CN102512430A - Medicinal composition for intestinal tract cleaning - Google Patents
Medicinal composition for intestinal tract cleaning Download PDFInfo
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- CN102512430A CN102512430A CN2011104443344A CN201110444334A CN102512430A CN 102512430 A CN102512430 A CN 102512430A CN 2011104443344 A CN2011104443344 A CN 2011104443344A CN 201110444334 A CN201110444334 A CN 201110444334A CN 102512430 A CN102512430 A CN 102512430A
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- glucose
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- tract cleaning
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Abstract
The invention discloses a medicine for colonoscopy and intestine tract preparation before colonic and rectal surgeries. The medicine is a medicinal combination containing L-glucose and L-mannose. The L-glucose and the L-mannose are not required to be separated, so the production cost is reduced; and the method has high industrial value. The medicinal combination of the L-glucose and the L-mannose has the characteristics of safety, reliability, convenience for use, good patient compliance and the like.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition that is used for intestinal tract cleaning, specifically a kind of Pharmaceutical composition that contains L-glucose and L-mannose.
Background technology
Intestinal before colonoscopy, the colonic operation, before the operation on rectum need carry out intestinal tract cleaning earlier when preparing.The generation of intestinal tract cleaning and nosocomial infection's control, clinical medical and nursing quality, complication is closely related, the clean-up performance that intestinal is prepared even directly influence carrying out of operation, check result and each item treatment work.
The intestinal preparation method has dietary restriction, clysmata, oral drugs method etc.Keeping on a diet separately to reach the purpose that intestinal is prepared, and is the basic householder method of various inspections and operation widespread usage.Light slag low fat diet, last late liquid diet, fasting in morning on the same day less in conventional 1～2 day.Clysmata, complex operation has certain damage to direct intestinal, general and oral medicine method coupling.The oral drugs method, taking convenience is easy to accept.Oral height oozes dehydrant 20% mannitol, and its zymolysis meeting in enteric cavity produces a large amount of gases, and GI irritation is obvious.Shortcomings such as polyethylene glycol electrolyte liquid main component is that nonabsorbable etc. oozes Polyethylene Glycol, is that intestinal relatively more commonly used is at present prepared medicine, but also exists effective dose big (each 4L), and taste bad will, side effect are many have increased the misery that patient's intestinal is prepared.
The L-glucose is as intestinal tract cleaning medicine (GASTROINTESTINAL ENDOSCOPY VOLUME 58, NO.1,2003), intestinal tract cleaning respond well and more than be 80%, approaching with the intestinal cleaning agents of present extensive use 82.3% ten minute.The L-glucose is pleasantly sweet, and using dosage little (each 240ml) helps the patient and takes.It is raw material with the L-arabinose that american documentation literature US4581447 discloses a kind of; Process and Blausure (German) addition, the mixture of acquisition 1-cyanic acid-L glucitol and 1-cyanic acid-L mannitol passes through hydrogenation then; Obtain the mixture of L-glucose and L-mannose, best ratio is 1:1.This method is considered to have most the method for the acquisition L-glucose of industrial value.However, because it is big from the mixture of L-glucose and L-mannose, to isolate the difficulty of L-glucose, yield is low, causes the L-glucose to cost an arm and a leg.According to 10000 yuan of/kilogram calculating of L-glucose market price, the each use amount 24g of each patient, only the cost of raw material is promptly 240 yuan, exceeds the existing product market price greatly, serious restriction the application of L-glucose.Likewise, it is high to prepare L-mannose cost separately, therefore is not applied to intestinal tract cleaning.
Summary of the invention
For this reason; Technical problem to be solved by this invention is to overcome that the L-glucose difficulty that is used for intestinal tract cleaning in the prior art is separated, yield is low and cause the expensive problem of L-glucose, thereby a kind of low cost, features good taste is provided, be used for the pharmaceutical composition of intestinal tract cleaning safely and effectively.
For achieving the above object, the present invention provides a kind of pharmaceutical composition that is used for intestinal tract cleaning.
Described compositions is made up of L-glucose and L-mannose.
The content of said L-glucose is 0.1wt%～99.9wt%, and the content of said L-mannose is 0.1wt%～99.9wt%.
Preferably, the content of said L-glucose is 10wt%～90wt%, and the content of said L-mannose is 10wt%～90wt%.
More preferably, the content of said L-glucose is 45wt%～55wt%, and the content of said L-mannose is 45wt%～55wt%.
A kind of oral formulations that is used for intestinal tract cleaning comprises following component: the pharmaceutical composition that is used for intestinal tract cleaning: 0.1wt%～99.9wt%; Water: 0.1wt%～99.9wt%.
A kind of medicament that is used for intestinal tract cleaning comprises following component: L-glucose: 0.1wt%～99.9wt%, L-mannose: 0.1wt%～99.9wt%.
The application of described pharmaceutical composition in the medicine of preparation intestinal tract cleaning.
Technique scheme of the present invention compared with prior art has the following advantages:
1. the invention provides a kind of pharmaceutical composition that is used for intestinal tract cleaning, described compositions is made up of L-glucose and L-mannose.L-glucose and L-mannose, pleasantly sweet, using dosage is little, has improved patient's compliance, simultaneously, as the medicine of intestinal tract cleaning, has avoided difficulty that the two separation is brought with both mixture, has greatly reduced use cost.
2.L-mannose can be as the medicine of intestinal tract cleaning.The L-mannose is similar with the L-glucose: not by intestinal absorption, can form hyperosmosis at intestinal, reach the purpose of intestinal tract cleaning.Therefore the L-mannose can not form intestinal flatulence not by the enteric microorganism metabolism.The L-mannose is pleasantly sweet, has improved patient's compliance.
3. the content of L-glucose is 0.1wt%～99.9wt%, and the content of L-mannose is 0.1wt%～99.9wt%.Make by L-arabinose in the process of L-glucose and L-mannose; Regulate catalyst consumption, the mixed proportion that obtains L-glucose and mannose is different, and this combination can mix with arbitrary proportion; Reduce workload, facilitate for realizing large-scale industrialization production.
4. the pharmaceutical composition of L-glucose and L-mannose can be two kinds of forms of solid mixture or liquid mixture as the oral formulations or the medicament of intestinal tract cleaning, makes the medicament forms multiformity washability is provided for the trouble patient.
5. pharmaceutical composition is a peroral dosage form, and taking convenience is quick, is accepted by people easily.
The specific embodiment
To do further description to the present invention through specific embodiment below.
239 examples accept the patient of outpatient service colonoscopy, patient that 247 examples are accepted colonic operation, patient that 200 examples are accepted operation on rectum (get rid of the age less than 18 and greater than 75 have pulmonary, heart, kidney, dysautonomia and endocrine regulation person use anesthetis, fiber supplement, anticholinergic agent, and the unusual patient of light purgative prescription clinical observation) be divided into 2 groups (A group, B groups) respectively.
The A group is carried out intestinal tract cleaning: inspection or the normal breakfast in morning of performing the operation the previous day; Noon a small amount of lunch; Avoid food, sugar and caffeine after 2 pm, the ratio (containing dry 25g) of the pharmaceutical composition of L-glucose and L-mannose among 5-6pm 10 minutes in the evening embodiment 1-embodiment 11 down for oral administration; Drink 250ml water again behind the defecation for the first time, fasting before inspection finishes., cleaning back preceding, inspection back or the cleer and peaceful urine check of the laggard promoting the circulation of blood of performing the operation to cleaning.
The B group is carried out intestinal tract cleaning: inspection or the normal breakfast in morning of performing the operation the previous day, and noon, a small amount of lunch was avoided food, sugar and caffeine after 2 pm; 5-6pm took polyethylene glycol electrolyte first and loose that (1 box of getting and feel well is poured in the lump and had in graduated glass respectively wrapping medicated powder in the box, and the boiled water of heating is to 1000ml evening; Stirring makes dissolving fully), take 600-1000ml first, took 1 time in every later on separated 10-15 minute; Be no less than 250ml, until having obeyed or having done as you wish until discharging water sample at every turn.
Embodiment 1:
The aqueous solution 2500ml (pH is 11.53) that will contain the 639.7g Cyanogran. behind the adding nitrogen replacement container 10min, is cooled to 7 ℃ with solution, slowly adds dense acetic acid and regulates pH to 7.94,16 ℃ of temperature.The 60wt% L-arabinose aqueous solution that adds 1666g then, adding dense acetic acid adjusting pH value once more is 8.1, makes to be reflected under 23 ℃ and carries out.Add the 385ml concentrated sulphuric acid behind the cooling 1.25h and regulate pH to 2.05.Product analysis shows that the L-arabinose conversion ratio is 99.4%.
The cyaniding product is added in the hydrogenation still of nitrogen protection, other adds the palladium Barium Sulfate catalyst of 500g 5wt%.Adding sulphuric acid makes the hydrogenation reaction pH value be controlled at 2.0.After reaction does not absorb hydrogen, remove by filter catalyst, ion-exchange process is removed dissolving salt, obtains the mixture of L-glucose and L-mannose.The content of said L-glucose is 52%, and the content of said L-mannose is 48%.Product analysis shows that intermediate cyanalcohol 100% transforms glucose and mannose yield 75%.This mixture L-glucose and L-mannose are used for intestinal tract cleaning.This pharmaceutical composition is a solid form.
Through regulating catalyst amount, obtain the L-glucose of different proportion and the mixture of L-mannose.
The A of table 1 embodiment 1, B group intestinal tract cleaning effect comparison
Embodiment 2～embodiment 11
The L-glucose and the L-mannose mixture of ratio that preparation (is seen table 2) as follows, the intestinal tract cleaning effect that obtains is seen table 3:
The ratio of table 2 embodiment 2～embodiment 11 Chinese medicine compositionss
The embodiment 2 described intestinal tract cleaning oral formulations that are used for, the pharmaceutical composition proportion is 68wt%; Water accounting example is 32wt%, and wherein to account for the ratio of pharmaceutical composition be 21.4wt% to the L-glucose; The ratio that the L-mannose accounts for pharmaceutical composition is 78.6wt%.Likewise, each component ratio of embodiment 3～embodiment 11 is seen table 2.
The A of table 3 embodiment 2～embodiment 11, B group intestinal tract cleaning effect comparison
Show that from the The above results demonstration combination colon cleaning effect of L-glucose and L-mannose is good, be superior to polyethylene glycol electrolyte and loose (with refreshing).The combination of L-glucose and L-mannose is a kind of ideal intestinal tract cleaning medicine of safe, effective, good patient dependence.
Obviously, the foregoing description only be for explanation clearly done for example, and be not qualification to embodiment.For the those of ordinary skill in affiliated field, on the basis of above-mentioned explanation, can also make other multi-form variation or change.Here need not also can't give exhaustive to all embodiments.And conspicuous variation of being extended out thus or change still are among the protection domain of the invention.
Claims (6)
1. pharmaceutical composition that is used for intestinal tract cleaning, it is characterized in that: described compositions is made up of L-glucose and L-mannose.
2. the pharmaceutical composition that is used for intestinal tract cleaning according to claim 1 is characterized in that: the content of said L-glucose is 0.1wt%～99.9wt%, and the content of said L-mannose is 0.1wt%～99.9wt%.
3. pharmaceutical composition according to claim 2 is characterized in that: the content of said L-glucose is 10wt%～90wt%, and the content of said L-mannose is 10wt%～90wt%.
4. oral formulations that is used for intestinal tract cleaning is characterized in that: comprise following component:
Claim 1 or the 2 described pharmaceutical composition that is used for intestinal tract cleaning: 0.1wt%～99.9wt%; Water: 0.1wt%～99.9wt%.
5. medicament that is used for intestinal tract cleaning is characterized in that: comprise following component:
L-glucose: 0.1wt%～99.9wt%, L-mannose: 0.1wt%～99.9wt%.
6. claim 1 or the 2 described pharmaceutical compositions application in the medicine of preparation intestinal tract cleaning.
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| CN201110444334.4A CN102512430B (en) | 2011-12-27 | 2011-12-27 | Medicinal composition for intestinal tract cleaning |
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| CN201110444334.4A CN102512430B (en) | 2011-12-27 | 2011-12-27 | Medicinal composition for intestinal tract cleaning |
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| CN102512430B CN102512430B (en) | 2015-04-22 |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4581447A (en) * | 1984-08-13 | 1986-04-08 | Uop Inc. | Process for making a mixture of L-glucose and L-mannose |
| US5000794A (en) * | 1989-08-17 | 1991-03-19 | Uop | Process for separating glucose and mannose with dealuminated Y zeolites |
| CN101306012A (en) * | 2008-06-19 | 2008-11-19 | 中国人民解放军第四军医大学 | Use of modified polysaccharide rich in mannose in preparing medicine for preventing the colitis cancer |
| WO2010141751A1 (en) * | 2009-06-03 | 2010-12-09 | Axcan Pharma Inc. | L-sugar colon cleansing agent and uses thereof |
-
2011
- 2011-12-27 CN CN201110444334.4A patent/CN102512430B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4581447A (en) * | 1984-08-13 | 1986-04-08 | Uop Inc. | Process for making a mixture of L-glucose and L-mannose |
| US5000794A (en) * | 1989-08-17 | 1991-03-19 | Uop | Process for separating glucose and mannose with dealuminated Y zeolites |
| CN101306012A (en) * | 2008-06-19 | 2008-11-19 | 中国人民解放军第四军医大学 | Use of modified polysaccharide rich in mannose in preparing medicine for preventing the colitis cancer |
| WO2010141751A1 (en) * | 2009-06-03 | 2010-12-09 | Axcan Pharma Inc. | L-sugar colon cleansing agent and uses thereof |
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| CN102512430B (en) | 2015-04-22 |
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