CN102232969A - Sodium phosphate composition - Google Patents
Sodium phosphate composition Download PDFInfo
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- CN102232969A CN102232969A CN 201010166215 CN201010166215A CN102232969A CN 102232969 A CN102232969 A CN 102232969A CN 201010166215 CN201010166215 CN 201010166215 CN 201010166215 A CN201010166215 A CN 201010166215A CN 102232969 A CN102232969 A CN 102232969A
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- sodium
- phosphate
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- ascorbyl phosphate
- simethicone
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Abstract
The invention discloses a sodium phosphate composition comprising sodium dihydrogen phosphate, disodium hydrogen phosphate and dimeticone. The composition has notable clinical effect on cleaning the intestinal tract, good cleanliness of the intestinal tract, good tolerance of patients and small water-electrolyte imbalance.
Description
Technical field
The present invention relates to technical field of medicine, be specifically related to a kind of sodium ascorbyl phosphate compositions of clearing up intestinal.
Background technology
The intestinal cleaning is before the operation or an important preparation before colon X-light and the intestinal splanchnoscopy.Reach the exposure in the visual field in X-light or the intestinal splanchnoscopy in the good and bad directly influence operation that intestinal is prepared, preparing can directly not increase the endoscopic difficulty of operation and X-light or intestinal completely, and traditional intestinal cleaning method has following several:
1, clysmata: solution commonly used adopts suds, normal saline or clear water, and this method not only makes distal rectal mucosa injury and liquid resorption cause poor effect easily, and complex operation, workload is big, it is frequent that the patient goes into the lavatory, and defecation is wayward, and the patient is difficult for accepting.
2, mouth medication: comprise Chinese medicine or Western medicine.Chinese medicine is commonly used Folium Sennae, Oleum Ricini and Chinese herbs decoction, and the Folium Sennae medicinal liquid is pale brown color, influences the intestinal tract cleaning observation on effect; The Oleum Ricini mouthfeel is poor, and clinical observation also owes desirable to the cleaning effect of intestinal; Chinese herbs decoction has rhubarb preparation, Natrii Sulfas preparation etc., and its mouthfeel and patient's compliance is poor.
Western medicine tradition is used mannitol, magnesium sulfate, Polyethylene Glycol etc.Wherein mannitol and intestinal bacteria can produce hydrogen and methane, do setting off an explosion easily when radio frequency, microwave etc. are fulgerized treatment at intestinal, and at present, intestinal cleaned before American-European countries had banned use of mannitol to carry out surgical operation; The magnesium sulfate taste bad will occurs easily when more patient takes feeling sick, senses of discomfort such as vomiting, stomachache, dehydration; Though and Polyethylene Glycol can reach effect preferably, must take heavy dose of solution simultaneously, the 3-4 liter has seriously hindered patient and has finished the intestinal cleaning usually.
Sodium ascorbyl phosphate is that a kind of high-quality intestinal is prepared medicine, clinical practice for many years through the North America and all over the world, the safety of this medicine, effectiveness, convenience and patient's compliance are extensively confirmed, become the north America region surgical operation now, the number one brand medicine that intestinal is prepared before colon X-light and the intestinal splanchnoscopy.
Its main component of sodium ascorbyl phosphate is: sodium hydrogen phosphate and sodium dihydrogen phosphate are a kind of hypertonicity laxatives, indication: preoperative intestinal cleaning; Intestinal cleaning before the colon X-light is checked; Intestinal cleaning before the colonoscopy.
The preparation of sodium ascorbyl phosphate listing at present has oral administration solution, tablet.Oral administration solution carries inconvenience, and contains antiseptic, and safety hidden danger is arranged, and is not suitable for gerontal patient or child and uses.And during its tablet oral administration, the consumption of an intestinal of cleaning is 40, and take 20 the evening before that day of operation or enteroscopy, and each 3, the drinking water with about 220～250ml takes at every turn, is 2 for the last time, and took once in 15 minutes at every interval; Again before operation or enteroscopy 3～5 hours with canonical with 20, tablets quantity is excessive, makes troubles to patient use.
The market in urgent need exploitation is a kind of both easy to carry, safe and effective, the sodium ascorbyl phosphate preparation of taking convenience again, the applicant is in the process of exploitation sodium ascorbyl phosphate preparation, by a large amount of tests and prescription screening, the unexpected discovery, on the basis of existing sodium ascorbyl phosphate preparation, add simethicone, its clinical application effect significantly improves.
Summary of the invention
The object of the present invention is to provide a kind of sodium ascorbyl phosphate compositions, said composition is cleared up the intestinal effect in clinical practice remarkable.
Said composition of the present invention comprises sodium dihydrogen phosphate, sodium hydrogen phosphate, simethicone, calculates 9.4～37.6 parts of sodium dihydrogen phosphate, 2.2～8.6 parts of sodium hydrogen phosphates, 0.05～0.3 part of simethicone by weight.
Said composition intestinal tract cleaning degree is good, patient tolerability good, and the Water-Electrolyte disorder is little.
Further, said composition also comprises glucose, and preferred dose is calculated 0.8～10 part of glucose by weight.
Further, calculate by weight, said composition also comprises 0.135～0.25 part of sweeting agent, 0.015～0.04 part in essence, 0.1～0.5 part of lubricant.
Wherein sweeting agent is selected from aspartame, saccharin sodium.
Wherein essence is selected from Fructus Citri Limoniae essence, Fructus Rubi essence.
Wherein lubricant is selected from silicon dioxide, magnesium stearate.
The specific embodiment
The present invention is further illustrated 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.Adjuvant in following examples can be replaced with acceptable accessories, perhaps reduces, increases.
Embodiment 1
Sodium ascorbyl phosphate powder
1, prescription:
Sodium dihydrogen phosphate (being monohydrate form 21.6kg) 18.8kg
Sodium hydrogen phosphate (for no hydrate form) 4.3kg
Simethicone 0.15kg
Silicon dioxide 0.1kg
Make 1000 bags altogether
2, processing step:
(1) just mixes: take by weighing sodium dihydrogen phosphate, sodium hydrogen phosphate, simethicone, the silicon dioxide of recipe quantity, place mixer to carry out just mixing 3 minutes;
(2) beating powder sieves: beat powder in Universalpulverizer, cross 80 mesh sieves, get mixed powder;
(3) total mixing: mixed powder is put in the mixer and was mixed 3 minutes, abundant mix homogeneously, and sealing is preserved;
(4) pack.
3, usage and dosage
Oral: the consumption of an intestinal of cleaning is 52.3g (2 bags).Take 26g the evening before that day of operation or enteroscopy, usage adopts dilution scheme, with taking after the drinking water stirring and dissolving more than the 750ml; Again in the operation or enteroscopy before 3～5 hours with canonical 26.15g.
Embodiment 2
Sodium ascorbyl phosphate powder
1, prescription:
Sodium dihydrogen phosphate (being monohydrate form 21.6kg) 18.8kg
Sodium hydrogen phosphate (for no hydrate form) 4.3kg
Simethicone 0.15kg
Glucose 2.35kg
Silicon dioxide 0.1kg
Make 1000 bags altogether
2, processing step:
(1) just mixes: take by weighing sodium dihydrogen phosphate, sodium hydrogen phosphate, simethicone, silicon dioxide, the glucose of recipe quantity, place mixer to carry out just mixing 3 minutes;
(2) beating powder sieves: beat powder in Universalpulverizer, cross 80 mesh sieves, get mixed powder;
(3) total mixing: mixed powder is put in the mixer and was mixed 3 minutes, abundant mix homogeneously, and sealing is preserved;
(4) pack.
3, usage and dosage
Oral: the consumption of an intestinal of cleaning is 57g (2 bags).Take 28.4g the evening before that day of operation or enteroscopy, usage adopts dilution scheme, with taking after the drinking water stirring and dissolving more than the 750ml; Again in the operation or enteroscopy before 3～5 hours with canonical 28.5g.
Embodiment 3
Sodium ascorbyl phosphate powder
1, prescription:
Sodium hydrogen phosphate (for no hydrate form) 4.3kg
Sodium dihydrogen phosphate (being monohydrate form 21.6kg) 18.8kg
Aspartame 0.2kg
Glycerol 0.05kg
Fructus Citri Limoniae essence 0.04kg
Simethicone 0.15kg
Silicon dioxide 0.5kg
Make 1000 bags altogether
2, processing step:
(1) just mixes: take by weighing sodium dihydrogen phosphate, sodium hydrogen phosphate, simethicone, the glycerol of recipe quantity, place mixer to carry out just mixing 3 minutes;
(2) beating powder sieves: beat powder in Universalpulverizer, cross 80 mesh sieves, get mixed powder;
(3) total mixed: the aspartame, Fructus Citri Limoniae essence, the silicon dioxide that add recipe quantity in the mixed powder are put the interior mixing of mixer 3 minutes, and fully mix homogeneously seals and preserves;
(4) pack.
3, usage and dosage
Oral: the consumption of an intestinal of cleaning is 53.7g (2 bags).Take 26.8g the evening before that day of operation or enteroscopy, usage adopts dilution scheme, with taking after the drinking water stirring and dissolving more than the 750ml;
Again in the operation or enteroscopy before 3～5 hours with canonical 26.8g.
The effect observation that self-control sodium ascorbyl phosphate preparation and commercially available sodium ascorbyl phosphate oral solution intestinal are prepared
Clinical data
In December, 2008 to 2009 Chongqing hospital in year March accepts patients underwent gynecological operation 120 examples altogether for medical treatment, hysteromyoma 42 examples wherein, ovarian cyst 30 examples, infertility 18 examples, uterine prolapse 8 examples, cervical cancer 10 examples, carcinoma of endometrium 9 examples, other 3 examples; 20～30 years old 14 age example, 31～40 years old 22 example, 41～50 years old 30 example, 51～60 years old 46 example, 61～80 years old 8 example; Laparohysterectomy 42 examples wherein, VAG HYST 15 examples, extensive uterectomy 18 examples, laparoscopic surgery 36 examples, other 9 examples of performing the operation.The preceding patient's cardiovascular and pulmonary function test of art is normal, non-diabetic, hypertensive patients disease.120 routine patients are divided into three groups of each 40 examples at random by lottery, three groups of ages, disease type aspect difference not statistically significant (P＞0.05).
Method
The A group: get 1 bag of sodium ascorbyl phosphate powder (embodiment 3 is seen in self-control) and heat boiled water 750ml dissolving fully, Rhizoma Atractylodis Macrocephalae is oral preceding 1 day at 3 o'clock in afternoon.
B group: get phosphate sodium solution (manufacturer: certain drugmaker, specification: 45ml: biphosphate sodium-hydrate 21.6g and sodium hydrogen phosphate 4.3g) the 45ml boiled water 750ml that heats and dilute, Rhizoma Atractylodis Macrocephalae is oral preceding 1 day at 3 o'clock in afternoon.
The C group: get 1 bag of sodium ascorbyl phosphate granule (embodiment 4 is seen in self-control) and heat boiled water 750ml dissolving fully, Rhizoma Atractylodis Macrocephalae is oral preceding 1 day at 3 o'clock in afternoon.
All encourage polydipsia water after taking medicine for three groups, prevent dehydration.
Observation item
Intestinal tract cleaning degree effective evaluation: excellent: intestinal tube inanition, the flat no pneumatosis that collapses, mucosa does not have hyperemia, and the art open country exposes fully; Very: intestinal tube is not full, and a small amount of gas is arranged, the mucosa mild hyperaemia, and art is wild not exclusively to be exposed; Difference: intestinal tube expands, and a large amount of pneumatosis are arranged, and mucosa is obviously congested, and the art open country covers fully.(2) patient's toleration: excellent: do not have obvious symptom of digestive tract and General Symptoms; Very: slight abdominal distention, stomachache or dizzy weak; Difference: serious nausea and vomiting is arranged, tormina, dizzy weak, performance such as be in a cold sweat.(3) Water-Electrolyte disorder: the preceding patient's no water electrolyte of art is unbalance, in postoperative check in the 1st day blood K
+, Na
+, Cl
-Deng, unusually promptly be decided to be the Water-Electrolyte disorder if any one occurs.(4) postoperative passage of gas by anus, defecation time: natural aerofluxus in the postoperative 24～48 hours, functional blocking do not appear in bowel movement in 3～4 days.
The result
1. three groups of patient's intestinal tract cleaning degree, toleration, Water-Electrolyte race conditio relatively, A group, C group intestinal tract cleaning effect all are better than the B group, see Table 1
The comparison of three kinds of sodium ascorbyl phosphate preparations of table 1 clean method effect (n, %)
2. three groups of patient's postoperative passage of gas by anus, defecation time comparison A group, C group patient's postoperative passage of gas by anus time and defecation times all are shorter than the B group, see Table 2
Three groups of patient's postoperatives of table 2 passage of gas by anus, defecation time be (x ± s) relatively
| Group | n | The postoperative evacuation time | Defecation time |
| A organizes (embodiment 3) | 40 | 16.76±4.024 | 45.66±15.144 |
| B organizes (commercially available product) | 40 | 20.64±4.426 | 56.24±20.184 |
| C organizes (embodiment 4) | 40 | 15.54±4.011 | 40.38±12.098 |
The result shows that self-control sodium ascorbyl phosphate preparation (powder and granule) is better than commercially available sodium ascorbyl phosphate oral solution clinical application effect, and promptly the intestinal tract cleaning degree is good, patient tolerability good, and the Water-Electrolyte disorder is little.
Embodiment 4
The sodium ascorbyl phosphate granule
1, prescription:
Sodium hydrogen phosphate (for no hydrate form) 4.3kg
Sodium dihydrogen phosphate (being monohydrate form 21.6kg) 18.8kg
Saccharin sodium 0.135kg
Glycerol 0.900kg
Fructus Citri Limoniae essence 0.023kg
Glucose 2.350kg
Simethicone 0.150kg
Silicon dioxide 0.1kg
Make 1000 bags altogether
2, processing step:
(1) just mixes: take by weighing sodium dihydrogen phosphate, sodium hydrogen phosphate, simethicone, the glucose of recipe quantity, place mixer to carry out just mixing 3 minutes;
(2) beating powder sieves: beat powder in Universalpulverizer, cross 80 mesh sieves, get mixed powder;
(3) granulation: mixed powder is placed efficient wet granulator, mixed 3 minutes under the stirring at low speed, low the cutting 30 seconds of adding recipe quantity glycerol is crossed 30 mesh sieves, gets granule;
(4) total mixed: the saccharin sodium, Fructus Citri Limoniae essence, the silicon dioxide that add recipe quantity in the granule are put the interior mixing of mixer 3 minutes, and fully mix homogeneously seals and preserves;
(5) pack.
3, usage and dosage
Oral: the consumption of an intestinal of cleaning is 59g (2 bags).Take 29.7g the evening before that day of operation or enteroscopy, usage adopts dilution scheme, with taking after the drinking water stirring and dissolving more than the 750ml; Again in the operation or enteroscopy before 3～5 hours with canonical 29.5g.
Embodiment 5
The sodium ascorbyl phosphate granule
1, prescription:
Sodium hydrogen phosphate (being heptahydrate form 8.1kg) 4.3kg
Sodium dihydrogen phosphate (being monohydrate form 21.6kg) 18.8kg
Aspartame 0.2kg
Glycerol 1.5kg
Fructus Rubi essence 0.015kg
Glucose 4.5kg
Simethicone 0.3kg
Silicon dioxide 0.15kg
Make 1000 bags altogether
2, processing step:
(1) just mixes: take by weighing sodium dihydrogen phosphate, sodium hydrogen phosphate, simethicone, the glucose of recipe quantity, place mixer to carry out just mixing 3 minutes;
(2) beating powder sieves: beat powder in Universalpulverizer, cross 80 mesh sieves, get mixed powder;
(3) granulation: mixed powder is placed efficient wet granulator, mixed 3 minutes under the stirring at low speed, low the cutting 30 seconds of adding recipe quantity glycerol is crossed 30 mesh sieves, gets granule;
(4) total mixed: the aspartame, Fructus Rubi essence, the silicon dioxide that add recipe quantity in the granule are put the interior mixing of mixer 3 minutes, and fully mix homogeneously seals and preserves;
(5) pack.
3, usage and dosage
Oral: the consumption of an intestinal of cleaning is 72.7g (2 bags).Take 36.4g the evening before that day of operation or enteroscopy, usage adopts dilution scheme, with taking after the drinking water stirring and dissolving more than the 750ml; Again in the operation or enteroscopy before 3～5 hours with canonical 36.4g.
Embodiment 6
Sodium ascorbyl phosphate powder
1, prescription:
Sodium hydrogen phosphate (for no hydrate form) 2.2kg
Sodium dihydrogen phosphate (being monohydrate form 10.81kg) 9.4kg
Saccharin sodium 0.25kg
Glycerol 0.05kg
Fructus Citri Limoniae essence 0.04kg
Glucose 10kg
Simethicone 0.05kg
Silicon dioxide 0.5kg
Make 1000 bags altogether
2, processing step:
(1) just mixes: take by weighing sodium dihydrogen phosphate, sodium hydrogen phosphate, simethicone, glycerol, the glucose of recipe quantity, place mixer to carry out just mixing 3 minutes;
(2) beating powder sieves: beat powder in Universalpulverizer, cross 80 mesh sieves, get mixed powder;
(3) total mixed: the saccharin sodium, Fructus Citri Limoniae essence, the silicon dioxide that add recipe quantity in the mixed powder are put the interior mixing of mixer 3 minutes, and fully mix homogeneously seals and preserves;
(4) pack.
3, usage and dosage
Oral: the consumption of an intestinal of cleaning is 95.6g (4 bags).Take 47.8g (2 bags) evening before that day of operation or enteroscopy, usage adopts dilution scheme, with taking after the drinking water stirring and dissolving more than the 750ml; Again before operation or enteroscopy 3～5 hours with canonical with 47.8g (2 bags).
Embodiment 7
Sodium ascorbyl phosphate powder
1, prescription:
Sodium hydrogen phosphate (for no hydrate form) 8.6kg
Sodium dihydrogen phosphate (being monohydrate form 43.24kg) 37.6kg
Saccharin sodium 0.135kg
Fructus Citri Limoniae essence 0.023kg
Glucose 0.8kg
Magnesium stearate 0.1kg
Make 1000 bags altogether
2, processing step:
(1) just mixes: take by weighing sodium dihydrogen phosphate, sodium hydrogen phosphate, the glucose of recipe quantity, place mixer to carry out just mixing 3 minutes;
(2) beating powder sieves: beat powder in Universalpulverizer, cross 80 mesh sieves, get mixed powder;
(3) total mixed: the saccharin sodium, Fructus Citri Limoniae essence, the magnesium stearate that add recipe quantity in the mixed powder are put the interior mixing of mixer 3 minutes, and fully mix homogeneously seals and preserves;
(4) pack.
3, usage and dosage
Oral: the consumption of an intestinal of cleaning is 52.9g (1 bag).Take 26.4g (half bag) evening before that day of operation or enteroscopy, usage adopts dilution scheme, with taking after the drinking water stirring and dissolving more than the 750ml; Again before operation or enteroscopy 3～5 hours with canonical with 26.4g (half bag).
Claims (8)
1. sodium ascorbyl phosphate compositions, described compositions comprises sodium dihydrogen phosphate, sodium hydrogen phosphate, simethicone.
2. sodium ascorbyl phosphate compositions according to claim 1 is characterized in that: described compositions also comprises glucose.
3. sodium ascorbyl phosphate compositions according to claim 1 is characterized in that, calculates 9.4～37.6 parts of sodium dihydrogen phosphate, 2.2～8.6 parts of sodium hydrogen phosphates, 0.05～0.3 part of simethicone by weight.
4. sodium ascorbyl phosphate compositions according to claim 2 is characterized in that, calculates 9.4～37.6 parts of sodium dihydrogen phosphate, 2.2～8.6 parts of sodium hydrogen phosphates, 0.15～0.3 part of simethicone, 0.8～10 part of glucose by weight.
5. according to the described sodium ascorbyl phosphate compositions of one of claim 1-4, it is characterized in that, calculate by weight, also comprise 0.135～0.25 part of sweeting agent, 0.015～0.04 part in essence, 0.1～0.5 part of lubricant.
6. sodium ascorbyl phosphate compositions according to claim 5, described sweeting agent is selected from aspartame, saccharin sodium.
7. sodium ascorbyl phosphate compositions according to claim 5, described essence are selected from Fructus Citri Limoniae essence, Fructus Rubi essence.
8. sodium ascorbyl phosphate compositions according to claim 5, described lubricant is selected from silicon dioxide, magnesium stearate.
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|---|---|---|---|
| CN 201010166215 CN102232969B (en) | 2010-05-07 | 2010-05-07 | Sodium phosphate composition |
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|---|---|---|---|
| CN 201010166215 CN102232969B (en) | 2010-05-07 | 2010-05-07 | Sodium phosphate composition |
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| CN102232969B CN102232969B (en) | 2012-12-19 |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106237295A (en) * | 2016-08-31 | 2016-12-21 | 海南三风友制药有限公司 | A kind of sodium ascorbyl phosphate oral solution compositions and preparation method thereof |
| CN108026555A (en) * | 2015-07-22 | 2018-05-11 | 印度化工学院 | The method that pure glucose is produced from cellulose |
| CN111110697A (en) * | 2019-12-25 | 2020-05-08 | 重庆健能医药开发有限公司 | Sodium phosphate powder and preparation method thereof |
| CN114081967A (en) * | 2021-10-25 | 2022-02-25 | 江苏海洋大学 | Composition with effects of clearing intestines and defoaming |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1705494A (en) * | 2002-10-25 | 2005-12-07 | 诺金欧洲公司 | Colon cleansing compositions and methods |
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2010
- 2010-05-07 CN CN 201010166215 patent/CN102232969B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1705494A (en) * | 2002-10-25 | 2005-12-07 | 诺金欧洲公司 | Colon cleansing compositions and methods |
Non-Patent Citations (2)
| Title |
|---|
| 《安徽医药》 20080731 谷静等 磷酸钠口服液用于结肠镜检查肠道准备的临床观察 639-641 1-8 第12卷, 第7期 * |
| 《第九届国际治疗内镜和消化疾病学术会议论文汇编》 20081231 汪治敏等 二甲硅油在胶囊内镜检查中的应用 582 1-8 , * |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108026555A (en) * | 2015-07-22 | 2018-05-11 | 印度化工学院 | The method that pure glucose is produced from cellulose |
| CN106237295A (en) * | 2016-08-31 | 2016-12-21 | 海南三风友制药有限公司 | A kind of sodium ascorbyl phosphate oral solution compositions and preparation method thereof |
| CN111110697A (en) * | 2019-12-25 | 2020-05-08 | 重庆健能医药开发有限公司 | Sodium phosphate powder and preparation method thereof |
| CN114081967A (en) * | 2021-10-25 | 2022-02-25 | 江苏海洋大学 | Composition with effects of clearing intestines and defoaming |
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|---|---|
| CN102232969B (en) | 2012-12-19 |
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