cells， the formulation and differential ability of mammo- sphere，and reduce the proportion of CD 44+/CD24－ subgroup. The effect may be associated with the inhibition of migration and invasion of breast cancer stem cells by inhibiting the expression of proteins related to epithelial mesenchymal transformation pathway.
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发布时间：2022-06-21 - 摘要：OBJECTIVE To evaluate the economics of pertuzumab combined with trastuzumab and docetaxel（PTD）regimenversus trastuzumab combined with docetaxel（TD）regimen in first-line treatment of human epidermal growth factor receptor 2 （HER2）-positive metastatic breast cancer. METHODS From the perspective of Chinese healthcare system，the partitioned survivalmodel was constructed by using survival data disclosed in the CLEOPATRA clinical trial and relevant literature data. The time horizon of the model was set as 20 years and the cycle length of the model was 3 weeks，and discount rate was 5％. The output indicators of the model included the cost and quality-adjusted life years（QALYs）of the two treatment regimens. The reshold of willingness-to-pay（WTP）was set as 1-3 times per capita gross domestic product（GDP）in China in 2020，i. e. 72 000-216 000 yuan/QALY. One-way sensitivity analysis and probabilistic sensitivity nalysis were used to evaluate the influence of model parameter changes on the robustness of the results. RESULTS The results of base-case analysis showed that within the horizon of 20 years，PTD regimen could bring more health benefit than TD regimen（3.28 QALYs vs. 2.50 QALYs），but the total costs was higher（1 219 376.83 yuan vs. 784 007.84 yuan）. Compared with TD regimen，the incremental cost-effectiveness ratio of PTD regimen was 554 625.46 yuan/QALY，which exceeded threshold of WTP. The results of one-way nsitivity analysis showed that the utility of progression-free survival state hadthe greatest impact on the results；the results of probability sensitivity analysis showed that the probability of PTD regimen considered as to be cost-effective was 1％ when using the 3 times per capita GDP in China in 2020 as the threshold of WTP；when the threshold of WTP increased to 550 000 yuan/QALY，the probability of PTD regimen considered as to be cost-effective would reach to 50％. CONCLUSIONS Compared with TD regimen，PTD regimen is unlikely to be cost-effective in first-line treatment of HER2-positive metastatic breast cancer.
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发布时间：2022-06-21 - 摘要：OBJECTIV E To investigate the calculation method of drug market share in budget impact analysis （BIA）in order to provide new ideas for BIA research. METHODS In view of the situation that some drugs had multiple indications or the indications in the drug instructions were not clear enough and inconsistent with the indications in the reimbursement catalogue ， starting from the concept of “times per person ”，the parameters such as sample hospital and average treatment time per person for each time were introduced to develop a new market share calculation method. At the same time ，the calculation process was demonstrated by taking the treatment drugs for liver cirrhosis as an example. RESULTS & CONCLUSIONS Taking treatment drugs of liver cirrhosis as an example ，the calculation results of market share showed that the results of the two calculation methods were quite different. The market share calculated on the basis of “the number of people ”was mostly higher than that calculated on the basis of “times per person ”. Compared with the traditional calculation method based on “the number of people ”，the calculation method of market share based on “times per person ”could calculate the market share more accurately ，which could solve the problem that the traditional method didn ’t fully consider that most drugs had multiple indications ，the indications of drug instructions were not clear enough and inconsistent with the reimbursement catalogue ，resulting in inaccurate calculation of market share；at the same time ，this method could also be used to try to solve the problem that the total number of patients could not be obtained from epidemiological data based on the average treatment time per person of each time in the sample hospital. This method can be considered when the indications of the target drug are not clear enough or there are multiple indications ，or when the researchers collect clinical ，epidemiological and medical insurance data to estimate the number of target population ，the prediction results of market capacity do not conform to the theoretical logic or actual situation due to the lack of necessary data ，or when the target disease has the characteristics of repeated attacks and short course of disease.关键词：budget impact a nalysis;market share;Calculation method;time per person
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发布时间：2022-06-21 - 摘要：OBJECTIVE To obser ve the efficacy and safety of rimazo lom for painless gastroscopy sedation in outpatients. METHODS Totally 84 patients who underwent painless gastroscopy were collected from the outpatient department of the Central Hospital of Enshi Tujia and Miao Autonomous Prefecture from March to June in 2021. By random number table method combined with envelope allocation concealment method ，they were randomly divided into observation group and control group ，with 42 cases in each group. The patients in the observation group were slowly injected with Sufentanil citrate injection 0.1 μg/kg+Rimazole toluenesulfonate for injection 0.2 mg/kg. Patients in the control group were slowly injected with Sufentanil citrate injection 0.1 μg/kg+ Propofol emulsion injection 2 mg/kg. Gastroscopy was performed after the patient ’s consciousness disappeared. The sedative efficiency，sedative onset time ，recovery time and the occurrence of adverse drug reaction were observed in 2 groups. The heart rate（HR），mean arterial pressure （MAP），pulse oxygen saturation （SpO2），modified observer ’s assessment of alertness/sedation （MOAA/S）score and Narcotrend score were recorded in 2 groups after entering the room （T0），after anesthesia induction （T1）， when gastroscope entered the throat （T2），at the end of gastroscope withdrawal （T3），5 min after gastroscopy （T4）. RESULTS There was no significant difference in the effective rate of sedation （100％），the incidence of respiratory depression ， nausea and vomiting between the two groups （P＞0.05）. The qq.com onset time of sedation in the observation group was longer than control group ，and the recovery time and the incidence ofhypotension，hypotension to be tre ated，injection pain and bradycardia in observation group were significantly shorter or lower than control group （P＜0.05）. At T 0，there was no significant difference in HR ，MAP，SpO2，MOAA/S score or Narcotrend score between two groups （P＞0.05）. From T 1 to T 4，the HR of control group was significantly lower than that of the same group at T 0，and significantly lower than observation group at the same time（P＜0.05）. From T 1 to T 3，the MAP of two groups were significantly lower than the same group at T 0（P＜0.05），but there were no significant differences between two groups and between T 4 and T 0（P＞0.05）. There was no significant difference in SpO 2 at different time points between two groups and HR at different time points in observation group （P＞0.05）. From T 1 to T 3，MOAA/S score and Narcotrend score of two groups were significantly lower than the same group at T 0，while the MOAA/S score and Narcotrend score at T 1 and T 3 and Narcotrend score at T 3 of observation group were significantly higher than control group at the same time （P＜0.05），and the Narcotrend score of observation group at T 2 was significantly lower than control group at the same time（P＜0.05）；at T 4，there were no significant differences in MOAA/S score and Narcotrend score between two groups （P＞ 0.05）. CONCLUSIONS Remazolam shows good sedative effect and safety for painless gastroscopy.关键词：painless gastroscope;remazolam;Propofol;sedation;Effectiveness;Safety
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发布时间：2022-06-21 - 摘要：OBJECTIVE To systematically evaluate the adverse effects of drug-resistant tuberculosis （DR-TB） drugs on pregnant women and fetuses ，so as to provide evidence-based reference for clinical medication. METHODS PubMed，Cochrane Library，Embase，CBM，CNKI，Wanfang database and VIP were searched by computer to collect randomized controlled trials （RCTs），cohort studies ，case-control studies ，case series and case reports about pregnant women exposed to DR-TB drugs. The retrieval time limit was from the establishment of each database to August 20，2021. After selecting the literature and extracting the data，the bias risk assessment tool recommended by 6.2 version of Cochrane system evaluator manual was used to evaluate the quality of the included RCTs ；Newcastle-Ottawa scale was used to evaluate the quality of the included cohort studies and case-control studies ；IHE scale issued by the Canadian Institute of Health Economics （IHE）was used to evaluate the quality of the included case series and case reports. RevMan 5.1 software was used for Meta-analysis of non-comparative binary data. RESULTS A total of 13 literature were included ，including 7 case series and 6 case reports ，involving 203 patients and 204 newborns；among them，there were 6 literature about non-comparative binary data. The results of meta-analysis showed that after exposure to DR-TB drugs，no newborn had birth defects ；the mortality of pregnant women was 0.09[95％CI（0.06，0.15），P＜0.000 01]；the neonatal mortality was 0.02[95％CI（0，0.06），P＜0.000 01]；the incidence of preterm birth was 0.14[95％CI（0.03，0.43），P＝0.02]；the incidence of infants with low birth weight was 0.17[95％CI（0.04，0.51），P＝0.06]；the incidence of growth retardation was 0.15[95％CI（0.09，0.22），P＜0.000 01]；the incidence of stillbirth was 0.05[95％CI（0.02，0.09），P＜0.000 01]；the incidence of abortion was 0.08[95％CI（0.05，0.14），P＜0.000 01]. CONCLUSIONS Pregnant women exposed to DR-TB drugs can cause pregnant women ’s death and abortion ，neonatal death ，premature birth ，infants with low birth weight ，growth retardation and stillbirth，but there is no neonatal birth defect ；these adverse outcomes may be related to the history of DR-TB.
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发布时间：2022-06-21 - 摘要：OBJECTIV E To provide ideas for diagnosis and treatment of fungal endocarditis. METHODS The diagnosis and treatment of 1 case of aspergillus endocarditis participated by clinical pharmacists were analyzed. Clinical pharmacists suggested that blood macrogenomic next-generation sequencing （mNGS）detection and blood microbial culture should be performed to assist in the diagnosis of fungal endocarditis ；considering the mechanism ，target and safety of the drug ，it was suggested to use voriconazole combined with micafungin for antifungal treatment ；through combining with the patient ’s condition and weighing up the pros and cons ，the dose of micafungin was adjusted to 300 mg per day ；clinical pharmacists prevented ，evaluated and dealt with adverse drug reactions during treatment ，and also provided medication guidance and long-term follow-up for the patient after discharge. RESULTS The clinician adopted the advice of the clinical pharmacists. Aspergillus fumigatus was detected in blood mNGS，which bought time for early diagnosis and individualized treatment of the patient. After 1 month treatment of voriconazole combined with micafungin ，the patient ’s condition was well controlled. The alkaline phosphatase and γ-glutamyl transferase of the patient returned to normal after treatment with adenosylmethionine succinate. With the help of medication guidance ，education and discharge follow-up of clinical pharmacists ，the medication compliance of the patient was good and the condition was stable. CONCLUSIONS The clinical pharmacists participate in the diagnosis and treatment process of the patient ，formulate an individualized anti-infective treatment plan for the patient and achieve good results ，which reflect the professional ability and service level of the clinical pharmacist ，and provide ideas for the clinical treatment of fungal endocarditis.
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发布时间：2022-06-21 - 摘要：Trollius chinensis has a wide range of pharmacological effects ，including anti-oxidative ，antibacterial，antiviral， anti-inflammatory，anti-tumor，anti-aging，antipyretic and analgesic effects ，relieving cough and removing phlegm ，viscera protection，and so on. Flavonoids and phenolic acids are the main medicinal components of it ，especially three monomers have a wide range of efficacy and have been studied more ，such as orientin ，vitexin and 2″-O-galactopyranosyl orientin. T. chinensis is mostly used in clinical practice in the form of Chinese patent medicines ，such as Jinlianhua granules ，Jinlianhua capsules ， Jinlianhua tablets and Jinlianhua oral liquid. These medicines are used to treatment of upper respiratory tract infection ，pharyngitis， tonsillitis，periodontitis，mumps，oral ulcer ，and hand-foot-mouth disease. They are usually used by combining with Western medicine. Due to its definite curative effect and less adverse drug reactions ，T. chinensis related preparations are more suitable for pediatric population ，and they can be used for the treatment of upper respiratory tract infection in children ，acute suppurative tonsillitis in children ，epidemic mumps in children ，hand-foot-mouth disease in children ，which is also one of its drug characteristics. This paper review the relevant literatures in recent 20 years from the respective of pharmacological effects and clinical applicationin order to provide reference for further promoting rational clinical application of T. chinensis and new drug research and development.关键词：Trollius chinensis;pharmacological effects;Clinical application
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发布时间：2022-06-21
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