CN103550249A - Pharmaceutical composition for bowel preparation - Google Patents
Pharmaceutical composition for bowel preparation Download PDFInfo
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- CN103550249A CN103550249A CN201310555933.2A CN201310555933A CN103550249A CN 103550249 A CN103550249 A CN 103550249A CN 201310555933 A CN201310555933 A CN 201310555933A CN 103550249 A CN103550249 A CN 103550249A
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- polyethylene glycol
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Abstract
The invention belongs to the field of pharmacy, and relates to a pharmaceutical composition for bowel preparation of mammal. The pharmaceutical composition is characterized by comprising 20 to 200g of polyethylene glycol and 2 to 20mg of picosulfate or pharmaceutically acceptable salt thereof.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, relate to a kind of pharmaceutical composition for the cleaning of mammal intestinal, it is characterized in that said composition contains Polyethylene Glycol and can sulphuric acid or its pharmaceutically acceptable salt, wherein Polyethylene Glycol is 20g-200g, can sulphuric acid or its pharmaceutically acceptable salt be 2mg-20mg.
Background technology
It is the necessary step of intestinal mirror that intestinal is prepared, and the effect that intestinal is prepared directly has influence on quality and the accuracy of enteroscopy.Meanwhile, intestinal is prepared also, is the essential step of abdominal operation, operation on pelvis, thoracic surgery.
At present, intestinal is prepared conventional medicine has sodium ascorbyl phosphate oral solution, polyethylene glycol electrolyte loose etc.Sodium ascorbyl phosphate oral solution is because the volume of its oral liquid is 750ml, and patient is acceptant.Yet, oral phosphate in a large number, the phosphate in blood rises greatly, can cause Ca * P to raise, and especially, to the bad patient of those renal functioies or old people, tends to cause injury of kidney.Therefore, use and be also subject to certain restrictions clinically.
Polyethylene Glycol (PEG) is osmotic laxative, and large usage quantity usually needs to use together with electrolyte.1980, Davis has reported the intestinal preparation medicine of Polyethylene Glycol and sodium sulfate, commodity are called GoLYTELY, wherein sodium sulfate consumption is 5.68g/L, the consumption of Polyethylene Glycol is 64g/L, the consumption of solution is 4L, is equivalent to an intestinal and prepares to use 22.72g sodium sulfate and 256g Polyethylene Glycol alcohol.In other one, commodity are that the intestinal preparation medicine of Klean Prep is sodium sulfate 5.68g/L, and Polyethylene Glycol is 59g/L, and the use amount of solution is also 4L, is equivalent to an intestinal and prepares to use 22.72g sodium sulfate and 236g Polyethylene Glycol.
Patent WO8700754 discloses containing the Polyethylene Glycol intestinal of the high concentration of a small amount of sodium sulfate or non-contains sodium sulfate and has prepared medicine, and wherein Polyethylene Glycol reaches 120g/L, and consumption is 4L.Being equivalent to the Polyethylene Glycol that intestinal prepares to use is 480g, and consumption is quite large.
Patent CN1705494 has reported the pharmaceutical composition of Polyethylene Glycol, sodium sulfate and ascorbic acid.The consumption of Polyethylene Glycol is that 100g/L sodium sulfate is 7.5g/L, although owing to having added ascorbic acid to reduce liquid, or need to take 2L, and therefore, the consumption of an intestinal preparation Polyethylene Glycol reaches 200g, and the consumption of sodium sulfate reaches 15g.The concentration of Polyethylene Glycol and sodium sulfate increases simultaneously, is difficult to obtain good mouthfeel.
Comprehensive the above, it is 200-480g Polyethylene Glycol that polyethylene glycol electrolyte intestinal is prepared medicine Polyethylene Glycol consumption, sodium sulfate 15g-23g, need 2-4 water dissolution, Polyethylene Glycol and sodium sulfate mouthfeel are bad, client need is stood to take when maximum volume reaches the solution of 4L and also will be stood bad mouthfeel, poor compliance.The untoward reaction such as that patient usually has is nauseating, vomiting, thereby reduce or stop use, cause intestinal cleaning bad or failed, affect work-up.
Visible, on market, need that a kind of mouthfeel is better, intestinal cleaning effect better, safety better intestinal prepare medicine.The inventor of this patent is by great many of experiments, and by Polyethylene Glycol with can combine use by sulfate, the consumption of an intestinal preparation Polyethylene Glycol is 20-200g, can sulfate be 2-20mg, and the volume of liquid is 0.1-2L good mouthfeel.If desired, this compositions can add sodium sulfate 2-15g.Compare with 15g-23g sodium sulfate containing 200-480g Polyethylene Glycol with the Polyethylene Glycol sodium sulfate compound preparation having gone on the market, reduced the consumption of Polyethylene Glycol and sodium sulfate, reduced the volume of taking of pharmaceutical liquid, obtain good mouthfeel, improved patient's compliance.
With the compound recipe sodium ascorbyl phosphate oral liquid phase ratio having gone on the market, do not have sodium ascorbyl phosphate easily to cause the too high situation of phosphate in body, can not cause the untoward reaction such as injury of kidney.
In a word, Polyethylene Glycol of the present invention and can sulfate combination, the two has potentiation, has reduced Polyethylene Glycol, has different unimaginable good taste simultaneously.With the conventional oral nearly liquid phase ratio of 4L of polyethylene glycol electrolyte, the present composition is 0.1-2 L liquid, can improve patient's compliance.
Summary of the invention
The present invention relates to a kind of intestinal and prepare pharmaceutical composition, it is characterized in that said composition contains Polyethylene Glycol and can sulphuric acid or its pharmaceutically acceptable salt, wherein Polyethylene Glycol is 10g-200g, can sulphuric acid or its pharmaceutically acceptable salt be 2mg-20mg.
Pharmaceutical composition of the present invention, wherein the molecular weight of Polyethylene Glycol is 2000-8000
Pharmaceutical composition of the present invention, wherein the molecular weight of Polyethylene Glycol is 2000-6000, PEG3325 for example, PEG4000.
Of the present invention can sulphuric acid or the primary structure of its pharmaceutically acceptable salt as follows:
R is H or is alkali metal.Preferred sodium, potassium.
Pharmaceutical composition of the present invention, is 20-200g containing Polyethylene Glycol, containing can sulphuric acid or its pharmaceutically acceptable salt be 2mg-20mg
Pharmaceutical composition of the present invention, is 80-120g containing Polyethylene Glycol, containing can sulphuric acid or its pharmaceutically acceptable salt be 2.5mg-10mg.
Pharmaceutical composition of the present invention, is 80-120g containing Polyethylene Glycol, containing can sulphuric acid or its pharmaceutically acceptable salt be 2.5mg-5mg.
Pharmaceutical composition of the present invention, is 30-80g containing Polyethylene Glycol, containing can sulphuric acid or its pharmaceutically acceptable salt be 5mg-12.5mg.
Pharmaceutical composition of the present invention, is 30-50g containing Polyethylene Glycol, containing can sulphuric acid or its pharmaceutically acceptable salt be 7.5mg-12.5mg.
Pharmaceutical composition of the present invention, is 50-200g containing Polyethylene Glycol, containing can sulphuric acid or its pharmaceutically acceptable salt be 2.5mg-20mg, compositions adds 500-2500ml dissolve or mix, and for patient, takes.
Pharmaceutical composition of the present invention, is 80-120g containing Polyethylene Glycol, containing can sulphuric acid or its pharmaceutically acceptable salt be 2.5mg-10mg.Be dissolved in common patient in 1000ml water and take, an intestinal is prepared to take two doses.
Pharmaceutical composition of the present invention, is 80-100g containing Polyethylene Glycol, containing can sulphuric acid or its pharmaceutically acceptable salt be 2.5mg-5mg.Be dissolved in common patient in 1000ml water and take, an intestinal is prepared to take two doses.
Pharmaceutical composition of the present invention, is 30-80g containing Polyethylene Glycol, containing can sulphuric acid or its pharmaceutically acceptable salt be 5mg-12.5mg.Be dissolved in common patient in 500ml water and take, one time intestinal prepares to take two doses of these compositionss.
Pharmaceutical composition of the present invention, is 30-50g containing Polyethylene Glycol, containing can sulphuric acid or its pharmaceutically acceptable salt be 7.5mg-12.5mg.Be dissolved in common patient in 250-500ml water and take, one time intestinal prepares to take two doses of these compositionss.
Of the present invention can sulphuric acid or its pharmaceutically acceptable be sodium picosulfate.
Pharmaceutical composition of the present invention, is characterized in that this combination is containing 2-20g sodium sulfate
Pharmaceutical composition of the present invention, is characterized in that this combination is containing 5-15g sodium sulfate.
Pharmaceutical composition of the present invention, is 20-200g containing Polyethylene Glycol, containing can sulphuric acid or its pharmaceutically acceptable salt be 2 mg-20mg, contains sodium sulfate 2-20g.
Pharmaceutical composition of the present invention, is 80-120g containing Polyethylene Glycol, containing can sulphuric acid or its pharmaceutically acceptable salt be 2.5mg-7.5mg, sodium sulfate 3-15g.
Pharmaceutical composition of the present invention, is 30-60g containing Polyethylene Glycol, containing can sulphuric acid or its pharmaceutically acceptable salt be 5mg-12.5mg, contains sodium sulfate 3-15g.
Pharmaceutical composition of the present invention, is 20-200g containing Polyethylene Glycol, containing can sulphuric acid or its pharmaceutically acceptable salt be 2 mg-20mg, contains sodium sulfate 3-15g.Be dissolved in 100-2500ml water, for patient, take.
Pharmaceutical composition of the present invention, is 80-120g containing Polyethylene Glycol, containing can sulphuric acid or its pharmaceutically acceptable salt be 2mg-20mg, contains sodium sulfate 3-15g.Be dissolved in 500-1000ml water, for patient, take, an intestinal is prepared to take two doses.
Pharmaceutical composition of the present invention, is 30-60g containing Polyethylene Glycol, containing can sulphuric acid or its pharmaceutically acceptable salt be 5mg-12.5mg, contains sodium sulfate 5-10g.Be dissolved in 250-500ml water and take for patient, an intestinal is prepared to take two doses.
Pharmaceutical composition of the present invention, is characterized in that this combination is containing osmotic pressure regulator sodium chloride or potassium chloride or sodium carbonate salt or their mixture.
Compositions of the present invention further contains appropriate sweeting agent, essence and acidic flavoring agent.
Compositions of the present invention, acidic flavoring agent is selected from citric acid, succinic acid, tartaric acid, maleic acid.
" intestinal prepare take two doses " of the present invention generally took two doses before patient carries out intestinal mirror, once in intestinal mirror noon before that day, and morning before intestinal mirror once.
Embodiment
Be below specific embodiments of the invention, but do not represent that the present invention only limits to following examples.
Embodiment 1-4
Embodiment 1 and embodiment 4 add water to 100ml, and embodiment 2, embodiment 3 and comparative example add water to 200ml.10 of dogs, average weight is 12.5kg, is divided at random 5 groups, every group intersects gavage successively, embodiment 1, embodiment 2, embodiment 3, embodiment 4 and comparative example's 1 compositions, the clean phase is 5 days.Take in latter 24 hours 1 hour 50m drinking water gavage of animal per.
The consumption that comparative example is PEG3350 and sodium sulfate is that the PEG3350 of Klean Prep and the consumption of sodium sulfate are converted according to people and beasle dog specific surface area, and convert formula is beasle dog consumption=1.88 * human body consumption/60 (kg) * 12.5kg.
The weight that checks defecation in 24 hours, result is as shown in the table.
Above result of study shows, uses combination of the present invention, and its defecation is obviously better than comparative example, illustrates that PEG and combination that can sulphuric acid can increase the effect of defecation, with comparative example's ratio, has significant difference, obtains beyond thought result.
Embodiment 1 and embodiment 4 add water to 100ml, and embodiment 2, embodiment 3 and comparative example add water to 200ml.Respectively get 10ml and to 6 volunteers, taste mouthfeel successively, mouthfeel is fine is 5 minutes; Preferably 4; Can accept 3; Mouthfeel is bad, can be accepted as 2 minutes; Mouthfeel is bad, is accepted as reluctantly 1, and mouthfeel is bad, is not accepted as 0 minute.Statistical result is as shown in the table.
Above experimental result shows, embodiment 1, embodiment 2, embodiment 3, embodiment 4 defecations are obviously better than comparative example, have significant difference, have obtained beyond thought result.Mouthfeel experiment shows, the embodiment of the present invention 1,2,3 and 4 are all better than comparative example, and especially best with embodiment 1 mouthfeel, embodiment 2 takes second place, embodiment 4 takes second place again, illustrate that reducing sodium sulfate has improved mouthfeel, because the amount of embodiment of the present invention sodium sulfate is all less than comparative example's amount, so mouthfeel of the present invention is all better than comparative example.
Above result of study shows, compositions of the present invention has not only improved defecation effect, and has good mouthfeel.
According to above result of the test, according to body surface area, convert out other mammiferous consumption, computing formula is: convert formula is human body consumption=0.531 * beasle dog amount/12.5 (kg) * 60kg.
Embodiment 1-4 compositions conversion people (with 60kg) dosage for oral use is roughly as shown in the table successively:
Embodiment 9-14 is that the present invention combines composition and method of making the same, but does not represent that the present invention only only limits to following compositions and preparation method.
Example 9
Preparation technology: by sodium picosulfate, saccharin sodium, cyclamate, citric acid is dissolved in appropriate distilled water, sprays in PEG3350 in fluid bed, dry, adds essence, and mix homogeneously, is distributed into 50.71g/ bag.Every bag is dissolvable in water in 250ml water for patient, and an intestinal is prepared to take twice, each one bag.
Embodiment 10
Sodium picosulfate is dissolved in appropriate distilled water, in fluid bed, sprays in sodium bicarbonate, dry.Add PEG3350, potassium chloride, sodium chloride, saccharin sodium, citric acid and essence, mix homogeneously, is distributed into 104.2g/ bag.Compositions is dissolvable in water in 500-1000ml water for patient.
Embodiment 11
Sodium picosulfate is dissolved in appropriate distilled water, in fluid bed, sprays in sodium bicarbonate, dry.Add PEG3350, sodium sulfate, sodium chloride, potassium chloride, saccharin sodium and essence, mix homogeneously, is distributed into 59.7g/ bag.
Embodiment 12
Sodium picosulfate is dissolved in appropriate distilled water, in fluid bed, sprays in sodium bicarbonate, dry.Add Macrogol 4000, sodium sulfate, potassium chloride, sodium chloride, cyclamate, citric acid and essence, mix homogeneously, is distributed into 91.7g/ bag.
Embodiment 13
Compositions content is dissolved in water into 1000-2000ml, and patient divides early take for twice evening.
Sodium picosulfate is dissolved in appropriate distilled water, in fluid bed, sprays in potassium bicarbonate, dry.Add Macrogol 4000, sodium sulfate, sodium chloride, saccharin sodium, citric acid and essence, mix homogeneously, is distributed into 182.7g/ bag.
Embodiment 14
Compositions is dissolved in 250-500ml water to be taken for patient.
Sodium picosulfate is dissolved in appropriate distilled water, in fluid bed, sprays in sodium bicarbonate, dry.Add Macrogol 4000, sodium sulfate, potassium chloride, sodium chloride, sucralose, tartaric acid and essence, mix homogeneously, is distributed into 42.7g/ bag.
Claims (10)
1. a pharmaceutical composition of preparing for mammiferous intestinal, it is characterized in that said composition contains Polyethylene Glycol and can sulphuric acid or its pharmaceutically acceptable salt, wherein Polyethylene Glycol is 20g-200g, can sulphuric acid or its pharmaceutically acceptable salt be 2mg-20mg.
2. pharmaceutical composition according to claim 1, is characterized in that it is 80-120g that said composition contains Polyethylene Glycol, can sulphuric acid or its pharmaceutically acceptable salt be 2.5mg-7.5mg.
3. pharmaceutical composition according to claim 1, is characterized in that it is 30-60g that said composition contains Polyethylene Glycol, can sulphuric acid or its pharmaceutically acceptable salt be 5mg-15mg.
4. pharmaceutical composition according to claim 3, is characterized in that it is 30-50g that said composition contains Polyethylene Glycol, can sulphuric acid or its pharmaceutically acceptable salt be 7.5mg-12.5mg.
5. pharmaceutical composition according to claim 1, wherein the molecular weight of Polyethylene Glycol is 2000-8000.
6. pharmaceutical composition according to claim 5, wherein the molecular weight of Polyethylene Glycol is 2000-6000.
7. pharmaceutical composition according to claim 1, is characterized in that this combination is containing 2-20g sodium sulfate.
8. pharmaceutical composition according to claim 7, is characterized in that this combination is containing 3-15g sodium sulfate.
9. pharmaceutical composition according to claim 1, is characterized in that this combination is containing osmotic pressure regulator.
10. pharmaceutical composition according to claim 9, osmotic pressure regulator is selected from one or more in sodium chloride, potassium chloride, sodium carbonate, potassium bicarbonate.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310555933.2A CN103550249B (en) | 2013-11-09 | 2013-11-09 | A kind of pharmaceutical composition for INTESTINAL CLEANSING |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201310555933.2A CN103550249B (en) | 2013-11-09 | 2013-11-09 | A kind of pharmaceutical composition for INTESTINAL CLEANSING |
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| CN103550249A true CN103550249A (en) | 2014-02-05 |
| CN103550249B CN103550249B (en) | 2015-08-12 |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8999313B2 (en) | 2012-09-11 | 2015-04-07 | Norgine Bv | Compositions |
| US9592252B2 (en) | 2011-03-11 | 2017-03-14 | Norgine Bv | Colonoscopy—preparation |
| CN107787223A (en) * | 2015-06-22 | 2018-03-09 | 西梯茜生命工学股份有限公司 | Cleaning intestinal tract purgatives composition |
| CN108601842A (en) * | 2016-01-28 | 2018-09-28 | 西梯茜生命工学股份有限公司 | Anti-constipation composition |
Citations (1)
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| WO2013039477A1 (en) * | 2011-09-12 | 2013-03-21 | University Of South Alabama | Non-invasive methods of detecting target molecules |
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- 2013-11-09 CN CN201310555933.2A patent/CN103550249B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2013039477A1 (en) * | 2011-09-12 | 2013-03-21 | University Of South Alabama | Non-invasive methods of detecting target molecules |
Cited By (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10646512B2 (en) | 2011-03-11 | 2020-05-12 | Norgine Bv | Colonoscopy - preparation |
| US11529368B2 (en) | 2011-03-11 | 2022-12-20 | Norgine Bv | Colonoscopy—preparation |
| US9592252B2 (en) | 2011-03-11 | 2017-03-14 | Norgine Bv | Colonoscopy—preparation |
| US10792306B2 (en) | 2011-03-11 | 2020-10-06 | Norgine Bv | Colonoscopy—preparation |
| US10780112B2 (en) | 2011-03-11 | 2020-09-22 | Norgine Bv | Colonoscopy-preparation |
| US9707297B2 (en) | 2012-09-11 | 2017-07-18 | Norgine Bv | Compositions |
| US10016504B2 (en) | 2012-09-11 | 2018-07-10 | Norgine Bv | Compositions |
| US8999313B2 (en) | 2012-09-11 | 2015-04-07 | Norgine Bv | Compositions |
| US10918723B2 (en) | 2012-09-11 | 2021-02-16 | Norgine Bv | Colon cleansing compositions and methods of use |
| US9326969B2 (en) | 2012-09-11 | 2016-05-03 | Norgine Bv | Compositions |
| CN107787223A (en) * | 2015-06-22 | 2018-03-09 | 西梯茜生命工学股份有限公司 | Cleaning intestinal tract purgatives composition |
| CN108601842A (en) * | 2016-01-28 | 2018-09-28 | 西梯茜生命工学股份有限公司 | Anti-constipation composition |
| JP2019507121A (en) * | 2016-01-28 | 2019-03-14 | シーティーシー バイオ，インコーポレイテッド | Laxative composition |
| EP3409290A4 (en) * | 2016-01-28 | 2019-09-18 | CTC Bio, Inc. | Purgative composition |
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Effective date of registration: 20220711 Address after: 401329 No. 1-1, building 2, No. 28, Gaoxin Avenue, Jinfeng Town, Jiulongpo District, Chongqing Patentee after: Chongqing yaoguiren Biomedical Technology Co.,Ltd. Address before: 402260 room 11-7, building D, Xingyun Manting, Dingshan street, Jiangjin District, Chongqing Patentee before: Wang Xianzhu |