WO2015027752A1 - Agent de couplage ultrasonore médical antibactérien et procédé de préparation de celui-ci - Google Patents

Agent de couplage ultrasonore médical antibactérien et procédé de préparation de celui-ci Download PDF

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Publication number
WO2015027752A1
WO2015027752A1 PCT/CN2014/081587 CN2014081587W WO2015027752A1 WO 2015027752 A1 WO2015027752 A1 WO 2015027752A1 CN 2014081587 W CN2014081587 W CN 2014081587W WO 2015027752 A1 WO2015027752 A1 WO 2015027752A1
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WO
WIPO (PCT)
Prior art keywords
coupling agent
raw materials
triethanolamine
quaternary ammonium
ammonium salt
Prior art date
Application number
PCT/CN2014/081587
Other languages
English (en)
Chinese (zh)
Inventor
李文亮
李玉新
孙陆果
鲍永利
石晶
王春红
石卫东
Original Assignee
长春东北师大基因工程有限公司
东北师范大学
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 长春东北师大基因工程有限公司, 东北师范大学 filed Critical 长春东北师大基因工程有限公司
Priority to KR1020167008027A priority Critical patent/KR101990185B1/ko
Publication of WO2015027752A1 publication Critical patent/WO2015027752A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00—Preparations for testing in vivo
    • A61K49/22—Echographic preparations; Ultrasound imaging preparations ; Optoacoustic imaging preparations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00—Preparations for testing in vivo
    • A61K49/001—Preparation for luminescence or biological staining
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00—Preparations for testing in vivo
    • A61K49/22—Echographic preparations; Ultrasound imaging preparations ; Optoacoustic imaging preparations
    • A61K49/222—Echographic preparations; Ultrasound imaging preparations ; Optoacoustic imaging preparations characterised by a special physical form, e.g. emulsions, liposomes

Definitions

  • the invention relates to an antibacterial medical ultrasonic coupling agent, and the invention further provides a preparation method of the coupling agent, which belongs to the technical field of reagents for medical examination.
  • B-ultrasound is a widely used test instrument in clinical practice.
  • the medical ultrasonic coupling agent used in medical examination is applied to the skin of the detection site to eliminate the air between the instrument probe and the skin. Therefore, the ultrasonic coupling agent is required to have the characteristics of easy coating, easy removal, no stimuli, moderate consistency, and no damage to the instrument probe.
  • the ultrasonic couplant During the use of the ultrasonic couplant, cross-contamination of skin diseases occurs, especially in the case of skin invasiveness and cross-infection of ultrasound examination when in contact with mucous membranes.
  • the product is “cytotoxic, non-sensitizing and non-irritating to the skin under short-term (24h) contact conditions.”
  • China's “Disinfection Management” Article 6 requires that medical devices and equipment that meet skin and mucous membranes must meet disinfection requirements to prevent and reduce the chance of hospital infections.
  • the antibacterial agents are mainly chlorhexidine acetate, povidone iodine, chlorhexidine iodine, p-chloro-xylenol, benzalkonium bromide and the like.
  • these antibacterial agents are not biocompatible and have experienced skin irritation or allergic reactions during use; on the other hand, these antibacterial agents are not biodegradable, once infiltrated during use or due to improper handling When entering the body, it will stay in the body for a long time without being metabolized, resulting in certain toxic side effects.
  • the invention provides an antibacterial medical ultrasonic coupling agent, which has the characteristics of good biocompatibility, biodegradability, simple process, low cost and stable performance.
  • the present invention still further provides a method for preparing an antibacterial medical ultrasonic coupling agent, which is suitable for industrial production.
  • the invention provides an antibacterial medical ultrasonic coupling agent which is prepared by weighting the following raw materials: carbomer 1%, triethanolamine 0.6%, polyethyleneimine quaternary ammonium salt (1 ⁇ 2) % , PEG (1 ⁇ 2) %, methylene blue (0. 05 ⁇ 0. 1 ) %, fragrance 0. 02%, the balance is distilled water.
  • the preparation method of the antibacterial medical ultrasonic coupling agent of the invention comprises the following steps:
  • the viscosity of the product of the invention is between 15.4 and 24.4 Pa.s, the consistency is suitable, the coating performance is good, the biocompatibility is good, the biodegradability is good, and the skin is not stimulated, and the sound attenuation is 0.193 to 0.246 dB.cm- ⁇ ⁇ - 1 , the sound attenuation is small, the sound guiding performance is good, the image is clear, and it can be antibacterial.
  • the polyethyleneimine quaternary ammonium salt with antibacterial agent has good biocompatible phase and biodegradability, no skin irritation, and wide antibacterial spectrum, which greatly reduces the use of ultrasonic couplant during use. Possible cross-infection problems.
  • Example 1 The physical and chemical properties of Example 1 are shown in Table 1, and the results showed that the viscosity was suitable and the sound attenuation was small.
  • the couplant of Example 1 was tested for clinical application, and the results showed that the couplant was easy to coat, has good slidability, no damage to the ultrasonic probe, and no stimulation to the skin.
  • the coupling of the couplant of Example 1 to the ultrasonic probe and the skin The effect is good and the image obtained is clear.
  • Example 2 The physical and chemical properties of Example 2 are shown in Table 2, and the results showed that the viscosity was suitable and the sound attenuation was small.
  • the couplant of Example 2 was tested for clinical application, and the results showed that the couplant was easy to coat, has good slidability, no damage to the ultrasonic probe, and no stimulation to the skin.
  • the coupling of the couplant of Example 2 to the ultrasonic probe and the skin The effect is good and the image obtained is clear.
  • Example 3 The physical and chemical properties of Example 3 are shown in Table 3, and the results showed that the viscosity was suitable and the sound attenuation was small.
  • the couplant of Example 3 was tested for clinical application, and the results showed that the couplant was easy to coat and had good slidability. There is no damage to the ultrasonic probe and no stimulation to the skin.
  • the coupling agent of the embodiment 3 has a good coupling effect on the ultrasonic probe and the skin, and the obtained image is clear.
  • Example 4 The physical and chemical properties of Example 4 are shown in Table 4, and the results showed that the viscosity was suitable and the sound attenuation was small.
  • the couplant of Example 4 was tested for clinical application, and the results showed that the couplant was easy to coat, has good slidability, no damage to the ultrasonic probe, and no stimulation to the skin.
  • the coupling of the couplant of Example 4 to the ultrasonic probe and the skin The effect is good and the image obtained is clear.
  • Example 5 The physical and chemical properties of Example 5 are shown in Table 5. The results showed that the viscosity was suitable and the sound attenuation was small.
  • the couplant of Example 5 was tested for clinical application, and the results showed that the couplant was easy to coat, no damage to the ultrasonic probe, and no stimulation to the skin.
  • the coupling agent of Example 5 had a good coupling effect on the ultrasonic probe and the skin. The images obtained are clear.
  • Example 6 The physical and chemical properties of Example 6 are shown in Table 6, and the results showed that the viscosity was suitable and the sound attenuation was small.
  • the couplant of Example 6 was tested for clinical application, and the results showed that the couplant was easy to coat, no damage to the ultrasonic probe, and no stimulation to the skin, and the coupling agent of Example 6 had a good coupling effect on the ultrasonic probe and the skin.
  • the images obtained are clear.
  • the antibacterial effect of the antibacterial medical ultrasonic coupling agent prepared by the present invention was examined and compared with the products on the market.
  • Siemens ACUS0N X150 ultrasonic diagnostic system antibacterial ultrasonic coupling agent prepared by the invention, Changchun Xingshi antibacterial ultrasonic coupling agent, sound friend brand medical antibacterial disinfection type ultrasonic coupling agent, 5cmX 5cm sterilization specification plate, sterile washing Deliquoring, cotton swabs, saline, nutrient agar medium, distilled water.
  • Example 1 The method used in this experiment is strictly implemented in accordance with the "Sanitary Standard for Sanitary Hygiene Products GB15979-1995". The specific experimental method will be described below by taking Example 1 as an example. Different ratios of the ultrasonic coupling agents prepared in the examples were subjected to ultrasonic examination.
  • the abdominal skin was first sampled as a control; after the ultrasonic examination was applied for 1 hour, the skin of the same abdominal examination area was sampled again.
  • the sampling method is carried out in accordance with the "Technical Disinfection Technical Specification - 2012 Edition", specifically: using a 5cmX 5cm sterilized specification plate, placed on the skin to be inspected, and immersed in cotton with a sterile eluate containing the corresponding neutralizing agent. 1 swab, rub it evenly in the specification plate for 5 times, and then rotate the cotton swab. After cutting the hand contact area, put the cotton swab into 200mL sterile saline, mix well and get A saline solution, for testing.
  • the examples 2 to 6 the Changchun Xingshi bacteriostatic ultrasonic coupling agent and the vocal brand antibacterial disinfection type ultrasonic coupling agent were respectively tested.
  • the test results are shown in Table 7, for the skin to be examined.
  • the number of colonies after 1 hour of ultrasound examination was much lower than the number of colonies before ultrasound examination, indicating that the various ratios of ultrasonic coupling agents prepared in Example 1 and the two marketed ultrasonic coupling agents have excellent antibacterial properties. effect.
  • Ultrasound examination was performed using the ultrasonic coupling agent of the present example, and the number of colonies after ultrasonic examination for 1 hour was between 64 and 88 cfu/mL, and two commercially available products were used for ultrasonic examination, one hour after the ultrasonic examination. The number of colonies is greater than 90 cfu/mL, indicating that the antibacterial medical ultrasonic coupling agent of the present invention has a better antibacterial effect.

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  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Radiology & Medical Imaging (AREA)
  • Acoustics & Sound (AREA)
  • Physics & Mathematics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Preparation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Ultra Sonic Daignosis Equipment (AREA)

Abstract

La présente invention concerne un agent de couplage ultrasonore médical antibactérien et un procédé de préparation de celui-ci, le pourcentage en poids des matières premières de celui-ci étant : 1 à 2 % de sel d'ammonium quaternaire de polyéthylénimine, 1 à 2 % de polyéthylène glycol, 0,05 à 0,1 % de bleu de méthylène, et le complément étant de l'eau distillée ; le procédé de préparation comprend les étapes suivantes : mélange proportionnel des différentes matières premières avec de l'eau ; puis agitation du mélange sous chauffage pour dissoudre et gonfler les matières premières ; et finalement élimination des bulles par décompression sous vide pour obtenir un produit de gel bleu clair.
PCT/CN2014/081587 2013-08-26 2014-07-03 Agent de couplage ultrasonore médical antibactérien et procédé de préparation de celui-ci WO2015027752A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
KR1020167008027A KR101990185B1 (ko) 2013-08-26 2014-07-03 항균성 의료용 초음파 커플링제 및 이의 제조방법

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201310374372.6 2013-08-26
CN201310374372.6A CN103432600B (zh) 2013-08-26 2013-08-26 一种抗菌型医用超声耦合剂及其制备方法

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WO2015027752A1 true WO2015027752A1 (fr) 2015-03-05

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KR (1) KR101990185B1 (fr)
CN (1) CN103432600B (fr)
WO (1) WO2015027752A1 (fr)

Cited By (3)

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Publication number Priority date Publication date Assignee Title
CN112741671A (zh) * 2019-10-29 2021-05-04 王强 一种体外冲击波碎石用能量介导液及其制备方法
CN112891567A (zh) * 2021-01-29 2021-06-04 陈卫东 一种乳化剂
CN117085151A (zh) * 2023-10-18 2023-11-21 吉林省海卓生物科技有限公司 一种超声耦合贴片及其制备方法和应用

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CN104208726B (zh) * 2014-02-28 2017-02-08 潍坊医学院 一种壳聚糖季铵盐耦合剂及其制备方法
JP6130538B1 (ja) * 2016-03-04 2017-05-17 伯東株式会社 超音波伝達効率向上組成物、超音波診断用ゲル組成物及び超音波撮影方法
CN105832652A (zh) * 2016-05-13 2016-08-10 沈阳赛镝医疗器械有限公司 超声耦合剂中介媒质
CN106039330A (zh) * 2016-06-16 2016-10-26 吉林医药学院 一种含中药成分的抗菌型医用超声耦合剂及其制备方法
CN107648621B (zh) * 2017-10-26 2018-11-27 广州华大生物科技有限公司 一种超声波探头耦合剂的辐照制备方法

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112741671A (zh) * 2019-10-29 2021-05-04 王强 一种体外冲击波碎石用能量介导液及其制备方法
CN112891567A (zh) * 2021-01-29 2021-06-04 陈卫东 一种乳化剂
CN117085151A (zh) * 2023-10-18 2023-11-21 吉林省海卓生物科技有限公司 一种超声耦合贴片及其制备方法和应用
CN117085151B (zh) * 2023-10-18 2024-02-23 吉林省海卓生物科技有限公司 一种超声耦合贴片及其制备方法和应用

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Publication number Publication date
KR20160046907A (ko) 2016-04-29
CN103432600A (zh) 2013-12-11
KR101990185B1 (ko) 2019-06-17
CN103432600B (zh) 2015-01-28

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