1.Bioequivalence study of buspirone hydrochloride tablets in Chinese healthy subjects
Ping LU ; Rui WANG ; Hui-Hui WU ; Hai-Yan LIU ; Ge-Fei HE ; Shun-Zhi ZHANG ; Wei WU
The Chinese Journal of Clinical Pharmacology 2024;40(5):723-727
Objective To study the pharmacokinetic characteristics of buspirone hydrochloride tablets in healthy adult populations under conditions of fasting and postprandial administration.Methods A single-center,randomized,three-cycle partially repeated crossover trial design was adopted,and 36 subjects were enrolled on fasting/postprandial,one tablet of the test preparation was taken in one cycle,one tablet of reference preparation(5 mg of buspirone tablets)was taken once in each of 2 cycles,the drug concentration of buspirone in plasma was determined by liquid chromatography-tandem mass spectrometry,and the pharmacokinetic parameters were calculated by WinNonlin software.Results Main pharmacokinetics of buspirone after oral administration of test and reference preparations in fasting group,the Cmax was(285.72±286.08)and(308.94±341.03)pg·mL-1;AUC0-t were(577.09±491.10)and(618.62±642.56)pg·mL-1·h;AUC0-∞ were(586.85±510.04)and(655.92±687.95)pg·mL-1·h;tmax was 0.75(0.33-4.00)and 0.75(0.33-1.75)h.Main pharmacokinetics of buspirone after oral administration of test and reference preparations in the postprandial group,the Cmax were(676.36±603.64)and(760.33±610.27)pg·mL-1;AUC0-t were(1 755.58±1 001.69)and(1 743.00±1 073.33)pg·h·mL-1;AUC0-∞ were(1 839.97±1 044.60)and(1 818.00±1 106.95)pg·mL-1·h;tmax was 1.25(0.25-4.50)and 1.00(0.25-3.50)h.The 90%confidence intervals of the AUC0-t and AUC0-∞ geometric mean ratios of the test preparation and the reference preparation in the fasting test and the postprandial test all fell between 80.00%and 125.00%,and the 95%upper confidence limit of of Cmax was ≤0 and geometric mean ratios point estimates fall between 80.00%and 125.00%.Conclusion Two kinds of buspirone hydrochloride are bioequivalent in Chinese healthy adult subject.
2.Application of China-made Toumai? Robot in laparoscopic radical prostatectomy
Zhi-Feng WEI ; Yu-Hao CHEN ; Ze-Peng ZHU ; Qi JIANG ; Yu XIONG ; Feng-Feng LU ; Zhen-Qian SONG ; Bin JIANG ; Xiao-Feng ZHU ; Tian-Hao FENG ; Xiao-Feng XU ; Gang YANG ; Wu WEI ; Ai-Bing YAO ; Jing-Ping GE
National Journal of Andrology 2024;30(8):696-700
Objective:To evaluate the safety and efficiency of China-made Toumai Robot-assisted laparoscopic radical prosta-tectomy(LRP).Methods:This study included 40 cases of PCa treated from January 2023 to May 2023 by robot-assisted LRP with preservation of the bladder neck and maximal functional urethral length,15 cases with the assistance of Toumai Robot(the TMR group)and the other 25 with the assistance of da Vinci Robot as controls(the DVR group).We recorded the docking time,laparo-scopic surgery time,vesico-urethral anastomosis time,intraoperative blood loss and postoperative urinary continence,and compared them between the two groups.Results:Operations were successfully completed in all the cases.No statistically significant differ-ences were observed between the TMR and DVR groups in the docking time(6 min vs 5 min,P>0.05)or intraoperative blood loss(200 ml vs 150 ml,P>0.05).The TMR group,compared with the DVR group,showed a significantly longer median laparoscopic surgery time(146 min vs 130 min,P<0.05)and median vesico-urethral anastomosis time(19 min vs 16 min,P<0.05).There were no statistically significant differences between the TMR and DVR groups in the rates of urinary continence recovery immediately af-ter surgery(60.0%[9/15]vs 64.0%[16/25],P>0.05)or at 1 month(80.0%[12/15])vs(76.0%[19/25],P>0.05),3 months(93.3%[14/15])vs(92.0%[23/25],P>0.05)and 6 months postoperatively(100%[15/15])vs(96%[24/25],P>0.05).Conclusion:China-made Toumai? Robot surgical system is safe and reliable for laparoscopic radical prosta-tectomy,with satisfactory postoperative recovery of urinary continence.
3.Technology and principle of improving solubility of Dioscoreae Rhizoma formula granules based on powder modification.
Wei LIAO ; Ding-Kun ZHANG ; Zhi-Ping GUO ; Yu-Hua LIU ; Chun-Li GE ; Yi-Chen SONG ; Jia-Bao LIAO ; Li HAN
China Journal of Chinese Materia Medica 2023;48(8):2138-2145
The powder modification technology was used to improve the powder properties and microstructure of Dioscoreae Rhizoma extract powder, thereby solving the problem of poor solubility of Dioscoreae Rhizoma formula granules. The influence of modifier dosage and grinding time on the solubility of Dioscoreae Rhizoma extract powder was investigated with the solubility as the evaluation index, and the optimal modification process was selected. The particle size, fluidity, specific surface area, and other powder properties of Dioscoreae Rhizoma extract powder before and after modification were compared. At the same time, the changes in the microstructure before and after modification was observed by scanning electron microscope, and the modification principle was explored by combining with multi-light scatterer. The results showed that after adding lactose for powder modification, the solubility of Dioscoreae Rhizoma extract powder was significantly improved. The volume of insoluble substance in the liquid of modified Dioscoreae Rhizoma extract powder obtained by the optimal modification process was reduced from 3.8 mL to 0 mL, and the particles obtained by dry granulation of the modified powder could be completely dissolved within 2 min after being exposed to water, without affecting the content of its indicator components adenosine and allantoin. After modification, the particle size of Dioscoreae Rhizoma extract powder decreased significantly, d_(0.9) decreased from(77.55±4.57) μm to(37.91±0.42) μm, the specific surface area and porosity increased, and the hydrophilicity improved. The main mechanism of improving the solubility of Dioscoreae Rhizoma formula granules was the destruction of the "coating membrane" structure on the surface of starch granules and the dispersion of water-soluble excipients. This study introduced powder modification technology to solve the solubility problem of Dioscoreae Rhizoma formula granules, which provided data support for the improvement of product quality and technical references for the improvement of solubility of other similar varieties.
Powders
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Solubility
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Technology, Pharmaceutical
;
Technology
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Plant Extracts
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Particle Size
4.Anti-inflammatory material basis and mechanism of Artemisia stolonifera based on UPLC-Q-TOF-MS combined with network pharmacology and molecular docking.
Le CHEN ; Yun-Yun ZHU ; Li-Ping KANG ; Chao-Wei GUO ; Yu-Qiao WANG ; Shuang-Ge LI ; Hong-Zhi DU ; Da-Hui LIU
China Journal of Chinese Materia Medica 2023;48(14):3701-3714
This study aimed to explore the anti-inflammatory material basis and molecular mechanism of Artemisia stolonifera based on the analysis of the chemical components in different extracted fractions of A. stolonifera and their antioxidant and anti-inflammatory effects in combination with network pharmacology and molecular docking. Thirty-two chemical components were identified from A. stolonifera by ultra-performance liquid chromatography coupled to tandem quadrupole time-of-flight mass spectrometry(UPLC-Q-TOF-MS). Among them, there were 7, 21 and 22 compounds in water, n-butanol and ethyl acetate fractions, respectively. The antio-xidant capacity of different extracted fractions was evaluated by measuring their scavenging ability against 1,1-diphenyl-2-picrylhydrazyl radical 2,2-diphenyl-1-(2,4,6-trinitrophenyl) hydrazyl(DPPH) and 2,2'-azinobis-(3-ethylbenzthiazoline-6-sulphonic acid)(ABTS) free radicals and total antioxidant capacity [ferric reducing antioxidant power(FRAP) assay]. The inflammatory model of RAW264.7 cells was induced by lipopolysaccharide(LPS), and the levels of nitrite oxide(NO), tumor necrosis factor-α(TNF-α), interleukin-6(IL-6) in the supernatant and the mRNA expression of related inflammatory factors in cells were used to evaluate the anti-inflammatory effects. The results revealed that ethyl acetate fraction of A. stolonifera was the optimal antioxidant and anti-inflammatory fraction. By network pharmacology, it was found that flavonoids such as rhamnazin, eupatilin, jaceosidin, luteolin and nepetin could act on key targets such as TNF, serine/threonine protein kinase 1(AKT1), tumor protein p53(TP53), caspase-3(CASP3) and epidermal growth factor receptor(EGFR), and regulate the phosphatidylinositol-3-kinase-protein kinase B(PI3K-AKT) and mitogen-activated protein kinase(MAPK) signaling pathways to exert the anti-inflammatory effects. Molecular docking further indicated excellent binding properties between the above core components and core targets. This study preliminarily clarified the anti-inflammatory material basis and mechanism of ethyl acetate fraction of A. stolonifera, providing a basis for the follow-up clinical application of A. stolonifera and drug development.
Antioxidants/chemistry*
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Molecular Docking Simulation
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Artemisia
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Network Pharmacology
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Phosphatidylinositol 3-Kinases
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Anti-Inflammatory Agents/chemistry*
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Drugs, Chinese Herbal/pharmacology*
;
Interleukin-6
5.The Exploration of Glymphatic System Alteration in Pediatric Acute Lymphoblastic Leukemia Using DTI-ALPS Method
Wei-feng HOU ; Shu SU ; Ying-qian CHEN ; Long QIAN ; Yan-lai TANG ; Li-bin HUANG ; Zhi-yun YANG ; Li-ping LIN
Journal of Sun Yat-sen University(Medical Sciences) 2023;44(3):456-461
ObjectiveThe glymphatic system regulates cerebral spinal fluid and interstitial fluid transport which might be one of the pathways of central nervous system (CNS) leukemia at the early stage. This study aimed to investigate the alteration of glymphatic system based on diffusion tensor image-analysis along the perivascular space (DTI-ALPS) in pediatric acute lymphoblastic leukemia (ALL) without clinically diagnosed CNS infiltration. MethodsTwenty-five ALL and typically developing (TD) children were prospectively recruited, and all subjects underwent DTI. Group differences in brain water diffusivities and ALPS-index were evaluated using the analysis of covariance. The Spearman correlation analysis was used to evaluate the relationship between biological characteristics and significant parameters in pediatric ALL. ResultsCompared with TDs, decreased Dxassoc value (PFDR-corrected = 0.048) and increased Dzassoc value (PFDR-corrected = 0.033) were found in pediatric ALL. Hence, lower ALPS-index was found in children with ALL (PFDR-corrected < 0.001). ALPS-index was negatively associated with the risk classification (rs = -0.47, P = 0.018) as well as immunophenotype (rs = -0.40, P = 0.046) in pediatric ALL. ConclusionsOur results show dysfunction of the glymphatic system is presented in pediatric ALL without clinically diagnosed CNS infiltration, which suggests that the glymphatic system might be one of pathway in the early-stage of ALL CNS infiltration. The DTI-ALPS method can be used to evaluate the change of glymphatic system, providing a new method for exploring the underlying mechanisms and early detection of pediatric ALL CNS infiltration.
6.The Brain Structure Volume Estimation Based on Synthetic MRI in Pediatric Acute Lymphoblastic Leukemia
Wei-feng HOU ; Shu SU ; Ying-qian CHEN ; Long QIAN ; Yan-lai TANG ; Li-bin HUANG ; Zhi-yun YANG ; Li-ping LIN
Journal of Sun Yat-sen University(Medical Sciences) 2023;44(2):271-276
ObjectiveCentral nervous system (CNS) infiltration commonly occurs in children with acute lymphoblastic leukemia (ALL). Early subclinical CNS infiltration in pediatric ALL is hard to detect with conventional methods. This study aimed to investigate the changes of brain structure volume parameters based on Synthetic MRI (SyMRI) in pediatric ALL without clinically diagnosed CNS infiltration. MethodsThirty-six ALL and twenty-nine typically developing (TD) children were prospectively collected and all underwent SyMRI. The Synthetic MR software was used to obtain brain volumetric parameters including total white matter volume (WMV), gray matter volume (GMV), cerebrospinal fluid (CSF) volume, etc. and their within-group differences were assessed by analysis of covariance. The Spearman correlation analysis was used to examine the correlation between biological characteristics and statistically significant brain volume parameters. ResultsALL children showed increased CSF volume (PFDR-corrected = 0.009) and decreased GMV (PFDR-corrected = 0.027) when compared to TD children. We also found a moderately negative association between GMV/intracranial volume and risk classification in pediatric ALL (rs = -0.380, P = 0.022). ConclusionsPediatric ALL without clinically diagnosed CNS infiltration presented with accumulation of CSF and reduction of gray matter. The brain volumetric changes in subclinical CNS infiltration of pediatric ALL provides a new attempt for exploring the underlying mechanism and early detection of CNS infiltration in pediatric ALL.
7.Preparation and evaluation of Indigo Naturalis dry suspension based on powder surface modification
Sheng-jie HUANG ; Juan SU ; Chun-li GE ; Jin XIE ; Zhi-ping GUO ; Ming YANG ; Zhen-feng WU ; Ding-kun ZHANG ; Li HAN
Acta Pharmaceutica Sinica 2023;58(5):1347-1353
A dry suspension of Indigo Naturalis (IN) based on lactose-IN composite particles was designed by powder modification technology to meet the clinical needs of IN. The contact angle was used as an evaluation index to investigate the effects of the type of modifier lactose, the amount of lactose, and the co-grinding time of lactose and IN on the hydrophilicity of IN. The difference between IN before and after modification was compared through physical properties such as particle size and scanning electron microscope, as well as hydrophilic properties such as surface free energy and multiple light scattering. The optimal process of lactose-IN composite particles is as follows: after lactose is ground alone for 2 minutes, it is co-ground with IN at a ratio of 1∶1 for 6 minutes. The results of the investigation of powder properties show that the particle size
8.Value of contrast-enhanced percutaneous ultrasound in the diagnosis of rotator cuff tear subtype.
Bi-Li LIU ; Yue SHAN ; Qi ZHONG ; Dan GE ; Yan-Ping LI ; Juan LYU ; Shu-Zhi GAN
China Journal of Orthopaedics and Traumatology 2023;36(10):974-981
OBJECTIVE:
To explore characteristics of contrast-enhanced ultrasound (CEUS) images features and diagnostic value of rotator cuff tear subtypes.
METHODS:
From January 2019 to March 2022, percutaneous ultrasound-guided subacromial bursography (PUSB) with persutaneous ultrasound-guide tendon lesionography (PUTL) was performed on 114 patients with suspected rotator cuff injury were evaluated, including 54 males and 60 females ranged in age from 35 to 75 years old with an average of (58.8±8.7 ) years old;76 patients on the right side and 38 patients on the left side;the course of disease ranged from 0.13 to 111 months with an average of (10.2±9.8) months. GE LOGIQ E9 color doppler ultrasound diagnostic high frequency(6 to 12 MHz) was used to CEUS Using arthroscopy as gold standard, receiver operating characteristic (ROC) curve was used to evaluate diagnostic efficacy of US, MRI and CEUS for rotator cuff injury, also sensitivity, specificity, positive predictive value, negative predictive value and accuracy were calculated.
RESULTS:
The sensitivity of US in diagnosing full-thickness tears was 72.1%, specificity was 93.0%, and accuracy was 85.1%. The sensitivity, specificity and accuracy of MRI diagnosis of full-thickness tear were 90.9%, 92.6% and 92.1% respectively. The sensitivity, specificity and accuracy of CEUS in diagnosis of full-thickness tear were 100%. The sensitivity, specificity and accuracy of US in the diagnosis of partial tear were 85.7%, 77.2% and 79.8% respectively. The sensitivity, specificity and accuracy of MRI diagnosis of partial tear were 83.7%, 81.7% and 82.5% respectively. The sensitivity, specificity and accuracy of CEUS in diagnosis of partial tear were 95.7%, 92.6% and 93.9% respectively. There were significant differences in diagnosis results of US, MRI and CEUS for rotator cuff bursa tear (P<0.001). Kapp test showed good consistency between CEUS and arthroscopy in diagnosing rotator cuff tear subtypes (full-thickness and partial tears).
CONCLUSION
Using PUSB/PUTL to observe distribution of contrast media in bursa, tendon and joint cavity to evaluate the type of rotator cuff tear, its diagnostic performance is significantly better than US and MRI. Therefore, percutaneous contrast-enhanced ultrasound can be a reliable method for diagnosing subtypes of rotator cuff tears.
Male
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Female
;
Humans
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Infant, Newborn
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Infant
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Child, Preschool
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Child
;
Rotator Cuff Injuries/diagnostic imaging*
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Rotator Cuff/diagnostic imaging*
;
Sensitivity and Specificity
;
Ultrasonography
;
Magnetic Resonance Imaging/methods*
;
Rupture
;
Arthroscopy
10.Qualitative study on psychological experiences of adolescents with comorbid depression and anxiety disorders after Williams life skills training
Ping WANG ; Juanjuan GE ; Qianna ZHI ; Hongying YU ; Huabin CHEN
Chinese Journal of Modern Nursing 2023;29(30):4138-4142
Objective:To understand the psychological experiences of adolescents with comorbid depression and anxiety disorders who have completed Williams life skills training (WLST) .Methods:This is a qualitative study. A total of 16 adolescents with comorbid depression and anxiety disorders who were treated at Hangzhou Seventh People's Hospital between March 2021 and January 2022 and completed the WLST during their hospitalization were selected by purposive sampling. Semi-structured interviews were conducted to gather and subsequently analyze interview data, leading to the extraction of main themes.Results:The psychological experiences of adolescents with comorbid depression and anxiety disorders after completing WLST included correctly recognizing and effectively addressing social phobia, strengthening psychological adjustment capabilities and enhancing self-efficacy, discovering a sense of belonging within a group.Conclusions:WLST can change depression and anxiety conditions, alleviate the fear of social interactions, enhance self-regulation efficacy, provide a sense of belonging within a team, maintain good mental and physical health, and improve the quality of life in adolescents with comorbid depression and anxiety disorders.

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