2.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.
3.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.
4.A retrospective study on management of gross hematuria in autosomal dominant polycystic kidney disease patients
Yiyi MA ; Dongping CHEN ; Changlin MEI ; Shengqiang YU ; Shu RONG ; Tong ZHANG ; Lin LI
Chinese Journal of Nephrology 2012;28(6):439-443
Objective To seauch the ideal management for gross hematuria in autosomal dominant polycystic kidney disease (ADPKD).Methods ADPKD patients who were ever hospitalized and followed up in our department since 1993 were enrolled in the study.Demographic and clinical data were colloected,such as gender,age of gross hematuria,level of renal function,causative factors,management strategies,duration of gross hematuria,blood platelet count,activated partial thromboplastin time,prothrombin time,international normalized ratio,size of kidney cyst and so on.ADPKD patients were divided into different groups according to causative factors or management.The clinical data were compared among groups.Results A total of 905 ADPKD patients were screened,among whom 279 patients ever had gross hematuria (male/female:150/129),One hundred and forty-six patients had integrated therapeutic process records,while only 101patients could provide relevant laboratory examination results.In these 101 patients,gross hematuria was found in any stage of chronic kidney disease (CKD); the average eGFR was (56.4±44.1) mml·min-1 ·(1.73 m2)-1; the duration of gross hematuria was (8.8±8.0) d; no significant difference between male and female in duration of gross hematuria existed [(8.2±7.3) d vs (9.5±8.8) d,P=0.426]; coagulation parameters were all normal.The platelet count was also normal in 91 patients.Duration of gross hematuria among groups divided according to different causative factors was significantly different (P<0.05).The patients in bed rest group had significantly shorter duration of gross hematuria compared with other groups (P<0.05).The platelet count,prothromhin time and international normalized ratio were all at similar level in different groups.Conclusions The causative factors in ADPKD patients with gross hematuria should be confirmed as the first step of management strategies.Bed rest is the key point in management.Antifibrinolytic agent is a proper choice in the cases receiving bemostatic drugs.It is unnecessary to use antibiotic agent for prevention.
5.Evaluation of analytical performance of open automatic biochemistry analysis systems measuring cholesterol
Chuanbao ZHANG ; Haijian ZHAO ; Rong MA ; Jiangtao ZHANG ; Shu WANG ; Wenxiang CHEN
Chinese Journal of Laboratory Medicine 2013;36(9):801-805
Objective to evaluate the analytical performance of 7 open automatic biochemistry analysis systems in terms of precision,linearity,anti-interference ability and trueness on determination of cholesterol.Methods Performance verification test.There were 7 open analysis measurement systems composed of 7 kits as well as calibrators from Biosina,Baiding,Fosun,Dongou,Kehua,Maker and Wako company respectively,and Hitachi 7170 automatic analyzer were chosen as test systems.The repeatability CV and inter-lab CV were assessed according to Clinical and Laboratory Standards Institute (CLSI) protocol EP5-A2.The linearity range was evaluated on the basis of CLSI EP6-A,the series concentrations of cholesterol were 0,2.07,4.14,6.21,8.28,10.35,12.93,20.69 and 25.86 mmol/L cholesterol.Hemoglobin,ascorbic acid (vitamin C) and intralipid were applied as interfere materials in interference testing according to CLSI EP7-A2.The trueness was evaluated on the basis of China national lipids standardization program,the concentrations of 10 samples ranged from 2.88 to 5.42 mmol/L measured by reference methods.Results When the low level sample (2.71 mmol/L) measured,the repeatability CV were 0.54%,0.79%,0.56%,0.51%,0.56%,0.48% and 0.49% respectively,intra-lab CV were 1.00%,1.06%,1.28%,0.89%,1.08%,1.13% and 1.05% respectively.When the high level sample (5.12 mmol/L) measured,the respective repeatability CV were 0.40%,0.41%,0.51%,0.48%,0.47%,0.45% and 0.47%,the respective intra-lab CV were 0.82%,0.69%,1.27%,0.70%,0.70%,1.08% and 0.69%.The upper limits of linearity range of A,B,D,F was 12.93 mmol/L and for C,E,G was 20.69 mmol/L.There is no significant interference on 7 systems with chyle concentration of 1.6% or hemoglobin concentration of 4 g/L.Given the interference bias ≤ 4%,the interference concentrations of ascorbic acid were 228,215,225,2840,2840,217 and 2840 μmol/L respectively.In trueness verification experiment,the bias of 7 systems all met the target value (≤ 3%).Conclusion The analytical performance of 7 systems in terms of precision,linearity,trueness and anti-interference all met the requirements of clinical specifications.The performance of anti-interference and measurement trueness of several systems could be improved.
6.Expression of Fascin-1 and β-catenin protein in colorectal adenocarcinoma and its relevance with K-ras gene mutations
Gui MA ; Lan WANG ; Shu-Ping MA ; Fang BIAN ; Yan-Ni REN ; Qing-Rong HU ; Rong YANG
Chinese Journal of Clinical and Experimental Pathology 2019;35(1):27-32
Purpose To examine the expression of Fascin-1 and β-catenin protein and K-ras gene mutation in colorectal adenocarcinoma, and to explore their role in progression of colorectal neoplasm and their relevance. Methods Fascin-1 and β-catenin were analyzed by use of immunohistochemistry En Vision two-step. K-ras gene mutation was detected by ARMS method.Relationship between overexpression of Fascin-1, the nuclear expression of β-catenin, and the mutations of K-ras gene and clinicopathologic parameters was analyzed, the correlation between them was also analyzed. Results In 112 colorectal adenocarcinoma samples, the overexpression rate of Fascin-1 protein was 27.7% (31/112), significantly higher than non-neoplastic mucosa (P < 0.01). The high nuclear expression rate of β-catenin was 29.5% (33/112) in adenocarcinoma and non-neoplastic mucosa respectively with a significant difference between two groups (P < 0.01). High expression rate of Fascin-1 protein and β-catenin were correlated significantly with lymph node metastasis (P = 0.022, P = 0.027), and TNM staging (P =0.042, P = 0.019) in colorectal adenocarcinoma. The overexpression of Fascin-1 protein was correlated with tumor location (P = 0.004). The mutation rate of K-ras gene was 34.8% (39/112), which showed no correlation with age, gender, tumor size, grade of differentiation, lymph node metastasis and TNM staging (P> 0.05). There was a correlation between the overexpressison of Fascin-1 protein, the nuclear expression of β-catenin and the mutation of K-ras gene (rs= 0.252, rs= 0.258, P < 0.05). The overexpression of Fascin-1 protein positively correlated with the nuclear expression of β-catenin (rs= 0.213, P < 0.05). Conclusion Fascin-1 protein and β-catenin protein are involved in invasion and metastasis of colorectal cancer and are associated with K-ras gene mutation. K-ras may promote the overexpression of Fascin-1 by virtue of nuclear expression ofβ-catenin, which provided a new research direction on the treatment of K-ras gene mutated colorectal adenocarcinoma.
7.Detection of circulating hypermethylated tumor-specific RASSF1A DNA in ovarian cancer patients.
Lin MA ; Fu-rong LIU ; Shu-lan ZHANG
Chinese Journal of Pathology 2005;34(12):785-787
OBJECTIVETo detect hypermethylated tumor-specific RASSF1A DNA in the circulation and its significance in ovarian cancers patients.
METHODSMethylation-specific polymerase chain reaction (MSP) was used to study the hypermethylation of RASSF1A in preoperative serum samples from 51 ovarian cancer patients.
RESULTSThe RASSF1A gene was not methylated in peripheral blood samples from 51 normal patients and 51 patients with benign ovarian tumors. Hypermethylation of RASSF1A gene was found in circulating tumor-specific DNA in 43.1% of patients (22 out of 51 cases) with ovarian cancers (P < 0.05). There was no difference in hypermethylation of RASSF1A gene amongst various ovarian cancer subtypes (P < 0.05). On the other hand, hypermethylation of RASSF1A gene was more frequently encountered in stage III and IV than stage I and II tumors (P < 0.05). It was rarely seen in well and moderately differentiated groups, as compared with poorly differentiated group (P < 0.05).
CONCLUSIONSThere is a higher frequency of RASSF1A hypermethylation in circulating tumor-specific DNA of ovarian cancer patients. RASSF1A has been postulated to play an important role as tumor suppressor gene and can be silenced by promoter hypermethylation. This methylation correlates with clinical stage and histopathologic grade. Such observation may carry diagnostic and prognostic implications when assessing ovarian tumors.
Carcinoma, Endometrioid ; blood ; pathology ; Cystadenocarcinoma, Mucinous ; blood ; pathology ; Cystadenocarcinoma, Serous ; blood ; pathology ; DNA Methylation ; Female ; Humans ; Neoplasm Staging ; Ovarian Neoplasms ; blood ; pathology ; Tumor Suppressor Proteins ; blood ; genetics
8.Expression of chemokine receptor--CXCR3 and CCR5 in liver tissues of patients with hepatitis B.
Chun-wen PU ; Chun-meng JIANG ; Shu-rong CONG ; Da-peng MA
Chinese Journal of Hepatology 2005;13(9):708-709
Adult
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Female
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Hepatitis B, Chronic
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metabolism
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Humans
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Liver
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metabolism
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Male
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Receptors, CCR5
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biosynthesis
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genetics
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Receptors, CXCR3
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Receptors, Chemokine
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biosynthesis
;
genetics
9.Evolutionary analysis of neuraminidase gene of A/H7N9 influenza virus.
Yi-Tong SUN ; Neng-Zhi JIN ; Hai-Rong ZHANG ; Yu-Lin SHEN ; Yao MA ; Tian-Shu PENG
Chinese Journal of Virology 2014;30(1):44-50
In 2013, the World Health Organization reported the first case of human infection with a new influenza A (H7N9) virus in China. This has caused damage and panic within certain areas in China. Therefore, analysis of this virus with bioinformatics technology is very necessary. Neuraminidase (NA) is one of the most important antigens of the influenza virus and an important target for anti-flu drugs. In this study, the nucleotide and protein sequences of NA gene of A/H7N9 influenza viruses were retrieved from the NCBI database, and MEGA 5.0 software was employed to construct a phylogenetic tree based on the nucleotide coding sequence; BioEdit software was used to align the nucleotide and protein sequences of NA and calculate the homologies of nucleotides and amino acids and then to analyze the important mutation sites of NA gene. The results demonstrated that the spread of influenza virus H7N9 showed certain geographical and temporal relations. The H7N9 virus isolated from China in 2013 belonged to Euroasiatic serotype, and its NA stalk region hadobvious variation, which may be one of the reasons that this virus infects human. These analyses may be very helpful for understanding the evolutionary relationship and mutation trend of A/H7N9 influenza viruses.
Databases, Genetic
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Evolution, Molecular
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Humans
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Influenza A Virus, H7N9 Subtype
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enzymology
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genetics
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Mutation
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Neuraminidase
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chemistry
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genetics
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Phylogeny
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Sequence Analysis