CN101804199A - Pharmaceutical composition used for alimentary canals and application thereof - Google Patents
Pharmaceutical composition used for alimentary canals and application thereof Download PDFInfo
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- CN101804199A CN101804199A CN 201010136337 CN201010136337A CN101804199A CN 101804199 A CN101804199 A CN 101804199A CN 201010136337 CN201010136337 CN 201010136337 CN 201010136337 A CN201010136337 A CN 201010136337A CN 101804199 A CN101804199 A CN 101804199A
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- simethicone
- pepsin
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- chain protease
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Abstract
The invention discloses a pharmaceutical composition used for alimentary canals and application thereof. The composition comprises a first pharmacology active component A containing at least one digestive enzyme and a second pharmacology active component B containing at least one silicone oil analogue. The composition can be made into various pharmaceutically acceptable formulations; the invention also relates to the application of the composition in preparing adjuvant drugs which are administrated before digestive endoscopy examination and treatment or iconography examination. The composition has both very strong defoaming function and grume removal function, and thereby, the view definition of the digestive endoscopy examination and treatment or the iconography examination can be effectively improved, misdiagnosis and missed diagnosis are reduced and the treatment availability is improved, which are beneficial to the early diagnosis discovery of digestive tract diseases.
Description
Technical field
The present invention relates to medical technical field, relate to a kind of be used for gastral pharmaceutical composition and application thereof particularly, described compositions comprises first pharmacological activity component A that contains at least a digestive enzyme and the second pharmacological activity B component that contains at least a silicone oil analog, and said composition application in the adjuvant drug before preparation is as digestive endoscopy inspection and treatment or imaging examination art.
Background technology
Digestive endoscopy has important status in the diagnosis digestive tract disease, be subjected to doctor's favor because of it is directly perceived, simple, and is commonly used especially in clinical diagnosis and treatment.But owing to have a large amount of foams and mucus in the digestive tract, cause the visual field unclear, the review time prolongs, and the patient suffering increases, and causes mistaken diagnosis easily and fail to pinpoint a disease in diagnosis, and also is unfavorable for the early diagnosis and the discovery of digestive tract disease.
Simethicone (I) is the most frequently used clinically medical science defoamer, is usually used in the preceding froth breaking of art of digestive endoscopy inspection and treatment or abdominal part imaging examination.United States Patent (USP) us4906478 discloses a kind of activated dimethicone preparation, wherein contains the granule calcium silicates of powdered and the mixture of activated dimethicone.United States Patent (USP) us5073384 discloses the activated dimethicone preparation of the mixture of the maltodextrin that contains water-soluable gelization and activated dimethicone.United States Patent (USP) us5458886 discloses a kind of free flowing granule shape compositions, wherein contains titanium dioxide and activated dimethicone with specified particle size and surface area.Simethicone is a dimethylsiloxane polymer, because its surface tension is little, can change bubble surface tension force, and it is broken, thereby eliminates foam.Simethicone (II) is the complex of simethicone and silicon dioxide, has the froth breaking ability identical or stronger with simethicone.Simethicone and Simethicone all belong to pharmacology and physiology's inert substance, and its froth breaking act as physical process, and material itself does not relate to chemical change.
Pepsin is a kind of digestible protein enzyme.Pepsin comprises that to most native protein substrates keratin, mucin, fibroin and protamine etc. can both hydrolysis.The most responsive to the peptide bond that amino generated of the carboxyl of acidic amino acid and ArAA especially, pepsin is incomplete to Proteolytic enzyme, and its product is peptone, polypeptide and amino acid whose mixture, in order to the decomposition and the absorption of small intestinal.
Chain protease at first in Japan's listing, is produced by scientific research Co., Ltd. as medicinal, and commodity are by name: Pronase ms, and specification is 0.5g, indication is: the mucous lytic agent of gastric in the gastroscopy.
Up to the present, the relevant report that does not also have the coupling in medical applications of simethicone and pepsin, chain protease.
Summary of the invention
The object of the present invention is to provide a kind of gastral pharmaceutical composition that is used for, this pharmaceutical composition can be eliminated the digestive tract inner foam, can dispel the viscous liquid in the digestive tract again.
For achieving the above object, the present invention adopts following technical scheme:
A kind ofly be used for gastral pharmaceutical composition, described compositions comprises first pharmacological activity component A that contains at least a digestive enzyme and the second pharmacological activity B component that contains at least a silicone oil analog, and said composition further comprises at least a pharmaceutically suitable carrier, solvent or diluent.Wherein said digestive enzyme is selected from pepsin, trypsin, chain protease, neutral protease, Chymotrypsin, bromelain, and wherein said silicone oil analog is selected from simethicone and/or Simethicone.
In said composition, wherein per 6 units～first pharmacological activity component A of 1012 units and 1 milligram of described second pharmacological activity B component are carried out proportioning, be preferably per 50 units～first pharmacological activity component A of 1000 units and 1 milligram of second pharmacological activity B component and carry out proportioning, wherein the preferred simethicone of the first pharmacological activity component A; The second pharmacological activity B component preference chain protease, wherein preferred per 250 units～500 unit simethicone and 1 milligram of chain protease carry out proportioning.
Described carrier comprises filler, binding agent, wetting agent, disintegrating agent, lubricant, suspending agent, emulsifying agent, correctives, antiseptic, antioxidant of pharmaceutical field routine etc.
Described alternative filler has: starch, dextrin, sucrose, microcrystalline Cellulose, mannitol, glucose, lactose, pregelatinized Starch etc.;
Alternative binding agent has: sodium carboxymethyl cellulose, polyvidone, hydroxypropyl methylcellulose, starch slurry etc.;
Alternative disintegrating agent has: starch, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose etc.;
Available lubricant has: magnesium stearate, Pulvis Talci, micropowder silica gel etc.;
Alternative suspending agent or emulsifying agent have: tragakanta, arabic gum, xanthan gum, sodium alginate, sodium carboxymethyl cellulose, hypromellose, ethyl cellulose, hydroxyethyl-cellulose, Tweens, spans, polyglycol distearate, Polyethylene Glycol cetylate, glyceryl monostearate etc.;
Alternative antiseptic has: methyl parahydroxybenzoate or its sodium salt, ethylparaben, propyl p-hydroxybenzoate or its sodium salt, sorbic acid, benzyl alcohol, benzoic acid, glycerol, propylene glycol etc.;
Selectable antioxidant has: disodiumedetate, EDTA calcium complex disodium salt, 2,6 ditertiary butyl p cresol, Butylated hydroxyanisole etc.;
Correctives is then selected sweeting agent and aromatic pharmaceutically commonly used for use, as saccharin sodium, sucrose, aspartame, sucralose, steviosin, sorbitol, mannitol, various fruity flavors etc.
Said composition can be prepared into granule, powder, suspensoid or Emulsion.
Another object of the present invention provides the application in the adjuvant drug before preparation is as digestive endoscopy inspection and treatment or imaging examination art of a kind of said composition, because simethicone or the effect of Simethicone froth breaking are stronger, but dispel a little less than the mucous effect of digestive tract, make that effect was not good enough when it was used separately in digestive endoscopy inspection and treatment or imaging examination, and with the coupling of digestive enzyme analog in being applied to digestive endoscopy inspection and treatment or imaging examination, the unexpected discovery, simethicone or Simethicone and the coupling of digestive enzyme analog be froth breaking and the viscous liquid of dispeling in the digestive tract significantly, thereby improve the visibility of checking, reduce mistaken diagnosis and fail to pinpoint a disease in diagnosis, be beneficial to the early diagnosis discovery of digestive tract disease.
The present invention is used for gastral pharmaceutical composition and has the following advantages:
(1) provides a kind of protease and dimeticone/simethicone compatibility to be used to prepare before digestive endoscopy inspection and treatment or the imaging examination froth breaking first and dispeled mucous pharmaceutical composition and purposes, said composition is carried out digestive endoscopy inspection and treatment or imaging examination after using again, can effectively improve and check and treatment degree of getting a clear view, improve the digestive tract disease particularly diagnosis of early lesion and the effectiveness of treatment.
(2) first to the froth breaking of the present composition and dispel the mucus effect and carried out inside and outside research, find to use simethicone, Simethicone, pepsin, chain protease group relatively with single with the blank group, the present composition has stronger froth breaking simultaneously and dispels the mucus ability, show compositions at froth breaking with to dispel aspect the mucus effect remarkable, consequently those skilled in the art institute is beyond thought.
(3) preparation technology of the present invention is simple, and drug quality is uniform and stable, can guarantee safety of clinical administration.
(4) the present invention has been prepared into compositions with simethicone or Simethicone and pepsin or chain protease, its definite effect, select for clinician and patient provide medication preferably, it is more easy that the present composition also makes the patient take medicine, and saved and once checked the trouble of repeatedly taking medicine.
Below routine by experiment beneficial effect of further setting forth medicine of the present invention.
Experimental example 1
Pepsin silicone oil composite and chain protease silicone oil composite drug efficacy study---froth breaking ability determination test
Material: logical X-100 (Triton X-100) in the spy, SIGMA reagent; Simethicone Emulsion, trade name: this health of coffee, Japanese Kissei Pharmaceutical Co., Ltd. produces, specification: 20mg/ml, lot number: AXN2899; Simethicone emulsion, trade name: Bai Xi, Berlin, Germany chemistry joint-stock company produces specification: 40mg/ml, lot number: 74041; The pepsin granule, specification: the 0.1g/ bag, Hainan drugmaker produces; Chain protease looses, specification: 0.5g/ bag, Japanese scientific research pharmaceutical manufacturing; Pepsin silicone oil composite granule, self-control (preparation method is seen embodiment 1); Chain protease silicone oil composite granule, self-control (preparation method is seen embodiment 6).
Method: get and lead to seven parts of X-100 aqueous solution 1000ml in 1% spy, the careful 800ml graduated cylinder that injects seven cleanings, add simethicone Emulsion 2ml, Simethicone emulsion 1ml, 4 bags of pepsin granules, diffusing 1 bag of chain protease, 1 bag of pepsin silicone oil composite granule, 1 bag of chain protease silicone oil composite granule respectively in graduated cylinder, the 7th graduated cylinder do not add.Seal seven graduated cylinder ports, place the strong jolting of shaking screen 2 minutes simultaneously, take out, write down the foam height of each graduated cylinder.Foam height with the 7th graduated cylinder of n.s is 100%, reduces foam volume percentage calculation froth breaking ability with each sample.Triplicate is averaged.
The result: the average froth breaking ability of six duplicate samples is respectively: 69%, 75%, 4%, 6%, 82%, 90%,
Show that present composition sample froth breaking is very capable, stronger than single with the froth breaking ability of simethicone or Simethicone or pepsin or chain protease.
Experimental example 2
Pepsin silicone oil composite and chain protease silicone oil composite drug efficacy study---dispel mucus ability determination test
Test sample: simethicone Emulsion, trade name: this health of coffee, Japanese Kissei Pharmaceutical Co., Ltd. produces, specification: 20mg/ml, lot number: AXN2899; Simethicone emulsion, trade name: Bai Xi, Berlin, Germany chemistry joint-stock company produces specification: 40mg/ml, lot number: 74041; The pepsin granule, specification: the 0.1g/ bag, Hainan drugmaker produces; Chain protease looses, specification: 0.5g/ bag, Japanese scientific research pharmaceutical manufacturing; Pepsin silicone oil composite suspensoid (self-control, preparation method is seen embodiment 3); Chain protease silicone oil composite granule (self-control, preparation method is seen embodiment 6).
Method: laboratory animal is 4 of the male dogs of about 15kg, and body weight and healthy sign no significant difference are tested preceding two days feeding same food.After phencyclidine hydrochloride anesthesia, tighten the duodenum end of stomach to the duodenum section excision esophagus lower end.Inject respectively from the esophagus end: water A.100ml; B. simethicone Emulsion 5ml+ water 100ml; C. Simethicone 2.5ml+ water 100ml; D. 2 bags+water of pepsin granule 100ml; E. chain protease 2.5 bag+water 100ml that loose; F. pepsin silicone oil composite suspensoid 2ml+ water 100ml; G. 2.5 bags+water of chain protease silicone oil composite granule 100ml; After 20 minutes, arrogant lateral bending cuts, and gathers each one of body of stomach top and pylorus specimen, and painted with the ivens orchid.Microscopically is observed mucus adhesion condition in the specimen.
Body of stomach top and pylorus that result: A organizes the flushing of water only gastric chamber all adhere to a large amount of mucus and bubble, pylorus position especially, and mucus that adheres to the A group and bubble are all as 100% benchmark; After B group and C group adopted simethicone or Simethicone emulsion to wash the gastric chamber, it is about 70% that body of stomach top and pylorus bubble reduce respectively, but mucus reduces about 7% respectively; After D group adopted pepsin granule flushing gastric chamber, it is about 50% that body of stomach top and pylorus mucus reduce, but bubble reduces about 8%; E group adopts chain protease to loose behind the flushing gastric chamber, and it is about 75% that body of stomach top and pylorus mucus reduce, but bubble reduces about 12%; And behind the F group employing pepsin silicone oil composite suspensoid 2ml+ water 100ml flushing gastric chamber, body of stomach top and pylorus mucus and bubble reduce about 75% and 80% respectively, and the F group can more clearly be observed area gastrica and superficial epithelium cell; After G group adopted 2.5 bags+100ml of chain protease silicone oil composite granule flushing gastric chamber, body of stomach top and pylorus mucus and bubble were less respectively about 90% and 85%, and the G group can very clearly be observed area gastrica and superficial epithelium cell.
Conclusion: pepsin silicone oil composite and chain protease silicone oil composite can obviously be eliminated the intravital mucus of gastral cavity.Its effect is significantly better than water and independent simethicone or Simethicone or pepsin or the chain protease of using.
Experimental example 3
Pepsin silicone oil composite accelerated stability test result
Investigate sample: pepsin silicone oil composite granule (seeing embodiment 1); Lot number: 080510
Investigation condition: 40 ± 2 ℃ of temperature, relative humidity 75% ± 5%.
The investigation time: 0 month, January, February, March, June.
Investigate index: (1) content
Content assaying method:
Simethicone: 2000 editions two ones the 13rd page of Chinese Pharmacopoeia
Pepsin: 2000 editions two ones the 466th page of Chinese Pharmacopoeia
Quicken to investigate result of the test
The result: investigate through quickening test in 6 months, compare with 0 month data, pepsin silicone oil composite granule content does not have significant change, shows that this product is basicly stable.
Experimental example 4
Simethicone and pepsin or the chain protease coupling value in observing at the bottom of the scope body of stomach stomach
Material and apparatus
Simethicone Emulsion, trade name: this health of coffee, Japanese Kissei Pharmaceutical Co., Ltd. produces, specification: 20mg/ml, lot number: AXN2899; The pepsin granule, specification: the 0.1g/ bag, Hainan drugmaker produces; Chain protease looses (Japanese first name: プ ロ Na one ゼ looses), specification: 0.5g/ bag, Japanese scientific research pharmaceutical manufacturing; Fuji can ∑ 440 electronic gastroscopes.
Clinical data
Chongqing hospital accepts gastroscopy patient (getting rid of residual stomach and liver cirrhosis person) 45 examples as seminar 1 between in January, 2008 to June, male's 28 examples wherein, women's 17 examples, 32～53 years old mean age; Accept gastroscopic 52 routine patients the same period as seminar 2, male's 30 examples wherein, women's 22 examples, 30～55 years old mean age; Accept gastroscopic 50 routine patients the same period and organize in contrast, male's 31 examples wherein, women's 19 examples, 30～55 years old mean age.
Method
Seminar 1 checks preceding 20 minutes oral simethicone Emulsion 2ml, checks 1 bag of preceding 10 minutes oral pepsin granule; Seminar 2 checks preceding 20 minutes oral simethicone Emulsion 2ml, checks preceding 10 minutes diffusing 1 bags of oral chain protease; Matched group is only at preceding 20 minutes oral simethicone Emulsion 2ml of inspection.All patients all carry out gastroscopy by the high age and service seniority chief physician special messenger of Gastroenterology dept., are divided into four grades of ABCD according to the degree of getting a clear view, and level evaluation is finished jointly by two doctors.The A level: full stomach non-foam gets a clear view; The B level: the gastric antrum non-foam gets a clear view; A little foam at the bottom of body of stomach, the stomach, the visual field is still clear; The C level: at the bottom of body of stomach, the stomach and the gastric antrum part foam that sporadically appears, the visual field is influenced; The D level: nearly all mucosa surface is adhered to the volume foam, needs can effectively observe the mucosa character with normal saline flushing.
The result
| ??A | ??B | ??C | ??D | |
| Seminar 1 | ??40(89％) | ??5(11％) | ??0 | ??0 |
| Seminar 2 | ??51(98％) | ??1(2％) | ??0 | ??0 |
| Matched group | ??38(76％) | ??8(16％) | ??4(8％) | ??0 |
The result shows, seminar 1 or seminar 2 be than the equal definition that can significantly improve in observing at the bottom of the scope body of stomach stomach of matched group, illustrate simethicone with enzyme linked use more remarkable than simethicone list with clinical effectiveness.
The specific embodiment
Invention is further described to this reality below in conjunction with the specific embodiment, but this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following embodiment.All technology that realizes based on foregoing of the present invention all belong to scope of the present invention.The adjuvant of each dosage form can be replaced with acceptable accessories in following examples, perhaps reduces, increases.
Pepsin (1200 units: 1g): represent that vigor is 1200 units among every 1g;
Trypsin 2500 units: 1mg): represent that vigor is 2500 units among every 1mg;
Chain protease (4000 units: 1mg): represent that vigor is 4000 units among every 1mg.
Embodiment 1
The preparation of pepsin silicone oil composite granule
1, prescription:
Simethicone 40g
Calcium hydrogen phosphate 40g
Pepsin (1200 units: 1g) 400g
Lactose 400g
Cross-linking sodium carboxymethyl cellulose 15g
10% starch slurry 20g (with amylometer)
Magnesium stearate 8g
????????????????????????????????????????
Make 1000 bags altogether
2, processing step:
(1) simethicone and absorbent calcium hydrogen phosphate mix homogeneously are standby;
(2) take by weighing pepsin, cross-linking sodium carboxymethyl cellulose, lactose by recipe quantity, add the mixture of simethicone and calcium hydrogen phosphate, mix homogeneously is made binding agent with 10% starch slurry and is granulated, cross 24 mesh sieves, dried 18 order granulate 1.5 hours for 40 ℃, add the magnesium stearate mixing, pack, 0.92g/ bag.
3, clinical use
In preceding 20 minutes of digestive endoscopy inspection and treatment or imaging examination, get 1 bag of pepsin silicone oil composite granule, disperse the back oral with about 50 ml waters dissolving, conduct a survey again after 20 minutes.Medication dose can be taken the circumstances into consideration increase and decrease according to actual effect.
Embodiment 2
The preparation of pepsin silicone oil composite powder
1, prescription:
Simethicone 80g
Calcium hydrogen phosphate 80g
Pepsin (1200 units: 1g) 400g
Cane sugar powder 400g
Polyvinylpolypyrrolidone (XL-10) 20g
Silica 1 4g
???????????????????????????????????????????
Make 1000 bags altogether
2, processing step:
(1) simethicone and absorbent calcium hydrogen phosphate mix homogeneously are standby;
(2) take by weighing pepsin, cane sugar powder, polyvinylpolypyrrolidone (XL-10) by recipe quantity, add the mixture of simethicone and calcium hydrogen phosphate, mix homogeneously adds the silicon dioxide mixing at last, pack, 0.98g/ bag.
3, clinical use
In preceding 20 minutes of digestive endoscopy inspection and treatment or imaging examination, get 1 bag of pepsin silicone oil composite powder, disperse the back oral with about 50 ml waters dissolving, conduct a survey again after 20 minutes.Medication dose can be taken the circumstances into consideration increase and decrease according to actual effect.
Embodiment 3
The preparation of pepsin silicone oil composite suspensoid
1, prescription:
Simethicone 50g
Silicon dioxide 2.5g
Pepsin (1200 units: 1g) 100g
Microcrystalline Cellulose 30g
Xanthan gum 5g
Aspartame 5g
Ethylparaben 2g
Disodiumedetate 1g
Ethanol 20g
The 1M sodium hydroxide solution is an amount of
???????????????????????????????
Purified water is to 1000ml
2, processing step:
(1) pepsin, microcrystalline Cellulose, xanthan gum are crossed 100 mesh sieves respectively, and be standby; Purified water is after boiling deoxidation treatment, and is standby; Sodium hydroxide is mixed with the sodium hydroxide solution that concentration is 1M, and is standby;
(2) simethicone is put 150 ℃ and was placed 3 hours with after silicon dioxide mixes, and take out the cooling back, mixture I; Ethylparaben is dissolved in the ethanol, gets solution I, and is standby; Disodiumedetate and aspartame get solution II with an amount of purified water dissolving fully, and be standby;
(3) behind pepsin and microcrystalline Cellulose, the xanthan gum mix homogeneously, add among the mixture I, repeatedly mix making it even, slowly be distributed under the stirring then in an amount of purified water after treatment, add solution I, solution II, when adding purified water to nearly full dose, regulate pH value to 6～7.5 with the 1M sodium hydroxide solution, the reuse purified water is settled to full dose, cross colloid mill after stirring, making its mean diameter is below the 50 μ m, collect the colloid mill effluent after, mix homogeneously once more.
(4) fill, specification 30ml/ bottle;
3, clinical use
In preceding 20 minutes of digestive endoscopy inspection and treatment or imaging examination, measure 2～4 milliliters of pepsin silicone oil composite suspensions, adding 50 ml waters, to shake up the back oral, conducts a survey after 20 minutes again.Medication dose can be taken the circumstances into consideration increase and decrease according to actual effect.
Embodiment 4
The preparation of pepsin silicone oil composite Emulsion
1, prescription:
Simethicone 100g
Tween 80 10g
Sorbester p17 10g
Trypsin 2500 units: 1mg) 2g
Sodium carboxymethyl cellulose 6g
Saccharin sodium 0.1g
Sorbic acid 1g
2,6 ditertiary butyl p cresol 0.05g
Disodiumedetate 1g
Ethanol 10g
?????????????????????????????????
Purified water is to 1000ml
2, processing step:
(1) trypsin is crossed 100 mesh sieves, and is standby; Purified water is after boiling deoxidation treatment, and is standby;
(2) 2,6 ditertiary butyl p cresol is dissolved in the ethanol, gets solution I, and is standby; Disodiumedetate, trypsin and saccharin sodium get solution II with an amount of purified water dissolving fully, and be standby; Sodium carboxymethyl cellulose is scattered in an amount of purified water, gets uniform dispersion soln III, and is standby;
(3) Simethicone and Tween 80, sorbester p17 mix, after adding the equal proportion purified water again, complete with high-shearing dispersion emulsifying machine emulsifying, get the uniform colostrum of milky, stir and slowly add solution III, solution II, solution I and sorbic acid down in first Ruzhong, be settled to full dose with purified water, mix;
(4) fill, specification: 30ml/ bottle.
3, clinical use
In preceding 20 minutes of digestive endoscopy inspection and treatment or imaging examination, measure 4～6 milliliters of trypsin silicone oil composite Emulsions, adding 100 ml waters, to shake up the back oral, conducts a survey after 20 minutes again.Medication dose can be taken the circumstances into consideration increase and decrease according to actual effect.
Embodiment 5
The preparation of pepsin silicone oil composite sheet
1, prescription:
Simethicone 16g
Calcium hydrogen phosphate 32g
Pepsin (1200 units: 1g) 800g
Microcrystalline Cellulose 600g
Carboxymethyl starch is received 30g
10% starch slurry 35g (with amylometer)
Magnesium stearate 20g
???????????????????????????????????
Make 1000 bags altogether
2, processing step:
(1) simethicone and absorbent calcium hydrogen phosphate mix homogeneously are standby;
(2) take by weighing pepsin, microcrystalline Cellulose, carboxymethyl starch by recipe quantity and receive, add the mixture of simethicone and calcium hydrogen phosphate, mix homogeneously is done the binding agent granulation with 10% starch slurry, cross 24 mesh sieves, dried 18 order granulate 1.5 hours for 40 ℃, add the magnesium stearate mixing, tabletting, 1.53g/ sheet.
3, clinical use
In preceding 20 minutes of digestive endoscopy inspection and treatment or imaging examination, get 1 of pepsin silicone oil composite, take with about 100 ml waters, conduct a survey again after 20 minutes.Medication dose can be taken the circumstances into consideration increase and decrease according to actual effect.
Embodiment 6
The preparation of chain protease silicone oil composite granule
1, prescription:
Simethicone 40g
Calcium hydrogen phosphate 60g
Chain protease (4000 units: 1mg) 5g
Mannitol 600g
8% starch slurry 17g (with amylometer)
Magnesium stearate 8g
??????????????????????????????????????
Make 1000 bags altogether
2, processing step:
(1) simethicone and absorbent calcium hydrogen phosphate mix homogeneously are standby;
(2) take by weighing chain protease by recipe quantity, by equivalent progressively increase method and mannitol mixing, the mixture that adds simethicone and calcium hydrogen phosphate then, mix homogeneously is made binding agent with 8% starch slurry and is granulated, cross 24 mesh sieves, dried 1.5 hours for 40 ℃, 18 order granulate add the magnesium stearate mixing, pack, the 0.73g/ bag.
3, clinical use
In preceding 20 minutes of digestive endoscopy inspection and treatment or imaging examination, get 1 bag of chain protease silicone oil composite granule, disperse the back oral with about 50 ml waters dissolving, conduct a survey again after 20 minutes.Medication dose can be taken the circumstances into consideration increase and decrease according to actual effect.
Embodiment 7
The preparation of chain protease silicone oil composite granule
1, prescription:
Simethicone 40g
Calcium hydrogen phosphate 40g
Chain protease (4000 units: 1mg) 2.5g
Lactose 600g
10% starch slurry 14g (with amylometer)
Pulvis Talci 8g
???????????????????????????????????
Make 1000 bags altogether
2, processing step:
(1) simethicone and absorbent calcium hydrogen phosphate mix homogeneously are standby;
(2) take by weighing chain protease by recipe quantity,, add the mixture of simethicone and calcium hydrogen phosphate then, mix homogeneously by equivalent progressively increase method and lactose mixing, make binding agent with 10% starch slurry and granulate, cross 24 mesh sieves, dried 18 order granulate 1.5 hours for 40 ℃, add the Pulvis Talci mixing, pack, 0.7g/ bag.
3, clinical use
In preceding 20 minutes of digestive endoscopy inspection and treatment or imaging examination, get 1 bag of chain protease silicone oil composite granule, disperse the back oral with about 50 ml waters dissolving, conduct a survey again after 20 minutes.Medication dose can be taken the circumstances into consideration increase and decrease according to actual effect.
Embodiment 8
The preparation of chain protease silicone oil composite granule
1, prescription:
Simethicone 40g
Calcium hydrogen phosphate 40g
Chain protease (4000 units: 1mg) 0.5g
Mannitol 600g
10% starch slurry 14g (with amylometer)
Magnesium stearate 10g
???????????????????????????????????????????
Make 1000 bags altogether
2, processing step:
(1) simethicone and absorbent calcium hydrogen phosphate mix homogeneously are standby;
(2) take by weighing chain protease by recipe quantity, by equivalent progressively increase method and mannitol mixing, the mixture that adds simethicone and calcium hydrogen phosphate then, mix homogeneously is made binding agent with 10% starch slurry and is granulated, cross 24 mesh sieves, dried 1.5 hours for 40 ℃, 18 order granulate add the magnesium stearate mixing, pack, the 0.7g/ bag.
3, clinical use
In preceding 20 minutes of digestive endoscopy inspection and treatment or imaging examination, get 1 bag of chain protease silicone oil composite granule, disperse the back oral with about 50 ml waters dissolving, conduct a survey again after 20 minutes.Medication dose can be taken the circumstances into consideration increase and decrease according to actual effect.
Embodiment 9
The preparation of chain protease silicone oil composite granule
1, prescription:
Simethicone 20g
Calcium hydrogen phosphate 20g
Chain protease (4000 units: 1mg) 5g
Lactose 600g
Low-substituted hydroxypropyl cellulose 15g
10% starch slurry 13g (with amylometer)
Micropowder silica gel 9g
?????????????????????????
Make 1000 bags altogether
2, processing step:
(1) simethicone and absorbent calcium hydrogen phosphate mix homogeneously are standby;
(2) take by weighing chain protease by recipe quantity, by equivalent progressively increase method and lactose mixing, the mixture, the low-substituted hydroxypropyl cellulose that add simethicone and calcium hydrogen phosphate then, mix homogeneously is made binding agent with 10% starch slurry and is granulated, cross 24 mesh sieves, dried 1.5 hours for 40 ℃, 18 order granulate add the micropowder silica gel mixing, pack, the 0.68g/ bag.
3, clinical use
In preceding 20 minutes of digestive endoscopy inspection and treatment or imaging examination, get 1 bag of chain protease silicone oil composite granule, disperse the back oral with about 50 ml waters dissolving, conduct a survey again after 20 minutes.Medication dose can be taken the circumstances into consideration increase and decrease according to actual effect.
Embodiment 10
The preparation of chain protease pepsin silicone oil composite granule
1, prescription:
Simethicone 20g
Calcium hydrogen phosphate 20g
Chain protease (4000 units: 1mg) 0.5g
Pepsin (1200 units: 1g) 200g
Mannitol 600g
Cross-linking sodium carboxymethyl cellulose 25g
10% starch slurry 18g (with amylometer)
Magnesium stearate 8g
??????????????????????????????????????
Make 1000 bags altogether
2, processing step:
(1) simethicone and absorbent calcium hydrogen phosphate mix homogeneously are standby;
(2) take by weighing chain protease by recipe quantity, by equivalent progressively increase method and pepsin mixing, add the mixture of mannitol, cross-linking sodium carboxymethyl cellulose, simethicone and calcium hydrogen phosphate then, mix homogeneously, make binding agent with 10% starch slurry and granulate, cross 24 mesh sieves, dried 1.5 hours for 40 ℃, 18 order granulate, add the magnesium stearate mixing, pack, 0.89g/ bag.
3, clinical use
In preceding 20 minutes of digestive endoscopy inspection and treatment or imaging examination, get 1 bag of chain protease pepsin silicone oil composite granule, disperse the back oral with about 50 ml waters dissolving, conduct a survey again after 20 minutes.Medication dose can be taken the circumstances into consideration increase and decrease according to actual effect.
Embodiment 11
The preparation of chain protease simethicone Simethicone composition granule
1, prescription:
Simethicone 10g
Simethicone 10g
Calcium hydrogen phosphate 20g
Chain protease (4000 units: 1mg) 5g
Mannitol 600g
10% starch slurry 16g (with amylometer)
Magnesium stearate 5g
?????????????????????????????????????
Make 1000 bags altogether
2, processing step:
(1) simethicone, Simethicone and absorbent calcium hydrogen phosphate mix homogeneously are standby;
(2) take by weighing chain protease by recipe quantity, by equivalent progressively increase method and mannitol mixing, the mixture that adds simethicone, Simethicone and calcium hydrogen phosphate then, mix homogeneously is made binding agent with 10% starch slurry and is granulated, cross 24 mesh sieves, dried 1.5 hours for 40 ℃, 18 order granulate add the magnesium stearate mixing, pack, the 0.67g/ bag.
3, clinical use
In preceding 20 minutes of digestive endoscopy inspection and treatment or imaging examination, get 1 bag of chain protease simethicone Simethicone composition grain, disperse the back oral with about 50 ml waters dissolving, conduct a survey again after 20 minutes.Medication dose can be taken the circumstances into consideration increase and decrease according to actual effect.
Embodiment 12
The preparation of chain protease pepsin simethicone Simethicone composition granule
1, prescription:
Simethicone 20g
Simethicone 20g
Calcium hydrogen phosphate 50g
Chain protease (4000 units: 1mg) 0.5g
Pepsin (1200 units: 1g) 100g
Lactose 600g
10% starch slurry 18g (with amylometer)
Magnesium stearate 8g
????????????????????
Make 1000 bags altogether
2, processing step:
(1) simethicone, Simethicone and absorbent calcium hydrogen phosphate mix homogeneously are standby;
(2) by recipe quantity take by weighing chain protease, by equivalent progressively increase method and pepsin mixing, add lactose then, the mixture of simethicone, Simethicone and calcium hydrogen phosphate, mix homogeneously, make binding agent with 10% starch slurry and granulate, cross 24 mesh sieves, dried 1.5 hours for 40 ℃, 18 order granulate, add the magnesium stearate mixing, pack, 0.82g/ bag.
3, clinical use
In preceding 20 minutes of digestive endoscopy inspection and treatment or imaging examination, get 1 bag of chain protease pepsin simethicone Simethicone composition grain, disperse the back oral with about 50 ml waters dissolving, conduct a survey again after 20 minutes.Medication dose can be taken the circumstances into consideration increase and decrease according to actual effect.
Claims (10)
1. one kind is used for gastral pharmaceutical composition, and described compositions comprises first pharmacological activity component A that contains at least a digestive enzyme and the second pharmacological activity B component that contains at least a silicone oil analog.
2. compositions according to claim 1 further comprises at least a pharmaceutically suitable carrier, solvent or diluent.
3. compositions according to claim 1, wherein said digestive enzyme is selected from pepsin, trypsin, chain protease.
4. compositions according to claim 1, wherein said silicone oil analog is selected from simethicone and/or Simethicone.
5. compositions according to claim 4, the described first pharmacological activity component A of wherein per 6 units～1012 units and 1 milligram of described second pharmacological activity B component are carried out proportioning.
6. compositions according to claim 5, the described first pharmacological activity component A of wherein per 50 units～1000 units and 1 milligram of described second pharmacological activity B component are carried out proportioning.
7. compositions according to claim 6, the wherein said first pharmacological activity component A is a simethicone, the described second pharmacological activity B component is a chain protease.
8. compositions according to claim 7, wherein per 250 units～described chain protease of 500 units and 1 milligram of described simethicone carry out proportioning.
9. according to the described pharmaceutical composition of above-mentioned arbitrary claim, the dosage form of wherein said compositions is a kind of in granule, powder, suspensoid, Emulsion, the sheet.
10. according to the application in the adjuvant drug before preparation is as digestive endoscopy inspection and treatment or imaging examination art of the described pharmaceutical composition of above-mentioned arbitrary claim.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN2010101363377A CN101804199B (en) | 2010-03-30 | 2010-03-30 | Pharmaceutical composition used for alimentary canals and application thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010101363377A CN101804199B (en) | 2010-03-30 | 2010-03-30 | Pharmaceutical composition used for alimentary canals and application thereof |
Publications (2)
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| CN101804199A true CN101804199A (en) | 2010-08-18 |
| CN101804199B CN101804199B (en) | 2012-07-25 |
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| CN2010101363377A Active CN101804199B (en) | 2010-03-30 | 2010-03-30 | Pharmaceutical composition used for alimentary canals and application thereof |
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102048690A (en) * | 2011-01-14 | 2011-05-11 | 四川健能制药有限公司 | Dimeticone emulsion and preparation method thereof |
| CN106074615A (en) * | 2016-07-27 | 2016-11-09 | 长春呈实健康实业有限公司 | Gastrointestinal hemostasis froth breaking antibacterial and preparation method thereof |
| CN106492231A (en) * | 2016-11-03 | 2017-03-15 | 山东威高药业股份有限公司 | A kind of lidocaine hydrochloride tract lubricates infusion of dispelling |
| CN107441509A (en) * | 2017-08-16 | 2017-12-08 | 陕西省人民医院 | A kind of GI Medicine cleans medicine with stomach |
| CN107779285A (en) * | 2016-08-30 | 2018-03-09 | 山东威高药业股份有限公司 | A kind of alimentary canal mucus cleaning agent |
| CN107789619A (en) * | 2016-08-30 | 2018-03-13 | 山东威高药业股份有限公司 | A kind of alimentary canal mucus cleaning agent |
| CN109200278A (en) * | 2018-10-08 | 2019-01-15 | 毛玉坤 | Hysteroscope removes mucus defoaming agent and preparation method thereof |
| CN109675057A (en) * | 2017-10-19 | 2019-04-26 | 北京泰德制药股份有限公司 | A kind of solid pharmaceutical preparation and preparation method thereof containing pronase |
| CN115400228A (en) * | 2022-08-30 | 2022-11-29 | 中国人民解放军总医院第二医学中心 | Formula of anti-flocculation defoaming agent in gastroscopy |
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|---|---|---|---|---|
| US4906478A (en) * | 1988-12-12 | 1990-03-06 | Valentine Enterprises, Inc. | Simethicone/calcium silicate composition |
| US5073384A (en) * | 1989-10-19 | 1991-12-17 | Valentine Enterprises, Inc. | Maltodextrin/defoaming composition combinate |
| US5458886A (en) * | 1993-06-04 | 1995-10-17 | Dow Corning France S.A. | Antifoam compositions |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4906478A (en) * | 1988-12-12 | 1990-03-06 | Valentine Enterprises, Inc. | Simethicone/calcium silicate composition |
| US5073384A (en) * | 1989-10-19 | 1991-12-17 | Valentine Enterprises, Inc. | Maltodextrin/defoaming composition combinate |
| US5458886A (en) * | 1993-06-04 | 1995-10-17 | Dow Corning France S.A. | Antifoam compositions |
Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102048690A (en) * | 2011-01-14 | 2011-05-11 | 四川健能制药有限公司 | Dimeticone emulsion and preparation method thereof |
| CN106074615A (en) * | 2016-07-27 | 2016-11-09 | 长春呈实健康实业有限公司 | Gastrointestinal hemostasis froth breaking antibacterial and preparation method thereof |
| CN106074615B (en) * | 2016-07-27 | 2019-12-20 | 长春呈实健康实业有限公司 | Gastrointestinal hemostasis defoaming bacteriostatic agent and preparation method thereof |
| CN107779285A (en) * | 2016-08-30 | 2018-03-09 | 山东威高药业股份有限公司 | A kind of alimentary canal mucus cleaning agent |
| CN107789619A (en) * | 2016-08-30 | 2018-03-13 | 山东威高药业股份有限公司 | A kind of alimentary canal mucus cleaning agent |
| CN106492231A (en) * | 2016-11-03 | 2017-03-15 | 山东威高药业股份有限公司 | A kind of lidocaine hydrochloride tract lubricates infusion of dispelling |
| CN106492231B (en) * | 2016-11-03 | 2019-09-20 | 山东威高药业股份有限公司 | A kind of lidocaine hydrochloride cavity lubrication is dispelled infusion |
| CN107441509A (en) * | 2017-08-16 | 2017-12-08 | 陕西省人民医院 | A kind of GI Medicine cleans medicine with stomach |
| CN109675057A (en) * | 2017-10-19 | 2019-04-26 | 北京泰德制药股份有限公司 | A kind of solid pharmaceutical preparation and preparation method thereof containing pronase |
| CN109675057B (en) * | 2017-10-19 | 2023-02-21 | 北京泰德制药股份有限公司 | Solid preparation containing pronase and preparation method thereof |
| CN109200278A (en) * | 2018-10-08 | 2019-01-15 | 毛玉坤 | Hysteroscope removes mucus defoaming agent and preparation method thereof |
| CN115400228A (en) * | 2022-08-30 | 2022-11-29 | 中国人民解放军总医院第二医学中心 | Formula of anti-flocculation defoaming agent in gastroscopy |
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|---|---|
| CN101804199B (en) | 2012-07-25 |
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