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.Study on the High Yield Strain of Gentamicin Producer by Protoplast Fused and Fermentor Test
Yu-Xia GUAN ; Ji-Xian LAN ; Guang-Xin YAN ; Jing-Shi ZHENG ;
China Biotechnology 2006;0(08):-
The protoplasts of Micromonospora purpurea,the high yield strains of gentammicin producer were mutagenized by diethyl sulfate(DES)and ultraviolet radiation(UV)respectively,then fused,screened by gentamicin resistance and regenerated.The average fermentation unit 2200?U/ml could be achieved by shake flask for 10 batches.The average fermentation unit 1900?U/ml could be obtained by 5L fermentor for 7 batches.The quality of the end product conformed to CP2000,BP2000 and USP26 pharmacopoeia.
3.Application of Fever Symptom Surveillance in Hospital Infection Prospective Monitoring
Xian-Ping WANG ; Yu-Lan YANG ; Hui-Ning YANG ; Min GAO ; Yan LV ;
Chinese Journal of Nosocomiology 2009;0(21):-
OBJECTIVE To explore the effect of fever symptom surveillance in hospital infection prospective monitoring.METHODS The material were divided into tow groups.A group was adopted retrospective method and B group was used prospective study method.A practical electronic function modules was applied in B group.The patients information of temperature ≥37.5 ℃ was collected to the data-base.Hospital information systems were utilized to estimate hospital infection.RESULTS There were significant difference(P
4.Monitoring and Management of Environment of in Laminar Air Flow Operating Center Before Use
Li CAO ; Xian-Ping WANG ; Yu-Lan YANG ; Hui-Ning YANG ; Yan LV ; Ling SUN ;
Chinese Journal of Nosocomiology 2009;0(22):-
OBJECTIVE To strictly manage the whole process for cleaning the laminar air flow(LAF) operating center to achieve the modernized hospital environment′s standard requests.METHODS Right before the use of the LAF operating center,scientific management was conducted strictly according the regulations and standards issued by state Ministry of Health.RESULTS Fulfilling the standards of the process for cleaning operating center was all for the goal of improving the efficiency of management.CONCLUSIONS A management is made efficient from checking all the things before use,monitoring them,and training people so that they can efficiently carry out their tasks.The purpose of the scientific management is to reach the expected quality.
5.Effects of different types and concentration of oral sweet solution on reducing neonatal pain during heel lance procedures.
Hong-yao LENG ; Xian-lan ZHENG ; Li YAN ; Xian-hong ZHANG ; Hua-yun HE ; Ming XIANG
Chinese Journal of Pediatrics 2013;51(9):654-658
OBJECTIVETo compare the effect of different types and concentrations of sweet solutions on neonatal pain during heel lance procedure.
METHODTotally 560 full term neonates (male 295, female 265) were randomized into 7 groups:placebo group (plain water), 10% glucose, 25% glucose, 50% glucose, 12% sucrose, 24% sucrose and 30% sucrose groups.In each group, 2 ml corresponding oral solutions were administered through a syringe by dripping into the neonate's mouth 2 minute before heel lance. The procedure process was recorded by videos, from which to collect heart rate, oxygen saturation and pain score 1 min before puncture, 3, 5 and 10 min after puncture.
RESULTThe average heart rate increase 3, 5 and 10 min after procedure in the 25% and 50% glucose groups, 12% and 24% and 30% sucrose groups was significantly lower than those in the placebo group (P < 0.01 or 0.05). The average heart rate increase 3 min after procedure in the sucrose group was lower than that in the glucose group (P < 0.01).Neonates who received 30% sucrose has a significantly lower average heart rate increase than those who received 12% and 24% sucrose 3 min after heel lance (both P < 0.05) . The average oxygen saturation decrease 3, 5, 10 min after procedure was significantly lower than those in the placebo group (P < 0.01). The average oxygen saturation decrease 3 min after procedure in the sucrose groups was significantly lower than that in the glucose groups (P < 0.01). The average pain score 3, 5, 10 min after procedure was significantly lower than those in the placebo group (P < 0.01). The average pain score 3 min after procedure in the sucrose groups was significantly lower than that in the glucose groups (P < 0.01).
CONCLUSIONOral administration of sweet solutions is an effective way to relieve neonatal pain on procedure, and sucrose has a better pain relief action than glucose, moreover, 30% sucrose provides better effect in control of heart rate increase 3 min after heel lance, but the best concentration of sucrose for pain relief needs further study.
Administration, Oral ; Analgesics ; administration & dosage ; therapeutic use ; Blood Specimen Collection ; adverse effects ; methods ; Facial Expression ; Female ; Glucose ; administration & dosage ; therapeutic use ; Heart Rate ; Heel ; Humans ; Infant, Newborn ; Male ; Oxygen ; blood ; Pain ; physiopathology ; prevention & control ; Pain Measurement ; Sucrose ; administration & dosage ; therapeutic use ; Sweetening Agents ; administration & dosage ; therapeutic use
6.Effect of adjuvant therapy with Dingguier umbilical paste on intestinal flora of diarrhea infants and its action characteristics.
Hai-Feng SUN ; Yan-Yun GAO ; Cui-Hong AN ; Yu-Lan LI ; Li-Jun DUAN ; Yu-Hong YU ; Wu-Xian REN
China Journal of Chinese Materia Medica 2014;39(14):2756-2761
The applicator therapy is a unique method to treat infant diarrhea in traditional Chinese medicines and widely applied in clinical practice. Currently, many researchers have proved the rationality of the therapy based on the traditional Chinese medicine mechanism and on the data from clinical practice, but its action mechanism is uncertain at present. In this study, with the assistance of pediatric practitioners, the automated ribosomal intergenic-spacer analysis (ARISA) was adopted to study the effect of the adjuvant therapy with Dingguier umbilical paste on intestinal flora of diarrhea infants, in which Dingguier umbilical paste served as the adjuvant therapy in oral traditional Chinese medicines and fecal samples of infants with different diarrhea symptoms were collected and used as the study materials. The results showed that the adjuvant therapy had a significant effect on the shift of intestinal flora, which was associated with the decrease in the similarity difference to the normal control group and the increase in the number of operational taxonomic units (OTUs) shared with the normal control group. Additionally, adjuvant therapy with Dingguier umbilical paste also showed long action duration and increased OTUs number. These results indicated that Dingguier umbilical paste has the effect in restoring the micro-ecosystem of unbalanced intestinal bacteria. Intestinal flora may be one of major targets for the applicator therapy for the infant diarrhea, but not for the single oral traditional Chinese medicine for infant diarrhea.
Adjuvants, Pharmaceutic
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therapeutic use
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Diarrhea
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drug therapy
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microbiology
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Feces
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microbiology
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Female
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Humans
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Infant
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Intestines
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drug effects
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microbiology
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Male
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Medicine, Chinese Traditional
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methods
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Ointments
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Treatment Outcome
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Umbilicus
7.Studies on chemical constituents in herb of Lamium maculatum var. kansuense (II).
Yan-ru DENG ; Lan DING ; Shui-xian WU ; Han-qing WANG
China Journal of Chinese Materia Medica 2005;30(4):272-274
OBJECTIVETo study the chemical constituents from Lamium maculatum var. kansuense.
METHODThe chemical constituents were isolated and repeatedly purified on silica gel column and the structures were elucidated by the NMR spectra and physico-chemical properties.
RESULTSix compounds were obtained and identified as polypodine B (I), 5-OH-8-epiloganin (II), shlanzhiside methyl ester (III), liriodendrin (IV), quercitroside (V), uridine (VI).
CONCLUSIONCompound IV was found from genus Lamium for the first time and the rest of the compounds were found from Lamium maculatum var kansuense for the first time.
Ecdysterone ; analogs & derivatives ; chemistry ; isolation & purification ; Furans ; chemistry ; isolation & purification ; Glucosides ; chemistry ; isolation & purification ; Lamiaceae ; chemistry ; Plants, Medicinal ; chemistry ; Uridine ; chemistry ; isolation & purification
8.Vector construction and silencing effect of Edg4 gene targeted small interfering RNA in ovarian cancer cell line
Yu-Huan QIAO ; Liu-Xia LI ; Rui-Xia GUO ; Wei ZHOU ; Miao WANG ; Xiao-Yan ZHANG ; Jian-Hao ZHANG ; Xian-Lan ZHAO ; Meng-Zhen ZHANG ; Guoqiang ZHAO ;
Chinese Journal of Obstetrics and Gynecology 2000;0(11):-
Objective To construct the recombinant eukaryotic expression vector pRNAT-U6,1- siEdg4 which curries small interfering RNA(siRNA)of Edg4 and observe the silencing effect of Edg4 gene targeted siRNA in ovarian cancer cell line SKOV3.Methods The Edg4 gene-targeted hairpin siRNA sequence was designed according to the Edg4 sequence in Genbank,and the two complementary oligo nucleotide strands were synthesized and annealed and inserted into the pRNAT-U6.1 plasmid to build a recombinant Edg4 siRNA eukaryotic expression vector,which was sequenced and identified to contain the correct Edg4 siRNA sequence.The human ovarian carcinoma cell lines SKOV3 were transfeeted with the vector using lipofeetamine method.The efficiency of transfecting cells was observed with fluorescent microscope and the mRNA expression level of Edg4 gene was detected by real time quantitative PCR.The LPA levels in cell supernatants were detected using a biochemical method.And the apoptosis of SKOV3 cells induced by the vector was evaluated by flow cytometry.Results The recombinant eukaryotic expression vector was confirmed to contain correct Edg4 siRNA sequence by PCR and sequencing.After transfection large amounts of green fluorescence were seen in plasma and nuclei of SKOV3 cells and the positive cell rates were 64%.The expression level of Edg4 mRNA in transfeeted SKOV3 cell line was significantly decreased (0.05?0.01 vs 0.29?0.04,P
9.Construction of Saccharomyces cerevisiae Mutant Deficient in adh2 and ald6 Genes
Yan-Zun WANG ; Juan-Juan LEI ; Xian-Zhang JIANG ; Yuan-Yuan GAO ; Xin LI ; Can-Hua LAN ; You-Qiang CHEN ; Ru-Kai CHEN ; Jian-Zhong HUANG
Microbiology 1992;0(02):-
The purpose of this investigation is to improve ethanol production and decrease acetate formation in Saccharomyces cerevisiae strain YS2-?adh2.The strain YS2-?adh2 with deleted alcohol dehydrogenase Ⅱ(adh2) gene was isolated in our lab with higher ethanol production than that of the strain YS2.The ace-taldehyde dehydrogenase Ⅵ(ald6) gene encoded a cytosolic acetaldehyde dehydrogenase,a key enzyme of the pyruvate dehydrogenase(PDH) bypass,transfers acetaldehyde to acetate.To disrupt ald6 gene of the strain YS2-?adh2,ald6 gene targeting cassettes were synthesized by long flanking homology PCR(LFH-PCR) and then were transformed into YS2-?adh2 mutants by LiAc/SS Carrier DNA/PEG method.Positive transformants were selected with G418 and further confirmed by PCR.Once correctly integrated into the genome,the selective marker was rescued by transforming the plasmid pSH65 into the positive transformants and inducing the Cre expression with a Cre/loxP-mediated marker removal procedure.We named the ald6 gene knocked-out strain as YS2-?adh2-?ald6 which has a 12.5% higher ethanol production and a 18% lower acetate formation compared to the strain YS2.
10.Hyperglycemia analysis in some community population in Xuhui District of Shanghai in 2010 and 2015
Xiao-hong ZHANG ; Hai-yan GU ; Lan WANG ; Xian WANG ; Chao-wei FU ; Ze-liang XUAN
Shanghai Journal of Preventive Medicine 2020;32(8):669-
Objective To investigate the hyperglycemia rate and its correlative factors for the undiagnosed diabetes population in Xuhui District of Shanghai, and to provide the basis for early intervention of diabetes mellitus. Methods Multi-stage cluster sampling was adopted by probability proportionate to size method, and physical examination information and questionnaires were made and collected from 10 130 and 9085 people in 2010 and 2015 respectively from 5 000 households, blood-glucose being examined at the same time.Univariate analysis was made by