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Reverse phase high-performance liquid chromatography (RP-HPLC) system for analysis of vitamin D3 soft capsules with soybean oil matrix

Meng-Han LI ; Xue-Mei DING ; Jian-Ying LIANG

Fudan University Journal of Medical Sciences.2019;46(1):23-31. doi:10.3969/j.issn.1672-8467.2019.01.004

Objective To develop a method for the determination and impurity analysis of vitamin D3 soft capsules with soybean oil matrix in reverse phase high performance liquid chromatography (RP-HPLC) system.Methods RP-HPLC system had Agilent Zorbax Eclipse XDB-C18 column (4.6 mm × 250 mm,5 ttm) with detection wavelength of 265 nm,column temperature of 25 ℃ and flow rate of 1 mL/min.Retention behaviors of vitamin D3 and its 3 isomers were studied by altering the mobile phase.Firstly,acetonitrile was mixed with different proportions of methanol,water and ethanol as the mobile phase to investigate the effects of these 4 mobile phase components on the retention behavior of vitamin D3 and its 3 main related substances (isomers) on a C18 column.Then,a suitable mobile phase was selected for content determination and impurity analysis according to the retention behavior study.Results The recovery was only 80.55％-84.37％ with 100％ acetonitrile as the mobile phase.The addition of ethanol in acetonitrile was found to make remarkably significant improvement.Recovery rate was achieved between 98.07 ％ and 103.23 ％ with V (acetonitrile) ∶V (ethanol) =90∶10 as the mobile phase,while improving pealk shape.The method showed good linearity [(0.52-5.2) x 10-4 t mol/L,R2＞0.999] and fine density (RSD＜2.32％) which can be used for determination.For impurities profile,it could be achieved using V (acetonitrile):V (water) =95:5 as the mobile phase which can obviate interference from soybean oil matrix.Conclusions The method established in this experiment can easily and accurately determine the content and impurity analysis of vitamin D3 soft capsules with soybean oil matrix in a RP-HPLC system.

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Multiple papillary adenomas (PA) coexisting with clear cell renal cell carcinoma (CCRCC):a case report

Xiao-Mu HU ; Zhong-Wen ZHOU ; Xiang NI ; Feng TANG

Fudan University Journal of Medical Sciences.2019;46(5):704-707. doi:10.3969/j.issn.1672-8467.2019.05.023

Papillary adenoma (PA) of kidney is defined as a lesion measuring less than 15 mm and featuring papillary or tubular architecture along with nuclei of low grade.Clear cell renal cell carcinoma (CCRCC) is the most common seen group of malignant neoplasms consists of cells with clear or eosinophilic cytoplasm.The coexistence of these two kinds of tumor is rare and was only reported in one piece of literature to date.We report a thought-provoking case in which CCRCC is coexisting with multiple PAs.The CCRCC shows no difference with other common cases while the PAs share the same clinical and pathological features with other ones and demonstrates no amplifying of 3,7 or 17 chromosome.However,the multiple PAs were neglected by imaging doctors and surgeons,and some tiny lesions were not found until the observation under microscope.This case reminds that patients accepting partial nephrectomy for CCRCC may have PAs,so attention should be paid to the image studies along with routine pathological examination of kidney for that there may exists two or more kinds of lesions.

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Bioavailability Evaluation of Sustained-Release Metformin Formulation After Single and Multiple Oral Dosing in Healthy Volunteers

Yanyan JIANG ; Rongqin HUANG ; Lingmei ZHENG ; Yuanying PEI

Fudan University Journal of Medical Sciences.2005;32(2):178-181.

Purpose To evaluate the relative bioavailability of a domestic sustained-release metformin tablets (SRM) compared against an immediate-release metformin tablets (IRM) using a multiple-dose,two-way crossover design after a single-dose study. Methods Eighteen healthy adult male volunteers,aged 18 to 22 years (mean,20 years),weighing 55 to 76 kg (mean,64 kg) and with height ranging from 166 to 180 cm (mean,173 cm),and blood glucose levels from 4.0 to 5.9 mmol/L (mean,4.3 mmol/L) participated in the study.The concentrations of metformin in plasma were determined using a ion-pair liquid chromatographic method. Results In single-dose study,the mean residence time (MRT),Tmax,and apparent elimination half-life (T1/2) for SRM were significantly longer and Cmax significantly lower than the corresponding values determined for IRM.The similar results were also demonstrated in multiple-dose study.The mean values of the relative bioavaibility of SRM compared with IRM in two administration ways were (85.95±0.97)% and (86.44±7.88)%,respectively.The single-dose and multiple-dose administration of the 90% confidence interval for the ratio of the logarithmic transformed AUC values of SRM over those of IRM were calculated to lie between 0.83 and 0.88,0.83 and 0.89,respectively,being within the acceptable bioequivalence limit of 0.80～1.25. Conclusion SRM was of the characteristic of sustained-release pharmacokinetics.The relative bioavailability for single dosing was similar to that of multiple dosing,and both of the administration ways demonstrated bioequivalence in absorption between SRM and IRM.

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Treatment for complex scapular fracture with minimally invasive modified Judet approach and annularity internal fixation

Mingxin WANG ; Dechang LIU ; Kun WANG ; Yue DING

Fudan University Journal of Medical Sciences.2017;44(4):507-511. doi:10.3969/j.issn.1672-8467.2017.04.020

Objective To investigate clinical effect of surgical treatment of complex scapular fracture with improved minimally invasive Judet approach and annularity internal fixation.Methods In this retrospective study,17 patients with complex scapular fracture accepted open reduction and internal fixation with improved minimally invasive Judet approach complying with the three points-two lines annularity internal fixation principle.After postoperative rehabilitation training,the curative effect was evaluated by the neer shoulder joint function score evaluation.Results All the 17 patients were followed up for 14 months on average (12-25 months).According to neer score evaluation,the percent of patients with excellent and good results was 88.2％ (excellent:12 cases;good:3 cases;middle:2cases;unsatisfactory:no case).Conclusions Improved minimally invasive Judet approach hase simple operation,adequate exposure and less injury.Annularity internal fixation complying with the three points-two lines principle is a safe and effective method for the treatment of complex scapular fracture.

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The pathgenetic role and potential clinical application of miRNAs in patients with Behcet's disease

Jingfen YE

Fudan University Journal of Medical Sciences.2017;44(4):538-541,547. doi:10.3969/j.issn.1672-8467.2017.04.026

As the endogenous mediators of RNA interference,miRNA play biological roles by inducing post-transcriptional silence of gene expression.Previous studies showed that miRNAs have multiple regulating potential to immune cells,involved in regulation of innate and adaptive immunity.Recently,aberrant expression of miRNAs have been confirmed to be relevant to the pathogenesis of Behcet's disease (BD) by regulating the expression of inflammatory cytokines in immune cells,which may become of its diagnostic marker and therapeutic target in the future.In this review,we discuss how miRNAs regulate autoimmunity.Several miRNAs associate with the pathogenesis of BD,thus they have the potential clinical application value.

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Progress of ameliorating the neurotoxicity of anaesthetics on developing brain

Ying GUO

Fudan University Journal of Medical Sciences.2017;44(4):532-537. doi:10.3969/j.issn.1672-8467.2017.04.025

General anesthetics are widely used in pregnant women,gravidas and infants.In the basic studies of rodents,mammals and non-human primate,general anesthetics can cause neurotoxicity,neuroapoptosis and damage neurodevelopment on the developing brain.Therefore,To explore protective measures and mechanism of anesthetic neurotoxicity is of great significance for formulating clinical anesthesia plan,guiding clinical obstetrics and pediatric anesthesia.This article reviewed the progress of ameliorating the neurotoxicity of general anaesthetics on developing brain including anesthetic assistants,hormone drugs,plant extracts,nutritional components and others.

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HPLC fingerprint of Xuanbo Shuangsheng Granule

Xiuwen ZHANG ; Shuang HU ; Nianzu CHEN ; Qin MA ; Donglei WANG ; Yonghua LAI ; Taomin HUANG

Fudan University Journal of Medical Sciences.2017;44(4):521-527. doi:10.3969/j.issn.1672-8467.2017.04.023

Objective To establish the HPLC fingerprint of Xuanbo Shuangsheng Granule for its quality control.Methods The components were separated on an Agilent TC-C18 column (150 mm ×4.6 mm,5 μm) at 25 ℃,with a gradient elution in 0-60 min at the flow rate of 1 mL/min using 0.2％ acetic acid aqueous solution and methanol as the mobile phase.The detection wavelength was 278 nm.By detecting 11 batches of Xuanbo Shuangsheng Granule,the HPLC fingerprint was established using Similarity Evaluation System for Chromatographic Fingerprint of TCMs (Version 2004A)and the common peaks were analyzed and identified in raw herbal material.Results The HPLC fingerprint of Xuanbo Shuangsheng Granule was obtained with similarity all over 0.9.Totally 27 common peaks were confirmed,and each common peak could be found in raw herbal medicines.Based on the reference substances,5 common peaks were identified,including phellodendrine (peak 11),liquiritin (peak 22),angoroside C (peak 25),cinnamic acid (peak 26) and harpagoside (peak 27).Conclusions This method is simple,accurate,repeatable and reliable,which could be applied in the quality control of Xuanbo Shuangsheng Granule.

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Sample size estimation for survival analysis in single-arm trials

Xiuping ZHANG ; Naiqing ZHAO

Fudan University Journal of Medical Sciences.2017;44(4):517-520. doi:10.3969/j.issn.1672-8467.2017.04.022

Objective To propose a method to calculate sample size for survival analysis in single-arm trials.Methods Through theoretical formula derivation,we provided sample size estimation method for survival analysis in single-arm trials.Monte-Carlo simulations using STATA software were conducted to obtain the empirical power,so as to verify the accuracy of the estimated sample size.Results Simulation results showed that,when α =0.025 and α =0.01,the power of the sample size calculated by the formula is in accordance with the predetermined power.Conclusions The formula of sample size estimation we proposed could achieve the predetermined power for survival analysis in single-arm trials.Findings of this study provide reliable basis for sample size estimation of early stage antineoplastic drug clinical studies.

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The clinical value of colour Doppler ultrasonography in diagnosis of uterine carcinosarcoma

Fangui ZHAO ; Yang XU ; Hao ZHANG ; Yunyun REN

Fudan University Journal of Medical Sciences.2017;44(4):512-516. doi:10.3969/j.issn.1672-8467.2017.04.021

Objective To explore the clinical value of color Doppler ultrasonography in the diagnosis of uterine carcinosarcoma (UCS).Methods The clinical data and ultrasonographic manifestations of 63 cases of UCS proved by operation and pathology in Obstetrics and Gynecology Hospital of Fudan University from January 2003 to December 2014 were retrospectively analyzed.The clinical features and characteristics of ultrasound images in UCS were summarized and classified according to their ultrasonographic features.Results It mostly occurred in postmenopausal women (77.8％).The average age of the 63 patients of UCS was (57.7 ± 11.5) years old.The most common symptoms of UCS were postmenopauseal vaginal bleeding (57.1％),menstrual disorders (20.6％),vaginal discharge (11.1％),uterine mass or thickened endometrium (11.1％).Tumor marker CA125 was evaluated in 36 women and found to be elevated in 15 women (41.7％),60％ of which (9/15) was less than 200 U/mL.Six cases (16.7％) of relative higher level of serum CA125 (＞ 200 U/mL) were at advanced stage or with malignant ovarian tumors.The sonographic findings of UCS had three types:Uterine cavity type (71.4％),endometrium type (14.3％),and myometrium type (14.3％).The ultrasonographic characteristics of uterine cavity type and myometrium type were fuzzy boundary,irregular shape,and internal uneven echo.Color doppler flow image showed rich blood signals and low resistance index (0.55 + 0.11) of the surrounding and internal artery of the lesions.The large volume of lesion was the characteristic of myometrium type.Conclusions UCS is a very aggressive and extremely rare tumor with the symptoms of postmenopauseal vaginal bleeding,menstrual disorders,vaginal discharge,et al.There are three types of sonographic findings of UCS:uterine cavity type,endometrium type and myometrium type.To strengthen the understanding of UCS and combined with clinical manifestations,the transvaginal color Doppler ultrasound was helpful to early detection,early diagnosis and making the appropriate treatment.

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A novel experimental model of New Zealand rabbit for the biocompatible assessment of 0.1 mm PTFE

Huifeng ZHANG ; Ming YE ; Xiangang YAN ; Gang CHEN ; Qilin TAO ; Bing JIA

Fudan University Journal of Medical Sciences.2017;44(4):503-506. doi:10.3969/j.issn.1672-8467.2017.04.019

Objective To establish a novel experimental model of New Zealand rabbit to assess the biocompatibility of 0.1 mm polytetrafluoroethylene (PTFE),a novel material of pulmonary valve.Methods Forty-two adult New Zealand rabbits about 3 kg were selected to give 35 mg/kg ketamine and 0.25 mg/kg dexmedetomidine intramuscularly for the anesthesia.The chest was open to expose the upper segment.The surface of right ventricular outflow tract (RVOT) was exposed after the pericardium was opened partially.The valve material (0.1 mm PTFE) was inserted into the right ventricle via the central mini-incision.Then the skin was closed and the rabbits were recoved with the oxygen inhalation.Results Forty-two adult New Zealand rabbits accepted the operation.Six rabbits died during the early period due to the inappropriate anesthesia drug (n =2),pneumothorax (n =1) and thrombosis (n =3),which occurred the 5th,7th and 8th postoperative day.The anticoagulation treatment was adjusted to solve the thrombosis problem.Thirty-six rabbits survived for several months with weight increase until the experiment was finished.Conclusions The experimental model of New Zealand rabbit is appropriate for the biocompatible assessment of 0.1 mm PTFE.The advantage is to avoid intubation and cardiopulmonary bypass (CPB) and to decrease the pneumothorax.

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