最新刊期
卷 32 ， 期 7 ， 2021
- 摘要：OBJECTIVE：To provide su ggestions for perfecting drug electronic commerce regulatory policy and online drug sale supervision mechanism in China. METHODS ：The evolution of online drug sale policy in China were sorted out. The related regulations of online drug sale supervision mechanism stated in newly revised Drug Administration Law in 2019 and Measures for Online Drug Sale Supervision （Exposure Draft ）in Nov. 2020（hereinafter referred to as New Exposure Draft ）were analyzed on the basis of regulatory science to put forward the opinion. RESULTS & CONCLUSIONS ：Drug e-commerce in China has experienced 4 stages of development ，and is now in a new stage of encouraging innovation ，inclusiveness and prudence. The newly revised Drug Administration Law and New Exposure Draft catch up with the trend of “Internet plus ”development in the new era ，and conditionally liberate the network prescription drug operation ，and build new advantages and new kinetic energy for the development of pharmaceutical business. The new network drug supervision mechanism is an important embodiment of the regulatory department ’s active adaptation to social development ，a specific practice of the innovation of scientific drug regulatory concept，and also provides legal guarantee and policy space for new business forms of innovation drug circulation. However ，the author thinks that the relationship between prescription drug information and drug advertising ，network prescription transmission and authenticity ，legitimacy audit ，as well as the concept definition of sales behavior and service behavior are still questionable. Relevant concepts and terms should be adjusted and redefined. It is suggested that online drug sellers should be defined as “drug e-commerce operators ”or“online drug operators ”. The third party platform of online drug trading is defined as “drug e-commerce platform operator ”or“online drug trading platform operator ”.关键词：Drug;Network sales;Electronic commerce;Supervision mechanism;Regulatory science
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To learn from the experie nce of post-marketing risk management of biopharmaceuticals in the United States，and to provide reference for post-marketing risk management of biopharmaceuticals in China. METHODS ：By studying guidance documents and website information issued by FDA ，the risk management of biopharmaceuticals after marketing in the United States was analyzed. Taking infliximab as an example ，the specific implementation situation was introduced ，the management characteristics were summarized ，and the enlightenment and relevant suggestions were put forward for the risk management of biopharmaceuticals after marketing in China. RESULTS & CONCLUSIONS ：The post-marketing risk management of biopharmaceuticals in the United States mainly includes two aspects as “risk evaluation and mitigation strategy （REMS）”and “post-marketing study and clinical trials system ”. The latter included post-marketing requirement （PMR） and post-marketing commitment（PMC）. Taking infliximab as an example ，since it was approved by FDA in August 1998，its manufacturer submitted REMS to FDA in 2009 and obtained approval ，and proposed post-marketing studies and clinical trials for five times. It can be seen that FDA has issued specific guidelines for post-marketing risk management of biopharmaceuticals to encourage multi-role participation in risk management ， realize effective communication with patients ， and continuously supervise the risk of biopharmaceuticals，so as to reduce the risk of the use of biopharmaceuticals. For biopharmaceuticals ，China has not yet formulated systematic and specific implementation rules and guidelines ，and there is still lack in post-marketing risk management. It is suggested that China can learn from the measures and system of post-marketing risk management of biopharmaceuticals in the United States ，involve stakeholders in post-marketing management ，enhance patients ’awareness of drug use risks through effective communication，and further improve the post-marketing research management system to guarantee patients ’safety of drug use.关键词：United States;Biopharmaceuticals;Post-marketing ri sk management;Enlightenment
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To define the core competitiveness of drug manufacturing enterprises ，and build its evaluation system. METHODS ：With“core competitiveness ”and“pharmaceutical”as Chinese and English keywords ，the laws ，policies and interpretation documents published on relevant Chinese government websites （from the inception/establishment of the database to June 2020，the same below ）were retrieved. Related literatures were collected from PubMed ，Embase，CBM，Wanfang database ， CNKI，VIP databases. The evidence-based research method was adopted to define the core competitiveness and elements of drug manufacturing enterprises. Based on above elements and retrieval method ，guideline database （National Guideline Clearinghouse ， Guidelines International Network ，Trip database ，The National Institute for Health and Care Excellence ）and systematic review ， health technology assessment （HTA），health economics evaluation research databases （NHS Economic Evaluation Database ，the Cochrane Library ，HTA，etc.）were retrieved. The output indexes of the core competitiveness of drug manufacturing enterprises were extracted ；according to the principles of scientificity ，hierarchy，comparability and comprehensiveness ，the evaluation system of core competitiveness of drug manufacturing enterprises was constructed. RESULTS & CONCLUSIONS ：The definition of core competitiveness of drug manufacturers is proposed as the strategic needs of the enterprises ，actively undertaking major national science and technology projects ，introducing top scientific and technological talents at home and abroad ，having independent intellectual property rights ，enhancing the ability of scientific and technological support ，strengthening original innovation ， increasing R&D investment ， strengthening key technology breakthrough ， perfecting the innovation mechanism of enterprises-univerisities-researches integration with enterprises as the main body. The elements included original innovation ， 60362951。 R&D investment and scientific and technological talents. Atotal of 25 original innovation output indexes [including two aspects of innovation system （such as national science and technology innovation base ，national laboratory ），innovation achievements （such as National Natural Science Award ， National Technological Invention Award ）]，1 R&D input-output indicator （R&D amount ），7 scientific and technological talent output indicators of production enterprises （such as those selected in the “National Million Talent Project ”，“National Outstanding Scientific and Technological Talents ”award） were extracted. The evaluation system composed of original innovation ，R&D investment and scientific and technological talents is constructed ，which can provide objective evaluation for core competitiveness of pharmaceutical manufacturing enterprises.关键词：Core competitiveness;Original innovation;R&D investment;Technology talents;Evidence-based research;Drug
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To c ompare the situation of adverse drug reaction （ADR） collection by social media between European and American countries and China ，so as to provide reference for the improvement of corresponding work in China. METHODS：By retrieving relevant literatures from CNKI ，Web of Science ，Elsevier ScienceDirect ，SpringerLink and so on ， referring to the official website of International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use （ICH），the current situation of ADR collection by social media in European and American countries（organizations）such as the United States ，the European Union ，the United Kingdom ，France was introduced ，and compared with the corresponding work in China. The advantages and possible problems of using social media to collect ADR were analyzed so as to put forward some suggestions on how to use social media to collect ADR in China. RESULTS & CONCLUSIONS：Since 2013，many countries in Europe and the United States have started to collect ADRs using social media （such as Twitter ，Facebook），such as the draft on drug safety issues on social media issued by the Pharmaceutical Research and Manufacturers of America （PhRMA），and the EU organization ’s Innovative Medicines Initiative （IMI）network to identify adverse drug reaction in web media （WEB-RADR）projects. Through this way ，it is more convenient for patients to report ADR ，and helpful for the pharmacovigilance department to collect ADR information in time ，and can be used as an important supplement to the traditional drug safety information report. However ，there are some advantages ，such as mismatch between the health vocabulary spontaneously reported by patients and medical professional vocabulary ，the challenges of balancing the relationship between public health maintenance and patient privacy protection ，and various deviations affecting the reporting rate and quality of ADR collected by social media. When using social media （such as Wechat ，microblog，QQ and other social media or tools ，as well as applications and small programs ）to collect ADR information in China ，it is suggested to ensure the ease of use and security of reporting ADR applications ，and improve the design of applications to comply with E 2B （R3） data elements and information specifications of ICH guidelines for the electronic transmission of individu al security reports. At the same time ，we should give full play to the supervisory role of regulatory department ，consider non-regulatory factors ，and take privacy protection measures to make it conform to ethics.关键词：Adverse drug reaction;Pharmacovigilance;Social media;EU;United States
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To preparea novel Curcumin （Cur）dry powder inhalation （DPI）loaded by nanoporous flower-shaped lactose（FL），and to provide a safe and effective intrapulmonary drug delivery method for the therapy of chronic obstructive pulmonary disease with insoluble drugs. METHODS ：FL-loaded Cur （Cur-FL） compound powder was prepared by solution adsorption method. Using drug-loading amount and adsorption rate as indicators ，single-factor experiment was used to optimize Cur concentration，Cur-FL ratio （m/m）and adsorption time so as to determine the optimal preparation technology for Cur-FL compound powder. Fourier transform infrared spectroscopy ，scanning electron microscope and differential scanning calorimetry were used to characterize the physical and chemical properties of Cur-FL compound powder prepared with optimal technology. The water content and aerodynamic properties were determined ；in vitro drug release behavior was investigated by simulating the environment of artificial lung fluid. RESULTS ：The optimal preparation technology of Cur-FL compound powder was Cur concentration of 5 mg/mL，Cur-FL ratio of 1 ∶ 4，adsorption time of 1 h. The drug-loading amount of compound powder was （23.37±0.43）％，the encapsulation rate was （91.64±0.44）％，and the adsorption rate was （30.50±0.72）％. Cur-FL particles were flower shaped ；Cur was physically adsorbed in the pores of FL without chemical changes. The bulk density of Cur-FL compound was （0.21±0.02） g/cm3，tap density was （0.33±0.01）g/cm3，angle of repose was（24.07±0.31）°，average particle size was （3.96±0.80） μm，aerodynamic particle size was （3.33±0.99）μm，water content was （5.63 ±0.24）％，emptying rate was （92.53± 0.87）％，and deposition rate of effective parts in vitro was son- （45.93 ± 1.77）％ . Its 24 h solubility in artificial lung gwen.tan@csu.edu.cn fluid [（358.93±1.67）μg/mL] were 3.28 times of Cur ，48 h cumulative release ratesin in vitro （90.21％）were 1.63 times of Cur ，but Cur+FL physical mixture could not improve the solubility and release of Cur in artificial lung fluid. CONCLUSIONS ：Cur-FL compound powder has good in vitro release property ，and its powder properties ，solubility，water content ，fluidity and aerodynamic properties meet the requirements of DPI in Chinese Pharmacopoeia.关键词：Curcumin;Flower-shaped lactose;Dry powder inhaler;Preparation;in vitro drug release
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To investigate the effe cts of Buyang huanwu decoction on hemorheology and platelet related biological indexes of hyperlipidemia model rats. METHODS ：Male Wistar rats were randomly divided into blank control group （10 rats）and model group （40 rats）. Blank control group was given normal diet ，and model group was given high-lipid diet for 6 weeks at least to induce hypelipidemia model. After modeling ，rats were randomly divided into model control group ，positive control group （simvastatin，0.004 g/kg），Buyang huanwu decoction low-dose and medium-dose groups （3.5，14.0 g/kg，by crude drug），with 10 rats in each group. Blank control group and model control group were given normal saline intragastrically ， administration groups were given relevant drug intragastrically ，0.01 mL/g，once a day ，for consecutive 4 weeks. Thirty min after last medication ，hemorheological indexes （whole blood viscosity ，plasma viscosity ），platelet adhesion related indexes [adhesion rate，von Willebrand factor （vWF），fibronectin（FN）]，platelet release related indexes [ β-thromboglobulin（β-TG），platelet factor 4 （PF4）] and platelet fibrinolytic system related indexes [tissue plasminogen activator （t-PA），plasminogen activator inhibitor （PAI-1）]，platelet parameters （PLT，PDW，MPV，PCT，PLCR），4 kinds of coagulation parameters （APTT，TT，PT，FIB）were detected. RESULTS ：Compared with blank control group ，the whole blood viscosity （low，medium and high shear rate ），plasma viscosity，platelet adhesion rate ，the contents or levels of vWF ，FN，β-TG，PAI-1，PLT，MPV，PCT，PLCR and FIB in model control group were increased significantly （P＜0.05 or P＜0.01），and t-PA content was significantly decreased （P＜0.05）. Compared with model control group ，the whole blood viscosity （except for whole blood viscosity of high shear rate in Buyang huanwu decoction high-dose group ），plasma viscosity ，platelet adhesion rate ，the contents or levels of vWF ，FN，β-TG，PAI-1， PLT，PDW（except for Buyang huanwu decoction low-dose and high-dose groups ），MPV，PCT，PLCR（except for Byang huanwu decoction low-dose group ）and FIB were decreased significantly （P＜0.05 or P＜0.01），while t-PA content （except for positive control group ） was increased significantly （P＜0.05）. CONCLUSIONS ：Buyang huanwu decoction can significantly improve the pathological state in hyperlipidemia model rats by reducing blood viscosity and FN content ，improving platelet adhesion，enhancing fibrinolytic activity ，improving platelet aggregation ，inhibiting hypercoagulability and hyperplatelet release.关键词：Buyang huanwu decoction;Hyperlipidemia;Platelet;Adhesion;Release;Fibrinolysis;Rats
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To study the h ypoglycemic effect of Hordeum vulgare polysaccharide（HVP）on diabetes mellitus model mice and its mechanism. METHODS ：The mice were given intraperitoneal injection of streptozotocin （120 mg/kg）to induce diabetes mellitus model. After modeling ，the mice were randomly divided into model group ，metformin group （positive control ， 200 mg/kg），HVP high-dose ，medium-dose and low-dose groups （300，150 and 75 mg/kg），with 10 mice in each group. Blank control group was established additionally. Administration groups were given relevant medicine intragastrically ；blank control group and model group were given constant volume of water intragastrically ，once a day ，for consecutive 30 days. The levels of fasting blood glucose （FBG）were determined after 10，20，30 days of administration. After last FBG test ，mice were intraperitoneally injected with 10％ glucose solution （2 g/kg），then the area under the glucose tolerance （GTT）curve was measured at 30 and 120 min after injection. The serum levels of insulin ，the content of superoxide dismutase （SOD），glutathione peroxidase （GSH-Px）， malondialdehyde（MDA）in liver tissue were detected. Pancreatic morphology of mice were detected by HE staining. RESULTS ： Compared with blank control group ，the FBG ，area under GTT curve and MDA contnet in liver tissue were increased significantly in model group （P＜0.01），while serum levels of insulin ，SOD and GSH-Px contents in liver tissue were decreased significantly （P＜0.01）；the pancreatic tissue was seriously damaged with incomplete morphology and obvious vacuoles. Compared with model group，FBG，area under GTT curve ，MDA content in liver Δ 基金项目：国家自然科学基金资助项目（No.81473179） tissue were decreased significantly in HVP high-dose group ＊主管药师 。研究方向 ：临床药学 。电话：0510-85351490。E- mail：Wangshengya_helen@126.com （P＜0.05 or P＜0.01），serum content of insulin ，the content # 通信作者 ：副主任药师 。研究方向 ：医院药学 。电话：0510- of SOD and GSH-Px in liver tissue were increased 85351490。E-mail：3103221944@qq.com significantly（P＜0.05 or P＜0.01）；above indexes of HVP 中国药房 2021年第32卷第7期 China Pharmacy 2021Vol. 32 No. 7 ·807· low-dose and medium-dose groups were improved partially ，with statistical significance （P＜0.05 or P＜0.01）；the pancreatic tissue damage was alleviated ，the morphology was relatively complete ，the islet cells were closely arranged ，and the vacuoles were reduced. CONLUSIONS ：HVP can reduce the level of blood glucose in diabetic model mice ，increase insulin level and relieve pancreatic injury. The mechanism may be related to its antioxidation.关键词：Hordeum vulgare polysaccharide;Diabetes mellitus;Antioixidation;Mice
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To study the improvement effects of ica riin（ICA）on cognitive function in schizophrenia model rats and its mechanism. METHODS ：SD rats were divided into blank control group ，model group ，ICA low-dose ，medium-dose and high-dose groups （15，30，60 mg/kg）. Except for blank control group ，other groups were given N-methyl-D-aspartate receptor antagonist MK- 801（0.2 mg/kg）intraperitoneally to induce schizophrenia rats models ，once a day ，for consecutive 14 days. After modeling，ICA groups were intragastrically administered with the corresponding drugs ，while blank control group and model group were intragastrically administered with the same volume of water ，once a day ，for consecutive 7 days. The behavioral com changes of rats were detected by Morris water maze test ，open field test ， forced swimming test and Y maze test pathological changes of hippocampus were observed by Nissl staining；the levels of cholinergic indexes [acetylcholine （Ach），choline acetyltransferase （ChAT） and acetylcholinesterase （AchE）] in cerebral tissues were detected by ELISA. The expression of BDNF ，ERK and CREB mRNA in cerebral tissue were detected by RT-PCR ；expression or phosphorylation level of BDNF ，ERK，CREB protein ，apoptosis related proteins （Bcl-2，Bax and Caspase- 3）were detected by Western blot. RESULTS ：Compared with blank control group ，escape latency ，distance at T 1-T3， cumulative immobility time and the expression of Caspase- 3 protein in cerebral tissues were significantly increased in model group （P＜0.05）；the times of crossing platform ，alternation rate ，the number of Nissl staining positive neurons in hippocampus tissues ， the levels of Ach and ChAT in cerebral tissues ，Bcl-2/Bax ratio ，mRNA and protein expression of BDNF ，mRNA expression of ERK and CREB ，the phosphorylation of ERK 1/2 and CREB were significantly decreased （P＜0.05）.Compared with model group ， escape latency ，distance at T 1-T3，cumulative immobility time ，the number of Nissl staining positive neurons ，AchE level in cerebral tissues and relative expression of Caspase- 3 protein were significantly decreased in ICA high-dose group （P＜0.05）；the times of crossing platform ，alternation rate ，levels of Ach and ChAT in cerebral tissues ，Bcl-2/Bax ratio ，mRNA and protein expression of BDNF ，mRNA expression of ERK and CREB ，the phosphorylation of ERK 1/2 and CREB were increased significantly（P＜0.05）. Above indexes in ICA low-dose and medium-dose groups were partially improved significantly than model group（P＜0.05）. CONCLUSIONS ：ICA can improve cognitive function in schizophrenia model rats.Its mechanism may be related to regulating cholinergic system ，inhibiting neuronal apoptosis ，and promoting the expression of BDNF/ERK/CREB signaling pathway.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To improve the quality standard of Taraxaci Herba ，and to evaluate the quality of T. officinale from different origins. METHODS ：Based on the provisions of the 2020 edition of Chinese Pharmacopoeia （part Ⅰ）under the item “Taraxaci Herba ”，the method of content determination was added for the detection of water-soluble extracts （hot extraction method）and alcohol-soluble extracts （hot extraction method ），total flavonoids ，chlorogenic acid ，caffeic acid ，cichoric acid and isochlorogenic acid A. HPLC fingerprint was established by using 42 batches of T. officinale from 8 producing areas as object ，and principal component analysis was performed on the basis of above results. RESULTS ：The contents of alcohol-soluble extracts in 42 batches of T. officinale were 15.30％-30.40％，and those of water-soluble extracts were 27.59％-38.96％. The concentration of total flavonoids（UV spectrophotometry ），chlorogenic acid ，caffeic acid ，cichoric acid and isochlorogenic acid A （HPLC method ）were 0.016-0.096，0.003-0.196，0.004-0.117，0.025-1.578，0.002-0.152 mg/mL，respectively （all R2＞0.999）；RSDs of precision ， stability and repeatability tests were all lower than 2.00％（n＝6）；average sample recovery were 98.97％-103.53％，and RSDs were 1.19％-1.58％. The contents of total flavonoids ，chlorogenic acid ，caffeic acid ，cichoric acid and isochlorogenic acid A were 0.734％ -3.700％ ，0.004％ -0.123％ ，0.006％ - 0.087％ ，0.073％ -1.499％ ，0.005％ -0.109％ respectively in 42 batches of T. officinale. For 42 batches of T. officinale samples in HPLC fingerprint ，RSDs of the relative retention time of the common peak were 0-0.94％，and RSDs of the relative peak area were 0-125.57％. Among them ，the similarity of 39 batches of samples was all higher than 0.900. Results of principal component analysis showed that the quality of T. officinale from Shaanxi province was better，followed by medicinal materials from Hebei province. CONCLUSIONS ：Tentatively，the contents of alcohol-soluble extract，water-soluble extract ，total flavonoids ，chlorogenic acid ，caffeic acid ，cichoric acid and isochlorogenic acid A shall not be less than 17.0％，27.0％，1.383％，0.024％，0.021％，0.450％，0.021％ for Taraxaci Herba. In addition to the low content of caffeic acid in T. officinale from Shaanxi province ，the other indexes were better ；the content of caffeic acid in T. officinale from Hebei province was higher than that from Shaanxi province ，and other indicators were slightly lower than that from Shaanxi province. The quality of comprehensive evaluation of T. officinale from other origins was relatively poor ，and the quality of different batches of medicinal materials from the same origin was unstable.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To study the effects of couplet medicine of Rheum p almatum-Salvia miltiorrhiza on the contents of enterogenous urotoxin and intestinal barrier function in chronic renal failure （CRF）model rats. METHODS ：Totally 55 male Wistar rats were randomly divided into sham operation group （10 rats）and modeling group （45 rats）. In sham operation group ，the kidneys were isolated but not removed ；CRF model was reproduced by 5/6 nephrectomy in modeling group. After modeling （excluding 5 dead and non-modeling rats ），modeling rats were divided into model group （water），Niaoduqing granules group （2.5 g/kg），couplet medicine of R. palmatum -S. miltiorrhiza groups（6，3 g/kg，by crude drug ），with 10 rats in each group. Sham operation group and model group were given constant volume of water intragastrically. Administration groups were given relevant medicine intragastrically ，once a day ，for consecutive 12 weeks. After last administration ，the contents of creatinine （Scr）and urea nitrogen（BUN）in serum ，the content of urinary creatinine （Ucr） in urine were determined by automatic biochemical analyzer；creatinine clearance rate （Ccr）was calculated. The contents of enterogenous urotoxin [trimethylamine-N-oxide （TMAO），indoxyl sulfate （IS）and p-cresyl sulphate （PCS）] were determined by UPLC-ESI-MS/MS. Real-time RT-PCR and immunofluorescence assay were used to detect the mRNA and protein expression of Occludin and ZO-1 in the ileum tissue. HE staining and Masson staining were used to observe the pathologi cal changes of renal tissue. The ultrastructural changes of rat colon were observed by transmission electron microscope. RESULTS ：Compared with sham operation group ，serum contents of Scr，BUN，TMAO，PCS and IS were increased significantly in model group （P＜0.01），while urine content of Ucr ，Ccr，mRNA and protein expression of Occludin and ZO- 1 in ileum tissue were decreased significantly （P＜0.01）；renal glomerulosclerosis ， renal tubules dilation and inflammatory invasion and fibrosisin the interstitium were all found ；the intestinal epithelial barrier structure of colon tissue was severely damaged. Compared with model group ，serum contents of Scr ，BUN，TMAO，PCS and IS were decreased significantly in administration groups （P＜0.05 or P＜0.01）；the mRNA and protein expression of Occludin and ZO-1 in the ileum tissue were increased significantly （except for mRNA expression of ZO- 1 in R. palmatum -S. miltiorrhiza low-dose group （P＜0.05 or P＜0.01）；the infiltration of inflammatory cells in renal interstitium ，the degree of fibrosis and the damage of intestinal epithelial barrier structure in colon tissue were reduced. CONCLUSIONS ：Couplet medicine of R. palmatum -S. miltiorrhiza can effectively protect the residual renal function of CRF model rats ，the mechanism of which may be associated with reducing the serum contents of enterogenous urotoxin ，up-regulating mRNA and protein expresssion of Occludin and ZO- 1 in the ileum tissue so as to improve intestinal barrier function.关键词：Rheum palmatum;Salvia miltiorrhiza;Chronic renal failure;Enterogenous urotoxins;Intestinal barrier;Rats
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To optimize the extraction technology of Zhideke granules. ME THODS：The extraction technology （water extraction ，alcohol extraction ，water extraction and ethanol precipitation ）of Zhideke granules was initially screened by ammonia-induced cough experiment and xylene-induced ear swelling experiment in mice. Based on its preparation route ，the immersion time of medicinal materials containing volatile oil was investigated with water absorption as index firstly. The single factor test was adopted to investigate the amount of water added and the extraction time taking the volatile oil yield as index to optimize the extraction technology of medicinal materials containing volatile oil. Taking the contents of irisflorentin and total flavonoids as indicators ，on the basis of single factor investigation ，orthogonal test was adopted to examine the influence of three factors including the amount of water added ，extraction time and extraction frequency ，so as to optimize the water extraction technology of Zhideke granules and the validation tests were conducted. RESULTS ：The results of pharmacodynamics experiment showed that the cough latency of mice in water extract low-dose and high-dose groups （6.34，12.68 g/kg，by crude drug ）and water-extraction alcohol-precipitation extract high-dose group （12.68 g/kg，by crude drug ）were significantly longer than those inmodel group ，and the number of cough within 2 minutes was significantly reduced （P＜0.05 or P＜0.01）. Compared with model group ， the ear swelling of mice in water extract low-dose and high-dose groups （6.34，12.68 g/kg，by crude drug），ethanol extract high-dose group （12.68 g/kg，by crude drug） and water-extraction alcohol-precipitation extract hig dose group （12.68 g/kg，by crude drug ） were decreased significantly （P＜0.05 or P＜0.01）. The swelling inhibition rates were 42.26％，55.08％，33.49％，51.56％，39.57％ and 44.36％ in low-dose and high-dose groups of water extract ，alcohol extract ， water-extraction and alcohol-precipitation extract respectively ，indicating that the water extract had better antitussive and anti-inflammatory effects. The optimal extraction technology of volatile oil was adding 5-fold water ，soaking for 30 minutes，and extracting for 3 hours. The optimal water extraction technology was adding 12-fold water ，extracting for 3 times after soaked for 50 min，lasting for 1 h each time. Results of 3 times of validation tests showed that average content of irisflorentin in the extract obtained by optimal technology was 76.47 μg/g（RSD＝ 2.15％，n＝3）and the average content of total flavonoids was 92.45 mg/g（RSD＝0.48％，n＝3）. CONCLUSIONS ：The optimal extraction technology of Zhideke granules is stable and feasible.关键词：Zhideke granules;Pharmacodynamics;Orthogonal test;Extraction technology
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To screen the effective compo nent in antioxi dant active fraction of Pueraria lobata . METHODS ：The antioxidant active fraction sample （S1-S20） of 20 batches of P. lobata were prepared. HPLC method was adopted. The determination was performed on SepaxBio-C 18 column with mobile phase consisted of methanol-water （gradient elution ）at the flow rate of 0.6 mL/min. The column temperature was set at 25 ℃，and detection wavelength was set at 250 nm. HPLC fingerprints of 20 batches of P. lobata were established by the Similarity Evaluation System of TCM Chromatographic Fingerprints （2012 edition），and common peaks were identified. Cluster analysis ，principal component analysis （PCA）and orthogonal partial least squares discriminant analysis （OPLS-DA）were used to screen the effective components in antioxidant active fraction of P. lobata . RESULTS：There were 18 common peaks in HPLC fingerprints of 20 batches of antioxidant active fraction in P. lobata ，and the similarity was more than 0.99. Eight common peaks were identified ，which were 3′-hydroxypuerarin（peak 2），puerarin（peak 3）， 3′-methoxypuerarin（peak 4），daidzein（peak 5），genistein（peak 7），formononetin（peak 11），daidzein（peak 13）and genistein （peak 16）. The results of cluster analysis and PCA analysis showed that samples S 1，S3，S4，S6，S8，S18 and S 19 were clustered into one category ，and samples S 2，S5，S7，S9-S17 and S 20 were clustered into one category ；peak 2，peak 3，peak 10，peak 11 and peak 13 had great influence on principal component 1；peak 8 and peak 9 had great influence on principal component 2. OPLS-DA analysis showed that peak 4，peak 3，peak 2，peak 16，peak 13 and peak 11 had great influence on the quality of antioxidant active fraction of P. lobata . CONCLUSIONS ： HPLC fingerprint for active fraction of P. lobata is established in the study and 8 components are identified ；among them ， com puerarin，3′-hydroxypuerarin，daidzein and formononetin maybe the material basis of antioxidant fraction of P. lobata .
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To study the effects of limonin on immune function and apo ptosis-related factors expression in MFC gastric cancer bearing model mice. METHODS ：MFC gastric cancer bearing model was established by inoculating MFC gastric cancer cells into the right armpit of mice. After modeling ，model mice were divided into model group ，cyclophosphamide group （positive control ，25 mg/kg）and limonin high-dose ，medium-dose and low-dose groups （100，50 and 25 mg/kg），with 10 mice in each group. Other groups were given relevant medicine intragastrically ，once a day ，for consecutive 14 days，except that model group was given 0.5％ sodium carboxymethyl cellulose intragastrically. Before administration and after last administration ，the body weight of mice was measured ；spleen，thymus and tumor tissue were taken after the last administration to calculate the spleen index，thymus index and tumor inhibition rate. The percentage of CD 4+ and CD 8+ T lymphocytes ，CD4+/CD8+ ratio were detected by flow cytometry. The expression of immune function related indexes （IL-2，IL-10，IFN-γ）in serum were detected by ELISA. RT-PCR and Western blot assay were adopted to detect relative mRNA and protein expression of apoptosis-related factors [cytochrome C （Cyt-C），Bcl-2，Bax] in tumor tissue of mice. RESULTS ：There was no significant difference in body weight among the other groups except that of cyclophosphamide group was decreased significantly ，compared with model group （P＜0.05）. Inhibitory rate of tumor were （58.16 ± 7.07）％ ，（37.09 ± 4.26）％ ，（27.30 ± 3.64）％ ，（15.13 ± 2.95）％ in cyclophosphamide group ，limonin high-dose ，medium-dose and low-dose groups. Compared with model group ，spleen index ， thymus index ，the percentages of CD 4+ and CD 8+T lymphocyte cells ，CD4+/CD8+ ratio，serum levels of IL- 2 and IL- 10，relative mRNA and protein expression of Bcl- 2 in tumor of mice in cyclophosphamide group as well as the expression of IL- 10，relative mRNA and protein expression of Bcl- 2 in limonin groups were decreased significantly （P＜0.05）. The expression of IFN-γ，relative mRNA and protein expression of Cyt-C and Bax of cyclophosphamide group as well as spleen index （except for low-dose group ）， thymus index ， the percentage of CD 4 + and CD 8 + T lymphocytes，CD4+/CD8+ ratio，the expression of IL- 2 and IFN-γ，and relative mRNA and protein expression of Cyt-C and Bax in limonin groups were increased significantly （P＜0.05）. CONCLUSIONS ：Limonin can inhibit tumor growth in MFC gastric cancer bearing model mice ，and the side effects are relatively weak. Its mechanism is related to the improvement of immune function and the induction of apoptosis.关键词：Limonin;MFC gastric cancer cell;Immune function;Apoptosis;Mice
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To systematicall y review the pharmacoeconomics of anticoagulants for the prevention and therapy of venous thromboembolism （VTE）in cancer patients. METHODS ：Retrieved from PubMed ，Embase，Cochrane library ，CNKI， Wanfang database ，VIP，SinoMed，The NHS Economic Evaluation Database ，The Healthy Technology Assessment Database and EconLit，supplemented by manual retrieval ，the economic evaluation studies on the prevention and therapy of VTE in cancer patients with different anticoagulants were collected. The retrieval time was from the inception to Nov. 12th，2020. After screening and extracting ，the Consolidated Health Economic Evaluation Reporting Standards （CHEERS）was used to evaluate the quality of the included literatures. The basic characteristics of the included literatures were summarized by descriptive methods ，and the economic results were summarized according to medication purpose and different intervention grouping. RESULTS ：A total of 15 literatures were included. Three literatures were of excellent quality ；ten were of good quality ；and the other two were of moderate quality. Included studies were widely conducted in countries of different economic levels ，including China （1 piece），the United States（7 pieces），Canada（3 pieces），France（2 pieces），the Netherlands （1 piece），Brazil（1 piece）and Austria （1 piece）. For preventing VTE in cancer patients ，the economic evaluation results of warfarin and low-molecular-weight heparin （LMWH）needed to be updated. Novel oral anticoagulants （NOACs）for the prevention of VTE were less cost-effective among cancer patients with medium- and high-risk venous thrombosis in China than in the United States ，but the economic advantage increased among the high-risk patients. Compared to enoxaparin ，aspirin was absolutely dominant to preventing VTE in patients with myeloma. For the treatment of VTE in cancer patients ，LMWH was not cost-effective ，compared to warfarin in the United States ；but it was cost-effective in Canada and some countries of Northern Europe. Compared with LMWH ，NOACs could save total cost ，but the incremental utility in the United States and Brazil were opposite. Sensitivity analysis showed that economic results were sensitive to drug prices ，the baseline rate of thrombosis risk ，and the risk of adverse events （thrombosis recurrence ，major bleeding and death ） of different interventions ，the first two of which could reverse the conclusions. CONCLUSIONS ：For the prevention of VTE in cancer patients ，compared with no intervention or placebo ，the economic advantages of NOACs were different in different countries or for patients with different thrombosis risk ；the economics of warfarin and LMWH were not yet clear. Aspirin had obvious economic advantages compared with enoxaparin. For the treatment of VTE in cancer patients ，LMWH had different economic advantages compared with warfarin in different countries ；NOACs could save costs compared with LMWH. Economic strategies are greatly affected by the risk of diseases ，medical systems ，drug price ，patient preferences and values ，economic levels ，cost-utility threshold standards in different countries. Therefore ，the final economic strategies need to be based on the contexts of different countries.关键词：Anticoagulants;Cancer;Venous thromboembolism;Pharmocoeconomics;Systematic review
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To c ompare the effects o f intravenous anesthesia with remimazolam and propofol on perioperative cellular immune function in patients underwent radical mastectomy. METHODS ：Eighty patients underwent selective radical mastectomy were collected ，and then randomly divided into remimazolam group （group R ）and propofol group （group P ）. During anesthesia induction ，group R was intravenously injected with remimazolam 0.2 mg/kg+sufentanil 0.3 μg/kg+cisatracurium 0.2 mg/kg；group R was intravenously injected with propofol 2 mg/kg+sufentanil 0.3 μg/kg+cisatracurium 0.2 mg/kg. During anesthesia maintenance，group R was intravenously pumped with remimazolam 0.4-1.2 mg/（kg·h）+remifentanil 0.1-0.2 μg（/ kg·min）；group P was intravenously pumped with propofol 4-10 mg/（kg·h）+remifentanil 0.1-0.2 μg（/ kg·min）. Both groups were given intravenous injection of cisatracurium intermittently. The anesthesia depth was monitored during the operation and the pumping speed of remimazolam，propofol and remifentanil was adjusted accordingly. The intraoperative infusion volume ，blood loss ，operation time ， opioid dosage ，and visual analogue scale （VAS）scores at 24 and 72 hours after operation were recorded in 2 groups；at the same time，the levels of T lymphocyte CD 3+，CD4+，CD8+ and NK cells were measured 30 min before anesthesia induction ，24 h and 72 h after operation ；CD4+/CD8+ was also calculated. The incidence of ADR was recorded in 2 groups. RESULTS ：There was no statistical significance in intraoperative infusion volume ，blood loss ，operation time ，opioid dosage ，VAS score at 24，72 hours after operation and the incidence of ADR between 2 groups（P＞0.05）. Compared with 30 min before anesthesia induction ，the levels of CD 3+，CD4+，NK cells and CD 4+/CD8+ ratio in 2 groups at 24 hours after operation were significantly decreased （P＜ 0.05）；compared with group P ，the levels of CD 3+，CD4+ and NK cells as well as CD 4+/CD8+ ratio in group R increased significantly in group R （P＜0.05）. CONCLUSIONS ：For anesthesia maintenance ，the inhibitory effects of remimazolam on perioperative cellular immunity in patients underwent radical mastectomy are poorer than propofol.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To investigate the effects of dexmedetomidine on regional cerebral oxygen saturation and cerebral function in patients undergoing intracranial aneurysm embolization. METHODS ：Totally 44 patients undergoing intracranial aneurysm embolization in the First Affiliated Hospital of Hunan University of TCM during Jun. 2017-Aug. 2019 were collected and randomly divided into group D （22 cases）and group C （22 cases）. Ten minutes before anesthesia induction ，group D was given intravenous injection of Dexmedetomidine hydrochloride injection 1 μg/kg；group C was given buffered normal saline 20 μL. Both groups were induced with Propofol emulsion injection+Midazolam injection+Fentanyl citrate injection+Cisatracurium besylate for injection. During the operation ，group D was given Dexmedetomidine hydrochloride injection 0.5 μg（/ kg·h）+Fentanyl citrate injection+Benzsulfosum atracurium for injection+Propofol emulsion injection to maintain anesthesia ；group C was continuously pumped with buffered normal saline 0.5 μg（/ kg·h）+Fentanyl citrate injection + Benzsulfosum aratracurium for injection Propofol emulsion injection to maintain anesthesia. Before anesthesia induction （T0）， immediately after anesthesia。induction （T1）， 1 min after tracheal intubation （T2）， immediately after operation finished （T3），immediately afte extubation（T4），the mean arterial pressure（MAP），heart rate 中国药房 2021年第32卷第7期 China Pharmacy 2021Vol. 32 No. 7 ·865· （HR），regional cerebral oxygen satur ation（rSO2）were observed in 2 groups. The levels of neuron specific enolase （NSE）and S100 β protein in serum were measured at T1，T3，6 h after operation （T6）. The recovery time ，intraoperative blood loss ， nitroglycerin amount and the occurrence of ADR were recorded. RESULTS ：MAP and HR of group D at T 2-T4 were significantly lower than those at T 0；MAP and HR of group C at T 2-T4 were significantly higher than those at T 0；the group D were significantly lower than the group C at the same period （P＜0.05）；there was no statistical significance in rSO 2 between 2 groups at T 0-T4（P＞ 0.05）. The levels of serum NSE and S 100β protein in 2 groups at T 3 were significantly higher than at T 1；those in 2 groups at T 6 were significantly lower than at T 3，but those of group D were significantly lower than the group C at T 3（P＜0.05）；there was no statistical significance in the levels of serum NSE or S 100β protein between 2 groups at T 1（P＞0.05）. The recovery time of anesthesia，the amount of nitroglycerin ，the incidence of tachycardia ，nausea and vomiting ，restlessness，shivering and cough in group D were significantly shorter or lower than group C （P＜0.05）；there was no statistical significance in the intraoperative blood loss between 2 groups（P＞0.05）. CONCLUSIONS ：Dexmedetomidine can maintain the hemodynamic stability of patients with intracranial aneurysm embolization during the perioperative period ，has little effect on rSO 2 and brain function ，and has good safety.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To systematically evaluate the efficacy and safety of Xianling gubao capsule combined with glucosamine in the treatment of knee osteoarthritis （KOA），and to provide evidence-based reference for clinical treatment of KOA. METHODS：Retrieved from Cochrane library ，PubMed，Embase，CNKI，Wanfang database ，CBM and VIP during the inception to Nov. 2020，randomized controlled trials （RCTs）about glucosamine （control group ）combined with Xianling gubao capsule （trial group）in the treatment of KOA were collected. After data extraction ，Cochrane 5.1.0 system evaluator manual was used to evaluate the quality of the included clinical studies met inclusion criteria ，and Rev Man 5.4 software was used for Meta-analysis. RESULTS ： A total of 11 RCTs with 970 patients were included in this study. Results of Meta-analysis showed that cure rate [OR ＝2.41，95％CI （1.48，3.93），P＜0.001]，marked effective rate [OR ＝1.95，95％CI（1.49，2.56），P＜0.001]，total effective rate [OR ＝4.00，95％CI （2.57，6.24），P＜0.001]，visual analogue scale （VAS）score [MD ＝－2.34，95％CI（－2.51，－2.17），P＜0.001]，knee function score [MD ＝31.32，95％CI（27.89，34.75），P＜0.001]，Japanese Orthopaedic Association （JOA）low back pain score [MD ＝ 12.22，95％CI（9.68，14.76），P＜0.001] and pain relief time [MD ＝－1.55，95％CI（－1.84，－1.25），P＜0.001] of trial group were all significantly better than those of control group. The incidence of ADR in trial group was significantly lower than control group [OR ＝0.04，95％CI（0.02，0.12），P＜0.001]. CONCLUSIONS ：Xianing gubao capsule combined with glucosamine in the treatment of KOA is significantly better in cure rate ，marked effective rate ，total effective rate ，VAS，score，knee function score，JOA low back pain score and pain relief time ，and could significantly reduce the incidence of ADR.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To explore the role of pharmacists i n developi ng the outpatient and emergency prescription pre-audit with the help of rational drug use software. METHODS ：With the help of rational drug use software ，outpatient and emergency prescription pre-aduit was conducted during Jan.-Apr. 2020；the intervention effects of irrational prescriptions were analyzed. The prescriptions from Sept. to Dec. in 2019 were included in the control group （only for post review ），and the prescriptions from Jan. to Apr. in 2020 were included in the intervention group （pre-audit and post review ）；the unreasonable prescriptions were compared before and after the intervention. The prescriptions intercepted by the software system from Nov. to Dec. in 2019 were further selected as the interception control group ，and the prescriptions intercepted from Jan. to Feb. in 2020 were selected as the interception intervention group ；the interception situation of prescriptions before and after the intervention was compared ，and the influence of pre-audit on physicians ’prescription behavior was evaluated. In addition ，108 992 prescriptions in Apr. 2020 were selected for post review using the traditional model （i.e. complete manual audit ）and the information model （i.e. software-assisted manual audit ）respectively；the effects of two models were compared. RESULTS ：From Jan. to Apr. in 2020，a total of 2 393 prescriptions were pre-audited by pharmacists ，among which 1 387 prescriptions were reasonable （57.96％）and 1 006 prescriptions were unreasonable and intervened （42.04％）. After pharmacist intervention ，983 prescriptions were modified by doctors ，and the success rate of intervention was 97.71％ . Compared with control group ，unreasonable rate of outpatient and emergency prescriptions，that of each type of prescriptions were all decreased significantly （P＜0.001）. Compared with interception control group（1 402 pieces），the number of intercepted prescriptions （721 pieces）was significantly reduced in interception intervention group （P＜0.001）. Compared with traditional model ， the number of prescriptions requiring manual post review and E-mail：xss306@126.com “false positive ” prescriptions were decreased significantly # under information model ， and the number of discovered unreasonable prescriptions were increased significantly （P＜ 0.001）. CONCLUSIONS ：With the help of rational drug use software ，prescription pre-audit by pharmacists can significantly improve reasonable rate of outpatient and emergency prescriptions. The work intensity of pharmacists in post review of prescriptions can be reduced and the accuracy of prescription review can be improved in the information mode.关键词：Rational drug use software;Pre-audit;Prescription review;Rational drug use
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发布时间：2022-06-21
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