CN109289058A - A kind of radiopaque merkers barium sulfate pellet and preparation method thereof - Google Patents
A kind of radiopaque merkers barium sulfate pellet and preparation method thereof Download PDFInfo
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- CN109289058A CN109289058A CN201811275472.2A CN201811275472A CN109289058A CN 109289058 A CN109289058 A CN 109289058A CN 201811275472 A CN201811275472 A CN 201811275472A CN 109289058 A CN109289058 A CN 109289058A
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- barium sulfate
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- powder supply
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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 kind of radiopaque merkers barium sulfate pellets, including capsule core, barium sulfate wrapping layer and coatings, the partial size of barium sulfate pellet is 6~7 mesh, capsule core includes barium sulfate, filler, adhesive, barium sulfate wrapping layer be include barium sulfate, the powder supply of diluent and adhesive, powder supply adheres to or is wrapped in capsule core outer layer, and coatings include slow-release material.The present invention also provides the preparation method of barium sulfate pellet and purposes.Barium sulfate pellet disclosed by the invention is when diagnosing astriction type for Colonic transit test, stability is good, clear effect of developing is good, improve the accuracy of Colonic transit test result, be conducive to the Accurate Diagnosis of astriction type, the matching accuracy of patient's successive treatment method is improved, the pain that patient postpones disease treatment due to false diagnosis is reduced;The preparation method of barium sulfate pellet disclosed by the invention is easy, easy to operate, safety and environmental protection, is advantageously implemented industrialization expanding production application.
Description
Technical field
The present invention relates to technical field of medicine more particularly to a kind of radiopaque merkers barium sulfate pellet and its systems
Preparation Method.
Background technique
Constipation of slow-remove type is a kind of Chronic gastrointestinal disorders common in clinic, due to dietary structure change, stress, people
Mouth aging and the influence of social factor, disease incidence increase year by year.China adult prevalence rate is 4%~6% at present.Due to slow
Mode transmission constipation often can lead to the anorectal diseases such as hemorrhoid, anal fissure, increases colon cancer, hepatic encephalopathy, Alzheimer disease etc. and occurs
Risk can also induce acute cardiovascular and cerebrovascular accident, lead to death, increase the economy and psychological burden of patient.Therefore, to slow
Mode transmission constipation, which carries out reasonable diagnosing and treating, seems very urgent.It is relatively simple to the diagnostic means of constipation at present, usually
It is to be judged according to clinical symptoms such as the times of defecation of patient and stools, this diagnostic method can neither reflect in enteron aisle
It is tolerant by extended concrete position, also cannot be distinguished constipation type examined such as Treatment of Outlet Obstruction Type Constipation and constipation of slow-remove type
Disconnected accuracy is low, to influence the selection for the treatment of method.
Currently, with the development of diagnostic techniques, Colonic transit test as diagnosis goldstandard, can effectively judge patient whether there is or not
Constipation of slow-remove type distinguishes the types such as Treatment of Outlet Obstruction Type Constipation, slow-remove type or normal type constipation.It is passed in existing disclosed colon
In defeated test, the radiopaque merkers for Colonic transit activity test are each hospital-made, and quality is different, of poor quality, cannot
The reliability and comparativity for guaranteeing Colonic transit test result, bring very big inconvenience to the diagnosis of constipation patient, to influence to tie
Intestines transmission test diagnoses accuracy when astriction, influences the determination of patient's successive treatment method, increases the pain of patient.Cause
This, develops a kind of high-quality, and the good radiopaque merkers of adaptability are very necessary and urgent.
The marker that is often used of the test of Colonic transit disclosed in the prior art is baric object, generally a kind of barium item, no
Aqueous, density is almost suitable with metallic aluminium;Mark will be made in dense barium injected plastic conduit or by wire insertion plastic tube in some
Will object, or high-density plastic's pipe is cut into dices;Selection nontoxic biological material also is mixed with medicinal barium sulfate, addition modeling
Property agent and elasticator (elasticizer), press mold forms at high temperature;Some adds layer of polyethylene to wrap up on marker surface to prevent dehydration, is packed into and meets
Water is to use in the gelatine capsule dissolved;The barium sulfate bead for taking orally impermeable X- line of some calcium alginates package.It is above-mentioned can
See, in the prior art specification is not standardized to baric marker, it is not detailed to its physical characteristic, ingredient, quality to retouch
It states.And above-mentioned existing disclosed marker form haves the defects that many, such as differs greatly, is used for the physical behavior of food
Its inspection result and the actual state transmitted of stomach are mutually far short of what is expected when Colonic transit is tested, and Colonic transit test result is caused to be not allowed
Really;After polyethylene wraps up, marker internal moisture just loses with gastric content to be exchanged, and character and food difference increase, shadow
Ring Colonic transit test result;Existing disclosed barium sulfate preparation is common for the forms such as ring-type, column, tubulose, rodlike, S shape,
Stability is poor when testing as marker for Colonic transit, and development effect is bad, is unsuitable for industrialized production.
Therefore, those skilled in the art is dedicated to developing a kind of radiopaque merkers barium sulfate pellet and its preparation side
Method, to solve above-mentioned the deficiencies in the prior art.
Summary of the invention
In view of the above drawbacks of the prior art, the technical problem to be solved by the present invention is to currently available technologies in sulfuric acid
Stability is poor when barium or its preparation are tested as marker for Colonic transit, and development effect is bad, and Colonic transit is caused to be tested
As a result inaccurate, accuracy when Colonic transit test diagnosis astriction type is reduced, patient's successive treatment method is influenced
It determines, increases the pain of patient, and the formulation preparation method of existing barium sulfate is complicated, is unsuitable for industrialized production.
To achieve the above object, first aspect present invention provides a kind of radiopaque merkers barium sulfate pellet, including ball
Core, barium sulfate wrapping layer and coatings;The partial size of the barium sulfate pellet is 6~7 mesh;
Further, the capsule core includes barium sulfate, filler, adhesive;
Further, in the capsule core, filler is microcrystalline cellulose, lactose, starch, sucrose, dextrin, pregelatinated shallow lake
One of powder, amylum pregelatinisatum, inorganic calcium salt are a variety of;
Further, in the capsule core, adhesive is hydroxypropyl methylcellulose, starch slurry, methylcellulose, povidone, second
One of base cellulose, sodium carboxymethylcellulose, sucrose solution, water or ethyl alcohol are a variety of;
Further, the capsule core, prepare raw material include weight percent be 70%~85% barium sulfate, 1%~
30% filler;
Further, the capsule core, prepare raw material include weight percent be 70%~85% barium sulfate, 10%~
30% filler;
Further, the capsule core, prepare raw material include weight percent be 70%~85% barium sulfate, 10%~
20% microcrystalline cellulose, 1%~10% lactose;
Further, 8~20 mesh of capsule core partial size;Preferably 10~16 mesh;
Further, the barium sulfate wrapping layer be include barium sulfate, the powder supply of diluent and adhesive, powder supply attachment or
It is wrapped in capsule core outer layer, the weight (gram) of the capsule core and powder supply is than being 1:(3.5~5);
Further, in the powder supply, diluent is microcrystalline cellulose, lactose, starch, sucrose, dextrin, pregelatinated shallow lake
One of powder, amylum pregelatinisatum, inorganic calcium salt are a variety of;
Further, in the powder supply, adhesive is hydroxypropyl methylcellulose, starch slurry, methylcellulose, povidone, second
One of base cellulose, sodium carboxymethylcellulose, sucrose solution, water or ethyl alcohol are a variety of;
Further, the barium sulfate wrapping layer, powder supply include weight percent be 75%~95% barium sulfate,
0.5%~25% diluent;
Further, the barium sulfate wrapping layer, powder supply include the barium sulfate that weight percent is 75%~95%, 4%
~15% microcrystalline cellulose, 0.5%~10% lactose;
Further, the barium sulfate wrapping layer, powder supply include the barium sulfate that weight percent is 85%~95%, 4%
~10% microcrystalline cellulose, 0.5%~5% lactose;
Further, the coatings include slow-release material, it is one or more in plasticizer;
Further, in the coatings, slow-release material is that cellulose acetate, ethyl cellulose, ethene-vinyl acetate are total
One of polymers, acrylic resin;Preferably ethyl cellulose;
Further, in the coatings, plasticizer is diethyl phthalate, dibutyl phthalate, castor-oil plant
One of oil, triethyl citrate, monoacetin, PEG;
Further, it is 5%~10% that the coatings, which account for entire barium sulfate pellet weight percent,.
Second aspect of the present invention additionally provides a kind of preparation method of radiopaque merkers barium sulfate pellet, including following
Step:
Step 1 mixes the barium sulfate, filler and adhesive of constant weight percentage, prepares softwood and squeezes out strip
Object, it is round as a ball in spheronizator, it crosses 8~20 meshes and obtains capsule core;
Step 2, in the presence of the powder supply and adhesive containing barium sulfate, by above-mentioned steps 1 capsule core carry out powder bed
Product technique increases wrapping layer in capsule core outer layer, obtains the interior pellet comprising capsule core and barium sulfate wrapping layer;
The interior pellet of step 2 is coated by step 3, is crossed 6~7 meshes and is obtained barium sulfate pellet product.
Further, the preparation method, step 1 include, by the barium sulfate of weight percent 70%~85%, 10%~
30% filler mixing, prepares softwood and squeezes out bar, round as a ball in spheronizator, crosses 8~20 meshes and obtains barium sulfate pellet
Capsule core;
Further, the preparation method, step 2 include, using weight percent be 75%~95% barium sulfate,
Capsule core in above-mentioned steps 1 is carried out powder lamination and obtains wrapping layer, crosses 6 by 0.5%~25% diluent and adhesive
~7 meshes obtain the interior pellet comprising capsule core and wrapping layer;
Further, the preparation method, step 3 include being coated the interior pellet of step 2 using slow-release material,
It crosses 6~7 meshes and obtains barium sulfate pellet product.
In better embodiment of the invention, the raw material for preparing of the barium sulfate pellet, capsule core includes weight percent
For 70% barium sulfate;
In another better embodiment of the invention, the raw material for preparing of the barium sulfate pellet, capsule core includes weight hundred
Score is 80% barium sulfate;
In another better embodiment of the invention, the raw material for preparing of the barium sulfate pellet, capsule core includes weight hundred
The barium sulfate that score is 85%;
In better embodiment of the invention, the raw material for preparing of the barium sulfate pellet, capsule core includes weight percent
For 10% microcrystalline cellulose;
In another better embodiment of the invention, the raw material for preparing of the barium sulfate pellet, capsule core includes weight hundred
The microcrystalline cellulose that score is 12%;
In another better embodiment of the invention, the raw material for preparing of the barium sulfate pellet, capsule core includes weight hundred
The microcrystalline cellulose that score is 19%;
In better embodiment of the invention, the raw material for preparing of the barium sulfate pellet, capsule core includes weight percent
For 1% lactose;
In another better embodiment of the invention, the raw material for preparing of the barium sulfate pellet, capsule core includes weight hundred
The lactose that score is 5%;
In another better embodiment of the invention, the raw material for preparing of the barium sulfate pellet, capsule core includes weight hundred
The lactose that score is 7%;
In another better embodiment of the invention, the raw material for preparing of the barium sulfate pellet, capsule core includes weight hundred
The lactose that score is 10%;
In better embodiment of the invention, weight (gram) ratio of the barium sulfate pellet, the capsule core and powder supply is
1:3.5;
In another better embodiment of the invention, the barium sulfate pellet, the weight (gram) of the capsule core and powder supply
Than for 1:4;
In another better embodiment of the invention, the barium sulfate pellet, the weight (gram) of the capsule core and powder supply
Than for 1:5;
In better embodiment of the invention, the barium sulfate wrapping layer, powder supply includes that weight percent is 85%
Barium sulfate;
In another better embodiment of the invention, the barium sulfate wrapping layer, powder supply is comprising weight percent
90% barium sulfate;
In another better embodiment of the invention, the barium sulfate wrapping layer, powder supply is comprising weight percent
94% barium sulfate;
In better embodiment of the invention, the barium sulfate wrapping layer, powder supply include weight percent be 5% it is micro-
Crystalline cellulose;
In another better embodiment of the invention, the barium sulfate wrapping layer, powder supply includes that weight percent is 8%
Microcrystalline cellulose;
In another better embodiment of the invention, the barium sulfate wrapping layer, powder supply is comprising weight percent
10% microcrystalline cellulose;
In better embodiment of the invention, the barium sulfate wrapping layer, powder supply includes that weight percent is 0.5%
Lactose;
In another better embodiment of the invention, the barium sulfate wrapping layer, powder supply includes that weight percent is 4%
Lactose;
In another better embodiment of the invention, the barium sulfate wrapping layer, powder supply is comprising weight percent
10% lactose;
In better embodiment of the invention, it is 5% that the coatings, which account for entire barium sulfate pellet weight percent,.
In another better embodiment of the invention, the coatings account for entire barium sulfate pellet weight percent and are
6%.
In another better embodiment of the invention, the coatings account for entire barium sulfate pellet weight percent and are
10%.
In better embodiment of the invention, the barium sulfate pellet, including capsule core, barium sulfate wrapping layer and coating
Layer;The partial size of the barium sulfate pellet is 6~7 mesh;The capsule core, preparing raw material includes the sulfuric acid that weight percent is 80%
Barium, 12% microcrystalline cellulose, 7% lactose;The barium sulfate wrapping layer, wrapping layer be include barium sulfate, diluent
Powder supply and adhesive, powder supply adhere to or are wrapped in capsule core outer layer, and the weight (gram) of capsule core and powder supply is than being 1:4;The barium sulfate
In wrapping layer, powder supply prepare raw material include weight percent be 85% barium sulfate, 10% microcrystalline cellulose, 4% lactose;
The coatings are ethyl cellulose, and accounting for entire barium sulfate pellet weight percent is 6%;
In better embodiment of the invention, the preparation method of the barium sulfate pellet, step 1 is specifically included weight
The barium sulfate of percentage 70%~85%, 10%~20% microcrystalline cellulose, the mixing of 1%~10% lactose, prepare softwood
And bar is squeezed out, and it is round as a ball in spheronizator, it crosses 8~20 meshes and obtains the capsule core of barium sulfate pellet;
In better embodiment of the invention, the preparation method of the barium sulfate pellet, step 2 is specifically included using weight
Amount percentage be 85%~95% barium sulfate, 4%~10% microcrystalline cellulose, 0.5%~5% lactose and hydroxypropyl
Ylmethyl cellulose solution is adhesive, and the capsule core in above-mentioned steps 1 is carried out powder lamination and obtains wrapping layer, crosses 6~7 meshes
Obtain the interior pellet comprising capsule core and wrapping layer;
In better embodiment of the invention, the preparation method of the barium sulfate pellet, step 3 is specifically included step
2 interior pellet is coated using 3% ethyl cellulose ethanol solution, is crossed 6~7 meshes and is obtained barium sulfate pellet product.
In better embodiment of the invention, the preparation method of the barium sulfate pellet, it is round as a ball, wrap up, be coated it is optional
It selects and is carried out in extrusion spheronization machine, centrifugal granulator, coating pan or fluidized bed.
The present invention also provides any one of first aspect present invention barium sulfate pellets to be used for Colonic transit activity in preparation
The purposes of inspection;
The present invention also provides any one of first aspect present invention barium sulfate pellets to test in preparation for Colonic transit
Marker purposes.
Using above scheme, barium sulfate pellet disclosed by the invention is had the advantage that
(1) barium sulfate pellet of the invention, in capsule core and wrapping layer containing the barium sulfate of optimized amount, coatings are using slow
It releases the internal pellet of material to be coated, for the barium sulfate pellet made when for Colonic transit test, corrosion resistance is strong, in stomach
Stability is good in intestines, and development is clear, and development effect is good, checks compliance and reproducible to Colonic transit activity, raising finishes
The accuracy of intestines transmission test result is conducive to the diagnosis of astriction type, and the matching for improving patient's successive treatment method is quasi-
True property reduces the pain that patient postpones disease treatment due to false diagnosis;
(2) barium sulfate pellet of the invention specifies the agent of colonic transit test markers using novel pellet preparations
Type ingredient, content are standardized specification to the marker of Colonic transit test, are conducive to the standardization of application, and standardization mentions
High diagnostic service quality, compared with the existing technology used in the barium sulfate-containings such as ring-type, column, tubulose, rodlike, S shape granellae,
Pellet of the invention provides new dosage form for the inspection that Colonic transit is tested, and has filled up research blank, has improved the standard of diagnosis
True property is conducive to Community health and develops and promote and apply;
(3) preparation method of barium sulfate pellet of the invention, simple and convenient, easy to operate, mild condition, no security risk,
Post-processing is simple free from environmental pollution, and production cost is low, high-efficient, is advantageously implemented industrialization expanding production application.
In conclusion barium sulfate pellet disclosed by the invention examines astriction type for Colonic transit test
When disconnected, stability is good, and development is clear, and effect is good, improves the accuracy of Colonic transit test result, is conducive to astriction class
The Accurate Diagnosis of type improves the matching accuracy of patient's successive treatment method, reduces patient due to false diagnosis and postpones disease
The pain for the treatment of;The preparation method of barium sulfate pellet disclosed by the invention is easy, and easy to operate, safety and environmental protection is advantageously implemented work
Industryization expands application.
Below with reference to technical effect of the specific embodiment to design of the invention, specific technical solution and generation make into
One step explanation, to fully understand the purposes, features and effects of the present invention.
Specific embodiment
Multiple preferred embodiments of the invention introduced below keep its technology contents more clear and are easy to understand.The present invention
It can be emerged from by many various forms of embodiments, these embodiments are exemplary description, protection model of the invention
Enclose the embodiment for being not limited only to mention in text.
If there is test method without specific conditions, usually according to normal condition, such as instructions book or handbook
Implemented.
Embodiment 1, the preparation of barium sulfate pellet
It includes: barium sulfate 126g, microcrystalline cellulose 34.2g, lactose 18g that capsule core, which prepares every part of raw material,;
It includes: barium sulfate 162g, microcrystalline cellulose 7.2g, lactose 0.9g that wrapping layer, which prepares every part of raw material,;
It includes: 3% ethyl cellulose ethanol solution that coatings, which prepare raw material,;
Preparation method specifically includes:
Take 1 part of above-mentioned capsule core to prepare raw material and carry out uniformly mixed, sieve with 100 mesh sieve, using hydroxypropyl methylcellulose solution by its
Softwood is made, is put into extrusion spheronization machine, the bar of certain length is made, it is further that bar is round as a ball, cross 8~20 mesh
It sieves, obtains the capsule core of barium sulfate pellet within dry 2 hours in 60 DEG C of air dry ovens;
It takes 3.5 parts of above-mentioned wrapping layers to prepare raw material and carries out uniformly mixed, sieve with 100 mesh sieve, it is molten with hydroxypropyl methyl cellulose
Liquid hydrojet, the capsule core for obtaining above-mentioned steps in extrusion spheronization machine are wrapped up, and are dried to obtain after crossing 6~7 meshes comprising ball
The interior pellet of core and wrapping layer;
In a fluidized bed, the interior pellet that above-mentioned steps obtain is coated with 3% ethyl cellulose ethanol solution, is increased weight
5%, it crosses 6~7 meshes and is dried to obtain barium sulfate pellet product.
Embodiment 2, the preparation of barium sulfate pellet
It includes: barium sulfate 144g, microcrystalline cellulose 21.6g, lactose 12.6g that capsule core, which prepares every part of raw material,;
It includes: barium sulfate 153g, microcrystalline cellulose 18g, lactose 7.2g that wrapping layer, which prepares every part of raw material,;
It includes: 3% ethyl cellulose ethanol solution that coatings, which prepare raw material,
Preparation method specifically includes:
Take 1 part of above-mentioned capsule core to prepare raw material and carry out uniformly mixed, sieve with 100 mesh sieve, using hydroxypropyl methylcellulose solution by its
Softwood is made, is put into extrusion spheronization machine, the bar of certain length is made, it is further that bar is round as a ball, cross 10~16 mesh
It sieves, obtains the capsule core of barium sulfate pellet within dry 2 hours in 60 DEG C of air dry ovens;
It takes 4 parts of above-mentioned wrapping layers to prepare raw material and carries out uniformly mixed, sieve with 100 mesh sieve, with Gonak
Hydrojet, the capsule core for obtaining above-mentioned steps in centrifugal granulator are wrapped up, and are dried to obtain after crossing 6~7 meshes comprising capsule core
With the interior pellet of wrapping layer;
In coating pan, the interior pellet that above-mentioned steps obtain is coated with 3% ethyl cellulose ethanol solution, is increased weight
6%, it crosses 6~7 meshes and is dried to obtain barium sulfate pellet product.
Embodiment 3, the preparation of barium sulfate pellet
It includes: barium sulfate 153g, microcrystalline cellulose 18g, lactose 1.8g that capsule core, which prepares every part of raw material,;
It includes: barium sulfate 168.3g, microcrystalline cellulose 9g, lactose 0.9g that wrapping layer, which prepares every part of raw material,;
It includes: 3% ethyl cellulose ethanol solution that coatings, which prepare raw material,
Preparation method specifically includes:
Take 1 part of above-mentioned capsule core to prepare raw material and carry out uniformly mixed, sieve with 100 mesh sieve, using hydroxypropyl methylcellulose solution by its
Softwood is made, is put into extrusion spheronization machine, the bar of certain length is made, it is further that bar is round as a ball, cross 10~16 mesh
It sieves, obtains the capsule core of barium sulfate pellet within dry 2 hours in 60 DEG C of air dry ovens;
It takes 5 parts of above-mentioned wrapping layers to prepare raw material and carries out uniformly mixed, sieve with 100 mesh sieve, with Gonak
Hydrojet, the capsule core for obtaining above-mentioned steps in centrifugal granulator are wrapped up, and are dried to obtain after crossing 6~7 meshes comprising capsule core
With the interior pellet of wrapping layer;
In centrifugal granulator, the interior pellet that above-mentioned steps obtain is coated with 3% ethyl cellulose ethanol solution,
Weight gain 10% crosses 6~7 meshes and is dried to obtain barium sulfate pellet product.
Test example 4: stability test
The barium sulfate pellet that Examples 1 to 3 is prepared is placed on simulated gastric fluid, simulated intestinal fluid, in artificial colonic fluid, is set
In on shaking table, 37 DEG C of insulating boxs are placed 120 hours, and barium sulfate pellet is unchanged, and it is all right to observe each solution clarification, and are just matched
The solution of system is compared nothing and is substantially change;Show the barium sulfate pellet of the preparation of the embodiment of the present invention 1~3 in gastric juice, intestinal juice, colon
Corrosion resistance is strong in liquid, has good stability;
The barium sulfate pellet that other embodiments of the present invention are prepared has stabilizing effect similar to above.
The barium sulfate pellet that the embodiment of the present invention 2 obtains is applied to check constipation of slow-remove type in Colonic transit test,
As the result is shown during the test, pellet in alimentary canal stablize advance, development effect is good, can efficient diagnosis slow-remove type just
It is secret;Repeat Colonic transit test, as a result reproducible, the barium sulfate pellet for showing that the embodiment of the present invention 2 obtains is being used for
Compliance is good when Colonic transit activity checks, reproducible, improves the accuracy of Colonic transit test result, is conducive to constipation
The diagnosis of disease type improves the matching accuracy of patient's successive treatment method, reduces patient due to false diagnosis and postpones disease
The pain of disease treatment;
The barium sulfate pellet that other embodiments of the invention are prepared has beneficial effect similar to above;
The barium sulfate pellet that other embodiments technical solution of the invention obtains has beneficial effect similar to above.
The preferred embodiment of the present invention has been described in detail above.It should be appreciated that the ordinary skill of this field is without wound
The property made labour, which according to the present invention can conceive, makes many modifications and variations.Therefore, all technician in the art
Pass through logic analysis, reasoning or the limited available technology of test on the basis of existing technology under this invention's idea
Scheme, all should be within the scope of protection determined by the claims.
Claims (10)
1. a kind of radiopaque merkers barium sulfate pellet, which is characterized in that including capsule core, barium sulfate wrapping layer and coatings;Institute
The partial size for stating barium sulfate pellet is 6~7 mesh;The capsule core includes barium sulfate, filler, adhesive;The barium sulfate wrapping layer
Being includes barium sulfate, the powder supply of diluent and adhesive, and capsule core outer layer, the weight of the capsule core and powder supply are adhered to or be wrapped in powder supply
Amount is than being 1:(3.5~5);The coatings include slow-release material.
2. barium sulfate pellet as described in claim 1, which is characterized in that in the capsule core,
Filler is microcrystalline cellulose, in lactose, starch, sucrose, dextrin, pregelatinized starch, amylum pregelatinisatum, inorganic calcium salt
It is one or more;
Adhesive be hydroxypropyl methylcellulose, starch slurry, methylcellulose, povidone, ethyl cellulose, sodium carboxymethylcellulose,
One of sucrose solution, water or ethyl alcohol are a variety of.
3. barium sulfate pellet as claimed in claim 2, which is characterized in that the capsule core, preparing raw material includes weight percent
For 70%~85% barium sulfate, 1%~30% filler.
4. barium sulfate pellet as described in claim 1, which is characterized in that in the powder supply,
Diluent is microcrystalline cellulose, in lactose, starch, sucrose, dextrin, pregelatinized starch, amylum pregelatinisatum, inorganic calcium salt
It is one or more;
Adhesive be hydroxypropyl methylcellulose, starch slurry, methylcellulose, povidone, ethyl cellulose, sodium carboxymethylcellulose,
One of sucrose solution, water or ethyl alcohol are a variety of.
5. barium sulfate pellet as claimed in claim 4, which is characterized in that the barium sulfate wrapping layer, powder supply include weight percent
Number is 75%~95% barium sulfate, 0.5%~25% diluent.
6. barium sulfate pellet as described in claim 1, which is characterized in that in the coatings,
Slow-release material is one of cellulose acetate, ethyl cellulose, ethylene-vinyl acetate copolymer, acrylic resin;
It is 5%~10% that the coatings, which account for entire barium sulfate pellet weight percent,.
7. a kind of preparation method of radiopaque merkers barium sulfate pellet, which comprises the following steps:
Step 1 mixes the barium sulfate, filler and adhesive of constant weight percentage, prepares softwood and squeezes out certain length
Bar, it is round as a ball in spheronizator, cross 8~20 meshes and obtain capsule core;
Step 2, in the presence of the powder supply and adhesive containing barium sulfate, by above-mentioned steps 1 capsule core carry out powder lamination work
Skill increases wrapping layer in capsule core outer layer, obtains the interior pellet comprising capsule core and barium sulfate wrapping layer;
The interior pellet of step 2 is coated by step 3, is crossed 6~7 meshes and is obtained barium sulfate pellet product.
8. preparation method as claimed in claim 7, which is characterized in that
The step 1, which specifically includes, mixes the filler of the barium sulfate of weight percent 70%~85%, 1%~30%, system
Standby softwood simultaneously squeezes out bar, round as a ball in spheronizator, crosses 8~20 meshes and obtains the capsule core of barium sulfate pellet;
The step 2 specifically include using weight percent be 75%~95% barium sulfate, 0.5%~25% diluent,
And adhesive, the capsule core in above-mentioned steps 1 is subjected to powder lamination and obtains wrapping layer, cross 6~7 meshes obtain comprising capsule core and
The interior pellet of wrapping layer;
The step 3, which is specifically included, is coated the interior pellet of step 2 using slow-release material, crosses 6~7 meshes and obtains barium sulfate
Pellet product.
9. the sulphur that any one of any one of the claim 1~6 barium sulfate pellet, claim 7-8 the method is prepared
Sour barium pellet is in preparation for the marker of Colonic transit test or the purposes of Colonic transit activity inspection.
10. the barium sulfate pellet that a kind of any one of claim 7-8 the method is prepared, which is characterized in that including capsule core,
Barium sulfate wrapping layer and coatings;The capsule core, prepare raw material include weight percent be 70%~85% barium sulfate,
10%~20% microcrystalline cellulose, 1%~10% lactose;8~20 mesh of capsule core partial size;The barium sulfate wrapping layer packet
Powder supply and adhesive are included, adheres to or be wrapped in capsule core outer layer, the weight ratio of capsule core and powder supply is 1:4;Powder supply prepares raw material
Weight percent be 85%~95% barium sulfate, 4%~10% microcrystalline cellulose, 0.5%~5% lactose;The packet
Clothing layer is ethyl cellulose, and accounting for entire barium sulfate pellet weight percent is 6%;The partial size of the barium sulfate pellet is 6~7
Mesh.
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CN201811275472.2A CN109289058B (en) | 2018-10-30 | 2018-10-30 | X-ray-opaque marker barium sulfate pellet and preparation method thereof |
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