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.Mechanism of Naoxintong Capsules Against Ischemia-reperfusion Injury in Rats via Inhibiting Pericyte Contraction Based on RHOA/ROCK1 Pathway
Yinlian WEN ; Jinfeng SHANG ; Bohong WANG ; Wanting WEI ; Xiaolu ZHANG ; Guijinfeng HUANG ; Xin LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(12):159-167
ObjectiveTo investigate the mechanism of Naoxintong capsules on ischemia-reperfusion (I/R) injury in rats based on the changes of pericytes mediated by Ras homolog family member A (RHOA)/Rho-associated coiled-coil containing protein kinase 1 (ROCK1) pathway. MethodsNinety rats (15 rats for each group) were randomly divided into a sham operation group, a model group, a positive control group receiving Ginkgo biloba extract (21.6 mg·kg-1), and groups receiving Naoxintong capsules at low, medium, and high doses of 55, 110, and 220 mg·kg-1 (NXT-L, NXT-M, and NXT-H groups), respectively. Except for those in the sham operation group, all rats were subjected to transient middle cerebral artery occlusion (tMCAO) to establish the experiment model. Nerve function was assessed using a neurological function score. Cerebral blood flow was detected using a laser speckle contrast imager, and the cerebral infarction rate was calculated using 2,3,5-Triphenyl tetrazolium chloride (TTC) staining. Pathological changes were observed by hematoxylin-eosin (HE) staining and Nissl staining, while pericyte morphology was observed via transmission electron microscopy. Blood-brain barrier destruction was observed by Evans blue staining. Albumin and ischemia-modified albumin levels were measured using assay kits. Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR) and Western blot were used to detect the mRNA and protein expression levels of RHOA, ROCK1, platelet-derived growth factor receptor β (PDGFRB), α-smooth muscle actin (α-SMA), tight junction protein (ZO-1), matrix metalloproteinase-2 (MMP-2), and matrix metalloproteinase-9 (MMP-9). ResultsCompared with the sham operation group, the model group exhibited decreased neurological function scores, higher percentage reduction in blood flow, and increased cerebral infarction rates (P<0.01). Additionally, cortical neuronal nucleus shrinkage, edema, a decreased number of Nissl bodies, reduced pericyte area, elevated albumin content in the cortex (P<0.05), and increased ischemic modified albumin levels (P<0.01) were observed. The mRNA and protein expression levels of RHOA, ROCK1, PDGFRB, α-SMA, MMP-2, and MMP-9 were increased (P<0.01), while those of ZO-1 were decreased. Compared with the model group, all treatment groups showed improved neurological function scores, lower percentage reduction in blood flow, reduced cerebral infarction rates (P<0.01), alleviated cortical histological changes, increased number of Nissl bodies, expanded pericyte area, decreased albumin content in the cortex, and reduced ischemia-modified albumin levels (P<0.01). The mRNA and protein expression levels of RHOA, ROCK1, PDGFRB, α-SMA, MMP-2, and MMP-9 were decreased (P<0.01), while those of ZO-1 were increased. Among the treatment groups, the NXT-M group showed the most pronounced improvement in cerebral I/R injury. ConclusionNaoxintong capsules can restore cerebral blood supply, reduce microcirculation disturbance, and protect blood-brain barrier in rats with I/R injury. Its mechanism of action may be related to the inhibition of the RHOA/ROCK1 signaling pathway and reduced pericyte contraction.
3.Mechanism of Naoxintong Capsules Against Ischemia-reperfusion Injury in Rats via Inhibiting Pericyte Contraction Based on RHOA/ROCK1 Pathway
Yinlian WEN ; Jinfeng SHANG ; Bohong WANG ; Wanting WEI ; Xiaolu ZHANG ; Guijinfeng HUANG ; Xin LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(12):159-167
ObjectiveTo investigate the mechanism of Naoxintong capsules on ischemia-reperfusion (I/R) injury in rats based on the changes of pericytes mediated by Ras homolog family member A (RHOA)/Rho-associated coiled-coil containing protein kinase 1 (ROCK1) pathway. MethodsNinety rats (15 rats for each group) were randomly divided into a sham operation group, a model group, a positive control group receiving Ginkgo biloba extract (21.6 mg·kg-1), and groups receiving Naoxintong capsules at low, medium, and high doses of 55, 110, and 220 mg·kg-1 (NXT-L, NXT-M, and NXT-H groups), respectively. Except for those in the sham operation group, all rats were subjected to transient middle cerebral artery occlusion (tMCAO) to establish the experiment model. Nerve function was assessed using a neurological function score. Cerebral blood flow was detected using a laser speckle contrast imager, and the cerebral infarction rate was calculated using 2,3,5-Triphenyl tetrazolium chloride (TTC) staining. Pathological changes were observed by hematoxylin-eosin (HE) staining and Nissl staining, while pericyte morphology was observed via transmission electron microscopy. Blood-brain barrier destruction was observed by Evans blue staining. Albumin and ischemia-modified albumin levels were measured using assay kits. Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR) and Western blot were used to detect the mRNA and protein expression levels of RHOA, ROCK1, platelet-derived growth factor receptor β (PDGFRB), α-smooth muscle actin (α-SMA), tight junction protein (ZO-1), matrix metalloproteinase-2 (MMP-2), and matrix metalloproteinase-9 (MMP-9). ResultsCompared with the sham operation group, the model group exhibited decreased neurological function scores, higher percentage reduction in blood flow, and increased cerebral infarction rates (P<0.01). Additionally, cortical neuronal nucleus shrinkage, edema, a decreased number of Nissl bodies, reduced pericyte area, elevated albumin content in the cortex (P<0.05), and increased ischemic modified albumin levels (P<0.01) were observed. The mRNA and protein expression levels of RHOA, ROCK1, PDGFRB, α-SMA, MMP-2, and MMP-9 were increased (P<0.01), while those of ZO-1 were decreased. Compared with the model group, all treatment groups showed improved neurological function scores, lower percentage reduction in blood flow, reduced cerebral infarction rates (P<0.01), alleviated cortical histological changes, increased number of Nissl bodies, expanded pericyte area, decreased albumin content in the cortex, and reduced ischemia-modified albumin levels (P<0.01). The mRNA and protein expression levels of RHOA, ROCK1, PDGFRB, α-SMA, MMP-2, and MMP-9 were decreased (P<0.01), while those of ZO-1 were increased. Among the treatment groups, the NXT-M group showed the most pronounced improvement in cerebral I/R injury. ConclusionNaoxintong capsules can restore cerebral blood supply, reduce microcirculation disturbance, and protect blood-brain barrier in rats with I/R injury. Its mechanism of action may be related to the inhibition of the RHOA/ROCK1 signaling pathway and reduced pericyte contraction.
4.Predictive Modeling of Symptomatic Intracranial Hemorrhage Following Endovascular Thrombectomy: Insights From the Nationwide TREAT-AIS Registry
Jia-Hung CHEN ; I-Chang SU ; Yueh-Hsun LU ; Yi-Chen HSIEH ; Chih-Hao CHEN ; Chun-Jen LIN ; Yu-Wei CHEN ; Kuan-Hung LIN ; Pi-Shan SUNG ; Chih-Wei TANG ; Hai-Jui CHU ; Chuan-Hsiu FU ; Chao-Liang CHOU ; Cheng-Yu WEI ; Shang-Yih YAN ; Po-Lin CHEN ; Hsu-Ling YEH ; Sheng-Feng SUNG ; Hon-Man LIU ; Ching-Huang LIN ; Meng LEE ; Sung-Chun TANG ; I-Hui LEE ; Lung CHAN ; Li-Ming LIEN ; Hung-Yi CHIOU ; Jiunn-Tay LEE ; Jiann-Shing JENG ;
Journal of Stroke 2025;27(1):85-94
Background:
and Purpose Symptomatic intracranial hemorrhage (sICH) following endovascular thrombectomy (EVT) is a severe complication associated with adverse functional outcomes and increased mortality rates. Currently, a reliable predictive model for sICH risk after EVT is lacking.
Methods:
This study used data from patients aged ≥20 years who underwent EVT for anterior circulation stroke from the nationwide Taiwan Registry of Endovascular Thrombectomy for Acute Ischemic Stroke (TREAT-AIS). A predictive model including factors associated with an increased risk of sICH after EVT was developed to differentiate between patients with and without sICH. This model was compared existing predictive models using nationwide registry data to evaluate its relative performance.
Results:
Of the 2,507 identified patients, 158 developed sICH after EVT. Factors such as diastolic blood pressure, Alberta Stroke Program Early CT Score, platelet count, glucose level, collateral score, and successful reperfusion were associated with the risk of sICH after EVT. The TREAT-AIS score demonstrated acceptable predictive accuracy (area under the curve [AUC]=0.694), with higher scores being associated with an increased risk of sICH (odds ratio=2.01 per score increase, 95% confidence interval=1.64–2.45, P<0.001). The discriminatory capacity of the score was similar in patients with symptom onset beyond 6 hours (AUC=0.705). Compared to existing models, the TREAT-AIS score consistently exhibited superior predictive accuracy, although this difference was marginal.
Conclusions
The TREAT-AIS score outperformed existing models, and demonstrated an acceptable discriminatory capacity for distinguishing patients according to sICH risk levels. However, the differences between models were only marginal. Further research incorporating periprocedural and postprocedural factors is required to improve the predictive accuracy.
5.Predictive Modeling of Symptomatic Intracranial Hemorrhage Following Endovascular Thrombectomy: Insights From the Nationwide TREAT-AIS Registry
Jia-Hung CHEN ; I-Chang SU ; Yueh-Hsun LU ; Yi-Chen HSIEH ; Chih-Hao CHEN ; Chun-Jen LIN ; Yu-Wei CHEN ; Kuan-Hung LIN ; Pi-Shan SUNG ; Chih-Wei TANG ; Hai-Jui CHU ; Chuan-Hsiu FU ; Chao-Liang CHOU ; Cheng-Yu WEI ; Shang-Yih YAN ; Po-Lin CHEN ; Hsu-Ling YEH ; Sheng-Feng SUNG ; Hon-Man LIU ; Ching-Huang LIN ; Meng LEE ; Sung-Chun TANG ; I-Hui LEE ; Lung CHAN ; Li-Ming LIEN ; Hung-Yi CHIOU ; Jiunn-Tay LEE ; Jiann-Shing JENG ;
Journal of Stroke 2025;27(1):85-94
Background:
and Purpose Symptomatic intracranial hemorrhage (sICH) following endovascular thrombectomy (EVT) is a severe complication associated with adverse functional outcomes and increased mortality rates. Currently, a reliable predictive model for sICH risk after EVT is lacking.
Methods:
This study used data from patients aged ≥20 years who underwent EVT for anterior circulation stroke from the nationwide Taiwan Registry of Endovascular Thrombectomy for Acute Ischemic Stroke (TREAT-AIS). A predictive model including factors associated with an increased risk of sICH after EVT was developed to differentiate between patients with and without sICH. This model was compared existing predictive models using nationwide registry data to evaluate its relative performance.
Results:
Of the 2,507 identified patients, 158 developed sICH after EVT. Factors such as diastolic blood pressure, Alberta Stroke Program Early CT Score, platelet count, glucose level, collateral score, and successful reperfusion were associated with the risk of sICH after EVT. The TREAT-AIS score demonstrated acceptable predictive accuracy (area under the curve [AUC]=0.694), with higher scores being associated with an increased risk of sICH (odds ratio=2.01 per score increase, 95% confidence interval=1.64–2.45, P<0.001). The discriminatory capacity of the score was similar in patients with symptom onset beyond 6 hours (AUC=0.705). Compared to existing models, the TREAT-AIS score consistently exhibited superior predictive accuracy, although this difference was marginal.
Conclusions
The TREAT-AIS score outperformed existing models, and demonstrated an acceptable discriminatory capacity for distinguishing patients according to sICH risk levels. However, the differences between models were only marginal. Further research incorporating periprocedural and postprocedural factors is required to improve the predictive accuracy.
6.Predictive Modeling of Symptomatic Intracranial Hemorrhage Following Endovascular Thrombectomy: Insights From the Nationwide TREAT-AIS Registry
Jia-Hung CHEN ; I-Chang SU ; Yueh-Hsun LU ; Yi-Chen HSIEH ; Chih-Hao CHEN ; Chun-Jen LIN ; Yu-Wei CHEN ; Kuan-Hung LIN ; Pi-Shan SUNG ; Chih-Wei TANG ; Hai-Jui CHU ; Chuan-Hsiu FU ; Chao-Liang CHOU ; Cheng-Yu WEI ; Shang-Yih YAN ; Po-Lin CHEN ; Hsu-Ling YEH ; Sheng-Feng SUNG ; Hon-Man LIU ; Ching-Huang LIN ; Meng LEE ; Sung-Chun TANG ; I-Hui LEE ; Lung CHAN ; Li-Ming LIEN ; Hung-Yi CHIOU ; Jiunn-Tay LEE ; Jiann-Shing JENG ;
Journal of Stroke 2025;27(1):85-94
Background:
and Purpose Symptomatic intracranial hemorrhage (sICH) following endovascular thrombectomy (EVT) is a severe complication associated with adverse functional outcomes and increased mortality rates. Currently, a reliable predictive model for sICH risk after EVT is lacking.
Methods:
This study used data from patients aged ≥20 years who underwent EVT for anterior circulation stroke from the nationwide Taiwan Registry of Endovascular Thrombectomy for Acute Ischemic Stroke (TREAT-AIS). A predictive model including factors associated with an increased risk of sICH after EVT was developed to differentiate between patients with and without sICH. This model was compared existing predictive models using nationwide registry data to evaluate its relative performance.
Results:
Of the 2,507 identified patients, 158 developed sICH after EVT. Factors such as diastolic blood pressure, Alberta Stroke Program Early CT Score, platelet count, glucose level, collateral score, and successful reperfusion were associated with the risk of sICH after EVT. The TREAT-AIS score demonstrated acceptable predictive accuracy (area under the curve [AUC]=0.694), with higher scores being associated with an increased risk of sICH (odds ratio=2.01 per score increase, 95% confidence interval=1.64–2.45, P<0.001). The discriminatory capacity of the score was similar in patients with symptom onset beyond 6 hours (AUC=0.705). Compared to existing models, the TREAT-AIS score consistently exhibited superior predictive accuracy, although this difference was marginal.
Conclusions
The TREAT-AIS score outperformed existing models, and demonstrated an acceptable discriminatory capacity for distinguishing patients according to sICH risk levels. However, the differences between models were only marginal. Further research incorporating periprocedural and postprocedural factors is required to improve the predictive accuracy.
7.Expert Consensus on Clinical Diseases Responding Specifically to Traditional Chinese Medicine: Perimenopausal Syndrome
Shiwan HU ; Haiyan LIANG ; Kun MA ; Xiaona MA ; Zihan FANG ; Wenpei BAI ; Xinmin LIU ; Hongtian LI ; Fengmei LIAN ; Wei ZHANG ; Lihua QIN ; Min SHANG ; Ailuan LAI ; Xiuxiang TENG ; Mei MO ; Xiaoxiao ZHANG ; Linhua ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(21):234-242
Perimenopausal syndrome (MPS), a common endocrine system disease, is one of the diseases responding specifically to traditional Chinese medicine (TCM). The China Association of Chinese Medicine organized experts in endocrinology, gynecology, and interdisciplinary fields of both Western and Chinese medicine to discuss the advantages and challenges of diagnosing and treating MPS with Western medicine, TCM, and integrative medicine. Experts at the conference believe that MPS is initiated by estrogen decline and rooted in deficiency, with the pathogenesis being imbalance between Yin and Yang in the kidney. The hormone replacement therapy in Western medicine for menopause can rapidly alleviate related symptoms by quickly restoring the estrogen level and timely detect and delay complications of menopause, whereas such a therapy has certain risks, necessitating close monitoring of adverse reactions. Moreover, the various contraindications and precautions limit the clinical application of the hormone replacement therapy. TCM has advantages in synergistically alleviating symptoms such as hot flashes, sweating, sleep disorders, and emotional abnormalities of MPS without causing obvious adverse reactions. However, its efficacy is slower than the hormone replacement therapy, and the TCM evidence for preventing and treating complications of menopause remains unclear. Three suggestions were proposed for the future development of both Western and TCM for ameliorating MPS. First, an integrated diagnosis and treatment system for MPS with both Western and Chinese medicine should be established. Second, high-quality evidence-based interventions for MPS should be developed with TCM alone or in combination with Western medicine. Third, efforts should be made to promote the new TCM drug development and the interdisciplinary cooperation for treating MPS.
8.Establishment and evaluation of a rapid PCR-colloidal gold test strip method for the detection of Fritillaria ussuriensis
Yu-he MA ; Cong-hui SHANG ; Qiu-he MA ; Tao LI ; Yue LIU ; Bei-zhen PAN ; Li-jun GAO ; Ming-cheng LI ; Wei XIA ; Yong-mei QU
Acta Pharmaceutica Sinica 2024;59(6):1773-1778
This study design of specific identification primers for the ITS2 sequence of
9.Expert consensus on the evaluation and management of dysphagia after oral and maxillofacial tumor surgery
Xiaoying LI ; Moyi SUN ; Wei GUO ; Guiqing LIAO ; Zhangui TANG ; Longjiang LI ; Wei RAN ; Guoxin REN ; Zhijun SUN ; Jian MENG ; Shaoyan LIU ; Wei SHANG ; Jie ZHANG ; Yue HE ; Chunjie LI ; Kai YANG ; Zhongcheng GONG ; Jichen LI ; Qing XI ; Gang LI ; Bing HAN ; Yanping CHEN ; Qun'an CHANG ; Yadong WU ; Huaming MAI ; Jie ZHANG ; Weidong LENG ; Lingyun XIA ; Wei WU ; Xiangming YANG ; Chunyi ZHANG ; Fan YANG ; Yanping WANG ; Tiantian CAO
Journal of Practical Stomatology 2024;40(1):5-14
Surgical operation is the main treatment of oral and maxillofacial tumors.Dysphagia is a common postoperative complication.Swal-lowing disorder can not only lead to mis-aspiration,malnutrition,aspiration pneumonia and other serious consequences,but also may cause psychological problems and social communication barriers,affecting the quality of life of the patients.At present,there is no systematic evalua-tion and rehabilitation management plan for the problem of swallowing disorder after oral and maxillofacial tumor surgery in China.Combining the characteristics of postoperative swallowing disorder in patients with oral and maxillofacial tumors,summarizing the clinical experience of ex-perts in the field of tumor and rehabilitation,reviewing and summarizing relevant literature at home and abroad,and through joint discussion and modification,a group of national experts reached this consensus including the core contents of the screening of swallowing disorders,the phased assessment of prognosis and complications,and the implementation plan of comprehensive management such as nutrition management,respiratory management,swallowing function recovery,psychology and nursing during rehabilitation treatment,in order to improve the evalua-tion and rehabilitation of swallowing disorder after oral and maxillofacial tumor surgery in clinic.
10.Expert consensus on cryoablation therapy of oral mucosal melanoma
Guoxin REN ; Moyi SUN ; Zhangui TANG ; Longjiang LI ; Jian MENG ; Zhijun SUN ; Shaoyan LIU ; Yue HE ; Wei SHANG ; Gang LI ; Jie ZHNAG ; Heming WU ; Yi LI ; Shaohui HUANG ; Shizhou ZHANG ; Zhongcheng GONG ; Jun WANG ; Anxun WANG ; Zhiyong LI ; Zhiquan HUNAG ; Tong SU ; Jichen LI ; Kai YANG ; Weizhong LI ; Weihong XIE ; Qing XI ; Ke ZHAO ; Yunze XUAN ; Li HUANG ; Chuanzheng SUN ; Bing HAN ; Yanping CHEN ; Wenge CHEN ; Yunteng WU ; Dongliang WEI ; Wei GUO
Journal of Practical Stomatology 2024;40(2):149-155
Cryoablation therapy with explicit anti-tumor mechanisms and histopathological manifestations has a long history.A large number of clinical practice has shown that cryoablation therapy is safe and effective,making it an ideal tumor treatment method in theory.Previously,its efficacy and clinical application were constrained by the limitations of refrigerants and refrigeration equipment.With the development of the new generation of cryoablation equipment represented by argon helium knives,significant progress has been made in refrigeration efficien-cy,ablation range,and precise temperature measurement,greatly promoting the progression of tumor cryoablation technology.This consensus systematically summarizes the mechanism of cryoablation technology,indications for oral mucosal melanoma(OMM)cryotherapy,clinical treatment process,adverse reactions and management,cryotherapy combination therapy,etc.,aiming to provide reference for carrying out the standardized cryoablation therapy of OMM.

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