CN102824361B - Composition containing glucose - Google Patents
Composition containing glucose Download PDFInfo
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- CN102824361B CN102824361B CN201210348872.8A CN201210348872A CN102824361B CN 102824361 B CN102824361 B CN 102824361B CN 201210348872 A CN201210348872 A CN 201210348872A CN 102824361 B CN102824361 B CN 102824361B
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- sodium
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- 239000000203 mixture Substances 0.000 title claims abstract description 123
- 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 abstract description 30
- 239000008103 glucose Substances 0.000 title abstract description 30
- 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 43
- 239000000843 powder Substances 0.000 claims abstract description 24
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims description 58
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 58
- 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 49
- 239000001509 sodium citrate Substances 0.000 claims description 48
- 238000000034 method Methods 0.000 claims description 46
- 229960001031 glucose Drugs 0.000 claims description 42
- 239000001103 potassium chloride Substances 0.000 claims description 29
- 235000011164 potassium chloride Nutrition 0.000 claims description 29
- 239000011780 sodium chloride Substances 0.000 claims description 29
- 239000000463 material Substances 0.000 claims description 11
- 238000004806 packaging method and process Methods 0.000 claims description 6
- 238000001556 precipitation Methods 0.000 claims description 5
- 239000012467 final product Substances 0.000 claims description 4
- 239000011812 mixed powder Substances 0.000 claims description 4
- 238000001035 drying Methods 0.000 claims description 3
- 229960000999 sodium citrate dihydrate Drugs 0.000 claims description 3
- 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 3
- 239000011734 sodium Substances 0.000 abstract description 3
- 229910052708 sodium Inorganic materials 0.000 abstract description 3
- 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 abstract description 2
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 abstract description 2
- 239000011591 potassium Substances 0.000 abstract description 2
- 229910052700 potassium Inorganic materials 0.000 abstract description 2
- 229910052736 halogen Inorganic materials 0.000 abstract 2
- -1 halogen salt Chemical class 0.000 abstract 2
- 238000002360 preparation method Methods 0.000 description 18
- 239000003814 drug Substances 0.000 description 8
- 238000012360 testing method Methods 0.000 description 8
- 238000004090 dissolution Methods 0.000 description 6
- 239000008187 granular material Substances 0.000 description 6
- 238000003556 assay Methods 0.000 description 5
- 229940079593 drug Drugs 0.000 description 5
- 238000005516 engineering process 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
- 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
- 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 compound 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
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical group OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 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
- 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
- 241000702670 Rotavirus Species 0.000 description 1
- 238000010521 absorption reaction Methods 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
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 1
- 229910052782 aluminium Inorganic materials 0.000 description 1
- 229960004543 anhydrous citric acid Drugs 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
- 239000000306 component 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
- 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
- 238000005469 granulation Methods 0.000 description 1
- 230000003179 granulation Effects 0.000 description 1
- 230000009931 harmful effect Effects 0.000 description 1
- 238000001990 intravenous administration Methods 0.000 description 1
- 150000002500 ions Chemical class 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
- 238000002156 mixing Methods 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
- 229910001415 sodium ion Inorganic materials 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 239000006228 supernatant Substances 0.000 description 1
- 230000001502 supplementing effect Effects 0.000 description 1
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- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention relates to a composition containing glucose. Specifically, the powder composition comprises glucose, halogen salt of potassium, halogen salt of sodium and the like. The composition has excellent medical performance.
Description
Technical field
The invention belongs to medical technical field, relate to one and be pulverous compositions, in said composition, comprise the salt of glucose and Na 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 these drug prescription compositions are rationally, cheap and easy to get, convenience and high-efficiency, and the speed of its correct dehydration is better than intravenous drip.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 supplementing salt in body fluid, this formula comprises as the glucose of active component, sodium chloride, potassium chloride and sodium citrate, and in this formula, can not add other material and directly be prepared into preparation, such as granule, powder etc.From pharmaceutical technology can handling, production cost, and the compliance of clinical practice says, for this formula, powder has many than the better advantage of granule.For example powder can through pulverize, mix after direct packaging in unit dose package medicated bag; And granule need to be after pulverizing, mixing, add aqueous binders granulation, dry, and then point install in unit dose package medicated bag.For powder, the preparation technology of granule extends in the cycle greatly, and because needs have dry run, need to consume a large amount of energy.In addition, powder is because its granule is less than granule, dissolves sooner after being added to the water, and is therefore more conducive to clinical use.
But in powder preparation process, and at finished product duration of storage, may run into variety of issue, such as in preparation process, occur agglomerating, the phenomenons such as balling-up of uniting of caking can affecting drugs packaging; In the dissolving that duration of storage caking is agglomerating may affect drug use time.
Therefore those skilled in the art need to have new method to prepare the new medicine with above-mentioned formula.
Summary of the invention
The inventor have been surprisingly found that, comprises the powder as glucose, sodium chloride, potassium chloride and the sodium citrate of active component, when this powder has particular characteristic and for example demonstrated when moisture the effect of desirable.Therefore the present invention is accomplished.
For this reason, first aspect present invention provide can be referred to as powder be fine grained or pulverous compositions, in said composition, comprise potassium chloride, sodium chloride, sodium citrate and glucose.
According to the compositions of first aspect present invention, wherein comprise:
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.
According to the compositions of first aspect present invention, wherein comprise:
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.
According to the compositions of first aspect present invention, wherein comprise:
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.
According to the compositions of first aspect present invention, 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.
According to the compositions of first aspect present invention, wherein comprise:
The potassium chloride of 1 weight portion,
The sodium chloride of approximately 1.73 weight portions,
The sodium citrate of approximately 1.93 weight portions and
The glucose of approximately 9 weight portions.
According to the compositions of first aspect present invention, wherein comprise:
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.
According to the compositions of first aspect present invention, 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.
According to the compositions of first aspect present invention, wherein comprise:
The potassium chloride of approximately 1 weight portion,
The sodium chloride of approximately 2.33 weight portions,
The sodium citrate of approximately 1.93 weight portions and
The glucose of approximately 13.3 weight portions.
According to the compositions of first aspect 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.
According to the compositions of first aspect present invention, wherein said glucose is anhydrous glucose or its hydrate.In one embodiment, described glucose is anhydrous glucose.
According to the compositions of first aspect present invention, its moisture is 0.5%～5% (w/w).
According to the compositions of first aspect present invention, its moisture is 1.0%～4% (w/w).
According to the compositions of first aspect present invention, its moisture is 1.2%～3.5% (w/w).
According to the compositions of first aspect present invention, its moisture is 1.4%～3% (w/w).
According to the compositions of first aspect present invention, wherein said moisture is two (Chinese Pharmacopoeia Commission's volumes of Pharmacopoeia of People's Republic of China according to version in 2010 by the present composition, Chinese Medicine science and technology publishing house publishes, ISBN 978-7-5067-4438-6, in the present invention can be referred to as two of version Chinese Pharmacopoeias in 2012) annex VIII M first method A measures the result obtaining.
In the present invention, if not otherwise indicated, % refers to percetage by weight.
According to the compositions of first aspect present invention, its moisture is between 1.4%～3%.In one embodiment, this moisture is to measure according to the volumetric precipitation method in two annex VIII M aquametry first methods of version Chinese Pharmacopoeia in 2010.In one embodiment, the present composition carries out determination of water by the volumetric precipitation method in two annex VIII M aquametry first methods of version Chinese Pharmacopoeia in 2010, and moisture is between 1.4%～3%.
According to the compositions of first aspect present invention, it is measured according to fixed funnel method, and be 30 °～45 ° angle of repose.In the present invention, referring to textbook " pharmaceutics ", (People's Health Publisher publishes the assay method of " angle of repose " for Xi Nianzhu chief editor, the third edition, April in 1996 the 3rd edition, ISBN7-117-00026-0) 248-249 page " the fixed funnel method " described.
According to the compositions of first aspect present invention, in its formula, except potassium chloride, sodium chloride, sodium citrate and four kinds of materials of glucose, substantially do not add in addition other material.But those skilled in the art understand, in the present composition, also can add appropriate non-active ingredient, for example can add a small amount of correctives, for example add a little saccharin sodium to improve mouthfeel, or for example add a little coloring agent using as distinguishing packing dosage use, these a little additive can not produce harmful effect to the object of the invention.
Second aspect present invention provides the method for 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 is processed or humidifying processing if desired, so that powder moisture reaches the scope that said composition specifies;
Divide and install in packaging bag, to obtain final product.
In one embodiment, dried described in the inventive method refers in dry air to be processed, so that the moisture of compositions reaches the scope that the present invention specifies.In one embodiment, this dry air processing is heat treated, for example dry in baking oven.In one embodiment, the processing of humidifying described in the inventive method refers in humid air to be processed, so that the moisture of compositions reaches the scope that the present invention specifies.In one embodiment, this humid air processing is to process in atmospheric environment, and generally speaking this atmospheric environment contains the dampness of a great deal of, thereby can make slowly moisture absorption of the present composition.Or can also in the present composition, blow humid air to increase the water content of material.In general, these dried or humidifying processing are the conventional technical ability that those skilled in the art possess, and those skilled in the art do not need to spend that creative work is realized dried with getting final product or the object of the invention is processed and realized to humidifying.
According to the method for second aspect present invention, wherein said four kinds of materials are to pulverize independently of one another, then mix.
According to the method for second aspect 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.For example, in an example of the present composition, for example, 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, while mentioning the moisture of the present composition, this moisture is two (Chinese Pharmacopoeia Commission's volumes of Pharmacopoeia of People's Republic of China according to version in 2010 by the present composition, Chinese Medicine science and technology publishing house publishes, ISBN 978-7-5067-4438-6, in the present invention can be referred to as two of version Chinese Pharmacopoeias in 2012) annex VIII M first method A is that volumetric precipitation method is measured the result obtaining, in the present invention, this assay method can be described as method A.
It should be noted that, the method that characterizes or measure present composition moisture has many, for example in two annex VIII M of Pharmacopoeia of People's Republic of China " aquametry " of version in 2010, some other assay method is also described, such as coulometric titration, toluene method etc.In the context of the invention, if not explanation in addition, the method that characterizes or measure present composition moisture is used said method A to carry out.
Detailed description of the invention
The present invention is described in further detail by the following examples, but the present invention should not be limited to these embodiment.In embodiment, during with " weight portion " statement formula composition, all feed intake with the amount of preparation total amount 5kg compositions below.Below in embodiment, while mentioning glucose, if not otherwise indicated, use be anhydrous glucose.Below in embodiment, while mentioning sodium citrate, if not otherwise indicated, use be sodium citrate dihydrate.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 for example every bag of about 5.125g or its 2 times, 2.5 times, 3 times, 4 times, 5 times, or the amount of for example every bag of about 5.58g or its 2 times, 2.5 times, 3 times, 4 times, 5 times, if not otherwise indicated, every 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 processing, so that powder composition moisture reaches 1.8～2.0% scope;
Divide and install in packaging bag, obtain compositions (can be designated as R1, below 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: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: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: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: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: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: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 in addition the saccharin sodium of total weight of material 0.01%, for improving mouthfeel.
preparation method: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:method with reference to embodiment 1 is carried out, but in the time controlling moisture, prepares the compositions of different in moisture content, as follows respectively:
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:method with reference to embodiment 1 is carried out, but in the time controlling moisture, prepares the compositions of different in moisture content, as follows respectively:
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, different is only anhydrous glucose wherein to be replaced with to Dextrose monohydrate, obtains compositions (being designated as R9p).
In addition, with reference to above R10f, different is only anhydrous glucose wherein to be replaced with to Dextrose monohydrate, obtains compositions (being designated as R10p).
embodiment 11
prescription:with embodiment 1.
preparation method:substantially with embodiment 1, but by controlling angle of repose that powder granularity makes the present composition within the scope of 10 of 55 ° of 30 ° of <, 30～33 °, 33～36 °, 36～39 °, 39～42 °, 42～45 °, 45～48 °, 48～52 °, 52～55 ° or >, obtain 10 formulas, be designated as respectively R11a, R11b, R11c, R11d, R11e, R11f, R11g, R11h, R11i, R11j.
In the present invention, the assay method of parameter " angle of repose " is referring to textbook " pharmaceutics " (Xi Nianzhu chief editor, the third edition, People's Health Publisher publishes, April in 1996 the 3rd edition, ISBN7-117-00026-0) 248-249 page, the method for description, is specifically used " the fixed funnel method " of the 249th page of 3-5 described in capable.
test example 1: the performance change of study group's compound
The sample that above prepared by each embodiment, every bag of sealing subpackage 5.125g.
Each sample is placed 50 days at 50 DEG C, and the dissolution velocity of testing each sample by method below changes:
(1) get testing sample 1 and wrap, impouring is equipped with in the beaker of 100ml distilled water, and beaker capacity is 500ml, diameter 9.3cm; To in water when impouring sample, impouring as soon as possible, and at the bottom of being evenly distributed on 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) being t1 (second) without 50 DEG C of dissolution times of placing 45 days processing samples, is t2 (second) through 50 DEG C of dissolution times of placing 45 days processing samples, calculates dissolution time percent change Δ t (%) with following formula:
Each sample of preparation above, dissolution time percent change after measured, 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 the about 2.1g of compositions, 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 1 of crystal violet indicator solution, be titrated to solution with perchloric acid titration liquid (0.1mol/L) aobvious blue, and titration results is proofreaied and correct with blank assay.Every 1ml perchloric acid titration liquid (0.1mol/L) is equivalent to the C of 9.803mg
6h
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3o
72H
2o.And calculate each sample through 50 DEG C of relative amounts (%) of placing sodium citrate remaining after 50 days with following formula:
Result shows, in each sample prepared by embodiment 1-10, when controlling moisture lower than 3.2% time, the relative amount of each sample remaining sodium citrate after 50 DEG C are placed 50 days is all more than 96%, particularly when controlling moisture lower than 3.0% time, the relative amount of each sample remaining sodium citrate after 50 DEG C are placed 50 days is all more than 98%, for example R1 and R2 are respectively 99.7% and 99.4%, R9i and R10i are respectively 98.2% and 98.4%, and basic expressions is that the lower sodium citrate of moisture relative amount remains relatively more high-level; But when compositions moisture is higher than 3.4% time, the relative amount of each sample remaining sodium citrate after 50 DEG C are placed 50 days is all below 94%, and basic expressions is that the higher sodium citrate of moisture relative amount remains relatively more low-level, and the sodium citrate relative amount of R9j, R9k, tri-samples of R9l is respectively 93.8%, 91.2%, 88.4%.Each sample of embodiment 9 and embodiment 10 shows basically identical trend.
In the other test of inventor, each sample of preparing for embodiment 11, test the wherein content of sodium citrate according to method mentioned above, every batch sample test 10 bags, get the meansigma methods and the standard deviation that calculate sodium citrate content, and calculate the relative standard deviation (RSD) of sodium citrate content in each batch sample 10 samples.Result shows, in the time that angle of repose of compositions is in the scope of 30 °～45 °, RSD is less than 6%, and for example R11b, R11c, R11d three's RSD is respectively 3.72%, 2.61%, 3.26%; But as 30 ° of < angle of repose, or when 45 ° of >, RSD is all greater than 8%, and for example R11a, R11g, R11i three's RSD is respectively 8.68%, 9.69%, 13.22%.
In inventor's other test, with the sample of embodiment 1 and embodiment 2, at 40 DEG C, place 6 months, result shows that its basicity is 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 with 0 month sample (that is, place and process for 6 months without 40 DEG C) content, all between 95%～105%.Show that the present composition has good pharmaceutical property.
Claims (10)
1. be a pulverous compositions, it consists of: 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 anhydrous glucose of 6 ~ 15 weight portions; The moisture of said composition is 1.4% ~ 3% (w/w), and be 30 ° ~ 45 ° the angle of repose that said composition is measured according to fixed funnel method; Described sodium citrate is sodium citrate dihydrate, and described moisture is to measure according to the volumetric precipitation method in two annex VIII M aquametry first methods of version Chinese Pharmacopoeia in 2010.
2. according to the compositions of claim 1, it consists of: 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 anhydrous glucose of 7 ~ 14 weight portions.
3. according to the compositions of claim 1, it consists of: 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 anhydrous glucose of 8 ~ 10 weight portions.
4. according to the compositions of claim 1, it consists of: 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 anhydrous glucose of 8.55 ~ 9.45 weight portions.
5. according to the compositions of claim 1, it consists of: 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 anhydrous glucose of 9 weight portions.
6. be a pulverous compositions, it consists of: 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 anhydrous glucose of 12 ~ 14.67 weight portions; The moisture of said composition is 1.4% ~ 3% (w/w), and be 30 ° ~ 45 ° the angle of repose that said composition is measured according to fixed funnel method; Described sodium citrate is sodium citrate dihydrate, and described moisture is to measure according to the volumetric precipitation method in two annex VIII M aquametry first methods of version Chinese Pharmacopoeia in 2010.
7. according to the compositions of claim 6, it consists of: 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 anhydrous glucose of 12.67 ~ 14 weight portions.
8. according to the compositions of claim 6, it consists of: 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 anhydrous glucose of 13.3 weight portions.
9. the method for preparing claim 1-5 any one 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 is processed or humidifying processing if desired, so that powder moisture reaches the scope that said composition specifies; Divide and install in packaging bag, to obtain final product.
10. the method for preparing claim 6-8 any one 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 is processed or humidifying processing if desired, so that powder moisture reaches the scope that said composition specifies; Divide and install in packaging bag, to obtain final product.
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| 张秀美.葡萄糖.《新编兽药实用手册》.山东科学技术出版社,2007,第461-462页. * |
| 罗Rowe,R.C.等.氯化钠、枸橼酸钠二水合物.《药用辅料手册》.化学工业出版社,2005,第638、640、643页. * |
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