CN104857019A - Novel oral rehydration salts solution and preparation method and use thereof - Google Patents

Novel oral rehydration salts solution and preparation method and use thereof Download PDF

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CN104857019A
CN104857019A CN201510349858.3A CN201510349858A CN104857019A CN 104857019 A CN104857019 A CN 104857019A CN 201510349858 A CN201510349858 A CN 201510349858A CN 104857019 A CN104857019 A CN 104857019A
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oresol
sodium
chloride
preparation
anhydrous glucose
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CN104857019B (en
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陈嫣
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Anhui Heal Star Pharmaceutical Co.,Ltd.
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陈嫣
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Abstract

The invention relates to a novel oral rehydration salts solution. The novel oral rehydration salts solution comprises the following components: sodium chloride, sodium citrate, carboxymethyl cellulose sodium, sodium potassium tartrate tetrahydrate, potassium chloride, zinc acetate, zinc chloride, glucosum anhydricum and deionized water. According to the novel oral rehydration salts solution and the preparation method and use thereof, the novel oral rehydration salts solution has excellent curative property and high diarrhea curative rate through selection of the specific components, limit to the content of specific ions and the specific preparation method, and a good application prospect and industrial production potential in the field of medicine are achieved.

Description

A kind of new oral fluid infusion salt and its production and use
Technical field
The present invention relates to a kind of liquid oral and its production and use, relate more particularly to a kind of new oral fluid infusion salt and its production and use, belong to diarrheal dehydration medicine field.
Background technology
Diarrhoea is disease common in a kind of daily life, refers to that defecation frequency is significantly more than normal 2-3 times/day, even more, presents that feces is thin, moisture proportion significantly increases, containing symptoms such as indigested food and/or mucus.
When diarrhoea occurs or when the diarrhoea persistent period is longer, patient generally can produce anus discomfort and fecal urgency etc., thus brings serious impact to the live and work of patient, has inconvenience.
In recent years, diarrhoea has become public health problem serious in world wide, particularly in some undeveloped countries, it has become the arch-criminal causing child's severe malnutrition and even death, also brings serious harm for daily life and work.
Therefore, treat diarrhoea timely and effectively, there is very important public health and social meaning.
Oresol (Oral Rehydration Solution, ORS) is the medicine of the prevention and therapy diarrheal dehydration of world health organisation recommendations.Since 1988, ORS is extensive China veterinary with apply clinically, and becomes a kind of common liquid replenishing method.
A large amount of facts have proved, oresol has good curative effect, such as oresol not only to acute diarrhea, dewater evident in efficacy, and with Intravenous Supplement liquid phase ratio, oresol has the advantage of its uniqueness: taking convenience, reduces the psychentonia of patient and body is painful, and reduce medical expense, alleviate patient economy burden, avoid puncture difficulty, alleviate nursery work.
At present, the main component of the oresol generally used is sodium chloride, potassium chloride, sodium citrate and glucose.In order to improve its composition, make it have better oral result and mouthfeel etc., in recent years, a large amount of scholars for improve oresol diarrhea treatment effect and from composition improve angle carried out certain research, as Wang Gang adopts the improvement such as oligofructose, glycine oresol, effective percentage achieves certain raising; Ou Yangshan etc. then from the angle of concentration reducing sodium chloride and glucose, reduce osmotic pressure, thus raising curative effect to a certain degree.Certainly, also there is other scholar, the curative effect improving oresol from the angle of dosage form such as favourable in Zhang Jindong, bandit.
As mentioned above, although the certain linguistic term of the carrying out of some scholars oral disposition fluid infusion salt, the effective percentage of diarrhea treatment still needs further to be improved, and its reason should be suffer from diarrhoea pathogenetic multiformity and complexity.Therefore, the oresol be only made up of basis is often difficult to the therapeutic effect with wide spectrum.
Therefore, based on foregoing description, a kind of oresol of brand-new formula is provided, remains the study hotspot in diarrhea treatment field and emphasis, this also just the basic place that is accomplished of the present invention and power lean on.
Summary of the invention
As mentioned above, in order to obtain a kind of oresol of brand-new formula, for diarrhea treatment field, the present inventor, to this has been deep research, after paying a large amount of creative work, thus completes the present invention.
Technical scheme of the present invention and content relate to following several aspect.
More specifically, first aspect, the present invention relates to a kind of oresol, described oresol comprises following component: sodium chloride, sodium citrate, Carboxymethyl cellulose sodium, sodium potassium tartrate tetrahydrate, potassium chloride, zinc acetate, zinc chloride, anhydrous glucose and deionized water.
In described oresol of the present invention, oresol described in every 1000ml, comprises the various components of following mM (mmol):
And: total sodium (Na +) content is 96-100mmol/L, total chlorine (Cl -) content is 78-80mmol/L, and zinc acetate is 1:2 with the ratio of the molar content of zinc chloride.
In the present invention, unless otherwise defined, relate to " comprising " or " comprising " that composition limits both contained open " comprising ", " comprising " etc. and similar meaning thereof, also contains enclosed " by ... composition " etc. and similar meaning thereof.
In described oresol of the present invention, in oresol described in every 1000ml, comprising sodium chloride is 70-75mmol, such as, can be 70mmol, 72mmol or 75mmol.
In described oresol of the present invention, in oresol described in every 1000ml, comprising sodium citrate is 1.5-2mmol, such as, can be 1.5mmol, 1.7mmol, 1.9mmol or 2mmol.
In described oresol of the present invention, in oresol described in every 1000ml, comprising Carboxymethyl cellulose sodium is 8-10mmol, such as, can be 8mmol, 9mmol or 10mmol.
In described oresol of the present invention, in oresol described in every 1000ml, comprising sodium potassium tartrate tetrahydrate is 10-12mmol, such as, can be 10mmol, 11mmol or 12mmol.
In described oresol of the present invention, in oresol described in every 1000ml, comprising potassium chloride is 1.5-4mmol, such as, can be 1.5mmol, 2mmol, 3mmol or 4mmol.
In described oresol of the present invention, in oresol described in every 1000ml, comprising zinc acetate is 0.4-0.8mmol, such as, can be 0.4mmol, 0.6mmol or 0.8mmol.
In described oresol of the present invention, in oresol described in every 1000ml, comprising zinc chloride is 1-2mmol, such as, can be 1mmol, 1.5mmol or 2mmol.
In described oresol of the present invention, in oresol described in every 1000ml, comprising anhydrous glucose is 90-100mmol, such as, can be 90mmol, 95mmol or 100mmol.
Second aspect, the present invention relates to the preparation method of above-mentioned oresol, and described preparation method comprises the steps:
S1: take various component respectively;
S2: sodium chloride, Carboxymethyl cellulose sodium, sodium potassium tartrate tetrahydrate, sodium citrate and the anhydrous glucose for the 70-80% of total consumption are joined in deionized water, is uniformly mixed completely, obtain just dosing;
S3: add potassium chloride, zinc acetate and zinc chloride in described just dosing, be uniformly mixed completely, obtain compositional liquor;
S4: add the anhydrous glucose with surplus in described compositional liquor, stirs completely, standardize solution, filter element fine straining, thus obtains described oresol of the present invention.
In described preparation method of the present invention, in described step S2, the consumption of the anhydrous glucose added is 75% of total consumption.
In described preparation method of the present invention, in described step S2, the consumption of deionized water is not particularly limited, as long as its concentration meeting each final component limits, such as preparation 1000ml oresol, the deionized water of about 900ml can be used in this step, be finally settled to final 1000ml in step s 4 which.
Therefore, for a person skilled in the art, can carry out suitable selection according to final prepared fluid infusion salt volume, this is the routine techniques of solution preparation, and this is no longer going to repeat them.
In described preparation method of the present invention, in described step S4, described standardize solution refers to that adding deionized water is settled to 1000ml, and thus make each component comprising above-mentioned restriction content in every 1000ml gained oresol, standardize solution operates the routine techniques means belonged in analytical chemistry field, and this is no longer going to repeat them.
In described preparation method of the present invention, in described step S4, filter element fine straining belongs to known technology in this area and means, such as, can adopt 1 μm of filter element fine straining, 0.5 μm of filter element fine straining or 0.22 μm of filter element fine straining etc., be preferably 0.22 μm of filter element fine straining, this is no longer going to repeat them.
In described preparation method of the present invention, inventor finds, by being added in different phases by anhydrous glucose in batches, can improve the stability of final gained oral rehydration salts solution, this storage for final products has significant meaning, can longer time its stable form of maintenance.
3rd aspect, the present invention relates to the purposes of above-mentioned oresol in preparation treatment anti-diarrhea drug.
4th aspect, the present invention relates to the purposes of above-mentioned oresol in preparation treatment dehydrated pharmaceutical.
Inventor finds, oresol of the present invention has good treatment diarrhoea and/or the performance of dehydration, thus can be used to the medicine preparing treatment diarrhoea and/or dehydration, has a good application prospect and industrialization potential at field of medicaments.
Detailed description of the invention
Below by specific embodiment, the present invention is described in detail; but the purposes of these exemplary embodiments and object are only used for exemplifying the present invention; not any type of any restriction is formed to real protection scope of the present invention, more non-protection scope of the present invention is confined to this.
Embodiment 1
S1: take 72.5mmol sodium chloride, 1.5mmol sodium citrate, 8mmol Carboxymethyl cellulose sodium, 11mmol sodium potassium tartrate tetrahydrate, 3.5mmol potassium chloride, 0.5mmol zinc acetate, 1mmol zinc chloride, 90mmol anhydrous glucose respectively;
S2: the sodium chloride taken by step S1, Carboxymethyl cellulose sodium, sodium potassium tartrate tetrahydrate, sodium citrate and 63mmol anhydrous glucose join in 900ml deionized water, is uniformly mixed completely, obtains just dosing;
S3: add potassium chloride, zinc acetate and zinc chloride that step S1 takes in described just dosing, be uniformly mixed completely, obtain compositional liquor;
S4: add remaining 27mmol anhydrous glucose in described compositional liquor, stirs completely, is then settled to 1000ml with deionized water, finally crosses 0.22 μm of filter element fine straining, thus obtains described oresol of the present invention, called after BYY1.
Embodiment 2
S1: take 75mmol sodium chloride, 2mmol sodium citrate, 8mmol Carboxymethyl cellulose sodium, 10mmol sodium potassium tartrate tetrahydrate, 2mmol potassium chloride, 0.75mmol zinc acetate, 1.5mmol zinc chloride, 95mmol anhydrous glucose respectively;
S2: the sodium chloride taken by step S1, Carboxymethyl cellulose sodium, sodium potassium tartrate tetrahydrate, sodium citrate and 76mmol anhydrous glucose join in 900ml deionized water, is uniformly mixed completely, obtains just dosing;
S3: add potassium chloride, zinc acetate and zinc chloride that step S1 takes in described just dosing, be uniformly mixed completely, obtain compositional liquor;
S4: add remaining 19mmol anhydrous glucose in described compositional liquor, stirs completely, is then settled to 1000ml with deionized water, finally crosses 0.22 μm of filter element fine straining, thus obtains described oresol of the present invention, called after BYY2.
Embodiment 3
S1: take 71mmol sodium chloride, 2mmol sodium citrate, 10mmol Carboxymethyl cellulose sodium, 12mmol sodium potassium tartrate tetrahydrate, 4mmol potassium chloride, 0.75mmol zinc acetate, 1.5mmol zinc chloride, 100mmol anhydrous glucose respectively;
S2: the sodium chloride taken by step S1, Carboxymethyl cellulose sodium, sodium potassium tartrate tetrahydrate, sodium citrate and 75mmol anhydrous glucose join in 900ml deionized water, is uniformly mixed completely, obtains just dosing;
S3: add potassium chloride, zinc acetate and zinc chloride that step S1 takes in described just dosing, be uniformly mixed completely, obtain compositional liquor;
S4: add remaining 25mmol anhydrous glucose in described compositional liquor, stirs completely, is then settled to 1000ml with deionized water, finally crosses 0.22 μm of filter element fine straining, thus obtains described oresol of the present invention, called after BYY3.
Comparative example 1-6
Comparative example 1-3: except by disposable for anhydrous glucose all add in step s 2 except, other operation is all constant, thus obtains comparative example 1-3 according to the same procedure of embodiment 1-3, by oresol called after D1, D2 and the D3 successively obtained.
Comparative example 4-6: except by disposable for anhydrous glucose all add in step s 4 which except, other operation is all constant, thus obtains comparative example 1-3 according to the same procedure of embodiment 1-3, by oresol called after D4, D5 and the D6 successively obtained.
Comparative example 7-9
Except the zinc acetate component dispensed wherein, other operation is all constant, thus obtains comparative example 7-9 according to the same procedure of embodiment 1-3, by oresol called after D7, D8 and the D9 successively obtained.
Comparative example 10
Except the amount of each component taken in step S1 is for except " 70mmol sodium chloride, 1.5mmol sodium citrate, 8mmol Carboxymethyl cellulose sodium, 10mmol sodium potassium tartrate tetrahydrate, 1.5mmol potassium chloride, 0.5mmol zinc acetate, 1mmol zinc chloride, 90mmol anhydrous glucose ", other operation is all constant, thus carried out comparative example 10 in the same manner as in Example 1, the fluid infusion salt called after D10 obtained.
Wherein, total sodium (Na +) be 92.5mmol/L, total chlorine (Cl -) be 73.5mmol/L.
Comparative example 11
Except the amount of each component taken in step S1 is for except " 75mmol sodium chloride, 2mmol sodium citrate, 10mmol Carboxymethyl cellulose sodium, 12mmol sodium potassium tartrate tetrahydrate, 3mmol potassium chloride, 0.75mmol zinc acetate, 1.5mmol zinc chloride, 95mmol anhydrous glucose ", other operation is all constant, thus carried out comparative example 11 with the method identical with embodiment 2, the fluid infusion salt called after D11 obtained.
Wherein, total sodium (Na +) be 103mmol/L, total chlorine (Cl -) be 81mmol/L.
Comparative example 12
Except the amount of each component taken in step S1 is for except " 70mmol sodium chloride, 1.8mmol sodium citrate, 9mmol Carboxymethyl cellulose sodium, 11mmol sodium potassium tartrate tetrahydrate, 4mmol potassium chloride, 0.5mmol zinc acetate, 1mmol zinc chloride, 100mmol anhydrous glucose ", other operation is all constant, thus carried out comparative example 12 with the method identical with embodiment 3, the fluid infusion salt called after D12 obtained.
Wherein, total sodium (Na +) be 95.4mmol/L, total chlorine (Cl -) be 76mmol/L.
The investigation of stability
To each fluid infusion salt 40 DEG C of standing placements 30 days, then observe the external morphology of fluid infusion salt, thus investigated its storage stability, concrete outcome is as follows:
As seen from the above table, the stagewise of anhydrous glucose adds has significant impact for final stability, all adds fashionable, all result in and produce turbid phenomenon after 30 days, and ought add fashionable in batches, then have good stability when disposable in step S2 or S4.
In diarrhea treatment test below, due to the less stable of D1-D6, therefore no longer any test is carried out to it.
Diarrhea treatment is tested
The rabbit model 180 with symptom of diarrhea, as administration object, is divided into 9 groups at random, often organizes 20, adopts different oral rehydration salts solution of the present invention, 2 times on the 1st, press 15ml/kg gavage every day, and the concrete fluid infusion salt divided into groups and use is as follows:
1st group: use BYY1 to carry out gavage;
2nd group: use BYY2 to carry out gavage;
3rd group: use BYY3 to carry out gavage;
4th group: use D7 to carry out gavage;
5th group: use D8 to carry out gavage;
6th group: use D9 to carry out gavage;
7th group: use D10 to carry out gavage;
8th group: use D11 to carry out gavage;
9th group: use D12 to carry out gavage.
Wherein, 1-3 group is experimental group, and 4-6 group is the 1st matched group, and 7-9 group is the 2nd matched group.Record therapeutic effect after Yu Yizhou, concrete outcome sees the following form:
In upper table, " completely healing " namely eliminates symptom of diarrhea completely, and " necessarily taking a turn for the better " takes a turn for the better for spirit or symptom of diarrhea alleviates, and engineering noise is dead or diarrhoea increases the weight of.
As seen from the above table, fluid infusion salt of the present invention has excellent diarrhea treatment performance, and when not comprising zinc acetate (see matched group 1), then performance decreases.More significantly, when the content of total sodium, total chlorine is not at " total sodium (Na +) content is 96-100mmol/L, total chlorine (Cl -) content is 78-80mmol/L " and scope in time (see matched group 2); therapeutic effect has and reduces the most significantly; reason may be that total sodium and chloride content have played body fluid balance effect within the scope of this, can suppress diarrheal dehydration, thus have significant therapeutic effect.
In sum, the invention provides a kind of novel oresol and preparation method thereof and purposes, described oresol is by the selection of special component, the content restriction of concrete ion and specific preparation method etc., thus obtain the oresol with excellent therapeutic performance, there is the cure rate of excellent diarrhoea, thus have a good application prospect and industrial production potential at field of medicaments.
Should be appreciated that the purposes of these embodiments is only not intended to for illustration of the present invention limit the scope of the invention.In addition; also should understand; after having read technology contents of the present invention, those skilled in the art can make various change, amendment and/or modification to the present invention, and these all equivalent form of values fall within the protection domain that the application's appended claims limits equally.

Claims (7)

1. an oresol, described oresol comprises following component: sodium chloride, sodium citrate, Carboxymethyl cellulose sodium, sodium potassium tartrate tetrahydrate, potassium chloride, zinc acetate, zinc chloride, anhydrous glucose and deionized water.
2. oresol as claimed in claim 1, is characterized in that: oresol described in every 1000ml, comprises the various components of following mM (mmol):
And: total sodium (Na +) content is 96-100mmol/L, total chlorine (Cl -) content is 78-80mmol/L, and zinc acetate is 1:2 with the ratio of the molar content of zinc chloride.
3. the preparation method of oresol described in claim 1 or 2, described preparation method comprises the steps:
S1: take various component respectively;
S2: sodium chloride, Carboxymethyl cellulose sodium, sodium potassium tartrate tetrahydrate, sodium citrate and the anhydrous glucose for the 70-80% of total consumption are joined in deionized water, is uniformly mixed completely, obtain just dosing;
S3: add potassium chloride, zinc acetate and zinc chloride in described just dosing, be uniformly mixed completely, obtain compositional liquor;
S4: add the anhydrous glucose with surplus in described compositional liquor, stirs completely, standardize solution, filter element fine straining, thus obtains described oresol.
4. preparation method as claimed in claim 3, it is characterized in that: in described step S2, the consumption of the anhydrous glucose added is 75% of total consumption.
5. the preparation method as described in claim 3 or 4, is characterized in that: in described step S4, and described filter element fine straining is 0.22 μm of filter element fine straining.
6. the purposes of the oresol described in claim 1 or 2 in preparation treatment anti-diarrhea drug.
7. the purposes of the oresol described in claim 1 or 2 in preparation treatment dehydrated pharmaceutical.
CN201510349858.3A 2015-06-23 2015-06-23 A kind of new oral fluid infusion salt and its production and use Active CN104857019B (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108853138A (en) * 2018-07-27 2018-11-23 安徽恒星制药有限公司 A kind of oral rehydration salt effervescent tablet and preparation method thereof
CN108904529A (en) * 2018-07-27 2018-11-30 安徽恒星制药有限公司 A kind of oral rehydration salts and preparation method thereof

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101732342A (en) * 2010-01-25 2010-06-16 中国人民解放军第二军医大学 Oral rehydration salt effervescent tablet and application thereof
CN102755347A (en) * 2012-07-03 2012-10-31 四川百利药业有限责任公司 Glucose electrolyte effervescent tablets and preparation method thereof
CN102824362A (en) * 2012-09-20 2012-12-19 西安安健药业有限公司 Medicine composition of oral rehydration salt

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101732342A (en) * 2010-01-25 2010-06-16 中国人民解放军第二军医大学 Oral rehydration salt effervescent tablet and application thereof
CN102755347A (en) * 2012-07-03 2012-10-31 四川百利药业有限责任公司 Glucose electrolyte effervescent tablets and preparation method thereof
CN102824362A (en) * 2012-09-20 2012-12-19 西安安健药业有限公司 Medicine composition of oral rehydration salt

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108853138A (en) * 2018-07-27 2018-11-23 安徽恒星制药有限公司 A kind of oral rehydration salt effervescent tablet and preparation method thereof
CN108904529A (en) * 2018-07-27 2018-11-30 安徽恒星制药有限公司 A kind of oral rehydration salts and preparation method thereof

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