1.Brief introduction on the development of Chinese Pharmacopoeia 2025 Edition
HONG Xiaoxu ; SONG Zonghua ; MA Shuangcheng ; LAN Fen ; SHU Rong
Drug Standards of China 2025;26(1):001-010
The Pharmacopoeia of the People’s Republic of China 2025 edition is to be issued in March 2025. Chinese Pharmacopoeia is the basic requirements on the drug manufacture, drug testing, drug use and drug administration. The new edition Chinese Pharmacopoeia will be dramatically improved on the pharmacopoeia monographs included, establishing the standards system, standards conversion and application of drug quality control for the new technology, new method & new tool, drug control on the safety and effectiveness as well as the drug standard international harmonization. It will take important role on improving the drug quality, ensuring the safety of drugs for public use, strengthen technical support for drug administration, promoting the high-quality development of China’s medical and pharmaceutical industry. This paper introduces the development and revision of the Chinese Pharmacopoeia 2025 Edition,aim at helping the industries well understanding and implantation the new edition Chinese Pharmacopoeia.
2.Changes and Trends in the microbiological-related standards in the Chinese Pharmacopoeia 2025 Edition
FAN Yiling ; ZHU Ran ; YANG Yan ; JIANG Bo ; SONG Minghui ; WANG Jing ; LI Qiongqiong ; LI Gaomin ; WANG Shujuan ; SHAO Hong ; MA Shihong ; CAO Xiaoyun ; HU Changqin ; MA Shuangcheng, ; YANG Meicheng
Drug Standards of China 2025;26(1):093-098
Objective: To systematically analyze the revisions content and technological development trends of microbiological standards in the Chinese Pharmacopoeia (ChP) 2025 Edition, and explore its novel requirements in risk-based pharmaceutical product lifecycle management.
Methods: A comprehensive review was conducted on 26 microbiological-related standards to summarize the revision directions and scientific implications from perspectives including the revision overview, international harmonization of microbiological standards, risk-based quality management system, and novel tools and methods with Chinese characteristics.
Results: The ChP 2025 edition demonstrates three prominent features in microbiological-related standards: enhanced international harmonization, introduced emerging molecular biological technologies, and established a risk-based microbiological quality control system.
Conclusion: The new edition of the Pharmacopoeia has systematically constructed a microbiological standard system, which significantly improves the scientificity, standardization and applicability of the standards, providing a crucial support for advancing the microbiological quality control in pharmaceutical industries of China.
3.Jianpi Yiqi Prescription Inhibits Proliferation and Invasion of Hepatic Carcinoma Cells by Targeting PTPN1
Shanshan SUN ; Jing HONG ; Shufan SONG ; Zongxi SUN ; Chao WANG ; Shaoyuan ZHUO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(3):80-88
ObjectiveTo investigate the key targets of Jianpi Yiqi prescription (JYP) in the treatment of hepatocellular carcinoma (HCC) based on network pharmacology and explore the effect of JYP on the invasion and proliferation of hepatocellular carcinoma cells via protein tyrosine phosphatase, non-receptor type 1 (PTPN1) by bioinformatics analysis and CRISPR/Cas9. MethodsThe potential targets of JYP in the treatment of HCC were retrieved from the Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform (TCMSP), SwissTargetPrediction, GeneCards, NCBI, and CTD. Additionally, the active components of JYP that could interact with PTPN1 were screened out, and then molecular docking between the targets and active components was performed in Autodock 4.0. UALCAN, HPA, and LinkedOmics were used to analyze the expression of PTPN1 in the HCC tissue, and the relationship of PTPN1 expression with the overall survival (OS) of HCC patients was discussed. CRISPR/Cas9 was used to knock down the expression of PTPN1 in HepG2 and SK-hep-1 cells, and the knockdown effect was examined by sequencing, Real-time PCR, and Western blot. HepG2 cells were classified into blank control, low-, medium-, and high-dose JYP (5.25, 10.5, 21 g·kg-1), and PTPN1 knockout groups. Real-time PCR and Western blot were employed to determine the mRNA and protein levels, respectively, of PTPN1 in HepG2 cells of each group. The effects of JYP and PTPN1 knockdown on the proliferation, invasion, and apoptosis of HepG2 cells were detected by Cell Counting Kit-8 (CCK-8), Transwell, and Annexin V-FITC/PI methods, respectively. ResultsJYP had the most active components targeting PTPN1, and 31 of the active components had the binding energy less than -5.0 kcal·mol-1 in molecular docking. The mRNA and protein levels of PTPN1 in the HCC tissue were higher than those in the normal tissue (P<0.01). Compared with that in the normal tissue, the mRNA level of PTPN1 in the HCC tissue was up-regulated at the pathological stages Ⅰ-Ⅲ and grades G1-G3 (P<0.01), and it was not significantly up-regulated at the stage Ⅳ or grade G4. The mRNA level of PTPN1 in the TP53-mutated HCC tissue was higher than that in the TP53-unmutated HCC tissue (P<0.01). The high mRNA level of PTPN1 was associated with the OS reduction (P<0.01). After treatment with the JYP-containing serum or knockdown of PTPN1, HepG2 cells demonstrated decreased proliferation and invasion and increased apoptosis (P<0.01). ConclusionPTPN1 may be one of the core targets of JYP in the treatment of HCC. It is highly expressed in the HCC tissue and cells, which is associated with the poor prognosis of patients. The expression level of PTPN1 is significantly up-regulated in the HCC tissue of the patients with TP53 mutation. However, TP53 mutation or deletion does not affect the expression of PTPN1 in HCC cells. JYP can significantly down-regulate the expression of PTPN1 to inhibit the proliferation and invasion and promote the apoptosis of HCC cells.
4.Role of prohibitin 2 in mitophagy pathway against atherosclerosis in rats undergoing endurance training
Mingxiao SONG ; Junshunzi CHEN ; Ningwei WANG ; Huan CAI ; Hong FENG
Chinese Journal of Tissue Engineering Research 2025;29(11):2294-2300
BACKGROUND:Exercises can reduce blood lipids and slow down the development of atherosclerosis.Atherosclerosis begins with mitochondrial dysfunction,and prohibitin 2 is involved in mitophagy by endurance training. OBJECTIVE:To explore the role of endurance training in the intervention of prohibitin 2 protein in the mitophagy autophagy pathway in atherosclerosis. METHODS:A total of 40 Wistar rats were randomly divided into control group,exercise group,atherosclerosis group and atherosclerosis combined with exercise group,with 10 rats in each group.A rat model of atherosclerosis was constructed by combining a high-fat diet(9 weeks)with vitamin D injections(weeks 1,3,and 6)in the latter two groups,while the two exercise groups were subjected to progressing intensity endurance training for 9 weeks.After the intervention,lipid and pathological detections were conducted to observe the modeling and interventional effects.Mitochondrial membrane potential and mitophagy proteins were detected by microplate reader and western blot.Immunofluorescence staining was used to observe the co-localization of mitophagy proteins in aortic tissue. RESULTS AND CONCLUSION:Lipid and pathological sections showed that compared with the atherosclerosis group,the serum low-density lipoprotein cholesterol and total cholesterol levels and aortic lipid deposition area were significantly reduced in the atherosclerosis combined with exercise group(P<0.001).The results of mitochondrial membrane potential showed that the significant decrease in mitochondrial membrane potential of the aorta in the atherosclerosis combined with exercise group was reversed(P<0.01).The results of western blot assay showed that compared with the control group,the mitochondrial protein expression of prohibitin 2,LC3Ⅱ/Ⅰ,PINK1 and Parkin was significantly increased(P<0.05),and the protein expression of PARL and PGAM5 decreased(P<0.05).Compared with the atherosclerosis group,the protein expression of PINK1 and Parkin in the mitchondria of rats in the atherosclerosis combined with exercise group was significantly decreased(P<0.05),and the protein expressions of prohibitin 2,LC3Ⅱ/Ⅰ,PARL and PGAM5 were significantly increased(P<0.05).Immunofluorescence results showed that compared with the control group,the co-localization of LC3 and PINK1 with TOMM20 was significantly increased in the atherosclerosis group(P<0.05),while compared with the atherosclerosis group,the co-localization of LC3 and PINK1 with TOMM20 was significantly increased in the atherosclerosis combined with exercise group(P<0.05).Co-localization of LC3 and PARL with prohibitin 2 was significantly increased in the atherosclerosis group compared with the control group(P<0.01),co-localization of LC3 with prohibitin 2 was significantly increased in the atherosclerosis combined with exercise group compared with the atherosclerosis group(P<0.01),and co-localization of PARL protein with prohibitin 2 was significantly decreased in the atherosclerosis combined with exercise group compared with the atherosclerosis group(P<0.01).To conclude,endurance training can induce the expression of prohibitin 2 in the inner mitochondrial membrane and promote the binding of prohibitin 2 to the mitophagy junction protein to complete mitophagy,restore mitochondrial function,and slow down the occurrence of atherosclerosis.
5.Use of Miniscrew-assisted Rapid Palatal Expansion in Children: Case Reports
Yoo Jin LEE ; Hyuntae KIM ; Ji-Soo SONG ; Teo Jeon SHIN ; Hong-Keun HYUN ; Young-Jae KIM ; Jung-Wook KIM ; Ki-Taeg JANG
Journal of Korean Academy of Pediatric Dentistry 2025;52(2):239-252
The use of miniscrew-assisted rapid palatal expansion (MARPE) has yielded successful outcomes in late adolescence and early adulthood, particularly in correcting transverse maxillary discrepancies and enhancing airway expansion. This report presents three cases of children at different dentition stages treated with MARPE. In one patient with severe crowding, MARPE enabled dental alignment without the need for premolar extractions. Additionally, MARPE combined with facemask therapy improved the patient’s facial profile, resulting in high patient and guardian satisfaction. These cases highlight MARPE’s potential as an effective treatment for maxillary discrepancies and severe arch length discrepancies in children.
6.Personalizing perioperative therapy in muscle-invasive bladder cancer: balancing oncologic benefit, toxicity, and the risk of overtreatment
Geehyun SONG ; Whi-An KWON ; Eui Hyun JUNG ; Dai Hong PHUC VO ; Ho Trong TAN TRUONG ; Ho Kyung SEO
Journal of the Korean Medical Association 2025;68(4):215-227
Muscle-invasive bladder cancer (MIBC) is an aggressive cancer with a high recurrence risk due to micrometastases. Standard treatment, neoadjuvant cisplatin-based chemotherapy followed by radical cystectomy, is not suitable for all patients, with many being ineligible or experiencing recurrence, alongside significant toxicity concerns.Current Concepts: The introduction of immune checkpoint inhibitors (ICIs) into the perioperative setting —including neoadjuvant ICI use in cisplatin-ineligible patients, adjuvant ICI use in high-risk individuals, and chemoimmunotherapy in either the preoperative or postoperative period—has demonstrated promising clinical outcomes. Additionally, bladder preservation strategies are currently under investigation in select patients who exhibit favorable treatment responses, aiming to maintain quality of life without compromising oncologic outcomes. Nevertheless, challenges such as overtreatment, long-term toxicity, and immune-related adverse events remain significant, underscoring the necessity for precise patient selection.Discussion and Conclusion: To personalize perioperative management of MIBC, it is essential to develop and clinically implement robust predictive biomarkers. Assessment of molecular residual disease using circulating tumor DNA is emerging as a promising method to stratify risk, guide adjuvant treatment decisions, and monitor therapeutic response in real time. Future research should prioritize the validation of these biomarkers, refinement of patient selection criteria for bladder preservation strategies, and evaluation of novel therapeutic agents such as antibody-drug conjugates and fibroblast growth factor receptor inhibitors in the perioperative setting. Ultimately, adopting a precision oncology approach will be critical for balancing oncologic efficacy with toxicity management and achieving patient-centered outcomes.
7.Incidence of complicated appendicitis before and after the COVID-19 pandemic: a comparative analysis
Haksoo KIM ; Dongkil JEONG ; Young Soon CHO ; Geum Jong SONG ; Hyung Jun MOON ; Tae Yong SHIN ; Dong Wook LEE ; Hyun Joon KIM ; Hyun Jung LEE ; Sun In HONG
Journal of the Korean Society of Emergency Medicine 2025;36(1):12-19
Objective:
It has been 1 year since the start of the worldwide coronavirus disease-19 (COVID-19) pandemic. This study analyzed the indirect effects of COVID-19 on treating patients with non-infectious diseases by comparing the incidence of complicated appendicitis before and after the pandemic.
Methods:
The target group included patients aged at least 16 years diagnosed with acute appendicitis between February 23 and July 31, 2020. Patients diagnosed during the same period in 2019 were selected as the control group. The differences in the incidence of complicated appendicitis before and after COVID-19 were investigated, and the association with various variables was analyzed using the odds ratios and 95% confidence intervals (CIs).
Results:
The study included 120 subjects in 2019 (pre-COVID group) and 119 cases in 2020 (post-COVID group). The pre-COVID group included 25 cases (20.8%) of complicated appendicitis, while the post-COVID group included 48 cases (40.3%). The median time from symptom onset to visit (pre-hospital time) increased from 15 to 22 hours, and the median time from the visit to surgery (in-hospital time) increased from 7 to 11 hours. Multivariate regression analysis of the three variables revealed odds ratios (95% CIs) of pre-hospital time, erythrocyte sedimentation rate, and inclusion in the post-COVID group of 1.02 (1.01-1.02), 2.07 (1.11-3.86), and 2.15 (1.12-4.11), respectively.
Conclusion
The incidence of complicated appendicitis increased after the COVID-19 pandemic. Therefore, a healthcare system that can minimize the delay in treating non-infectious emergency patients is needed.
8.Early Administration of Nelonemdaz May Improve the Stroke Outcomes in Patients With Acute Stroke
Jin Soo LEE ; Ji Sung LEE ; Seong Hwan AHN ; Hyun Goo KANG ; Tae-Jin SONG ; Dong-Ick SHIN ; Hee-Joon BAE ; Chang Hun KIM ; Sung Hyuk HEO ; Jae-Kwan CHA ; Yeong Bae LEE ; Eung Gyu KIM ; Man Seok PARK ; Hee-Kwon PARK ; Jinkwon KIM ; Sungwook YU ; Heejung MO ; Sung Il SOHN ; Jee Hyun KWON ; Jae Guk KIM ; Young Seo KIM ; Jay Chol CHOI ; Yang-Ha HWANG ; Keun Hwa JUNG ; Soo-Kyoung KIM ; Woo Keun SEO ; Jung Hwa SEO ; Joonsang YOO ; Jun Young CHANG ; Mooseok PARK ; Kyu Sun YUM ; Chun San AN ; Byoung Joo GWAG ; Dennis W. CHOI ; Ji Man HONG ; Sun U. KWON ;
Journal of Stroke 2025;27(2):279-283
9.Low-Density Lipoprotein Cholesterol Level, the Lower the Better? Analysis of Korean Patients in the Treat Stroke to Target Trial
Hanim KWON ; Jae-Chan RYU ; Jae-Kwan CHA ; Sang Min SUNG ; Tae-Jin SONG ; Kyung Bok LEE ; Eung-Gyu KIM ; Yong-Won KIM ; Ji Hoe HEO ; Man Seok PARK ; Kyusik KANG ; Byung-Chul LEE ; Keun-Sik HONG ; Oh Young BANG ; Jei KIM ; Jong S. KIM
Journal of Stroke 2025;27(2):228-236
Background:
and Purpose The Treat Stroke to Target (TST) was a randomized clinical trial involving French and Korean patients demonstrating that a lower low-density lipoprotein cholesterol (LDL-C, <70 mg/dL) target group (LT) experienced fewer cerebro-cardiovascular events than a higher target (90–110 mg/dL) group (HT). However, whether these results can be applied to Asian patients with different ischemic stroke subtypes remains unclear.
Methods:
Patients from 14 South Korean centers were analyzed separately. Patients with ischemic stroke or transient ischemic attack with evidence of atherosclerosis were randomized into LT and HT groups. The primary endpoint was a composite of ischemic stroke, myocardial infarction, coronary or cerebral revascularization, and cardiovascular death.
Results:
Among 712 enrolled patients, the mean LDL-C level was 71.0 mg/dL in 357 LT patients and 86.1 mg/dL in 355 HT patients. The primary endpoint occurred in 24 (6.7%) of LT and in 31 (8.7%) of HT group patients (adjusted hazard ratio [HR]=0.78; 95% confidence interval [CI]=0.45–1.33, P=0.353). Cardiovascular events alone occurred significantly less frequently in the LT than in the HT group (HR 0.26, 95% CI 0.09–0.80, P=0.019), whereas there were no significant differences in ischemic stroke events (HR 1.12, 95% CI 0.60–2.10, P=0.712). The benefit of LT was less apparent in patients with small vessel disease and intracranial atherosclerosis than in those with extracranial atherosclerosis.
Conclusion
In contrast to the French TST, the outcomes in Korean patients were neutral. Although LT was more effective in preventing cardiovascular diseases, it was not so in stroke prevention, probably attributed to the differences in stroke subtypes. Further studies are needed to elucidate the efficacy of statins and appropriate LDL-C targets in Asian patients with stroke.
10.Use of Miniscrew-assisted Rapid Palatal Expansion in Children: Case Reports
Yoo Jin LEE ; Hyuntae KIM ; Ji-Soo SONG ; Teo Jeon SHIN ; Hong-Keun HYUN ; Young-Jae KIM ; Jung-Wook KIM ; Ki-Taeg JANG
Journal of Korean Academy of Pediatric Dentistry 2025;52(2):239-252
The use of miniscrew-assisted rapid palatal expansion (MARPE) has yielded successful outcomes in late adolescence and early adulthood, particularly in correcting transverse maxillary discrepancies and enhancing airway expansion. This report presents three cases of children at different dentition stages treated with MARPE. In one patient with severe crowding, MARPE enabled dental alignment without the need for premolar extractions. Additionally, MARPE combined with facemask therapy improved the patient’s facial profile, resulting in high patient and guardian satisfaction. These cases highlight MARPE’s potential as an effective treatment for maxillary discrepancies and severe arch length discrepancies in children.

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