2.Sampling results and quality assessment of recombinant human interferon α1b injection
Dening PEI ; Youxue DING ; Ying GUO ; Xinchang SHI ; Hua BI ; Xi QIN ; Chunming RAO
Drug Evaluation Research 2017;40(3):341-344
Objective To evaluate the quality status of recombinant human interferon α1b injection and find out some quality problems.Methods Totally 31 batches of recombinant human interferon α1b for injection and 11 batches of recombinant human interferon α1b injection from two enterprises were examined according to Chinese Pharmacopoeia Volume Ⅲ (2010),and the quality status of recombinant human interferon α1b injection was evaluated by statistical analysis of the results.Results All 42 batches of samples were qualified.The production process of each enterprise was steady.Conclusion At present the quality of recombinant human interferon αlb injection is generally good.The current standards are feasible,but the specified standard of osmolality needs to be improved.
3.Research on Chinese medicine pairs (IV)--Their compatibility effects.
Wei-Xia LI ; Yu-Ping TANG ; Xu-Qin SHI ; Jian-Ming GUO ; Pei LIU ; Jin-Ao DUAN
China Journal of Chinese Materia Medica 2013;38(24):4203-4207
Chinese medicine pairs (CMP) are specific compatibility with traditional Chinese medicine (TCM) theory as principle, which was formed on basis of effect and treatment theory of TCM. The compatibility of CMP can enhance the effect, or reduce the toxicity. So, compatibility effects of CMP were studied from different pharmacology levels including animals, tissues and organs, cell and molecular levels, their synergy and compatibility attenuation were also evaluated with monomer component-component (group) compatibility-single herb-CMP-formulae as the main line, and the action mechanisms were investigated, all of which can provide scientific basis for the clinical applications of CMP and creation of TCM new drugs.
Animals
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Drug Interactions
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Drug Synergism
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Drug-Related Side Effects and Adverse Reactions
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prevention & control
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Humans
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Medicine, Chinese Traditional
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adverse effects
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methods
4.Expression of B lymphocyte stimulator in peripheral blood mononuclear cells in individuals with systemic lupus erythematosus and the role of interferon-? on it's expression
Yu-Jin YE ; Han-Shi XU ; Liu-Qin LIANG ; Pei-Da YIN ; Xiu-Yan YANG ; Zhong-Ping ZHAN ; Fan LIAN ;
Chinese Journal of Rheumatology 2003;0(10):-
Objective To determine the expression of membrane-bound B lymphocyte stimulator (BLyS) protein and its mRNA in vitro of peripheral blood mononuclear cells (PBMCs) from individuals with systemic lupus erythematosus (SLE),and to investigate the role of interferon-?(IFN-?) on the expression of BLyS.Methods PBMCs were obtained from 25 SLE patients (mean age of 31+14) and 20 healthy volunteers (mean age of 28?10).They were randomized into IFN-?(5 ng/ml) group and control group.PBMCs were col- lected at 0,6,12 and 24 h for BLyS mRNA assessment using semi-quantitative reverse transcription-PCR (RT-PCR).PBMCs were also collected at 72 h for membrane-bound BLyS protein detection using flow cy- tometry (FACS) and direct immunofluorescence.Results①The expression of BLyS mRNA and membrane- bound protein in PBMCs was significantly higher in individuals with SLE compared with healthy controls (P<0.05);②IFN-?enhanced BLyS mRNA expression in PBMCs in both healthy controls and SLE patients,with the greatest effect at 6 h (stimulated vs unstimulated,0.42?0.19 vs 0.25?0.14,P<0.01;0.59?0.28 vs 0.44?0.21,P<0.01 );③IFN-?also increased the expression of membrane-bound BLyS protein in both healthy con- trols and individuals with SLE (FACs,mean fluorescence intensity,4.5+3.0 vs 3.7~2.6,P
5.Correlation of bacteria in the contaminated drug and the environmental microbes in the clean room for pharmaceutical microbial test investigated by FTIR.
Lin PEI ; Chang-qin HU ; Shi-hong MA ; Hui DAI ; Tai-jun HANG
Acta Pharmaceutica Sinica 2007;42(11):1189-1194
The FTIR method was used to investigate the correlation of bacteria in the contaminated drug and the environmental microbes in the clean room for pharmaceutical microbial test. The similarity of bacteria in the contaminated drug and environmental microbes was compared by critical hit value method and cluster analysis method. This constructed the FTIR spectra library of clean room environmental microbe, and determined the criterion to promptly judge if the bacteria isolated from pharmaceuticals were contaminated by environment or not, hence the exactness of "one-off report" of sterile test result can be guaranteed, and can be used for the dynamic monitoring of environmental bacteria of clean room. The method is proven to be simple, accurate and rapid, and can be easily spread to the pharmaceutical microbial control.
Bacteria
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isolation & purification
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Cluster Analysis
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Drug Contamination
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Drug and Narcotic Control
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Environment, Controlled
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Environmental Microbiology
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Spectroscopy, Fourier Transform Infrared
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methods
6.Significance of serum cholesterol and fibrinogen in evaluating the risk of glomerulosclerosis in children with nephrotic syndrome.
Jian-Jiang ZHANG ; Shu-Qin FU ; Wen-Jie DOU ; Pei-Pei SHI ; Miao WANG ; Xi-Yan TIAN
Chinese Journal of Contemporary Pediatrics 2014;16(4):356-360
OBJECTIVETo investigate the significance of serum cholesterol and fibrinogen (Fib) in evaluating the risk of glomerulosclerosis in children with nephrotic syndrome.
METHODSSixty-three children with primary nephrotic syndrome were divided into two groups according to their pathological types: minimal change glomerulopathy (MCG) (n=39) and focal segmental glomerulosclerosis (FSGS) groups (n=24). Serum levels of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), non-HDL-C and Fib and 24-hour urinary protein excretion were retrospectively analyzed.
RESULTSSerum levels of TC, non-HDL-C, and LDL-C were significantly higher in the FSGS group than in the MCG group (P<0.05), but there were no significant differences in HDL-C, Fib and 24-hour urinary protein excretion between the two groups (P>0.05). According to the results of logistic regression analysis, high levels of LDL-C, non-HDL-C and TC were risk factors for FSGS (P<0.05). In patients whose proteinuria did not disappear after taking enough glucocorticoid for 4 weeks, the level of non-HDL-C was significantly higher in the FSGS group than in the MCG group (P<0.05); there were no significant differences in TC, LDL-C, HDL-C, and Fib between the MCG and FSGS groups (P>0.05).
CONCLUSIONSSerum cholesterol, especially non-LDL-C, is of great significance in evaluating the risk of glomerulosclerosis in children with nephrotic syndrome. There is no sufficient evidence to support serum Fib as a marker for predicting glomerulosclerosis in these children.
Child ; Child, Preschool ; Cholesterol ; blood ; Female ; Fibrinogen ; analysis ; Glomerulosclerosis, Focal Segmental ; etiology ; Humans ; Logistic Models ; Male ; Nephrosis, Lipoid ; etiology ; Nephrotic Syndrome ; blood ; complications ; Retrospective Studies ; Risk
7.A clinico-pathological comparison between Henoch-Schonlein purpura nephritis and IgA nephropathy in children.
Hong-Xiang GUO ; Jian-Jiang ZHANG ; Pei-Pei SHI ; Shu-Qin FU ; Li-Guo ZHANG ; Miao WANG ; Feng-Xia LU
Chinese Journal of Contemporary Pediatrics 2012;14(7):506-509
OBJECTIVETo study the difference in clinico-pathological features between IgA nephropathy (IgAN) and Henoch-Schonlein purpura nephritis (HSPN) in children.
METHODSThe medical data of 103 children with HSPN and 61 children with IgAN were retrospectively studied.
RESULTSThere were no significant differences in age, sex and disease course between the HSPN and IgAN groups (P>0.05). Clinical classification demonstrated that more severe conditions were found in the IgAN group than in the HSPN group and gross hematuria was more common in the IgAN group (P<0.05). Serum creatinine and cholesterol levels were higher in the IgAN group than in the HSPN group (P<0.05). Fibrinogen-related antigen deposition was more common in the HSPN group, while complement 3(C3) deposition was more common in the IgAN group. Interstitial fibrosis, tubular casts and tubular inflammatory infiltration were also more common in the IgAN group (P<0.05).
CONCLUSIONSSignificant clinico-pathological differences can be found between HSPN and IgAN in children, and these differences do not support a one disease entity hypothesis.
Child ; Child, Preschool ; Female ; Glomerulonephritis, IGA ; immunology ; pathology ; Humans ; Kidney ; pathology ; Male ; Nephritis ; immunology ; pathology ; Purpura, Schoenlein-Henoch ; immunology ; pathology ; Retrospective Studies
9.An analysis of randomized controlled trials published in the Chinese Journal of Gastrointestinal Surgery between 2003-2009.
Pei-hua LU ; Chen LI ; Yao PAN ; Zhi-qin XU ; Shu-ping SI ; Hu DU ; Xi-dong LV ; Li-ping SHI ; Guo-qing TAO
Chinese Journal of Gastrointestinal Surgery 2010;13(4):294-297
OBJECTIVETo study the academic level of randomized controlled trials (RCT) published in the Chinese Journal of Gastrointestinal Surgery between 2003 and 2009.
METHODSPublished RCTs in the 42 issues of the Chinese Journal of Gastrointestinal Surgery was searched for relevant articles published between 2003 and 2009. Data extracted for analysis included the time at manuscript received, publication time, total number of citations, number of citations in Chinese, number of citations in English, author's affiliations, single- or multi- center study, positive conclusions from RCTs, number of patients recruited in RCTs, research funding source, the start time, the finish time and the number of authors in RCTs.
RESULTSDuring the past seven years, a total of 80 clinical RCTs were published in the Chinese Journal of Gastrointestinal Surgery, accounting for 12% of all the clinical studies published in the journal, and the average number of RCTs in each issue was 1.6. The average delay time before publication was 208 days. The total number of citations and the total number of patients in RCTs were 685 and 9402. The average number of citations, the average number of patients recruited in each RCT, and the average research period in RCTs were 8.6, 118 and 29.2. There were 7 multi-center studies, and the number of single-center study was 73. All the RCT studies had significant conclusions, and 17 (21.3%) RCT studies were funded. Nanjing general hospital of Nanjing military command had the largest number of RCTs (n=6).
CONCLUSIONThe Chinese Journal of Gastrointestinal Surgery puts emphasis on clinical studies of high evidence level such as RCT, which provide evidence for making the clinical guidelines in the specialty of gastrointestinal surgery.
Digestive System Surgical Procedures ; Periodicals as Topic ; Randomized Controlled Trials as Topic
10.Apoptosis induction of rhesus peripheral blood lymphocytes.
Li-pei FAN ; Er-wei SUN ; Xiao-peng YUAN ; Xiao LU ; Hai-qin WANG ; Zhan-guo LIU ; Min LI ; Ming ZHAO ; Shi-zhen ZHONG
Journal of Southern Medical University 2007;27(5):628-630
OBJECTIVETo establish a method for inducing apoptosis of rhesus peripheral blood lymphocytes (PBLs).
METHODSRhesus PBLs were irradiated with X-ray, (60)Co gamma-rays and ultraviolet (UVC254 nm), respectively, and the cell apoptosis was evaluated with flow cytometry using annexin-V staining and propidium iodide staining.
RESULTSX-ray and (60)Co gamma-ray irradiation induced only low apoptotic rates of the PBLs, and UVC resulted in the highest apoptotic rate of about 60%. UVC irradiation of the PBLs in RPMI supplemented with 10% heat-inactivated fetal calf serum for 60 min at a distance of 20 cm led to an early apoptotic rate of 58.85% and necrotic rate of 11.5%. The apoptotic rate of PBLs increased in a dose- and time-dependent fashion.
CONCLUSIONFor inducing apoptosis of the rhesus PBLs, UVC can be more effective than X-ray and (60)Co gamma-ray. The highest apoptotic rate can be achieved when the rhesus PBLs in RPMI supplemented with 10% heat-inactivated fetal calf serum are exposed to UVC for 60 min at the distance of 20 cm.
Animals ; Apoptosis ; radiation effects ; Cells, Cultured ; Dose-Response Relationship, Radiation ; Flow Cytometry ; Gamma Rays ; Leukocytes, Mononuclear ; cytology ; radiation effects ; Lymphocytes ; cytology ; radiation effects ; Macaca mulatta ; Male ; Time Factors ; Ultraviolet Rays ; X-Rays