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Results and Discussion on National Vaccine Proficiency Testing Schemes in 2020 2020年国家疫苗水平检测方案实施结果与探讨
Pub Date : 2021-01-01 DOI: 10.11669/cpj.2021.13.013
Y. Liu, X. Xiang, W. Huang, B. Wang, Z. Hu, X. Yu
OBJECTIVE: To acquire the knowledge of quality control performance through carrying out proficiency Testing Schemes (PTS) nationwide. METHODS: National Institutes for Food and Drug Control(NIFDC) schemed three PTS to evaluate the testing competence of participants from the aspects of safety and stability of vaccine products and pseudotyped virus-based neutralization assay, pseudotyped virus based neutralization assay(PBNA), which takes as a hand of COVID-19 vaccine development. RESULTS: Eighty-nine participants took part in the three PTS and the satisfaction rate stated as 96.9%, 96.4% and 76.0%. CONCLUSION: The testing ability and quality control performance of Official Medical Control Laboratories (OMCL), manufacturers and research institutes are acceptable. The testing results of sterile testing and aluminum assay of aluminum adjuvanted vaccine can be assured well, while the ability of PBNA needs to be improved by some manufacturers.
目的:通过在全国范围内实施能力检验计划(PTS),获取质量控制绩效知识。方法:美国国家食品药品监督管理研究院(NIFDC)策划了3个PTS,从疫苗产品的安全性和稳定性以及基于伪病毒的中和试验、基于伪病毒的中和试验(PBNA)等方面评价参与者的检测能力,为COVID-19疫苗开发提供参考。结果:89名患者参加了3次PTS,满意度分别为96.9%、96.4%和76.0%。结论:药检机构、生产企业和科研院所的检测能力和质控绩效均可接受。铝佐剂疫苗的无菌检测和铝含量测定结果可以得到很好的保证,而部分厂家的PBNA检测能力有待提高。
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引用次数: 0
Case Study of Icotinib on The Impact of Domestic Innovative Drugs Timely Covered by Medical Insurance 伊可替尼对国产创新药及时纳入医保影响的案例研究
Pub Date : 2021-01-01 DOI: 10.11669/cpj.2021.14.011
T. Huang, S. Han, X. Guan, Luwen Shi
OBJECTIVE: To explore the impact of timely inclusion of medical insurance on the use of high-quality domestic innovative drugs, using the domestic innovative drug, icotinib, as an example. METHODS Province X and province Z with large difference on the timing to include icotinib in medical insurance were selected as sample provinces to compare and analyze the price, volume and expenditure changes of three targeted drugs (gefitinib, erlotinib and icotinib) for non-small cell lung cancer (NSCLC), using the sample hospital procurement data covering two provinces from 2013 to 2018 in the China Medical Economic Information Network (CMEI) database. RESULTS In two sample provinces, icotinib's daily cost had been the lowest among three sample drug's for a long time. Province Z has included icotinib in the basic health insurance since 2013. After that, the market shares of icotinib's volume and expenditure had increased rapidly from 0, and remained at about 85% for a long period of time, occupying the dominant position in province Z's market. However, province X has not included icotinib until 2016. The highest market share of icotinib's volume was only 8% in province X's market. There was little difference of sample drugs' daily cost between two provinces. After the national health insurance negotiation, the daily cost of sample drugs decreased significantly, with an overall decrease between 60% to 79%. By the second half of 2018, the daily cost of sample drugs was almost the same. CONCLUSION Timely inclusion of high-quality domestic innovative drugs in the scope of medical insurance reimbursement can greatly promote the use of high-quality domestic innovative drugs. Compared with foreign drugs with same indications, high-quality domestic innovative drugs can save money for patients, which will greatly benefit them.
目的:以国产创新药伊可替尼为例,探讨医保及时纳入对国产优质创新药使用的影响。方法选取伊可替尼纳入医保时间差异较大的X省和Z省作为样本省份,利用中国医药经济信息网(CMEI)数据库2013 - 2018年两省样本医院采购数据,比较分析吉非替尼、厄洛替尼和伊可替尼三种治疗非小细胞肺癌(NSCLC)的靶向药物的价格、用量和支出变化。结果在2个样本省份中,伊可替尼的日费用长期以来在3种样本药物中最低。Z省自2013年起将伊可替尼纳入基本健康保险。此后,伊可替尼的市场份额从0迅速上升,并长期保持在85%左右,在Z省市场占据主导地位。然而,X省直到2016年才纳入伊可替尼。伊可替尼在X省的市场占有率最高,仅为8%。两省样品药品日费用差异不大。全国医保谈判后,样品药品日费用大幅下降,总体下降幅度在60% - 79%之间。到2018年下半年,样品药的日成本基本持平。结论及时将国产优质创新药纳入医保报销范围,可大大促进国产优质创新药的使用。与国外相同适应症的药物相比,高质量的国产创新药可以为患者省钱,使患者受益匪浅。
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引用次数: 0
Research Progress of Pharmacokinetic Interactions between Lopinavir/Ritonavir and Statins 洛匹那韦/利托那韦与他汀类药物相互作用的研究进展
Pub Date : 2021-01-01 DOI: 10.11669/cpj.2021.12.002
F. Bu, J. Chen, N. Ding, Z. Jiao, X. Xiang
OBJECTIVE: To provide references for the selection of an appropriate statin and its dose adjustment in clinical practice when combined lopinavir/ritonavir (LPV/r) and statins. METHODS: Pharmacokinetic interactions between LPV/r and seven commonly used statins were reviewed by searching relevant domestic and foreign literatures. RESULTS AND CONCLUSIONS: Ritonavir is a potent time dependent inhibitor of cytochrome P450 3A4 (CYP3A4) and will greatly increase the plasma exposure of simvastatin and lovastatin, leading to the increasing risk of liver damage and rhabdomyolysis. Therefore, it is forbidden to use LPV/r together with these two statins. Whereas atorvastatin and rosuvastatin need to be used with caution and started at the lowest dose. No clinical data has been reported to support the relationship and extent of fluvastatin and LPV/r interactions, nor is there a dose recommendation for the combination. Moreover, LPV/r almost have no effect on the pharmacokinetic profiles of pravastatin and pitavastatin, so it is recommended to use pravastatin/pitavastatin with LPV/r in clinical practice.
目的:为临床应用洛匹那韦/利托那韦(LPV/r)联合他汀类药物时选择合适的他汀类药物及剂量调整提供参考。方法:检索国内外相关文献,回顾LPV/r与7种常用他汀类药物的药动学相互作用。结果与结论:利托那韦是一种有效的时间依赖性细胞色素P450 3A4 (CYP3A4)抑制剂,会大大增加辛伐他汀和洛伐他汀的血浆暴露,导致肝损伤和横纹肌溶解的风险增加。因此,禁止LPV/r与这两种他汀类药物同时使用。而阿托伐他汀和瑞舒伐他汀需要谨慎使用,并以最低剂量开始。没有临床数据报道支持氟伐他汀和LPV/r相互作用的关系和程度,也没有联合使用的剂量推荐。此外,LPV/r对普伐他汀和匹伐他汀的药代动力学特征几乎没有影响,因此在临床实践中推荐使用LPV/r的普伐他汀/匹伐他汀。
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引用次数: 0
Evaluation of α-Interferon Applied in COVID-19 Therapy Regimen α-干扰素在COVID-19治疗方案中的应用评价
Pub Date : 2020-05-22 DOI: 10.11669/CPJ.2020.10.004
Ning Pang, Li Yang, Rongsheng Zhao
OBJECTIVE: To use IFNα injection as inhalant for there is no proper dosage form for aerosol inhalation and evaluate the feasibility of IFN-α off-label use. METHODS: The clinical studies in SARS and MERS were reviewed to discuss the efficacy and safety of IFN-α application in COVID-19. Meanwhile, the features of aerosol inhalation, characteristics of IFN-α and related clinical researches were analyzed to argue the possibility of IFN-α aerosol inhalation. RESULTS: IFN-α seems to be effective in relieving early symptoms but likely invalid in reducing mortality of severe patients, however, the exact therapeutic effect calls for further clinical tests. Proper atomization of IFN-α injection won't reduce biological activity of the protein, but absorption and utilization of IFN-α in lung may be unsatisfactory for the lack of sorbefacient. More than that, ingredients in IFN-α injection may increase risk of adverse reaction. CONCLUSION: The aerosol inhalation of IFN-α injection should be fully evaluated on the side of patients. If there is a lack of proper atomization device or operation staff, subcutaneous injection of IFN-α may be a tentative administration.
目的:在目前尚无合适的雾化吸入剂型的情况下,将IFN-α注射液作为吸入剂,并评价IFN-α超说明书使用的可行性。方法:回顾SARS和MERS的临床研究,探讨IFN-α应用于COVID-19的有效性和安全性。同时对雾化吸入的特点、IFN-α的特点及相关临床研究进行分析,论证IFN-α雾化吸入的可能性。结果:IFN-α似乎对缓解早期症状有效,但对降低重症患者的死亡率可能无效,然而,确切的治疗效果需要进一步的临床试验。适当雾化IFN-α注射液不会降低蛋白的生物活性,但由于缺乏吸附剂,肺对IFN-α的吸收和利用可能不理想。除此之外,IFN-α注射液中的成分可能会增加不良反应的风险。结论:雾化吸入IFN-α注射液应充分评价患者侧。如果没有合适的雾化设备或操作人员,皮下注射IFN-α可能是一种试验性给药。
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引用次数: 0
Potential Mechanistic Investigation of Bromhexine for the Treatment of COVID-19 溴甲基辛治疗COVID-19的潜在机制研究
Pub Date : 2020-05-08 DOI: 10.11669/CPJ.2020.09.003
Yong Yang, Hao Shen, S. Zhao, Dong Wang, Hao Wang
OBJECTIVE: To investigate antiviral mechanism of bromhexine for the treatment of COVID-19. METHODS: Based on the existing literature, the infection pathways of new coronavirus(SARS-CoV-2) were systematically summarized by us, and used the SWISSDOCK molecular simulation method to carry out virtual screen systematically for key targets and marketed drugs. RESULTS: TMPRSS2/ACE2 pathway was found to be the most efficient and probably the major pathway for SARS-CoV-2 virus to infect the lung and other tissue by us. Bromhexine, an expectorant, can strongly inhibit TMPRSS2 protease (EC 50:0.75 μmol•L -1) in vitro. Bromhexine has few adverse effects and also has the beneficial effects of promoting the release and maintenance of endogenous active substances in the lung, alveolar function, and promoting sputum excretion, which is suitable for use together with other COVID19 medication and therapies. CONCLUSION: Bromhexine has a unique potential antiviral mechanism, and clinical research should be conducted to play its role in the prevention, treatment and prognosis of COVID19.
目的:探讨溴克辛治疗COVID-19的抗病毒机制。方法:我们在现有文献的基础上,系统总结新型冠状病毒(SARS-CoV-2)的感染途径,并利用SWISSDOCK分子模拟方法对关键靶点和上市药物进行系统的虚拟筛选。结果:我们发现TMPRSS2/ACE2途径是SARS-CoV-2病毒感染肺部和其他组织最有效的途径,可能是其主要途径。祛痰剂溴己辛在体外对TMPRSS2蛋白酶有较强的抑制作用(EC 50:0.75 μmol•L -1)。溴克辛不良反应少,还具有促进肺部内源性活性物质释放和维持、肺泡功能、促进痰液排泄的有益作用,适合与其他covid - 19药物和疗法合用。结论:溴甲基辛具有独特的潜在抗病毒机制,应开展临床研究,以发挥其在covid - 19的预防、治疗和预后中的作用。
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引用次数: 2
Detection and Analysis of Safety Signals of Chloroquine Based Upon FDA Adverse Event Database 基于FDA不良事件数据库的氯喹安全信号检测与分析
Pub Date : 2020-05-08 DOI: 10.11669/CPJ.2020.09.004
Xi Hu, D. Hong, Hong Yang, D. Zheng, Q. Zhao
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引用次数: 0
Management Strategy on Donated Medicines for COVID-19 Prevention and Control COVID-19防控捐赠药品管理策略
Pub Date : 2020-05-08 DOI: 10.11669/CPJ.2020.09.006
Xiaolin Xu, Li Yang, Chen Chen, S. Zhai, Rongsheng Zhao
OBJECTIVE: To provide reference of donated drugs management for pharmaceutical departments during public health emergencies, so as to ensure the quality, safety and reasonable use of donated drugs. METHODS: Combined with the legal requirements and common problems of donated drugs, explore scientific and reasonable donated drug management principles, and establish donated drug management systems and processes. RESULTS: In the past, when medical institutions responded to major public health emergencies, there were some problems in the management of the demand, qualification and quality, validity, use, price, and surplus drugs of donated drugs. According to the requirements of the relevant laws, regulations and guidance on the characteristics, management, use and communication between donors and recipients of donated drugs, we established a scientific, reasonable and orderly management model, and clarified the management system, method and comprehensive management process. CONCLUSION: The problems, principles and models of donated drugs management were sorted out comprehensively, which is helpful to prevent and control of coronavirus disease 2019 (COVID-19).
目的:为突发公共卫生事件中药学部门捐赠药品管理提供参考,确保捐赠药品的质量、安全和合理使用。方法:结合法律要求和捐赠药品存在的常见问题,探索科学合理的捐赠药品管理原则,建立捐赠药品管理制度和流程。结果:以往医疗机构应对重大突发公共卫生事件时,对捐赠药品的需求、资质质量、有效性、使用、价格、剩余药品等管理存在一定问题。根据相关法律法规和指导意见对捐赠药品的特点、管理、使用、捐赠人与受赠人之间的沟通等方面的要求,建立了科学、合理、有序的管理模式,明确了管理制度、方法和综合管理流程。结论:全面梳理了捐赠药品管理存在的问题、原则和模式,有助于防控2019冠状病毒病。
{"title":"Management Strategy on Donated Medicines for COVID-19 Prevention and Control","authors":"Xiaolin Xu, Li Yang, Chen Chen, S. Zhai, Rongsheng Zhao","doi":"10.11669/CPJ.2020.09.006","DOIUrl":"https://doi.org/10.11669/CPJ.2020.09.006","url":null,"abstract":"OBJECTIVE: To provide reference of donated drugs management for pharmaceutical departments during public health emergencies, so as to ensure the quality, safety and reasonable use of donated drugs. METHODS: Combined with the legal requirements and common problems of donated drugs, explore scientific and reasonable donated drug management principles, and establish donated drug management systems and processes. RESULTS: In the past, when medical institutions responded to major public health emergencies, there were some problems in the management of the demand, qualification and quality, validity, use, price, and surplus drugs of donated drugs. According to the requirements of the relevant laws, regulations and guidance on the characteristics, management, use and communication between donors and recipients of donated drugs, we established a scientific, reasonable and orderly management model, and clarified the management system, method and comprehensive management process. CONCLUSION: The problems, principles and models of donated drugs management were sorted out comprehensively, which is helpful to prevent and control of coronavirus disease 2019 (COVID-19).","PeriodicalId":22409,"journal":{"name":"The Chinese Pharmaceutical Journal","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89684865","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
Investigation the importance of serglycinin the drug-resistance to the doxorubicin in breast cancer 探讨谢尔甘氨酸对乳腺癌阿霉素耐药的重要性
Pub Date : 2017-02-22 DOI: 10.11669/CPJ.2017.04.008
L. Cao, Tao Liu, Zhuo-Jia Chen, S. Jia, B. Huang, Hong-Bing Huang
{"title":"Investigation the importance of serglycinin the drug-resistance to the doxorubicin in breast cancer","authors":"L. Cao, Tao Liu, Zhuo-Jia Chen, S. Jia, B. Huang, Hong-Bing Huang","doi":"10.11669/CPJ.2017.04.008","DOIUrl":"https://doi.org/10.11669/CPJ.2017.04.008","url":null,"abstract":"","PeriodicalId":22409,"journal":{"name":"The Chinese Pharmaceutical Journal","volume":"14 1","pages":"284-287"},"PeriodicalIF":0.0,"publicationDate":"2017-02-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91093723","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Chemical constituents from the aerial parts of ribes diacanthum pall 滇滇滇地生部分的化学成分
Pub Date : 2016-11-22 DOI: 10.11669/CPJ.2016.22.006
Baoping Zhou, Chunlei Zhang, Xiaoqing Zou, Jian Xu, Yan Li, Xichun Li, Chengzhi Chai, Zhengyu Cao
OBJECTIVE: To investigate the chemical constituents of the aerial parts of Ribes diacanthum Pall. METHODS: The compounds were isolated and purified by silica gel, Sephadex LH-20 colunm chromatography and HPLC. The structures were elucidated on the basis of spectral data and physiochemical properties. RESULTS: Nineteen compounds were isolated from 95% ethanol extracts and identified as quercetin (1), quercetin-3-O-β-D-glucopyranoside (2), quercetin-3-O-α-L-rhamnopyranoside (3), quercetin-3-O-β-D-neohesperoside (4), mearnsetin (5), myricetin-3-O-α-L-rhamnoside (6), myricetin-3-O-β-D-glucopyranoside (7), mearnsetin 3-O-β-D-glucopyranoside (8), mearnsetin 3-O-α-L-rhamnopyranoside (9), kaempferol-3-O-β-D-glucopyranoside (10), kaempferol 3-O-β-D-(2-O-α-L-rhamnopyranosyl) glucopyranoside (11), kaempferol 3-(2'', 6''-di-O-α-L-rhamnosyl)-β-D-glucoside (12), 1, 2, 4-trihydroxybenzene (13), vanillic acid (14), protocatechuic acid (15), 4-hydroxy benzoic acid (16), gallic acid (17), blumenol C glucoside (18), conocarpan (19). CONCLUSION: All the compounds are isolated from the title plant and the NMR data for 8 is reported here for the first time.
目的:研究白刺地上部的化学成分。方法:采用硅胶、Sephadex LH-20柱层析和高效液相色谱法对化合物进行分离纯化。根据光谱数据和理化性质对其结构进行了鉴定。结果:19化合物- 95%乙醇提取物中分离鉴定为槲皮素(1)quercetin-3-O -β-D-glucopyranoside (2), quercetin-3-O -α-L-rhamnopyranoside (3), quercetin-3-O -β-D-neohesperoside (4), mearnsetin (5), myricetin-3-O -α-L-rhamnoside (6), myricetin-3-O -β-D-glucopyranoside (7), mearnsetin 3 -β-D-glucopyranoside (8), mearnsetin 3点-α-L-rhamnopyranoside (9), kaempferol-3-O -β-D-glucopyranoside(10)、山柰酚3 -β- d - (2 o -α-L-rhamnopyranosyl)吡喃葡萄糖苷(11),山奈酚3-(2′,6′-二- o -α- l -鼠李糖基)-β- d -葡萄糖苷(12)、1,2,4 -三羟基苯(13)、香草酸(14)、原儿茶酸(15)、4-羟基苯甲酸(16)、没食子酸(17)、蓝薄荷醇C -葡萄糖苷(18)、康康康(19)。结论:所有化合物均从该植物中分离得到,其中8个化合物的NMR数据为首次报道。
{"title":"Chemical constituents from the aerial parts of ribes diacanthum pall","authors":"Baoping Zhou, Chunlei Zhang, Xiaoqing Zou, Jian Xu, Yan Li, Xichun Li, Chengzhi Chai, Zhengyu Cao","doi":"10.11669/CPJ.2016.22.006","DOIUrl":"https://doi.org/10.11669/CPJ.2016.22.006","url":null,"abstract":"OBJECTIVE: To investigate the chemical constituents of the aerial parts of Ribes diacanthum Pall. METHODS: The compounds were isolated and purified by silica gel, Sephadex LH-20 colunm chromatography and HPLC. The structures were elucidated on the basis of spectral data and physiochemical properties. RESULTS: Nineteen compounds were isolated from 95% ethanol extracts and identified as quercetin (1), quercetin-3-O-β-D-glucopyranoside (2), quercetin-3-O-α-L-rhamnopyranoside (3), quercetin-3-O-β-D-neohesperoside (4), mearnsetin (5), myricetin-3-O-α-L-rhamnoside (6), myricetin-3-O-β-D-glucopyranoside (7), mearnsetin 3-O-β-D-glucopyranoside (8), mearnsetin 3-O-α-L-rhamnopyranoside (9), kaempferol-3-O-β-D-glucopyranoside (10), kaempferol 3-O-β-D-(2-O-α-L-rhamnopyranosyl) glucopyranoside (11), kaempferol 3-(2'', 6''-di-O-α-L-rhamnosyl)-β-D-glucoside (12), 1, 2, 4-trihydroxybenzene (13), vanillic acid (14), protocatechuic acid (15), 4-hydroxy benzoic acid (16), gallic acid (17), blumenol C glucoside (18), conocarpan (19). CONCLUSION: All the compounds are isolated from the title plant and the NMR data for 8 is reported here for the first time.","PeriodicalId":22409,"journal":{"name":"The Chinese Pharmaceutical Journal","volume":"1 1","pages":"1918-1922"},"PeriodicalIF":0.0,"publicationDate":"2016-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90092955","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 3
Research of protein phosphatase 2A inhibition by norcantharidin on radiosensitivity enhancement of nasopharyngeal carcinoma CNE1 去甲斑蝥素抑制鼻咽癌CNE1对蛋白磷酸酶2A放射敏感性增强的研究
Pub Date : 2016-09-22 DOI: 10.11669/CPJ.2016.18.009
P. Lu, Dafei Xu, Qi Wu, Yue Wang, Ai-ping Wang, Z. Wang, Y. Zeng, Z. Zhuang
{"title":"Research of protein phosphatase 2A inhibition by norcantharidin on radiosensitivity enhancement of nasopharyngeal carcinoma CNE1","authors":"P. Lu, Dafei Xu, Qi Wu, Yue Wang, Ai-ping Wang, Z. Wang, Y. Zeng, Z. Zhuang","doi":"10.11669/CPJ.2016.18.009","DOIUrl":"https://doi.org/10.11669/CPJ.2016.18.009","url":null,"abstract":"","PeriodicalId":22409,"journal":{"name":"The Chinese Pharmaceutical Journal","volume":"46 1","pages":"1579-1585"},"PeriodicalIF":0.0,"publicationDate":"2016-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79346272","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
The Chinese Pharmaceutical Journal
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