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Ultrasonic contrast agent as well as preparation method and application thereof

A technology of ultrasound contrast agent and emulsion, which is applied in the field of medical ultrasound imaging diagnosis, can solve the problems of microbubble particle size and distribution, complex composition, complex preparation process, etc., achieve good clinical application prospects, simple preparation method, particle size Evenly distributed effect

Pending Publication Date: 2018-04-24
BEIJING KAILAI TIANCHENG MEDICINE TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

HyCoSy technology has achieved satisfactory results in the diagnosis of ovarian, intrauterine and fallopian tube lesions, but there are some problems in the existing ultrasound contrast agents at home and abroad: for example, the ultrasonic microbubble membrane material has complex components, many materials, and synthetic preparation. In the process, chloroform, tert-butanol and other harmful solvents are used, so it is necessary to select the membrane material and its configuration ratio to prepare more economical, effective, safe and easy-to-prepare microbubbles; the synthesis process is complex and the steps are cumbersome , Ultrasonic cavitation method, mechanical formulation method, freeze-drying method, repeated freeze-thaw method, etc., either the preparation process is relatively complicated, or the particle size and distribution of the prepared microbubbles are not ideal enough, and further improvement is needed; the film-like material layer that wraps the gas Too many liposomes in the blood vessel or cavity can not release the gas in time, thus affecting the effect of ultrasound

Method used

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  • Ultrasonic contrast agent as well as preparation method and application thereof
  • Ultrasonic contrast agent as well as preparation method and application thereof
  • Ultrasonic contrast agent as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] The preparation of embodiment 1 ultrasound contrast agent

[0020] Take the prescribed amount of DSPC, DSPG, Tween 60, PEG4000, and palmitic acid, add water to make a solution containing DSPC 0.5mg, DSPG 0.5mg, Tween 60 0.5mg, PEG4000 60.9mg, and palmitic acid 0.1mg per 1ml, as After adding the prescribed amount of chlorotrifluoromethane to the aqueous phase, shear and emulsify for 60 seconds to obtain an emulsion and sterilize it; take the emulsion, divide it into packages, and freeze-dry it to obtain a freeze-dried powder. When used, mix with normal saline and six The sulfur fluoride gas was thoroughly mixed to obtain a microbubble emulsion containing 10ml of gas and 62.5mg of lyophilized powder per 5ml of normal saline.

Embodiment 2

[0021] Embodiment 2 Preparation of ultrasound contrast agent

[0022] Take the prescribed amount of DPPC, DSPG, Span-80, PEG4000, and behenic acid, add water to make a solution containing DSPG 0.4mg, DPPC 0.6mg, Span-80 0.3mg, PEG4000 61.1mg, and behenic acid 0.1mg per 1ml, As the water phase, after adding the prescribed amount of perfluorobutene, shear and emulsify for 60s to obtain an emulsion, and sterilize it; take the emulsion, divide it into packages, and freeze-dry it to obtain a freeze-dried powder. When used, mix with normal saline and Sulfur hexafluoride was thoroughly mixed to obtain a microbubble emulsion containing 10ml of gas and 62.5mg of lyophilized powder per 5ml of normal saline.

Embodiment 3

[0023] Embodiment 3 Preparation of ultrasound contrast agent

[0024] Take prescription amount of DAPC, DAPG, Span-60, polybutyl-2-cyanoacrylate, palmitic acid, add water to make each 1ml contains DAPC 0.5mg, DAPG 0.5mg, Span-60 0.6mg, polybutyl- A solution of 60.8 mg of 2-cyanoacrylate and 0.1 mg of palmitic acid was used as the water phase. After adding the prescribed amount of perfluorocyclohexane, it was sheared and emulsified for 60 seconds to obtain an emulsion, which was sterilized; , carry out freeze-drying to obtain the freeze-dried powder, which is fully mixed with medicinal water and nitrogen gas to obtain a microbubble emulsion containing 10ml of gas and 62.5mg of freeze-dried powder per 5ml of normal saline.

[0025] Get the ultrasonic contrast agent prepared in embodiment 1-3 to carry out concrete detection, the result is as follows:

[0026] Average particle size and number of particles

[0027] The ultrasonic contrast agents (3 batches) of the present inventi...

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Abstract

The invention relates to an ultrasonic contrast agent as well as a preparation method and an application thereof in hystero-salpingography. A preparation of the ultrasonic contrast agent consists of three parts, namely freeze-dried powder, physiological saline and active gas; when the ultrasonic contrast agent is used, the three parts are mixed, so that an emulsion that the bio-active gas is covered in the freeze-dried powder is formed; the proportion of the prepared emulsion is 10ml of gas and 62.5mg of a freeze-dried matrix in terms of 5ml of the physiological saline, wherein the freeze-dried matrix consists of 0.1-5wt% of phospholipid, 0.01-0.05wt% of a surfactant, 0.1-1wt% of a film-forming stabilizing agent and the balance of a freeze-drying protective additive. With the application of the formula, a film-forming material can conduct emulsifying well; generated bubbles are uniform in granularity, the number can reach 108 bubbles / ml, and the bubbles cannot get broken easily and canexist in vivo for a relatively long time; the ultrasonic contrast agent is applicable to the hystero-salpingography; and the hystero-salpingography, which makes use of the ultrasonic contrast agent,is free from irritation to mucous membranes and is free from harm to human bodies.

Description

technical field [0001] The invention relates to a medical ultrasonic contrast agent, a preparation method thereof, and an application thereof for hysterosalpingography, belonging to the field of medical ultrasonic image diagnosis. Background technique [0002] Ultrasound contrast agent (UCA) is a kind of diagnostic agent that can significantly enhance the signal of medical ultrasound detection. It has incomparable advantages in the detection and imaging of human microvascular and tissue perfusion. . Microbubbles are considered to be the best imaging materials in human microvessels because of their strong echo reflection properties. Ideally, UCA can be used as a blood cell tracer distributed throughout the body with the blood flow; it can reflect the blood perfusion of organs without interfering with hemodynamics. This blood cell tracing technique has broad application prospects in the ultrasonic diagnosis of myocardium, liver and kidney. Research data in recent years show...

Claims

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Application Information

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IPC IPC(8): A61K49/22
CPCA61K49/223
Inventor 刘素云狄忠冯朴纯黄巧萍
Owner BEIJING KAILAI TIANCHENG MEDICINE TECH CO LTD
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