1.BIOEQUIVALENCE OF BAMBUTERAL AND ITS METABOLITES TERBUTALINE AFTER ORAL BAMBUTERAL TABLET IN HEALTHY VOLUNTEERS BY HPLC/MS
Chunhua SUN ; Lei LIU ; Qi YIN
Acta Pharmaceutica Sinica 2001;36(5):368-372
AIM To study bioequivalence of bambuteral and its metablites terbutaline in 20 healthy male volunteers. METHODS A single oral dose of domestic or imported bambuteral tablet was given according to a randomized 2-way cross-over design. The plasma bambuteral and terbutaline concentrations were determined by HPLC/MS. RESULTS The pharmacokinetic parametrs of domestic and imported bambuteral: AUC0-t were (52±21) μg*h*L-1 and (51±20) μg*h*L-1, Tmax were (2.9±0.9) h and (2.6±0.7) h, Cmax were (6.0±2.6) μg*L-1 and (6.2±2.9) μg*L-1, T1/2Ke were (11.2±2.3) h and (11.2±1.9) h, respectively; terbutaline: AUC0-t were (191±30) μg*h*L-1 and (197±37) μg*h*L-1; Tmax were (4.2±1.0) h and (4.2±1.0) h; Cmax were (10±5) μg*L-1 and (10±4) μg*L-1; T1/2Ke were (20±3) h and (21±4) h, respectively. The bioavaiability of the domestics was 102%±8% (bambuteral) and 100%±12% (terbutaline). CONCLUSION The results demonstrate that the two forms of bambuteral and terbutaline were bioequivalent by analysis of variance, two-one sided test and 90% confidential limit.
2.The Measurement Analysis of Doctor Workload Based on the Analytic Hierarchy Process
Yongguo SUN ; Lili QI ; Aitian YIN
Chinese Health Economics 2014;(1):39-41
Objective: To search for the weighting the doctor’s service value and method to give the payment to doctors. Methods:From the hierarchy of medical service items, medical service items are classified, the weight of medical service item are calculated by analytic hierarchy process (AHP) , the Harvard University doctor workload measurement model is established. Results: According to the weight of medical service items, to calculate the workload of doctors integrated with practical work quantity. Conclusion:By applying the theoretical results into practices, the estimation system of doctor workload was smoothly operated in the organization.
3.Supplementing the effects of a stroke unit with community health services for stroke patients
Suping QI ; Lin YIN ; Shujie SUN ; Yan WU ; Jun WU ; Chunhuan QI ; Rang FAN ; Yue ZHENG ; Yang YU
Chinese Journal of Physical Medicine and Rehabilitation 2009;31(11):744-747
Objective To evaluate the clinical efficacy of a stroke unit combined with community health services for treating stroke survivors. Methods A total of 120 stroke patients were randomly divided into a " stroke unit combined with community medicine" group ( combined group) , a stroke unit group and a general treatment group. Patients in the former 2 groups were treated in a hospital stroke unit during their hospitali-zation. The general treatment group was given conventional medical treatment. After discharge, the combined group continued to receive regular rehabilitation therapy and guidance in the form of community medical services, while the stroke unit group received follow-up only. Assessment was by means of Fugl-Meyer scores, the Barthel index and self-rating on a depression scale ( SDS). The patients were assessed at admission, on discharge and 3 months after discharge. Results There were no significant differences in average limb motor function, ability in the activities of daily living ( ADL) or depressive mood among the 3 groups on admission, but at discharge, limb motor function and ADL ability in the combined group and stroke unit groups were significantly superior to those in the general therapy group. Limb motor function and ADL ability in the combined and stroke unit groups had improved further 3 months after discharge, with more significant improvements in the combined group. No significant change in depression was observed in any group at discharge, but average depression scores in the combined and stroke unit groups improved significantly in the 3 months after discharge, and there was a statistically significant difference between the combined group and the general group. Conclusion Supplementing the work of a stroke unit with community health services significantly improves stroke patients' recovery of limb motor function and ADL ability.
4.The application of prenatal ultrasound in pregnancy with several kinds of pathogen infection
Lingling, SUN ; Xuedong, DENG ; Hong, LIANG ; Chen, LING ; Fengyu, WU ; Linliang, YIN ; Qi, PAN
Chinese Journal of Medical Ultrasound (Electronic Edition) 2014;(7):571-576
Objective To investigate the fetal ultrasonographic features in pregnancies with Toxoplasma (TOX), rubella virus (RV), cytomegalovirus (CMV) and herpes simplex virus (HSV) infection. Methods From January 2011 to March 2013, prenatal ultrasound examination was performed in 545 fetuses with mothers of speciifc positive IgM of TOX, RV, CMV and HSV, detected by enzyme-linked immune sorbent assay (ELISA) in Nanjing Medical University Affiliated Suzhou Hospital. Ultrasonographic features were summarized and pregnancy outcome was followed up in fetuses with abnormal ifndings. Results Among the 545 fetuses, 56 cases with abnormal sonographic ifndings:6 cases with central nervous systerm abnormalities (2 intracranial calcifications, 4 hydrocephaly);9 cases with digestive system abnormalities (1 intrahepatic calcifications, 8 echogenic bowel);2 cases with heart abnormalities (1 interventricular septal defect, 1 right heart enlargement);17 cases with abnormal amniotic fluid volume (16 polyhydramnios, 1 oligohydramnios);3 cases with placental abnormality (1 thick placenta, 2 placenta abnormal calciifcation);13 cases with urinary systerm abmormality appearing as renal sinus separation;and 6 cases with other systerm abnormalities (1 neck lymphatic hygroma, 1 single umbilical artery, 1 sacrococygeal teratoma and 3 intrauterine growth restriction);2 cases of complicated abnormalities. Conclusions Prenatal ultrasonography is signiifcant in detecting serious fetal malformations, such as hydrocephaly, heart abnormalities and characteristic ultrasound features such as intracranial calciifcations, echogenic bowel, placenta abnormal calciifcation complicated with TOX, RV, CMV and HSV infection, providing valuable information for further clinical treatment, such as induced labour.
5.Determination of Bioequivalence of Cefixime by Three-way Crossover Design
Aixin SHI ; Yufei FENG ; Kexin LI ; Lei LIU ; Qi YIN ; Chunhua SUN
China Pharmacy 1991;0(02):-
OBJECTIVE:To study the bioequivalence of suspension formulation of cefixime(A),capsule formulation of ce-fixime(B) and reference preparation(C: Cefixime Capsules or Cefspan) in human body.METHODS: The study was conducted as a 3- way crossover design in 18 healthy volunteers whose plasma concentrations of cefixime were determined by HPLC after receiving a single oral dose of 200 mg trial preparations or reference preparation.RESULTS:The main pharmacokinetics of the three preparations(A、B、C) were as follows after undergoing BIO3 program fitting:AUC0-1 were(18.54?6.31)mg?h-1?L-1, (16.10?5.51)mg?h-1?L-1 and (17.16?5.96)mg?h-1?L-1, Cmax were(2.63?0.76) mg?L-1, (2.43?0.78)mg?L-1 and (2.57?0.90)mg?L-1;tmax were(4.11?0.58)h,(4.56?0.51)h and (4.56?0.70)h,respectively .The relative bioavailability of cefixime suspensions(A) and cefixime capsules(B) were (108.8?12.3)% and (95.7?15.9)% ,respectively as against reference preparation(C) .CONCLUSION:The test formulations(A and B) were found bioequivalent to the reference formulation(C).
6.Bioequivalence of Domestic Meloxicam Tablets in Healthy Volunteers
Jie HAN ; Aixin SHI ; Guangwei HE ; Lei LIU ; Qi YIN ; Chunhua SUN ; Youhua SONG
China Pharmacy 2001;0(12):-
OBJECTIVE:The bioequivalence and pharmacokinetics of two kinds of domestic meloxicam tablets were studied in 20 healthy male volunteers METHODS:A dose of 15mg of domestic or imported meloxicam(test and reference preparation)was given according to arandomized 2-way cross-over design,blood samples were withdrawn up to 96 hours post administration,and plasma concentration of meloxicam was determined by high performance liquid chromatography(HPLC)method RESULTS:The peak plasma levels(Cmax)of meloxicam test drug and reference drug were (2 736 2?312 0)and(2 665 6?333 8)?g/L,respectively,the peak time(Tmax)were(4 25?1 16)h and(4 00?1 30)h,respectively,T1/2ke were(21 67?3 81)h and(21 05?3 30)h,respectively,and AUC0~t were(96 454 6?25 526 6)and(95 692 5?24 532 6)?g/(h?L),respectively There were no significant differences in AUC0~t,Tmax,Cmax and T1/2ke between two kinds of tablet CONCLUSION:The relative bioavailability data obtained in the study furnished definite proof of bioequivalence of both domestic meloxicam tablets and imported meloxicam tablets The relative bioavailablility of the test drug was(101 3?11 9)%
7.Serial recombinant expression and anti-tumor activity in vitro of antibiotic peptide Alloferon-1.
Xiao-yin XU ; Jie YAN ; Qi SUN
Journal of Zhejiang University. Medical sciences 2011;40(5):501-507
OBJECTIVETo generate a recombinant expression system of repeated serial antibiotic peptide Alloferon-1 DNA segment with trypsin digestion site and to determine its anti-tumor activity in vitro.
METHODSA 14 repeated serial DNA segment of Alloferon-1 with a lysine residual at the C-end that acts as the trypsin digestion site was constructed. pET42a vector and E.coli BL21DE3 were applied to generate the prokaryotic expression system of the repeated serial DNA segment of Alloferon-1. The yield of target recombinant product was measured by SDS-PAGE and Bio-Rad Gel image system. Ni-NTA affinity column, trypsin digestion and Sephadex G-50 column were used to purify 14 rAlloferon-1-K fusion protein and rAlloferon-1-K monomer. By using the co-cultivation of BALB/c mouse splenocyte with K562, KB or SGC tumor cells and CCK-8 detection method, the effects of rAlloferon-1-K, chemosynthetic Alloferon-1 (cAlloferon-1) and Alloferon-1-K (cAlloferon-1-K) on the growth and proliferation of tumor cells were detected.
RESULTSThe prokaryotic expression system E.coli BL21DE3pET42a-14 Alloferon-1-K efficiently expressed 14 rAlloferon-1-K fusion protein under inducement of IPTG,and the yield of fusion protein was approximate 30% of the total bacterial proteins. 0.1≊10 ng/ml rAlloferon-1-K remarkably increased the effect of mouse splenocytes to inhibit the growth and proliferation of K562, KB and SGC cells (P<0.05), and there was no statistically significant difference of the anti-tumor ability of rAlloferon-1-K compared to that of cAlloferon-1 or cAlloferon-1-K (P>0.05).
CONCLUSIONA prokaryotic expression system of repeated serial Alloferon-1 DNA segment has been successfully constructed with high yield of rAlloferon-1-K, which maintains anti-tumor activity in vitro.
Animals ; Antineoplastic Agents ; pharmacology ; Cell Line, Tumor ; Genetic Vectors ; Humans ; Male ; Mice ; Mice, Inbred BALB C ; Peptides ; genetics ; pharmacology ; Recombinant Fusion Proteins ; biosynthesis ; genetics ; pharmacology
8.Effects of Icariin promotion on proliferation and osteogenic differentiation of human periodontal ligament stem cells.
Zishun QIN ; Lihua YIN ; Kajuan WANG ; Qi LIU ; Wenxiao CHENG ; Peng GAO ; Kemo SUN ; Mei ZHONG ; Zhanhai YU
West China Journal of Stomatology 2015;33(4):370-376
OBJECTIVETo evaluate the effects of Icariin (ICA) on the proliferation and osteogenic differentiation of human periodontal ligament stem cells (hPDLSCs) in vitro and in vivo.
METHODSAn enzymatic digestion block was used in vitro to culture hPDLSCs, which were separated and purified by limited dilution cloning. The hPDLSCs were identified using cell-surface markers and cocultured with 1 x 10(-7) mol.L-1 ICA solution. The proliferation ability of these cells was determined by thiazolyl blue tetrazolium bromide (MTT) assay. After staining with alkaline phosphatase (ALP), osteogenesis was detected by enzyme-linked immunosorbent assay. Osteoblast-related genes were analyzed by reverse transcription-polymerase chain reaction. Alizarin red staining was performed to measure the level of calcium deposition. The hPDLSCs were cocultured with 1 x 10(-7) mol.L-1 ICA and nano-hydroxyapatite scaffolds in vivo before transplantation into subcutaneous tissues of nude mice. Osteogenic abilities were histochemically analyzed after 30 days of induction.
RESULTSThe hPDLSCs were affected by 1 x 10(-7) mol.L-1 ICA, and MTT assay showed that the proliferation of the groups treated with ICA in vitro was better than that of the control groups on the second day. The ALP activity of the treated hPDLSCs was significantly enhanced after cell culture for 3, 5, and 7 days. The gene expression of osteoblastic markers was also significantly enhanced after 7 days. The deposition of mineralization after incubation with 1 x 10(-7) mol.L-1 ICA increased compared with the control after cell culture for 14, 21, and 28 days. Furthermore, the bone expression of the treatment groups in vivo was significantly enhanced compared with that of the control groups.
CONCLUSIONTreatment with 1 x 10(-7) mol.L-1 ICA can significantly promote proliferation and differentiation of hPDLSCs in vitro and in vivo. ICA can effectively function as a bioactive growth factor in periodontal tissue engineering to replace traditional growth factors.
Alkaline Phosphatase ; Animals ; Cell Culture Techniques ; Cell Differentiation ; Cell Proliferation ; Coculture Techniques ; Enzyme-Linked Immunosorbent Assay ; Flavonoids ; Humans ; Mice ; Mice, Nude ; Osteoblasts ; Osteogenesis ; Periodontal Ligament ; Stem Cells
9.Epidemiological analysis of brucellosis in Hebei province from 2006 to 2010
Xia, JIANG ; Zhen-yu, QIAN ; Xiao-li, LIU ; Yue-ping, LI ; Zhao-yi, JIA ; Ying-tong, WANG ; Yin-qi, SUN
Chinese Journal of Endemiology 2012;31(2):209-211
ObjectiveBy analyzing the epidemiological characteristics and trends of brucellosis in Hebei province,provide a scientific basis for the formulation of strategies for effective prevention and control of the disease.MethodsUsing the descriptive epidemiological method,data of the “China information system for disease control and prevention” from 2006 to 2010 were statistically analyzed.ResultsThere were 13 632 reported cases from 2006 to 2010 in Hebei province,no death,the annual incidence rates reported were 3.4068/10 million,3.4851/10 million,4.5701/10 million,4.6045/10 million,and 3.5582/10 million,respectively.Eleven counties throughout the province had reported cases.The cases were found intensively in Zhangjiakou,Chengde,Baoding,Handan and Shijiazhuang,which accounting for 90.02% (12 271/13 632) of the total cases.The disease was found each month throughout the year,and showed a seasonal cycle with peak period in spring and summer.The disease was most commonly found in 25 - 65 age people,which accounting for 84.57%(11 529/13 632).The incidence in male was higher than that of female,and male to female ratio was about 3.56:1.00.Vocational high risk population was farmers,accounting for 91.15% of the total cases(12 425/13 632).ConclusionsBrucellosis epidemic in Hebei province is relatively serious,and the epidemic range has expand each year,even highly active in some particular areas.To control the outbreak of brucellosis,departments cooperation between health and animal husbandry should be strengthened; management of source of infection should be strengthened; health education and behavior intervention should be carried out thoroughly and deeply for high-risk groups.
10.Development and application of extramedullary femoral osteotomy module in total knee arthroplasty
Hongmei ZHANG ; Mingjiang HE ; Pengcheng SHAN ; Lin JING ; Qi YAN ; Tiejun ZHAO ; Gang SUN ; Lijun GU ; Tian YIN
Chinese Journal of Orthopaedics 2017;37(11):651-659
Objective To investigate the outcome of a new designed extramedullary femoral osteotomy module and to compare with conventional intramedullary system in clinical study.Methods The extramedullary femoral osteotomy module was designed with the extramedullary alignment rod connecting with the T type rod at right angle,and it had a 5°-7° adjustable valgus design.The positioning module fixation screw was parallel with the epicondylar axis.The coronal plane of the distal femur bone cut was orientated by the extramedullary alignment rod pointing to the inguinal midpoint,and the sagittal plane was orientated by the extramedullary alignment rod keeping parallel with the distal femoral medullary cavity.The terminal distal femoral bone cut was conducted with suitable osteotomy after the orientation.Sixty patients who underwent unilateral total knee arthroplasty (TKA) from October 2015 to March 2016 were randomly divided into intramedullary and extramedullary group for prospective controlled study.Blood loss,drainage and the incidence of deep vein thrombosis (DVT) were evaluated at one week postoperatively.Knee valgus angle and femoral prosthesis flexion angle were analyzed at two weeks postoperatively.Moreover,the extramedullary femoral osteotomy module was used in 273 patients (78 males and 195 females) with an average age of 68.7 (range,57-82 years old) who underwent unilateral TKA from April 2016 to January 2017.Blood loss,operation duration and lower limb ultrasonography preoperatively and at one week postoperatively were recorded.Knee valgus angle and femoral prosthesis flexion angle were measured at 2 weeks postoperatively.Range of knee motion and Hospital for Special Surgery (HSS) knee score at six weeks postoperatively were also reported.Results In the randomized controlled trial,blood loss and drainage in extramedullary group was less than that in intramedullary group (t=-3.330,P=0.004).There was no significant difference in the incidence of DVT at 1 week postoperatively (x2=2.269,P=0.132) and the knee valgus angle and femoral prosthesis flexion angle at 2 weeks postoperatively within the two groups.In the clinical application,operation time was 60.13± 13.69 min,and blood loss and drainage was 109.11±70.73 ml.There were four cases of popliteal vein thrombosis,nine cases of posterior tibial vein thrombosis,and seventeen cases of muscular venous thrombosis at one week postoperatively.The incidence rate of DVT was 11.0%.There was no symptomatic pulmonary embolism at three months postoperatively.Knee valgus angle was 7.34°±0.69°,and 211 knees accounting for 77.3% were in the range of ±3° error.Femoral prosthesis flexion angle was 6.43°±1.59°,and 273 knees were all in the range of ±10° error.Range of knee motion improved from 54.52±5.96 preoperative to 86.20±4.92 at six weeks postoperative.HSS knee score improved from 100.88°±7.51° preoperative to 110.42°±7.08° at six weeks postoperative.Conclusion The new designed extramedullary femoral osteotomy module used in distal femoral osteotomy during TKA can significantly reduce the risk of bleeding and the incidence rate of DVT postoperatively.Furthermore,patients can obtain as excellent prosthesis position and limb alignment as conventional intramedullary system.