CN102836172B - Powder combination containing glucose - Google Patents
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- CN102836172B CN102836172B CN201210348873.2A CN201210348873A CN102836172B CN 102836172 B CN102836172 B CN 102836172B CN 201210348873 A CN201210348873 A CN 201210348873A CN 102836172 B CN102836172 B CN 102836172B
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Abstract
The invention relates to a powder combination containing glucose and a preparation method of the powder combination. Particularly, the powder combination contains glucose, halogeno salts of potassium, halogeno salts of sodium and the like. The powder combination achieves favorable pharmaceutical performance.
Description
Technical field
The invention belongs to medical art, relate to a kind of compositions that can be used as powder in Powdered or graininess, 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 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 therapeutic effect of desirable when this powder has specific physical property, such as convenient preparation.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 angle of repose is 25 ° ~ 55 °.
Compositions according to a first aspect of the present invention, its angle of repose is 28 ° ~ 50 °.
Compositions according to a first aspect of the present invention, its angle of repose is 29 ° ~ 48 °.
Compositions according to a first aspect of the present invention, its angle of repose is 30 ° ~ 45 °.
In the present invention, if not otherwise indicated, 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) method that describes of 248-249 page, concrete use the 249th page of 3-5 capable described in " fixed funnel method ".It should be noted that, the method characterizing or measure present composition granule/powder angle of repose has many, such as, also list some other assay method at the third edition " pharmaceutics " textbook of Xi Nianzhu chief editor.In the context of the present invention, if do not illustrated in addition, the method characterizing or measure present composition granule/powder angle of repose uses above-mentioned " fixed funnel method " to carry out.
The present inventor also finds, the present composition with specified particle size feature has the unique features of some desirable.Therefore, compositions according to a first aspect of the present invention, its granularity is: the particle footpath of more than 65% is between 50 order ~ 80 orders.Compositions according to a first aspect of the present invention, its granularity is: the particle footpath of more than 70% is between 50 order ~ 80 orders.Compositions according to a first aspect of the present invention, its granularity is: the particle footpath of more than 75% is between 50 order ~ 80 orders.
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; Be dispensed in packaging bag, obtain final product.
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.
In an embodiment of second aspect present invention method, described material is pulverized on suitable pulverizer, at any time by measuring the angle of repose of material to monitor the mobility (preferably making reach scope described in first aspect present invention compositions the angle of repose of powder material) of material in crushing process, monitor at any time if desired material particle size change and appearance uniform degree (in the present invention, above-mentioned at any time monitor material " particle size change " can shine methods described herein A carry out; " appearance uniform degree " can carry out with reference to [appearance uniform degree] inspection technique under version Chinese Pharmacopoeia in 2012 two annex powder items, to guarantee potassium chloride, sodium chloride and the uniformity of sodium citrate three in material).
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, phrase " the particle footpath of more than 65% is between 50 order ~ 80 orders " is for characterizing the physical size that the present invention is pulverous compositions powder body, its implication is, have the particle of more than 65% (w/w) in the present composition, these particles can by 50 object medicine sieves but not by 80 object medicine sieves.The phrase of other similar statement also has similar meaning.One of ordinary skill in the art will readily recognize that the phrase " the particle footpath of more than 65% is between 50 order ~ 80 orders " of the physical size of above-mentioned sign compositions powder body at least can A mensuration obtain by the following method:
Method A: method is according to Pharmacopoeia of People's Republic of China two (Chinese Pharmacopoeia Commission's volume of 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) the second method (sieve method) in annex 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 the granule/powder be trapped between two medicine sieves, weighed weight, calculates its proportion (%).
If this measurement result is more than 65%, then meet the regulation of phrase " the particle footpath of more than 65% is between 50 order ~ 80 orders ".In addition, if measurement result is 75%, then represent that said composition has the particle of 75% by 50 mesh sieves still not by 80 mesh sieves.
It should be noted that, the method characterizing or measure present composition granule/powder physical size has many, such as, in Pharmacopoeia of People's Republic of China two annex IX E " granularity and particle size distribution method " of version in 2010, also describe some other assay method.In the context of the present invention, if do not illustrated in addition, the method characterizing or measure present composition granule/powder physical size uses said method A to carry out.
In the present invention, if not otherwise indicated, % refers to percetage by weight.
In the present invention, need when preparing the present composition that various crushing material is had specific angle of repose to regulation performance, and be optionally crushed to the particle size of regulation.Just realize with regard to the object of the invention, the method pulverized and device therefor are not particularly limited, such as can use stirring-type comminuting method (such as shear agitation), polishing (such as ball-milling method) etc. can also be used, as long as monitor the powder body feature such as angle of repose of the present composition in crushing process.With regard to the present composition, its four kinds of materials are when particularly anhydrous glucose, sodium citrate dihydrate and sodium chloride and potassium chloride directly mix without pulverizing, the mixture of mobility very good directly mixing after measured can reach less than 30 degree angle of repose, but in the process pulverized, along with the reduction of granularity, angle of repose can slowly increase, based on this feature, the powder body that the mobility with the present invention's expectation particularly has specific angle of repose can be obtained in the process increased gradually this angle of repose.
In the present invention, represent that " order " of particle size or medicine sieve specification has and well known to a person skilled in the art implication, especially, for the present invention, it to have under Pharmacopoeia of People's Republic of China two note on the use " metering " items of version in 2010 Article 28 (9) money about the implication of this pharmacopeia institute medication sieve.
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:
(1) each material of respective amount is taken, mix homogeneously;
(2) pulverize on suitable pulverizer, the mobility (taking angle of repose as parameter) of material is monitored at any time in crushing process, can also monitor particle size change and appearance uniform degree (in the present invention, above-mentioned " the particle size change " monitoring material at any time can be shone method A mentioned above and be carried out simultaneously; " appearance uniform degree " can carry out with reference to [appearance uniform degree] inspection technique under version Chinese Pharmacopoeia in 2012 two annex powder items; Mobility parameter measures according to fixed funnel method angle of repose);
(3) treat that material powder body measures through fixed funnel method, angle of repose, 35 ° ~ 40 ° time, stops pulverizing, and point packaging, obtains 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:method with reference to embodiment 1 is carried out, and 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 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 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 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 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 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:method with reference to embodiment 1 is carried out, and obtains the present composition (can be designated as R8).
After measured, the granularity of above embodiment 1-8 powder body is: the particle footpath of more than 65% is between 50 order ~ 80 orders.
embodiment 9
prescription:with embodiment 1.
preparation method:method with reference to embodiment 1 is carried out, but when controlling the mobility of powder body in crushing process, prepares the compositions with different angle of repose, as follows respectively:
Control powder body and reach 25 ± 1 ° angle of repose, obtain compositions R9-1;
Control powder body and reach 27 ± 1 ° angle of repose, obtain compositions R9-2;
Control powder body and reach 29 ± 1 ° angle of repose, obtain compositions R9-3;
Control powder body and reach 31 ± 1 ° angle of repose, obtain compositions R9-4;
Control powder body and reach 33 ± 1 ° angle of repose, obtain compositions R9-5;
Control powder body and reach 35 ± 1 ° angle of repose, obtain compositions R9-6;
Control powder body and reach 37 ± 1 ° angle of repose, obtain compositions R9-7;
Control powder body and reach 39 ± 1 ° angle of repose, obtain compositions R9-8;
Control powder body and reach 41 ± 1 ° angle of repose, obtain compositions R9-9;
Control powder body and reach 43 ± 1 ° angle of repose, obtain compositions R9-10;
Control powder body and reach 45 ± 1 ° angle of repose, obtain compositions R9-11;
Control powder body and reach 47 ± 1 ° angle of repose, obtain compositions R9-12;
Control powder body and reach 49 ± 1 ° angle of repose, obtain compositions R9-13;
Control powder body and reach 51 ± 1 ° angle of repose, obtain compositions R9-14;
Control powder body and reach 53 ± 1 ° angle of repose, obtain compositions R9-15;
Control powder body and reach 55 ± 1 ° angle of repose, obtain compositions R9-16;
Control powder body and reach 57 ± 1 ° angle of repose, obtain compositions R9-17.
embodiment 10
prescription:with embodiment 2.
preparation method:method with reference to embodiment 1 is carried out, but when controlling the mobility of powder body in crushing process, prepares the compositions with different angle of repose, as follows respectively:
Control powder body and reach 25 ± 1 ° angle of repose, obtain compositions R10-1;
Control powder body and reach 27 ± 1 ° angle of repose, obtain compositions R10-2;
Control powder body and reach 29 ± 1 ° angle of repose, obtain compositions R10-3;
Control powder body and reach 31 ± 1 ° angle of repose, obtain compositions R10-4;
Control powder body and reach 33 ± 1 ° angle of repose, obtain compositions R10-5;
Control powder body and reach 35 ± 1 ° angle of repose, obtain compositions R10-6;
Control powder body and reach 37 ± 1 ° angle of repose, obtain compositions R10-7;
Control powder body and reach 39 ± 1 ° angle of repose, obtain compositions R10-8;
Control powder body and reach 41 ± 1 ° angle of repose, obtain compositions R10-9;
Control powder body and reach 43 ± 1 ° angle of repose, obtain compositions R10-10;
Control powder body and reach 45 ± 1 ° angle of repose, obtain compositions R10-11;
Control powder body and reach 47 ± 1 ° angle of repose, obtain compositions R10-12;
Control powder body and reach 49 ± 1 ° angle of repose, obtain compositions R10-13;
Control powder body and reach 51 ± 1 ° angle of repose, obtain compositions R10-14;
Control powder body and reach 53 ± 1 ° angle of repose, obtain compositions R10-15;
Control powder body and reach 55 ± 1 ° angle of repose, obtain compositions R10-16;
Control powder body and reach 57 ± 1 ° angle of repose, obtain compositions R10-17.
In addition, with reference to above R9-6, unlike only anhydrous glucose wherein being replaced with Dextrose monohydrate, obtain compositions (being designated as R9-18).
In addition, with reference to above R10-6, unlike only anhydrous glucose wherein being replaced with Dextrose monohydrate, obtain compositions (being designated as R10-18).
In above embodiment 9 and embodiment 10, be less than the powder body of 30 ° angle of repose, its particle is thicker, only have less than 50% particle footpath between 50 order ~ 80 orders, there is comparatively multiparticle can not by 50 mesh sieve, such as R9-1 and R10-1 two samples, its only have an appointment 26% particle footpath between 50 order ~ 80 orders.But when being less than 45 ° angle of repose, powder particle is thinner, only have less than 45% particle footpath between 50 order ~ 80 orders, have comparatively multiparticle by 80 mesh sieve, such as R9-14 and R10-14 two samples, its only have an appointment 31% particle footpath between 50 order ~ 80 orders.
embodiment 11
prescription:with embodiment 1.
preparation method:basic with embodiment 1, but by monitoring powder body crushing process, measure at any time powder body particle size change and appearance uniform degree:
Treat the particle size of material through method A detect, have an appointment 30% particle footpath between 50 order ~ 80 orders time, stop pulverize, point packaging, obtain compositions (being designated as R11-1);
Treat the particle size of material through method A detect, have an appointment 40% particle footpath between 50 order ~ 80 orders time, stop pulverize, point packaging, obtain compositions (being designated as R11-2);
Treat the particle size of material through method A detect, have an appointment 50% particle footpath between 50 order ~ 80 orders time, stop pulverize, point packaging, obtain compositions (being designated as R11-3);
Treat the particle size of material through method A detect, have an appointment 60% particle footpath between 50 order ~ 80 orders time, stop pulverize, point packaging, obtain compositions (being designated as R11-4);
Treat the particle size of material through method A detect, have an appointment 65% particle footpath between 50 order ~ 80 orders time, stop pulverize, point packaging, obtain compositions (being designated as R11-5);
Treat the particle size of material through method A detect, have an appointment 70% particle footpath between 50 order ~ 80 orders time, stop pulverize, point packaging, obtain compositions (being designated as R11-6);
Treat the particle size of material through method A detect, have an appointment 75% particle footpath between 50 order ~ 80 orders time, stop pulverize, point packaging, obtain compositions (being designated as R11-7);
Treat the particle size of material through method A detect, have an appointment 80% particle footpath between 50 order ~ 80 orders time, stop pulverize, point packaging, obtain compositions (being designated as R11-8);
Treat the particle size of material through method A detect, have an appointment 85% particle footpath between 50 order ~ 80 orders time, stop pulverize, point packaging, obtain compositions (being designated as R11-9).
embodiment 12
prescription:sodium chloride 3.5 weight portion, potassium chloride 1.5 weight portion, sodium bicarbonate 2.5 weight portion, anhydrous glucose 20 weight portion.
Preparation method: shine compositions R9-6 method for making above and carry out, control powder body and reach 35 ± 1 ° angle of repose, point packaging, obtains compositions (being designated as R12-1).
In addition, reference above compositions R9-6 is prepared, and different is only that anhydrous glucose is wherein replaced with Dextrose monohydrate, controls powder body and reaches 35 ± 1 ° angle of repose, and point packaging, obtains compositions (being designated as R12-2).
test example 1: the Character change of study group's compound
The sample prepared of each embodiment above, every bag of sealing subpackage 5.125g.
The present invention can 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, puts 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, add 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.
Each formulation samples of preparing for each embodiment (each formula prepare be a batch sample), every batch sample randomly draws 20 bags, the content of wherein sodium citrate is tested according to method mentioned above, sodium citrate content is represented with the percent that sodium citrate is shared in the composition, then meansigma methods and the standard deviation of sodium citrate content is calculated, and calculate the relative standard deviation (RSD, %) of sodium citrate content in each batch sample 20 samples, result shows below:
| Sample | RSD | Sample | RSD | Sample | RSD | Sample | RSD |
| R1 | 2.93 | R9-7 | 3.34 | R10-3 | 7.92 | R10-17 | 15.9 |
| R2 | 3.28 | R9-8 | 3.92 | R10-4 | 3.22 | R10-18 | 8.87 |
| R3 | 2.78 | R9-9 | 2.67 | R10-5 | 1.93 | R11-1 | 15.3 |
| R4 | 3.82 | R9-10 | 1.87 | R10-6 | 3.29 | R11-2 | 16.6 |
| R5 | 2.26 | R9-11 | 4.07 | R10-7 | 2.02 | R11-3 | 9.31 |
| R6 | 4.02 | R9-12 | 7.78 | R10-8 | 2.89 | R11-4 | 7.52 |
| R7 | 3.23 | R9-13 | 8.42 | R10-9 | 4.11 | R11-5 | 4.21 |
| R8 | 2.93 | R9-14 | 9.73 | R10-10 | 3.20 | R11-6 | 3.11 |
| R9-1 | 17.2 | R9-15 | 12.5 | R10-11 | 2.73 | R11-7 | 2.98 |
| R9-2 | 13.9 | R9-16 | 14.1 | R10-12 | 8.02 | R11-8 | 3.36 |
| R9-3 | 7.75 | R9-17 | 16.3 | R10-13 | 8.97 | R11-9 | 2.34 |
| R9-4 | 3.92 | R9-18 | 9.53 | R10-14 | 10.8 | R12-1 | 3.28 |
| R9-5 | 4.11 | R10-1 | 16.4 | R10-15 | 12.3 | R12-2 | 2.08 |
| R9-6 | 2.87 | R10-2 | 14.6 | R10-16 | 13.9 |
Generally, for the present composition, reasonable option with the content difference of the wherein Content evaluation product of less component sodium citrate, and typically, for the present composition, the RSD of its sodium citrate is preferred below 5%, and when RSD is more than 7.5%, people can produce doubt to drug quality, and when RSD is greater than 10%, this medicine can not be accepted by those skilled in the art substantially.
test example 2: the Character change of study group's compound
The sample prepared of each embodiment above, every bag of sealing subpackage 5.125g.
R11-1 to R11-9 nine samples are placed 40 days at 55 DEG C, test 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 9.2cm; 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 40 days processing samples without 55 DEG C is t1 (second), and the dissolution time placing 40 days processing samples through 55 DEG C is t2 (second), calculates dissolution time percent change Δ t (%) with following formula:
The each sample prepared above, dissolution time percent change after measured, result shows, the Δ t (%) of R11-1 to R11-4 four samples is between 75 ~ 130%, and the particle between 50 order ~ 80 orders is fewer, Δ t (%) is larger, and the Δ t (%) of such as R11-1 is the Δ t (%) of 75.8%, R11-3 is 94.5%; And the Δ t (%) of R11-5 to R11-9 five samples is between 15 ~ 45%, the Δ t (%) of such as R11-5 is 43.8%, and the Δ t (%) of such as R11-8 is 16.4%.Through measuring in addition, the < 30 ° angle of repose of above R11-1 to R11-4 four samples, the angle of repose of R11-5 to R11-9 five samples is between 33 ° ~ 39 °.
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 (13)
1., in 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; Described sodium citrate is sodium citrate dihydrate, and the angle of repose that said composition measures according to fixed funnel method is 30 ° ~ 45 °, and the particle footpath of said composition more than 65% is between 50 order ~ 80 orders;
Wherein, angle of repose fixed funnel method used is measured as follows:
Funnel is fixed on the suitable height on the graph paper of horizontal positioned, funnel end opening is made to be H apart from the distance of graph paper, carefully powder is poured in funnel, until the outlet of the nib contacts funnel of the cone formed under funnel, measure the radius r bottom cone by graph paper, the angle [alpha] calculated by following formula is angle of repose: tan α=H ÷ r.
2. compositions according to 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.
3. compositions according to 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.
4. compositions according to 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.
5. compositions according to claim 1, its particle footpath of more than 70% is between 50 order ~ 80 orders.
6. compositions according to claim 1, its particle footpath of more than 75% is between 50 order ~ 80 orders.
7., in 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; Described sodium citrate is sodium citrate dihydrate, and the angle of repose that said composition measures according to fixed funnel method is 30 ° ~ 45 °, and the particle footpath of said composition more than 65% is between 50 order ~ 80 orders;
Wherein, angle of repose fixed funnel method used is measured as follows:
Funnel is fixed on the suitable height on the graph paper of horizontal positioned, funnel end opening is made to be H apart from the distance of graph paper, carefully powder is poured in funnel, until the outlet of the nib contacts funnel of the cone formed under funnel, measure the radius r bottom cone by graph paper, the angle [alpha] calculated by following formula is angle of repose: tan α=H ÷ r.
8. compositions according to claim 7, 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.
9. compositions according to claim 7, 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.
10. compositions according to claim 7, its particle footpath of more than 70% is between 50 order ~ 80 orders.
11. compositionss according to claim 7, its particle footpath of more than 75% is between 50 order ~ 80 orders.
12. methods preparing compositions described in any one of claim 1-6, 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; Be dispensed in packaging bag, obtain final product.
13. methods preparing compositions described in any one of claim 7-11, 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; Be dispensed in packaging bag, obtain final product.
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| CN105457654B (en) * | 2015-12-14 | 2018-06-19 | 厦门宇净环保科技有限公司 | Catalyst of room temperature catalytic oxidation removing formaldehyde and preparation method thereof |
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| 胡荣峰.粉碎、过筛与混合.《工业药剂学》.中国中医药出版社,2010,第202-203、207-209页. * |
| 韩树荣.口服补液盐.《铁路红十字救护员培训教材》.中国铁道出版社,2010,第37页. * |
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