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
3.Empirical Study on the Effect of Osmotic Opening of Blood Brain Barrier on the Facilitation of Nerve Growth Factor Passing
tian-ming, JIA ; ru, BAO ; yu-feng, LIU ; kai-xian, DU ; bin, GAN
Journal of Applied Clinical Pediatrics 1992;0(06):-
Objective To explore the change of nerve growth factors(NGF) through the blood brain barrier(BBB) after distal intravenous injection of mannitol into the experimental rats and the effect of exogenous NGF on the expression of growth associated protein-43 in hypoxic-ischemic brain.Methods One hundred cases of 7 days rats were divided into 2 units.One unit was divided into 3 groups:treatment group,control group and sham operated group,20 rats in each group.The other unit was divided into 4 groups:mannitol and NGF treated group,NGF treated group,control group,and sham operated group,there were 10 rats in each group.The model rats with perinatal hypoxic-ischemic brain damage(HIBD) rats were prepared by ligation of left common carotid artery with a temporary systemic hypoxia(inhaling 80 mL/L O2 and 920 mL/L N2).The sections of brains were processed by immunochemistry with antibodies against GAP-43,and the study and memory ability of rats were tested by maze test.The effect of osmotic opening of BBB on the facilitation of NGF′s passage was tested by ELISA.Results The expression of GAP-43 increased after NGF treatment,and the differences were remarkable(P
4.Study on absorption mechanism of genistein self-microemulsifying system in rat intestines.
Xian-hua DU ; Xin NIU ; Qian-jin FENG ; Hong DU ; Hai-yan LI
China Journal of Chinese Materia Medica 2008;33(12):1406-1409
OBJECTIVETo investigate the absorption mechanism of genistein self-microemulsifying system in rat intestines.
METHODThe concentrations of phenol red and genistein by in situ perfusion in rats were determined by UV and HPLC, respectively. The effects of drug concentrations, pH, various intestinal segments and P-glycoprotein (P-gp) inhibitor verapamil on the absorption had been studied.
RESULTThe absorption rate constant (Ka) of genistein had no significant difference at concentrations of 0.05-0.5 mg x mL(-1) and pH of 5.4-7.8 in perfusion. It was Ka of jejunum > ileum > duodenum > colon. The absorption of genistein in jejunum had significant difference (P < 0.05) compared with other parts of intestines. Ka was increased obviously when verapamil was coper-fused with genistein (P < 0. 05).
CONCLUSIONThe absorption of genistein self-microemulsifying system is a first order process with passive diffusion mechanism related to P-gp efflux. It can be absorbed at all segments of rat intestine, and the jejunum is the best absorption segment, pH had no special effect on the absorption of genistein self-microemulsifying system in rat intestine.
ATP Binding Cassette Transporter, Sub-Family B ; antagonists & inhibitors ; Animals ; Chromatography, High Pressure Liquid ; Emulsions ; Genistein ; analysis ; metabolism ; pharmacokinetics ; Hydrogen-Ion Concentration ; Intestinal Absorption ; drug effects ; Intestines ; drug effects ; metabolism ; Male ; Organ Specificity ; Rats ; Rats, Wistar ; Temperature ; Verapamil ; pharmacology
5.Effects of social background of the song dynasty on the science of acupuncture and moxibustion .
Xian-feng YE ; Cheng-wen LI ; Du-hai YAN
Chinese Acupuncture & Moxibustion 2007;27(1):66-68
The government of the Song Dynasty paid high attention to develop the science of acupuncture and moxibustion, improved the position of acupuncture and moxibustion, specially made collation and systematization on ancient books of acupuncture and moxibustion, compiled monograph of acupuncture and moxibustion, set up acupuncture and moxibustion program and founded acupuncture bronze statue, launched experiment teaching and so on, which made acupuncture and moxibustion spread and be populated, accelerating the development and advancement of acupuncture and moxibustion sciences.
Acupuncture
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history
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China
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History, Medieval
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Moxibustion
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history
7.Correlation study between CT perfusion parameters and biologic characters in nasopharyngeal carcinoma
Yu-Lin LIU ; Xian CHEN ; Jun CHEN ; Dong-Ping DU ; Lian-Feng AN ; Zhao-Xi ZHANG ; Ning XU ;
Chinese Journal of Radiology 2001;0(09):-
Objective To explore the correlation between MSCT perfusion parameters and biologic characters in nasopharyngeal carcinoma(NPC),and to investigate the clinical utility of MSCT perfusion for NPC.Methods Nasopharynx in 49 cases was studied using MSCT perfusion imaging,including 30 NPC cases before radiotherapy,14 post-radiotherapy NPC cases,and 5 cases of normal nasopharynx as controls. The perfusion data of tumors and nasopharyngeal wall such as blood flow(BF),peak enhancement index (PEI),time to peak (TTP),and blood volume (BV)were calculated.MVD defined by CD34 stain was counted in 16 cases of NPC.The correlation of MSCT perfusion parameters,MVD,and clinical stage was analyzed.Results 1 case of NPC failed in CT perfusion exam.In NPC group (n=29),BF,PEI,TTP, and BV were (48.6?16.9)ml?100 g~(-1)?min~(-1),(32.3?7.9)HU,(17.5?4.9)s,and (12.8? 4.4)ml?100 g~(-1),respectively.BF,PEI,TTP,and BV in control group (5 cases)were (15.9? 5.9)ml?100g~(-1)?min~(-1),(12.6?1.3)HU,(22.6?6.9)s,and (3.5?0.5)ml?100 g~(-1), respectively,and those in post-radiotherapy group (14 cases)were (25.2?7.0)ml?100 g~(-1)?min~(-1), (19.8 ?5.9)HU,(22.6?4.3 )s,and (6.1?2.4)ml?100 g~(-1),respectively.The perfusion values in NPC group had significant difference compared with those in the other two groups (P
8.Pregnancy weight gain and nutritional therapy on the outcome of gestational diabetes mellitus.
Yan-feng FAN ; Rong-xian XU ; Li-qian CAI ; Li-ya DU
Chinese Journal of Preventive Medicine 2010;44(10):903-907
OBJECTIVETo study the relationship of bodyweight gain and the occurrence of gestational diabetes mellitus (GDM) during pregnancy, and analyze the effect of the nutritional therapy on the outcome of GDM.
METHODSWe collected 265 pregnant women who were diagnosed to be GDM and 571 pregnant women as the control group in the Xiamen Maternal and Child Health Hospital during 2007 - 2009. The general information of the subjects were collected. The bodyweight of the subjects were measured before the 20(th) week of pregnancy, 26 - 27(th) week (mid-gestation), 35 - 36(th) week (late-gestation) of pregnancy and prior to delivery. The bodyweight gain of different pregnancy weeks of the two groups and the effect of bodyweight on GMD occurrence before 28(th) week of pregnancy were analyzed by ages (< 25, 25-, 30-, ≥ 35). Meanwhile, we prescribed the nutrition therapy to the GDM pregnant woman and the effect of the blood sugar control on the outcome of the pregnancy were evaluated.
RESULTSThe bodyweight gain of 25-, 30-, older than 35 year-old subjects of the GDM group were (16.9 ± 6.3), (16.8 ± 6.1), (16.5 ± 6.0) kg, respectively, the bodyweight gain of the control group were (13.9 ± 3.0), (13.8 ± 2.7), (13.3 ± 2.7) kg (t = 6.259, 5.885, 3.533, respectively, all P values < 0.05). During the 20(th) to 27(th) week of the pregnancy, the bodyweight gain of the subjects younger than 25, 25-, 30-year-old in GDM group were (5.2 ± 1.0), (5.4 ± 1.7), (4.8 ± 1.3) kg, respectively, the bodyweight gain of the control group were (3.3 ± 1.3), (3.7 ± 1.6) and (3.5 ± 0.7) kg (t = 5.026, 9.659, 11.19, respectively, all P values < 0.05). During the period between 26(th) to 36(th) week, the bodyweight gain of subjects older than 35 year-old in GDP group was (3.6 ± 2.0) kg which was less than the control group ((4.0 ± 0.9) kg, t = -2.449, P < 0.05). 41.22% (54/131) and 44.94% (40/89) of 25-, 30-year-old subjects in GDM group showed bodyweight gain more than 13 kg, but 30.04% (76/253) and 26.07% (55/211) in the control group (OR values were 1.633 and 2.315, both P values < 0.05). The rate of the abnormal birth weight of the GDM group with blood sugar controlled and the control group were 6.6% (12/182) and 9.4% (54/571) which was lower than the GDP group with blood sugar control failure (20.5% (17/83)) (χ(2) values were 11.460, 9.119, respectively, both P values < 0.0125). The rate of premature delivery was 21.7%(18/83), higher than the control group (10.8%, 62/571) (χ(2) = 7.945, P < 0.0125). The rate of the cesarean in the control group was 25.4%(145/571) which was lower than the two GDM groups, including the group which the blood sugar was well controlled (46.7%, 85/182) and not well controlled (65.0%, 54/83) (χ(2) values were 29.540, 53.860, respectively, both P values < 0.0125).
CONCLUSIONThe bodyweight gain in the mid-gestation could affect the occurrence of GDM. The bodyweight gain should be less than 13 kg before 28(th) week of the pregnancy whose age was 25-year-old. Nutritional therapy and blood sugar control in GDM pregnant women could improve the pregnancy outcome.
Adult ; Blood Glucose ; Case-Control Studies ; Diabetes, Gestational ; diet therapy ; Female ; Humans ; Nutrition Therapy ; Pregnancy ; Pregnancy Outcome ; Treatment Outcome ; Weight Gain
9.Pharmacokinetics of puerarin and hydrochlorothiazide from maijunan tablets in rats.
Xian ZHANG ; Feng-Mei HAN ; Peng DU ; Yong CHEN
Acta Pharmaceutica Sinica 2009;44(9):1056-1060
After oral administration of low, middle, high dose of simulative Maijunan tablets to SD rats and puerarin, hydrochlorothiazide at middle dosage to SD rats separately, plasma samples were collected at different times and treated with acetonitrile to precipitate protein. The contents of puerarin and hydrochlorothiazide in plasma were determined by HPLC method. The mean plasma concentration-time profiles of puerarin and hydrochlorothiazide at different dosages of medication administration were processed by 3P97 pharmacokinetic software and SPSS statistics 17.0 software. The results indicated that the in vivo kinetic processes of puerarin in rats were all fitted to a two-compartment open model and hydrochlorothiazide fitted to a one-compartment open model. Hydrochlorothiazide in vivo kinetic process in rats was in accordance with the linear dynamics. The combination of hydrochlorothiazide and rhynchophylla with pueraria promoted the absorption, reduced the elimination rate and prolonged the action time of puerarin in vivo. Meanwhile, the combination also promoted the absorption rate and the bioavailability, prolonged the action time and the accumulation time of hydrochlorothiazide in vivo.
Animals
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Biological Availability
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Drugs, Chinese Herbal
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chemistry
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Female
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Hydrochlorothiazide
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pharmacokinetics
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Isoflavones
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pharmacokinetics
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Male
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Rats
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Rats, Sprague-Dawley
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Tablets
10.Changes of brain mast cells after transient global ischemia in rats.
Wei-wei HU ; Zhong CHEN ; Li-sha XU ; Xian-feng DU ; Cheng-fu XU ; Er-qing WEI
Journal of Zhejiang University. Medical sciences 2004;33(3):193-200
OBJECTIVETo investigate changes of brain mast cells after transient global ischemia in rats.
METHODSTransient global ischemia damage was induced by four-vessel occlusion. After 1 h to 14 days of ischemia, rats were perfused intracardially by 4% paraformaldehyde. The brains were dissected to serial sections using freeze microtome, and then stained with toluidine blue. Brain mast cell was observed under microscope.
RESULTMost brain mast cells were located in thalamus. The number of mast cells in thalamus markedly decreased during reperfusion after transient global ischemia. However, the degranulation rate of thalamus mast cells showed reverse change after ischemia.
CONCLUSIONBrain mast cells markedly degranulate after transient global ischemia, which may be involved in the pathological process after ischemia.
Animals ; Brain ; pathology ; Cell Degranulation ; Ischemic Attack, Transient ; pathology ; Male ; Mast Cells ; pathology ; Rats ; Rats, Sprague-Dawley ; Reperfusion Injury ; pathology