CN110251694B - Gastrointestinal ultrasonic contrast agent and preparation method thereof - Google Patents
Gastrointestinal ultrasonic contrast agent and preparation method thereof Download PDFInfo
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Abstract
The invention provides a gastrointestinal ultrasonic contrast agent, which is prepared from the following raw materials in parts by weight: 40-70 parts of wheat flour, 15-30 parts of black sesame, 5-18 parts of lotus root and 1-10 parts of bletilla striata. The gastrointestinal ultrasonic contrast agent has fine particles, simple and convenient modulation, no water or solute layering, no light spot formation to cause artifact, extremely high ultrasonic resolution, and clear obtained ultrasonic image, and is more beneficial to clinical diagnosis. Meanwhile, the tuber of the traditional Chinese medicine bletilla striata contains mucus, starch and the like, can be used as paste and also can be used as medicine, has medicine and food dual purposes, and has a certain effect of protecting hemorrhagic ulcer gastric mucosa.
Description
Technical Field
The invention belongs to the technical field of medical supplies, and particularly relates to a gastrointestinal ultrasound contrast agent and a preparation method thereof.
Background
Imaging examination of gastrointestinal diseases has been mainly performed by gastroscopy, barium meal fluoroscopy and CT, and the application of ultrasound in the gastrointestinal tract is limited due to the interference of gas and contents in the gastrointestinal tract. The appearance of contrast agents for gastrointestinal ultrasound breaks this situation and makes gastrointestinal ultrasound examinations possible. At present, among the gastrointestinal ultrasound contrast agent products used in clinical practice, representative are: the patent of gastrointestinal color ultrasonic contrast agent (patent application No. CN1403160) applied by Jade nepheline and the patent of gastrointestinal color ultrasonic contrast agent (patent application No. CN1535730) applied by Zhang Dong, as well as the acoustic contrast agent of "Heart Jade tablet" brand stomach window produced by Houqingyutang of Zhejiang province and the "Tianxia" brand gastrointestinal ultrasonic auxiliary contrast agent produced by east Asia medical supplies Limited company of Huzhou city. The contrast agents described in the first two patent applications are prepared from traditional Chinese medicines, although they have certain health care and treatment effects, the ultrasonic images have common display effects, and the modulation method is complex and tedious, and the diagnostic effect is affected by artifacts caused by slight attention or modulation difficulty. The gastrointestinal ultrasonic imaging assistant under the name of Tianxia has the defects of large particles, nonuniform echo, easy layering of water and contrast agent solute, light spots formed, artifact and the like, thereby influencing the diagnostic effect of the gastrointestinal ultrasonic imaging assistant. The 'heart jade' brand acoustic contrast agent for the gastric window also has the defects of complicated soaking, easy caking and deposition, light spot formation, influence on diagnosis and the like. Therefore, the imaging diagnosis effect of the current gastrointestinal ultrasonic contrast agent has certain problems.
Disclosure of Invention
In order to solve the problems, the invention provides a gastrointestinal ultrasound contrast agent and a preparation method thereof.
The invention provides a gastrointestinal ultrasonic contrast agent, which is prepared from the following raw materials in parts by weight: 40-70 parts of wheat flour, 15-30 parts of black sesame, 5-18 parts of lotus root and 1-10 parts of bletilla striata.
Further, the gastrointestinal ultrasound contrast agent is prepared from the following raw materials in parts by weight: 60 parts of wheat flour, 25 parts of black sesame, 10 parts of lotus root and 5 parts of bletilla striata;
or 50 parts of wheat flour, 20 parts of black sesame, 15 parts of lotus root and 5 parts of bletilla striata.
Further, the wheat flour is obtained by parching wheat, pulverizing, and sieving with 100 mesh sieve; the black sesame is powder obtained by stir-frying the black sesame, crushing and sieving with a 100-mesh sieve; the lotus root is powder obtained by steaming, crushing and sieving with a 100-mesh sieve; the bletilla striata is powder obtained by boiling the bletilla striata until no white heart exists, crushing the bletilla striata and sieving the powder with a 100-mesh sieve.
Further, after being fried, the wheat is crushed into yellow by being fried by slow fire, cooled and crushed; the black sesame is fried and crushed, fried for 3 to 5 minutes by slow fire, cooled and crushed; the lotus root is steamed and then crushed, and then is dried and crushed; the preparation method comprises decocting rhizoma Bletillae to no white core, pulverizing, sun drying, removing outer skin, and pulverizing.
Furthermore, the gastrointestinal ultrasound contrast agent is prepared by mixing the raw materials in the weight ratio and adding pharmaceutically acceptable auxiliary materials or auxiliary components.
Further, the contrast agent is a powder type contrast agent, a particle type contrast agent or a solvent type contrast agent.
The invention also provides a preparation method of the gastrointestinal ultrasonic contrast agent, which comprises the following steps: weighing the raw materials in the weight ratio, mixing the raw materials, and adding pharmaceutically acceptable auxiliary materials or auxiliary components to prepare the composition.
Further, the preparation method comprises the following steps:
weighing the raw materials in the weight ratio, directly and uniformly mixing the raw materials, sterilizing and packaging to obtain the product;
or weighing the raw materials in the weight ratio, uniformly mixing the raw materials, drying, performing puffing treatment to obtain granules, finishing granules, sterilizing and packaging to obtain the feed additive;
or weighing the raw materials in the weight ratio, uniformly mixing the raw materials, adding 5 times (v/w) of water, uniformly stirring, sterilizing and packaging to obtain the traditional Chinese medicine composition.
Further, the sterilization is high temperature sterilization.
In the invention, v/w is mL/g and represents a volume-to-mass ratio.
The gastrointestinal ultrasonic contrast agent has fine particles, simple and convenient modulation, no water or solute layering, no light spot formation to cause artifact, extremely high ultrasonic resolution, and clear obtained ultrasonic image, and is more beneficial to clinical diagnosis. Meanwhile, the tuber of the traditional Chinese medicine bletilla striata contains mucus, starch and the like, can be used as paste and also can be used as medicine, has medicine and food dual purposes, and has a certain effect of protecting hemorrhagic ulcer gastric mucosa.
Obviously, many modifications, substitutions, and variations are possible in light of the above teachings of the invention, without departing from the basic technical spirit of the invention, as defined by the following claims.
The present invention will be described in further detail with reference to the following examples. This should not be understood as limiting the scope of the above-described subject matter of the present invention to the following examples. All the technologies realized based on the above contents of the present invention belong to the scope of the present invention.
Detailed Description
The raw materials and equipment used in the embodiment of the present invention are known products and obtained by purchasing commercially available products.
EXAMPLE 1 preparation of ultrasound contrast Agents of the invention
60g of wheat, 25g of black sesame, 10g of lotus root and 5g of bletilla are weighed according to the proportion. Placing clean wheat in a frying container, frying with slow fire to yellow, taking out when the wheat is not sticky, cooling, pulverizing, grinding, and sieving with 100 mesh sieve to obtain fine powder; putting clean black sesame into a stir-frying container, stir-frying with slow fire for 3-5 minutes, taking out when the black sesame is not sticky, cooling, crushing, grinding, and sieving with a 100-mesh fine sieve to obtain fine powder for later use; cleaning rhizoma Nelumbinis, slicing, steaming, sun drying, pulverizing, and sieving with 100 mesh sieve to obtain fine powder; decocting rhizoma Bletillae in boiling water, sun drying, removing outer skin, pulverizing, and sieving with 100 mesh sieve to obtain fine powder; mixing the above fine powders, sterilizing at high temperature, and packaging according to the standard of 50 g/bag to obtain powder type gastrointestinal ultrasound contrast agent.
EXAMPLE 2 preparation of the ultrasound contrast agent for gastrointestinal tract of the invention
60g of wheat, 25g of black sesame, 10g of lotus root and 5g of bletilla are weighed according to the proportion. Placing clean wheat in a frying container, frying with slow fire to yellow, taking out when the wheat is not sticky, cooling, pulverizing, grinding, and sieving with 100 mesh sieve to obtain fine powder; putting clean black sesame into a stir-frying container, stir-frying with slow fire for 3-5 minutes, taking out when the black sesame is not sticky, cooling, crushing, grinding, and sieving with a 100-mesh fine sieve to obtain fine powder for later use; cleaning rhizoma Nelumbinis, slicing, steaming, sun drying, pulverizing, and sieving with 100 mesh sieve to obtain fine powder; decocting rhizoma Bletillae in boiling water, sun drying, removing outer skin, pulverizing, and sieving with 100 mesh sieve to obtain fine powder; mixing the above fine powders, drying, puffing to obtain granule, grading, sterilizing at high temperature, and packaging according to 50 g/bag to obtain granule type gastrointestinal ultrasonic contrast agent.
EXAMPLE 3 preparation of the ultrasound contrast agent for gastrointestinal tract of the invention
60g of wheat, 25g of black sesame, 10g of lotus root and 5g of bletilla are weighed according to the proportion. Placing clean wheat in a frying container, frying with slow fire to yellow, taking out when the wheat is not sticky, cooling, pulverizing, grinding, and sieving with 100 mesh sieve to obtain fine powder; putting clean black sesame into a stir-frying container, stir-frying with slow fire for 3-5 minutes, taking out when the black sesame is not sticky, cooling, crushing, grinding, and sieving with a 100-mesh fine sieve to obtain fine powder for later use; cleaning rhizoma Nelumbinis, slicing, steaming, sun drying, pulverizing, and sieving with 100 mesh sieve to obtain fine powder; decocting rhizoma Bletillae in boiling water, sun drying, removing outer skin, pulverizing, and sieving with 100 mesh sieve to obtain fine powder; and uniformly mixing the fine powder, then putting the powder type gastrointestinal ultrasound contrast agent into a container according to the parts (50 g/bag), adding 500ml of aqueous solution, fully and uniformly stirring, sterilizing at high temperature, and packaging to obtain the solvent type gastrointestinal ultrasound contrast agent.
Example 4 preparation of gastrointestinal ultrasound contrast Agents of the invention
Weighing 50g of wheat, 20g of black sesame, 15g of lotus root and 5g of bletilla striata according to a proportion. Placing clean wheat in a frying container, frying with slow fire to yellow, taking out when the wheat is not sticky, cooling, pulverizing, grinding, and sieving with 100 mesh sieve to obtain fine powder; putting clean black sesame into a stir-frying container, stir-frying with slow fire for 3-5 minutes, taking out when the black sesame is not sticky, cooling, crushing, grinding, and sieving with a 100-mesh fine sieve to obtain fine powder for later use; cleaning rhizoma Nelumbinis, slicing, steaming, sun drying, pulverizing, and sieving with 100 mesh sieve to obtain fine powder; decocting rhizoma Bletillae in boiling water, sun drying, removing outer skin, pulverizing, and sieving with 100 mesh sieve to obtain fine powder; mixing the above fine powders, sterilizing at high temperature, and packaging according to the standard of 50 g/bag to obtain powder type gastrointestinal ultrasound contrast agent.
EXAMPLE 5 preparation of the ultrasound contrast agent for gastrointestinal tract of the invention
Weighing 50g of wheat, 20g of black sesame, 15g of lotus root and 5g of bletilla striata according to a proportion. Placing clean wheat in a frying container, frying with slow fire to yellow, taking out when the wheat is not sticky, cooling, pulverizing, grinding, and sieving with 100 mesh sieve to obtain fine powder; parching clean semen Sesami Niger with slow fire for 3-5 min, taking out when it is not sticky, cooling, pulverizing, grinding, and sieving with 100 mesh sieve to obtain fine powder; cleaning rhizoma Nelumbinis, slicing, steaming, sun drying, pulverizing, and sieving with 100 mesh sieve to obtain fine powder; decocting rhizoma Bletillae in boiling water, sun drying, removing outer skin, pulverizing, and sieving with 100 mesh sieve to obtain fine powder; mixing the above fine powders, drying, puffing to obtain granule, grading, sterilizing at high temperature, and packaging according to 50 g/bag to obtain granule type gastrointestinal ultrasonic contrast agent.
EXAMPLE 6 preparation of the ultrasound contrast agent for gastrointestinal tract of the invention
Weighing 50g of wheat, 20g of black sesame, 15g of lotus root and 5g of bletilla striata according to a proportion. Placing clean wheat in a frying container, frying with slow fire to yellow, taking out when the wheat is not sticky, cooling, pulverizing, grinding, and sieving with 100 mesh sieve to obtain fine powder; putting clean black sesame into a stir-frying container, stir-frying with slow fire for 3-5 minutes, taking out when the black sesame is not sticky, cooling, crushing, grinding, and sieving with a 100-mesh fine sieve to obtain fine powder for later use; cleaning rhizoma Nelumbinis, slicing, steaming, sun drying, pulverizing, and sieving with 100 mesh sieve to obtain fine powder; decocting rhizoma Bletillae in boiling water, sun drying, removing outer skin, pulverizing, and sieving with 100 mesh sieve to obtain fine powder; and uniformly mixing the fine powder, then putting the powder type gastrointestinal ultrasound contrast agent into a container according to the parts (50 g/bag), adding 500ml of aqueous solution, fully and uniformly stirring, sterilizing at high temperature, and packaging to obtain the solvent type gastrointestinal ultrasound contrast agent.
The advantageous effects of the present invention are demonstrated by specific test examples below.
Test example 1 examination of the ultrasonic image display effect of the gastrointestinal ultrasonic contrast agent of the present invention
The ultrasonic contrast agent prepared in example 1 is prepared into paste by 500ml of warm water at 37 ℃, is administered to a patient to be subjected to gastrointestinal ultrasonic contrast, is orally taken for 200ml at one time, is immediately subjected to ultrasonic examination after being taken, and is increased in contrast agent amount according to the gastrointestinal filling condition, wherein the maximum dosage is not more than 500 ml. Clinical ultrasonic image shows that the stomach cavity has good and uniform sound transmission, the contrast of the 5-layer structure of the stomach wall with three bright surfaces and two dark surfaces is clear, and the developing effect is good.
Test example 2 contrast of ultrasonic image display effect of gastrointestinal ultrasonic contrast agent
Test groups: the gastrointestinal ultrasound contrast agent prepared in example 1 of the present invention.
Control group: the gastrointestinal ultrasound contrast agent is prepared from 40g of wheat, 15g of black sesame, 10g of lotus root and 5g of bletilla striata according to the preparation method of the example 1.
Healthy college students are used as test objects, male and female are not limited, the age is 10-23 years, 50 cases of the control group and the test group respectively take stomach cavity sound transmission and display of the structure of the stomach wall with three bright and two dark as targets, and the imaging effects of different proportions are compared. In the aspect of clearly displaying the 5-layer structure of the stomach wall, 36 cases are clearly displayed in a control group, 47 cases are clearly displayed in a test group, and the test group is superior to the control group (p is less than 0.05); in the aspect of the sound transmission of the gastric cavity, the sound transmission of a control group is good and uniform for 33 cases, the sound transmission of a test group is good and uniform for 46 cases, and the test group is superior to the control group (p is less than 0.05).
Test example 3 contrast of ultrasonic image display effect of gastrointestinal ultrasonic contrast agent
Test groups: the gastrointestinal ultrasound contrast agent prepared in example 5 of the present invention.
Control group: the raw material is 90g of black sesame, and the gastrointestinal ultrasound contrast agent is prepared according to the preparation method of the example 5.
Healthy college students are used as test objects, male and female are not limited, the age is 10-23 years, 50 cases of the control group and the test group respectively take stomach cavity sound transmission and display of the structure of the stomach wall, namely three bright and two dark as targets, and the imaging effects of the control group and the test group are compared. In the aspect of clearly displaying the 5-layer structure of the stomach wall, 5 cases are clearly displayed in a control group, 46 cases are clearly displayed in a test group, and the test group is superior to the control group (p is less than 0.05); in the aspect of the sound transmission of the gastric cavity, 4 cases of the control group have good and uniform sound transmission, 48 cases of the test group have good and uniform sound transmission, and the test group is superior to the control group (p is less than 0.05).
Test example 4 contrast of ultrasonic image display effect of gastrointestinal ultrasonic contrast agent
In order to further verify the effect of the gastrointestinal ultrasonic contrast agent, a control test with a gastrointestinal ultrasonic contrast agent of the brand of "Tianxia" manufactured by east Asia medical supplies, Inc. in Huzhou is set up. Patients who need gastrointestinal ultrasound in gastrointestinal outpatient service of subsidiary hospitals of Shaanxi Chinese medicine university from 2 months to 3 months in 2018 are randomly divided into 2 groups, the first group and the second group are 235 persons, the baseline conditions such as age, sex, weight and the like have no statistical difference (p is more than 0.05), and the imaging and diagnosis effects of two gastrointestinal ultrasound contrast agents are compared by taking gastroscopy or pathology as a gold standard. The group A takes the ultrasonic contrast agent prepared in the embodiment 1 of the invention, the group B takes the contrast group 'Tianxia' brand gastrointestinal ultrasonic contrast agent, and the two groups of contrast agents take the dosage which is the optimal dosage of the contrast effect of the contrast agent. In the aspect of clearly displaying the 5-layer structure of the stomach wall, 221 cases of contrast agents and 207 cases of contrast agents under the brand of 'Tian Xia' are clearly displayed, and the contrast agents are superior to the contrast agents under the brand of 'Tian Xia' (p is less than 0.05); in the aspect of diagnosing gastric ulcer, 43 cases of contrast agent diagnoses and 35 cases of contrast agent diagnoses under the brand of 'Tian Xian', the contrast agent is superior to the contrast agent under the brand of 'Tian Xian' (p is less than 0.05).
The test result shows that the imaging effect of the gastrointestinal ultrasonic contrast agent prepared by the invention is greatly improved, the contrast agent is superior to the gastrointestinal ultrasonic contrast agent in the prior art, and the obtained ultrasonic image is clearer and is more beneficial to clinical diagnosis.
In conclusion, the gastrointestinal ultrasonic contrast agent disclosed by the invention is fine in particles, simple and convenient to modulate, free of water and solute layering, free of light spot to cause artifact, extremely high in ultrasonic resolution, and very clear in obtained ultrasonic image, and more beneficial to clinical diagnosis. Meanwhile, the tuber of the traditional Chinese medicine bletilla striata contains mucus, starch and the like, can be used as paste and also can be used as medicine, has medicine and food dual purposes, and has a certain effect of protecting hemorrhagic ulcer gastric mucosa.
Claims (8)
1. A gastrointestinal ultrasound contrast agent characterized by: the composition is prepared from the following raw materials in parts by weight: 40-70 parts of wheat flour, 15-30 parts of black sesame, 5-18 parts of lotus root and 1-10 parts of bletilla striata; the wheat flour is obtained by stir-frying wheat, pulverizing, and sieving with 100 mesh sieve; the black sesame is powder obtained by stir-frying the black sesame, crushing and sieving with a 100-mesh sieve; the lotus root is powder obtained by steaming, crushing and sieving with a 100-mesh sieve; the bletilla striata is powder obtained by boiling the bletilla striata until no white heart exists, crushing the bletilla striata and sieving the powder with a 100-mesh sieve.
2. The contrast agent for gastrointestinal ultrasound according to claim 1, wherein: the composition is prepared from the following raw materials in parts by weight: 60 parts of wheat flour, 25 parts of black sesame, 10 parts of lotus root and 5 parts of bletilla striata;
or 50 parts of wheat flour, 20 parts of black sesame, 15 parts of lotus root and 5 parts of bletilla striata.
3. The gastrointestinal ultrasound contrast agent according to claim 1, wherein: the wheat is fried and crushed, fried to yellow with slow fire, cooled and crushed; the black sesame is fried and crushed, fried for 3 to 5 minutes by slow fire, cooled and crushed; the lotus root is steamed and then crushed, and then is dried and crushed; the preparation method comprises decocting rhizoma Bletillae to no white core, pulverizing, sun drying, removing outer skin, and pulverizing.
4. The contrast agent for gastrointestinal ultrasound according to claim 1 or 2, characterized in that: the contrast agent is prepared by mixing the raw materials in the weight ratio and adding pharmaceutically acceptable auxiliary materials.
5. The contrast agent for gastrointestinal ultrasound according to claim 4, wherein: the contrast agent is a powder type contrast agent, a particle type contrast agent or a solvent type contrast agent.
6. A method for preparing the gastrointestinal ultrasound contrast agent according to any one of claims 1 to 5, wherein: it comprises the following steps: weighing the raw materials in the weight ratio, mixing the raw materials, and adding pharmaceutically acceptable auxiliary materials to prepare the traditional Chinese medicine composition.
7. The method of claim 6, wherein: it comprises the following steps:
weighing the raw materials in the weight ratio, directly and uniformly mixing the raw materials, sterilizing and packaging to obtain the product;
or weighing the raw materials in the weight ratio, uniformly mixing the raw materials, drying, performing puffing treatment to obtain granules, finishing granules, sterilizing and packaging to obtain the feed additive;
or weighing the raw materials in the weight ratio, uniformly mixing the raw materials, adding 5 times of v/w of water, uniformly stirring, sterilizing and packaging to obtain the traditional Chinese medicine composition.
8. The method of claim 7, wherein: the sterilization is high temperature sterilization.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201910636746.4A CN110251694B (en) | 2019-07-15 | 2019-07-15 | Gastrointestinal ultrasonic contrast agent and preparation method thereof |
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| CN201910636746.4A CN110251694B (en) | 2019-07-15 | 2019-07-15 | Gastrointestinal ultrasonic contrast agent and preparation method thereof |
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