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1、Medical Biomat(法国)/index.php/en该企业同类产品较多详细可见 同类产品MEDICALBIOMAT 文件夹产品名产品照片组成及规格适用范围备注Atlantik 人工骨由 70%羟基磷灰石和 30% -磷酸三钙组成双相合成人工骨。 因为由高纯度合成材料组成,Atlantik 人工骨人骨矿物成份十分相同,从而含有非常理想生物相容性这种人工骨适适用于由外伤或外科手术中骨缺损填充,其中括:关节置换手术脊椎手术闭合骨折切骨术肿瘤切除术后填充上颌面手术牙科手术等产品性能Atlantik 人工骨有良好多孔性和最优化表面处理,保障了快速骨再生和良好骨结合。Atlantik 人工骨结构

2、包含两种不一样空隙,空隙之间完全链接保障宏观孔隙中细胞渗透,微观孔隙则增加了与生物体液接触面。Atlantik 人工骨良好机械特征使它们能够很好配合大多数临床适应症。 在试验测试中,动物植入试验以及临床结果显示 Atlantik 人工骨有着十分理想骨结核效果。Antartik 磷酸三钙Antartik TCP 是由贝塔磷酸三钙 ( TCP)组成合成骨代替品。这种人工骨合成原料纯度极高,非常靠近于骨矿物成份。所以ANTARTIK TCP 骨代替品含有完全生物兼容性。Antartik 医用海绵Antartik Sponge 是由羟基磷灰石和磷酸三钙,外加一类和三类胶原蛋白组成人工骨填充物。国食药监

3、械(进)字第3464652号第1页Atlantik 含抗生素型人工骨可替换骨填充物与庆大霉素相结合人工骨系列Atlantik Genta 是由 70%羟基磷灰石和30%磷酸三钙,外加庆大霉素合成人工骨。它适合用于外伤或外壳手术中骨缺损填充手术,其中包含: 关节置换术 脊椎手术 闭合手术 切骨术 肿瘤切除术后填充这款产品尤其推荐于抵制细菌对庆大霉素敏感出现风险。产品性能Atlantik Genta 人工骨拥有优化孔隙率和表面,促使快速骨再生和良好骨整合。我们人工骨材料结构拥有两种不一样孔隙率,两种孔隙率之间完全连接使宏观空隙促进了细胞渗透,而微观孔隙率增加与生物体液接触面。Atlantik Ge

4、nta 人工骨颗粒状能够对复杂形态骨缺损空腔进行填充,使外科医生在手术中效率大大提升。Atlantik Genta 人工骨包含 150 毫克庆大霉素,在手术后数小时内,庆大霉素将逐步扩散到手术执行区域。 释放不少于 48 小时,以预防任何细菌产生耐药性风险。 庆大霉素常规治疗剂量(3 毫克/千克)适合用于 50 千克以上体重患者。 释放数剂量与均匀释放率到达局部高效浓度(远高于细菌对庆大霉素感最低杀菌浓度*)。当与血清混合后在使用期限内产生峰值(图 1)) *CMB:最低杀菌浓度载药材料设计参考。第2页Antartik Inject 50%磷酸三钙和 50%羟基磷灰石组成,外加增塑剂。此产品由

5、两种不一样结构混合而成(液体状和粉末状)使用时操作视频:/index.php/zh/liste-des-produits/substituts-osseux-synthetiques/antartikinject注射材料设计参考。骨水泥使用设计详见:MEDICALBIOMAT AntartikInjectableEN-CN第3页Bi-Ostetic Slow Resorbtion Bone FillerBi-Ostetic is a cost-effective synthetic bone filler tailored for slow resorbtion. Based on Trica

6、lcium Phosphate (TCP) and Hydroxyapatite (HAP), its composition mimics that of human bone. Berkeley Advanced Biomaterials, Inc. formulates the chemistry and microstructure of Bi-Ostetic to enhance bone regeneration. This formulation provides optimal osteo-conduction. The spongy Bi-Ostetic bioceramic

7、 granules with true interconnected porosity resemble cancellous bone chips. The structure enhances osteo-conduction and ensures complete bone in-growth.Common use of Bi-OsteticDefect filling in total hip revisionSpinal fusionHand and foot surgeryFracture repairJoint reconstruction优点:Safe and Biocomp

8、atibleEasy to use100% Synthetic Scaffold (composed of 60% HA and 40% -TCP)100% Resorbable and EffectiveOsteoconductive and biocompatibleRadiopaque(不透射线)Safe, sterilized by Gamma irradiation有很完整临床试验图片能够参考,详见链接网址。/Berkeley Advanced Biomaterials, Inc.(美国)/国食药监械(进)字第3463438号第4页Bi-Ostetic Foam Excellent

9、BiocompatibilityBi-Ostetic Foam is a sterile bone graft composed of highly purified fibrillar Type I bovine collagen and Bi-Ostetic resorbable 60% hydroxyapatite and 40 % tricalcium phosphate granules. Bi-Ostetic Foam is safe and has excellent biocompatibility. After it is implanted, it resorbs and

10、is later replaced by natural bone. Bi-Ostetic Foam is a safe choice for sparing patients the trauma of autograft harvesting. Common Use of Bi-Ostetic FoamTreatment of bone fractures and traumatic osseous defects in:Extremities of the skeletal systemSpinePelvis(盆骨)Safe and BiocompatibleEasy to UseCol

11、lagen and Synthetic ScaffoldResorbable and EffectiveOsteoconductive and BiocompatibleBiodegradableRadiopaqueSafe, Sterilized by Gamma irradiationBerkeley Advanced Biomaterials, Inc.(美国)/第5页Cem-OsteticOptimal Bone GenerationCem-Ostetic is a neutral pH bone putty that contains calcium-based biocompati

12、ble calcium salts that have been used for decades in orthopedic surgery. These materials are often used to provide an additional source of bone to help the patient heal faster. Berkeley Advanced Biomaterials, Inc. formulates the chemistry and microstructure to enhance bone regeneration, provide opti

13、mal osteo-conduction and reduce the time for the bone to regain its full health. Cem-Ostetics unique putty formula sets up quickly with marginal exothermic reaction (less than 4C).Cem-Ostetic is available in Putty, Injection Kit, Granules and Block. Common use of Cem-OsteticJoint reconstructionSpina

14、l fusionHand and foot surgeryFracture repairSafe and BiocompatibleEasy to use Quick to prepare (5 minutes)100% Synthetic (Calcium Salts Scaffold, including nanocrystalline hydroxyapatite)100% Resorbable and Effective (three to four months in animal tests and clinical studies)Osteoconductive, biocomp

15、atible and neutral pHSafe, sterilized by Gamma irradiationBerkeley Advanced Biomaterials, Inc.(美国)/第6页GenerOsFor a complete bone in-growthGenerOs is an osteoconductive bone void filler composed of -tri-calcium phosphate (TCP). Once implanted, GenerOs provides a scaffold that stimulates the formation

16、 of the bone. GenerOs then resorbs and is later replaced by natural bone.GenerOs is provided in granules which porosity resembles the patients bone. Its structure enhances osteoconduction and ensures complete bone in-growth.Common use of GenerOsDefect filling in total hip revisionSpinal fusionHand a

17、nd foot surgeryFracture repairJoint reconstructionCyst treatmentLimb salvage Safe and BiocompatibleEasy to use100% Synthetic Scaffold100% Resorbable and EffectiveOsteoconductive and biocompatibleRadiopaqueSafe, sterilized by Gamma irradiationBerkeley Advanced Biomaterials, Inc.(美国)/GenerOsGranules -

18、 Instruction for UseMaterialsGenerOs is composed of beta-tricalcium phosphate (TCP). TCP has been the topic of extensive clinical studies for several decades. GenerOs is safe and has excellent biocompatibility. After it is implanted, the implant resorbs and is later replaced by natural bone. GenerOs

19、 is a natural choice for sparing patients the trauma of autograft harvesting. It also provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission.Indications-For-UseGenerOs is an osteoconductive bone substitute shaped as granules (can

20、cellous, cortical or cortico-cancellous) that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium.The granules may be pressed into the void or into the surgical

21、site by hand. The GenerOs granules provide void filling material that acts as a temporary support medium. The granules are not intended to provide structural support during the healing process. The implant is radio-opaque. GenerOs is biocompatible and resorbs in the body as bone ingrowth occurs.第7页D

22、emineralized Bone MatrixQuick revascularizationDemineralized Bone Matrix (DBM) is produced from ground cortical bone and contains osteoinductive proteins. It is intended to be used to fill bone defects and cavities.The increased activity of DBM is assumed to be attributed to the osteoinductive prote

23、ins activity.DBM can be used to augment autologous cancellous or corticocancellous grafts.It may also be an alternative for a patient who has no autologous bone available for use as a graft or for a patient who does not wish to undergo an extensive open procedure or for whom open procedure carries a

24、 very high risk.Common use of Demineralized Bone MatrixCranio-facial surgerySpinal fusionHand and foot surgeryFracture repairJoint reconstructionCase StudiesThese Case Studies (D1, D2 and D3) introduce the treatment using DBM and the postoperative results in patients presenting back pain, lumbar sco

25、liosis and lumbar radiculopathy. Those cases demonstrate the potential for use of DBM as a bone graft substitute: after few months, the use of DBM demonstrate that spine fusion is safe and effective.SafeEasy to use and quick to prepare (rehydrated in 5 minutes)Safe, sterilized by gamma irradiationDo

26、nor tissue recovered, processed and distributed by TBI/Tissue Banks International National Processing Center (an AATB-accredited tissue bank). Berkeley Advanced Biomaterials, Inc.(美国)/第8页NovaBone(美国)并未公布组成/NB/orthopedic.htmlNovaBone PariculateThe particulate formulation provides users with a small (

27、90-710m) granular graft that readily mixes with local bone or blood, forming a slurry that can be packed into a defect.As new bone generation occurs, the material is resorbed by the body.ENGINEERED BONE REGENERATION特点:NovaBone Particulate Formulated for Small Graft AreasMixes easilyExceptional handl

28、ing and placementIdeal for smaller voids(空隙) and defectsNovaBone PuttyNovaBone Putty is a versatile bone graft substitute that is ready to use out of the package with exceptional handling characteristics that will save time and improve placement.The specially formulated consistency means it can be p

29、acked into any size or shape void without sticking to surgical gloves. The binder resists migration during irrigation allowing the bioactive component to stay as placed.Exceptional Handling CharacteristicsHighly malleable(可塑性), easy to mold and pack into any defectStays at the surgical siteWill not

30、migrate during irrigationReady to use out of the packageDoes not stick to surgical gloves国食药监械(进)字第3632317号不过用于非口腔并未被引进口腔用生物玻璃人工骨(商品名:倍骼生)第9页NovaBone Bioactive StripNovaBone Bioactive Strip is a sterile bone graft composed of purified fibrillar collagen and resorbable bioactive calcium phospho- sili

31、cate granules. The open structure allows for rapid vascularization and mineralization and permits complete device absorption and replacement by new bone. NovaBone is the only graft that signals and recruits osteo progenitor cells while controlling the cell cycle to favor proliferation and differenti

32、ation of cells that generate new bone. NovaBonedemonstrated equivalent rates of bone growth when compared to autograft in clinical studiesCompression resistant formable Bioactive Bone Graft.Bioactive Synthetic Granules activating chemistry promotes bone formation and creates a highly Osteoconductive

33、 Matrix for new bone growth.Type I Collagen provides sites for cell and protein binding.Optimal composition and pore size designed to mimic cancellous bone.Hydrates rapidly in bone marrow aspirate.Ability to visualize bone graft placementNovaBone 企业几款产品比较有参考价值,能够重点参阅一下相关文件第10页meta-biomed(韩国)/eng/Bon

34、eMedik第11页meta-biomed(韩国)/eng/NT-Ceram第12页meta-biomed(韩国)/eng/NT-Cem第13页meta-biomed(韩国)/eng/DM-Bone第14页meta-biomed(韩国)/eng/DM-Bone第15页GENOSS(韩国)/ORTHOPEDIC OSTEON合成骨移植替换材料GenossORTHOPEDIC OSTEON具与人体骨骼类似结构,是一个具骨传导性合成骨骼,由Hydroxyapatite(HA)和-tricalcium phosphate (-TCP)组成。因为生物活性优异且生物降解速度慢,HA scaffold从结构

35、上可长时间支撑。在HA scaffold上涂一层生物活性及吸收性优异-TCP,从而实现早期骨融合及长久支撑作用。适用范围:在进行骨损坏、损失、矫正等骨科手术时,移植所需骨部位,并促进骨骼再生。-填充并重组骨折造成骨损坏部位- 依据假关节有没有骨缺失部位- 进行胫骨骨折手术时-进行关节整形术、矫正术或其它特定部位矫正术时- 使用于关节穿刺、口腔颌面外科、牙周科等ORTHOPEDIC OSTEON II合成骨移植替换材料GenossORTHOPEDIC OSTEON II为高-TCP含量骨传导性合成骨移植材料。结构上与海绵骨类似,经过提升-TCP含量帮助快速吸收,从而促进新骨形成。第16页GENO

36、SS(韩国)主要是人工骨和再生膜/ORTHOPEDIC OSTEONII Collagen合成骨移植替换材料Orthopedic OSTEON II Collagen是为修复或再生骨缺失部位而开发骨移植生物材料,由具优异骨传导性合成骨材料OSTEON II和Type I胶原蛋白组成。适用范围:在进行骨损坏、损失、矫正等外科手术时,移植所需骨部位,并促进骨骼再生。-填充并重组骨折造成骨损坏部位- 依据假关节有没有骨缺失部位- 进行胫骨骨折手术时-进行关节整形术、矫正术或其它特定部位矫正术时使用于关节穿刺(E.N.T)、口腔颌面外科等特点:- 涂有一层胶原蛋白,易于操作, 并可缩短手术时间-在湿润

37、状态下可变形为各种形状- 在提升早期操作简易度后,胶原蛋白将吸收到人体内- 空间保持功效及新骨形成功效优异- 止血作用国械注进3461730第17页GENOSS(韩国)/OSTEON合成骨移植材料- 100% 合成骨移植材料 = 涂有-TCPHA支架- OSTEON = HA 70% + -TCPOSTEON合成骨移植材料IIHA和-TCP之比为30:70合成骨移植材料第18页第19页GENOSS(韩国)/NEWBONE 合成骨移植材料GENOSS NEWBONE为具骨传导性合成骨移植材料,由20%Hydroxyapatite (HA)和80%-tricalcium phosphate (-T

38、CP)组成。0.22.0mm大小范围多空型粒子包装于小瓶或注射器中,经伽马射线灭菌后供给。第20页STRYKERhttp:/en-us/products/Orthobiologicals/index.htm#该企业产品较多,其中Vitoss Strip能够重点参考一下。不过并未公布产品组成信息,能够参考其参考文件,了解一下第21页Wright/healthcare-professionals/biologics第22页Allosource/ALLOFUSE DBM GEL & PUTTYAlloFuse DBM Gels, Pastes and Putties are unique bone

39、graft substitutes composed of demineralized bone matrix in a reverse phase medium. This distinctive reverse phase medium becomes more viscous at warm temperatures to provide exceptional handling characteristics. AlloFuse DBM Gel and Putty are available in a variety of sizes第23页Iso Tis/family/isotis/

40、IsoTis Mozaik MorselsOur IsoTis Mozaik morsels form a moldable putty when hydrated with bone marrow aspirate. -TCP granules are larger than those in our putty configuration, adding additional volume.Key FeaturesAdvanced Engineering - With a blend of 20% type 1 bovine collagen and 80% highly purified

41、 -TCP, the matrix was developed to resemble the composition and pore structure of natural human bone. The resorption rate is consistent with the formation of new bone.Carrier for Cells and Proteins - An interconnected pore structure absorbs bone marrow aspirate, which contains cells and proteins tha

42、t play an important role in bone formation.Radiographic Visualization - The -TCP component provides radiographic visualization of graft placement.Terminal Sterilization - As the last step in manufacturing, the scaffold is terminally sterilized.第24页Iso Tis/family/isotis/IsoTis Mozaik PuttyOur IsoTis

43、Mozaik putty is a compression-resistant, osteoconductive scaffold composed of purified collagen and -TCP. The matrix readily hydrates with bone marrow aspirate.Key FeaturesAdvanced Engineering - With a blend of 20% type 1 bovine collagen and 80% highly purified -TCP, the matrix was developed to rese

44、mble the composition and pore structure of natural human bone. The resorption rate is consistent with the formation of new bone.Carrier for Cells and Proteins - An interconnected pore structure absorbs bone marrow aspirate, which contains cells and proteins that play an important role in bone format

45、ion.Radiographic Visualization - The -TCP component provides radiographic visualization of graft placement.Terminal Sterilization - As the last step in manufacturing, the scaffold is terminally sterilized.第25页Iso Tis/family/isotis/IsoTis Mozaik StripOur IsoTis Mozaik strip is a compression-resistant

46、, osteoconductive scaffold composed of purified collagen and -TCP. The matrix readily hydrates with bone marrow aspirate.Key FeaturesClinical Evidence - Equivalent fusion performance to autograft has been demonstrated in a retrospective study on posterolateral lumbar fusion. The study found 100% fus

47、ion in all one- and two-level procedures, with an overall fusion rate of 90%.Advanced Engineering - With a blend of 20% type 1 bovine collagen and 80% highly purified -TCP, the matrix was developed to resemble the composition and pore structure of natural human bone. The resorption rate is consisten

48、t with the formation of new bone.Carrier for Cells and Proteins - An interconnected pore structure absorbs bone marrow aspirate, which contains cells and proteins that play an important role in bone formation.Compression Resistance - A matrix with compression resistance has an increased ability to r

49、etain bone marrow aspirate within the matrix.Radiographic Visualization - The -TCP component provides radiographic visualization of graft placement.Terminal Sterilization - As the last step in manufacturing, the scaffold is terminally sterilized.第26页Regeneration Technologies/en_us/products/category/

50、cardiothoracic参考文件:Ahn, E. & Webster, T. Enhanced Osteoblast & Osteoclast Function on nanOss a Calcium Phosphate Nanotechnology. . *Research and Development, Pioneer Surgical Technology, Greenville, NC & Woburn, MA. Study sponsored by Pioneer Surgical.*C. Lauryssen MD*, S. Robbins MD* & M. Songer MD

51、*. Lumbar Spinal Fusion Results Using nanOss: One Year Follow-Up. *Served as clinical evaluator/consultant of nanOss in posterolateral spine fusion and compensated for time summarizing patient oucomes, also were shareholders or option holders of Pioneer Surgical stock at the time they authored the s

52、tudy. 第27页BioAlpha Inc. (韩国)/intro/idea.asp主要产品特点是:三维网状结构、高孔隙率、骨传导国食药监械(进)字第3460914号(更)第28页北京奥精医药科技有限企业/cn/index.aspx产品名注册号组成及规格适用范围备注人工骨修复材料国食药监械(准)字第3461579号该产品主要由I型胶原蛋白和羟基磷灰石组成,形状为圆柱体、长方体、梯形体或颗粒状。该产品经射线灭菌,一次性使用。人工骨材料是一个新型生物矿化骨修复材料,国内首创、国际领先,临床中与骨髓混合,成骨愈合效果与自体骨相同。矿化胶原是骨组织主要成份之一,能为钙化组织结构提供必不可少三维结构,

53、并为成骨细胞黏附、增殖及发挥成骨作用提供良好微环境,人工骨修复材料模仿了天然骨成份和微结构特征,使其本身具备了与骨键合能力,使其在新骨形成过程中被吸收转化为新骨主要成份。人工骨修复材料适用范围:骨科、齿科和神经外科。骼金第29页上海瑞邦生物材料有限企业/瑞邦同类产品较多,可做参考第30页一、产品性能上海瑞邦生物材料有限企业自固化型磷酸钙人工骨产品(瑞邦骨泰),又称CPC,是国际上八十年代中期开始临床应用非陶瓷型羟基磷灰石类人造骨材料。它由磷酸钙粉末和固化液两部分组成,使用时将二者按一定百分比调和后呈膏体状,填充于骨缺损处,并可依据骨缺损处解剖要求随意修整,到达准确修复骨缺损目标。它克服了羟基磷

54、灰石(HAP)陶瓷烧结、修整困难缺点,防止了陶瓷与骨之间密接性差,易于造成纤维组织介入生长而影响界面结合强度不足。同时CPC硬化过程基本不放热,不会引发周围组织损伤。利用特定百分比固化液调和后浆体优良流动性,可用注射器将其注射到待填充修复部位,实现在填充部位原位固化。固化后其最终成份转化为人体无机成份羟基磷灰石。二、物理性能凝结时间:15-18min固化体抗压强度:35MPa内部孔径:10m孔隙率:40%三、产品规格注射型骨泰3.8克,7.6克四、使用方法CPC用于椎体,可采取常规切开注射及经皮微创注射(PVP、PKP详细操作参见后面附文)等 方法:常规手术前准备;将穿刺针预置于待注射椎体(P

55、VP需在C臂机或CT导引下定位);依据缺损部位大小,选择适当包装剂量;将粉末同固化液按已配好百分比(一包粉末配一支固化液)在20ml消毒注射器内充分调和成较牙膏略稀浆体,再转注入1ml或2ml小注射器中备用;将注满CPC浆体注射器与穿刺针相连接,随即迟缓加压,将浆体注射到待填充部位,充填满意后停顿并统计,通常椎体一侧注射6-10ml(PVP需在C臂机或CT监视下进行);充填部位内压较高时,可选取加压注射器,应在注射前对充填部位预作处理;注射前应排空注射器内空气。第31页自固化磷酸钙人工骨粉末产品使用方法:(10克可填充约4立方厘米)使用前先检验产品(粉末及固化液)有没有破损。使用调和器材有否严

56、格无菌消毒,凡不合格者切勿使用。填充前,将粉末及固化液充分混合后调成软硬适中面团状。普通一袋粉末配一包固化液,若固化液浪费,则调和糊状物过干过硬,须开启备用固化液,酌量加入,防止过稀不成形。对待填充部位降低渗血渗液,如用纱布填塞,纤维蛋白酶止血剂或明胶海绵等。用含40-45生理盐水拧干热纱布敷盖15分钟,在此时间内调换2-3次以维持温度,加速材料固化。关闭伤口前,用纱布敷盖人工骨,清洗创面。关闭创面,渗血渗液多区域用负压引流管引流,降低创面渗液和积留对材料固化影响。自固化磷酸钙人工骨粉末一、产品性能上海瑞邦生物材料有限企业自固化型磷酸钙人工骨产品(瑞邦骨泰),又称CPC,是国际上八十年代中期开

57、始临床应用非陶瓷型羟基磷灰石类人造骨材料。它由磷酸钙粉末和固化液两部分组成,使用时将二者按一定百分比调和后呈膏体状,填充于骨缺损处,并可依据骨缺损处解剖要求随意修整,到达准确修复骨缺损目标。它克服了羟基磷灰石(HAP)陶瓷烧结、修整困难缺点,防止了陶瓷与骨之间密接性差,易于造成纤维组织介入生长而影响界面结合强度不足。同时CPC硬化过程基本不放热,不会引发周围组织损伤。二、物理性能凝结时间:315min固化体抗压强度:35Mpa内部孔径:10m孔隙率:30%三、产品规格粉末型骨泰:2克,5克,10克第32页一、产品性能上海瑞邦生物材料有限企业自固化型磷酸钙人工骨产品(瑞邦骨泰),又称CPC,是国

58、际上八十年代中期开始临床应用非陶瓷型羟基磷灰石类人造骨材料。它由磷酸钙粉末和固化液两部分组成,使用时将二者按一定百分比调和后呈膏体状,填充于骨缺损处,并可依据骨缺损处解剖要求随意修整,到达准确修复骨缺损目标。它克服了羟基磷灰石(HAP)陶瓷烧结、修整困难缺点,防止了陶瓷与骨之间密接性差,易于造成纤维组织介入生长而影响界面结合强度不足。同时CPC硬化过程基本不放热,不会引发周围组织损伤。利用特定百分比粉末,抗生素与固化液调和后制成载药型骨泰,填充于病灶区域,迟缓释放药品,维持病灶区药品高浓度,最终有效控制与治愈感染,同时CPC可有效传导成骨。使用方法方法一:粉末加药:是在手术过程中,用CPC粉末现场调制成CPC载药颗粒。详细操作方法以下:第一步,依据病灶腔大小,取适量CPC粉末,倒在调试皿上,按5%百分比混合药品粉末;第二步,计量注入固化液,调和,制成CPC载药颗粒(做载药颗粒是为了增加颗粒表面积,有利药品释放),并将制好载药颗粒用40左右温纱布包裹2

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