1.Discussion on research and development of new traditional Chinese medicine preparation process based on idea of QbD.
Yi FENG ; Yan-Long HONG ; Jie-Chen XIAN ; Ruo-Fei DU ; Li-Jie ZHAO ; Lan SHEN
China Journal of Chinese Materia Medica 2014;39(17):3404-3408
Traditional processes are mostly adopted in traditional Chinese medicine (TCM) preparation production and the quality of products is mostly controlled by terminal. Potential problems of the production in the process are unpredictable and is relied on experience in most cases. Therefore, it is hard to find the key points affecting the preparation process and quality control. A pattern of research and development of traditional Chinese medicine preparation process based on the idea of Quality by Design (QbD) was proposed after introducing the latest research achievement. Basic theories of micromeritics and rheology were used to characterize the physical property of TCM raw material. TCM preparation process was designed in a more scientific and rational way by studying the correlation among enhancing physical property of raw material, preparation process and product quality of preparation. So factors affecting the quality of TCM production would be found out and problems that might occur in the pilot process could be predicted. It would be a foundation for the R&D and production of TCM preparation as well as support for the "process control" of TCMIs gradually realized in the future.
Drug Compounding
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methods
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standards
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Drugs, Chinese Herbal
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chemistry
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isolation & purification
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standards
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Humans
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Medicine, Chinese Traditional
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standards
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trends
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Quality Control
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Research
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standards
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trends
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Research Design
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standards
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Technology, Pharmaceutical
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instrumentation
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methods
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standards
2.Effects of exhaustive exercise-induced oxidative stress on red blood cell deformability.
Yan-Lian XIONG ; Yan-Lei XIONG ; Yao-Jin LI ; Fu-Zhou TANG ; Ruo-Feng WANG ; Ya-Jin ZHAO ; Xiang WANG
Chinese Journal of Applied Physiology 2014;30(4):289-293
OBJECTIVEThe aim of the present study is to explore the effects of exhaustive exercise-induced oxidative stress on the antioxidant capacity and diformability of rat red blood cells.
METHODSRats were divided into three group (n = 10): sedentary control (C), exhaustive running exercise (ERE) and moderate running exercise (MRE) groups. Animals in the ERE group started treadmill running at a speed of 20 m/min speed with a 5% gradient, and reached a speed of 25 m/min with gradient 15% in 20 min. Running was continued until exhaustion. MRE group rats running at a speed of 20 m/min with a 5% gradient for 40 min. The levels of free thiol in erythrocyte membrane protein, lipidperoxidation levels and membrane protein components were analyzed. The red blood cell deformability of different groups was also observed.
RESULTSThe results showed that red blood cells were damaged by severe oxidative stress and the anti-oxidative capacity decreased significantly under exhaustive exercise conditions. Besides, lipid peroxidation and protein sulfhydryl cross-link based clustering of membrane were found after exhaustive exercise, and polymers high molecular weight (HMW) was formed. The elongation index (EI) was found to decline significantly in the ERE group compared with the C and MRE groups under shear stress (control group, 0.41 +/- 0.01 at 3 Pa and 0.571 +/- 0.008 at 30 Pa; ERE group, 0.314 +/- 0.013 at 3 Pa and 0.534 +/- 0.009 at 30 Pa; P < 0.05 and P < 0.01, respectively).
CONCLUSIONThese exercise-induced oxidative injure result in a significant decrease in deformability of rat erythrocytes, which in turn leads to dysfunction in the microcirculatory.
Animals ; Disease Models, Animal ; Erythrocyte Deformability ; Fatigue ; metabolism ; physiopathology ; Male ; Oxidative Stress ; Physical Conditioning, Animal ; Rats ; Rats, Sprague-Dawley
3.Differences on ethical consciousness issues between the Chinese Journal of Epidemiology and the American Journal of Epidemiology
Ruo-Gu MENG ; Yan-Bing ZHAI ; Sen CHEN ; Yan-Chang ZHANG ; Yue-Lun ZHANG ; Jian-Yun ZHAO ; Feng SUN
Chinese Journal of Epidemiology 2012;33(1):106-110
To compare the differences on current ethical issues in the areas of epidemiological practice between China and America,to identify the major ethical problems existing in the epidemiological studies in China.Through searching and reviewing papers published on Chinese Journal of Epidemiology and American Journal of Epidemiology from Jan.2006 to Dec.2010,we made a comparison on ethical issues involved in the original studies that focusing on human beings.In total,749 Chinese articles and 1221 American articles were recruited,with the following findings: (1)The proportion with announcements of “Informed consent by the subjects” was 29.24% in Chinese literature and 38.08% in the Americans (x2=16.02,P<0.001 ).The proportion with “having had approvals from the ethic committees” was 29.24% in Chinese,while 38.08% in American ( x2=604.40,P< 0.0001 ).(2) Both in China and America,there had been an increase of ethical issues in the last 5 years.(3)Articles derived from trial studies had better involvement on ethics than those from observational studies.(4) The level on ethical issues in the American Research Institutes exceeded those in China (5)American studies also had showed better ideas on Ethic issues on biological specimens collection and privacy protection,than those in Chinese studies.Among the studies on Chinese Journal of Epidemiology,the proportion of ‘informed consent' was higher than in ethical review,but both ethical review and awareness on ‘informed consent' had left far behind than the American Journal of Epidemiology.This could be seen at the institution level of the writers,during specimen collection and privacy protection,as well as at the overall level.The results reminded us that the Departments of Technology Management should spend more efforts on the improvement of public education regarding ethics for researchers and to update the process of edition for Journals as well as to reinforce the rules of ethics in epidemiological research.
4.Dual-phase contrast-enhancement multislice computed tomography imaging in assessment of acute myocardial infarction-reperfusion injury
Shao-feng, GUAN ; Wei-yi, FANG ; Xin-kai, QU ; Jian-ding, YE ; Yan, SHEN ; Jing, JIAO ; Ruo-gu, LI ; Hui, LI
Journal of Shanghai Jiaotong University(Medical Science) 2009;29(6):623-626
Objective To explore the value of dual-phase contrast-enhancement multislice computed tomography (MSCT) in the assessment of acute myocardial infarction volume and perfusion in porcine models. Methods The distal left anterior descending coronary arteries of 5 pigs were balloon-occluded for 90 min and followed by reperfusion. MSCT was performed 1 min (early phase) and 5 min (delayed phase) after administration bolus of 100 mL of iodinated contrast material 30 min after reperfusion. On the same day, hearts were excised, sectioned in 8 mm short-axis slices, and stained with TTC. Infarction volume was defined as the sum of the hyper-enhanced area and surrounding hypo-enhanced area in all slices on delay enhanced phase of MSCT and the TTC-negative area on TTC staining slices. Infarction volume was expressed as percentage of total slice volume. Results Acute infarction detected by MSCT was characterized by early myocardial perfasion defects in the early phase of the contrast bolus (early defects) with surrounding residual defects and late enhancement observed in the late phase. Mean CT attenuation value of early defects was significantly different from CT attenuation value of remote myocardium [(213±55)HU vs (304±30)HU](P < 0.05), CT attenuation values of residual defects and late enhancement were also significantly different from those of remote myocardium [(360±75) HU vs (90±37) HU and (152±23) HU vs (190±37) HU, repectively](P < 0.01, P < 0.05). The mean infarction volume was (8.9± 1.0)% on MSCT and (9.2±1.4)% on TTC pathology images. The infarction volume assessed by MSCT compared well with TTC staining slices. Conclusion Acute reperfused myocardial infarction zone has specific enhancement pattens different to remote normal zone on dual phase MDCT, which is in good agreement with in vivo Trc pathology in the assessment of acute reperfused myocardial infarction shortly offer reperfusion.
5.Analysis of titer stability and inactivation kinetics of harvest solution of SARS-CoV-2
GUO Bing-feng ; HAN Bin ; HAO Yi-nan ; WANG Kui ; YIN Ji-xiang ; LI Yan ; LI Nan ; LING Xiang-ping ; PAN Ruo-wen
Chinese Journal of Biologicals 2023;36(2):129-132+144
Objective To investigate the titer stability of the harvest solution of severe acute respiratory syndrome coronavirus2(SARS-CoV-2)at 2 ~ 8 ℃ and the inactivation effect of β-propiolactone inactivator on the virus.Methods Three batches of SARS-CoV-2 harvest solution(batch numbers:202111001,202111002 and 202111003)were stored at 2 ~ 8 ℃ for 12 d and sampled every 3 d(0,3,6,9 and 12 d)for detection of the titers by Karber method;Three batches of virus harvest solution equilibrated overnight at 2 ~ 8 ℃ were inactivated by adding β-propiolactone at a volume fraction of 1∶4 000 and detected for the titers at different inactivation time points(0,0.5,1,1.5,2,3,4,8,16 and 24 h),of which samples inactivated for 8,16 and 24 h were taken for inactivation verification,and samples inactivated for 24 h were observed by transmission electron microscope.Results The titers of SARS-CoV-2 decreased with the prolongation of storage time at 2 ~8 ℃,which showed no obvious decrease during 0 ~ 3 d,while decreased from the initial 7.75,6 and 7.5 lgCCID_(50)/mL to5.75,4.625 and 6.25 lgCCID_(50)/mL on day 12,indicating that the virus activity showed a gradual decrease trend at 2 ~8 ℃;With the inactivation time,the virus titer decreased continuously and could not be detected after inactivation for 3 h.Transmission electron microscope observation showed that the inactivated virus particles were intact and the spike protein was evenly distributed.Conclusion The virulence of SARS-CoV-2 stored at 2 ~ 8 ℃ was unstable,so the subsequent inactivation and purification process should be carried out as soon as possible;The titer of virus could not be detected after3 h of inactivation,which provided a reference for the determination of the inactivation process.
6.Molecular-epidemiological characteristics of HIV-1 isolated from newly diagnosed female subjects in Beijing, 2006 - 2010.
Jing-rong YE ; Xue-li SU ; Shuang-qing YU ; Ruo-lei XIN ; Ming-qiang HAO ; Hong-yan LU ; Xia FENG ; Xiong HE ; Yi ZENG
Chinese Journal of Epidemiology 2013;34(1):49-52
OBJECTIVETo analyze the molecular-epidemiological characteristics of HIV-1 strains prevailing among female people living with HIV in Beijing.
METHODSGag gene fragments from the 100 newly diagnosed female HIV-1 infections during 2006 to 2010 in Beijing were amplified, sequenced, and phylogenetically analyzed.
RESULTSEighty-two HIV-1 gag gene fragments were amplified and analyzed. 1 (1.22%), 1 (1.22%), 3 (3.66%), 23 (28.05%), 8 (9.76%), 2 (2.44%), 1 (1.22%), 18 (21.95%), 3 (3.66%), 1 (1.22%), 14 (17.07%), 4 (4.88%) and 3 (3.66%) individuals were infected with HIV-1 subtypes A1, A2, B, B', C, D, G, H, CRF01_AE, CRF02_AG, CRF07_BC, CRF08_BC and B'/C recombinants respectively.
CONCLUSIONThe subtypes circulating in female HIV infections in Beijing were more diverse than in male and the proportions of B' and rare subtypes were relatively high. Surveillance programs on HIV-1 genetic diversity should be strengthened.
Acquired Immunodeficiency Syndrome ; epidemiology ; Adolescent ; Adult ; Aged ; Child ; Child, Preschool ; China ; epidemiology ; Female ; HIV-1 ; genetics ; isolation & purification ; Humans ; Middle Aged ; Molecular Epidemiology ; Phylogeny ; Young Adult
7.Relatively light general anesthesia is more effective than fluid expansion in reducing the severity of epinephrine-induced hypotension during functional endoscopic sinus surgery.
Wei-yan LI ; Zhi-qiang ZHOU ; Jun-feng JI ; Ze-qing LI ; Jian-jun YANG ; Ruo-jing SHANG
Chinese Medical Journal 2007;120(15):1299-1302
BACKGROUNDEpinephrine infiltration of the nasal mucosa causes hypotension during functional endoscopic sinus surgery (FESS) under general anesthesia. A prospective randomized-controlled study was designed to determine whether relatively light general anesthesia is superior to fluid expansion in reducing epinephrine-induced hypotension during FESS.
METHODSNinety patients undergoing elective FESS under general anesthesia were randomly assigned to three groups with 30 patients in each. Each patient received local infiltration with adrenaline-containing (5 microg/ml) lidocaine (1%, 4 ml) under different conditions. For Group I, anesthesia was maintained with propofol 2 microg/ml and rimifentanil 2 ng/ml by TCI. Group II (control group) and Group III received propofol 4 microg/ml and rimifentanil 4 ng/ml, respectively. In Groups I and II, fluid expansion was performed with hetastarch 5 ml/kg within 20 minutes; hetastarch 10 ml/kg was used in Group III. Mean arterial pressure (MAP) and heart rate (HR) were recorded at 30-second-intervals for 5 minutes after the beginning of local infiltration. Simultaneously, the lowest and the highest MAP were recorded to calculate the mean maximum increase or decrease percent in MAP for all patients in each group. Data analysis was performed by chi(2) test, one-way analysis of variance, or one-way analysis of covariance.
RESULTSHemodynamic changes, particularly a decrease in MAP accompanied by an increase in HR at 1.5 minutes (P < 0.05), were observed in all groups. The mean maximum decrease in MAP below baseline was 14% in Group I, 24% in Group III and 26% in Group II. There were statistically significant differences between Group I and Groups II and III (P < 0.05). The mean maximum increase in MAP above baseline was 9% in Group I, 6% in Group III and 2% in Group II.
CONCLUSIONRelatively light general anesthesia can reduce the severity of epinephrine-induced hypotension more effectively than fluid expansion during FESS under general anesthesia.
Adolescent ; Adult ; Anesthesia, General ; Endoscopy ; Epinephrine ; adverse effects ; Female ; Humans ; Hypotension ; chemically induced ; prevention & control ; Male ; Middle Aged ; Paranasal Sinuses ; surgery ; Plasma Volume ; Prospective Studies
8.Relationship between classification of vitreoretinal interface features and pathological myopia
Han Xiao WANG ; Chun Mei XIAO ; Shi Ruo WANG ; Qi Shi YANG ; Tong LI ; Ping Yan ZHOU ; Hua Feng WANG ; Dong Xiao SUN
Journal of Shanghai Jiaotong University(Medical Science) 2017;37(11):1517-1522
Objective· To investigate the relationship between pathological myopia and classification of vitreoretinal interface features using enhanced vitreous imaging optical coherence tomography (EVI-OCT). Methods · High myopia patients were included from 2015 to 2016. All participants underwent standardized medical interviews and ophthalmic examination. Results · The included eyes were divided into two groups of pathological myopia and simple high myopia based on myopic macular degeneration observed on fundus photography . There were four types of vitreoretinal interface changes demonstrated on EVI-OCT scans in included eyes: Type1, posterior precortical vitreous pockets (PPVP), Type2, partial posterior vitreous detachment with vitreous adhesion (VA), Type 3, epiretinal membrane (ERM), and Type 4, no traction (NT). Pathological myopia was mostly detected in VA, ERM, and NT groups. Conclusion · EVI-OCT was able to demonstrate the early changes of vitreoretinal interface in high myopia eyes. Vitreous adhesions and traction detected by OCT may facilitate the occurrence of pathological myopia.
9.Increased stromal-cell-derived factor 1 enhances the homing of bone marrow derived mesenchymal stem cells in dilated cardiomyopathy in rats.
Yan-Li ZHOU ; Hai-Feng ZHANG ; Xin-Li LI ; Ruo-Min DI ; Wen-Ming YAO ; Dian-Fu LI ; Jian-Lin FENG ; Jun HUANG ; Ke-Jiang CAO ; Michael FU
Chinese Medical Journal 2010;123(22):3282-3287
BACKGROUNDStem cell transplantation has been shown to have beneficial effects on dilated cardiomyopathy. However, mechanism for stem cell homing to cardiac tissue in dilated cardiomyopathy has not yet been elucidated.
METHODSMesenchymal stem cells were obtained from rat bone marrow, expanded in vitro, and labeled with (99m)Tc. Cardiomyopathy model was induced by doxorubicin in rats. (99m)Tc labeled cells were infused into the left ventricles in cardiomyopathy and control rats. Sixteen hours after injection, animals were sacrificed and different tissues were harvested to measure specific radioactivity. By use of real-time polymerase chain reaction and immunohistochemistry, mRNA and protein expressions for stromal-cell-derived factor 1 in cardiac tissue were measured.
RESULTSLabeling efficiency of mesenchymal stem cells was (70.0 ± 11.2)%. Sixteen hours after mesenchymal stem cell transplantation, the heart-to-muscle radioactivity ratio was increased significantly in cardiomyopathy hearts as compared to control hearts. Both mRNA and protein expressions of stromal-cell-derived factor 1 were up-regulated in cardiomyopathy hearts as compared with control hearts.
CONCLUSIONIn dilated cardiomyopathy induced by doxorubicin up-regulated expression of stromal-cell-derived factor 1 in heart may induce mesenchymal stem cells home to the heart.
Animals ; Bone Marrow Cells ; cytology ; metabolism ; Cardiomyopathy, Dilated ; therapy ; Cells, Cultured ; Chemokine CXCL12 ; genetics ; metabolism ; Immunohistochemistry ; Mesenchymal Stem Cell Transplantation ; Mesenchymal Stromal Cells ; cytology ; metabolism ; Rats ; Rats, Sprague-Dawley ; Reverse Transcriptase Polymerase Chain Reaction
10.Pathogenicity of Five Strains of Toxoplasma gondii from Different Animals to Chickens.
Shuai WANG ; Guang Wei ZHAO ; Wang WANG ; Zhen Chao ZHANG ; Bo SHEN ; I A HASSAN ; Qing XIE ; Ruo Feng YAN ; Xiao Kai SONG ; Li Xin XU ; Xiang Rui LI
The Korean Journal of Parasitology 2015;53(2):155-162
Toxoplasma gondii is a protozoan parasite with a broad range of intermediate hosts. Chickens as important food-producing animals can also serve as intermediate hosts. To date, experimental studies on the pathogenicity of T. gondii in broiler chickens were rarely reported. The objective of the present study was to compare the pathogenicity of 5 different T. gondii strains (RH, CN, JS, CAT2, and CAT3) from various host species origin in 10-day-old chickens. Each group of chickens was infected intraperitoneally with 5 x 10(8), 1 x 10(8), 1 x 10(7), and 1 x 10(6) tachyzoites of the 5 strains, respectively. The negative control group was mockly inoculated with PBS alone. After infection, clinical symptoms and rectal temperatures of all the chickens were checked daily. Dead chickens during acute phage of the infection were checked for T. gondii tachyzoites by microscope, while living cases were checked for T. gondii infection at day 53 post-inoculation (PI) by PCR method. Histopathological sections were used to observe the pathological changes in the dead chickens and the living animals at day 53 PI. No significant differences were found in survival periods, histopathological findings, and clinical symptoms among the chickens infected with the RH, CN, CAT2, and CAT3 strains. Histopathological findings and clinical symptoms of the JS (chicken origin) group were similar to the others. However, average survival times of infected chickens of the JS group inoculated with 5 x 10(8) and 1 x 10(8) tachyzoites were 30.0 and 188.4 hr, respectively, significantly shorter than those of the other 4 mammalian isolates. Chickens exposed to 10(8) of T. gondii tachyzoites and higher showed acute signs of toxoplasmosis, and the lesions were relatively more severe than those exposed to lower doses. The results indicated that the pathogenicity of JS strain was comparatively stronger to the chicken, and the pathogenicity was dose-dependent.
Animals
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Antibodies, Protozoan/blood
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Cat Diseases/parasitology
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Cats
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Chickens
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Poultry Diseases/blood/mortality/*parasitology/pathology
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Swine
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Swine Diseases/parasitology
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Toxoplasma/genetics/growth & development/*pathogenicity/physiology
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Toxoplasmosis, Animal/blood/mortality/*parasitology/pathology
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Virulence