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Objective@#To investigate the early diagnosis and treatment options for steroid-induced osteonecrosis of the femoral head (SONFH).@*Methods@#Retrospective analysis was conducted in 73 patients with unilateral SONFH from January 2010 to June 2017. There were 27 males and 46 females, aged 34.26±10.35 years (range, 20-45 years). The following type of cases were included, 21 cases of ARCO I, 24 cases of IIa, 8 cases of IIb, 18 cases of IIc and 2 cases of IIIa. Patients with ARCO I were limited in weight and were treated with low molecular weight heparin sodium and ginkgo dharma drugs after excluding bleeding risk. Core decompression was performed in patients with ARCO IIa and IIb vascularized greater trochanter bone transfer was conducted in patients with IIc and IIIa. During the follow-up duration, when the ARCO I progressed to ARCO IIa and IIb, the core decompression was performed. When the ARCO IIa and IIb progressed to the ARCO IIc or IIIa, the vascularized greater trochanter bone transfer was conducted. Vascularized greater trochanter bone combined with the tantalum rod was implanted in ARCO IIIb. The femoral head reconstruction with the larger trochanter bone flap or joint replacement was performed in ARCO IIIc and above. The Harris hip score was used to evaluate the clinical outcomes. The femoral head survival curve of SONFH was drawn with the end of joint replacement.@*Results@#All 73 patients were followed up for an average of 29 months (range, 18 to 48 months). After treatment of 21 patients with ARCO I, a total of 14 (67%) patients had no ARCO staging progress. After 6 months, three patients progressed to ARCO IIb and 4 patients progressed to ARCO IIc. All 32 patients with ARCO IIa and IIb were treated, of which 25 (78%) did not progress but 4 patients progressed to ARCO IIIa at 6 months. Only one patient progressed to ARCO IIIb at 6 months, and 2 patient progressed to ARCO IIIc at 12 months. There were 18 patients with ARCO IIc underwent treatment, of which 14 patients (78%) did not progress but 2 patients progressed to ARCO IIIa at 6 months and 2 patients progressed to ARCO IIIc at 24 months and to ARCO IV at 42 months, respectively. Two patients of ARCO IIIa, 1 patient did not progress and the other one progressed to ARCO IV at 36 months. The Harris hip score was 90.48±5.36 before treatment and 91.76±8.19 at the last follow-up. The difference was not statistically significant (t=1.231, P=0.402). The Harris hip score of patients with ARCO IIa and IIb in creased from 75.22±8.30 to 84.47±16.77 with statistically significant difference (t=5.624, P<0.001). The Harris hip score of patients with ARCO IIc and IIIa increased from 59.80±9.24 to 77.75±20.75 with statistically significant difference (t=12.033, P<0.001). Four patients eventually underwent arthroplasty. The femoral head survival rate was 98.6% at 2 years and 94.5% at 4 years.@*Conclusion@#The SONFH can be diagnosed early by screening, and is treated by different reserving hip methods according to severe stages. The short-term clinical effects are satisfied.
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Objective To investigate the difference of blood supply in different areas of the normal femoral head in adults.Methods A retrospective study analyzed the DCE-MRI parameters data of 2 5 normal adults (25 right hips)in our hospital.The femoral head was assumed to be a sphere.On T1 WI of DCE-MRI,the right femoral head was divided into three parts equally in coronal,sagittal, and transverse plane respectively.Time to peak(TTP),maximum of enhancement at first past(fEmax),maximum of enhancement (Emax)were measured in three parts and compared in coronal,sagittal and transverse plane respectively.Results (1 )In coronal plane,there were no significant differences between the three parts in TTP,fEmax and Emax.(2 )In transverse plane,fEmax and Emax were lower in the transverse superior zone than that in the transverse central zone significantly (P＝0.024 and P＝0.001)and the transverse inferior zone(P＝0.005 and P＝0.018).TTP was higher in the transverse superior zone than that in the transverse central zone and the transverse inferior zone(P＝0.005 and P＝0.018).(3)In sagittal plane,fEmax and Emax were lower in the sagittal lateral zone than that in the sagittal centralzone (P＝0.019 and P＝0.041)and sagittal medial zone (P＝0.047 and P＝0.01 1).TTP was higher in the sagittal lateral zone than that in the sagittal central zone and the sagittal medial zone(P＝0.014 and P＝0.010).There were no significant differences between other paired zones of the any values.Conclusion DCE-MRI can show the microcirculation in the normal adult femoral head in a non-invasive way.According to DCE-MRI parameters,there are poor perfusions on the transversesuperior and sagittallateral zones of the normal femoral head in adults.
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BACKGROUND:There are a variety of treatments for femoral head necrosis,but their efficacy is not confirmed and unified.How to improve the differentiation ability of osteoblasts in the femoral head and improve the biomechanical support after the repair of the femoral head is an urgent problem to be solved.OBJECTIVE:To explore the clinical outcome of stem cells combined with vascularized iliac bone flap and tantalum rod implantation for the treatment of osteonecrosis of the femoral head (ONFH).METHODS:Totally 28 cases (36 hips) of non-traumatic ONFH admitted at the Zhongshan Hospital of Dalian University from January 2010 to January 2011 were enrolled.Bone marrow samples were extracted from each patient to isolate bone marrow stromal stem cells which were cultured in vitro for 2 weeks.Tantalum rod implantation with vascularized iliac bone graft was conducted to restore the femoral head shape,and then,prepared stem cell suspension were injected into the iliac bone flap and into the subchondral space of the femoral head.RESULTS AND CONCLUSION:All the 28 cases (36 hips) were followed up for 6-20 months (average 12 months),and their Harris hip scores and visual analogue scale scores at postoperative 6 and 12 months were significantly higher than the baseline (P ＜ 0.05).The Harris hip score at postoperative 12 months was significantly higher than that at postoperative 6 months (P ＜ 0.05),but there was no significant difference in the visual analogue scale scores at 6 and 12 months postoperatively (P ＞ 0.05).At the end of 12-month follow-up,clinical outcomes were excellent in 13 hips,good in 15 hips,fair in 4 hips,and poor in 4 hips,with an excellent and good rate of 90％.These findings indicate that autologous bone marrow stromal stem cell transplantation with vascularized iliac bone flap and tantalum rob implantation is an effective method with high clinical success rate for the treatment of ONFH.
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BACKGROUND: The imaging methods of evaluating the volume of necrotic femoral head are based on Kerboul angle and necrosis index revealed on X-ray, as well as CT and MRI three-dimensional reconstruction, but the accuracy of each method is different, and none is widely accepted. Additionally, the association of the volum and degree of necrotic femoral head with the status of blood supply to the femoral head remain unclear. OBJECTIVE: To evaluate the accuracy of each imaing method for assessing different stages of femoral head necrosis, and to confirm a convenient method used for measuring the volum of necrotic femoral head. METHODS: This diagnostic in vivo animal trial was finished in the Affiliated Zhongshan Hospital of Dalian University, Liaoning Province, China. The canine models of steroid-induced necrosis of femoral head were prepared, and received CT and MRI examinations, followed by three-dimensional reconstruction combined with Micro-CT to make accuratediagnosis; the degree of necrotic femoral head and its association with the status of blood supply were evaluated throughangiography and histopathological examination. All above outcome measures were compared with the Association Research Circulation Osseous to testify the consistency of this precise method with traditional methods. The experiment follows the national guidelines for the Care and Use of Laboratory Animals, and Consensus author guidelines on animal ethics and welfare by the international Association for Veterinary Editors (IAVE). The article was prepared in accordance with the Animal Research: Reporting of In Vivo Experiments Guidelines (ARRIVE Guidelines). RESULTS AND CONCLUSION: The aim of the study is to obtain a accurate measurement method by detecting different stages of osteonecrosis using different imaging techniques, which enables surgeons make exact diagnosis and clinical stage of osteonecrosis, thus desiging standardized treatment program.
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Objective To investigate the possibility of the domestic reticulated vitreous carbon as a kind of scaffold material for bone tissue engineering,the biocompatibility of domestic reticulated vitreous carbon was first successfully tested with bone marrow stromal cells (BMSCs) in vitro and for bone tissue repair in vivo.Methods From June,2013 to August,2014,the morphology and proliferation of BMSCs co-cultured with scaffold material in vitro was measured.Differences of measurement were compared with single factor analysis of variance to detect the cytotoxicity of reticulated vitreous carbon.In vivo reticulated vitreous carbon were implanted into the bone defect site and the groin.After 12 weeks,the biocompatibility of reticulated vitreous carbon was observed.Results MTT results showed that after 7d co-culture,the survival and proliferation of BMSCs had not been significantly inhibited (P ＞ 0.05).Inverted fluorescence microscope and scanning electron microscope found that newly developed three-dimensional domestic reticulated vitreous carbon could promote adhesion,aggregation and proliferation of BMSCs in vitro.Studies in vivo demonstrate that implanted reticulated vitreous carbon with a high porosity and host bone may produce a stable connection and integration.Conclusion Non-cytotoxic domestic reticulated vitreous carbon can promote the adhesion and proliferation of bone marrow mesenchymal stem cells in vitro and has good bone induction properties in vivo.
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Objective To investigate the clinical effect of the iliac periosteal flap with ascending branch of lateral femoral circumflex artery for the treatment of Legg-Calvé-Perthes disease.Methods Followed-up 18 patients with Legg-Calvé-Perthes disease who had undergone the treatment of iliac periosteal flap with ascending branch of lateral femoral circumflex artery from January,2008 to May,2012 in our hospital.Minimum follow-up time was from 24 to 60 months,and the average time was 38 months.The followed-up period ended in May,2014.Assessed the effect of surgery by X-ray,clinical examination and Harris scoring system.Results Sixteen patients had good healing with iliac periosteal flap according to X-ray show.Their epiphyseal height recovered and the femoral head rounded gradually.Two cases became flat and collapse.The result of excellent and good rate was 88.9％ by Mose method combined with the results of X-ray.The average Harris hip score improved from 72.3 ± 4.9 points preoperatively to 91.3 ± 2.4 points postoperatively.The difference of the result was statistically significant (P ＜ 0.05).Conclusion The transfer of iliac periosteal flap with ascending branch of lateral femoral circumflex artery is an effective treatment for Legg-Calvé-Perthes disease.
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Objective To analyze retrospectively the clinical efficacy that the application with vascularized greater trochanter to reconstruct the collapse of femoral head necrosis.Methods Followed-up the data of 21 patients who underwent reconstruction of the femoral head from January,2008 to December,2012,by this we made the clinical and radiological assess,Harris hip scoring system was used to evaluate the situation of hip function.All patients were followed up regularly for X-ray film (after 3 months,6 months and then be reviewed once a year),by the film we assessed the bone healing and repair of the femoral head,and determined whether had the progress in phases.The clinical survival was decided by receiving or not the arthroplasty.Results All 21 patients were followed up for 24-72 months,with an average of 47 months.The postoperative Harris hip score was 82.8 ± 7.1 points,compared with the preoperative,the score improved significantly (average 52.4 ± 4.3 points for preoperative),the difference was statistically significant (P ＜ 0.05).Based on Ficat stage for osteonecrosis,8 patients in this group had progress after 24 to 48 months (mean 33 months),whose femoral heads got collapse worsened.The radiographic success rate was 61.9％.Six cases received arthroplasty in 18 to 48 months (mean 34 months) due to progressive collapse of the femoral head or severe hip pain,or both.FicatⅢ contained 25％ (4 hips),and Ⅳ had 40％ (2 hips),the clinical survival rate was 71.4％.Conclusion The application with vascularized greate.r trochanter transfer coverage to rebuild the collapse of the femoral head in patients with osteonecrosis is a good way.It' s worthy to be applied.
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Objective To explore the clinical outcome of vascularized iliac bone flap combined with tantalum rod implantation for the treatment of osteonecrosis of the femoral head (ONFH).Methods Totally 28 cases (36 hips) of non traumatic avascular necrosis of the femoral head patients from January 2010 to January 2011,which were 15 males and 13 females; a mean age of 40 years (ranged,18-53years),according to ARCO stages:eight hips of stage Ⅱ a,ten hips of stage Ⅱ b,nine hips of stage Ⅲ a,nine hips of stage Ⅲ b,adopt to vascularized iliac grafting combined with tantalum rod Implantation for osteonecrosis of the femoral head.The Harris hip score and VAS score of pre-and post-operation was recorded to evaluate the clinical outcome,and to compare observe and analyze the change of postoperative of patients by used three-dimensional gait.Results All 28 cases (36 hips) were followed up 6 ～20 months,averaged 12 months.The results of Harris hip score and VAS score of the 6 months postoperatively and last follow-up were significantly higher than preoperative ones (P ＜0.05).And the Harris hip score of the last follow-up was also significantly higher than the one of 6 months postoperatively (P ＜ 0.05).However,there was no significant different in that of VAS score (P ＞0.05).There were 13 cases in excellent,fourteen in good and 4 in fair with an excellent and good rate of 89.8％,which shows that the extension of time and changes in patients gait tends to normal by three-dimensional gait analysis.Conclusion Vascularized iliac bone flap transplantation combined with tantalum screw was an effective method with high clinical success rate for treatment of younger patients with early-mid stage ONFH.It provided good blood supply and enough mechanical support to reduce the progress of femoral head collapse.
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Objective To compare open reduction and cannulated screws combined with ascending branch of lateral femoral circumflex artery iliac bone flap with closed reduction and cannulated screw fixation for the treatment of displaced femoral neck fracture in young adults.Methods From January 1992 to January 2007,totally 204 cases of displaced femoral neck fracture were treated.Group A:one hundred and three cases were treated with open reduction and 2 cannulated screw fixation,covered by the vascular pedicled iliac bone flap with ascending branch of lateral femoral circumflex artery.Garden classification:type Ⅲ.68 cases,type Ⅳ:35 cases.Group B:one hundred and one cases,treated with closed reduction and three cannulated screw fixation.Garden classification:type Ⅲ in 62 cases and type Ⅳ in 39 cases.Results Two groups were followed up for 5-15 years.The healing time of group A was (73 ±21.2) days,including 4 cases of nonunion fracture (3.9％) and 5 cases of femoral head avascular necrosis occurred (4.9％) ; The healing time of group B was (89 ± 12.5) days,including 12 cases of nonunion fracture (11.9％) and 18 cases of femoral head avascular necrosis occurred (17.8％).The healing time,the rate of nonunion of fracture and the rate of femoral head necrosis were significantly different of these 2 groups.Conclusion The treatment of open reduction and 2 cannulated screw fixation,covered by the vascular pedicled iliac bone flap with ascending branch in young adults can effectively prevent nonunion of fractures and osteonecrosis of the femoral head.
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BACKGROUND:Porous tantalum rods, possessing high porosity and highly similar elastic modulus to the trabecular bone, not only can provide effective mechanical support for the femoral head, but also can enhance revascularization in the areas of necrosis, reduce stress shielding, and provide guarantee for bone ingrowth in necrotic area. OBJECTIVE:To investigate the attachment and proliferation of bone marrow mesenchymal stem cells on the surface of porous tantalum rod. METHODS:The purified bone marrow mesenchymal stem cells which were separated from canines were seeded on the surface of porous tantalum rod by the celldensity of 1.5×109/L. cellattachment and proliferation was observed under phase microscope and scanning electron microscope at 5, 10 and 15 days under co-cultured condition. RESULTS AND CONCLUSION:(1) Inverted microscope:Within 1-5 days after co-culture, the cells began to proliferate, and less cells were found near the tantalum rod, but more cells far from the rod. At 6-10 days after co-culture, the cells increased significantly and gradual y migrated to the rod, and even some cells attached to the edges of the rod. After 14 days, the cells were interconnected to form a film, packing the surrounding and dents of the tantalum rod. cells were visible to agglomerate and cellcalcification occurred. (2) Scanning electron microscope:At 5 days after co-culture, no celladhesion appeared on the the tantalum rod surface. At 10 days after co-culture, the cells scattered on the surface of tantalum rod, but there was no interconnection between them. After 15 days, cells were polygon shaped and connected into pieces. It could be seen that the cells secreted large amounts of col agen fibers, and the cells that were fusiform and polygon shaped were surrounded by a great amount of extracellular matrice. Bone marrow mesenchymal stem cells appear to have good adhesion and proliferation capability on the surface of tantalum rod.
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BACKGROUND:Seed cells and scaffold are two key factors for cartilage defects after osteonecrosis of femoral head using tissue-engineered method. OBJECTIVE:To explore the feasibility of Bio-gide col agen membrane combined with dog bone marrow mesenchymal stem cells into chondrocytes. METHODS:Bone marrow mesenchymal stem cells were isolated from beagle dogs by whole bone marrow blood centrifugation method and adherence screening method in vitro and cultured. Morphological changes in cells were observed, and identification was done using cellsurface antigens. Bone marrow mesenchymal stem cells of passage 3 were induced by chondrocyte induction medium to differentiate into chondrocytes (experimental group). cells cultured in normal medium were considered as control group. 3-(4, 5-Dimethylthiazol-2-yl) 2, 5-diphenyl tetrazolium bromide assay was used to measure growth curve of chondrocytes. cells underwent typeⅡcol agen immunohistochemistry and toluidine blue staining. The coculture of bone marrow mesenchymal stem cells at passage 3 and Bio-gide col agen membrane were observed under an inverted phase contrast microscope and scanning electron microscope. RESULTS AND CONCLUSION: Bone marrow mesenchymal stem cells with high purity and high viability were obtained by whole bone marrow blood centrifugation method and adherence screening method. cells grew wel and had strong amplified ability, and successful y differentiated into chondrocytes. Numerous bone marrow mesenchymal stem cells adhered on the Bio-gide col agen membrane, showing a tendency of multi-layer growth. cells and Bio-gide col agen membrane seem to blend into an integrant part. Cel processes appeared and connected each other and gradual y wrapped the Bio-gide col agen membrane, with the presence of obvious cel matrix secretion. These results suggested that bone marrow mesenchymal stem cells can grow and differentiate into chondrocytes on the Bio-gide col agen membrane.
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Objective To investigate the incidence of osteonecrosis of the femoral head (ONFH) in divers of Dalian.Methods From January 2010 to December 2010,all registered 855 divers in Dalian were enrolled in this study.All divers underwent a unified medical examination and a questionnaire including height,weight,blood pressure and hip inspection.Radiological examination (anteroposterior and frog position)was used for all divers.Suspicious persons with hip pain but normal X-ray performance were confirmed by MRI.Results Sixty-eight divers were confirmed as ONFH,and the incidence of ONFH in divers of Dalian was 7.95％.According to the Ficat classification,12 patients (12 hips) were in Phase 1,40 patients (47 hips)in phase Ⅱ,3 patients (3 hips) in phase Ⅲ,13 patients (15 hips) in phase Ⅳ.The mean age of divers was 32.6+5.5 years (range,18-55 years).The onset ages of most patients ranged from 30 years to 50 years,accounted for 83.82％ (57/68).Among all patients,primary school education accounted for 10.58％ (38/359),junior high school education 6.28％ (28/446),high school education 4.26％ (2/47),university education 0 (0/3); seniority less than 5 years accounted for 4.55％ (20/440),6-10 years 9.69％ (28/289),11-15 years 13.04％ (12/92),16-20 years 21.05％ (4/19),more than 20 years 26.67％ (4/15); self-employed accounted for 11.88％ (19/160),private enterprise 8.41％ (38/452),and national enterprise 4.53％ (11/243).Conclusion The incidence of ONFH is high in divers of Dalian,which is different in terms of age,seniority,level of education,enterprise nature.
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Objective To discuss the surgical outcome of fenestration assistant by microscopy for single-level lumbar disc protrusion (LDH), compared with tradition laminotomy and discectomy. Methods From January 2008 to January 2010, forty-eight patients underwent traditional open discectomy and 40 underwent microscopy surgery. The lumbar disc protrusion involved L3- L4 level in 12 cases, L4-L5 level in 46 cases, and L5-S1 level in 30 cases; preoperative JOA score was 8-19 points (average 12.9 points) for traditional open discectomy patients and 7-19 points (average 12.7 points) for microscopy surgery patients. Results Cauda equina injury was occurred and repaired in 2 cases in traditional surgery group. The follow-up period was 10-34 months (average 18 months) for all patients. No complications such as wrong orientation, nerve root injury, and infection occurred. The JOA score 10 months after operation was (24.0 ± 2.6) for traditional surgery patients with 87.5% success rate and (24.2 ± 2.8) for microscopy surgery patients with 90% success rate. Conclusion Two methods have similar clinical outcomes, but microscopy assistant fenestration for LDH has advantages of minimal invasion, shorter operative time, shorter length of hospital stay and less intraoperative blood loss. It is one of ideal minimally invasive operations for single-level lumbar disc protrusion.
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The aim of this study is to establish an HPLC method for simultaneous determinations of mifepristone and its metabolites, mono-demethylated mifepristone, di-demethylated mifepristone and C-hydroxylated mifepristone in plasma and to evaluate the pharmacokinetic characteristics of mifepristone tablet. Twenty healthy female Chinese subjects were recruited and a series of blood samples were collected before and after 0.25, 0.5, 1.0, 1.5, 2.0, 4.0, 8.0, 12.0, 24.0, 48.0, 72.0 and 96.0 hours administration by a single oral dose of 75 mg mifepristone tablet. Mifepristone and its three metabolites were extracted from plasma using ethyl acetate and determined by high performance liquid chromatography. The main pharmacokinetic parameters of mifepristone and its metabolites, including Cmax, tmax, MRT, t(1/2), V, CL, AUC(0-96 h) and AUC(0-infinity), were calculated by Drug and Statistical Software Version 2.0. The simple, accurate and stable method allows the sensitive determinations ofmifepristone and its metabolites in human plasma up to 4 days after oral administration of 75 mg mifepristone tablet and the clinical applications of their pharmacokinetic studies.
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Objective To evaluate the safety and accuracy in treating the avascular necrosis of femoral head (ANFH) with computer navigated core decompression and bone marrow stream cell transportation and to guide the clinical treatment. Method Within the prospective study, 36 patients suffered ANFH (ARCO Ⅰ - Ⅱ ) and treated with computer navigated core decompression and bone marrow stream cell transportation were studied. The operating time, blood loss, x ray exposure, preoperative and 6 week postoperative Harris score and imaging evaluation were recorded and compared with conventional core decompression and bone marrow stream cell transportation. Results There were no obvious difference between the two groups in imaging evaluation, operating time and blood loss ( P ＞ 0. 05 ). There were statistical difference between the two groups in x ray exposure and 6 week postoperative Harris score [ (4. 1 ± 1.8 ) s,(13.6±3.2)s,P ＜0. 01,and89.4±10. 1,83.1±10. 5, P ＜0.01]. Conclusion Computer navigated core decompression and bone marrow stream cell transportation have good security and precision in treating early stage ANFH.
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-mid stage ONFH. It provided good blood supply and enough mechanical support as to reduce the progress of femoral head collapse.
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A sensitive and selective liquid chromatography-tandem mass spectrometric (LC-MS/MS) method was developed and validated for the determination of betamethasone in human plasma. The analyte was isocratically eluted on a Venusil XBP C8 column (200 mm ×3.9 mm ID, 5 μm) with methanol-water with a triple quad LC-MS/MS using ESI with positive ionization. Ions monitored in the multiple reaction monitoring (MRM) mode were m/z 393.3→355.2 for betamethasone and m/z 361.3→343.2 for prednisolone (IS). Betamethasone was extracted from 0.5 mL human plasma with ethyl acetate. The validation study demonstrated excellent precision and accuracy across the calibration range of 0.5 - 80.0 injection in healthy Chinese volunteers.
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Objective To research on treament of femoral head of patients with osteoneerosis of the femoral head fracture.Methods Twenty-six patients half of femaoral head of patients with osteonecrosis of the femoral head fracture who treated with vascularzed bone graft were determined.Twenty-one hips treated with internal fixation unloaded and vascularzed bone graft after selective digital subtraction angiography (DSA) was performed to confirm the blood supply of femoral head.one case underwent total hip replacement after internal fixation unloaded.Results All patients were followed up for a mean of 23 months (range,12-38months)and were assessed clinically and radiologically according to Harris scoring.Selective digital subtraction angiography (DSA) was performed in 15 cases to confirm the blood reconstruction of femoral head.Two cases underwent total hip replacement postoperatively.Preoperative and postoperative Harris score were 54 and 86.2,clinical success rate was 92.0% and radiological success rate was 84.0%.DSA demonstrated blood supply was found reconstruction in the necrotic femoral head.Conclusion Femoral head of patients with osteonecrosis of the femoral head fracture was very much (recent 40%).Taking out of internal fixation,treatment of osteonecrosis of the femoral head by using vascularzed bone graft was confirmed,early clinical results were satisfied.
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AIM: To establish a sensitive HPLC method for determining the concentrations of paeonol in human plasma and to evaluate its pharmacokinetic characteristics. METHODS: A single oral dose of 160 mg paeonol capsules was given to 24 Chinese healthy volunteers. Paeonol was separated on a XB-C18 column with tetrahydrofuran-methanol-water-phosphonic acid (6∶60∶34∶0.1, V∶V) as mobile phase. The plasma concentrations of paeonol were determined and its pharmacokinetic parameters were calculated and evaluated using DAS 2.0. RESULTS: The linear range of the paeonol was 10-500 ng/mL and the determination limit was 10 ng/mL. The main pharmacokinetic parameters, as Cmax, tmax, t1/2,AUC0-3, AUC0-∞ after a single dose of paeonol capsules were (116±46)ng/mL,(1.02±0.13) h,(1.03±0.35) h, (174±45) ng/mL, (217±56) ng/mL,respectively. CONCLUSION: The HPLC method for determining paeonol concentration in plasma is rapid, sensitive and suitable for pharmacokinetic studies.
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AIM:To establish an LC-MS method for determining the concentrations of loratadine (LOR) in human plasma and to evaluate its pharmacokinetic characteristics. METHODS: A ZORBAX Eclipse XDB-C8 (5 μm, 150 mm×4.6 mm) column was used, atmospheric pressure electronic spray ionization (AP-ESI) and ion mass spectrum (m/z) of 388.2 (M+H)+ were selected to quantify LOR, and 275.1 (M+H)+ for ropivacaine (internal standard, IS). RESULTS: The linear range of LOR standard curve was 0.5-50 ng·ml-1, and the determination limit was 0.5 ng·ml-1. The pharmacokinetic parameters of LOR after a single dose of 20 mg tablet (T1), capsule (T2) and reference (R) were as follows, the half life (t1/2) 13.52±1.35, 13.14±0.98 and 14.00±1.25 h, the time to peak concentration (Tmax) 1.24±0.06, 1.18±0.12 and 1.17±0.12 h, the peak concentration (Cmax) 21.72±7.70, 21.49±8.34 and 20.50±8.65 ng·ml-1, the area under time-concentration curve (AUC0-48 and AUC0-∞) 137.24±47.84 and 146.61±51.03 ng·ml-1·h, 139.65±45.69 and 148.04±48.10 ng·ml-1·h, 134.19±49.03 and 143.70±52.08 ng·ml-1·h, the relative bioavailability of LOR tablet and capsule were (105.49±8.08)% and (102.90±10.02)%, respectively. CONCLUSION: The LC-MS method for determining the concentration of LOR in human plasma is sensitive and accurate and can be used for LOR bioavailability and pharmacokinetic studies. LOR tests and reference are bioequivalent.