1.Interpretation of the Standard Establishment Approach and Compilation Rationale for Metallic Pharmaceutical Packaging Standard Development in the 2025 Edition of the Pharmacopeia of the People's Republic of China
Fangfang ZHANG ; Rong CAI ; Wanling LAN ; Lei CHEN ; Lin YAO ; Hao DING ; Weiyi LU ; Yaju ZHOU ; Fenglan ZHANG ; Yuan LIU ; Kai XU ; Liang CHANG ; Yan LIU ; Feifei JIA ; Ying LI ; Yan JIANG ; Dandan WANG ; Shengli WU ; Yong SHEN ; Xiangwei XU ; Yanggege LYU
Herald of Medicine 2025;44(11):1745-1751
To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.
2.Interpretation of the Standard Establishment Approach and Compilation Rationale for Metallic Pharmaceutical Packaging Standard Development in the 2025 Edition of the Pharmacopeia of the People's Republic of China
Fangfang ZHANG ; Rong CAI ; Wanling LAN ; Lei CHEN ; Lin YAO ; Hao DING ; Weiyi LU ; Yaju ZHOU ; Fenglan ZHANG ; Yuan LIU ; Kai XU ; Liang CHANG ; Yan LIU ; Feifei JIA ; Ying LI ; Yan JIANG ; Dandan WANG ; Shengli WU ; Yong SHEN ; Xiangwei XU ; Yanggege LYU
Herald of Medicine 2025;44(11):1745-1751
To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.
3.Study on Quality Evaluation of Notopterygii Rhizoma et Radix through UPLC Fingerprint Combined with Chemometrics Analysis and Multi Index Component Content Determination
Guangming HE ; Xiaoying LU ; Tianrui XIA ; Feifei XIE ; Rui LUO ; Weisheng LYU ; Yueyi LIANG ; Zhenyu LI ; Xiuzhi LI ; Jianxiang ZHANG ; Xiangdong CHEN ; Dongmei SUN
Chinese Journal of Information on Traditional Chinese Medicine 2024;31(8):126-132
Objective To establish the ultra-high performance liquid chromatography(UPLC)chromatographic fingerprint of Notopterygii Rhizoma et Radix;To determine the contents of ferulic acid,nodakenin,ammijin,notopterol,isoimperatorin and volatile oil of Notopterygii Rhizoma et Radix from different producing areas;To provide reference for quality evaluation of Notopterygii Rhizoma et Radix.Methods Waters BEH C18 chromatographic column(2.1 mm×150 mm,1.7 μm)was used,with mobile phase acetonitrile-0.02%formic acid aqueous solution gradient elution,flow rate 0.25 mL/min,column temperature 25℃,detection wavelength 330 nm,injection volume 2 μL.UPLC fingerprints of 25 batches of Notopterygii Rhizoma et Radix were established,and the similarity analysis and chemometrics analysis were carried out.The contents of ferulic acid,nodakenin,ammijin,notopterol and isoimperatorin were determined simultaneously,and the contents of volatile oil was determined by steam distillation method.Results Totally 23 common fingerprint peaks were calibrated,11 known components were identified.According to the results of the cluster analysis and principal component analysis,25 batches of Notopterygii Rhizoma et Radix samples were divided into 3 categories,and the 6 potential differential components were screened out by orthogonal partial least squares-discriminant analysis(OPLS-DA).The results showed that the contents of notopterol and volatile oil from Sichuan Province were higher than those from Gansu Province and Qinghai Province.Conclusion The method established in the study is accurate and reliable,which can provide scientific basis and reference for the quality evaluation and control of Notopterygii Rhizoma et Radix.
4.Role of CD8 + T cells in lethal Plasmodium yoelii 17XL infection
Tong LYU ; Yuzhi CHANG ; Feifei LI ; Chenchen ZHANG ; Yaming CAO ; Hui FENG
Chinese Journal of Microbiology and Immunology 2024;44(7):620-628
Objective:To investigate the role of CD8 + T cells in lethal Plasmodium yoelii 17XL ( Py 17XL) infection. Methods:BALB/c mice and C57BL/6 mice were infected with Py 17XL-infected red blood cells (1×10 6 cells/0.1 ml) through intraperitoneal injection to establish the mouse models of Py 17XL infection. Parasitemia (the percentage of erythrocytes infected with Py 17XL) and the survival rates of the mice was observed dynamically. Flow cytometry was used to detect the number of effector T cells (T EFF) and central memory T cells (T CM) of CD8 + T cell subpopulations, the expression of IFN-γ and granzyme B (GB) levels, and the expression of surface chemokine receptors CXCR3, CXCR6 and CX3CR1. FTY720 blocking experiment was conducted on Py 17XL-infected C57BL/6 mice to analyze the impact of CD8 + T cell migration on Py 17XL infection. Results:The parasitemia of BALB/c mice increased rapidly 5 d after infection and reached the peak on 8 d [(79.57±3.82)%]. Besides, the parasitemia was higher in BALB/c mice than in C57BL/6 mice 5-8 d after infection ( P<0.000 1). All BALB/c mice died on 9 d. The parasitemia of C57BL/6 mice reached the peak on 14 d [(48.19±3.19)%] and then decreased to 0 on 26 d. There was statistically significant difference in the survival rate between the two groups ( P<0.000 1). Flow cytometry results showed that compared with the BALB/c mice, the absolute number of CD8 + T cells in spleen and liver tissues and the number of CD8 + T EFF and CD8 + T CM cells in spleen and lymph nodes of C57BL/6 mice increased significantly ( P<0.05). Compared with the BALB/c mice, the levels of GB, IFN-γ and chemokines expressed by CD8 + T cells in spleen and liver tissues of C57BL/6 mice increased significantly ( P<0.05). The FTY720 blocking experiment showed that the survival rate, the absolute number of CD8 + T cells in liver and spleen, and the number of CD8 + CXCR3 + T cells decreased significantly in the experimental group ( P<0.05). Conclusions:CD8 + T EFF and CD8 + T CM cells contribute to resistance against Py 17XL infection by secreting GB and IFN-γ. The chemokine receptor CXCR3 plays an important role in mediating the chemotaxis of CD8 + T cells to spleen and liver.
5.Application of whole-course multi-disciplinary nutrition model in hip surgery in elderly patients
Xiahe CHEN ; Yangxun LYU ; Qifan CHEN ; Zhou LIN ; Feifei LIAO
China Modern Doctor 2024;62(22):17-21
Objective To analyze the application effect of whole-course multi-disciplinary nutrition model in elderly patients undergoing hip surgery.Methods A total of 90 elderly patients undergoing hip surgery admitted to Wenzhou Central Hospital from October 2021 to December 2023 were selected and divided into control group and study group according to random number table method,with 45 cases in each group.The control group was treated with dietary management model,while the study group was treated with whole-course multi-disciplinary nutrition model.Recovery,nutritional status,quality of life,hip function and satisfaction were compared between two groups.Results The hospital stay and fracture healing time in study group were significantly shorter than those in control group(P<0.05).After intervention,prealbumin(PA),albumin(Alb),hemoglobin(Hb),dimensions scores of 36-item short form health survey(SF-36)and Harris hip scores of patients in two groups were significantly higher than before intervention(P<0.05).PA,Alb,Hb,dimensions scores of SF-36 and Harris hip scores in study group were significantly higher than those in control group(P<0.05).The satisfaction of patients in study group was significantly higher than that in control group(χ2=5.075,P=0.024).Conclusion The application of whole-course multi-disciplinary nutrition model in hip surgery in elderly patients can improve their nutritional status,improve their quality of life,enhance hip function,and facilitate postoperative recovery.
6.Application of modified presentation assimilation discussion combined with heuristic clinical medicine teaching in training of extracorporeal membrane oxygenation specialist nurses
Huili LYU ; Zhan YANG ; Fuhua LI ; Dandan WANG ; Xiang ZHAO ; Jianfang CHANG ; Feifei WANG ; Xiangke ZHAO ; Xiaojun LIU ; Shaoyan QI
Chinese Journal of Modern Nursing 2024;30(22):3047-3051
Objective:To explore the application effect of the modified presentation assimilation discussion combined with heuristic clinical medicine teaching in training of extracorporeal membrane oxygenation specialist nurses.Methods:The convenient sampling method was used to select 62 nurses who participated in training of extracorporeal membrane oxygenation specialist nurses in the Second Affiliated Hospital of Zhengzhou University from January to June 2023 as the research objects. A total of 30 nurses who participated in the 25th training session from January to March 2023 were selected as the control group, and 32 nurses who participated in the 26th training session from April to June 2023 were selected as the observation group. The control group received conventional training method, while the observation group received modified presentation assimilation discussion combined with heuristic clinical medicine teaching. The theoretical knowledge and operational skills of nurses, core competence of extracorporeal membrane oxygenation specialist nurses and training satisfaction were compared between the two groups after training.Results:After training, the scores of theoretical knowledge and operational skills, core competence of extracorporeal membrane oxygenation specialist nurses and training satisfaction in observation group were higher than those in control group, and the differences were statistically significant ( P<0.05) . Conclusions:The modified presentation assimilation discussion combined with heuristic clinical medicine teaching can improve the theoretical knowledge and operational skills of extracorporeal membrane oxygenation specialist nurses, and the nurses' training satisfaction is higher.
7.Cranial ultrasound in perioperative period of acute severe traumatic brain injury
Yangang WANG ; Zhenpu LYU ; Xianzhao ZHENG ; Zheng QIN ; Jianxin LI ; Ran GE ; Feifei ZHAO
Chinese Journal of Medical Imaging Technology 2024;40(8):1156-1159
Objective To observe the value of cranial ultrasound for perioperative patients with acute severe traumatic brain injury(sTBI).Methods Data of 55 sTBI patients who underwent craniotomy were retrospectively analyzed.The patients were divided into observation group(n=15)and control group(n=40)according to received perioperative cranial ultrasound or not.The general data and surgical data were compared between groups,and ultrasonic data of observation group were analyzed.Results The proportions of good prognosis 1 and 6 months after operation in observation group were both higher than those in control group,while the incidence of cerebral infarction in observation group was lower than that in control group(all P<0.05).No significant difference of general data nor other surgical data was found between groups(all P>0.05).Acute encephalocele occurred in 1 case in observation group during operation,and cranial ultrasound accurately showed the contralateral secondary epidural hematoma.Increased intracranial pressure in different degrees were found in all 15 cases(15/15,100%)in observation group after operation with transcranial color coded Doppler(TCCD)or transcranial Doppler(TCD),while cerebral vascular spasm was observed in 5 cases(5/15,33.33%),among them 4 cases(4/5,80.00%)were diagnosed cerebral infarction based on CT examination.Conclusion Cranial ultrasound could be used to evaluate changes of sTBI in perioperative period and guide adjusting treatment strategy in time,being valuable for reducing risk of postoperative cerebral infarction and improving prognosis.
8.The effect of prone position ventilation on hypoxemia in patients with severe brain damage
Qingqing YE ; Shaokun SHAO ; Haifeng LYU ; Feifei WANG ; Guojie SHEN ; Weina FAN ; Xiaoliang WU
Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care 2024;31(1):46-49
Objective To explore the clinical efficacy of prone position ventilation(PPV)in improving hypoxemia in patients with severe brain damage.Methods A retrospective research method was conducted,140 patients with severe brain damage who were admitted to the department of critical care medicine of the First Affiliated Hospital,Zhejiang University School of Medicine from August 2020 to August 2021 were selected as subject objected.According to the inclusion and exclusion criteria,20 patients with oxygenation index≤200 mmHg(1 mmHg≈0.133 kPa)who were treated with PPV were statistically analyzed.The patients'blood gas analysis related indicators[including arterial partial pressure of oxygen(PaO2),fractional of inspired oxygen(FiO2),oxygenation index,arterial oxygen saturation(SaO2),arterial partial pressure of carbon dioxide(PaCO2),pH value],ventilator-related parameters[including peak inspiratory pressure(PIP),positive end-expiratory pressure(PEEP),tidal volume(VT),lung dynamic compliance(Cdyn),etc.],and mean arterial pressure(MAP),heart rate(HR)were compared before PPV,12 hours after PPV,and 12 hours after reverting to supine position.At the same time,the related complications of patients during PPV were recorded.Results There were 15 males and 5 females,the mean age of the patients was(46.10±17.22)years old,the average PPV time was(22.20±5.94)hours.Compared with before PPV,patients showed significant increases in PaO2,oxygenation index,SaO2,VT,and Cdyn at 12 hours after PPV and 12 hours after recovery from supine position[PaO2(mmHg):98.35±21.85,98.45±17.90 vs.72.15±10.14,oxygenation index(mmHg):198.82±40.51,202.27±46.39 vs.133.20±33.95,SaO2:0.97±0.02,0.97±0.01 vs.0.94±0.03,VT(mL):558.42±111.23,580.29±119.44 vs.484.82±123.77,Cdyn(mL/cmH2O):26.11±5.42,27.90±5.80 vs.24.15±6.13,all P<0.05];Compared with 12 hours after PPV,the Cdyn of the patient still showed a significant increase after 12 hours of recovery from supine position(P<0.05).There were no statistical differences in the FiO2,PaCO2,pH value,PIP,PEEP,HR,and MAP of patients at various time points before and after PPV(all P>0.05).Five patients developed redness and swelling at the skin compression site mainly on the face after PPV,which gradually improved after returning to a supine position.During this period,there was no occurrence of catheter detachment,malignant arrhythmia,or significant hemodynamic instability.Conclusion PPV has a certain clinical effect on improving hypoxemia in patients with severe brain damage.
9.Correlation between risky drinking and decision-making ability in offspring of fathers with alcohol dependence
Feifei SI ; Xiaozhen LYU ; Ying ZHANG ; Tingfang WU ; Yujia QIU ; Xin YU
Chinese Mental Health Journal 2024;38(3):193-199
Objective:To investigate the association of risky drinking and decision-making ability among off-spring of fathers with alcohol dependence(OFAD).Methods:A case-control study was conducted according to the cutoff of the Alcohol Use Disorder Identification Test(AUDIT)(delimited as 7).OFAD were divided into"risky drinking group"(n=29)and"non-risky drinking group"(n=43).The Iowa Gambling Task(IGT)was used to e-valuate the decision-making ability.Covariance analysis was used to compare differences of IGT between the two groups,and multivariate logistic regression was used to explore the association between risky drinking and decision making ability.Results:There was no significant difference in total scores of IGT between the risky drinking group and the non-risky drinking group(P>0.05).Risky drinking group had less Selection 2 in block 5 of IGT[(3.8± 2.5)v.s.(5.7±3.1),P<0.05]than non-risky drinking group.Selection 2 in block 5 was still associated with risky drinking after controlling the covariates(OR=0.72,95%CI:0.57~0.90,P<0.05).Conclusion:This study indicates that risky drinking group in offspring of parents with alcohol dependence may have better decision-making ability.
10.Overview of the Application of Automated Intelligent Drug Cabinet in the Field of Hospital Medicine Management
DONG Zhiyong ; LI Weijun ; TENG Tianli ; LYU Ning ; CHEN Liangfang ; CHEN Feifei ; CAI Beibo ; HE Hangkai ; YUAN Hongye ; JIANG Saiping
Chinese Journal of Modern Applied Pharmacy 2023;40(17):2378-2383
OBJECTIVE To review the application and development of automatic intelligent drug cabinet in hospitals at home and abroad. METHODS The relevant research articles published from 2010 to 2022 were retrieved from CNKI, Wanfang, VIP, PubMed and other databases. RESULTS The application of automatic intelligent drug cabinet could shorten the execution time of inpatient medical orders, improve the work efficiency of pharmacists and doctors and nurses, improve the quality of drug management in wards and promote the transformation of hospital pharmaceutical care. CONCLUSION The construction of decentralized dispensing mode with automated intelligent drug cabinets as the core has important theoretical guiding significance and broad application prospects for the automation, informatization, intelligence and whole process management of drugs in medical institutions, and also helps to improve the level of medical pharmacy service management.


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