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Quantification of rhBMP2 in bioactive bone materials

Regenerative Biomaterials 2020年第1期7卷 71-75页

作者： Huan Lian Han wang Qianqian Han chunren wang Division of Biomaterials Department of Medical DevicesNational Institutes for Food and Drug ControlNo.31 Huatuo RoadBeijing 102629China

Bone morphogenetic protein(BMP),belongs to transforming growth factor-b(TGF-b)superfamily except *** BMP into muscular tissues induces ectopic bone formation at the site of implantation,which provides opportunity for the treatment of bone *** human BMP-2(rhBMP-2)has been used clinically,but the lack of standard methods for quantifying rhBMP-2 biological activity greatly hindered the progress of *** this article,we describe an in vitro rhBMP-2 quantification method,as well as the data analyzation pipeline through logistic regression in *** studies indicated that alkaline phosphatase(ALP)activity of C2C12 cells was significantly increased when exposed to rhBMP-2,and showed dose-dependent effects in a certain concentration range of ***,we chose to quantify ALP activity as an indicator of rhBMP-2 bioactivity in vitro.A sigmoid relationship between the ALP activity and concentration of rhBMP-2 was ***,there are tons of regression models for such a non-linear *** has always been a major concern for researchers to choose a proper model that not only fit data accurately,but also have parameters representing practical ***,to fit our rhBMP-2 quantification data,we applied two logistic regression models,three-parameter log-logistic model and four-parameter log-logistic *** four-parameter log-logistic model(adj-R2>0.98)fits better than three-parameter log-logistic model(adj-R2>0.75)for the sigmoid ***,our results indicate rhBMP-2 quantification in vitro can be accomplished by detecting ALP activity and fitting four-parameter log-logistic ***,we also provide a highly adaptable R script for any additional logistic models.

关键词： rhBMP-2 bioactivity quantification statistical model fitting R programming

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Regulation challenge of tissue engineering and regenerative medicine in China

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Burns & Trauma 2013年第2期1卷 56-62页

作者： Liang Chen chunren wang Tingfei Xi Center for Biomaterials and Tissue Engineering National Institutes for Food and Drug ControlPeking University Beijing China Center for Biomedical Materials and Tissue Engineering Peking University Beijing China

The current regulatory status in the USA, European Union (EU), Japan, and China, associated with the clinical application of tissue engineering and regenerative medicine is presented. It is found that similar regulatory framework has been constructed in the USA and EU, in which risk-based regulatory strategy is used to determine which regulatory mode is more desirable between medical technique and medical product. Also, it is suggested that two-tier regulatory framework of medical products be constructed, with the first level built on existing and newly introduced regulatory provisions and the second technical level encompassing all the technical requirements. In China, the demarcation line between medical technique mode and medical product mode is not made clear and coherent and flexible regulatory framework has not been intentionally designed. If the recommendations concerning the desirability of regulatory framework will be adopted in China, it means the present application of medical technique mode should be reconsidered and adjusted based on the risk analysis. Furthermore, the construction of two-tier regulatory framework which is tailored to meet the demands of development of medical products of tissue engineering and regenerative medicine still remains a challenge.

关键词： Regenerative medicine tissue engineering medical product regulation technique

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In vitro genotoxicity evaluation and metabolic study of residual glutaraldehyde in animal-derived biomaterials

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Regenerative Biomaterials 2020年第6期7卷 619-625页

作者： Jianfeng Shi Huan Lian Yuanli Huang Danmei Zhao Han wang chunren wang Jingli Li Linnan Ke Institute for Medical Devices Control National Institutes for Food and Drug ControlNo.31 Huatuo RoadBeijing 102629China

Glutaraldehyde(GA)is an important additive that is mainly used in animal-derived biomaterials to improve their mechanical and antimicrobial ***,GA chemical toxicity and the metabolic mechanism remain relatively ***,residual GA has always been a major health risk consideration for animal-derived medical *** this study,extracts of three biopatches were tested via the GA determination test and mouse lymphoma assay(MLA).The results showed that dissolved GA was a potential mutagen,which could induce significant cytotoxic and mutagenic effects in mouse lymphoma *** toxic reactions were relieved by the S9 metabolic activation(MA)***,we confirmed that GA concentration decreased and glutaric acid was generated during the catalytic *** revealed GA could be oxidized via cytochrome P450 which was the main metabolic factor of *** found that even though GA was possibly responsible for positive reactions of animal-derived biomaterials’biocompatibility evaluation,it may not represent the real situation occurring in human bodies,owing to the presence of various detoxification mechanisms including the S9 ***,in order to achieve a general balance between risk management and practical application,rational decisions based on comprehensive analyses must be considered.

关键词： glutaraldehyde cytochrome P450 biocompatibility evaluation of medical devices animal-derived biomaterials

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Effect of the IABP on the renal artery blood flow

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Chinese Journal of Biomedical Engineering(English Edition) 1997年第3期6卷 143-144页

作者： LU Songfang XV Haiyan KONG Hua BAO Yusheng wang chunren PENG Yi YANG Zibin Institute of Basic Medical Sciences CAMS&PUMCBeijing 100005China

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THE CORRELATION STUDY BETWEEN PLASMA VISCOSITY AND FIBRINOGEN COAGULABILITY

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Chinese Journal of Biomedical Engineering(English Edition) 1995年第4期4卷 187-188页

作者： $$$$wang chunren Yang Zibin Xi Tingfei(Institute of Basic Medicine,PUMC &. CAMS’ Beijing 100005,China)( National institute for the Control of Pharmaceutical andBiological Products, Bet im 100050,China)The microenviroment around fibrinogen molecules is v

ＴＨＥＣＯＲＲＥＬＡＴＩＯＮＳＴＵＤＹＢＥＴＷＥＥＮＰＬＡＳＭＡＶＩＳＣＯＳＩＴＹＡＮＤＦＩＢＲＩＮＯＧＥＮＣＯＡＧＵＬＡＢＩＬＩＴＹＴＨＥＣＯＲＲＥＬＡＴＩＯＮＳＴＵＤＹＢＥＴＷＥＥＮＰＬＡＳＭＡＶＩＳＣＯＳＩＴＹ... 详细信息

ＴＨＥＣＯＲＲＥＬＡＴＩＯＮＳＴＵＤＹＢＥＴＷＥＥＮＰＬＡＳＭＡＶＩＳＣＯＳＩＴＹＡＮＤＦＩＢＲＩＮＯＧＥＮＣＯＡＧＵＬＡＢＩＬＩＴＹＴＨＥＣＯＲＲＥＬＡＴＩＯＮＳＴＵＤＹＢＥＴＷＥＥＮＰＬＡＳＭＡＶＩＳＣＯＳＩＴＹＡＮＤＦＩＢＲＩＮＯＧＥＮＣＯＡＧ...

关键词： on screen or the front of panelo f the equipment.There are one year or half a year for training of nursing staff in ICU in advanced countries.There should be short-term training (one to three months) according to the condition of ourcountry.3. How to tra

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Effects on the renal artery blood flow during the intra-aortic balloonpumping was used

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Chinese Journal of Biomedical Engineering(English Edition) 1998年第3期7卷 98-101页

作者： Songfang Lu Yusheng Bao Yi Peng chunren wang Zibin Yang(Institute of Basic Medical Sciences, PUMC & CAMS, Beijing 100005, China)

The effects of intra-aortic balloon pumping(IABP) on hemodynamic parameters inthe kidney were studied. The pulse produced by pumping activated the renal nervoussystem and reduced the renal vascular resistance. Therefore, the reduction of the renalvascular resistance is an important reason for the increase the renal blood flow duringintra-aortic balloon pumping.

关键词： intra-aortic balloon pumping(IABP) hemodynamics kidney

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基于多聚鸟氨酸的海藻酸微囊化肝细胞体内移植治疗肝衰竭大鼠的研究

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生物医学工程学杂志 2014年第3期31卷 642-647页

作者：王健徐丽明汤京龙王硕王春仁中国食品药品检定研究院北京100050

本研究探讨海藻酸钠-多聚鸟氨酸-海藻酸(A-PLO-A)和海藻酸钡-多聚鸟氨酸-海藻酸(B-PLO-A)两种新型微囊作为细胞移植载体的效果。两种微囊包裹小鼠肝细胞后,植入D-氨基半乳糖腹腔注射法制备的急性肝衰竭模型大鼠体内,观察大鼠死亡率,检... 详细信息

本研究探讨海藻酸钠-多聚鸟氨酸-海藻酸(A-PLO-A)和海藻酸钡-多聚鸟氨酸-海藻酸(B-PLO-A)两种新型微囊作为细胞移植载体的效果。两种微囊包裹小鼠肝细胞后,植入D-氨基半乳糖腹腔注射法制备的急性肝衰竭模型大鼠体内,观察大鼠死亡率,检测微囊内肝细胞的生长、增殖、代谢的情况,以及能否有效改善肝衰大鼠的肝功能。实验分为A-PLO-A空微囊、B-PLO-A空微囊、移植游离的肝细胞、A-PLO-A微囊化肝细胞、B-PLO-A微囊化肝细胞五组。研究结果表明,单纯的空微囊对肝衰大鼠病情无缓解作用,移植后两个空囊移植组3d死亡率均达到了100%。游离肝细胞组、A-PLO-A微囊化肝细胞组和B-PLO-A微囊化肝细胞组大鼠的ALT、AST、ALB水平均有所恢复,4周时微囊移植组的上述指标均优于游离肝细胞组,说明微囊化肝细胞移植有效缓解了肝脏损伤的程度,治疗效果好于游离肝细胞组。微囊化肝细胞组大鼠的存活率明显高于空囊移植组和游离肝细胞移植组;4周后回收的微囊表面光滑,无细胞包裹,无纤维化。研究结果提示基于多聚鸟氨酸的海藻酸微囊物理稳定性和生物相容性良好,适合作为肝细胞体内移植的载体。

关键词：多聚鸟氨酸微囊肝细胞肝脏体内移植组织工程

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一次性使用血液灌流器的体外血液相容性

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中国组织工程研究 2021年第4期25卷 588-592页

作者：许建霞王召旭王春仁中国食品药品检定研究院北京市102629

背景:作为与循环血液大面积、长时间接触的医疗器械,血液灌流器的血液相容性检测非常重要。目的:检测供试血液灌流器的血液相容性。方法:取供试血液灌流器与已经上市血液灌流器(对照)中的树脂微粒,分别与人抗凝血混合,置于37℃的旋转培... 详细信息

背景:作为与循环血液大面积、长时间接触的医疗器械,血液灌流器的血液相容性检测非常重要。目的:检测供试血液灌流器的血液相容性。方法:取供试血液灌流器与已经上市血液灌流器(对照)中的树脂微粒,分别与人抗凝血混合,置于37℃的旋转培养器上,进行体外血液学、血小板、凝血、补体检测。将两种树脂微粒分别与半抗凝兔血接触,通过检测血浆中剩余纤维蛋白原的含量来比较两者血栓形成的程度。将两种树脂微粒置入生理盐水中,再加入稀释抗凝兔血,进行溶血实验。动物实验经中国食品药品检定研究院伦理委员会批准。结果与结论:①供试血液灌流器树脂微粒组的活化部分凝血活酶时间、血小板数量大于对照灌流器树脂微粒组(P0.05);②血栓形成实验中,两组的纤维蛋白原浓度比较差异无显著性意义(P>0.05);③供试血液灌流器树脂微粒的溶血率为0.2%;④结果表明与对照灌流器中的树脂微粒相比,供试血液灌流器中的树脂微粒对补体和凝血系统的激活相对较为严重(与对照的相对百分比在85%-115%之间),但对血小板数量的影响相对较小,供试血液灌流器中树脂微粒的溶血率较小,其血液相容性可被接受。

关键词：材料血液灌流器凝血补体血小板血液学血栓形成溶血

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THE HEMODYNAMIC EFFECTS OF THE DOUBLE CHAMBER INTRA-AORTIC BALLOON PUMPING

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Chinese Journal of Biomedical Engineering(English Edition) 1998年第2期7卷 69-74页

作者： Songfang Lu Yi Peng Yusheng Bao chunren wang Xiaojun Yu Hua Kong Zibin Yang(Institute of Basic Medical Sciences,CAMS and PUMC,Beijing 100005,China)

Our experimental results showed that the effect of the double chamber intra-aortic balloon pumping was better than that of single chamber intraaortic balloon pumping. It significantly improved the hemodynamic parameters andimproved the efficiency of the counterpulsation. The result is consistent with the design of the computer simulation.

关键词： IABP hemodynamics coronary artery kidney

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THE ADSORPTION BEHAVIORS OF PLASMAPROTEINS ON THE POLYETHERPOLYURETHANE SURFACES

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Chinese Journal of Biomedical Engineering(English Edition) 1997年第3期6卷 103-104页

作者： XU Haiyan LU Songfang KONG Hua PENG Yi wang chunren and YANG Zibin(Department of Biomedical Engineering, Institute of BasicMedical Sciences, CAMS & PUMC, Beijing 100005)

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