1.Comprehensive evaluation of powder-liquid double-chamber bag products: a systematic review
Fei SHU ; Rui SUN ; Kai SONG ; Yuanlin ZHANG ; Jiaming YAN ; Lixin SHU
Journal of Pharmaceutical Practice and Service 2025;43(2):92-96
Objective To evaluate the advantages of powder-liquid double-chamber bag products compared with traditional powder injection. Methods The systematic review method was used to collect the literature on powder-liquid double-chamber bag, extract common evaluation indicators, evaluate the use value of powder-liquid double-chamber bag products, and conduct a comprehensive comparison with traditional powder injection products. Results A total of 23 articles were included in the literature. The effectiveness indicators used for evaluation were the stability of the liquid medicine, the accuracy of the preparation concentration, and the residual amount of the liquid medicine; the safety indicators were the incidence of insoluble particles and the incidence of punctures and scratches. The economic indicators were preparation cost, occupied volume of preparation supplies, waste weight, hospitalization cost and incidence of blood infection. The applicability indicators were preparation time, average occupation of medical staff, packaging weight and storage and transportation volume, environmental adaptability, and ease of waste disposal. Accessibility indicators are the number of manufacturers, raw material supply capacity, and patient affordability. Through the evaluation of literature evidence, it was found that the stability and concentration accuracy of the powder-liquid double-chamber bag were higher than those of the traditional powder injection, and the domestic supply had been achieved. The double-chamber bag method can reduce the infusion reaction and shorten the preparation time of the liquid medicine. Conclusion Compared with traditional powder injectabler products, powder-liquid double-chamber bags have advantages in the dimensions of effectiveness, safety, economy, suitability and innovation, and the accessibility dimension meets the requirements.
2.The approaches and implications of emergency drug authorization by the U.S. FDA
Dan HAN ; Wen GAO ; Lunuan WANG ; Rui SUN ; Mingming GUO ; Lixin SHU
Journal of Pharmaceutical Practice and Service 2024;42(12):533-536
Objective To provide valuable insights for improving China’s special drug approval system by conducting an in-depth analysis of the practices of the U.S. Food and Drug Administration (FDA) in granting Emergency Use Authorizations (EUAs) for drugs. Methods A retrospective analysis was conducted on the FDA’s EUA decision-making process for COVID-19 therapeutics between January 2020 and June 2023. Results During the COVID-19 pandemic, the FDA adopted a series of regulatory science approaches to facilitate rapid approval of COVID-19 therapeutic drugs. The FDA granted EUA for a total of 15 COVID-19 therapeutic drugs and 4 COVID-19 vaccines, including expanded indications for marketed drugs, EUA for investigational drugs, revocation of EUA, and marketing after EUA. The main mechods for the rapid approval of EUA drugs by the FDA included the use of existing clinical trial data, omission of animal efficacy testing, merging of phase 1 and phase 2 clinical trials, and the use of clinical outcomes as surrogate endpoints, among other regulatory science methods. Conclusion The practices of the FDA in Emergency Use Authorization (EUA) of drugs, particularly its incorporation of regulatory scientific methods into the EUA process and the establishment of proactive monitoring mechanisms for drugs granted EUA, are worthy of emulation by China. It is suggested that China consider the experience of the FDA in the EUA system for drugs to further optimize and improve its special approval system for drugs.
3.Review of drug utilization research based on real-world data
Yuanlin ZHANG ; Kai SONG ; Rui SUN ; Fei SHU ; Lixin SHU ; Zhangwei YANG
Journal of Pharmaceutical Practice and Service 2024;42(6):238-243
In recent years,the rapid development of medical information technology has made it critical to analyze large-scale diagnosis and therapeutic data and extract rules based on real medical environment.This has become an essential approach for marketing evaluation and regulatory decision-making of drugs and devices both domestically and internationally.Real world study(RWS),as a novel methodology for clinical evaluation of drugs in the field of drug utilization research(DUR),have presented opportunities and challenges for observational studies in assessing actual efficacy or effectiveness.However,despite being a popular methodological approach among scholars in the field,there are still limitations and deficiencies when analyzing population medication characteristics in RWS.Systematic evaluation research methods have not yet been established,leading to inadequate generation of real-world evidence(RWE).The research design,methodological pathways,evaluation indicators,confounding factors,and bias management involved in DUR based on real-world data(RWD)were reviewed in this artical with the intention of providing guidance for further exploration into DUR.
4.Study on odor composition change of traditional Chinese medicine sachet during placement based on ultra-fast gasphase electronic nose technology
Xiaocong YU ; Lixin ZHANG ; Zekun WANG ; Yachun SHU ; Xianlin ZHANG ; Yi YAO ; Chunqin MAO
China Pharmacy 2023;34(3):339-344
OBJECTIVE To analyze the odor composition changes of two kinds of traditional Chinese medicine sachet (children type and adults type) with different placement time by using ultra-fast gasphase electronic nose technology. METHODS The change rule of sachet components at different storage times was analyzed by gas chromatography. At the same time, the qualitative results were obtained by combining electronic nose with Arochembase database. Discriminant factor analysis was used to analyze the overall odor composition differences of the two sachet samples. RESULTS A total of 10 odor compositions were identified in children-type sachet, including α-pinene and β-pinene as the functional index compositions; five odor compositions of children-type sachet disappeared after 0.25 days, and most of them disappeared after 7 days; the cumulative contribution rate of discriminant factor analysis was 99.225%. A total of 8 odor compositions were identified in adult-type sachets, including α-pinene and α-phellandrene as the functional index compositions; four odor components disappeared after the adult-type sachet was placed for 0.25 days; after 15 days of placement, the peak 6-8 disappeared, and the intensity of peak 5 decreased by 34.3% compared with 0 day of placement; the cumulative contribution rate of discriminant factor analysis was 91.965%. CONCLUSIONS With the extension of storage time, the smell and composition of the two traditional Chinese medicine sachets are decreasing. It is recommended that the use time of children-type sachet is 7 days, and that of adult-type sachet is 15 days.
5.Bibliometric analysis of brucellosis by CiteSpace
Kai SONG ; Yuanlin ZHANG ; Rui SUN ; Mingming GUO ; Dan HAN ; Lei REN ; Lixin SHU
Journal of Pharmaceutical Practice 2023;41(5):310-315
Objective To perform a visual bibliometric analysis of hot spots as well as areas of Brucella disease research by searching brucellosis related literature. Methods A thematic search was conducted in the web of science core set database using Brucella disease or brucellosis as keywords to retrieve literature between January 1985 and December 2021. CiteSpace was used to visualize the countries, institutions, authors, and keywords in the retrieved relevant literatures. Results A total of 4 495 eligible articles studies were included, with the United States being the most populous country and the University of Sao Paulo being the most influential. Jilin University and Shihezi University in Xinjiang, China were relatively influential in this field. For the key words analysis, the top 3 of high-frequency words were infection, diagnosis, abortion, and in the 12 clusters formed, the clusters formed by #1, #4 were larger and the research hotspot continued. Keywords in the last five years including human brucellosis, immunity, zoonotic disease, were highlighted. Conclusion Study analysis suggested that human brucellosis with zoonosis was a research hotspot, more scholars focused on the infectious route and other exposure risks of cattle as intermediate hosts, epidemiological studies on brucellosis or will be new trends.
6.Systematic evaluation of prehospital external hemostatic dressings
Rui SUN ; Fei SHU ; Kai SONG ; Yuanlin ZHANG ; Dan HAN ; Lei REN ; Lixin SHU
Military Medical Sciences 2023;47(12):928-933
Objective To evaluate the effectiveness,safety and operability of different types of pre-hospital topical hemostatic dressings given the limited clinical evidence of pre-hospital topical hemostatic dressings so as to provide reference for the subsequent establishment of a comprehensive index system.Methods A systematic review method was used to sift through and summarize the evaluation indexes of zeolite,kaolin and chitosan.Results Fifteen studies were included,only one of which was randomized controlled trial(RCT)study,and the rest were descriptive studies,involving military and civilian subjects.All the three types of hemostatic dressings in the included studies had good haemostatic effects,but the amount of data was too limited to compare the haemostatic effects between different types.Except for zeolite wounds that were likely to be burned by exothermic heat,the other types caused few adverse reactions but with unclear operability.There was no data on stability and economy in the selected literature.Conclusion Considering the ideal hemostatic agent and the standard requirements of Chinese expert consensus,it is recommended that the indicators in follow-up studies include efficacy,safety,operability,stability and economy,and that preclinical animal studies be included to supplement related indicators.
7.Chinese expert consensus on the diagnosis and treatment of traumatic cerebrospinal fluid leakage in adults (version 2023)
Fan FAN ; Junfeng FENG ; Xin CHEN ; Kaiwei HAN ; Xianjian HUANG ; Chuntao LI ; Ziyuan LIU ; Chunlong ZHONG ; Ligang CHEN ; Wenjin CHEN ; Bin DONG ; Jixin DUAN ; Wenhua FANG ; Guang FENG ; Guoyi GAO ; Liang GAO ; Chunhua HANG ; Lijin HE ; Lijun HOU ; Qibing HUANG ; Jiyao JIANG ; Rongcai JIANG ; Shengyong LAN ; Lihong LI ; Jinfang LIU ; Zhixiong LIU ; Zhengxiang LUO ; Rongjun QIAN ; Binghui QIU ; Hongtao QU ; Guangzhi SHI ; Kai SHU ; Haiying SUN ; Xiaoou SUN ; Ning WANG ; Qinghua WANG ; Yuhai WANG ; Junji WEI ; Xiangpin WEI ; Lixin XU ; Chaohua YANG ; Hua YANG ; Likun YANG ; Xiaofeng YANG ; Renhe YU ; Yongming ZHANG ; Weiping ZHAO
Chinese Journal of Trauma 2023;39(9):769-779
Traumatic cerebrospinal fluid leakage commonly presents in traumatic brain injury patients, and it may lead to complications such as meningitis, ventriculitis, brain abscess, subdural hematoma or tension pneumocephalus. When misdiagnosed or inappropriately treated, traumatic cerebrospinal fluid leakage may result in severe complications and may be life-threatening. Some traumatic cerebrospinal fluid leakage has concealed manifestations and is prone to misdiagnosis. Due to different sites and mechanisms of trauma and degree of cerebrospinal fluid leak, treatments for traumatic cerebrospinal fluid leakage varies greatly. Hence, the Craniocerebral Trauma Professional Group of Neurosurgery Branch of Chinese Medical Association and the Neurological Injury Professional Group of Trauma Branch of Chinese Medical Association organized relevant experts to formulate the " Chinese expert consensus on the diagnosis and treatment of traumatic cerebrospinal fluid leakage in adults ( version 2023)" based on existing clinical evidence and experience. The consensus consisted of 16 recommendations, covering the leakage diagnosis, localization, treatments, and intracranial infection prevention, so as to standardize the diagnosis and treatment of traumatic cerebrospinal fluid leakage and improve the overall prognosis of the patients.
8.Identification of the Origin of Schizonepeta tenusfolia Based on “Odor”Information
Lixin ZHANG ; Xiaocong YU ; Zekun WANG ; Chunqin MAO ; Yachun SHU
China Pharmacy 2021;32(18):2203-2209
OBJECTIVE:To esta blish the m ethod for identifying Schizonepeta tenusfolia from different habitats based on odor information. METHODS :The odor of S. tenusfolia from different habitats were identified by Heracles Ⅱ ultra-fast gas phase electronic nose. Qualitative analysis was conducted according to obtained chromatographic information combined with AroChemBase database and Kovats retention index qualitative database. Principle component analysis (PCA)and discriminant factor analysis (DFA)were conducted by using Alpha Soft V 14.2 software,and cluster analysis (CA)was performed with SPSS 22.2 software. RESULTS :There were 16 common peaks in 15 batches of S. tenusfolia from different habitats. After comparison with AroChemBase database and Kovates retention index qualitative database ,a total of 13 possible components were obtained. The possible components and sensory description information of S. tenusfolia from different habitats were basically the same ,but only the content was different. The chromatographic peak intensities of common peak No. 2 were in descending order as Anhui > Gansu>Henan>Hebei>Jiangsu,the chromatographic peak intensities of common peak No. 6 were in descending order as Anhui > Hebei>Gansu≈Henan>Jiangsu,the chromatographic peak intensities of common peak No. 9 were in descending order as Anhui > Gansu>Henan>Jiangsu>Hebei,the chromatographic peak intensity of common peak No. 13 were in descending order as Anhui ≈ Gansu>Hebei>Jiangsu>Henan,which represented the chromatographic peak intensity of methyl formate (peak No. 2),α-pinene (peak No. 6),3-nonone(peak No. 9)and α-terpineol(peak No. 13)were significantly different due to the change of habitats. PCA results showed that the cumulative contribution rate of the first two principal components was 96.807%. Results of DFA showed that contribution rates of discriminant factor 1 and discriminant factor 2 were 92.089% and 3.982%. CA results showed that when the distance was 10,15 batches of samples could be clustered into 3 categories,B1-B5 and J 1-J3 into one category ,A1-A3 into one category ,G1,G2,N1 and N 2 into one category. The results were basically consistent with those of PCA and DFA. CONCLUSIONS:Ultra-fast gas phase electronic nose technology can be used to identify S. tenusfolia from different habitats rapidly. Methyl formate ,α-pinene,3-nonone and α-terpineol may be the key factors to distinguish S. tenusfolia from different habitats.
9.Overseas warehouses for prepositioning medicine materials
Jing CHEN ; Lijun CUI ; Ruimin LI ; Yiqian ZHANG ; Zhipeng LUAN ; Lixin SHU
Journal of Pharmaceutical Practice 2021;39(3):280-282
In order to meet our country strategic needs of “The Belt and Road”, it was proposed to use the existing overseas warehouses from domestic companies as prepositioning locations. The situation and functionality were clarified. A comprehensive evaluation for the existing overseas warehouses in the Indian Ocean was conducted. The authors screened out several countries suitable for prepositioning medicinal supplies. Meanwhile, the potential problems were discussed in order to provide a theoretical basis for the future research on overseas medicinal supplies.
10.Bibliometric analysis of pharmaceutical papers from Double First-rate universities in China
Ruimin LI ; Lijun CUI ; Lixin SHU ; Jing CHEN
Journal of Pharmaceutical Practice 2021;39(4):331-335
Objective To understand the development status in the subject of pharmacy and provide recommendations for the construction of universities and the development of pharmacy by the bibliometric analysis of pharmaceutical papers from Double First-rate universities in China. Methods China National Knowledge Network (CNKI), Wanfang and VIP databases were searched for Chinese literature, and Scopus database was searched for English literature. Duplicates and non-research literatures were deleted. 12 028 literatures were included. Excel 2016 software was used for statistical analysis. Results From 2014 to 2019, the total number of papers published by Double First-rate universities increased year by year, with the highest increase rate of 14%. From 2014 to 2020, 11 178 papers were published in international journals, while only 850 were published in domestic journals. Nearly 93% of pharmaceutical papers flowed to foreign journals. Peking Union Medical College published the most papers in international journals. Sun Yat-sen University published the most SCI papers. Peking University published the most papers in domestic journals, while Fudan University published the highest number of papers in Q1 area. Only a few papers published with international coauthors from colleges or universities. The cooperation works were limited in the same province or municipality directly under the central government. Conclusion Double First-rate universities should focus on strengthening international cooperation and inter-provincial cooperation, improving industry-university collaboration, and accelerating the transformation from scholar research to productions.

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