CN109289058B - X-ray-opaque marker barium sulfate pellet and preparation method thereof - Google Patents
X-ray-opaque marker barium sulfate pellet and preparation method thereof Download PDFInfo
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- CN109289058B CN109289058B CN201811275472.2A CN201811275472A CN109289058B CN 109289058 B CN109289058 B CN 109289058B CN 201811275472 A CN201811275472 A CN 201811275472A CN 109289058 B CN109289058 B CN 109289058B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K49/00—Preparations for testing in vivo
- A61K49/04—X-ray contrast preparations
- A61K49/0404—X-ray contrast preparations containing barium sulfate
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
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Abstract
The invention discloses a barium sulfate pellet for an X-ray opaque marker, which comprises a pellet core, a barium sulfate coating layer and a coating layer, wherein the particle size of the barium sulfate pellet is 6-7 meshes, the pellet core comprises barium sulfate, a filling agent and an adhesive, the barium sulfate coating layer is a powder supply layer and an adhesive, the powder supply layer comprises barium sulfate and a diluent, the powder supply layer is attached to or coated on the outer layer of the pellet core, and the coating layer comprises a slow release material. The invention also provides a preparation method and application of the barium sulfate pellet. When the barium sulfate pellet disclosed by the invention is used for colon transmission tests to diagnose the types of constipation diseases, the barium sulfate pellet has good stability and good developing clear effect, improves the accuracy of colon transmission test results, is beneficial to the accurate diagnosis of the types of the constipation diseases, improves the matching accuracy of subsequent treatment methods of patients, and reduces the pain of delaying the disease treatment of the patients due to diagnosis errors; the preparation method of the barium sulfate pellet disclosed by the invention is simple and convenient, easy to operate, safe and environment-friendly, and is beneficial to realizing industrial expanded production and application.
Description
Technical Field
The invention relates to the technical field of pharmaceutical preparations, in particular to an X-ray opaque marker barium sulfate pellet and a preparation method thereof.
Background
Slow transit constipation is a chronic gastrointestinal disease commonly seen in clinic, and the incidence rate of the chronic gastrointestinal disease is increased year by year due to the influence of dietary structure change, mental stress, population aging and social factors. At present, the prevalence rate of adults in China is 4-6%. The slow transit constipation can cause anorectal diseases such as hemorrhoids, anal fissure and the like, increase the occurrence risk of colon cancer, hepatic encephalopathy, Alzheimer disease and the like, also can induce acute cardiovascular and cerebrovascular accidents, cause death of patients and increase the economic and psychological burden of the patients. Therefore, it is very urgent to make a reasonable diagnosis and treatment of the slow transit constipation. At present, the constipation diagnosis means is single, and the constipation diagnosis means usually judges according to clinical symptoms such as the times of defecating, the characteristics of defecating and the like of a patient, and the diagnosis method can not reflect the specific parts of intestinal contents passing through the prolongation, can not distinguish the types of constipation, such as outlet obstruction type constipation and slow transit type constipation, has low diagnosis accuracy, and influences the selection of treatment methods.
At present, with the development of diagnostic technology, a colon transmission test is used as a diagnostic gold standard, which can effectively judge whether a patient has slow transmission constipation, and distinguish types such as outlet obstruction type constipation, slow transmission type constipation or normal type constipation. In the existing colon transmission test, the X-ray opaque markers for the colon transmission function test are self-made by hospitals, have different quality and poor quality, cannot ensure the reliability and comparability of the colon transmission test result, bring great inconvenience to the diagnosis of patients with constipation, thereby influencing the accuracy of the colon transmission test in diagnosing the constipation disease, influencing the determination of the subsequent treatment method of the patients and increasing the pain of the patients. Therefore, it is necessary and urgent to develop an X-ray opaque marker with good quality and adaptability.
The marker commonly used in the colonic transit test disclosed in the prior art is a barium-containing substance, generally a barium bar, which contains no water and has a density almost equivalent to that of metallic aluminum; some methods inject the concentrated barium into the plastic conduit or insert the metal wire into the plastic pipe to make the marker, or cut the high density plastic pipe into small particles; the other is prepared by selecting nontoxic biological materials, mixing with medical barium sulfate, adding plasticizer and elastic agent, and pressing at high temperature; some markers are coated with a layer of polyethylene to prevent dehydration, and are filled into gelatin capsules which can be dissolved when meeting water for use; some are orally administered X-ray opaque barium sulfate pellets coated with calcium alginate. As can be seen from the above, the prior art does not standardize the barium-containing marker, and does not describe the physical properties, components and quality of the marker in detail. In addition, the marker form disclosed in the prior art has a plurality of defects, such as the physical properties of the marker are far from those of food, and the test result of the marker form used for the colon transmission test is far from the actual condition of the stomach transmission, so that the result of the colon transmission test is inaccurate; after being wrapped by polyethylene, the water inside the marker and the stomach content lose exchange, the difference between the character and the food is increased, and the colon transmission test result is influenced; the prior barium sulfate preparation is usually in the forms of ring, column, tube, rod, S and the like, has poor stability when being used as a marker for colon transmission tests, has poor developing effect and is not suitable for industrial production.
Therefore, those skilled in the art have devoted their efforts to develop a radiopaque marker barium sulfate pellet and a method for preparing the same to solve the above-mentioned deficiencies of the prior art.
Disclosure of Invention
In view of the above-mentioned defects of the prior art, the technical problems to be solved by the present invention are that in the prior art, when barium sulfate or a preparation thereof is used as a marker in a colon transmission test, the stability is poor, the developing effect is poor, the result of the colon transmission test is inaccurate, the accuracy of the colon transmission test in diagnosing the type of constipation disease is reduced, the determination of the subsequent treatment method of a patient is influenced, the pain of the patient is increased, and the preparation method of the prior barium sulfate is complex and is not suitable for industrial production.
In order to achieve the above object, the present invention provides in a first aspect an radiopaque marker barium sulfate pellet comprising a pellet core, a barium sulfate coating layer and a coating layer; the particle size of the barium sulfate pellets is 6-7 meshes;
further, the pill core comprises barium sulfate, a filling agent and a bonding agent;
furthermore, in the pill core, the filler is one or more of microcrystalline cellulose, lactose, starch, sucrose, dextrin, pregelatinized starch, compressible starch and inorganic calcium salt;
further, in the pellet core, the adhesive is one or more of hydroxypropyl methylcellulose, starch slurry, methylcellulose, povidone, ethyl cellulose, sodium carboxymethylcellulose, sucrose solution, water or ethanol;
further, the preparation raw materials of the pellet core comprise 70-85 wt% of barium sulfate and 1-30 wt% of a filling agent;
further, the preparation raw materials of the pellet core comprise 70-85 wt% of barium sulfate and 10-30 wt% of a filling agent;
further, the preparation raw materials of the pellet core comprise 70-85% of barium sulfate, 10-20% of microcrystalline cellulose and 1-10% of lactose by weight percentage;
further, the particle size of the pellet core is 8-20 meshes; preferably 10-16 meshes;
further, the barium sulfate coating layer is powder supply and adhesive which comprise barium sulfate and diluent, the powder supply is attached to or coated on the outer layer of the pellet core, and the weight (gram) ratio of the pellet core to the powder supply is 1 (3.5-5);
further, in the powder supply, the diluent is one or more of microcrystalline cellulose, lactose, starch, sucrose, dextrin, pregelatinized starch, compressible starch and inorganic calcium salt;
further, in the powder supply, the adhesive is one or more of hydroxypropyl methylcellulose, starch slurry, methylcellulose, povidone, ethyl cellulose, sodium carboxymethyl cellulose, sucrose solution, water or ethanol;
further, the powder supply of the barium sulfate coating comprises 75-95 wt% of barium sulfate and 0.5-25 wt% of a diluent;
further, the barium sulfate coating layer contains 75-95 wt% of barium sulfate, 4-15 wt% of microcrystalline cellulose and 0.5-10 wt% of lactose;
further, the barium sulfate coating layer contains 85-95 wt% of barium sulfate, 4-10 wt% of microcrystalline cellulose and 0.5-5 wt% of lactose;
further, the coating layer comprises one or more of a slow release material and a plasticizer;
furthermore, in the coating layer, the slow release material is one of cellulose acetate, ethyl cellulose, ethylene-vinyl acetate copolymer and acrylic resin; preferably ethyl cellulose;
further, in the coating layer, the plasticizer is one of diethyl phthalate, dibutyl phthalate, castor oil, triethyl citrate, monoacetin and PEG;
further, the coating layer accounts for 5-10% of the weight of the whole barium sulfate pellet.
The invention also provides a preparation method of the X-ray opaque marker barium sulfate pellet, which comprises the following steps:
step 1, mixing barium sulfate, a filling agent and an adhesive in a certain weight percentage to prepare a soft material, extruding a strip-shaped object, rolling the object in a rolling machine, and sieving the object with a sieve of 8-20 meshes to obtain a pill core;
step 2, in the presence of powder supply containing barium sulfate and an adhesive, carrying out a powder lamination process on the pellet core in the step 1, and adding a coating layer on the outer layer of the pellet core to obtain an inner pellet containing the pellet core and a barium sulfate coating layer;
and 3, coating the inner pellets obtained in the step 2, and sieving the inner pellets with a 6-7-mesh sieve to obtain a barium sulfate pellet product.
Further, the preparation method comprises the step 1 of mixing 70-85 wt% of barium sulfate and 10-30 wt% of a filling agent to prepare a soft material and extrude a strip-shaped object, rolling the soft material in a rolling machine, and sieving the soft material with a sieve of 8-20 meshes to obtain a pellet core of the barium sulfate pellet;
further, the preparation method comprises the step 2 of using 75-95 wt% of barium sulfate, 0.5-25 wt% of diluent and adhesive to perform powder lamination on the pellet core obtained in the step 1 to obtain a coating layer, and sieving the coating layer by a 6-7-mesh sieve to obtain inner pellets containing the pellet core and the coating layer;
further, the preparation method comprises the step 3 of coating the inner pellets obtained in the step 2 with a slow-release material, and sieving the coated inner pellets with a 6-7-mesh sieve to obtain a barium sulfate pellet product.
In a preferred embodiment of the invention, the preparation raw material of the pellet core of the barium sulfate pellet comprises 70 weight percent of barium sulfate;
in another preferred embodiment of the present invention, the preparation raw material of the pellet core of the barium sulfate pellet comprises 80 wt% of barium sulfate;
in another preferred embodiment of the present invention, the preparation raw material of the pellet core of the barium sulfate pellet comprises 85% by weight of barium sulfate;
in a preferred embodiment of the invention, the preparation raw material of the pellet core of the barium sulfate pellet comprises microcrystalline cellulose with the weight percentage of 10%;
in another preferred embodiment of the present invention, the barium sulfate pellet, the pellet core, is prepared from raw materials comprising microcrystalline cellulose with a weight percentage of 12%;
in another preferred embodiment of the present invention, the preparation raw material of the pellet core of the barium sulfate pellet comprises microcrystalline cellulose with a weight percentage of 19%;
in a preferred embodiment of the invention, the barium sulfate pellet, the pellet core, is prepared from raw materials containing 1% by weight of lactose;
in another preferred embodiment of the present invention, the barium sulfate pellet, the pellet core, is prepared from raw materials including 5% by weight of lactose;
in another preferred embodiment of the present invention, the barium sulfate pellet, the pellet core, is prepared from raw materials including 7% by weight of lactose;
in another preferred embodiment of the present invention, the barium sulfate pellet, the pellet core, is prepared from 10% by weight of lactose;
in a preferred embodiment of the invention, the weight (gram) ratio of the pellet core to the powder supply of the barium sulfate pellets is 1: 3.5;
in another preferred embodiment of the present invention, the weight (g) ratio of the pellet core to the powder supply of the barium sulfate pellet is 1: 4;
in another preferred embodiment of the present invention, the weight (g) ratio of the pellet core to the powder supply of the barium sulfate pellet is 1: 5;
in a preferred embodiment of the present invention, the barium sulfate coating is provided with powder containing 85% by weight of barium sulfate;
in another preferred embodiment of the present invention, the barium sulfate coating layer is provided with powder containing 90% by weight of barium sulfate;
in another preferred embodiment of the present invention, the barium sulfate coating is provided with powder containing 94% by weight of barium sulfate;
in a preferred embodiment of the present invention, the barium sulfate coating is provided with a powder containing 5 wt% of microcrystalline cellulose;
in another preferred embodiment of the present invention, the barium sulfate coating is provided with a powder containing 8% by weight of microcrystalline cellulose;
in another preferred embodiment of the present invention, the barium sulfate coating is provided with powder containing microcrystalline cellulose 10 wt%;
in a preferred embodiment of the present invention, the barium sulfate coating, the powder supply, comprises 0.5% by weight of lactose;
in another preferred embodiment of the present invention, the barium sulfate coating is provided with a powder containing 4% by weight of lactose;
in another preferred embodiment of the present invention, the barium sulfate coating is provided with a powder containing 10% by weight of lactose;
in a preferred embodiment of the present invention, the coating layer accounts for 5% by weight of the total barium sulfate pellet.
In another preferred embodiment of the present invention, the coating layer is 6% by weight of the whole barium sulfate pellet.
In another preferred embodiment of the present invention, the coating layer accounts for 10% of the total weight of the barium sulfate pellet.
In a preferred embodiment of the invention, the barium sulfate pellet comprises a pellet core, a barium sulfate coating layer and a coating layer; the particle size of the barium sulfate pellets is 6-7 meshes; the preparation raw materials of the pellet core comprise 80 percent of barium sulfate, 12 percent of microcrystalline cellulose and 7 percent of lactose in percentage by weight; the coating layer of the barium sulfate coating layer is powder supply and adhesive comprising barium sulfate and diluent, the powder supply is attached to or coated on the outer layer of the pellet core, and the weight (gram) ratio of the pellet core to the powder supply is 1: 4; in the barium sulfate coating layer, the powder supply preparation raw materials comprise 85 weight percent of barium sulfate, 10 weight percent of microcrystalline cellulose and 4 weight percent of lactose; the coating layer is ethyl cellulose and accounts for 6 percent of the weight of the whole barium sulfate pellet;
in a preferred embodiment of the invention, the preparation method of the barium sulfate pellet comprises the following steps of 1, mixing 70-85 wt% of barium sulfate, 10-20 wt% of microcrystalline cellulose and 1-10 wt% of lactose, preparing a soft material, extruding out a strip-shaped material, rolling in a rolling machine, and sieving with a sieve of 8-20 meshes to obtain a pellet core of the barium sulfate pellet;
in a preferred embodiment of the present invention, in the preparation method of the barium sulfate pellet, step 2 specifically includes using 85-95% by weight of barium sulfate, 4-10% by weight of microcrystalline cellulose, 0.5-5% by weight of lactose, and a hydroxypropyl methyl cellulose solution as an adhesive, performing powder lamination on the pellet core obtained in the step 1 to obtain a coating layer, and sieving the coating layer with a 6-7 mesh sieve to obtain an inner pellet containing the pellet core and the coating layer;
in a preferred embodiment of the present invention, in the preparation method of the barium sulfate pellet, step 3 specifically includes coating the inner pellet in step 2 with a 3% ethyl cellulose ethanol solution, and sieving with a 6-7 mesh sieve to obtain a barium sulfate pellet product.
In a preferred embodiment of the present invention, the preparation method of the barium sulfate pellet, spheronization, coating and coating can be performed in an extrusion spheronizer, a centrifugal granulator, a coating pan or a fluidized bed.
The invention also provides the use of the barium sulfate pellet of the first aspect of the invention in the preparation of a drug for colon transport function examination;
the invention also provides the use of a barium sulfate pellet as defined in any one of the first aspect of the invention in the preparation of a marker for a colonic transit test.
By adopting the scheme, the barium sulfate pellet disclosed by the invention has the following advantages:
(1) according to the barium sulfate pellet, the pellet core and the coating layer both contain barium sulfate in optimized amount, and the coating layer adopts a slow-release material to coat the inner pellet, so that the obtained barium sulfate pellet has strong corrosion resistance, good stability in the stomach and intestine, clear development, good development effect, good compliance and repeatability for colon transmission function examination, improved accuracy of colon transmission test results, facilitated diagnosis of constipation disease types, improved matching accuracy of subsequent treatment methods of patients, and reduced pain of patients caused by delay of disease treatment due to diagnosis errors;
(2) the barium sulfate pellet adopts a novel pellet preparation, defines the formulation components and the content of the colon transmission test marker, standardizes the colon transmission test marker, is favorable for standardization and normalization of application, improves the diagnosis service quality, provides a new formulation for the examination of the colon transmission test, fills up the research blank, improves the diagnosis accuracy, is favorable for the healthy development of society and popularization and application compared with barium sulfate-containing barium particles used in the prior art, such as rings, columns, tubes, rods, S-shaped particles and the like;
(3) the preparation method of the barium sulfate pellet is simple and convenient, easy to operate, mild in condition, free of potential safety hazard, simple in post-treatment, free of environmental pollution, low in production cost, high in efficiency and beneficial to realizing industrial expanded production and application.
In conclusion, when the barium sulfate pellet disclosed by the invention is used for colon transmission tests to diagnose the types of constipation diseases, the barium sulfate pellet has the advantages of good stability, clear development and good effect, improves the accuracy of colon transmission test results, is beneficial to the accurate diagnosis of the types of the constipation diseases, improves the matching accuracy of subsequent treatment methods of patients, and reduces the pain of delaying the disease treatment of the patients due to diagnosis errors; the preparation method of the barium sulfate pellet disclosed by the invention is simple and convenient, easy to operate, safe and environment-friendly, and is beneficial to realizing industrial expanded application.
The conception, the specific technical solutions and the technical effects produced by the present invention will be further described with reference to the following detailed description so as to fully understand the objects, the features and the effects of the present invention.
Detailed Description
The following describes several preferred embodiments of the present invention to make the technical contents thereof clearer and easier to understand. The invention may be embodied in many different forms of embodiments, which are intended to be illustrative only, and the scope of the invention is not intended to be limited to the embodiments shown herein.
If there is an experimental method not specified specific conditions, it is usually carried out according to conventional conditions, such as the relevant instructions or manuals.
Example 1 preparation of barium sulfate pellets
The pill core preparation raw materials comprise: 126g of barium sulfate, 34.2g of microcrystalline cellulose and 18g of lactose;
the preparation raw materials of the wrapping layer each part comprises: 162g of barium sulfate, 7.2g of microcrystalline cellulose and 0.9g of lactose;
the preparation raw materials of the coating layer comprise: 3% ethyl cellulose ethanol solution;
the preparation method specifically comprises the following steps:
taking 1 part of the pellet core preparation raw materials, uniformly mixing, sieving with a 100-mesh sieve, preparing a soft material by using a hydroxypropyl methylcellulose solution, putting the soft material into an extrusion rounding machine to prepare a strip-shaped object with a certain length, further rounding the strip-shaped object, sieving with an 8-20-mesh sieve, and drying in a 60 ℃ blast drying oven for 2 hours to obtain a pellet core of the barium sulfate pellet;
uniformly mixing 3.5 parts of the coating layer preparation raw materials, sieving with a 100-mesh sieve, spraying a liquid with hydroxypropyl methyl cellulose solution, coating the pellet core obtained in the step in an extrusion spheronizer, sieving with a 6-7-mesh sieve, and drying to obtain inner pellets containing the pellet core and the coating layer;
and (3) coating the inner pellets obtained in the step in a fluidized bed by using a 3% ethyl cellulose ethanol solution, increasing the weight by 5%, sieving by using a 6-7-mesh sieve, and drying to obtain a barium sulfate pellet product.
Example 2 preparation of barium sulfate pellets
The pill core preparation raw materials comprise: 144g of barium sulfate, 21.6g of microcrystalline cellulose and 12.6g of lactose;
the preparation raw materials of the wrapping layer each part comprises: 153g of barium sulfate, 18g of microcrystalline cellulose and 7.2g of lactose;
the preparation raw materials of the coating layer comprise: 3% ethyl cellulose ethanol solution
The preparation method specifically comprises the following steps:
taking 1 part of the pellet core preparation raw materials, uniformly mixing, sieving with a 100-mesh sieve, preparing a soft material by using a hydroxypropyl methylcellulose solution, putting the soft material into an extrusion rounding machine to prepare a strip-shaped object with a certain length, further rounding the strip-shaped object, sieving with a 10-16-mesh sieve, and drying in a 60 ℃ blast drying oven for 2 hours to obtain a pellet core of the barium sulfate pellet;
taking 4 parts of the coating layer preparation raw materials, uniformly mixing, sieving with a 100-mesh sieve, spraying a liquid with a hydroxypropyl methyl cellulose solution, coating the pellet cores obtained in the step in a centrifugal granulator, sieving with a 6-7-mesh sieve, and drying to obtain inner pellets containing the pellet cores and the coating layer;
and (3) coating the inner pellets obtained in the step in a coating pan by using a 3% ethyl cellulose ethanol solution, increasing the weight by 6%, sieving by using a 6-7-mesh sieve, and drying to obtain a barium sulfate pellet product.
Example 3 preparation of barium sulfate pellets
The pill core preparation raw materials comprise: 153g of barium sulfate, 18g of microcrystalline cellulose and 1.8g of lactose;
the preparation raw materials of the wrapping layer each part comprises: 168.3g of barium sulfate, 9g of microcrystalline cellulose and 0.9g of lactose;
the preparation raw materials of the coating layer comprise: 3% ethyl cellulose ethanol solution
The preparation method specifically comprises the following steps:
taking 1 part of the pellet core preparation raw materials, uniformly mixing, sieving with a 100-mesh sieve, preparing a soft material by using a hydroxypropyl methylcellulose solution, putting the soft material into an extrusion rounding machine to prepare a strip-shaped object with a certain length, further rounding the strip-shaped object, sieving with a 10-16-mesh sieve, and drying in a 60 ℃ blast drying oven for 2 hours to obtain a pellet core of the barium sulfate pellet;
taking 5 parts of the coating layer preparation raw materials, uniformly mixing, sieving with a 100-mesh sieve, spraying a liquid with a hydroxypropyl methyl cellulose solution, coating the pellet core obtained in the step in a centrifugal granulator, sieving with a 6-7-mesh sieve, and drying to obtain inner pellets containing the pellet core and the coating layer;
and (3) coating the inner pellets obtained in the step in a centrifugal granulator by using a 3% ethyl cellulose ethanol solution, increasing the weight by 10%, sieving by using a 6-7-mesh sieve, and drying to obtain a barium sulfate pellet product.
Test example 4: stability test
The barium sulfate pellets prepared in the examples 1-3 are placed in artificial gastric juice, artificial intestinal juice and artificial colon juice, the artificial colon juice is placed on a shaking table and placed in a constant temperature box at 37 ℃ for 120 hours, the barium sulfate pellets do not change, the clarification condition of each solution is observed to be good, and the solution is not obviously changed compared with the initially prepared solution; the barium sulfate pellets prepared in the embodiments 1-3 have strong corrosion resistance and good stability in gastric juice, intestinal juice and colonic fluid;
the barium sulfate pellets prepared by other embodiments of the invention have similar stability effects as described above.
The barium sulfate pellets obtained in the embodiment 2 of the invention are applied to colon transmission tests to check slow transmission type constipation, and the results show that the pellets stably advance in the digestive tract in the test process, the developing effect is good, and the slow transmission type constipation can be effectively diagnosed; the colon transmission test is repeatedly carried out, and the result repeatability is good, which shows that the barium sulfate pellet obtained in the embodiment 2 has good compliance and good repeatability when being used for colon transmission function examination, improves the accuracy of colon transmission test results, is beneficial to the diagnosis of constipation disease types, improves the matching accuracy of subsequent treatment methods of patients, and reduces the pain of patients caused by delayed disease treatment due to diagnosis errors;
the barium sulfate pellets prepared by other embodiments of the invention have similar beneficial effects as described above;
the barium sulfate micro-pill obtained by the technical scheme of other embodiments of the invention has similar beneficial effects as the above.
The foregoing detailed description of the preferred embodiments of the invention has been presented. It should be understood that numerous modifications and variations could be devised by those skilled in the art in light of the present teachings without departing from the inventive concepts. Therefore, the technical solutions available to those skilled in the art through logic analysis, reasoning and limited experiments based on the prior art according to the concept of the present invention should be within the scope of protection defined by the claims.
Claims (2)
1. An X-ray opaque marker barium sulfate pellet is characterized by comprising a pellet core, a barium sulfate coating layer and a coating layer; the preparation raw materials of the pellet core comprise 80 percent of barium sulfate, 12 percent of microcrystalline cellulose and 7 percent of lactose in percentage by weight; the barium sulfate coating layer is powder supply containing 85 wt% of barium sulfate, 10 wt% of microcrystalline cellulose and 4 wt% of lactose, and the weight ratio of the pellet core to the powder supply is 1: 4; the coating layer is ethyl cellulose and accounts for 6 percent of the weight of the whole barium sulfate pellet;
the preparation method of the barium sulfate pellet comprises the following steps:
step 1, mixing 80 wt% of barium sulfate, 12 wt% of microcrystalline cellulose and 7 wt% of lactose, preparing the mixture into a soft material by using a hydroxypropyl methylcellulose solution, extruding a strip-shaped object, rolling the object in a rolling machine, and sieving the object by using a sieve with 8-20 meshes to obtain a pellet core of a barium sulfate pellet;
step 2, using 85% of barium sulfate, 10% of microcrystalline cellulose, 4% of lactose and hydroxypropyl methyl cellulose solution as adhesives in percentage by weight, performing powder lamination on the pellet core obtained in the step 1 to obtain a coating layer, and sieving the coating layer by a 6-7-mesh sieve to obtain inner pellets containing the pellet core and the coating layer;
and 3, coating the inner pellets obtained in the step 2 by using a 3% ethyl cellulose ethanol solution, and sieving by using a 6-7-mesh sieve to obtain a barium sulfate pellet product.
2. Use of the barium sulfate pellets of claim 1 in the preparation of a marker for colonic transit testing, or a colonic transit functional test formulation.
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