1.Overview of the amendments and revisions to the General Technical Requirements adopted by the Volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition
ZHANG Jun ; NING Baoming ; WEI Shifeng ; SHEN Haoyu ; SHANG Yue ; ZHU Ran ; XU Xinyi ; CHEN Lei ; LIU Tingting ; MA Shuangcheng
Drug Standards of China 2025;26(1):034-044
To introduce the general thinking, guidelines, work objectives and elaboration process of the general technical requirements adopted by volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition, and to summarize and figure out the main characteristics on dosage forms, physico-chemical testing, microbial and biological testing, reference standards and guidelines The newly revised general chapters of pharmacopoeia give full play to the normative and guiding role of the Chinese Pharmacopoeia standard, track the frontier dynamics of international drug regulatory science and the elaboration of monographs, expand the application of state-of-the-art technologies, and steadily promote the harmonization and unification with the ICH guidelines; further enhance the overall capacity of TCM quality control, actively implement the 3 R principles on animal experiments, and practice the concept of environmental-friendly; replace and/or reduce the use of toxic and hazardous reagents, strengthen the requirements of drug safety control This paper aims to provide a full-view perspective for the comprehensive, correct understanding and accurate implementation of general technical requirements included in the Chinese Pharmacopoeia 2025 Edition.
2.Research progress on the effect of α7 nicotinic acetylcholine receptor on perioperative neurocognitive function
Shang-Kun SI ; Ying-Xue XU ; Wei-Liang ZHANG ; Jia-Fu JI ; Dong-Bin ZHANG
Medical Journal of Chinese People's Liberation Army 2024;49(3):343-348
α7 nicotinic acetylcholine receptor(α7nAChR)is widely expressed in the central nervous system and immune system,and plays a neuro-immunoregulatory role.On the one hand,α7nAChR is involved in the transmission of neurotransmitters,the conduction of excitatory signals and the maintenance of synaptic plasticity,which is of great significance for maintaining the normal and stable neurocognitive function.On the other hand,as an important part of the cholinergic anti-inflammatory pathway,α7nAChR is involved in the regulation of physiological and pathological processes such as inflammatory response,oxidative stress,apoptosis and autophagy in the central system,and plays an immunomodulatory and neuroprotective role,thus being potential target for improving perioperative neurocognitive function.This article reviews the biological characteristics of α7nAChR and its effect on perioperative neurocognitive function,in order to provide ideas and methods for clinical improvement of perioperative neurocognitive function in surgical patients.
3.2,6-dimethoxy-1,4-benzoquinone alleviates septic shock in mice by inhibiting NLRP3 inflammasome activation
Wei ZHANG ; Mengmeng DENG ; Yao ZENG ; Chenfei LIU ; Feifei SHANG ; Wenhao XU ; Haoyi JIANG ; Fengchao WANG ; Yanqing YANG
Journal of Southern Medical University 2024;44(6):1024-1032
Objective To investigate the mechanism of 2,6-dimethoxy-1,4-benzoquinone(DMQ),an active ingredients in fermented wheat germ extract,for inhibiting NLRP3 inflammasome activation and alleviating septic shock in mice.Methods Cultured murine bone marrow-derived macrophages(BMDM)stimulated with lipopolysaccharide(LPS)were treated with DMQ,followed by treatment with Nigericin,ATP,and MSU for activating the canonical NLRP3 inflammasome;the non-canonical NLRP3 inflammasome was activated by intracellular transfection of LPS,and AIM2 inflammasome was activated using Poly A:T.In human monocytic THP-1 cells,the effect of Nigericin on inflammasome activation products was examined using Western blotting and ELISA.Co-immunoprecipitation was performed to explore the mechanism of DMQ-induced blocking of NLRP3 inflammasome activation.In a male C57BL/6J mouse model of LPS-induced septic shock treated with 20 and 40 mg/kg DMQ,the levels of IL-1β and TNF-α in the serum and peritoneal lavage fluid were determined using ELISA,and the survival time of the mice within 36 h was observed.Results Treatment with DMQ effectively inhibited LPS-induced activation of canonical NLRP3 inflammasome in mouse BMDM and human THP-1 cells and also inhibited non-canonical NLRP3 inflammasome activation in mouse BMDM,but produced no significant effect on AIM2 inflammasome activation.DMQ significantly blocked the binding between ASC and NLRP3.In the mouse models of septic shock,DMQ treatment significantly reduced the levels of IL-1β in the serum and peritoneal fluid and obviously prolonged survival time of the mice.Conclusion DMQ can effectively block ASC-NLRP3 interaction to inhibit NLRP3 inflammasome activation and alleviate LPS-induced septic shock in mice.
4.Risk factors for early postoperative hypertension after transcatheter aortic valve implantation in patients with severe aortic stenosis: A retrospective cohort study in a single center
Jigao SHANG ; Peide ZHANG ; Xu WANG ; Xiang FENG ; Xuanshu LI ; Yanbo ZHANG ; Wei WANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(12):1813-1819
Objective To explore the risk factors and potential mechanisms of hypertension events on the same day after transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis. Methods Clinical data of patients who underwent TAVI for severe aortic stenosis at Department of Structural Heart Disease, Fuwai Hospital from December 2023 to February 2024 were retrospectively collected. According to the peak systolic blood pressure on the same day after surgery, patients were divided into a hypertension group (≥140 mm Hg) and a normal blood pressure group (<140 mm Hg). Logistic regression model was used to analyze the risk factors for hypertension on the same day after TAVI. Results A total of 54 patients after TAVI were included, with 41 patients in the hypertension group, including 18 males and 23 females, with an average age of (72.83±6.78) years; 13 patients in the normal blood pressure group, including 9 males and 4 females, with an average age of (70.00±7.57) years. Univariate analysis found that there were statistical differences in interventricular septal thickness [(13.71±1.98) mm vs. (12.23±1.59) mm, P=0.018], preoperative left ventricular ejection fraction (LVEF)>55% [33 (80.5%) vs. 6 (46.2%), P=0.040], and postoperative same-day LVEF>55% [33 (80.5%) vs. 4 (30.8%), P=0.003]. Multivariate logistic regression analysis found that postoperative same-day LVEF>55% [OR=10.173, 95%CI (1.044, 99.115), P=0.046] was an independent risk factor for hypertension on the same day after TAVI. Conclusion Myocardial contractility mainly participates in the occurrence of hypertension on the same day after TAVI. This study can not only improve our understanding of early hemodynamic changes after TAVI, but also provide a basis for the formulation of early hypertension treatment plans after TAVI to improve the short- and long-term prognosis of patients.
5.Effect of Portable Oto-endoscopy System in Clinical Teaching of Otorhinolaryngology
Bin WANG ; Wei LYU ; Zhiqiang GAO ; Hua YANG ; Keli CAO ; Guodong FENG ; Haiyan WU ; Yingying SHANG ; Xingming CHEN ; Jian WANG ; Xu TIAN ; Weiqing WANG
Medical Journal of Peking Union Medical College Hospital 2024;15(6):1475-1479
To explore the value of portable oto-endoscopy system in clinical teaching of otolaryngology residents. The postgraduate students serving as resident doctors in the Department of Otolaryngology of Peking Union Medical College Hospital from February to March 2022 and from February to March 2023 were selected as the research objects. Random number table method was used to divide them into experimental group and control group. The control group was first taught by theoretical explanation + electrooto-endoscopy system, and the experimental group was first taught by theoretical explanation + portable oto-endoscopy system. After one month, the two groups interchanged their teaching methodologies. The results of theoretical assessment, self-evaluation at the end of the first month of clinical learning and satisfaction with teaching effectiveness at the end of two months of clinical learning were compared between the two groups. A total of 36 residents were included in this study, with 18 in each group. After one month of clinical study, the theoretical test scores of the experimental group were significantly higher than those of the control group[(93.17±4.16) points The portable oto-endoscopy system can display the anatomy and diseases of otolaryngology more vividly and intuitively in the clinical teaching of otolaryngology, facilitate the management of clinical data, increase the learning interest of residents, fully mobilize the image thinking of medical students, and improve the post competence of residents more efficiently.
6.Effect of Portable Oto-endoscopy System in Clinical Teaching of Otorhinolaryngology
Bin WANG ; Wei LYU ; Zhiqiang GAO ; Hua YANG ; Keli CAO ; Guodong FENG ; Haiyan WU ; Yingying SHANG ; Xingming CHEN ; Jian WANG ; Xu TIAN ; Weiqing WANG
Medical Journal of Peking Union Medical College Hospital 2024;15(6):1475-1479
To explore the value of portable oto-endoscopy system in clinical teaching of otolaryngology residents. The postgraduate students serving as resident doctors in the Department of Otolaryngology of Peking Union Medical College Hospital from February to March 2022 and from February to March 2023 were selected as the research objects. Random number table method was used to divide them into experimental group and control group. The control group was first taught by theoretical explanation + electrooto-endoscopy system, and the experimental group was first taught by theoretical explanation + portable oto-endoscopy system. After one month, the two groups interchanged their teaching methodologies. The results of theoretical assessment, self-evaluation at the end of the first month of clinical learning and satisfaction with teaching effectiveness at the end of two months of clinical learning were compared between the two groups. A total of 36 residents were included in this study, with 18 in each group. After one month of clinical study, the theoretical test scores of the experimental group were significantly higher than those of the control group[(93.17±4.16) points The portable oto-endoscopy system can display the anatomy and diseases of otolaryngology more vividly and intuitively in the clinical teaching of otolaryngology, facilitate the management of clinical data, increase the learning interest of residents, fully mobilize the image thinking of medical students, and improve the post competence of residents more efficiently.
7.2,6-dimethoxy-1,4-benzoquinone alleviates septic shock in mice by inhibiting NLRP3 inflammasome activation
Wei ZHANG ; Mengmeng DENG ; Yao ZENG ; Chenfei LIU ; Feifei SHANG ; Wenhao XU ; Haoyi JIANG ; Fengchao WANG ; Yanqing YANG
Journal of Southern Medical University 2024;44(6):1024-1032
Objective To investigate the mechanism of 2,6-dimethoxy-1,4-benzoquinone(DMQ),an active ingredients in fermented wheat germ extract,for inhibiting NLRP3 inflammasome activation and alleviating septic shock in mice.Methods Cultured murine bone marrow-derived macrophages(BMDM)stimulated with lipopolysaccharide(LPS)were treated with DMQ,followed by treatment with Nigericin,ATP,and MSU for activating the canonical NLRP3 inflammasome;the non-canonical NLRP3 inflammasome was activated by intracellular transfection of LPS,and AIM2 inflammasome was activated using Poly A:T.In human monocytic THP-1 cells,the effect of Nigericin on inflammasome activation products was examined using Western blotting and ELISA.Co-immunoprecipitation was performed to explore the mechanism of DMQ-induced blocking of NLRP3 inflammasome activation.In a male C57BL/6J mouse model of LPS-induced septic shock treated with 20 and 40 mg/kg DMQ,the levels of IL-1β and TNF-α in the serum and peritoneal lavage fluid were determined using ELISA,and the survival time of the mice within 36 h was observed.Results Treatment with DMQ effectively inhibited LPS-induced activation of canonical NLRP3 inflammasome in mouse BMDM and human THP-1 cells and also inhibited non-canonical NLRP3 inflammasome activation in mouse BMDM,but produced no significant effect on AIM2 inflammasome activation.DMQ significantly blocked the binding between ASC and NLRP3.In the mouse models of septic shock,DMQ treatment significantly reduced the levels of IL-1β in the serum and peritoneal fluid and obviously prolonged survival time of the mice.Conclusion DMQ can effectively block ASC-NLRP3 interaction to inhibit NLRP3 inflammasome activation and alleviate LPS-induced septic shock in mice.
8.Clinical trial of nintedanib combined with tetrandrine in the treatment of patients with connective tissue disease-related pulmonary interstitial fibrosis
Dong-Ming YANG ; Jian-Jun NIE ; Wei REN ; Rui ZHANG ; Ben-Shang GONG ; Dong-Feng XU
The Chinese Journal of Clinical Pharmacology 2024;40(19):2781-2785
Objective To observe the influence of nintedanib ethanesulfonate soft capsules combined with tetrandrine tablets on pulmonary function and dyspnea symptoms in patients with connective tissue disease-related pulmonary interstitial fibrosis.Methods Patients with connective tissue disease-related pulmonary interstitial fibrosis were divided into treatment group and control group by cohort method.The control group was given basic treatment such as glucocorticoids and immunosuppressants according to the patient's condition;the treatment group was given ethanesulfonate nintedanib soft capsules(100 mg,bid)and tetrandrine tablets(40 mg,tid)on the basis of the control group,and the treatment course was 3 months.The clinical efficacy,severity of dyspnea[modified British Medical Research Council Dyspnea Scale(mMRC)and St.George's Respiratory Questionnaire(SGRQ)],pulmonary function indicators,pulmonary fibrosis score,and blood gas analysis indicators were compared between the two groups,and the safety was assessed.Results A total of 42 cases were included in the treatment group and the control group,respectively.The total effective rates of the treatment group and the control group were 92.86%(39 cases/42 cases)and 76.19%(32 cases/42 cases)respectively(P<0.05).After treatment,the mMRC scores of the treatment group and the control group were(1.43±0.27)and(1.69±0.31)points;the SGRQ scores were(46.51±4.39)and(51.08±4.76)points;the forced expiratory volume in one second(FEV1)values were(64.96±6.55)%and(58.67±5.01)%;the fibrosis scores were(1.12±0.14)and(1.26±0.18)points;the partial pressure of arterial oxygen values were(80.31±7.03)and(75.02±6.94)mmHg.The above indexes of the treatment group were compared with those of the control group,and the differences were statistically significant(all P<0.05).There were no adverse drug reactions in the treatment group,and the main adverse drug reactions in the control group were gastrointestinal discomfort.The total incidence rates of adverse drug reactions in the treatment group and the control group were 0 and 2.38%,respectively(P>0.05).Conclusion Compared with basic treatment,nintedanib ethanesulfonate soft capsules combined with tetrandrine tablets can better improve the pulmonary fibrosis degree and dyspnea degree in patients with connective tissue disease-related pulmonary interstitial fibrosis,and delay the decline of pulmonary function of patients.
9.Expert consensus on the evaluation and rehabilitation management of shoulder syndrome after neek dissection for oral and maxillofacial malignancies
Jiacun LI ; Moyi SUN ; Jiaojie REN ; Wei GUO ; Longjiang LI ; Zhangui TANG ; Guoxin REN ; Zhijun SUN ; Jian MENG ; Wei SHANG ; Shaoyan LIU ; Jie ZHANG ; Jicheng LI ; Yue HE ; Chunjie LI ; Kai YANG ; Zhongcheng GONG ; Qing XI ; Bing HAN ; Huaming MAI ; Yanping CHEN ; Jie ZHANG ; Yadong WU ; Chao LI ; Changming AN ; Chuanzheng SUN ; Hua YUAN ; Fan YANG ; Haiguang YUAN ; Dandong WU ; Shuai FAN ; Fei LI ; Chao XU ; Wei WEI
Journal of Practical Stomatology 2024;40(5):597-607
Neck dissection(ND)is one of the main treatment methods for oral and maxillofacial malignancies.Although ND type is in con-stant improvement,but intraoperative peal-pull-push injury of the accessory nerve,muscle,muscle membrane,fascia and ligament induced shoulder syndrome(SS)is still a common postoperative complication,combined with the influence of radiochemotherapy,not only can cause pain,stiffness,numbness,limited dysfunction of shoulder neck and arm,but also may have serious impact on patient's life quality and phys-ical and mental health.At present,there is still a lack of a systematic evaluation and rehabilitation management program for postoperative SS of oral and maxillofacial malignant tumors.Based on the previous clinical practice and the current available evidence,refer to the relevant lit-erature at home and abroad,the experts in the field of maxillofacial tumor surgery and rehabilitation were invited to discuss,modify and reach a consenusus on the etiology,assessment diagnosis,differential diagnosis,rehabilitation strategy and prevention of SS,in order to provide clinical reference.
10.CP-25 inhibits GRK2 activity to treat osteoarthritis in mice
Hui-Min WANG ; Xu-Lei WANG ; Zhu-Ping CHU ; Ting-Ting GUO ; Nuo XU ; Kang WANG ; Ying LI ; Wei WEI ; Shang-Xue YAN
Chinese Pharmacological Bulletin 2024;40(5):936-944
Aim To investigate the protective poten-tial of paeoniflorin 6-oxy-benzenesulfonate(CP-25)in preserving knee cartilage integrity in osteoarthritis mice through inhibition of GRK2 activity.Methods The posttraumatic osteoarthritis model was established fol-lowing DMM surgery.The experiment consisted of a sham operation group,a model group,a CP-25 admin-istration group,and a paroxetine positive control group.Intragastric administration commenced after the surgery.After 12 weeks of administration,the animals were euthanized.Micro-CT imaging was used to ob-serve the knee cartilage degeneration and abnormal bone remodeling,and the joint histopathology of mice was observed by staining with ferrubens solid green.Immunohistochemistry and immunofluorescence were used to detect the expression level of related molecules in cartilage tissue.Furthermore,Western blot was em-ployed to determine GRK2 and EP4 membrane protein expression levels as well as total protein levels of GRK2 and MMP13 following CP-25 treatment.Results Compared with the sham operation group,the articular cartilage in the model group was significantly degrad-ed,with the cartilage surface calcifying and osteo-phytes forming.CP-25 could significantly reduce the number of osteophytes and the thickness of the sub-chondral plate of articular cartilage,promote the regen-eration of the cartilage matrix,reduce the expression of cartilage matrix degradation protein,and have a signifi-cant protective effect on knee cartilage.Immunohisto-chemical and immunofluorescence results showed that compared with the model group,CP-25 treatment sig-nificantly decreased the expressions of GRK2,AD-AMTS5 and MMP13 in knee tissue and increased the expressions of Col Ⅱ and Aggrecan in knee tissue.The results of in vitro experiments showed that CP-25 ad-ministration could significantly reduce the expression levels of GRK2 membrane protein and total protein,in-crease the level of EP4 membrane protein,and de-crease the level of MMP13.Conclusions The ad-ministration of CP-25 can significantly promote the re-generation of articular cartilage matrix in OA mice,re-duce the degradation of cartilage matrix,and exhibit therapeutic effects on OA.The mechanism behind this is related to the inhibition of GRK2-mediated cartilage matrix metabolism.

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