A ready-to-use liquid oral gastric ultrasound contrast agent formula and preparation method

Abstract

The invention belongs to the technical field of medical ultrasonic diagnostic reagents and specifically relates to an instant oral liquid stomach ultrasonic developing agent formula and a preparationmethod of the developing agent. The ultrasonic developing agent is composed of a suspending thickening agent, a protective adhesive, an ultrasonic imaging granular matter, a de-foaming agent, a taste-modifying agent, a solvent, a preservative and water. The ultrasonic developing agent is capable of guaranteeing excellent ultrasonic imaging quality and greatly simplifying preparation and use processes. An instant oral liquid stomach ultrasonic developing agent with convenience in use is provided and is suitable for the clinic medical diagnosis of stomach ultrasonic developing.

Description

technical field [0001] The invention belongs to the technical field of medical ultrasonic diagnostic reagents, and in particular relates to a ready-to-use liquid oral gastric ultrasonic contrast agent formula and a preparation method thereof. Background technique [0002] Because gastroscopy is painful, not easy to popularize, and there is a risk of cross-infection, gastroscopy is not recommended by the World Health Organization as a way to screen gastric cancer. An important means of checking gastric cancer. In recent years, with the improvement of the resolution of ultrasonic instruments, gastric filling ultrasonography is expected to replace barium fluoroscopy and become an important method for large-scale physical examination and general screening of gastric cancer in thin people [see inventor Liu Zhijun’s paper, such as: GastricCancer.2018 Jan 25 .Preliminary opinion on assessment categories of stomach ultrasound report and data system(Su-RADS); Gastric Lesions:Demonst...

AI Technical Summary

Problems solved by technology

[0003] According to the echo characteristics of the contrast agent, it can be generally divided into two categories: anechoic ultrasound contrast agent and echogenic gastric ultrasound contrast agent: 1) anechoic gastric ultrasound contrast agent includes degassed water, traditional Chinese medicine defoaming agent (such as gastric rapid imaging Such as liquid and Huoxiangzhengqi water), etc., its biggest disadvantage is that there is no obvious echo contrast between anechoic contrast agent and hypoechoic gastric cancer and gastric ulcer, and the rate of missed diagnosis of lesions is high. It is no longer commonly used; 2) There are echo-type gastric ultrasound contrast agents, and the formulas that have been authorized for invention patents include traditional Chinese medicine formulas, food-type formulas, food-drug mixed formulas, chemical or other granular substances, etc.

其中第一大类中药型配方(专利公开号1142398A、1089866A、104189923A、101905001A、104189923B、105727321A、104740657A、1954888B、1977977A、1977977B、103083690A、103083690B、104436247A、105536004A、105056255A、103041410B、106075479A、107551281A、107551282A、 107551283A, etc.) have certain health-care and therapeutic effects on the stomach, but the ultrasound image shows that the effect is general, and the medicinal taste is often strong. application

The second largest category of minerals and other granular material formulas (such as patent publication numbers 87105799A, 1403160A, 1059600C, 105079829A, 107551283A, etc.), although the above patent constituent materials have stable particle sizes and are not easy to deteriorate, there are also the following shortcomings and deficiencies: 1 ) After taking the contrast agent mainly prepared from sea octopus fine powder, the gastric acid reaction is strong, and there is pain and discomfort, and this contrast agent cannot be used for patients with gastric bleeding; 2) The contrast agent prepared mainly from calcium carbonate powder can be Soluble in gastric acid, and easy to absorb and cause blood calcium to rise; 3) The developer mainly prepared by pearl powder belongs to a prescription drug, and its adverse drug reactions are not completely clear, and the dosage is often large, which limits its clinical application; 4) dilute Barium-based contrast agent Ultrasonic contrast agent has poor effect and is no longer used

Wherein, Patent Publication No. 105079829A discloses that its formula is composed of solid contrasting substance (calcium carbonate, microcrystalline cellulose, micronized silica gel or pearl powder), suspending agent (gum arabic or xanthan gum), stabilizer (maltodextrin), correction agent Flavoring agent (lemon flavor or stevioside) is formulated, and this patent also has following shortcoming and deficiency except having above-mentioned shortcoming: 1) suspending agent is xanthan gum in the patent, and dosage form is dry suspension, uses It is difficult to mix evenly before adding water; 2) The ultrasonic image effect of the formula of microcrystalline cellulose+xanthan gum is not very satisfactory, see applicant's initial screening experiment figure 2 As shown in E, the development quality of gastric ultrasound image is poor

[0004] Most of the currently commercialized gastric ultrasound contrast agents are food-based formulas. Although they are safe, cheap and widely used, there are still some shortcomings and deficiencies.

Among them, the "Xinzhang" brand gastric window acoustic contrast agent (patent publication No. 1030186A) produced by Hu Qingyutang in Hangzhou has the disadvantages of cumbersome brewing (the pulp needs to be mixed first and then brewed), easy to agglomerate and deposit, and the formation of light spots affects the ultrasound image.

"Tianxia" brand gastrointestinal ultrasound contrast agent produced by Huzhou Dongya Medical Supplies Co., Ltd. (patent publication No. 1073859C) and "Dongbeide" brand oral gastric ultrasound contrast agent produced by Beijing (Liaoyang) Zhongdao Aode Medical Equipment Co., Ltd. (Patent Publication No. 104707151A) There is also the cumbersome use of doctors to make brewed drinks (boiling water above 90°C is required for brewing, and the hot water temperature of ordinary water dispensers cannot reach it. After brewing in boiling water, it needs to be dried to a suitable oral temperature before taking ), easy to form spots and cause artifacts and other shortcomings (see attached image 3 h)

In addition, the current commercialized vegetable protein starch cellulose oral gastric ultrasound imaging agent has the following disadvantages and shortcomings that limit its widespread use: 1) The process of brewing and using is cumbersome, requiring boiling water above 90°C The temperature of the hot water cannot be reached), and it needs to be stirred quickly and for a long time, otherwise the developer will agglomerate and cannot form a uniform paste, and it will appear as a strong echo light group with a rear sound during ultrasound examination. Shadow (see attached figure 1 B), causing great interference to gastric ultrasound examination; after stirring, it needs to stand for about 1 hour before it can be reduced to a suitable drinking temperature, so the workload of medical staff is large, and it causes time inconvenience to the examinee, and the patient's compliance is poor ; 2) protein starch developer is easy to condense into agglomerates, corrupt and moldy, so it is difficult to be made into an easy-to-use liquid dosage form for production and sales

Images