CN102824362A - Medicine composition of oral rehydration salt - Google Patents
Medicine composition of oral rehydration salt Download PDFInfo
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- CN102824362A CN102824362A CN2012103488747A CN201210348874A CN102824362A CN 102824362 A CN102824362 A CN 102824362A CN 2012103488747 A CN2012103488747 A CN 2012103488747A CN 201210348874 A CN201210348874 A CN 201210348874A CN 102824362 A CN102824362 A CN 102824362A
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- Prior art keywords
- glucose
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- weight portions
- sodium citrate
- potassium chloride
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- 239000000203 mixture Substances 0.000 title claims abstract description 89
- 239000003814 drug Substances 0.000 title abstract description 18
- 229940079901 oral rehydration salt formulations Drugs 0.000 title abstract 8
- 229940079593 drug Drugs 0.000 title description 9
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims abstract description 188
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims abstract description 165
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims abstract description 125
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims abstract description 110
- 239000008103 glucose Substances 0.000 claims abstract description 110
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims abstract description 95
- 239000001509 sodium citrate Substances 0.000 claims abstract description 95
- 239000001103 potassium chloride Substances 0.000 claims abstract description 94
- 235000011164 potassium chloride Nutrition 0.000 claims abstract description 94
- 239000011780 sodium chloride Substances 0.000 claims abstract description 81
- 239000000843 powder Substances 0.000 claims abstract description 75
- 229960001031 glucose Drugs 0.000 claims description 124
- 238000000034 method Methods 0.000 claims description 104
- 239000002245 particle Substances 0.000 claims description 60
- 238000012856 packing Methods 0.000 claims description 11
- GZCGUPFRVQAUEE-VANKVMQKSA-N aldehydo-L-glucose Chemical compound OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)C=O GZCGUPFRVQAUEE-VANKVMQKSA-N 0.000 claims description 7
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical group OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 6
- 239000011734 sodium Substances 0.000 claims description 5
- 229910052708 sodium Inorganic materials 0.000 claims description 4
- 229960004543 anhydrous citric acid Drugs 0.000 claims description 3
- 238000004090 dissolution Methods 0.000 abstract description 30
- 238000002360 preparation method Methods 0.000 abstract description 18
- 238000005516 engineering process Methods 0.000 abstract description 6
- 230000008901 benefit Effects 0.000 abstract description 2
- 238000002425 crystallisation Methods 0.000 abstract description 2
- 230000008025 crystallization Effects 0.000 abstract description 2
- 238000004886 process control Methods 0.000 abstract description 2
- 230000008569 process Effects 0.000 description 24
- 238000010348 incorporation Methods 0.000 description 23
- 239000000243 solution Substances 0.000 description 15
- 239000000463 material Substances 0.000 description 11
- 239000008187 granular material Substances 0.000 description 10
- 238000002156 mixing Methods 0.000 description 10
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 10
- 238000012360 testing method Methods 0.000 description 9
- 238000005054 agglomeration Methods 0.000 description 8
- 230000002776 aggregation Effects 0.000 description 8
- 239000000047 product Substances 0.000 description 7
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 description 5
- 210000002381 plasma Anatomy 0.000 description 5
- 239000011591 potassium Substances 0.000 description 5
- 229910052700 potassium Inorganic materials 0.000 description 5
- 150000003839 salts Chemical class 0.000 description 5
- 239000013535 sea water Substances 0.000 description 5
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 4
- 210000003677 hemocyte Anatomy 0.000 description 4
- 229940000351 hemocyte Drugs 0.000 description 4
- 229910052500 inorganic mineral Inorganic materials 0.000 description 4
- 239000007788 liquid Substances 0.000 description 4
- 235000010755 mineral Nutrition 0.000 description 4
- 239000011707 mineral Substances 0.000 description 4
- VLTRZXGMWDSKGL-UHFFFAOYSA-N perchloric acid Chemical compound OCl(=O)(=O)=O VLTRZXGMWDSKGL-UHFFFAOYSA-N 0.000 description 4
- 238000010298 pulverizing process Methods 0.000 description 4
- 238000004448 titration Methods 0.000 description 4
- 238000003556 assay Methods 0.000 description 3
- 230000018044 dehydration Effects 0.000 description 3
- 238000006297 dehydration reaction Methods 0.000 description 3
- 150000004683 dihydrates Chemical class 0.000 description 3
- 210000003743 erythrocyte Anatomy 0.000 description 3
- 230000036541 health Effects 0.000 description 3
- 238000007689 inspection Methods 0.000 description 3
- FTLYMKDSHNWQKD-UHFFFAOYSA-N (2,4,5-trichlorophenyl)boronic acid Chemical compound OB(O)C1=CC(Cl)=C(Cl)C=C1Cl FTLYMKDSHNWQKD-UHFFFAOYSA-N 0.000 description 2
- 229960000583 acetic acid Drugs 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 239000012153 distilled water Substances 0.000 description 2
- 238000009826 distribution Methods 0.000 description 2
- 239000012362 glacial acetic acid Substances 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 239000012528 membrane Substances 0.000 description 2
- 238000004806 packaging method and process Methods 0.000 description 2
- 239000008194 pharmaceutical composition Substances 0.000 description 2
- 239000013558 reference substance Substances 0.000 description 2
- 229940085605 saccharin sodium Drugs 0.000 description 2
- 229910001415 sodium ion Inorganic materials 0.000 description 2
- 238000003860 storage Methods 0.000 description 2
- 229910001631 strontium chloride Inorganic materials 0.000 description 2
- AHBGXTDRMVNFER-UHFFFAOYSA-L strontium dichloride Chemical compound [Cl-].[Cl-].[Sr+2] AHBGXTDRMVNFER-UHFFFAOYSA-L 0.000 description 2
- 206010012735 Diarrhoea Diseases 0.000 description 1
- 208000004232 Enteritis Diseases 0.000 description 1
- 206010018910 Haemolysis Diseases 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- 241000702670 Rotavirus Species 0.000 description 1
- FKNQFGJONOIPTF-UHFFFAOYSA-N Sodium cation Chemical compound [Na+] FKNQFGJONOIPTF-UHFFFAOYSA-N 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 201000009840 acute diarrhea Diseases 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 230000000996 additive effect Effects 0.000 description 1
- 239000002671 adjuvant Substances 0.000 description 1
- 238000013019 agitation Methods 0.000 description 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 1
- 229910052782 aluminium Inorganic materials 0.000 description 1
- 208000022531 anorexia Diseases 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- 238000003321 atomic absorption spectrophotometry Methods 0.000 description 1
- 238000000498 ball milling Methods 0.000 description 1
- 239000011230 binding agent Substances 0.000 description 1
- 210000001772 blood platelet Anatomy 0.000 description 1
- 210000001124 body fluid Anatomy 0.000 description 1
- 239000010839 body fluid Substances 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 210000000170 cell membrane Anatomy 0.000 description 1
- 239000003086 colorant Substances 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- 238000000205 computational method Methods 0.000 description 1
- 239000013078 crystal Substances 0.000 description 1
- 206010061428 decreased appetite Diseases 0.000 description 1
- 230000004069 differentiation Effects 0.000 description 1
- 238000003113 dilution method Methods 0.000 description 1
- 208000002173 dizziness Diseases 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 201000006549 dyspepsia Diseases 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000003792 electrolyte Substances 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 230000009931 harmful effect Effects 0.000 description 1
- 230000008588 hemolysis Effects 0.000 description 1
- 230000001771 impaired effect Effects 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
- 230000003834 intracellular effect Effects 0.000 description 1
- 238000001990 intravenous administration Methods 0.000 description 1
- 210000000265 leukocyte Anatomy 0.000 description 1
- 238000011068 loading method Methods 0.000 description 1
- 206010025482 malaise Diseases 0.000 description 1
- 230000008520 organization Effects 0.000 description 1
- 239000012466 permeate Substances 0.000 description 1
- 238000005498 polishing Methods 0.000 description 1
- 229960000999 sodium citrate dihydrate Drugs 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 239000006228 supernatant Substances 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- HRXKRNGNAMMEHJ-UHFFFAOYSA-K trisodium citrate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O HRXKRNGNAMMEHJ-UHFFFAOYSA-K 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention relates to a medicine composition of oral rehydration salt, which also can be called oral rehydration salt powder III in some embodiments. Specifically, the medicine composition of oral rehydration salt comprises potassium chloride, sodium chloride, sodium citrate and glucose. More specifically, the oral rehydration salt powder comprises 1 part of potassium chloride, 1.3-2.5 parts of sodium chloride, 1.5-2.5 parts of sodium citrate and 6-15 parts of glucose by weight. The oral rehydration salt powder provided by the invention has the characteristics that the preparation technology is simple, the process control is easy, the phenomena of crystallization and clustering are avoided in the preparation process, the product dissolution speed is high, and the like. The oral rehydration salt powder provided by the invention obviously overcomes some important technical problems often caused by the common powder, can provide an oral rehydration salt preparation with good pharmaceutical performance for clinical use, has significant innovation, and is certainly to bring tremendous social and economic benefits.
Description
Technical field
The invention belongs to medical technical field, relate to a kind of pharmaceutical composition that Powdered or granular ORS looses that is, also can be described as the diffusing III of ORS in some instances.Comprise glucose and sodium chloride, potassium chloride, sodium citrate in this medicine.
Background technology
Salt is one of indispensable composition in the human life; According to A Palin (world-renowned former Soviet Union biochemist; 1894-1980) said in " origin of life ": " human mater to all life evolution of all from sea water, deriving; some life lands, and some life is then still stayed in the sea water and lived.”
Originally human animal and plant with all lands is all risen in the ocean.Up to today, nobody raises an objection to this theory.The sea is the mother of all life.Contain several mineral materials in the sea water, the mineral in the sea water is the mineral that contains of human body just.Potassium, sodium ions content in the sea water are the highest, and potassium, the sodium ion intravital two kinds of main cationes that also are our machine.They preside over the inside and outside work of cell separately, regulate the normal electrolyte balance of human body.If human body lacks these mineral, whole machine body will receive very big influence, and health will be impaired, and various abnormal body running situations can show with the mode of various diseases.Salinity is that human body is indispensable, if lacked salinity in the human body, the people will dizziness, malaise, anorexia, goes down for a long time and will cause numerous disease, and hair bleaches.
In hospital, we see patient infusion through regular meeting, and many is exactly sodium chloride normal saline (being that concentration is 0.9% saline solution).Blood in the human body all contains the Sal composition.Blood is made up of erythrocyte and liquid blood plasma.Hemocyte has three kinds of erythrocyte, leukocyte and platelet, and wherein, erythrocyte accounts for the overwhelming majority.Cell membrane is exactly a semipermeable membrane, and under normal situation, intracellular solution must be kept certain concentration with extracellular blood plasma liquid.The people gets into the saline of blood plasma when transfusion, also must keep certain concentration is 0.09%.If the normal saline latting drown or misused distilled water, after the transfusion, the concentration of blood plasma can be thinning so, like this, the moisture in the blood plasma will permeate in the big hemocyte of concentration.The result just causes the expansion of hemocyte, even breaks, and haemolysis takes place.If the saline overrich, so, the moisture in the hemocyte again can be to exosmosis.The mode that present people mend salt also rests on the traditional approach with medical form injecting normal saline at present; The people if not go to hospital, is exactly to dissolve a little saline solution at home when replenishing salt like this; Cause the mode of mending salt very single like this, and bother very much.
The medicine of world health organisation recommendations treatment acute diarrhea dehydration is an ORS, and these drug prescriptions are formed rationally, and are cheap and easy to get, and convenient efficient, the speed of its correct dehydration is superior to intravenous drip.Be used to treat the slight and moderate dehydration that infantile dyspepsia and rotavirus enteritis cause.Have been found that a kind of prescription that effectively can be used for replenishing salt in the body fluid; This prescription comprises glucose, sodium chloride, potassium chloride and the sodium citrate as active component; And can not add other material in this prescription and directly be prepared into preparation, for example granule, powder etc.From pharmaceutical technology can handling, production cost, and the compliance of clinical practice says that for this prescription, powder all has many than the better advantage of granule.For example powder can be after pulverizing, mixing direct packaging in the unit dose package medicated bag; And granule need add aqueous binders to process granule, drying after pulverizing, mixing, and then branch installs in the unit dose package medicated bag.The preparation technology of granule prolongs in the cycle greatly for powder, and owing to need dry run, needs to consume a large amount of energy.In addition, powder is because its granule is littler than granule, and the back dissolving that is added to the water is faster, therefore more helps clinical use.Yet prepare in the process at powder, and, may run into variety of issue, occur phenomenons such as caking is agglomerating, the balling-up of uniting in the for example preparation process, can influence drugs packaging at the finished product duration of storage; In the dissolving that duration of storage caking is agglomerating then possibly influence drug use the time.
In addition, mix each composition of disposable pulverizing by traditional powder production method; Full dose is mixed; Or by the general equivalent incremental method phenomenons such as agglomerating, the balling-up of uniting of in mixed process, more or less can luming, the product that obtains should not disperse, and has influenced mixing uniformity; Also can't carry out next step packing, it is qualified that the manufactured goods uniformity is difficult for.In addition; When the granularity of the highest anhydrous glucose of our content is ground more than 80 orders,, process finished product behind the mix homogeneously in every way with other compositions again like 100 orders, 120 orders; When discovery is dissolved in water before finished product uses; The agglomerating phenomenon of crystallization can occur, the dissolving of product is slow, has a strong impact on use.
Therefore those skilled in the art need new method and overcome the problem that exists in this powder process of preparation.
Summary of the invention
The inventor unexpectedly finds, comprises the powder of glucose, sodium chloride, potassium chloride and sodium citrate as active component, and the glucose granularity accurately is controlled between 60～80 orders, and manufactured goods are very fast when dissolving.In addition; If the potassium chloride of the anhydrous glucose of an amount of 60～80 purposes is earlier sugared and full dose was with 0.5: 1～2.0: 1 part by weight mixings; All the other composition additional mixing; Both always mix with the anhydrous glucose sugar of residue at last, and phenomenons such as agglomerating, the balling-up of uniting of then in whole mixed process, can not occurring luming make mixed process very by the way with quick.If substitute the potassium chloride in the above method with other compositions, then can't realize its effect.Therefore the present invention is accomplished.
For this reason, first aspect present invention provides a kind of fine grained or pulverous compositions of being that can be referred to as powder, can also be called ORS in the present invention and loose.Particularly, first aspect present invention provides a kind of ORS to loose, and wherein comprises potassium chloride, sodium chloride, sodium citrate and glucose.
ORS according to first aspect present invention looses, and wherein comprises:
The potassium chloride of 1 weight portion,
1.3 the sodium chloride of～2.5 weight portions,
1.5 the sodium citrate of～2.5 weight portions and
The glucose of 6～15 weight portions.
ORS according to first aspect present invention looses, and wherein comprises:
The potassium chloride of 1 weight portion,
1.5 the sodium chloride of～2.4 weight portions,
1.6 the sodium citrate of～2.2 weight portions and
The glucose of 7～14 weight portions.
ORS according to first aspect present invention looses, and wherein comprises:
The potassium chloride of 1 weight portion,
1.56 the sodium chloride of～1.91 weight portions,
1.74 the sodium citrate of～2.13 weight portions and
The glucose of 8～10 weight portions.
ORS according to first aspect present invention looses, and wherein comprises:
The potassium chloride of 1 weight portion,
1.65 the sodium chloride of～1.82 weight portions,
1.84 the sodium citrate of～2.03 weight portions and
8.55 the glucose of～9.45 weight portions.
ORS according to first aspect present invention looses, and wherein comprises:
The potassium chloride of 1 weight portion,
The sodium chloride of about 1.73 weight portions,
The sodium citrate of about 1.93 weight portions and
The glucose of about 9 weight portions.
ORS according to first aspect present invention looses, and wherein comprises:
The potassium chloride of 1 weight portion,
2.1 the sodium chloride of～2.57 weight portions,
1.74 the sodium citrate of～2.13 weight portions and
The glucose of 12～14.67 weight portions.
ORS according to first aspect present invention looses, and wherein comprises:
The potassium chloride of 1 weight portion,
2.22 the sodium chloride of～2.45 weight portions,
1.84 the sodium citrate of～2.03 weight portions and
12.67 the glucose of～14 weight portions.
ORS according to first aspect present invention looses, and wherein comprises:
The potassium chloride of about 1 weight portion,
The sodium chloride of about 2.33 weight portions,
The sodium citrate of about 1.93 weight portions and
The glucose of about 13.3 weight portions.
ORS according to first aspect present invention looses, and wherein said sodium citrate is anhydrous citric acid sodium or its hydrate.In one embodiment, said sodium citrate is the dihydrate of sodium citrate.
ORS according to first aspect present invention looses, and wherein said glucose is anhydrous glucose or its hydrate.In one embodiment, said glucose is an anhydrous glucose.
ORS according to first aspect present invention looses, and wherein the footpath of the glucose particle more than 70% is between 60 orders～80 orders.In the present invention, like not explanation in addition, % is meant percetage by weight.
ORS according to first aspect present invention looses, and wherein the footpath of the glucose particle more than 80% is between 60 orders～80 orders.
ORS according to first aspect present invention looses, and wherein the footpath of the glucose particle more than 90% is between 60 orders～80 orders.
ORS according to first aspect present invention looses, and wherein the potassium chloride more than 80%, sodium chloride and/or sodium citrate particle footpath are between 65 orders～120 orders.
ORS according to first aspect present invention looses, and wherein the potassium chloride more than 80%, sodium chloride and/or sodium citrate particle footpath are between 80 orders～120 orders.
ORS according to first aspect present invention looses, and wherein the potassium chloride more than 80%, sodium chloride and/or sodium citrate particle footpath are between 80 orders～100 orders.
ORS according to first aspect present invention looses, and its granularity is: the particle footpath more than 65% is between 50 orders～80 orders.
ORS according to first aspect present invention looses, and its granularity is: the particle footpath more than 70% is between 50 orders～80 orders.
ORS according to first aspect present invention looses, and its granularity is: the particle footpath more than 75% is between 50 orders～80 orders.
ORS according to first aspect present invention looses, and it is that the method for shining following steps prepares:
(1) glucose is pulverized;
(2) with potassium chloride, sodium chloride, sodium citrate pulverize separately;
(3) get the potassium chloride powder of the recipe quantity that step (2) obtains, pulverize the glucose powder that obtains with an amount of step (1) and mix;
(4) it is even to get sodium chloride and two kinds of powder mixes of sodium citrate of the recipe quantity that step (2) obtains;
(5) step (1) the gained glucose powder three with step (3) gained mixture, step (4) gained mixture and residue recipe quantity is mixed together evenly, gets final mixture, and packing promptly gets.
In above-mentioned ORS looses, in its preparation process, step (1) be glucose powder is broken into (for example more than 80%, for example more than 90%) 70% or more the glucose particle directly between 60 orders～80 orders.
In above-mentioned ORS looses; In its preparation process; Step (2) is to become particle footpath more than 80% at (for example the footpath of the particle 80% or more is between 80 orders～120 orders, and for example the particle more than 80% is directly between 80 orders～100 orders) between 65 orders～120 orders potassium chloride, sodium chloride, sodium citrate pulverize separately.
In above-mentioned ORS looses; In its preparation process; Step (3) is to get the potassium chloride powder of the recipe quantity that step (2) obtains, and (be that glucose is 0.5～2.0 with the weight ratio of potassium chloride: step 1) (1) is pulverized the glucose powder that obtains and mixed with 0.5～2.0 times of weight.
ORS according to first aspect present invention looses, and it is that the method for shining following steps prepares:
(1) the glucose particle footpath that glucose powder is broken into (for example more than 80%, for example more than 90%) more than 70% is between 60 orders～80 orders;
(2) become particle footpath more than 80% at (for example the footpath of the particle 80% or more is between 80 orders～120 orders, and for example the particle more than 80% is directly between 80 orders～100 orders) between 65 orders～120 orders potassium chloride, sodium chloride, sodium citrate pulverize separately;
(3) get the potassium chloride powder of the recipe quantity that step (2) obtains, (be that glucose is 0.5～2.0 with the weight ratio of potassium chloride: step 1) (1) is pulverized the glucose powder that obtains and is mixed with 0.5～2.0 times of weight;
(4) it is even to get sodium chloride and two kinds of powder mixes of sodium citrate of the recipe quantity that step (2) obtains;
(5) step (1) the gained glucose powder three with step (3) gained mixture, step (4) gained mixture and residue recipe quantity is mixed together evenly, gets final mixture, and packing promptly gets.
In above-mentioned ORS looses, in its preparation process, when mixing in the step (4), do not add glucose and potassium chloride.
ORS according to first aspect present invention looses; It is the 3-50 gram through being distributed into every bag or weight per package; For example be distributed into perhaps its 2 times, 2.5 times, 3 times, 4 times, 5 times amount of every bag of about 5.125g, perhaps be distributed into perhaps its 2 times, 2.5 times, 3 times, 4 times, 5 times amount of every bag of about 5.58g.
Second aspect present invention provides the method for preparing ORS diffusing (for example the said ORS of the arbitrary embodiment of first aspect present invention looses); This ORS Bales Off contains potassium chloride, sodium chloride, sodium citrate and glucose, and this method may further comprise the steps:
(1) glucose is pulverized;
(2) with potassium chloride, sodium chloride, sodium citrate pulverize separately;
(3) get the potassium chloride powder of the recipe quantity that step (2) obtains, pulverize the glucose powder that obtains with an amount of step (1) and mix;
(4) it is even to get sodium chloride and two kinds of powder mixes of sodium citrate of the recipe quantity that step (2) obtains;
(5) step (1) the gained glucose powder three with step (3) gained mixture, step (4) gained mixture and residue recipe quantity is mixed together evenly, gets final mixture, and packing promptly gets.
According to the method for second aspect present invention, wherein step (1) be glucose powder is broken into (for example more than 80%, for example more than 90%) more than 70% glucose particle footpath between 60 orders～80 orders.
Method according to second aspect present invention; Wherein step (2) is to become particle footpath more than 80% at (for example the footpath of the particle 80% or more is between 80 orders～120 orders, and for example the particle more than 80% is directly between 80 orders～100 orders) between 65 orders～120 orders potassium chloride, sodium chloride, sodium citrate pulverize separately.
Method according to second aspect present invention; Wherein step (3) is to get the potassium chloride powder of the recipe quantity that step (2) obtains, and (be that glucose is 0.5～2.0 with the weight ratio of potassium chloride: step 1) (1) is pulverized the glucose powder that obtains and mixed with 0.5～2.0 times of weight.
According to the method for second aspect present invention, this method may further comprise the steps:
(1) the glucose particle footpath that glucose powder is broken into (for example more than 80%, for example more than 90%) more than 70% is between 60 orders～80 orders;
(2) become particle footpath more than 80% at (for example the footpath of the particle 80% or more is between 80 orders～120 orders, and for example the particle more than 80% is directly between 80 orders～100 orders) between 65 orders～120 orders potassium chloride, sodium chloride, sodium citrate pulverize separately;
(3) get the potassium chloride powder of the recipe quantity that step (2) obtains, (be that glucose is 0.5～2.0 with the weight ratio of potassium chloride: step 1) (1) is pulverized the glucose powder that obtains and is mixed with 0.5～2.0 times of weight;
(4) it is even to get sodium chloride and two kinds of powder mixes of sodium citrate of the recipe quantity that step (2) obtains;
(5) step (1) the gained glucose powder three with step (3) gained mixture, step (4) gained mixture and residue recipe quantity is mixed together evenly, gets final mixture, and packing promptly gets.
According to the method for second aspect present invention, when wherein mixing in the step (4), do not add glucose and potassium chloride.
Method according to second aspect present invention; Wherein said powder is the 3-50 gram through being distributed into every bag or weight per package; For example be distributed into perhaps its 2 times, 2.5 times, 3 times, 4 times, 5 times amount of every bag of about 5.125g, perhaps be distributed into perhaps its 2 times, 2.5 times, 3 times, 4 times, 5 times amount of every bag of about 5.58g.
According to the method for second aspect present invention, wherein said ORS Bales Off contains:
The potassium chloride of 1 weight portion,
1.3 the sodium chloride of～2.5 weight portions,
1.5 the sodium citrate of～2.5 weight portions and
The glucose of 6～15 weight portions.
According to the method for second aspect present invention, wherein said ORS Bales Off contains:
The potassium chloride of 1 weight portion,
1.5 the sodium chloride of～2.4 weight portions,
1.6 the sodium citrate of～2.2 weight portions and
The glucose of 7～14 weight portions.
According to the method for second aspect present invention, wherein said ORS Bales Off contains:
The potassium chloride of 1 weight portion,
1.56 the sodium chloride of～1.91 weight portions,
1.74 the sodium citrate of～2.13 weight portions and
The glucose of 8～10 weight portions.
According to the method for second aspect present invention, wherein said ORS Bales Off contains:
The potassium chloride of 1 weight portion,
1.65 the sodium chloride of～1.82 weight portions,
1.84 the sodium citrate of～2.03 weight portions and
8.55 the glucose of～9.45 weight portions.
According to the method for second aspect present invention, wherein said ORS Bales Off contains:
The potassium chloride of 1 weight portion,
The sodium chloride of about 1.73 weight portions,
The sodium citrate of about 1.93 weight portions and
The glucose of about 9 weight portions.
According to the method for second aspect present invention, wherein said ORS Bales Off contains:
The potassium chloride of 1 weight portion,
2.1 the sodium chloride of～2.57 weight portions,
1.74 the sodium citrate of～2.13 weight portions and
The glucose of 12～14.67 weight portions.
According to the method for second aspect present invention, wherein said ORS Bales Off contains:
The potassium chloride of 1 weight portion,
2.22 the sodium chloride of～2.45 weight portions,
1.84 the sodium citrate of～2.03 weight portions and
12.67 the glucose of～14 weight portions.
According to the method for second aspect present invention, wherein said ORS Bales Off contains:
The potassium chloride of about 1 weight portion,
The sodium chloride of about 2.33 weight portions,
The sodium citrate of about 1.93 weight portions and
The glucose of about 13.3 weight portions.
According to the method for second aspect present invention, wherein said sodium citrate is anhydrous citric acid sodium or its hydrate.In one embodiment, said sodium citrate is the dihydrate of sodium citrate.
According to the method for second aspect present invention, wherein said glucose is anhydrous glucose or its hydrate.In one embodiment, said glucose is an anhydrous glucose.
According to the method for second aspect present invention, the glucose particle footpath during wherein said ORS looses more than 70% is between 60 orders～80 orders.In the present invention, like not explanation in addition, % is meant percetage by weight.
According to the method for second aspect present invention, the glucose particle footpath during wherein said ORS looses more than 80% is between 60 orders～80 orders.
According to the method for second aspect present invention, the glucose particle footpath during wherein said ORS looses more than 90% is between 60 orders～80 orders.
According to the method for second aspect present invention, the potassium chloride during wherein said ORS looses more than 80%, sodium chloride and/or sodium citrate particle footpath are between 65 orders～120 orders.
According to the method for second aspect present invention, the potassium chloride during wherein said ORS looses more than 80%, sodium chloride and/or sodium citrate particle footpath are between 80 orders～120 orders.
According to the method for second aspect present invention, the potassium chloride during wherein said ORS looses more than 80%, sodium chloride and/or sodium citrate particle footpath are between 80 orders～100 orders.
According to the method for second aspect present invention, the granularity that wherein said ORS looses is: the particle footpath more than 65% is between 50 orders～80 orders.
According to the method for second aspect present invention, the granularity that wherein said ORS looses is: the particle footpath more than 70% is between 50 orders～80 orders.
According to the method for second aspect present invention, the granularity that wherein said ORS looses is: the particle footpath more than 75% is between 50 orders～80 orders.
The ORS that ORS looses or the second aspect method prepares according to first aspect present invention looses, and except potassium chloride, sodium chloride, sodium citrate and four kinds of materials of glucose, does not add other material basically in addition in its prescription.Yet it will be apparent to those skilled in the art that; Also can add an amount of non-active ingredient in the present composition; For example can add a spot of correctives; For example add a little saccharin sodium to improve mouthfeel, perhaps for example add a little coloring agent with as differentiation packing dosage usefulness, these a little additive can not produce harmful effect to the object of the invention.
Be further described in the face of the present invention down.
Present invention relates in general to a kind of ORS that obtains through special process looses; This ORS Bales Off contains the method for preparing of the ORS of anhydrous glucose, potassium chloride; Through granularity and the anhydrous glucose of control anhydrous glucose and the order that mixes of other composition; Make whole process of preparation agglomerating phenomenon can not occur, mix homogeneously and finished product dissolving are rapidly.The present invention at first controls the anhydrous glucose granularity between 60～80 orders, then with the potassium chloride of the anhydrous glucose of part sugar and full dose with 0.5: 1～2.0: 1 part by weight mixings, all the other composition additional mixing, both always mix with the anhydrous glucose sugar of residue at last.
In the present invention, term " weight portion " expression can be with the amount of any unit of weight or mass unit calculating, and this amount can be an integer number, can also be smallest number.For example, in an instance of the present composition, for example in a prescription, said per 1 " weight portion " can be represented about 0.375g.Thus, in the prescription of an instance, comprise about 0.375g potassium chloride, about 0.65g sodium chloride, 0.725g sodium citrate and 3.375g glucose in the present composition.
In an instance of the present invention; Said sodium citrate is the dihydrate of sodium citrate, i.e. chemical compound shown in the following formula:
In an instance of the present invention; Said glucose is an anhydrous glucose, i.e. chemical compound shown in the following formula:
In the present invention; Phrase " the particle footpath more than 65% is between 50 orders～80 orders " is used to characterize the physical size that the present invention is pulverous compositions powder body; Its implication is; The above particle of 65% (w/w) is arranged in the present composition, and these particles can sieve through 50 purpose medicines but can not be through 80 purpose medicines sieve.The phrase of other similar statement also has similar meaning.The phrase " the particle footpath more than 65% is between 50 orders～80 orders " that one of ordinary skill in the art will readily recognize that the physical size of above-mentioned characterize combinations powder body can obtain through following method A mensuration at least:
Method A: method is according to two (Chinese Pharmacopoeia Commission's volumes of Pharmacopoeia of People's Republic of China of version in 2010; Chinese Medicine science and technology publishing house publishes; ISBN 978-7-5067-4438-6; Can abbreviate two ones of version Chinese Pharmacopoeias in 2012 in the present invention as) second method (sieve method) among the appendix IX E " granularity and particle size distribution method ", carry out with " two sieve method " in " rider point-score "; Upper strata medicine sieve is 50 orders, and lower floor's medicine sieve is 80 orders; Get and be trapped in two granule/powder between the medicine sieve, claim to decide weight, calculate its proportion (%).
If should measure the result, then meet the regulation of phrase " the particle footpath more than 65% is between 50 orders～80 orders " more than 65%.In addition, be 75% if measure the result, represent that then said composition has 75% particle still can not pass through 80 mesh sieves through 50 mesh sieves.
Need to prove; The method that characterizes or measure present composition granule/powder physical size has many, for example in two appendix IX of Pharmacopoeia of People's Republic of China of version in 2010 E " granularity and particle size distribution method ", has also described some other assay method.In context of the present invention, if not explanation in addition, the method that characterizes or measure present composition granule/powder physical size is to use said method A to carry out.
Need various materials be crushed to the particle size of regulation when in the present invention, preparing the present composition.With regard to realizing the object of the invention; Method of pulverizing and device therefor are not receive special restriction; For example can use stirring-type comminuting method (for example shear agitation), can also use polishing (for example ball-milling method) etc., as long as in crushing process, monitor the grain size characteristic of the present composition.
In the present invention; " order " of expression particle size or medicine sieve specification has the implication of well known to a person skilled in the art; Especially; For the present invention, it has the implication of two notes on the use of Pharmacopoeia of People's Republic of China " metering " following the 28 article of (9) money of version in 2010 about this pharmacopeia institute medication sieve.
The specific embodiment
Below through embodiment the present invention is described in further detail, but the present invention should not be limited to these embodiment.Among the embodiment, when forming with " weight portion " statement prescription, all the amount with preparation total amount 5kg compositions feeds intake below.Below among the embodiment, when mentioning glucose, like explanation in addition, use be anhydrous glucose.Below among the embodiment, when mentioning sodium citrate, like explanation in addition, use be sodium citrate dihydrate.Below among the embodiment; The compositions of preparation can pack in paper aluminum composite membrane bag; Every bag can be approximately 3g～30g, the amount of every bag of about 5.125g or its 2 times, 2.5 times, 3 times, 4 times, 5 times for example, perhaps perhaps its 2 times, 2.5 times, 3 times, 4 times, 5 times amount of every bag of about 5.58g for example; As not explanation in addition, every bag branch loading amount is 5.125g.
Embodiment 1
Prescription:The glucose of the sodium citrate of the sodium chloride of the potassium chloride of 375 weight portions, 650 weight portions, 725 weight portions and 3375 weight portions.The compositions that obtains can be designated as R1, and the hereinafter gained present composition can similarly be represented.
Method for preparing:
(1) glucose powder is broken into glucose particle footpath more than 80% between 60 orders～80 orders;
(2) become particle footpath more than 80% between 80 orders～120 orders potassium chloride, sodium chloride, sodium citrate pulverize separately;
(3) get the potassium chloride powder of the recipe quantity that step (2) obtains, pulverize the glucose powder that obtains with the step (1) of 1.5 times of weight and mixes, mixability reaches the requirement that [the outward appearance uniformity] inspection technique is stipulated under two appendix powder of version Chinese Pharmacopoeia in 2012 item;
(4) it is even to get sodium chloride and two kinds of powder mixes of sodium citrate of the recipe quantity that step (2) obtains, and mixability reaches the requirement of [the outward appearance uniformity] inspection technique regulation under two appendix powder of version Chinese Pharmacopoeia in 2012 item;
(5) step (1) the gained glucose powder three with step (3) gained mixture, step (4) gained mixture and residue recipe quantity is mixed together evenly, gets final mixture, and packing promptly gets
The process control of step (5) mixability:
(a) three kinds of materials are being carried out in the blended process, checking and requirement up to specification according to [the outward appearance uniformity] inspection technique under two appendix powder of version Chinese Pharmacopoeia in 2012 item, to guarantee potassium chloride, sodium chloride and the uniformity of sodium citrate three in material;
(b) think by rule of thumb after the abundant mixing; Guarantee the relative standard deviation (RSD of sodium citrate content and potassium content; %) (RSD is preferred less than 5% less than 5%; RSD can produce doubt to drug quality greater than 7.5% o'clock people, when RSD this medicine greater than 10% time can not be accepted by those skilled in the art basically).Relative standard deviation test/computational methods are: get 20 parts of samples at random; Test the content of sodium citrate in each part sample; Represent sodium citrate content with sodium citrate shared percent in compositions; Calculate the meansigma methods and the standard deviation of sodium citrate content then, and calculate sodium citrate content in 20 samples of each lot sample article relative standard deviation (RSD, %); Similar in addition test and calculate potassium content in 20 samples of each lot sample article relative standard deviation (RSD, %).Wherein:
The content assaying method of sodium citrate is: get the about 2.1g of compositions, the accurate title, decide, and puts in the 100ml measuring bottle, adds glacial acetic acid 80ml; Jolting is heated to 50 ℃, puts coldly, adds glacial acetic acid and is diluted to scale; Shake up, leave standstill, precision is measured supernatant 20ml; Add 1 of crystal violet indicator solution, show blue, and titration results is proofreaied and correct with blank assay with perchloric acid titration liquid (0.1mol/L) titration to solution.Every 1ml perchloric acid titration liquid (0.1mol/L) is equivalent to the C of 9.803mg
6H
5Na
3O
72H
2O.
The content assaying method of potassium is: the 105 ℃ of potassium chloride that are dried to constant weight of learning from else's experience, accurate claim fixed, be dissolved in water and quantitatively dilution process the solution that contains potassium chloride 50 μ g among every 1ml, shake up, as reference substance solution.Get the about 2.7g of compositions, accurate claim surely, put in the 100ml measuring bottle, be dissolved in water and be diluted to scale, shake up, promptly get solution (1); Precision is measured solution (1) 2ml, puts in the 100ml measuring bottle, is diluted with water to scale, shakes up, and promptly gets solution (2); Precision is measured solution (2) 5ml, puts in the 100ml measuring bottle, adds 2% strontium chloride solution 3.0ml, is diluted with water to scale, shakes up, as need testing solution.Precision is measured reference substance solution 3ml, 4ml, 5ml, puts respectively in the 100ml measuring bottle, respectively adds 2% strontium chloride solution 3.0ml, is diluted with water to scale, shakes up.With above-mentioned each solution and need testing solution, according to atomic absorption spectrophotometry (two appendix IV of Chinese Pharmacopoeia version in 2010 D, first method), measure in the wavelength of 767nm, calculate, promptly get.
Preparation process and product evaluation:
(i) agglomeration: each blend step does not have agglomerate to occur;
(ii) incorporation time: step (5) is mixed required time 0.8h;
(iii) dissolution time: dissolution time 110s.
The dissolution time assay method: get testing sample 1 bag, impouring is equipped with in the beaker of 100ml distilled water, and the beaker capacity is 500ml, the about 9.2cm of diameter; In water during the impouring sample, impouring as quickly as possible, and be evenly distributed at the bottom of the beaker as far as possible; Beaker leaves standstill in the whole process, does not stir; To the consoluet time, each sample repeats 5 times from the impouring sample in calculating, get average as the dissolution time of this sample (second, s).
Above compositions R1 is prepared into powder; It is a kind of hypotonic ORS; In the present invention and those skilled in the art can be described as " ORS loose III " or similar title, can be packaged into specification is 5.125g, this be a kind of be the prescription that does not contain adjuvant; Be the low sodium of selecting for use World Health Organization (WHO) and international United Nations Children's Fund to recommend, the new prescription of low sugar, prescription as follows
Embodiment 2
Prescription:The glucose of the sodium citrate of the sodium chloride of the potassium chloride of 1 weight portion, 2.33 weight portions, 1.93 weight portions and 13.3 weight portions.The present composition that obtains can be designated as R2.
Method for preparing:Method with reference to embodiment 1 is carried out the result:
(i) agglomeration: each blend step does not have agglomerate to occur;
(ii) incorporation time: step (5) is mixed required time 0.7h;
(iii) dissolution time: dissolution time 85s.
Embodiment 3
Prescription:The glucose of the sodium citrate of the sodium chloride of the potassium chloride of 1 weight portion, 2.4 weight portions, 1.6 weight portions and 14 weight portions.
Method for preparing:Method with reference to embodiment 1 is carried out the result:
(i) agglomeration: each blend step does not have agglomerate to occur;
(ii) incorporation time: step (5) is mixed required time 0.9h;
(iii) dissolution time: dissolution time 90s.
Embodiment 4
Prescription:The glucose of the sodium citrate of the sodium chloride of the potassium chloride of 1 weight portion, 1.5 weight portions, 2.2 weight portions and 7 weight portions.
Method for preparing:Method with reference to embodiment 1 is carried out the result:
(i) agglomeration: each blend step does not have agglomerate to occur;
(ii) incorporation time: step (5) is mixed required time 1.1h;
(iii) dissolution time: dissolution time 105s.
Embodiment 5
Prescription:The glucose of the sodium citrate of the sodium chloride of the potassium chloride of 1 weight portion, 1.65 weight portions, 2.03 weight portions and 8.55 weight portions.
Method for preparing:Method with reference to embodiment 1 is carried out the result:
(i) agglomeration: each blend step does not have agglomerate to occur;
(ii) incorporation time: step (5) is mixed required time 0.6h;
(iii) dissolution time: dissolution time 140s.
Embodiment 6
Prescription:The glucose of the sodium citrate of the sodium chloride of the potassium chloride of 1 weight portion, 1.82 weight portions, 1.84 weight portions and 9.45 weight portions.
Method for preparing:Method with reference to embodiment 1 is carried out the result:
(i) agglomeration: each blend step does not have agglomerate to occur;
(ii) incorporation time: step (5) is mixed required time 0.9h;
(iii) dissolution time: dissolution time 125s.
Embodiment 7
Prescription:The glucose of the sodium citrate of the sodium chloride of the potassium chloride of 1 weight portion, 2.45 weight portions, 1.84 weight portions and 14 weight portions.
Method for preparing:Method with reference to embodiment 1 is carried out the result:
(i) agglomeration: each blend step does not have agglomerate to occur;
(ii) incorporation time: step (5) is mixed required time 0.9h;
(iii) dissolution time: dissolution time 105s.
Embodiment 8
Prescription:The glucose of the sodium citrate of the sodium chloride of the potassium chloride of 1 weight portion, 2.22 weight portions, 2.03 weight portions and 12.67 weight portions; The saccharin sodium that adds total weight of material 0.01% in addition is to be used to improve mouthfeel.
Method for preparing:Method with reference to embodiment 1 is carried out the result:
(i) agglomeration: each blend step does not have agglomerate to occur;
(ii) incorporation time: step (5) is mixed required time 1.0h;
(iii) dissolution time: dissolution time 95s.
Embodiment 9
It is identical with embodiment 1 to write out a prescription; In step (3), being designed to glucose respectively is 0.2,0.4,0.5,1,2,2.5,3,3.5,4,5,7,9 than the ratio R (being that glucose amount is a potassium chloride amount multiple) of potassium chloride amount, prepares the compositions that a plurality of different process processes obtain.The result shows, R be 0.2 or 0.4 o'clock or R more than or equal to 4 o'clock, reach enough mixabilities; Step (5) is mixed required time all above 3.2 hours; Between 3.2h to 7.9 hour, for example the incorporation time of R=0.4 is 3.6h, and the incorporation time of R=5 is 6.2h.And R mixes required time and all is lower than 1.5 hours in 0.5 to 2 scope.And R dissolves all above 4 minutes, in 4.2～7.5 minutes scope greater than in whole samples of 2 hours.For example during R=2.5, incorporation time 2.3 hours, dissolution time 4.2 minutes, for example during R=4, incorporation time 4.5 hours, dissolution time 5.6 minutes.And find that it is 0.5～2 sample that R is only arranged, step (5) is mixed required time short (in 1.5 hours) and dissolution time short (in 2.5 minutes).
Find in addition; In the long compositions of these incorporation times; For example in R=0.2,0.4,2.5,3,3.5,4,5,7, each preparation of compositions process of 9, the agglomerate that differs in size in various degree all occurred and occurred, this possibly be the reason that causes incorporation time to prolong.But in each preparation of compositions process of R=0.5～2 phenomenon does not appear all gathering.
Embodiment 10
In some tests; It is identical with embodiment 1 to write out a prescription; In step (3), make full dose sodium chloride mix (and potassium chloride mixes with sodium citrate) with glucose in step (4); And being designed to glucose respectively is 0.5,1,2 than the ratio R of sodium chloride amount, prepares the compositions that a plurality of different process processes obtain.The result shows, three compositionss that different R values obtain, incorporation time all between 2.1～3.7 hours, dissolution time all between 3～5min, for example between the compositions incorporation time 2.1 hours of R=1, dissolution time 4.5min.
In other tests; It is identical with embodiment 1 to write out a prescription; In step (3), make the full dose sodium citrate mix (and potassium chloride mixes with sodium chloride) with glucose in step (4); And being designed to glucose respectively is 0.5,1,2 than the ratio R of sodium citrate amount, prepares the compositions that a plurality of different process processes obtain.The result shows, three compositionss that different R values obtain, incorporation time all between 1.9～3.5 hours, dissolution time all between 2.5～5min, for example between the compositions incorporation time 2.4 hours of R=1, dissolution time 2.5min.
In other tests, it is identical with embodiment 1 write out a prescription, and be about to whole materials in step (3) and be mixed together, as a result between the incorporation time 6.2 hours, dissolution time 4.5min, and the agglomerate appearance is arranged in mixed process.
In other tests; It is identical with embodiment 1 to write out a prescription; Be about to potassium chloride, sodium chloride, sodium citrate three in step (3) and be mixed together, then this mixture is mixed with glucose, result and glucose are between the blended 4.6 hours time; Dissolution time 4.2min, and in mixed process, have agglomerate to occur.
Among the above embodiment 1-10, the compositions of preparation is that the granularity that ORS of the present invention looses is: the particle footpath more than 70% is between 50 orders～80 orders.
Embodiment 11
The inventor attempts to increase the granularity of glucose and investigates.According to prescription and the method for embodiment 1, but the glucose particle more than 80% directly is controlled between 50 orders～60 orders, the result will reach satisfactory mixability in the mixed process of step (5), and incorporation time is more than 7.5 hours.
In addition, inventor's granularity of attempting to reduce glucose is investigated.Prescription and method according to embodiment 1; But the glucose particle more than 80% directly is controlled between 80 orders～120 orders; The result will reach satisfactory mixability in the mixed process of step (5), incorporation time is more than 6.5 hours; And agglomerate often occurs, dissolution time is also more than 3min.
In addition; The inventor has also investigated the influence of the granularity of potassium chloride, sodium chloride, sodium citrate three kinds of materials to technology; The result shows that different grain size is little to the dissolution time influence, but influential to incorporation time; Particularly when the potassium chloride more than 80%, sodium chloride and sodium citrate particle footpath were between 80 orders～120 orders, incorporation time was shorter relatively for other particle size range of three kinds of materials.
Claims (10)
1. an ORS looses, and wherein comprises potassium chloride, sodium chloride, sodium citrate and glucose.
2. the ORS according to claim 1 looses, and wherein comprises:
The potassium chloride of 1 weight portion,
1.3 the sodium chloride of～2.5 weight portions,
1.5 the sodium citrate of～2.5 weight portions and
The glucose of 6～15 weight portions;
Perhaps, wherein comprise:
The potassium chloride of 1 weight portion,
1.5 the sodium chloride of～2.4 weight portions,
1.6 the sodium citrate of～2.2 weight portions and
The glucose of 7～14 weight portions;
Perhaps, wherein comprise:
The potassium chloride of 1 weight portion,
1.56 the sodium chloride of～1.91 weight portions,
1.74 the sodium citrate of～2.13 weight portions and
The glucose of 8～10 weight portions;
Perhaps, wherein comprise:
The potassium chloride of 1 weight portion,
1.65 the sodium chloride of～1.82 weight portions,
1.84 the sodium citrate of～2.03 weight portions and
8.55 the glucose of～9.45 weight portions;
Perhaps, wherein comprise:
The potassium chloride of 1 weight portion,
The sodium chloride of about 1.73 weight portions,
The sodium citrate of about 1.93 weight portions and
The glucose of about 9 weight portions;
Perhaps, wherein comprise:
The potassium chloride of 1 weight portion,
2.1 the sodium chloride of～2.57 weight portions,
1.74 the sodium citrate of～2.13 weight portions and
The glucose of 12～14.67 weight portions;
Perhaps, wherein comprise:
The potassium chloride of 1 weight portion,
2.22 the sodium chloride of～2.45 weight portions,
1.84 the sodium citrate of～2.03 weight portions and
12.67 the glucose of～14 weight portions;
Perhaps, wherein comprise:
The potassium chloride of about 1 weight portion,
The sodium chloride of about 2.33 weight portions,
The sodium citrate of about 1.93 weight portions and
The glucose of about 13.3 weight portions.
3. loose according to each ORS of claim 1 to 2, wherein:
Said sodium citrate is anhydrous citric acid sodium or its hydrate; And/or
Said glucose is anhydrous glucose or its hydrate.
4. loose according to each ORS of claim 1 to 3, wherein:
Glucose particle footpath more than 70% is between 60 orders～80 orders;
Potassium chloride more than 80%, sodium chloride and/or sodium citrate particle footpath are between 65 orders～120 orders; And/or
The granularity that this ORS looses is: the particle footpath more than 65% is between 50 orders～80 orders.
5. loose according to each ORS of claim 1 to 4, it is that method according to following steps prepares:
(1) glucose is pulverized;
(2) with potassium chloride, sodium chloride, sodium citrate pulverize separately;
(3) get the potassium chloride powder of the recipe quantity that step (2) obtains, pulverize the glucose powder that obtains with an amount of step (1) and mix;
(4) it is even to get sodium chloride and two kinds of powder mixes of sodium citrate of the recipe quantity that step (2) obtains;
(5) step (1) the gained glucose powder three with step (3) gained mixture, step (4) gained mixture and residue recipe quantity is mixed together evenly, gets final mixture, and packing promptly gets.
6. the ORS according to claim 5 looses, wherein:
Step (1) is that glucose powder is broken into glucose particle footpath more than 70% between 60 orders～80 orders;
Step (2) is to become particle footpath more than 80% between 65 orders～120 orders potassium chloride, sodium chloride, sodium citrate pulverize separately; And/or
Step (3) is to get the potassium chloride powder of the recipe quantity that step (2) obtains, and pulverizes the glucose powder that obtains with the step (1) of 0.5～2.0 times of weight and mixes.
7. loose according to each ORS of claim 1 to 4, it is that method according to following steps prepares:
(1) glucose powder is broken into glucose particle footpath more than 70% between 60 orders～80 orders;
(2) become particle footpath more than 80% between 65 orders～120 orders potassium chloride, sodium chloride, sodium citrate pulverize separately;
(3) get the potassium chloride powder of the recipe quantity that step (2) obtains, pulverize the glucose powder that obtains with the step (1) of 0.5～2.0 times of weight and mix;
(4) it is even to get sodium chloride and two kinds of powder mixes of sodium citrate of the recipe quantity that step (2) obtains;
(5) step (1) the gained glucose powder three with step (3) gained mixture, step (4) gained mixture and residue recipe quantity is mixed together evenly, gets final mixture, and packing promptly gets.
8. loose according to each ORS of claim 1 to 7; It is the 3-50 gram through being distributed into every bag or weight per package; For example be distributed into perhaps its 2 times, 2.5 times, 3 times, 4 times, 5 times amount of every bag of about 5.125g, perhaps be distributed into perhaps its 2 times, 2.5 times, 3 times, 4 times, 5 times amount of every bag of about 5.58g.
9. prepare the method for ORS diffusing (for example the said ORS of the arbitrary embodiment of first aspect present invention looses), this ORS Bales Off contains potassium chloride, sodium chloride, sodium citrate and glucose, and this method may further comprise the steps:
(1) glucose is pulverized;
(2) with potassium chloride, sodium chloride, sodium citrate pulverize separately;
(3) get the potassium chloride powder of the recipe quantity that step (2) obtains, pulverize the glucose powder that obtains with an amount of step (1) and mix;
(4) it is even to get sodium chloride and two kinds of powder mixes of sodium citrate of the recipe quantity that step (2) obtains;
(5) step (1) the gained glucose powder three with step (3) gained mixture, step (4) gained mixture and residue recipe quantity is mixed together evenly, gets final mixture, and packing promptly gets.Perhaps this method such as the arbitrary embodiment of description second aspect are said.
10. according to the method for claim 9, this method may further comprise the steps:
(1) glucose powder is broken into glucose particle footpath more than 70% between 60 orders～80 orders;
(2) become particle footpath more than 80% between 65 orders～120 orders potassium chloride, sodium chloride, sodium citrate pulverize separately;
(3) get the potassium chloride powder of the recipe quantity that step (2) obtains, pulverize the glucose powder that obtains with the step (1) of 0.5～2.0 times of weight and mix;
(4) it is even to get sodium chloride and two kinds of powder mixes of sodium citrate of the recipe quantity that step (2) obtains;
(5) step (1) the gained glucose powder three with step (3) gained mixture, step (4) gained mixture and residue recipe quantity is mixed together evenly, gets final mixture, and packing promptly gets.
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| CN116870026A (en) * | 2023-09-07 | 2023-10-13 | 中国人民解放军总医院第四医学中心 | Oral rehydration salt pharmaceutical composition and preparation method thereof |
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| CN104027351A (en) * | 2013-03-05 | 2014-09-10 | 肖云彩 | Oral composition of supplement |
| CN103380900A (en) * | 2013-06-19 | 2013-11-06 | 安徽恒星制药有限公司 | Preparation method for novel corrective flavor type oral rehydration salt powders and novel corrective flavor type oral rehydration salt powders |
| CN103479664A (en) * | 2013-09-24 | 2014-01-01 | 辽宁亿灵科创生物医药科技有限公司 | Liquid oral rehydration salt |
| CN103479664B (en) * | 2013-09-24 | 2015-01-07 | 辽宁亿灵科创生物医药科技有限公司 | Liquid oral rehydration salt |
| CN103610692A (en) * | 2013-12-05 | 2014-03-05 | 厦门恩成制药有限公司 | Preparation method of low-permeability oral rehydration salt |
| CN103610692B (en) * | 2013-12-05 | 2015-11-18 | 厦门恩成制药有限公司 | A kind of preparation method of low-permeability oral rehydration salt |
| CN104258370A (en) * | 2014-10-14 | 2015-01-07 | 北京国仁堂医药科技发展有限公司 | Drug composition of oral rehydration salt and preparation method of drug composition |
| CN107205464A (en) * | 2014-11-19 | 2017-09-26 | 卡尔玛纳有限公司 | ORT composition and its method |
| CN104857019A (en) * | 2015-06-23 | 2015-08-26 | 陈嫣 | Novel oral rehydration salts solution and preparation method and use thereof |
| CN104857019B (en) * | 2015-06-23 | 2018-01-12 | 安徽恒星制药有限公司 | A kind of new oral fluid infusion salt and its production and use |
| CN107296198A (en) * | 2017-07-19 | 2017-10-27 | 东莞市山河电脑科技有限公司 | A kind of electuary or beverage of microelement-supplementing and energy |
| CN108272084A (en) * | 2018-01-11 | 2018-07-13 | 中国人民解放军第二军医大学 | It is a kind of prevent thermoplegia composition and its application |
| CN110693933A (en) * | 2019-10-08 | 2020-01-17 | 安徽九华华源药业有限公司 | Stable oral rehydration salt powder (III) and preparation method thereof |
| CN116870026A (en) * | 2023-09-07 | 2023-10-13 | 中国人民解放军总医院第四医学中心 | Oral rehydration salt pharmaceutical composition and preparation method thereof |
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