Gastrointestinal motivity marker capsule
Technical field:
The present invention relates to a kind of medical contrast medium, for gastrointestinal tract X-ray radiography, measure gastrointestinal tract solid emptying time.
Background technology:
Utilize barium sulfate insoluble in water, be not absorbed, roentgenopaque feature, does gastrointestinal imaging medication and has applied for many years.X ray gastrointestinal contrast agent is in the past mainly that to use the material fine powder of the high absorption of x-rays of metallic salt of nonhazardous in gastrointestinal tract such as barium sulfate be material, is aided with the powdery agent of the seasonings such as flavouring agent, and furnishing pulpous state is drunk or coloclysis uses.
The constipation of the diagnosis of medical matters circle at present atony of colon needs the result of colonic transit test.This test is: patient is oral nontoxic does not dissolve in gastrointestinal, not cracking, X ray, the spherical label clearly that develops thoroughly, and the quantity of the label retaining according to the passing of time and colonic judges the function of colonic peristalsis.Its weak point is that patient takes after label and need clap an X-ray film every 24 hours, until label is discharge all of only, this not only makes troubles to patient, but also has increased too much roentgen radiation x amount.
In order to address the above problem, there are some trial work.CN1078911A adopts medical grade silicon rubber, ethylene methacrylic polysiloxanes, methyl phenyl silicone oil, medicinal barium sulfate, fumed silica, 2,5-dimethyl-2,5-di-t-butyl ethane peroxide prepares granule and incapsulates middle use, this label is off-white color, quality softness, high resilience, not easy damaged digestive tract, with low cost, image definition under X ray.The label granule that the method makes is easily assembled in actual applications in body, skewness, and inconvenience counting, thus cause digestive tract power assessment inaccurate or difficult.
CN2212392Y improves the geometry of label of colonic transportation test, its geometry have spheroid, multi-angular body and in have the lamellar body of through hole.The barium ball label that above method makes, due to single spheroid weight, in body, intestine evacuation velocity is too fast, cannot accurate evaluation digestive tract power situation.
In view of above-mentioned weak point of the prior art, the object of the present invention is to provide a kind of label of colonic transportation test that can overcome above-mentioned defect.
Summary of the invention:
The gastrointestinal motivity marker capsule that the object of the present invention is to provide a kind of development effect to improve.
Another object of the present invention is to provide a kind of convenient oral, and smooth surface is nontoxic non-stimulated, the gastrointestinal motivity marker capsule little with gastrointestinal tract frictional resistance.
Another object of the present invention be to provide a kind of not easily digested, can measure easily and reflect exactly stomach solid emptying time and the gastrointestinal motivity marker capsule of mouth-anus time.
Gastrointestinal motivity marker capsule of the present invention, it is filled with label in medicinal hollow capsule, and label comprises barium sulfate, medical grade silicon rubber and montorillonite clay.
Wherein in each capsule, fill 5-15 label, be preferably 10 labels
Wherein, based on label gross weight, barium sulfate content is 15%-40%, and medical grade silicon rubber content is 50%-80%, and montorillonite clay content is 5%-10%.
Wherein label is ring, and the cross section of described ring is annulus.The outer diameter D 1 of this annulus is 4-5mm, is preferably 4.4-4.6mm, most preferably is 4.5mm.The inner diameter D 2 of this annulus is 3.0-3.5mm, is preferably 3.2-3.4mm, most preferably is 3.3mm.
Wherein label is ring, and the cross section of described ring is the annulus in inner circle with " people " font.The outer diameter D 1 of this annulus is 4-5mm, is preferably 4.4-4.6mm, most preferably is 4.5mm.The inner diameter D 2 of this annulus is 3.2-3.8mm, is preferably 3.4-3.6mm, most preferably is 3.5mm.Should " people " font width D 3 be 0.5-1.5mm, be preferably 0.95-1.05mm, most preferably be 1mm.
Wherein label is ring, and the cross section of described ring is the annulus in inner circle with " one " font.The outer diameter D 1 of this annulus is 4-5mm, is preferably 4.4-4.6mm, most preferably is 4.5mm.The inner diameter D 2 of this annulus is 3.2-3.8mm, is preferably 3.4-3.6mm, most preferably is 3.5mm.Should " one " font width D 3 be 0.5-1.5mm, be preferably 0.95-1.05mm, most preferably be 1mm.
Wherein label is ring, and the cross section of described ring is the annulus in inner circle with " ten " font.The outer diameter D 1 of this annulus is 4-5mm, is preferably 4.4-4.6mm, most preferably is 4.5mm.The inner diameter D 2 of this annulus is 3.2-3.8mm, is preferably 3.4-3.6mm, most preferably is 3.55mm.Should " ten " font width D 3 be 0.5-1.5mm, be preferably 0.85-1.05mm, most preferably be 0.95mm.
The preparation method of this gastric motility marker capsule is: in medical grade silicon rubber, add barium sulfate and montorillonite clay etc. and (can add other fillers, such as flavouring agent etc.) raw material, barium sulfate and montorillonite clay obtain described label after fully being wrapped up after sulfidization molding, and label is placed in medicinal hollow capsule.
Beneficial effect of the present invention:
1, in label, add montorillonite clay, can improve the dispersion of barium sulfate, barium sulfate is disperseed in label more even, strengthen development effect.
2, circular high resilience, more soft, do not damage digestive tract, and complex geometry, develops more clear.
3, in the inner circle of annulus, increase reinforcement, can improve the mechanical strength of label, prevent that it from damaging in vivo.
Brief description of the drawings:
Fig. 1 is that cross section is the sectional view of the label of annulus.
Fig. 2 is that cross section is the sectional view in inner circle with the label of the annulus of " people " font.
Fig. 3 is that cross section is the sectional view in inner circle with the label of the annulus of " one " font.
Fig. 4 is that cross section is the sectional view in inner circle with the label of the annulus of " ten " font.
Detailed description of the invention:
Embodiment 1
This label formula with and proportioning in, barium sulfate content is 15%, medical grade silicon rubber content is 80%, montorillonite clay content is that 5%, three kind of raw material is mixing on rubber mixing machine, until its evenly after, slice, then cutting cutter cutting; On vulcanizing press, according to sulfidization molding on the mould of 4 kinds of toroidal retrofits, make 4 kinds of circular labels.Label is after cleaning, and every 10 circular labels pack in a capsule for medicine, pack, sterilize and be for subsequent use.
Embodiment 2
This label formula with and proportioning in, barium sulfate content is 25%, medical grade silicon rubber content is 67%, montorillonite clay content is that 8%, three kind of raw material is mixing on rubber mixing machine, until its evenly after, slice, then cutting cutter cutting; On vulcanizing press, according to sulfidization molding on the mould of 4 kinds of toroidal retrofits, make 4 kinds of circular labels.Label is after cleaning, and every 10 circular labels pack in a capsule for medicine, pack, sterilize and be for subsequent use.
Embodiment 3
This label formula with and proportioning in, barium sulfate content is 40%, medical grade silicon rubber content is 50%, montorillonite clay content is that 10%, three kind of raw material is mixing on rubber mixing machine, until its evenly after, slice, then cutting cutter cutting; On vulcanizing press, according to sulfidization molding on the mould of 4 kinds of toroidal retrofits, make 4 kinds of circular labels.Label is after cleaning, and every 10 circular labels pack in a capsule for medicine, pack, sterilize and be for subsequent use.
Using method:
Oral two capsules that contain label of patient (each capsule contains 10 labels) carry out x-ray imaging inspection on the 5th day after taking.
The first step
First day allows oral two capsules that contain label of patient (water is swallowed, and is preferably under doctor or nurse's supervising and guiding), and informs that patient forbids any charthartic, enema, suppository etc. in 5 days.
Within the 5th day, carry out abdominal part radiography and determine label distributing position and scope.
If patient excretes at least 80% (16 or more) and illustrates that colon transport function is normal.
If still remain 4 or multi-tracer more in patient's intestinal, need to carry out extra x-ray imaging inspection in ensuing several days.
Be flocked in proctosigmoid or label exists in colon in a large number for label, need the disposal of second step.
Second step: the 5th day, if exceed 20% (4-6 sheet) still in body.
Allow patient take bulking agent 1-2 week every day.
Within this 1-2 week, allow the capsule of two labels of clothes for patients, within the 5th day after taking, carry out x-ray imaging and come check mark thing distributing position and scope.
Reading of result:
Discharge in body in the time of the 5th day if exceed 80% label, illustrate that colon transport function is normal; If remaining label is dispersed in colon, be likely Colon Movement miopragia; If remaining label is gathered in rectum or sigmoid colon, be probably that functional discharge postpones, for example: proctoptosis, Anismus.