CN103585173B - Sulfur acid sodium and can the pharmaceutical composition of sulphuric acid - Google Patents
Sulfur acid sodium and can the pharmaceutical composition of sulphuric acid Download PDFInfo
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- CN103585173B CN103585173B CN201310515394.XA CN201310515394A CN103585173B CN 103585173 B CN103585173 B CN 103585173B CN 201310515394 A CN201310515394 A CN 201310515394A CN 103585173 B CN103585173 B CN 103585173B
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Abstract
The invention belongs to pharmaceutical field, relate to a kind of pharmaceutical composition for mammalian gut cleaning, it is characterised in that said composition contains sodium sulfate 2g-15g, can sulphuric acid or its pharmaceutically acceptable salt be 2mg-20mg.
Description
Technical field
The invention belongs to pharmaceutical field, relate to a kind of pharmaceutical composition for mammalian gut cleaning, it is characterised in that said composition contains sodium sulfate 2g-15g, can sulphuric acid or its pharmaceutically acceptable salt be 2mg-20mg.
Background technology
INTESTINAL CLEANSING is the necessary step of intestinal mirror, and the effect of INTESTINAL CLEANSING directly influences quality and the accuracy of enteroscopy.Meanwhile, INTESTINAL CLEANSING also, is the required step of abdominal operation, operation on pelvis, thoracic surgery.
At present, the medicine that INTESTINAL CLEANSING is conventional has sodium ascorbyl phosphate oral solution, Polyethylene Glycol-electrolyte Powder etc..Sodium ascorbyl phosphate oral solution is 750ml due to the volume of its oral liquid, and patient is acceptant.But, substantial amounts of phosphate has been administered orally, the phosphate in blood rises significantly, can cause that Ca × P raises, and especially to the bad patient of those renal functioies or old people, frequently can lead to injury of kidney.Therefore, use is subject to being also affected by certain restriction clinically.
Sodium sulfate generally needs separately as INTESTINAL CLEANSING to use 15-20g every time, and consumption is very big, and INTESTINAL CLEANSING needs use twice, and total amount is 30-40g, and consumption is easily caused very greatly dehydration.
Polyethylene Glycol is osmotic laxative, large usage quantity, usually needs to use together with electrolyte.1980, Davis reports the INTESTINAL CLEANSING 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, and being equivalent to an INTESTINAL CLEANSING needs to use 22.72g sodium sulfate and 256g Polyethylene Glycol alcohol.In other one, commodity are the INTESTINAL CLEANSING medicine of KleanPrep is sodium sulfate 5.68g/L, and Polyethylene Glycol is 59g/L, and the consumption that makes of solution is also 4L, and being equivalent to an INTESTINAL CLEANSING needs to use 22.72g sodium sulfate and 236g Polyethylene Glycol.
Patent WO8700754 discloses the Polyethylene Glycol INTESTINAL CLEANSING medicine containing a small amount of sodium sulfate or the high concentration without sodium sulfate, and wherein Polyethylene Glycol reaches 120g/L, and consumption is 4L.Being equivalent to an INTESTINAL CLEANSING needs the Polyethylene Glycol used to be 480g, and consumption is quite big, and the volume taken is also very big, reaches 4L.
Patent CN1705494 reports the pharmaceutical composition of Polyethylene Glycol, sodium sulfate and ascorbic acid.The consumption of Polyethylene Glycol is 100g/L sodium sulfate is 7.5g/L, although decreases liquid owing to adding ascorbic acid, but needs for taking 2L.
Can sulphuric acid or sodium picosulfate as the slow cathartic of zest, usually need to use together with magnesium salt (citrate of magnesia) just to have good effect of intestinal tract preparation, such as commercial Prepopik contains sodium picosulfate 10mg, magnesium oxide 3.5g and citric acid 12g at present.Due to the magnesium oxide containing larger dose, after dissolving before using, form citrate of magnesia, also nearly 15-30% absorbs, causing that in blood samples of patients, magnesium ion concentration, higher than normal level, can cause the untoward reaction such as cardiovascular and bile duct, magnesium is from being also required to through renal excretion, therefore, renal function has patient's use of obstacle to be subject to certain restrictions.Meanwhile, magnesium salt is high osmosis cathartic, it is easy to cause electrolyte imbalance.
The inventor of this patent passes through great many of experiments, by sodium sulfate salt with can be used in combination by sulfate, sodium sulfate 2-10g, can sulfate be 2-20mg, compared with sodium sulfate or sodium picosulfate, sodium sulfate salt and can being used in combination by sulfate, the effect of the intestinal cleaning of increase, there is obvious difference, achieve beyond thought intestinal tract cleaning effect and mouthfeel.Meanwhile, the compositions of the present invention, compared with the INTESTINAL CLEANSING preparation of sulfur acid sodium and Polyethylene Glycol, has good mouthfeel, has been greatly reduced the volume taking liquid, improves the compliance of patient.Compared with Prepopik, due to without magnesium ion, it is possible to reduce the generation of hypermagnesemia, reduce owing to magnesium ion raises the untoward reaction of issuable cardiovascular, biliary tract and central nervous system.
Summary of the invention
The present invention relates to a kind of INTESTINAL CLEANSING pharmaceutical composition, it is characterised in that said composition contain sodium sulfate and can sulphuric acid or its pharmaceutically acceptable salt, wherein sodium sulfate 1-15g, can sulphuric acid or its pharmaceutically acceptable salt be 5mg-20mg.
The present invention can the primary structure of sulphuric acid or its pharmaceutically acceptable salt as follows:
R is H or is alkali metal.Preferred sodium, potassium.
Pharmaceutical composition of the present invention containing can sulphuric acid or its pharmaceutically acceptable salt being 5mg-20mg, sulfur acid sodium 2-20g.
The compositions of the present invention contains sodium sulfate 2-15g, can sulfate 2-20mg.
The compositions of the present invention contains sodium sulfate 2-15g, can sulfate 5-15mg.
The compositions of the present invention contains sodium sulfate 3-10g, can sulfate 5-15mg.
The compositions of the present invention contains sodium sulfate 3-8g, can sulfate 5-12.5mg.
The compositions of the present invention contains sodium sulfate 3-5.5g, can sulfate 7.5-12.5mg.
Pharmaceutical composition of the present invention, it is characterised in that this combination is containing osmotic pressure regulator.
Osmotic pressure regulator of the present invention includes, but are not limited to sodium salt and potassium salt.
Sodium salt sodium salt of the present invention includes, but are not limited to the sodium salt of sodium chloride, sodium bicarbonate, sodium carbonate, citric acid.
Potassium salt of the present invention includes, but are not limited to the potassium salt of potassium chloride, potassium carbonate, potassium bicarbonate, citric acid.
Compositions of the present invention contains acidic flavoring agent, sweeting agent and essence further.
Compositions of the present invention, acidic flavoring agent is selected from citric acid, succinic acid, tartaric acid, maleic acid.Preferably citric acid.
The compositions of the present invention contains sodium picosulfate 2-20mg, sodium sulfate 2-15g, potassium salt 0-2.0g, sodium salt (except sodium sulfate) 0-5g, acidic flavoring agent 0-5.0g.
The compositions of the present invention contains sodium sulfate 2-15g, sodium picosulfate 5-20mg, potassium bicarbonate 0-2.0g, sodium chloride 0-5g, acidic flavoring agent 0-5.0g, sweeting agent 0-5.0g.
The compositions of the present invention contains sodium sulfate 5-15mg, sodium picosulfate 3-10g, potassium bicarbonate 0.1-1.0g, citric acid 0.2-5.0g, saccharin sodium 0.05-2g.
The compositions of the present invention contains sodium sulfate 3-5.5g, sodium picosulfate 5-15mg, potassium bicarbonate 0.1-1.0g, citric acid 0.2-5.0g, saccharin sodium 0.05-2g.
The compositions of the present invention contains sodium sulfate 5g, sodium picosulfate 10mg, potassium bicarbonate 0.4g, citric acid 1.0g, saccharin sodium 0.1g.
The compositions of the present invention contains sodium sulfate 7.5g, sodium picosulfate 7.5mg, potassium bicarbonate 0.4g, citric acid 01.0g, saccharin sodium 0.1g.
The compositions of the present invention can be dissolved before in 50-1000ml water and be taken twice, once in intestinal mirror noon before that day, and the once morning before intestinal mirror.
Embodiment
The following is specific embodiments of the invention, it is not intended that present invention is limited only to following example.
Embodiment 1-3
Embodiment 1-3 and comparative example add water to 50ml.Dog 10, average weight is 12.1kg, is randomly divided into 5 groups, and often group intersects gavage successively, and the compositions of embodiment 1, embodiment 2, embodiment 3, comparative example 1 and comparative example 2, the clean phase is 5 days.Take in latter 24 hours, 2 hours 50ml drinking water gavages of animal per.Check average defecation weight in 24 hours of every treated animal.
The weight of defecation in checking 24 hours, result is as shown in the table.
| Embodiment | Empty the bowels weight (g) |
| Embodiment 1 | 550 |
| Embodiment 2 | 480 |
| Embodiment 3 | 560 |
| Comparative example 1 | 220 |
| Comparative example 2 | 230 |
Above result of study shows, use the combination of the present invention, its defecation is substantially better than comparative example 1 and comparative example 2, illustrate that the combination of sodium sulfate and sodium picosulfate can increase sodium picosulfate and sodium sulfate defecation and enteron-cleaning effect, the two is used in combination the effect of potentiation, there is obvious advantage compared with comparative example, achieve beyond thought effect.
Embodiment 1, embodiment 2, embodiment 3 and comparative example add water to 100ml and dissolve.Respectively taking 10ml and taste mouthfeel to 6 volunteers successively, mouthfeel is 5 points very well；Preferably 4；3 can be accepted；Mouthfeel is bad, it is possible to be accepted as 2 points；Mouthfeel is bad, is accepted as 1 reluctantly, and mouthfeel is bad, is not accepted as 0 point.Statistical result is as shown in the table.
It is shown that along with the minimizing of sodium sulfate consumption, mouthfeel is greatly increased, the present invention substantially can increase the compliance of patient.
By embodiment 1-3 according to computing formula: human dose (mg/kg)=(beasle dog consumption mg/ beasle dog body weight) × 0.531 × body weight, calculate the dosage below embodiment 4-6 of the single administration of 60kg adult.
Embodiment 7-12 is that the present invention combines composition and method of making the same, it is not intended that the present invention is only limited to following compositions and preparation method.
Example 7
Preparation technology: by sodium picosulfate in appropriate distilled water, sprays in potassium bicarbonate in fluid bed, dry, adds sodium sulfate, citric acid, saccharin sodium, cyclamate, strawberry essence mix homogeneously, is distributed into 6.51g/ bag.Compositions is dissolvable in water in 50-250ml water and once takes for patient.
Embodiment 8
Preparation technology: sodium picosulfate is dissolved in appropriate distilled water, sprays in potassium bicarbonate in fluid bed, dry, add sodium sulfate, citric acid, aspartame, cyclamate, orange flavor mix homogeneously, be distributed into 9.708g/ bag.Compositions is dissolvable in water in 200-500ml water and once takes for patient.
Embodiment 9
Preparation technology: sodium picosulfate, saccharin sodium are dissolved in appropriate distilled water, spray in potassium bicarbonate in fluid bed, dry, add sodium sulfate, citric acid, Mint Essence mix homogeneously, be distributed into 5.712g/ bag.Compositions is dissolvable in water in 50-500ml water and once takes for patient.
Embodiment 10
Sodium picosulfate is dissolved in appropriate distilled water, sprays in potassium bicarbonate in fluid bed, dry, add sodium sulfate, citric acid, saccharin sodium and orange flavor, mix homogeneously, be distributed into 6.37g/ bag.Compositions content dissolves in 50-500ml and takes for patient.
Embodiment 11
Sodium picosulfate is dissolved in appropriate distilled water, sprays in potassium bicarbonate in fluid bed, dry, add sodium sulfate, citric acid, sucralose and essence, mix homogeneously, be distributed into 7.06g/ bag.Compositions content dissolves in 250ml and takes for patient.
Embodiment 12
Sodium picosulfate, sodium bicarbonate are dissolved in appropriate distilled water, spray into middle sodium sulfate in fluid bed, dry, add tartaric acid, saccharin sodium, potassium chloride and essence, mix homogeneously, be distributed into 18.12g/ bag.Compositions divides content to be dissolved in water into 500-100ml, and before patient makees intestinal mirror, afternoon takes 250-500ml, and take 250-500ml in the morning.
Claims (10)
1. a good mouthfeel, take the INTESTINAL CLEANSING pharmaceutical composition that volume reduces, it is characterised in that said composition sulfur acid sodium 2-15g, containing can sulphuric acid or its pharmaceutically acceptable salt being 2mg-20mg.
2. pharmaceutical composition according to claim 1, said composition sulfur acid sodium 2-15g, containing can sulphuric acid or its pharmaceutically acceptable salt being 5mg-15mg.
3. pharmaceutical composition according to claim 2, said composition sulfur acid sodium 3-10g, containing can sulphuric acid or its pharmaceutically acceptable salt being 5-15mg.
4. pharmaceutical composition according to claim 3, said composition sulfur acid sodium 3-8g, containing can sulfate 5-12.5mg.
5. pharmaceutical composition according to claim 4, said composition sulfur acid sodium 3-5.5g, containing can sulfate 7.5-12.5mg.
6. pharmaceutical composition according to claim 1, this combination is containing osmotic pressure regulator, acidic flavoring agent and sweeting agent.
7. pharmaceutical composition according to claim 6, described osmotic pressure regulator is selected from sodium salt, potassium salt；Described acidic flavoring agent is selected from citric acid, succinic acid, tartaric acid, maleic acid；Described sweeting agent is selected from saccharin sodium, cyclamate, sucralose, aspartame.
8. pharmaceutical composition according to claim 6, described compositions contains sodium picosulfate 5-20mg, sodium sulfate 2-15g, potassium bicarbonate 0-2.0g, sodium chloride 0-5g, acidic flavoring agent 0-5.0g, sweeting agent 0-5.0g.
9. pharmaceutical composition according to claim 8, described compositions contains sodium picosulfate 5-20mg, sodium sulfate 2-15g, potassium bicarbonate 0-1.0g, acidic flavoring agent 0-2.0g, sweeting agent 0-2.0g.
10. pharmaceutical composition according to claim 1, described compositions is dissolved in 50-1000ml wet suit and uses.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310515394.XA CN103585173B (en) | 2013-10-28 | 2013-10-28 | Sulfur acid sodium and can the pharmaceutical composition of sulphuric acid |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310515394.XA CN103585173B (en) | 2013-10-28 | 2013-10-28 | Sulfur acid sodium and can the pharmaceutical composition of sulphuric acid |
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| CN103585173A CN103585173A (en) | 2014-02-19 |
| CN103585173B true CN103585173B (en) | 2016-06-29 |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6103268A (en) * | 1995-11-03 | 2000-08-15 | Borody; Thomas Julius | Administering osmotic colonic evacuant containing a picosulfate |
| CN101087593A (en) * | 2003-11-19 | 2007-12-12 | 萨利克斯药物公司 | Colonic purgative composition with soluble binding agent |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| BR112014009946A2 (en) * | 2011-10-27 | 2017-04-25 | Salix Pharmaceuticals Inc | "purgative composition, pharmaceutical composition or formulation and use thereof" |
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- 2013-10-28 CN CN201310515394.XA patent/CN103585173B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6103268A (en) * | 1995-11-03 | 2000-08-15 | Borody; Thomas Julius | Administering osmotic colonic evacuant containing a picosulfate |
| CN101087593A (en) * | 2003-11-19 | 2007-12-12 | 萨利克斯药物公司 | Colonic purgative composition with soluble binding agent |
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| CN103585173A (en) | 2014-02-19 |
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Effective date of registration: 20220712 Address after: 401329 No. 1-1, building 2, No. 28, Gaoxin Avenue, 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 |
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