CN104208093A - Glucose-containing composition - Google Patents
Glucose-containing composition Download PDFInfo
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- CN104208093A CN104208093A CN201410401641.8A CN201410401641A CN104208093A CN 104208093 A CN104208093 A CN 104208093A CN 201410401641 A CN201410401641 A CN 201410401641A CN 104208093 A CN104208093 A CN 104208093A
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- glucose
- sodium citrate
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- sodium
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- 239000000203 mixture Substances 0.000 title claims abstract description 116
- 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 title claims abstract description 43
- 239000008103 glucose Substances 0.000 title claims abstract description 43
- 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 48
- 239000011734 sodium Substances 0.000 claims abstract description 4
- 229910052708 sodium Inorganic materials 0.000 claims abstract description 4
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims description 62
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 62
- 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 description 51
- 239000001509 sodium citrate Substances 0.000 claims description 50
- 229960001031 glucose Drugs 0.000 claims description 49
- 238000000034 method Methods 0.000 claims description 49
- 239000001103 potassium chloride Substances 0.000 claims description 31
- 235000011164 potassium chloride Nutrition 0.000 claims description 31
- 239000011780 sodium chloride Substances 0.000 claims description 31
- 239000000843 powder Substances 0.000 claims description 20
- 230000008569 process Effects 0.000 claims description 13
- 239000000463 material Substances 0.000 claims description 12
- 238000004806 packaging method and process Methods 0.000 claims description 5
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical group OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 4
- 238000001035 drying Methods 0.000 claims description 3
- 239000011812 mixed powder Substances 0.000 claims description 3
- 239000004480 active ingredient Substances 0.000 claims description 2
- 229960004543 anhydrous citric acid Drugs 0.000 claims description 2
- 239000012467 final product Substances 0.000 claims description 2
- 229960000999 sodium citrate dihydrate Drugs 0.000 claims description 2
- HRXKRNGNAMMEHJ-UHFFFAOYSA-K trisodium citrate Chemical group [Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O HRXKRNGNAMMEHJ-UHFFFAOYSA-K 0.000 claims description 2
- 239000011591 potassium Substances 0.000 abstract description 2
- 229910052700 potassium Inorganic materials 0.000 abstract description 2
- -1 potassium halide Chemical class 0.000 abstract 2
- 238000002360 preparation method Methods 0.000 description 16
- 239000008187 granular material Substances 0.000 description 7
- 238000012360 testing method Methods 0.000 description 7
- 238000004090 dissolution Methods 0.000 description 6
- 239000003814 drug Substances 0.000 description 6
- 238000003556 assay Methods 0.000 description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 5
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 4
- 230000008859 change Effects 0.000 description 4
- VLTRZXGMWDSKGL-UHFFFAOYSA-N perchloric acid Chemical compound OCl(=O)(=O)=O VLTRZXGMWDSKGL-UHFFFAOYSA-N 0.000 description 4
- YXFVVABEGXRONW-UHFFFAOYSA-N Toluene Chemical compound CC1=CC=CC=C1 YXFVVABEGXRONW-UHFFFAOYSA-N 0.000 description 3
- 150000001875 compounds Chemical class 0.000 description 3
- 230000018044 dehydration Effects 0.000 description 3
- 238000006297 dehydration reaction Methods 0.000 description 3
- 229940079593 drug Drugs 0.000 description 3
- 238000005516 engineering process Methods 0.000 description 3
- 230000036541 health Effects 0.000 description 3
- 238000002156 mixing Methods 0.000 description 3
- 238000001556 precipitation Methods 0.000 description 3
- 150000003839 salts Chemical class 0.000 description 3
- 238000004448 titration 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
- SPFMQWBKVUQXJV-BTVCFUMJSA-N (2r,3s,4r,5r)-2,3,4,5,6-pentahydroxyhexanal;hydrate Chemical group O.OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C=O SPFMQWBKVUQXJV-BTVCFUMJSA-N 0.000 description 2
- 229960000583 acetic acid Drugs 0.000 description 2
- 238000007664 blowing Methods 0.000 description 2
- 210000001124 body fluid Anatomy 0.000 description 2
- 239000010839 body fluid Substances 0.000 description 2
- 239000000306 component Substances 0.000 description 2
- 229960000673 dextrose monohydrate Drugs 0.000 description 2
- 150000004683 dihydrates Chemical class 0.000 description 2
- 230000014509 gene expression Effects 0.000 description 2
- 239000012362 glacial acetic acid Substances 0.000 description 2
- 125000002791 glucosyl group Chemical group C1([C@H](O)[C@@H](O)[C@H](O)[C@H](O1)CO)* 0.000 description 2
- 150000002500 ions Chemical class 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 229940085605 saccharin sodium Drugs 0.000 description 2
- 238000003860 storage Methods 0.000 description 2
- ZAMOUSCENKQFHK-UHFFFAOYSA-N Chlorine atom Chemical compound [Cl] ZAMOUSCENKQFHK-UHFFFAOYSA-N 0.000 description 1
- 206010012735 Diarrhoea Diseases 0.000 description 1
- 208000004232 Enteritis 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
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 description 1
- 241000702670 Rotavirus Species 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 201000009840 acute diarrhea Diseases 0.000 description 1
- 239000000654 additive Substances 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
- 239000011230 binding agent Substances 0.000 description 1
- 239000000460 chlorine Substances 0.000 description 1
- 229910052801 chlorine Inorganic materials 0.000 description 1
- 239000003086 colorant Substances 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- 238000005443 coulometric titration Methods 0.000 description 1
- 239000013078 crystal Substances 0.000 description 1
- 230000004069 differentiation Effects 0.000 description 1
- 239000012153 distilled water Substances 0.000 description 1
- 201000006549 dyspepsia Diseases 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 235000021050 feed intake Nutrition 0.000 description 1
- 230000009931 harmful effect Effects 0.000 description 1
- 238000001990 intravenous administration Methods 0.000 description 1
- 238000011068 loading method Methods 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 238000012856 packing Methods 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 238000010298 pulverizing process Methods 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 239000006228 supernatant Substances 0.000 description 1
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention relates to a glucose-containing composition. The above powdery composition concretely comprises glucose, potassium halide and sodium halide. The composition has good pharmaceutical performances.
Description
The application is the Chinese Patent Application No. 2012103488728 of JIUYUE in 2012 submission on the 20th, and the divisional application that denomination of invention " comprises the compositions of glucose ", its full content is incorporated to herein by reference.
Technical field
The invention belongs to medical art, relate to a kind of in pulverous compositions, in said composition, comprise glucose and N
athe salt of ion and K ion.
Background technology
In supplementary body fluid for oral use, the medicine of salt is the medicine of world health organisation recommendations treatment acute diarrhea dehydration, and rationally, cheap and easy to get, convenience and high-efficiency, the speed of its correct dehydration is better than intravenous drip to these drug prescriptions composition.Be used for the treatment of the slight and moderate dehydration that infantile dyspepsia and rotavirus enteritis cause.
Have been found that a kind of formula that effectively can be used for salt in supplementary body fluid, this formula comprises as the glucose of active component, sodium chloride, potassium chloride and sodium citrate, and other material can not be added in this formula and directly be prepared into preparation, such as granule, powder etc.From pharmaceutical technology can handling, production cost, and the compliance of clinical practice is said, for this formula, powder has many advantages more better than granule.Such as powder can through pulverize, mixing after direct packaging in unit dose package medicated bag; And granule needs after pulverizing, mixing, adding aqueous binders makes granule, drying, and then is dispensed in unit dose package medicated bag.For powder, the preparation technology of granule extends in the cycle greatly, and owing to needing dry run, needs to consume a large amount of energy.In addition, powder is less than granule due to its granule, dissolves faster, be therefore more conducive to Clinical practice after being added to the water.
But in powder preparation process, and at finished product duration of storage, various problem may be run into, such as, there is agglomerating, the phenomenons such as balling-up of uniting of caking in preparation process, can drugs packaging be affected; Agglomerating at duration of storage caking, dissolving during drug use may be affected.
Therefore those skilled in the art need new method to prepare the new medicine with above-mentioned formula.
Summary of the invention
The present inventor have been surprisingly found that, comprises the powder as the glucose of active component, sodium chloride, potassium chloride and sodium citrate, shows the effect of desirable when this powder has particular characteristic such as moisture.Therefore the present invention is accomplished.
For this reason, first aspect present invention provide can be referred to as powder in fine grained or pulverous compositions, in the composition, comprise potassium chloride, sodium chloride, sodium citrate and glucose.
Compositions according to a first aspect of the present invention, wherein comprises: the potassium chloride of 1 weight portion, the sodium chloride of 1.3 ~ 2.5 weight portions, the sodium citrate of 1.5 ~ 2.5 weight portions and the glucose of 6 ~ 15 weight portions.
Compositions according to a first aspect of the present invention, wherein comprises: the potassium chloride of 1 weight portion, the sodium chloride of 1.5 ~ 2.4 weight portions, the sodium citrate of 1.6 ~ 2.2 weight portions and the glucose of 7 ~ 14 weight portions.
Compositions according to a first aspect of the present invention, wherein comprises: the potassium chloride of 1 weight portion, the sodium chloride of 1.56 ~ 1.91 weight portions, the sodium citrate of 1.74 ~ 2.13 weight portions and the glucose of 8 ~ 10 weight portions.
Compositions according to a first aspect of the present invention, wherein comprises: the potassium chloride of 1 weight portion, the sodium chloride of 1.65 ~ 1.82 weight portions, the sodium citrate of 1.84 ~ 2.03 weight portions and the glucose of 8.55 ~ 9.45 weight portions.
Compositions according to a first aspect of the present invention, 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.
Compositions according to a first aspect of the present invention, wherein comprises: the potassium chloride of 1 weight portion, the sodium chloride of 2.1 ~ 2.57 weight portions, the sodium citrate of 1.74 ~ 2.13 weight portions and the glucose of 12 ~ 14.67 weight portions.
Compositions according to a first aspect of the present invention, wherein comprises: the potassium chloride of 1 weight portion, the sodium chloride of 2.22 ~ 2.45 weight portions, the sodium citrate of 1.84 ~ 2.03 weight portions and the glucose of 12.67 ~ 14 weight portions.
Compositions according to a first aspect of the present invention, 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.
Compositions according to a first aspect of the present invention, wherein said sodium citrate is anhydrous citric acid sodium or its hydrate.In one embodiment, described sodium citrate is the dihydrate of sodium citrate.
Compositions according to a first aspect of the present invention, wherein said glucose is anhydrous glucose or its hydrate.In one embodiment, described glucose is anhydrous glucose.
Compositions according to a first aspect of the present invention, its moisture is 0.5% ~ 5% (w/w).
Compositions according to a first aspect of the present invention, its moisture is 1.0% ~ 4% (w/w).
Compositions according to a first aspect of the present invention, its moisture is 1.2% ~ 3.5% (w/w).
Compositions according to a first aspect of the present invention, its moisture is 1.4% ~ 3% (w/w).
Compositions according to a first aspect of the present invention, wherein said moisture is by Pharmacopoeia of People's Republic of China two (Chinese Pharmacopoeia Commission volume of the present composition according to version in 2010, China Medical Science Press publishes, ISBN 978-7-5067-4438-6, in the present invention can referred to as version Chinese Pharmacopoeia in 2012 two) annex VIII M first method A measures the result obtained.
In the present invention, if not otherwise indicated, % refers to percetage by weight.
Compositions according to a first aspect of the present invention, its moisture is between 1.4% ~ 3%.In one embodiment, this moisture carries out measuring according to the volumetric precipitation method in version Chinese Pharmacopoeia in 2010 two annex VIII M aquametry first methods.In one embodiment, the present composition carries out determination of water by the volumetric precipitation method in version Chinese Pharmacopoeia in 2010 two annex VIII M aquametry first methods, and moisture is between 1.4% ~ 3%.
Compositions according to a first aspect of the present invention, it measures according to fixed funnel method, and angle of repose is 30 ° ~ 45 °.In the present invention, see textbook " pharmaceutics ", (Xi Nianzhu edits the assay method of " angle of repose ", the third edition, and People's Health Publisher publishes, April in 1996 the 3rd edition, ISBN 7-117-00026-0) 248-249 page " the fixed funnel method " that describe.
Compositions according to a first aspect of the present invention, in its formula except potassium chloride, sodium chloride, sodium citrate and glucose four kinds of materials, does not add other material substantially in addition.But those skilled in the art understand, also appropriate non-active ingredient can be added in the present composition, such as can add a small amount of correctives, such as add a little saccharin sodium to improve mouthfeel, or such as add a little coloring agent using as differentiation packing dosage use, these a little additives can not produce harmful effect to the object of the invention.
Second aspect present invention provides the method preparing powder composition described in first aspect present invention, and it comprises the following steps:
Two or more are pulverized together independently of one another or arbitrarily to make four kinds of materials;
By each powder pulverized powder mix homogeneously;
Control the moisture of mixed-powder, drying process if desired or humidifying process, the scope reaching said composition to make aqueous powder content and specify;
Be dispensed in packaging bag, obtain final product.
In one embodiment, dried described in the inventive method refers to and to process in dry air, the scope reaching the present invention to make the moisture of compositions and specify.In one embodiment, this dry air process is heat treated, such as dry in an oven.In one embodiment, the process of humidifying described in the inventive method refers to and to process in humid air, the scope reaching the present invention to make the moisture of compositions and specify.In one embodiment, this humid air process processes in atmospheric environment, the dampness of this atmospheric environment generally speaking containing a great deal of, thus can make the present composition slowly moisture absorption.Or humid air can also be blown to increase the water content of material in the present composition.In general, these dried or humidifying process are the conventional technical ability that those skilled in the art possess, and those skilled in the art do not carry out realizing dried or humidifying process and realize the object of the invention with not needing cost creative work.
Method according to a second aspect of the present invention, wherein said four kinds of materials pulverize independently of one another, then carries out mixing.
Method according to a second aspect of the present invention, wherein said four kinds of materials are mixed together and together pulverize.
The present invention is further illustrated below.
In the present invention, term " weight portion " represents the amount that can calculate with any unit of weight or mass unit, and this amount can be integer number, can also be smallest number.Such as, in an example of the present composition, such as, in a formula, described every 1 " weight portion " can represent about 0.375g.Thus, in the formula of an example, the present composition comprises about 0.375g potassium chloride, about 0.65g sodium chloride, 0.725g sodium citrate and 3.375g glucose.
In an example of the present invention, described sodium citrate is the dihydrate of sodium citrate, i.e. compound shown in following formula:
In an example of the present invention, described glucose is anhydrous glucose, i.e. compound shown in following formula:
In the present invention, when mentioning the moisture of the present composition, this moisture is by Pharmacopoeia of People's Republic of China two (Chinese Pharmacopoeia Commission volume of the present composition according to version in 2010, China Medical Science Press publishes, ISBN978-7-5067-4438-6, in the present invention can referred to as version Chinese Pharmacopoeia in 2012 two) annex VIII M first method A and volumetric precipitation method measure the result obtained, and in the present invention, this assay method can be described as method A.
It should be noted that, the method characterizing or measure present composition moisture has many, such as in Pharmacopoeia of People's Republic of China two annex VIII M " aquametry " of version in 2010, also describe some other assay method, such as coulometric titration, toluene method etc.In the context of the present invention, if do not illustrated in addition, the method characterizing or measure present composition moisture uses said method A to carry out.
Detailed description of the invention
By the following examples the present invention is described in further detail, but the present invention should not be limited to these embodiments.Below in embodiment, when stating formula composition with " weight portion ", all feed intake with the amount preparing total amount 5kg compositions.Below in embodiment, when mentioning glucose, if not otherwise indicated, anhydrous glucose is used.Below in embodiment, when mentioning sodium citrate, if not otherwise indicated, sodium citrate dihydrate is used.Below in embodiment, the compositions of preparation can pack in paper aluminum composite membrane bag, every bag can be about 3g ~ 30g, the amount of such as every bag about 5.125g or its 2 times, 2.5 times, 3 times, 4 times, 5 times, or the amount of such as every bag about 5.58g or its 2 times, 2.5 times, 3 times, 4 times, 5 times, if not otherwise indicated, often bag dispensed loading amount is 5.125g.
embodiment 1
Prescription: the potassium chloride of 1 weight portion, the sodium chloride of 1.73 weight portions, the sodium citrate of 1.93 weight portions and the glucose of 9 weight portions.Preparation method: four kinds of materials are pulverized respectively; By each powder pulverized powder mix homogeneously; Control the moisture of mixed-powder, if desired through blowing hot air treatment or blowing humid air process, with the scope making powder composition moisture reach 1.8 ~ 2.0%; Be dispensed in packaging bag, obtain compositions (can be designated as R1, hereafter the gained present composition can similarly represent).
embodiment 2
Prescription: the potassium chloride of 1 weight portion, the sodium chloride of 2.33 weight portions, the sodium citrate of 1.93 weight portions and the glucose of 13.3 weight portions.Preparation method: the method with reference to embodiment 1 is carried out, and compositions moisture reaches 1.7 ~ 1.9%, obtains the present composition (can be designated as R2).
embodiment 3
Prescription: the potassium chloride of 1 weight portion, the sodium chloride of 2.4 weight portions, the sodium citrate of 1.6 weight portions and the glucose of 14 weight portions.Preparation method: the method with reference to embodiment 1 is carried out, and compositions moisture reaches 1.6 ~ 1.8%, obtains the present composition (can be designated as R3).
embodiment 4
Prescription: the potassium chloride of 1 weight portion, the sodium chloride of 1.5 weight portions, the sodium citrate of 2.2 weight portions and the glucose of 7 weight portions.Preparation method: the method with reference to embodiment 1 is carried out, and compositions moisture reaches 1.9 ~ 2.1%, obtains the present composition (can be designated as R4).
embodiment 5
Prescription: the potassium chloride of 1 weight portion, the sodium chloride of 1.65 weight portions, the sodium citrate of 2.03 weight portions and the glucose of 8.55 weight portions.Preparation method: the method with reference to embodiment 1 is carried out, and compositions moisture reaches 2.0 ~ 2.2%, obtains the present composition (can be designated as R5).
embodiment 6
Prescription: the potassium chloride of 1 weight portion, the sodium chloride of 1.82 weight portions, the sodium citrate of 1.84 weight portions and the glucose of 9.45 weight portions.Preparation method: the method with reference to embodiment 1 is carried out, and compositions moisture reaches 2.2 ~ 2.4%, obtains the present composition (can be designated as R6).
embodiment 7
Prescription: the potassium chloride of 1 weight portion, the sodium chloride of 2.45 weight portions, the sodium citrate of 1.84 weight portions and the glucose of 14 weight portions.Preparation method: the method with reference to embodiment 1 is carried out, and compositions moisture reaches 1.7 ~ 1.9%, obtains the present composition (can be designated as R7).
embodiment 8
Prescription: the potassium chloride of 1 weight portion, the sodium chloride of 2.22 weight portions, the sodium citrate of 2.03 weight portions and the glucose of 12.67 weight portions; Add the saccharin sodium of total weight of material 0.01% in addition, for improving mouthfeel.Preparation method: the method with reference to embodiment 1 is carried out, and compositions moisture reaches 1.7 ~ 1.9%, obtains the present composition (can be designated as R8).
embodiment 9
Prescription: with embodiment 1.Preparation method: the method with reference to embodiment 1 is carried out, but prepare the compositions of different in moisture content when controlling moisture, as follows respectively: to control moisture and reach 0.5 ± 0.1%, obtain compositions R9a; Control moisture and reach 0.75 ± 0.1%, obtain compositions R9b; Control moisture and reach 1.0 ± 0.1%, obtain compositions R9c; Control moisture and reach 1.2 ± 0.1%, obtain compositions R9d; Control moisture and reach 1.4 ± 0.1%, obtain compositions R9e; Control moisture and reach 1.8 ± 0.1%, obtain compositions R9f; Control moisture and reach 2.2 ± 0.1%, obtain compositions R9g; Control moisture and reach 2.6 ± 0.1%, obtain compositions R9h; Control moisture and reach 3.0 ± 0.1%, obtain compositions R9i; Control moisture and reach 3.4 ± 0.1%, obtain compositions R9j; Control moisture and reach 3.8 ± 0.1%, obtain compositions R9k; Control moisture and reach 4.5 ± 0.1%, obtain compositions R9l; Control moisture and reach 5.0 ± 0.1%, obtain compositions R9m; Control moisture and reach 6.0 ± 0.1%, obtain compositions R9n.
embodiment 10
Prescription: with embodiment 2.Preparation method: the method with reference to embodiment 1 is carried out, but prepare the compositions of different in moisture content when controlling moisture, as follows respectively: to control moisture and reach 0.5 ± 0.1%, obtain compositions R10a; Control moisture and reach 0.75 ± 0.1%, obtain compositions R10b; Control moisture and reach 1.0 ± 0.1%, obtain compositions R10c; Control moisture and reach 1.2 ± 0.1%, obtain compositions R10d; Control moisture and reach 1.4 ± 0.1%, obtain compositions R10e; Control moisture and reach 1.8 ± 0.1%, obtain compositions R10f; Control moisture and reach 2.2 ± 0.1%, obtain compositions R10g; Control moisture and reach 2.6 ± 0.1%, obtain compositions R10h; Control moisture and reach 3.0 ± 0.1%, obtain compositions R10i; Control moisture and reach 3.4 ± 0.1%, obtain compositions R10j; Control moisture and reach 3.8 ± 0.1%, obtain compositions R10k; Control moisture and reach 4.5 ± 0.1%, obtain compositions R10l; Control moisture and reach 5.0 ± 0.1%, obtain compositions R10m; Control moisture and reach 6.0 ± 0.1%, obtain compositions R10n.
In addition, with reference to above R9f, unlike only anhydrous glucose wherein being replaced with Dextrose monohydrate, obtain compositions (being designated as R9p).
In addition, with reference to above R10f, unlike only anhydrous glucose wherein being replaced with Dextrose monohydrate, obtain compositions (being designated as R10p).
embodiment 11
prescription:with embodiment 1.
preparation method:basic with embodiment 1, but make the angle of repose of the present composition within the scope of 10 of <30 °, 30 ~ 33 °, 33 ~ 36 °, 36 ~ 39 °, 39 ~ 42 °, 42 ~ 45 °, 45 ~ 48 °, 48 ~ 52 °, 52 ~ 55 ° or >55 ° by controlling powder granularity, obtain 10 formula, be designated as R11a, R11b, R11c, R11d, R11e, R11f, R11g, R11h, R11i, R11j respectively.In the present invention, see textbook " pharmaceutics ", (Xi Nianzhu edits the assay method of parameter " angle of repose ", the third edition, People's Health Publisher publishes, April in 1996 the 3rd edition, ISBN 7-117-00026-0) 248-249 page, the method for description, " fixed funnel method " described in concrete use the 249th page of 3-5 is capable.
test example 1: the performance change of study group's compound
The sample prepared of each embodiment above, every bag of sealing subpackage 5.125g.Each sample is placed 50 days at 50 DEG C, tests the dissolution velocity change of each sample by method the following:
(1) get testing sample 1 to wrap, impouring is equipped with in the beaker of 100ml distilled water, and beaker capacity is 500ml, and diameter is about 9.3cm; In water during impouring sample, impouring as soon as possible, and be evenly distributed at the bottom of beaker as far as possible; In whole process, beaker leaves standstill, and does not stir; Calculate from impouring sample to the consoluet time, each sample repeats 5 times, gets the dissolution time of average as this sample;
(2) dissolution time placing 45 days processing samples without 50 DEG C is t1 (second), and the dissolution time placing 45 days processing samples through 50 DEG C is t2 (second), calculates dissolution time percent change Δ t (%) with following formula:
The each sample prepared above, after measured dissolution time percent change, result is as follows:
| Sample | Δt(％) | Sample | Δt(％) | Sample | Δt(％) |
| R1 | 23 | R9f | 21 | R10d | 69 |
| R2 | 36 | R9g | 35 | R10e | 39 |
| R3 | 31 | R9h | 27 | R10f | 27 |
| R4 | 28 | R9i | 41 | R10g | 31 |
| R5 | 39 | R9j | 72 | R10h | 29 |
| R6 | 34 | R9k | 93 | R10i | 38 |
| R7 | 25 | R9l | 104 | R10j | 79 |
| R8 | 29 | R9m | 138 | R10k | 114 |
| R9a | 98 | R9n | 147 | R10l | 143 |
| R9b | 107 | R9p | 89 | R10m | 166 |
| R9c | 88 | R10a | 109 | R10n | 151 |
| R9d | 64 | R10b | 128 | R10p | 77 |
| R9e | 31 | R10c | 91 | ? | ? |
In addition, test the content of sodium citrate in compositions prepared by each embodiment according to following methods: get compositions and be about 2.1g, accurately weighed, put in 100ml measuring bottle, add glacial acetic acid 80ml, jolting, be heated to 50 DEG C, let cool, add glacial acetic acid and be diluted to scale, shake up, leave standstill, precision measures supernatant 20ml, adds crystal violet indicator solution 1, be titrated to solution with perchloric acid titration liquid (0.1mol/L) aobvious blue, and titration results blank assay is corrected.Every 1ml perchloric acid titration liquid (0.1mol/L) is equivalent to the C of 9.803mg
6h
5na
3o
72H
2o.And calculate the relative amount (%) of each sample through 50 DEG C of placements sodium citrate of remnants after 50 days with following formula:
Result shows, in each sample prepared by embodiment 1-10, when control moisture lower than 3.2% time, each sample through 50 DEG C of relative amounts placing sodium citrate remaining after 50 days all more than 96%, particularly when control moisture lower than 3.0% time, each sample through 50 DEG C of relative amounts placing sodium citrate remaining after 50 days all more than 98%, such as R1 and R2 is respectively 99.7% and 99.4%, R9i and R10i is respectively 98.2% and 98.4%, and basic expressions is that moisture lower then sodium citrate relative amount remains relatively more high-level; But when compositions moisture higher than 3.4% time, each sample through 50 DEG C of relative amounts placing sodium citrate remaining after 50 days all below 94%, and basic expressions is moisture higher then sodium citrate relative amount maintains relatively more low-level, and the sodium citrate relative amount of R9j, R9k, R9l tri-samples is respectively 93.8%, 91.2%, 88.4%.The each sample of embodiment 9 and embodiment 10 shows basically identical trend.
In the test that inventor is other, for each sample prepared by embodiment 11, the content of wherein sodium citrate is tested according to method mentioned above, every batch sample test 10 bag, get the meansigma methods and standard deviation that calculate sodium citrate content, and calculate the relative standard deviation (RSD) of sodium citrate content in each batch sample 10 sample.Result shows, and when the angle of repose of compositions is in the scope of 30 ° ~ 45 °, RSD is less than 6%, and such as the RSD of R11b, R11c, R11d three is respectively 3.72%, 2.61%, 3.26%; But as <30 ° angle of repose, or during >45 °, RSD is all greater than 8%, and such as the RSD of R11a, R11g, R11i three is respectively 8.68%, 9.69%, 13.22%.
In the other test of inventor, with the sample of embodiment 1 and embodiment 2, place 6 months at 40 DEG C, result shows its basicity all between 7.0 ~ 8.8, the content of total sodium amount, potassium amount, total chlorine amount and sodium citrate (dihydrate) and anhydrous glucose, compare, all between 95% ~ 105% with 0 month sample (that is, place without 40 DEG C process for 6 months) content.The display present composition has good pharmaceutical property.
Claims (10)
1. a compositions, wherein comprises potassium chloride, sodium chloride, sodium citrate and glucose.
2. compositions according to claim 1, wherein comprises: the potassium chloride of 1 weight portion, the sodium chloride of 1.3 ~ 2.5 weight portions, the sodium citrate of 1.5 ~ 2.5 weight portions and the glucose of 6 ~ 15 weight portions.
3. compositions according to claim 2, wherein comprises: the potassium chloride of 1 weight portion, the sodium chloride of 1.5 ~ 2.4 weight portions, the sodium citrate of 1.6 ~ 2.2 weight portions and the glucose of 7 ~ 14 weight portions.
4. compositions according to claim 3, wherein comprises: the potassium chloride of 1 weight portion, the sodium chloride of 1.56 ~ 1.91 weight portions, the sodium citrate of 1.74 ~ 2.13 weight portions and the glucose of 8 ~ 10 weight portions;
Or, wherein comprise: the potassium chloride of 1 weight portion, the sodium chloride of 1.65 ~ 1.82 weight portions, the sodium citrate of 1.84 ~ 2.03 weight portions and the glucose of 8.55 ~ 9.45 weight portions;
Or, 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.
5. compositions according to claim 3, wherein comprises: the potassium chloride of 1 weight portion, the sodium chloride of 2.1 ~ 2.57 weight portions, the sodium citrate of 1.74 ~ 2.13 weight portions and the glucose of 12 ~ 14.67 weight portions;
Or, wherein comprise: the potassium chloride of 1 weight portion, the sodium chloride of 2.22 ~ 2.45 weight portions, the sodium citrate of 1.84 ~ 2.03 weight portions and the glucose of 12.67 ~ 14 weight portions;
Or, 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.
6. according to the compositions of any one of claim 1-5, wherein: described sodium citrate is anhydrous citric acid sodium or its hydrate; And/or described glucose is anhydrous glucose or its hydrate.
7. according to the compositions of any one of claim 1-6, wherein: described sodium citrate is sodium citrate dihydrate; And/or described glucose is anhydrous glucose.
8., according to the compositions of any one of claim 1-7, its moisture is 0.5% ~ 5% (w/w) or 1.0% ~ 4% (w/w) or 1.2% ~ 3.5% (w/w) or 1.4% ~ 3% (w/w).
9., according to the compositions of any one of claim 1-8, in its formula except potassium chloride, sodium chloride, sodium citrate and glucose four kinds of materials, substantially do not add other material in addition, or be added with appropriate non-active ingredient such as correctives.
10. prepare the method for any one of claim 1-9 compositions, it comprises the following steps: two or more are pulverized together independently of one another or arbitrarily to make four kinds of materials; By each powder pulverized powder mix homogeneously; Control the moisture of mixed-powder, drying process if desired or humidifying process, the scope reaching said composition to make aqueous powder content and specify; Be dispensed in packaging bag, obtain final product.
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| CN103638069A (en) * | 2013-11-14 | 2014-03-19 | 长春博瑞饲料集团有限公司 | Electrolyte supplement for treating calf diarrhoea and application method |
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| CN1559434A (en) * | 2004-03-12 | 2005-01-05 | 杨理林 | Oral liquid-supplement salt disperson tablets, and prepn. method therefor |
| US20070259054A1 (en) * | 2006-05-03 | 2007-11-08 | Nelson Ayala | Oral rehydration compositions |
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| CN1559434A (en) * | 2004-03-12 | 2005-01-05 | 杨理林 | Oral liquid-supplement salt disperson tablets, and prepn. method therefor |
| US20070259054A1 (en) * | 2006-05-03 | 2007-11-08 | Nelson Ayala | Oral rehydration compositions |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105030881A (en) * | 2015-07-28 | 2015-11-11 | 安徽科技学院 | Compound preparation for preventing beef cattle transport stress, and use method thereof |
| CN105030881B (en) * | 2015-07-28 | 2018-03-27 | 安徽科技学院 | A kind of compound preparation and its application method for being used to prevent and treat beef cattle transport stress |
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| CN102824361A (en) | 2012-12-19 |
| CN102824361B (en) | 2014-09-10 |
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