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.The development and characteristics of general notice in Chinese Pharmacopoeia 2025 Edition
WANG Fei ; SONG Zonghua ; MA Shuangcheng ; SHU Rong
Drug Standards of China 2025;26(1):011-016
Objective: Introduce and briefly describe the status, characteristics, and writing ideas of general notice in the Chinese Pharmacopoeia 2025 edition, providing reference and suggestions for better understanding and implementation of the Chinese Pharmacopoeia 2025 edition.
Methods:This article elaborates on the content and revision of general notice in the Chinese Pharmacopoeia 2025 edition from the perspective of frame structure and main contents.
Results:Compared with other pharmacopoeias of various countries, Chinese Pharmacopoeia includes standards for traditional Chinese medicine, chemical drugs, biological products and excipients, pharmaceutical packaging materials, etc. Each section of Chinese Pharmacopoeia has its own general notice, with 34 to 48 items arranged in 11 to 12 chapters. Depending on the type of products included and the development history, the general notice in each section present differences in format and content. Given the importance and significance of the standards in Chinese Pharmacopoeia, it is necessary for the industry to coordinate and unify the general notice in various parts of Chinese Pharmacopoeia. With the introduction and revision of regulations, changes in the content of pharmacopoeias, and the application of new technologies, methods, and concepts in drug quality control, considering the unique characteristics of various drugs in quality control and supervision, Chinese Pharmacopoeia has comprehensively standardized relevant requirements. While taking into account the characteristics of the first, second, third, and fourth parts of the pharmacopoeia, it retains the characteristics of relative uniformity and the content of each part, achieving the unified standardization of the general rules of each general notice in the Chinese Pharmacopoeia 2025 edition and the coordination and consistency of common content.
Conclusion: The current version of Chinese Pharmacopoeia has undergone significant changes and improvements in both form and content. By introducing the overall situation and revised content of general notice in the Chinese Pharmacopoeia 2025 edition, pharmacopoeia users can have a deeper understanding of Chinese Pharmacopoeia and use it correctly.
3.Updates and amendments of the Chinese Pharmacopoeia 2025 Edition (Volume Ⅰ)
LI Hao ; SHEN Mingrui ; ZHANG Pang ; ZHAI Weimin ; NI Long ; HAO Bo ; ZHAO Yuxin ; HE Yi ; MA Shuangcheng ; SHU Rong
Drug Standards of China 2025;26(1):017-022
The Chinese Pharmacopoeia is the legal technical standard which should be followed during the research, production, use, and administration of drugs. At present, the new edition of the Chinese Pharmacopoeia is planned to be promulgated and implemented. This article summarizes and analyzes the main characteristics and the content of updates and amendments of the Chinese Pharmacopoeia 2025 Edition(Volume Ⅰ), to provide a reference for the correct understanding and accurate implementation the new edition of the pharmacopoeia.
4.Pharmacological effects of Yindan Pinggan capsules in treating intrahepatic cholestasis
Shu-xin CAO ; Feng HUANG ; Fang WU ; Rong-rong HE
Acta Pharmaceutica Sinica 2025;60(2):417-426
This study aimed to investigate the therapeutic effect of Yindan Pinggan capsules (YDPG) on intrahepatic cholestasis (IHC) through animal experiments, while utilizing network pharmacology and molecular docking techniques to explore its potential mechanisms. Initially, the therapeutic effect of YDPG on an
5.Research progress of NLRP3 inflammasome inhibitors
Chen-Guang LI ; Feng-Yi MAI ; Jing-Rong LIANG ; Wen-Tao YANG ; Jie GUO ; Jun-Xiang SHU ; Li-Zu XIAO
Chinese Pharmacological Bulletin 2024;40(10):1801-1808
NLRP3 can recruit proteins such as ASC and pro-caspase1 to form NLRP3 inflammasomes after being stimulated by pathogen and danger signals in vivo,and then induce pyropto-sis and promote the inflammatory reactions to maintain the home-ostasis.However,the overactivation of NLRP3 inflammasomes is closely related to many inflammatory and autoimmune diseases in humans.Targeted inhibition of NLRP3 inflammasomes can sig-nificantly inhibit inflammation and alleviate the relative symp-toms.Therefore,it is an important research direction for treating diseases of NLRP3 inflammasome that searching for effective in-hibitors targeting NLRP3 inflammasome activation and achieving clinical transformation.This review summarizes the latest re-search progress based on the sources of NLRP3 inflammasome inhibitors.
6.Detection of Neoehrlichia mikurensis in rodents on the basis of the groEL gene in Yunnan commensal rodent plague foci
Rong WEI ; Zi-Wei LI ; Yun-Yan LUO ; Na WANG ; Shu-Qing LIU ; Jin-Chun LI ; Jiang-Li LU ; Jia-Xiang YIN
Chinese Journal of Zoonoses 2024;40(7):689-695
The purpose of this study was to understand the prevalence of Neoehrlichia mikurensis in rodents in Yunnan commensal rodent plague foci.Lianghe Country,Mangshi City,and Mile City in Yunnan Province were chosen as sampling sites,where rodents were captured with dead-traps.The N.mikurensis groEL gene in rodent spleen samples was detected with nested PCR,and the positive products were sequenced with Sanger bidirectional assays.The infection rate of N.mikurensis a-mong plague foci,habitats,species,and sexes was compared with Chi-square tests or Fisher's exact probability method.Of 656 rodent spleen samples,12 N.mikurensis positive samples were detected in R.tanezumi,R.sladeni,N.confucianus,and B.bowersi.The positivity rate was 1.83%.No significant difference in the N.mikurensis positivity rate was observed a-mong plague foci,habitats,species,and sexes(P>0.05).Genetic evolution analysis of the groEL gene indicated that the se-quence similarity of nucleic acid sequences in 12 positive samples was 99.5%-100%,and the nucleic acid sequences of N.mikurensis were in the same branch,belonging to cluster Ⅳ.Thus,four species of rodents were found to have low frequency infection with N.mikurensis in Yunnan commensal rodent plague foci.
7.Effect of Houpu Sanwu decoction on exosomes in colorectal cancer model mice based on Rab27a
Shu CHEN ; Jinglei ZHANG ; Kang RONG ; Nan ZHANG ; Weiyi SUN
Chinese Journal of Comparative Medicine 2024;34(10):18-27
Objective To investigate the effect and mechanism of Houpu Sanwu decoction on subcutaneous tumors in C57BL/6J mice.Methods Mouse colorectal cancer MC-38 cells were injected subcutaneously into C57BL/6J mice to establish a subcutaneous tumor model of colorectal cancer.The model mice were then divided randomly into model control,Houpu Sanwu decoction(HPSWD)low dose,HPSWD medium dose,HPSWD high dose,5-fluorouracil(5-FU),and combination groups(5-FU+HPSWD medium dose)(n=6 mice per group).The mice were treated with normal saline and Houpu Sanwu decoction by gavage,or normal saline and 5-FU by intraperitoneal injection once a day for 24 consecutive days.During the intervention period,the mental state,diet,and other general conditions of the mice,as well as changes in tumor volume,were monitored regularly.At the end of the experiment,the subcutaneous tumors in each group were removed and weighed,and pathological features were examined by hematoxylin and eosin staining.Transmission electron microscopy,Western blot,and nanoparticle tracking analysis were used to identify exosomes derived from colorectal cancer tissues.Tumor mRNA and protein expression levels of Rab27a and the exosome markers CD63,TSG101,and ALIX were detected by reverse transcription-quantitative polymerase chain reaction and Western blot,respectively.Results Houpu Sanwu decoction inhibited tumor growth in mice.Tumor growth was inhibited to varying degrees in all the HPSWD dose groups and in the combination group.The HPSWD medium does group showed the greatest anticancer effect,and the combination group showed a synergistic effect with 5-FU.Houpu Sanwu decoction induced tumor necrosis in a dose-dependent manner,with a similar anticancer effect to 5-FU.Houpu Sanwu decoction also inhibited the protein and mRNA expression levels of Rab27a and the exosome-specific markers CD63,ALIX,and TSG101 in mice.Conclusions Houpu Sanwu decoction inhibits tumor growth and the secretion of exosomes,possibly by regulating Rab27a.
8.Protective effect of Naru-3 on collagen-induced arthritis in rats
Hai-Yue ZHAO ; Xiao-Shan ZHANG ; Sha-Sha DUAN ; Yi-Lu SHI ; Min-Jie ZHANG ; Shu-Rong YUN ; Ya-Xi WANG
Chinese Traditional Patent Medicine 2024;46(6):1842-1849
AIM To investigate the protective effect of Mongolian medicine Naru-3 on rat rheumatoid arthritis(RA)using imaging method.METHODS With the rats divided into the normal group,the model group,the positive medicine group,and the low,medium and high dose Naru-3 groups(0.1,0.2 and 0.4 g/kg),the rat model of collagen-induced arthritis(CIA)was established by immune induction method.After 4 weeks of corresponding drug administration,the rats had their changes of arthritis index(AI)level and body weight observed;their serum levels of VEGF,TNF-α and IL-1 detected by ELISA;their synovial hyperplasia and neovascularization evaluated by high-frequency ultrasound and contrast-enhanced ultrasound(CEUS);their bone destruction of ankle joint evaluated by X-ray and high-resolution micro-CT;and their synovial membrane and expressions of CD31,VEGF,TNF-α and IL-1 β observed by HE and immunohistochemistry.RESULTS Compared with the model group,the Naru-3 groups displayed increased rat weight(P<0.05);no significantly changed AI score(P>0.05);and overally decreased levels of serum VEGF,TNF-α,synovial membrane thickness,blood flow signal by power Doppler imaging(PDI)and contrast intensity revealed,X-ray score,and CD31 expression(P<0.05),in addition to the decreased level of IL-1 and HE score in high-dose group(P<0.05).CONCLUSION Naru-3 is protective to the joint tissue in rat model of RA through alleviating synovitis,bone erosion and delaying the progress of the disease by inhibiting synovial neovascularization and inflammatory cytokines.
9.Clinicopathologic characteristics and survival analysis of primary large B-cell lymphoma of the central nervous system
Qifan XU ; Rong SHEN ; Yige SHEN ; Yiwen CAO ; Ying QIAN ; Pengpeng XU ; Shu CHENG ; Li WANG ; Weili ZHAO
Chinese Journal of Hematology 2024;45(5):481-487
Objective:To retrospectively analyze the clinical and pathologic characteristics, response to treatment, survival, and prognosis of patients with primary large B-cell lymphoma of the central nervous system (PCNSLBCL) .Methods:Clinical and pathologic data of 70 patients with PCNSLBCL admitted to Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine from December 2010 to November 2022 were collected for retrospective analysis. Survival analysis was performed using the Kaplan-Meier method and log-rank test, and prognosis analysis was conducted using the Cox proportional hazards model.Results:Among 70 patients with PCNSLBCL, complete remission (CRs) were achieved in 49 (70.0% ) and partial remission in 4 (5.7% ) after the first-line induction therapy; the overall remission rate was 75.7%. The 2-year progression-free survival (PFS) rate was 55.8% and the median progression-free survival (mPFS) time was 35.9 months, whereas the 2-year overall survival (OS) rate was 79.1% with a median OS time not reached. After CR induced by first-line therapy, cumulative incidence of relapse (CIR) was lower in patients who had received auto-HSCT than in those who had not received consolidation therapy ( P=0.032), whose 2-year PFS rate was 54.4% and mPFS time was 35.9 months; comparatively, the 2-year PFS rate in patients having received oral maintenance of small molecule drugs reached 84.4% with a mPFS time of 79.5 months ( P=0.038). Multivariant analysis demonstrated that Class 3 in the Memorial Sloan-Kettering Cancer Center (MSKCC) prognostic model is an independent adverse prognostic factor of OS in patients with PCNSLBCL ( HR=3.127, 95% CI 1.057-9.253, P=0.039) . Conclusions:In patients with PCNSLBCL achieving CR after the first-line induction therapy, auto-HSCT as consolidation therapy would lead to a decreased CIR, and PFS time could be prolonged by oral maintenance of small molecule drugs. Class 3 MSKCC prognostic model is independently associated with poorer OS.
10.Acute heart failure in a neonate
Shu-Juan LI ; Li-Yuan HU ; Rong ZHANG ; Lin YANG ; Li XI ; Fang LIU ; Yun CAO ; Wen-Hao ZHOU ; Guo-Qiang CHENG
Chinese Journal of Contemporary Pediatrics 2024;26(3):321-324,封3
The male patient,one day old,was admitted to the hospital due to hypoglycemia accompanied by apnea appearing six hours after birth.The patient had transient hypoglycemia early after birth,and acute heart failure suddenly occurred on the eighth day after birth.Laboratory tests showed significantly reduced levels of adrenocorticotropic hormone and cortisol,and pituitary magnetic resonance imaging was normal.Genetic testing results showed that the patient had probably pathogenic compound heterozygous mutations of the TBX19 gene(c.917-2A>G+c.608C>T),inherited respectively from the parents.The patient was conclusively diagnosed with congenital isolated adrenocorticotropic hormone deficiency caused by mutation of the TBX19 gene.Upon initiating hydrocortisone replacement therapy,cardiac function rapidly returned to normal.After being discharged,the patient continued with the hydrocortisone replacement therapy.By the 18-month follow-up,the patient was growing and developing well.In neonates,unexplained acute heart failure requires caution for possible endocrine hereditary metabolic diseases,and timely cortisol testing and genetic testing should be conducted.[Chinese Journal of Contemporary Pediatrics,2024,26(3):321-324,V]

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