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基于工艺与装备视角分析中药制剂质量的关键影响因素

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中国中药杂志 2024年第6期49卷 1699-1704页

作者：万鑫浩舒清霞王子千杨东印杨明王学成伍振峰江西中医药大学现代中药制剂教育部重点实验室江西南昌330004 江西省药品检验检测研究院江西南昌330004 江西省药品检查员中心江西南昌330004

中药制剂的质量直接关乎患者的安全,在其诸多的影响因素中以制剂的工艺环节及相应关键设备较为突出,是中药制剂质量的关键影响因素。为了更好地提高中药制剂质量,该文围绕中药制剂制造过程中各工艺环节及相应关键设备存在的问题进行总... 详细信息

中药制剂的质量直接关乎患者的安全,在其诸多的影响因素中以制剂的工艺环节及相应关键设备较为突出,是中药制剂质量的关键影响因素。为了更好地提高中药制剂质量,该文围绕中药制剂制造过程中各工艺环节及相应关键设备存在的问题进行总结分析,并建立以安全性和有效性为前提,结合药物自身性质、制备工艺、制剂特征的药品关键质量属性评价体系,为以质量提升为目标的工艺与设备改进提供依据。

关键词：药品质量中药制剂工艺环节关键装备关键质量属性

Numerical Simulations of Liquid-Solid Flows in A Vertical Pipe by MPS-DEM Coupling Method

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China Ocean Engineering 2022年第4期36卷 542-552页

作者： xie Feng-ze MENG qing-jie wan De-cheng Computational Marine Hydrodynamics Lab(CMHL) School of Naval ArchitectureOcean and Civil EngineeringShanghai Jiao Tong UniversityShanghai 200240China Wuhan Second Ship Design and Research Institute Wuhan 430205China

In the process of deep-sea mining,the liquid-solid flows in the vertical transportation pipeline are very *** the present work,an in-house solver MPSDEM-SJTU based on the improved MPS and DEM is developed for the simulation of hydraulic ***,three examples including the multilayer cylinder collapse,the Poiseuille flow and two-phase dam-break are used to validate the precision of the DEM model,the pipe flow model and MPS-DEM coupling model,***,the hydraulic conveying with coarse particles in a vertical pipe is *** solid particle distribution is presented and investigated in ***,the coupling method is successfully applied for the simulation of the liquid-solid flows in a vertical pipe with rotating blades,which shows the stability of the solver under rotating boundary *** fully Lagrangian model is expected to be a new approach for analyzing hydraulic conveying.

关键词： liquid-solid flows MPS DEM vertical pipe rotating boundary conditions

Effect and Safety of Herbal Medicine Foot Baths in Patients with Diabetic Peripheral Neuropathy:A Multicenter Double-Blind Randomized Controlled Trial

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Chinese Journal of Integrative Medicine 2024年第3期30卷 195-202页

作者： HUANG hao-yue LIN Yu-ping WEI Hua FU Yu ZHOU Yue-hong FANG Zhao-hui QIU Xiao-tang wanG Mei LI qing-bo LI Shan-shan wanG Shi-dong DAI Fang LIU Zhen-jie Zhao Ling WEN Jian-xuan WU Li-yan ZENG Hui-yan ZHANG Jin-ming LU Qi-yun HE Liu SONG Wei SUN Lu LUO Lu-lu HE Jia-li xie Wen-wen LIANG qing-shun HUANG Yuan ZHU Sheng-ling LONG Jie-er GAO Zhi-juan WEN Ze-huai LI Chun-ji OUYANG Wen-wei LI Geng WU Ming-hui LI An-xiang HUANG Jin-zhu Sanjoy K Paul TANG Xian-yu FAN Guan-jie Department of Endocrinology Guangdong Provincial Hospital of Chinese MedicineGuangzhou510120China The Second Clinical College of Guangzhou University of Chinese Medicine Guangzhou510120China Department of Endocrinology The Second Affiliated Hospital of Guangzhou University of Chinese MedicineGuangzhou510120China Guangdong Provincial Academy of Chinese Medical Sciences Guangzhou510120China Department of Endocrinology The First Affiliated Hospital of Henan University of Chinese MedicineZhengzhou450000China Department of Endocrinology Liuyang Hospital of Chinese MedicineChangsha410000China Department of Endocrinology The First Affiliated Hospital of Anhui University of Chinese MedicineHefei230000China Department of Endocrinology Hainan Provincial Hospital of Traditional Chinese MedicineHaikou570100China Department of Endocrinology The Affiliated Hospital of Liaoning University of Traditional Chinese MedicineShenyang110000China Department of Geriatric Luoyang No.1 Hospital of Traditional Chinese MedicineLuoyangHenan Province471000China Department of Endocrinology The Second Affiliated Hospital of Guizhou University of Traditional Chinese MedicineGuiyang550000China Department of Endocrinology Beijing University of Chinese Medicine Affiliated Dongzhimen HospitalBeijing100000China Department of Endocrinology The First Affiliated Hospital of Guizhou University of Traditional Chinese MedicineGuiyang550000China Melbourne EpiCentre The University of Melbourne and Melbourne HealthMelbourne3013Australia

Objective:To evaluate the effect and safety of foot baths with Tangbi Waixi Decoction(TW)in treating patients with diabetic peripheral neuropathy(DPN).Methods:It is a multicenter double-blinded randomized controlled *** with DPN were recruited between November 18,2016 and May 30,2018 from 8 hospitals in *** patients received basic treatments for glycemic *** received foot baths with TW herbal granules either 66.9 g(intervention group)or 6.69 g(control group)for 30 min once a day for 2 weeks and followed by a 2-week rest,as a therapeutic *** the Toronto Clinical Scoring System total score(TCSS-TS)6 points,the patients received a total of 3 therapeutic courses(for 12 weeks)and were followed up for 12 *** primary outcome was change in TCSS-TS score at 12 and 24 *** outcomes included changes in bilateral motor nerve conduction velocity(MNCV)and sensory nerve conduction velocity(SNCV)of the median and common peroneal *** was also ***:Totally 632 patients were enrolled,and 317 and 315 were randomized to the intervention and control groups,*** the 12-week intervention,patients in both groups showed significant declines in TCSSTS scores,and significant increases in MNCV and SNCV of the median and common peroneal nerves compared with pre-treatment(P0.05),and no serious adverse event was related with ***:Treatment of TW foot baths was safe and significantly benefitted patients with DPN.A low dose of TW appeared to be more effective than a high dose.(Registry *** CTR-IOR-16009331)

关键词： diabetic peripheral neuropathy herbal medicine foot baths Chinese medicine randomized controlled trial Tangbi Waixi Decoction

甲硝唑片在中国健康受试者中的生物等效性研究

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中国临床药理学杂志 2024年第13期40卷 1943-1947页

作者：彭秀晴郭彩会刘亚丽赵娜宋浩静白万军董占军河北省人民医院药学部Ⅰ期临床研究室河北省临床药学重点实验室河北石家庄050050 石家庄四药有限公司河北石家庄052100

目的评价甲硝唑片受试和参比试剂在中国健康受试者中的生物等效性。方法采用单剂量、两周期、随机、开放、自身交叉、空腹和餐后两种状态下的试验设计。空腹和餐后试验分别入组24例受试者,每周期分别单次口服甲硝唑片受试和参比制剂200... 详细信息

目的评价甲硝唑片受试和参比试剂在中国健康受试者中的生物等效性。方法采用单剂量、两周期、随机、开放、自身交叉、空腹和餐后两种状态下的试验设计。空腹和餐后试验分别入组24例受试者,每周期分别单次口服甲硝唑片受试和参比制剂200 mg。用高效液相色谱串联质谱(HPLC-MS/MS)法测定血样中甲硝唑的药物浓度,应用非房室模型计算药代动力学参数并用SAS 9.3软件进行生物等效性分析。结果空腹试验口服甲硝唑片受试制剂和参比制剂的主要药动学参数:C_(max)分别为(4855.00±1383.97)和(4799.13±1195.32)ng·mL^(-1),AUC_(0-t)分别为(54834.68±12697.88)和(55931.35±11935.28)ng·h·mL^(-1),AUC_(0-∞)分别为(56778.09±13937.76)和(57922.83±13260.54)ng·h·mL^(-1),T_(max)分别为1.17和1.00 h,t_(1/2)别为(8.99±1.76)和(9.11±1.73)h。C_(max)、AUC_(0-t)和AUC_(0-∞)几何平均值(90%置信区间,CI)均在等效区间80.00%~125.00%。餐后试验口服甲硝唑片受试制剂和参比制剂主要药代动力学参数:C_(max)分别为(4057.08±655.08)和(4044.17±773.98)ng·mL^(-1),AUC_(0-t)分别为(55956.42±12228.12)和(55121.04±11784.55)ng·h·mL^(-1),AUC_(0-∞)分别为(58212.83±13820.00)和(57350.38±13229.46)ng·h·mL^(-1),T_(max)分别为2.50和2.25 h,t_(1/2)别为(9.37±1.68)和(9.37±1.79)h。C_(max)、AUC_(0-t)和AUC_(0-∞)几何均值(90%置信区间CI)均在等效区间80.00%~125.00%。结论甲硝唑片受试制剂和参比制剂对于中国健康成年受试者在空腹和餐后条件下均具有生物等效性。

关键词：甲硝唑液相色谱-串联质谱法生物等效性药代动力学

Self-assembled nanoformulations of paclitaxel for enhanced cancer theranostics

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Acta Pharmaceutica Sinica B 2023年第8期13卷 3252-3276页

作者： qing Pei Bowen Jiang Dengyuan hao Zhigang xie State Key Laboratory of Polymer Physics and Chemistry Changchun Institute of Applied ChemistryChinese Academy of SciencesChangchun 130022China School of Applied Chemistry and Engineering University of Science and Technology of ChinaHefei 230026China

Chemotherapy has occupied the critical position in cancer therapy,especially towards the post-operative,advanced,recurrent,and metastatic ***(PTX)-based formulations have been widely used in clinical practice,while the therapeutic effect is far from satisfied due to off-target toxicity and drug *** caseless multi-components make the preparation technology complicated and aggravate the concerns with the excipients-associated *** self-assembled PTX nanoparticles possess a high drug content and could incorporate various functional molecules for enhancing the therapeutic *** this work,we summarize the self-assembly strategy for diverse nanodrugs of ***,the advancement of nanodrugs for tumor therapy,especially emphasis on monochemotherapy,combinational therapy,and theranostics,have been ***,the challenges and potential improvements have been briefly spotlighted.

关键词： Paclitaxel Self-assembly Homodimeric prodrug Heterodimeric prodrug Poly-prodrug Chemotherapy Combinational therapy Theranostics

The precipitation behaviours and strengthening mechanism of a Cu-0.4 wt% Sc alloy

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Journal of Materials Science & Technology 2022年第3期98卷 1-13页

作者： Zifan hao Guoliang xie Xinhua Liu qing Tan Rui wang State Key Laboratory for Advanced Metals and Materials University of Science and Technology BeijingBeijing100083China Key Laboratory for Advanced Materials Processing of Ministry of Education Institute of Advanced Materials and TechnologyUniversity of Science and Technology BeijingBeijing100083China Beijing Laboratory of Metallic Materials and Processing for Modern Transportation University of Science and Technology BeijingBeijing100083China

The precipitation behaviours during the aging process and the corresponding strengthening mechanism of a Cu-0.4 wt%Sc alloy were systematically investigated in this *** phase transformation sequence of the precipitation in the aging process of the Cu-0.4 wt%Sc alloy was found to be:supersaturated solid solution→Sc-enriched atomic clusters→metastable phase→Cu4Sc *** tetragonal structured lamellar Cu4Sc precipitates,with a habit plane parallel to the{111}plane of the Cu matrix and orientation relationships of(022)_(α)//(211)_(Cu4Sc)and[011]_(α)//[113]_(Cu4Sc),are found homogeneously distributed in the matrix.A combined process of cryogenic rolling(CR)and aging was designed for optimization of the mechanical and electrical *** integration of yield strength(696 MPa)and electrical conductivity(62.8%IACS)of this alloy was achieved by cryogenic rolling and subsequent aging process at 400℃for 4 *** significant precipitation strengthening effect of this alloy is attributed to the Cu4Sc precipitates with an extremely small size of only 1.5–3 *** leading strengthening mechanism is considered as the superposition of both coherent strengthening and Orowan strengthening effects.

关键词： Cu-Sc alloy Precipitation Aging process Strengthening mechanism

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基于FPGA的X光机焦点测量仪系统设计

中国测试 2024年第8期50卷 137-143页

作者：敖子逸杨建万清周伟袁婷萱范浩成都理工大学核技术与自动化工程学院四川成都610059 中国测试技术研究院四川成都610021 四川中测辐射科技有限公司四川成都610052

X光机的焦点尺寸是影响X射线成像质量的关键因素之一,针对X光机焦点尺寸测量方法繁琐、测量效率低等问题,文章提出一种以FPGA为核心控制芯片,狭缝法为测量原理的X光机焦点测量仪系统设计方案,通过线阵CCD传感器采集狭缝成像后的焦点信息... 详细信息

X光机的焦点尺寸是影响X射线成像质量的关键因素之一,针对X光机焦点尺寸测量方法繁琐、测量效率低等问题,文章提出一种以FPGA为核心控制芯片,狭缝法为测量原理的X光机焦点测量仪系统设计方案,通过线阵CCD传感器采集狭缝成像后的焦点信息,随后进行模数转换,并采用USB2.0传输方式将数据传输至上位机进行处理和计算。文章重点讨论线阵CCD、A/D转换和USB传输的驱动与时序设计,以及焦点尺寸的计算方法,该系统具有高精度、实时性低延迟的特点。实验结果表明,在对X光机大、小焦点尺寸各进行10次测量后,测量重复性分别为0.2808%和0.4779%,示值误差均在±0.15 mm范围内,这证明了该系统能够实现对X光机焦点尺寸的精准测量。

关键词： X光机焦点狭缝法焦点测量 FPGA 线阵CCD

Polymorphisms of angiotensin-converting enzyme 2 gene confer a risk to lone atrial fibrillation in Chinese male patients

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Chinese Medical Journal 2013年第24期126卷 4608-4611页

作者： wanG shu-xia TAO Tao FU Zhi-qing xie Xiang-zhu wanG hao wanG Yu-tang First Geriatric Cardiology Department Chinese People's LiberationArmy General Hospital Beijing 100853 China~

Background Growing epidemiologic evidence has indicated that genetics can predispose individuals to the occurrence of lone atrial fibrillation （AF）. The angiotensin-converting enzyme 2 （ACE2） gene has been established to be associated with hypertension and left ventricular hypertrophy. The objective of our study was to investigate the association of ACE2 gene polymorphisms with lone AF. Methods A total of 265 consecutive lone AF patients and 289 healthy controls were successfully investigated. The polymorphisms rs2106809 and rs2285666 were genotyped by polymerase chain reaction （PCR） and direct sequencing. A Logistic regression model was used to determine the odds ratio （OR） and 95% confidence intervals （CO of variations of ACE2 for lone AF. Results The T allele of rs2106809 conferred an increased risk for lone AF （OR 1.24, 95% CI 1.01-1.52, P=0.03） in males after adjustment for conventional risk factors. SNP at rs2285666 in males was not significantly different between AF patients and controls. No association was found between the two polymorphisms in the female population with lone AF. After （36.3±4.5） months of follow-up, the end point data were obtained： death （cardiac and noncardiac）, ischemic stroke, and heart failure. In the male subgroup, the associations between rs2106809 T male carriers and combined end points including ischemic stroke, heart failure, and death in our study were of significance （OR 3.6, 95% CI 1.0-13.1, P=-0.04）. Conclusions The results indicate that polymorphism at ACE2 gene is associated with male lone AF in a Chinese Han population. Lone AF males who *** the. rs2106809T ***, are. associate.d with adverse cardiac, ***

关键词： polymorphism ACE2 gene lone atrial fibrillation follow up

Effect of exogenous spastin combined with polyethylene glycol on sciatic nerve injury

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Neural Regeneration Research 2019年第7期14卷 1271-1279页

作者： Yao-Fa Lin Zheng xie Jun Zhou Hui-hao Chen wan-wan Shao hao-Dong Lin Department of Orthopedics Changzheng Hospitalthe Second Military Medical University Department of Orthopedics the Second People's Hospital of Karamay

Polyethylene glycol can connect the distal and proximal ends of an injured nerve at the cellular level through axonal fusion to avoid Wallerian degeneration of the injured distal nerve and promote peripheral nerve ***,this method can only prevent Wallerian degeneration in 10% of axons because the cytoskeleton is not repaired in a timely *** of the cytoskeletal trunk and microtubule network has been suggested to be the key for improving the efficiency of axonal *** a microtubule-severing protein,spastin has been used to enhance cytoskeletal ***,we hypothesized that spastin combined with polyethylene glycol can more effectively promote peripheral nerve regeneration.A total of 120 male Sprague-Dawley rats were randomly divided into sham,suture,polyethylene glycol,and polyethylene glycol + spastin *** suture group rats,only traditional nerve anastomosis of the end-to-end suture was performed after transection of the sciatic *** polyethylene glycol and polyethylene glycol + spastin groups,50 μL of polyethylene glycol or 25 μL of polyethylene glycol + 25 μL of spastin,respectively,were injected immediately under the epineurium of the distal *** fiber regeneration distance,which was used to assess early nerve regeneration at 1 week after surgery,was shortest in the suture group,followed by polyethylene glycol group and greatest in the polyethylene glycol + spastin *** assessment of motor function recovery in rats showed that limb function was restored in polyethylene glycol and polyethylene glycol + spastin groups at 8 weeks after *** 1,2,4 and 8 weeks after surgery,sciatic functional index values and percentages of gastrocnemius muscle wet weight were highest in the sham group,followed by polyethylene glycol + spastin and polyethylene glycol groups,and lowest in the suture *** staining was utilized to assess the morphology of muscle *** change

关键词： nerve regeneration peripheral nerves Wallerian degeneration polyethylene glycol axonal fusion spastin peripheral nerve injuries Masson staining microtubule neural regeneration