Release date: 2007-07-30
07 Boao International New Materials Forum Excellent Paper: Special Adhesive-Cyanoacrylate Medical Plastic Tianxia Lu Yongshun Beijing Fu Aile Technology Development Co., Ltd. (100081) [Author] Tianxia female senior engineer enjoys special contribution from the State Council Lu Yongshun, senior engineer and husband and wife, have experienced hardships and have been engaged in the research and development of medical adhesives for 30 years. In 1978, the company developed the n-octyl cyanoacrylate (NOCA) and the subsequent 508 series of medical adhesives in Xi'an, taking the national 65-95. The scientific and technological project completed 16 appraisals and won 28 national science and technology awards. In 1991, the company established a company in Shenzhen and Guangzhou to make medical plastics enterprise production, fill the gap of national medical adhesive standards, and set up a high-tech enterprise in Zhongguancun, Beijing in 2000. The third generation of medical glue - Fu Aile, developed into 3 specifications and 7 models, its standard is listed as the national testing standard. Hosted the National Medical Glue Seminar 5 times, and is the Chairman of the Board of Directors of Beijing Fu Aile Technology Development Co., Ltd. 010-62179078) [Key words] ç¦çˆ±ä¹ FAL medical adhesive medical adhesive α-cyanoacrylate [Abstract] This article outlines the medical adhesive Yi, classification, standards, brief history of development, development status at home and abroad, especially introduced the biological properties of FAL medical glue; because FAL (NOCA + NBCA) improved monomer purity (> 99%), optimize the comprehensive performance of medical glue Equipped with a variety of suitable tools, medical glue has become a must-have item in many departments, and has developed into medical gel therapy. FAL has the functions of hemostasis, sealing, adhesion, plugging, embolization, crushing bone fixation, anti-adhesion, etc. Widely used. In general, laparoscopic, extraneural, cardiothoracic, gynecological, urinary, orthopedic, oral, ENT, burn, and other departments, 30 years of clinical practice is safe and effective. Adheseve of sperticular kind –α-cyanoacrylate Medical AdheseveTian Xia LU Yong -Swen (Beijing Fuaile science and Technoiogy Developmnt Co.Ldt, Beijing 100081 ChinaKey mordds Adiheseve Medical Adiheseve α-cyanoacryiateAbstract This introduction specstandard of medical adhesive and its evolution history and the current status, especially focuses on the biological performance of FAL Medical adhesive; The primary characteristics of Fuai Le medical adhesive of splay type (FAL)-99% n-octyyl-α-cyanoacrylate (NOCA) and n-butyl-α-cyanoacrylate (NBCA) structure was described briefly and its primary properties including physicochemical, and medical properties were test( Bacteria pyroge hemolysis acute full body toxicity derma sensitization stimulation unde skin implantation test are all negative and analize test). Based on these points, the medical applications of FAL were introduced systematically. (General surgery, Cardio and Chest surgery, Tumor, Neurosurgery, Gynecology and For the thirty years, more than ten million cases of clinic application were carried out. Not only had the rapid healing function and only working but also eased the patients' suffering and saved thousand's Lives 1. Overview of medical adhesives 1.1 Definition of medical adhesives Medical adhesives are biomedical special functional adhesives, in addition to the usual bonding and mechanical functions. In addition, it should also have biomedical functions. The medical supplies used to make contact with the human physiological environment (human tissues and blood, etc.) are collectively referred to as biomedical engineering materials. In China, as a 6685-III medical device management.1.2 Classification and standards of medical adhesives According to the 2005 Chinese Medical Device Regulations and Supervision Guidelines, medical adhesives are classified as Class III 6865-3 in medical device classifications, medical α-cyanoacrylates, and α-cyanoacrylates are chemically reactive. Adhesive, has the following characteristics: one-component, liquid, solvent-free, rapid curing at room temperature, and at the same time, it produces large bonding strength to polar substances (metal, plastic, glass, organism). Its structure CNCH2CC00R α carbon atom The combination of the -CN and -C00R groups makes the carbon atom at the β position generate a strong electric absorption property, so that a very small amount of anions (-OH, -NH2) are instantaneously polymerized to be on the living tissue. The polymerization rate is the fastest, because the basic substance of the living tissue is protein, and the protein is a linear macromolecular compound composed of amino acids. The macromolecule contains -NH2 and -COOH groups at both ends. Experiments prove that: The amines are the first type of catalysts for this type of ester. Adding 0.05-1% to the system will cause rapid agglomeration. It naturally has the characteristics of rapidly bonding the living tissue without any need to add any catalyst. Aile medical adhesive standard YZB/National 0941-2003 is listed as the nationally recognized medical adhesive testing standard.)1.3 Brief history and current status of medical adhesive development In the surgical operation, antibacterial and hemostasis are the basis for the repair of biological tissues. Sewing and tying are two basic operations. This method is not only cumbersome and laborious, but also prone to bleeding and new damage, causing more pain to the patient; for large areas of bleeding that cannot find bleeding points, The doctor also feels helpless. If glue can be used instead of or partially to replace suture, it is a revolution in surgery to stop bleeding of small blood vessels or to seal the serosal surface of the cancer. For nearly a hundred years, people have been looking for an ideal medical treatment. Glue, has made unremitting efforts. Thousands of adhesives have been developed so far, but few are suitable for medical use and are eliminated by strict medical indicators. In 1959, the Eastman 910 (α-cyanoacrylate) instant bond produced by Eastman Kodak Company of the United States attracted the medical community. From 1960, Nathan et al first used it for arterial anastomosis experiments [1]. In 1972, the FDA approved (α-cyanoacrylate) medical treatment after 1990 [2], in 2003, Johnson & Johnson China imported FDA-approved "2-OCA" (2-octyl Cyanoacrylate), which entered China in 2004, but was expensive and limited to epidermal applications. To the cold [3]
In 1963, the Japanese Ministry of Health and Welfare approved 「A "Sankyo" (α-cyanoacrylate B / n-butyl ester) as a dental glue and surgical glue. Histoacry Blau (n-butyl cyanoacrylate) was produced by B. Braun in Germany. It was sold at 375 yuan/0.5ml in 1994. In 2000, Meyer-H????k in Germany? ? The company imported EPIGLU human tissue adhesive (α-cyanoacrylate) to China, the price is high and refrigerated, it is strictly forbidden to enter the body and only use the epidermis.
<661>(I-Isobutyl cyanoacrylate) (IBCA) produced in Gai County, Liaoning Province, China in 1966, 1999 Yongcheng County, Henan Province, Beijing Instant Kang Medical Glue (Kamper) (Kefeng), Yichang (Shengkang) and other products, the main glue is (IBCA).
In 1971, Shaanxi Province first created <504>(N-BCA) (n-butyl cyanoacrylate) produced by Shanghai Xinyi Pharmaceutical Co., Ltd. for the sterilization of the fallopian tube. It was clinically proven that the polymerization was too fast for doctors to operate. In the 1974 National Family Planning Work Conference, Lin Jiamei and Lin Qiaozhi proposed that they must be modified before they can enter the human body. January 1978 I studied in Xi'an Chemical Industry all the lucky six-five scientific research projects for female sterilization and later male and female sterilization and blocking agents. After consulting a large number of British, Japanese, Russian and German materials, I was inspired by a paper from the former Soviet Union. That is, the performance of the lower ester (501) can be changed with the high carbon ester (506). Can it be changed with N-octyl-α-Cyanoacrylate (N-OCYL) (N-octyl-α-Cyanoacrylate) Performance of 504). After more than 200 synthetic tests, <508> monomers with purity of only 92% (through infrared, nuclear magnetic, elemental analysis) were developed, and after 84 screenings, the tubal sterilization was developed in 1978. Agent, referred to as J-2 glue [4.5]. On the basis of the success of animal experiments, it entered the clinical. Fine tube adhesive agent J-3 glue [6.7].. 1980-1983 completed by the Fourth Military Medical University, Wuhan Tongji Medical College, Tianjin Labor Health Research Institute, without any reference materials for modern toxicology test The results of acute poisoning, subacute poisoning, chromosomal aberration, cancer promoting, triad (mutagenic, teratogenic, carcinogenic) and reproduction were all negative. The bacteriostatic test (Staphylococcus aureus) was completed by the Second Affiliated Hospital of Xi'an Medical College. , Staphylococcus aureus, four-cocci, hemolytic streptococcus, streptococcus mutans, pneumococci, Escherichia coli, Proteus, Bacillus subtilis, Pseudomonas aeruginosa, yeast, etc.) to form a bacteriostatic zone for 11 kinds of bacteria. On the basis of the above biological tests, the Xi'an Medical University First Affiliated Hospital, Xi'an First, Second, Fourth, Central Hospital, Siji Hospital, Tangdu Hospital, Stomatological Hospital, Wuhan Tongji Medical College Organ Research Institute Suzhou University First Hospital, Shenzhen Hospital, Shenyang Chinese Medical University First Hospital, Tianjin Pulmonary Hospital, Dalian Friendship Hospital, Fujian Nanping Municipal Hospital, Shandong Qilu Hospital, Shanghai Renji Hospital, Baotou City Center In the hospitals, Anyang City Hospital, Xinmi Anorectal Disease Research Institute and other hospitals, the famous organ transplant professor Xia Suisheng, led by hundreds of doctors, assisted and participated together. In the 10 years (1978-1988), we developed: J -2 glue, J-3 glue, developed CD glue, ZT glue, V-1 glue, V-2 glue, TH glue, ophthalmic glue, OB glue, BC glue, spray PW glue, EC ear glue, F-TH Glue, D-TH Glue, ZM Glue, Xenon Glue, etc. <508> series of medical adhesives. About 1 million cases in 20 clinical departments, only J-3 glue in 100 cities and counties in Shaanxi Province reached 100,000 cases. [8.9] In Xi'an, 1988-1989, we held two sessions of medical adhesives. It is a new milestone in the application of medical adhesives in China. It has been fully infiltrated into various clinical fields. In 1991, the medical adhesive research laboratory moved south to Shenzhen and Guangzhou. (1993) Realized the transformation of scientific research results. (1993-1996) held 3-4 sessions in Guangzhou. Five seminars received 625 papers. Some departments of many hospitals have used medical glue as Surgical routine use of glue [10]. 1994 series of medical glue passed the national production and appraisal, medical α-cyanoacrylate was included in the 1997 edition of the National Classification of Medical Devices Category III 6 865-3. If we use 504 monomer as the first generation of medical glue, 508 as the second generation of medical glue, in 2002 in Beijing Zhongguancun High-tech Park, we developed the spray-type Fu Aile Medical glue can be called the third generation of medical glue. 2005 Fu Aile medical glue standard: YZB / country 0941-2003 has been listed as the only recognized medical glue testing standard in the country [11] In 2006, three specifications and seven models were formed. Roots of different operations require medical freedom to choose. Fu Aile medical plastic cavity mirror type is included in Zhongguancun high-tech enterprise new products (2006-2010). Clinical needs and doctors' creative application, cast medical gel therapy [12] Different from fibrin glue Category: source of medical source infection, allergic constitution, absorption, storage, bonding strength, plugging, embolization, convenient, fast, love, love, 6865-3, medical adhesive, synthetic, no single component, 2-4 weeks, room temperature, greater than human body Physiological value 78-hundred grams of anti-intestinal cerebrospinal fluid leakage pancreatic duct embolization 3 specifications 7 models optional fiber protein 6864-3 dressing class 08 changed to drug number human cattle pig blood products hepatitis C hepatitis B AIDS disabled 4 bottles of two components 2-4 weeks refrigerator is less than 38 grams, that is, the eyeball rotates open Can be warmed with dissolved double-tube injection. The Japanese government announced in June 2006 that it would stop producing blood products after compensation for those infected with blood products. The US FDA stopped production and imported blood products in 1977. Although China banned the import of blood products, it approved Fibrin glue produced by pig blood, such as: embroidery, Yueling, Fenglian, Anke, creation and other products. 2. Fu Aile medical glue (FAL) 2.1 FAL optimized composition (developed with purity >99% Monomer), improve the overall performance of the glue [13-41]
After more than 20 years of continuous improvement of the synthesis process, high purity (>99%) of α-cyanoacrylate n-octyl ester (N-OCA) and α-cyanoacrylate n-butyl ester (N-BCA) have been developed, and the best Composition of FAL. Removed 502, plexiglass, Freon and other additives in the second generation of medical adhesive formulations. FAL curing time is 2-6S (to get operation), good diffusion and sealing performance, good toughness of polymer film, 180 degree cracking, low heat of polymerization, high bonding strength, etc. meet the clinical requirements. The performance comparison is as follows: Purity% Additive Polymerization Thermal Diffusion Membrane cm Toughness Tool Application Test Storage Fu Ailele 3rd Generation 508/N0CA504/NBCA >99>99 1.6 8 (Plate Garden Transparent) Pick up and bend the continuous spraying tool complete in vivo and external experience 23 17 items of room temperature EC ear gel second generation 502/ECA >92 plexiglass 8.8 punctate non-diffusible hard glass-free ear bone fixation incomplete room temperature instant plastic first generation isobutyl ester / IBCA
4.8 Unformed peaches can not be hard and brittle without in vitro use 3 room temperature US skin with gum octyl ester / 2-0CA
6 in vitro refrigerators, German love skin 502/ECA
8.8 It is a point-like non-diffusion like glass. It is strictly forbidden to enter the refrigerator in the body. 2.2 FAL perfect sterile supporting tools and specifications have developed a handy glue tool (all patented) [13-41], freely sprayed, rooted in different clinical requirements, The doctor can choose the corresponding specifications. FAL size application type 0.5ml / set spray type 1.0ml / set (ABCD) type cavity type 1.5ml / set (AB) type aseptic matching tool suction bottle + glue stick glue Bottle + spray bottle + with different steering nozzles suction bottle + endoscope under the glue device for application (hemostatic bonding closed plugging plug anti-adhesion) small wounds will be glued on the glue stick coating wound end with tweezers rubber age A /Small wound surface B/large wound surface C/deep wound surface D/endoscopic small wound surface A/endoscopic B/multi-purpose tool Features: 1 The whole glue bottle is smooth, the glue mouth is properly ensured to use a drop of glue; 2 dexterous Glue sticks, the size of each head has its own 3 spray bottles can be sprayed all over, without any propellant 4 different parts use different steering 360 degree nozzle 5 equipped with a minimally invasive laparoscopic surgery spray device. The problem of difficult bleeding closure after laparoscopic surgery. 2.3 Biological properties of FAL FAL completed 17 biological tests, more than 100 pathological experimental studies, more than 10 million clinical cases, 29 years of follow-up observation, no adverse reactions were found. The United States "skin rubber" completed 6 tests [ 3], Instant Kang completes 3 tests. Test item Fu Aile medical glue N-OCA+N-BCA American skin glue 2-OCA Instant Kang medical glue I-BCA cytotoxic negative negative negative intradermal sputum negative negative Negative skin sensitization negative negative negative acute systemic toxicity negative negative hemolytic negative
Pyrogen negative
Mutagenic (Ames) negative
Teratogenicity
Carcinogenic (long-term toxicity) negative
Negative negative implants, negative degradation, non-toxic and harmless low molecular weight
Negative eye stimuli negative for cancer
Chromosomal aberration negative
Two generations of reproductive negative mice without teratogenicity
Subacute negative
Bacteriostatic inhibition of 11 kinds of bacteria
3. FAL clinical application (see the instruction manual or application report for details)
Because FAL improves monomer purity, optimizes the comprehensive performance of medical glue, and is equipped with various applicable tools, medical glue has become a must-have item in many departments, and has developed into medical gel therapy. It is widely used in general, laparoscopy, and nerve. External, cardiothoracic, maternity, urology, orthopedics, oral cavity, ENT, burn and plastic surgery, etc. in 20 departments of surgery. It has the functions of hemostasis, sealing, adhesion, plugging, embolism, anti-adhesion, fixed comminuted fracture, etc. Limited introduction.) References 1. Experiences With Pdhesive in the Nonsuture Repair of Body Tissues JOHN E.HEALEY American Journal of Surgery Vol 109 April 19652. Transcatheter Occlusive Therapy of Genitourinary Abnormalities Using Isobutyl 2-Cyanoacrylate(Bucryate) FREENY ET AL AJR: 133; October 19793. CLOSURE Medical Corporation November 21 19974. Tianxia J-2 gel sterilization plugging agent successfully developed Xi'an Chemical 1979 (1) 5. Tianxia α-cyanoacrylate medical adhesive synthetic chemistry Bonding with 1983. (1) 6. Tian Xia Lu Yongshun sterilizing blocking agent J-3 glue 1986.7. (6) 7. Song Qixia a new Adhesive blocking agent passed the appraisal of People's Daily 1983.8.238. Tianxia Xiasheng Lu Yongshun rapid medical adhesive 508 series application manual China Science and Technology Literature Publishing House Beijing 1995.49. Zhou Huan comprehensively penetrated health report in various fields of clinical therapy 1990.1.1110. Xia Suisheng Zhang Yuwang Li Li 4th National Medical Adhesive Clinical Application Seminar Conference Minutes Chinese Journal of Surgery 1997.35.(8)11. Approved Medical Device Examined List China Medical Device Regulations Compilation of State Food and Drug Administration P246 2005.612. Xia Suisheng talks about medical gel treatment Xue Huimin, Song Jingmin, Li Yuehua, Fu Ailee Medical Adhesive Clinical Surgery, Clinical Surgery 2003.11.(1)14. Xia Suisheng Tianxia Lu Yongshun, New Generation Spraying Fuerle Medical Glue (Basic Research) Clinical Surgery Journal 2003.11.(2)15. Xia Suisheng Tian Xia Lu Yongshun New Generation Spraying Fu Aile Medical Glue (Clinical Application) Journal of Clinical Surgery 2003.11.(3)16. Wang Shubao Xu Huimian Wu Yunfei Fu Aile Medical Glue Covering Cancer Membrane Surface Clinical Report of Clinical Surgery 2003.11(4)17. Review of the application of Xi'an Leihujiang Lianglu medical glue in the treatment of spleen trauma Journal of Bed Surgery 2003 .11.518. Ma Haitao Qin Yong He Jing Kang Fu Aile Medical Glue Application in General Thoracic Surgery 2003.11.(6)19. Li Ming Liu Wei Liu Yingsong Spray-type Fu Aile Medical Glue Journal of Clinical Surgery, General Surgery, 2004.12. (2)20. Yang Jun, Yang Senfu, Philharmonic Medical Adhesive Plugging, Treatment of 10 Cases of Anal fistula, Clinical Surgery, 2004.12. (3) 21. Su Ying, Ma Lan, Yang Lihua, Modified Fascia 100 Cases of Clinical Surgery, 2004.12.(5)22. Wang Shubao, Xiaodong, Yao Fanfu, Ailee Medical Glue, Treatment of Major Hemorrhage after Pancreatic Duodenal Resection, Journal of Clinical Surgery, 2004.12.(7)23. Tianxia Lu Yongshun Spraying Fu Aile Medical glue performance and clinical application and endoscopic hemostasis 2004 CHINA MATERIALS BIOMATERIALS P66-69 BEIJNG CHINA 24. Wang Shubao Jin Feng Yao Fanfu Ailee Medical Glue Application in Pancreatectomy Clinical Surgery Journal 2004.12.(9)25. Li Shanquan Wanjie Qing Li Xiaoxiong Fu Ailee Medical Glue Clinical Application in the Dural Sealing of Posterior Cranial Surgery. Journal of Clinical Surgery 2004.12.926. Song Jiming Xu Hongchun Fu Ailee Medical Glue in Bronchial Journal of Clinical Surgery, Journal of Clinical Surgery, 2004.12.(11)27. Zhang Tao, Wang Jianhua, Wang Xiaoqiang, Fu Ailee Medical Glue, Application in the Treatment of Colon Cancer. Journal of Clinical Surgery 2004.12.(11)28. Li Mingzhang, Qi Haifeng, Yao Bihui, Fu Aile Medical Glucose for hemostasis in hepatectomy section. Journal of Clinical Surgery 2005.13.(2)29. Xie Fangping, Zhang Zonglin, Chen Jinchuan, Fu Aile Medical Gel, 120 Cases of Applied Clinical Surgery, 2005.13.(4)30. Zhang Shiming, Zhou Yifu, Aile Medical Application of Glue in Neurosurgery Clinical Surgery Journal 2005.13.(6)31. Wang Lina Zhao Chunyan Xing Lingling Fu Ailee Medical Glue Application in Laparoscopic Surgery Journal of Clinical Surgery 2005.13.(9)32. Zou Yiping Li Weimin Zheng Fang Abdominal Cavity Application of Fu Aile Medical Glue in Mirror Cholecystectomy Clinical Surgery Journal 2005.13.(9)33. Chinese Patent 01 233681534. Chinese Patent 2004 20077876835. Chinese Patent 87 1 03468936. Chinese Patent 86 1 07191337. Chinese Patent 02 1 57982238 Tian Xia Lu Yongshun Fu Ailee Medical Adhesive and Its Application, International Journal of Surgery, Vol. 33, No. 1, 2006, P74-79; Phase 2, P145-15139, Lin Gang, Ma Penglin Fan Shuangyifu Philharmonic Medical Glue Application in Nodular Goiter Resection Clinical Surgery Journal 2006.14.540 Zhu Yulan Fu Ailee Medical Glue Prevention and Treatment of Subcutaneous Hydronephrosis after Breast Cancer Surgery Journal of Clinical Surgery 2006.14.941 Yao Guozhong Huang or Wo Cold and bright acute inflammatory laparoscopic cholecystectomy in the application of Fu Aile medical glue clinical surgery journal 2006.14.11 from: 07 Boao International New Materials Forum excellent paper; chemical new material 35 volume 3 supplement P112-115
Pesticide generalized definition is used to prevent, eliminate or control hazards of agriculture, forestry disease, insect, grass and other harmful organisms and purposefully regulate, control, influence plant and harmful biological metabolism, growth, development, reproduction process of chemical synthesis or other natural products derived from biological, and application of biotechnology to produce a substance or a mixture of several substances and their preparations.In the narrow sense refers to the agricultural production, to protect and promote the growth of plants and crops, the use of insecticidal, sterilization, destroy harmful animals (or weeds) to a category of drugs.Especially used in pest control and regulating plant growth in agriculture, weeding, etc.
According to the sources of raw materials can be divided into organic chemicals, inorganic chemicals, pesticides, microbial pesticide plant.In addition, there are insects.According to the processing formulations can be divided into powder, wettable powder, soluble powder, cream, butter, concentrated emulsion, cream, paste, gel agent, smoke agent, fumigants, smoke agent, agent, granulation and particles, etc.Most is liquid or solid, is a gas.
Pesticide
Pesticides Rat Bait,Organic Pesticide,Mix Pesticide,Chemical Pesticides
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