CN102836172A - Powder combination containing glucose - Google Patents
Powder combination containing glucose Download PDFInfo
- Publication number
- CN102836172A CN102836172A CN2012103488732A CN201210348873A CN102836172A CN 102836172 A CN102836172 A CN 102836172A CN 2012103488732 A CN2012103488732 A CN 2012103488732A CN 201210348873 A CN201210348873 A CN 201210348873A CN 102836172 A CN102836172 A CN 102836172A
- Authority
- CN
- China
- Prior art keywords
- weight portions
- compositions
- glucose
- sodium citrate
- orders
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
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 technical field, relate to a kind of compositions that Powdered or graininess can be used as powder that is, comprise glucose and Na ion and the ionic salt of K in the said composition.
Background technology
The medicine of salt is the medicine of world health organisation recommendations treatment acute diarrhea dehydration in the additional body fluid for oral use, and these drug prescriptions are formed rationally, and are cheap and easy to get, and convenient efficient, the speed of its correct dehydration is superior to intravenous drip.Be used to treat the slight and moderate dehydration that infantile dyspepsia and rotavirus enteritis cause.
Have been found that a kind of prescription that effectively can be used for replenishing salt in the body fluid; This prescription comprises glucose, sodium chloride, potassium chloride and the sodium citrate as active component; And can not add other material in this prescription and directly be prepared into preparation, for example granule, powder etc.From pharmaceutical technology can handling, production cost, and the compliance of clinical practice says that for this prescription, powder all has many than the better advantage of granule.For example powder can be after pulverizing, mixing direct packaging in the unit dose package medicated bag; And granule need add aqueous binders to process granule, drying after pulverizing, mixing, and then branch installs in the unit dose package medicated bag.The preparation technology of granule prolongs in the cycle greatly for powder, and owing to need dry run, needs to consume a large amount of energy.In addition, powder is because its granule is littler than granule, and the back dissolving that is added to the water is faster, therefore more helps clinical use.
Yet prepare in the process at powder, and, may run into variety of issue, occur phenomenons such as caking is agglomerating, the balling-up of uniting in the for example preparation process, can influence drugs packaging at the finished product duration of storage; In the dissolving that duration of storage caking is agglomerating then possibly influence drug use the time.
Therefore those skilled in the art need new method and prepare the new medicine with above-mentioned prescription.
Summary of the invention
The inventor unexpectedly finds, comprises the powder of glucose, sodium chloride, potassium chloride and sodium citrate as active component, when this powder has the physical performance, has demonstrated the pharmacy effect of desirable, for example convenient preparation.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.
Compositions according to first aspect present invention wherein comprises:
The potassium chloride of 1 weight portion,
1.3 the sodium chloride of～2.5 weight portions,
1.5 the sodium citrate of～2.5 weight portions and
The glucose of 6～15 weight portions.
Compositions according to first aspect present invention wherein comprises:
The potassium chloride of 1 weight portion,
1.5 the sodium chloride of～2.4 weight portions,
1.6 the sodium citrate of～2.2 weight portions and
The glucose of 7～14 weight portions.
Compositions according to first aspect present invention wherein comprises:
The potassium chloride of 1 weight portion,
1.56 the sodium chloride of～1.91 weight portions,
1.74 the sodium citrate of～2.13 weight portions and
The glucose of 8～10 weight portions.
Compositions according to first aspect present invention wherein comprises:
The potassium chloride of 1 weight portion,
1.65 the sodium chloride of～1.82 weight portions,
1.84 the sodium citrate of～2.03 weight portions and
8.55 the glucose of～9.45 weight portions.
Compositions according to first aspect 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 first aspect present invention wherein comprises:
The potassium chloride of 1 weight portion,
2.1 the sodium chloride of～2.57 weight portions,
1.74 the sodium citrate of～2.13 weight portions and
The glucose of 12～14.67 weight portions.
Compositions according to first aspect present invention wherein comprises:
The potassium chloride of 1 weight portion,
2.22 the sodium chloride of～2.45 weight portions,
1.84 the sodium citrate of～2.03 weight portions and
12.67 the glucose of～14 weight portions.
Compositions according to first aspect 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.
According to the compositions of first aspect present invention, wherein said sodium citrate is anhydrous citric acid sodium or its hydrate.In one embodiment, said sodium citrate is the dihydrate of sodium citrate.
According to the compositions of first aspect present invention, wherein said glucose is anhydrous glucose or its hydrate.In one embodiment, said glucose is an anhydrous glucose.
According to the compositions of first aspect present invention, be 25 °～55 ° its angle of repose.
According to the compositions of first aspect present invention, be 28 °～50 ° its angle of repose.
According to the compositions of first aspect present invention, be 29 °～48 ° its angle of repose.
According to the compositions of first aspect present invention, be 30 °～45 ° its angle of repose.
In the present invention; As not explanation in addition, the assay method of parameter " angle of repose " is referring to textbook " pharmaceutics " (Xi Nianzhu chief editor, the third edition; The People's Health Publisher publishes; April in 1996 the 3rd edition, ISBN 7-117-00026-0) method that the 248-249 page or leaf is described is specifically used the 249th page of 3-5 capable described " fixed funnel method ".Need to prove that the method that characterizes or measure present composition granule/powder angle of repose has many, has for example also enumerated some other assay method at Xi Nianzhu chief editor's the third edition " pharmaceutics " textbook.In context of the present invention, if explanation in addition, the method that characterizes or measure present composition granule/powder angle of repose is to use above-mentioned " fixed funnel method " to carry out.
The inventor finds that also the present composition with specified particle size characteristic has the unique features of some desirable.Therefore, according to the compositions of first aspect present invention, its granularity is: the particle footpath more than 65% is between 50 orders～80 orders.According to the compositions of first aspect present invention, its granularity is: the particle footpath more than 70% is between 50 orders～80 orders.According to the compositions of first aspect present invention, its granularity is: the particle footpath more than 75% is between 50 orders～80 orders.
According to the compositions of first aspect present invention, except potassium chloride, sodium chloride, sodium citrate and four kinds of materials of glucose, do not add other material basically in addition in its prescription.Yet it will be apparent to those skilled in the art that; Also can add an amount of non-active ingredient in the present composition; For example can add a spot of correctives; For example add a little saccharin sodium to improve mouthfeel, perhaps for example add a little coloring agent with as differentiation packing dosage usefulness, these a little additive can not produce harmful effect to the object of the invention.
Second aspect present invention provides the method for preparing the said powder composition of first aspect present invention, and it may further comprise the steps:
Two or more are pulverized together independently of one another or arbitrarily to make four kinds of materials;
The powder mixes of each pulverizing is even; Divide to install in the packaging bag, promptly get.
According to the method for second aspect present invention, wherein said four kinds of materials are to pulverize independently of one another, carry out blended then.
According to the method for second aspect present invention, wherein said four kinds of materials are mixed together and together pulverize.
In an embodiment of second aspect present invention method; Said material is pulverized on suitable pulverizer; In the crushing process at any time the angle of repose through measuring material with the flowability of monitoring material (preferably make and reach angle of repose of powder material the said scope of first aspect present invention compositions); At any time the particle size of monitoring material in case of necessity changes and the outward appearance uniformity (in the present invention, above-mentioned " the particle size variation " of monitoring material at any time can be shone methods described herein A and carried out; " the outward appearance uniformity " can carry out with reference to [the outward appearance uniformity] inspection technique under two appendix powder of version Chinese Pharmacopoeia in 2012 item, to guarantee potassium chloride, sodium chloride and the uniformity of sodium citrate three in material).
Be further described in the face of the present invention down.
In the present invention, term " weight portion " expression can be with the amount of any unit of weight or mass unit calculating, and this amount can be an integer number, can also be smallest number.For example, in an instance of the present composition, for example in a prescription, said per 1 " weight portion " can be represented about 0.375g.Thus, in the prescription of an instance, comprise about 0.375g potassium chloride, about 0.65g sodium chloride, 0.725g sodium citrate and 3.375g glucose in the present composition.
In an instance of the present invention, said sodium citrate is the dihydrate of sodium citrate, i.e. chemical compound shown in the following formula:
In an instance of the present invention; Said glucose is an anhydrous glucose, i.e. chemical compound shown in the following formula:
In the present invention; Phrase " the particle footpath more than 65% is between 50 orders～80 orders " is used to characterize the physical size that the present invention is pulverous compositions powder body; Its implication is; The above particle of 65% (w/w) is arranged in the present composition, and these particles can sieve through 50 purpose medicines but can not be through 80 purpose medicines sieve.The phrase of other similar statement also has similar meaning.The phrase " the particle footpath more than 65% is between 50 orders～80 orders " that one of ordinary skill in the art will readily recognize that the physical size of above-mentioned characterize combinations powder body can obtain through following method A mensuration at least:
Method A: method is according to two (Chinese Pharmacopoeia Commission's volumes of Pharmacopoeia of People's Republic of China of version in 2010; Chinese Medicine science and technology publishing house publishes; ISBN 978-7-5067-4438-6; Can abbreviate two ones of version Chinese Pharmacopoeias in 2012 in the present invention as) second method (sieve method) among the appendix IX E " granularity and particle size distribution method ", carry out with " two sieve method " in " rider point-score "; Upper strata medicine sieve is 50 orders, and lower floor's medicine sieve is 80 orders; Get and be trapped in two granule/powder between the medicine sieve, claim to decide weight, calculate its proportion (%).
If should measure the result, then meet the regulation of phrase " the particle footpath more than 65% is between 50 orders～80 orders " more than 65%.In addition, be 75% if measure the result, represent that then said composition has 75% particle still can not pass through 80 mesh sieves through 50 mesh sieves.
Need to prove; The method that characterizes or measure present composition granule/powder physical size has many, for example in two appendix IX of Pharmacopoeia of People's Republic of China of version in 2010 E " granularity and particle size distribution method ", has also described some other assay method.In context of the present invention, if not explanation in addition, the method that characterizes or measure present composition granule/powder physical size is to use said method A to carry out.
In the present invention, like not explanation in addition, % is meant percetage by weight.
In the present invention, need various materials be crushed to the regulation performance during preparation present composition and have specific angle of repose, and the particle size that randomly is crushed to regulation.With regard to realizing the object of the invention; Method of pulverizing and device therefor are not receive special restriction; For example can use stirring-type comminuting method (for example shear agitation); Can also use polishing (for example ball-milling method) etc., if in crushing process powder body characteristic angle of repose for example of the monitoring present composition.With regard to the present composition; Its four kinds of materials particularly anhydrous glucose, sodium citrate dihydrate and sodium chloride and potassium chloride when pulverizing directly mixing; Mobile very good warp is measured direct blended mixture and can be reached below 30 degree angle of repose; Yet in the process of pulverizing, along with the reduction of granularity, can slowly increase angle of repose; Based on this characteristic, the flowability that in the process that increases gradually this angle of repose, can obtain to have the present invention's expectation particularly has the powder body of specific angle of repose.
In the present invention; " order " of expression particle size or medicine sieve specification has the implication of well known to a person skilled in the art; Especially; For the present invention, it has the implication of two notes on the use of Pharmacopoeia of People's Republic of China " metering " following the 28 article of (9) money of version in 2010 about this pharmacopeia institute medication sieve.
The specific embodiment
Below through embodiment the present invention is described in further detail, but the present invention should not be limited to these embodiment.Among the embodiment, when forming with " weight portion " statement prescription, all the amount with preparation total amount 5kg compositions feeds intake below.Below among the embodiment, when mentioning glucose, like explanation in addition, use be anhydrous glucose.Below among the embodiment, when mentioning sodium citrate, like explanation in addition, use be sodium citrate dihydrate.Below among the embodiment; The compositions of preparation can pack in paper aluminum composite membrane bag; Every bag can be approximately 3g～30g, the amount of every bag of about 5.125g or its 2 times, 2.5 times, 3 times, 4 times, 5 times for example, perhaps perhaps its 2 times, 2.5 times, 3 times, 4 times, 5 times amount of every bag of about 5.58g for example; As not explanation in addition, every bag branch loading amount is 5.125g.
Embodiment 1
Prescription:The glucose of the sodium citrate of the sodium chloride of the potassium chloride of 1 weight portion, 1.73 weight portions, 1.93 weight portions and 9 weight portions.
Method for preparing:
(1) takes by weighing each material of respective amount, mix homogeneously;
(2) on suitable pulverizer, pulverize; At any time monitor the flowability (is parameter with the angle of repose) of material in the crushing process; Can also monitor simultaneously that particle size changes and the outward appearance uniformity (in the present invention, above-mentioned " the particle size variation " of monitoring material at any time can be shone method A mentioned above and carried out; " the outward appearance uniformity " can carry out with reference to [the outward appearance uniformity] inspection technique under two appendix powder of version Chinese Pharmacopoeia in 2012 item; Mobile parameter is measured according to the fixed funnel method angle of repose);
(3) treat the material powder body through fixed funnel method mensuration, stop to pulverize angle of repose in the time of 35 °～40 °, divides packing, promptly gets compositions (can be designated as R1, the hereinafter gained present composition can similarly be represented).
Embodiment 2
Prescription:The glucose of the sodium citrate of the sodium chloride of the potassium chloride of 1 weight portion, 2.33 weight portions, 1.93 weight portions and 13.3 weight portions.
Method for preparing:Method with reference to embodiment 1 is carried out, and gets the present composition (can be designated as R2).
Embodiment 3
Prescription:The glucose of the sodium citrate of the sodium chloride of the potassium chloride of 1 weight portion, 2.4 weight portions, 1.6 weight portions and 14 weight portions.
Method for preparing:Method with reference to embodiment 1 is carried out, and gets the present composition (can be designated as R3).
Embodiment 4
Prescription:The glucose of the sodium citrate of the sodium chloride of the potassium chloride of 1 weight portion, 1.5 weight portions, 2.2 weight portions and 7 weight portions.
Method for preparing:Method with reference to embodiment 1 is carried out, and gets the present composition (can be designated as R4).
Embodiment 5
Prescription:The glucose of the sodium citrate of the sodium chloride of the potassium chloride of 1 weight portion, 1.65 weight portions, 2.03 weight portions and 8.55 weight portions.
Method for preparing:Method with reference to embodiment 1 is carried out, and gets the present composition (can be designated as R5).
Embodiment 6
Prescription:The glucose of the sodium citrate of the sodium chloride of the potassium chloride of 1 weight portion, 1.82 weight portions, 1.84 weight portions and 9.45 weight portions.
Method for preparing:Method with reference to embodiment 1 is carried out, and gets the present composition (can be designated as R6).
Embodiment 7
Prescription:The glucose of the sodium citrate of the sodium chloride of the potassium chloride of 1 weight portion, 2.45 weight portions, 1.84 weight portions and 14 weight portions.
Method for preparing:Method with reference to embodiment 1 is carried out, and gets the present composition (can be designated as R7).
Embodiment 8
Prescription:The glucose of the sodium citrate of the sodium chloride of the potassium chloride of 1 weight portion, 2.22 weight portions, 2.03 weight portions and 12.67 weight portions; The saccharin sodium that adds total weight of material 0.01% in addition is to be used to improve mouthfeel.
Method for preparing:Method with reference to embodiment 1 is carried out, and gets the present composition (can be designated as R8).
Through measuring, the granularity of above embodiment 1-8 powder body is: the particle footpath more than 65% is between 50 orders～80 orders.
Embodiment 9
Prescription:With embodiment 1.
Method for preparing:Method with reference to embodiment 1 is carried out, but in the control crushing process, during powder body mobile, prepares the compositions with different angle of reposes, distinguishes as follows:
The control powder body reaches 25 ± 1 ° angle of repose, gets compositions R9-1;
The control powder body reaches 27 ± 1 ° angle of repose, gets compositions R9-2;
The control powder body reaches 29 ± 1 ° angle of repose, gets compositions R9-3;
The control powder body reaches 31 ± 1 ° angle of repose, gets compositions R9-4;
The control powder body reaches 33 ± 1 ° angle of repose, gets compositions R9-5;
The control powder body reaches 35 ± 1 ° angle of repose, gets compositions R9-6;
The control powder body reaches 37 ± 1 ° angle of repose, gets compositions R9-7;
The control powder body reaches 39 ± 1 ° angle of repose, gets compositions R9-8;
The control powder body reaches 41 ± 1 ° angle of repose, gets compositions R9-9;
The control powder body reaches 43 ± 1 ° angle of repose, gets compositions R9-10;
The control powder body reaches 45 ± 1 ° angle of repose, gets compositions R9-11;
The control powder body reaches 47 ± 1 ° angle of repose, gets compositions R9-12;
The control powder body reaches 49 ± 1 ° angle of repose, gets compositions R9-13;
The control powder body reaches 51 ± 1 ° angle of repose, gets compositions R9-14;
The control powder body reaches 53 ± 1 ° angle of repose, gets compositions R9-15;
The control powder body reaches 55 ± 1 ° angle of repose, gets compositions R9-16;
The control powder body reaches 57 ± 1 ° angle of repose, gets compositions R9-17.
Embodiment 10
Prescription:With embodiment 2.
Method for preparing:Method with reference to embodiment 1 is carried out, but in the control crushing process, during powder body mobile, prepares the compositions with different angle of reposes, distinguishes as follows:
The control powder body reaches 25 ± 1 ° angle of repose, gets compositions R10-1;
The control powder body reaches 27 ± 1 ° angle of repose, gets compositions R10-2;
The control powder body reaches 29 ± 1 ° angle of repose, gets compositions R10-3;
The control powder body reaches 31 ± 1 ° angle of repose, gets compositions R10-4;
The control powder body reaches 33 ± 1 ° angle of repose, gets compositions R10-5;
The control powder body reaches 35 ± 1 ° angle of repose, gets compositions R10-6;
The control powder body reaches 37 ± 1 ° angle of repose, gets compositions R10-7;
The control powder body reaches 39 ± 1 ° angle of repose, gets compositions R10-8;
The control powder body reaches 41 ± 1 ° angle of repose, gets compositions R10-9;
The control powder body reaches 43 ± 1 ° angle of repose, gets compositions R10-10;
The control powder body reaches 45 ± 1 ° angle of repose, gets compositions R10-11;
The control powder body reaches 47 ± 1 ° angle of repose, gets compositions R10-12;
The control powder body reaches 49 ± 1 ° angle of repose, gets compositions R10-13;
The control powder body reaches 51 ± 1 ° angle of repose, gets compositions R10-14;
The control powder body reaches 53 ± 1 ° angle of repose, gets compositions R10-15;
The control powder body reaches 55 ± 1 ° angle of repose, gets compositions R10-16;
The control powder body reaches 57 ± 1 ° angle of repose, gets compositions R10-17.
In addition, with reference to above R9-6, different is only anhydrous glucose wherein to be replaced with Dextrose monohydrate, promptly gets compositions (being designated as R9-18).
In addition, with reference to above R10-6, different is only anhydrous glucose wherein to be replaced with Dextrose monohydrate, promptly gets compositions (being designated as R10-18).
In above embodiment 9 and embodiment 10; Angle of repose is less than 30 ° powder body; Its particle is thicker, only has less than 50% particle footpath between 50 orders～80 orders, has than multiparticle and can not pass through 50 mesh; Two samples of R9-1 and R10-1 for example, it only has an appointment 26% particle footpath between 50 orders～80 orders.Yet when angle of repose during less than 45 °, powder particle is thinner; Only have less than 45% particle footpath between 50 orders～80 orders; Have than multiparticle through 80 mesh, two samples of R9-14 and R10-14 for example, it only has an appointment 31% particle directly between 50 orders～80 orders.
Embodiment 11
Prescription:With embodiment 1.
Method for preparing:Basically with embodiment 1, but through in the monitoring powder body crushing process, measure at any time powder body particle size change and the outward appearance uniformity:
The particle size of treating material detects through method A, has an appointment 30% particle footpath between 50 orders～80 orders the time, stops to pulverize, and divides packing, promptly gets compositions (being designated as R11-1);
The particle size of treating material detects through method A, has an appointment 40% particle footpath between 50 orders～80 orders the time, stops to pulverize, and divides packing, promptly gets compositions (being designated as R11-2);
The particle size of treating material detects through method A, has an appointment 50% particle footpath between 50 orders～80 orders the time, stops to pulverize, and divides packing, promptly gets compositions (being designated as R11-3);
The particle size of treating material detects through method A, has an appointment 60% particle footpath between 50 orders～80 orders the time, stops to pulverize, and divides packing, promptly gets compositions (being designated as R11-4);
The particle size of treating material detects through method A, has an appointment 65% particle footpath between 50 orders～80 orders the time, stops to pulverize, and divides packing, promptly gets compositions (being designated as R11-5);
The particle size of treating material detects through method A, has an appointment 70% particle footpath between 50 orders～80 orders the time, stops to pulverize, and divides packing, promptly gets compositions (being designated as R11-6);
The particle size of treating material detects through method A, has an appointment 75% particle footpath between 50 orders～80 orders the time, stops to pulverize, and divides packing, promptly gets compositions (being designated as R11-7);
The particle size of treating material detects through method A, has an appointment 80% particle footpath between 50 orders～80 orders the time, stops to pulverize, and divides packing, promptly gets compositions (being designated as R11-8);
The particle size of treating material detects through method A, has an appointment 85% particle footpath between 50 orders～80 orders the time, stops to pulverize, and divides packing, promptly gets compositions (being designated as R11-9).
Embodiment 12
Prescription:Sodium chloride 3.5 weight portions, potassium chloride 1.5 weight portions, sodium bicarbonate 2.5 weight portions, anhydrous glucose 20 weight portions.
Method for preparing: carry out according to preceding text compositions R9-6 method for making, the control powder body reaches 35 ± 1 ° angle of repose, divides packing, promptly gets compositions (being designated as R12-1).
In addition, R9-6 prepares with reference to the preceding text compositions, and different only is replaces with Dextrose monohydrate with wherein anhydrous glucose, and the control powder body reaches 35 ± 1 ° angle of repose, divides packing, promptly gets compositions (being designated as R12-2).
Test Example 1: the character of study group's compound changes
The sample of each embodiment preparation of preceding text, every bag of sealing packing 5.125g.
The present invention can be shone the content that following method is tested sodium citrate in the compositions of each embodiment preparation: get the about 2.1g of compositions, the accurate title, decide, and puts in the 100ml measuring bottle, adds glacial acetic acid 80ml; Jolting is heated to 50 ℃, puts coldly, adds glacial acetic acid and is diluted to scale; Shake up, leave standstill, precision is measured supernatant 20ml; Add 1 of crystal violet indicator solution, show blue, and titration results is proofreaied and correct with blank assay with perchloric acid titration liquid (0.1mol/L) titration to solution.Every 1ml perchloric acid titration liquid (0.1mol/L) is equivalent to the C of 9.803mg
6H
5Na
3O
72H
2O.
To the sample of respectively filling a prescription of each embodiment preparation (each formulation be a collection of sample); Every lot sample article are randomly drawed 20 bags, test the wherein content of sodium citrate according to method mentioned above, represent sodium citrate content with sodium citrate shared percent in compositions; Calculate the meansigma methods and the standard deviation of sodium citrate content then; And calculate sodium citrate content in 20 samples of each lot sample article relative standard deviation (RSD, %), the 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 |
Usually; For the present composition, the content difference of estimating product with the content of less component sodium citrate wherein is reasonable option, and usually; For the present composition; The RSD of its sodium citrate is being preferred below 5%, and RSD can produce doubt to drug quality 7.5% people when above, when RSD this medicine greater than 10% time can not be accepted by those skilled in the art basically.
Test Example 2: the character of study group's compound changes
The sample of each embodiment preparation of preceding text, every bag of sealing packing 5.125g.
Nine sample samples of R11-1 to R11-9 were placed 40 days at 55 ℃, and the dissolution velocity of testing each sample with following method changes:
(1) get testing sample 1 bag, impouring is equipped with in the beaker of 100ml distilled water, and the beaker capacity is 500ml, the about 9.2cm of diameter; In water during the impouring sample, impouring as quickly as possible, and be evenly distributed at the bottom of the beaker as far as possible; Beaker leaves standstill in the whole process, does not stir; To the consoluet time, each sample repeats 5 times, gets the dissolution time of average as this sample from the impouring sample in calculating;
(2) placing the dissolution times of handling sample in 40 days without 55 ℃ is t1 (second), is t2 (second) through 55 ℃ of dissolution times of placing 40 days processing samples, with computes dissolution time percent change Δ t (%):
Each sample of preceding text preparation; Through measuring the dissolution time percent change, the result shows that the Δ t (%) of four samples of R11-1 to R11-4 is between 75～130%; And the particle between 50 orders～80 orders is few more; Δ t (%) is big more, and for example the Δ t (%) of R11-1 is 75.8%, and the Δ t (%) of R11-3 is 94.5%; And the Δ t (%) of five samples of R11-5 to R11-9 is between 15～45%, and for example the Δ t (%) of R11-5 is 43.8%, and for example the Δ t (%) of R11-8 is 16.4%.Through measuring in addition, angle of repose＜30 of four samples of above R11-1 to R11-4 °, the angle of repose of five samples of R11-5 to R11-9 is between 33 °～39 °.
In inventor's other test; With the sample of embodiment 1 and embodiment 2,40 ℃ of held 6 months, the result showed 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, placing processing in 6 months) content, all between 95%～105% without 40 ℃.Show that the present composition has good pharmaceutical property.
Claims (10)
1. a compositions wherein comprises potassium chloride, sodium chloride, sodium citrate and glucose.
2. according to the compositions of claim 1, wherein comprise:
The potassium chloride of 1 weight portion,
1.3 the sodium chloride of～2.5 weight portions,
1.5 the sodium citrate of～2.5 weight portions and
The glucose of 6～15 weight portions.
3. according to the compositions of claim 2, wherein comprise:
The potassium chloride of 1 weight portion,
1.56 the sodium chloride of～1.91 weight portions,
1.74 the sodium citrate of～2.13 weight portions and
The glucose of 8～10 weight portions;
Perhaps, wherein comprise:
The potassium chloride of 1 weight portion,
1.65 the sodium chloride of～1.82 weight portions,
1.84 the sodium citrate of～2.03 weight portions and
8.55 the glucose of～9.45 weight portions;
Perhaps, wherein comprise:
The potassium chloride of 1 weight portion,
The sodium chloride of about 1.73 weight portions,
The sodium citrate of about 1.93 weight portions and
The glucose of about 9 weight portions.
4. according to the compositions of claim 2, wherein comprise:
The potassium chloride of 1 weight portion,
2.1 the sodium chloride of～2.57 weight portions,
1.74 the sodium citrate of～2.13 weight portions and
The glucose of 12～14.67 weight portions;
Perhaps, wherein comprise:
The potassium chloride of 1 weight portion,
2.22 the sodium chloride of～2.45 weight portions,
1.84 the sodium citrate of～2.03 weight portions and
12.67 the glucose of～14 weight portions;
Perhaps, wherein comprise:
The potassium chloride of about 1 weight portion,
The sodium chloride of about 2.33 weight portions,
The sodium citrate of about 1.93 weight portions and
The glucose of about 13.3 weight portions.
5. the compositions arbitrary according to claim 1-4, be 25 °～55 ° its angle of repose, perhaps is 28 °～50 °, perhaps is 29 °～48 °, perhaps is 30 °～45 °.
6. the compositions arbitrary according to claim 1-5, wherein:
Said sodium citrate is anhydrous citric acid sodium or its hydrate; And/or
Said glucose is anhydrous glucose or its hydrate.
7. the compositions arbitrary according to claim 1-6, wherein:
Said sodium citrate is a sodium citrate dihydrate; And/or
Said glucose is an anhydrous glucose.
8. the compositions arbitrary according to claim 1-7, its:
Particle footpath more than 65% is between 50 orders～80 orders;
Particle footpath more than 70% is between 50 orders～80 orders, perhaps
Particle footpath more than 75% is between 50 orders～80 orders.
9. the compositions arbitrary according to claim 1-8 except potassium chloride, sodium chloride, sodium citrate and four kinds of materials of glucose, do not added other material in its prescription basically in addition, perhaps is added with an amount of non-active ingredient.
10. prepare each said method for compositions of claim 1-9, it may further comprise the steps:
Two or more are pulverized together independently of one another or arbitrarily to make four kinds of materials;
The powder mixes of each pulverizing is even; Divide to install in the packaging bag, promptly get.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210348873.2A CN102836172B (en) | 2012-09-20 | 2012-09-20 | Powder combination containing glucose |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210348873.2A CN102836172B (en) | 2012-09-20 | 2012-09-20 | Powder combination containing glucose |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN102836172A true CN102836172A (en) | 2012-12-26 |
| CN102836172B CN102836172B (en) | 2015-04-29 |
Family
ID=47364075
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201210348873.2A Active CN102836172B (en) | 2012-09-20 | 2012-09-20 | Powder combination containing glucose |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN102836172B (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103610692A (en) * | 2013-12-05 | 2014-03-05 | 厦门恩成制药有限公司 | Preparation method of low-permeability oral rehydration salt |
| CN105457654A (en) * | 2015-12-14 | 2016-04-06 | 厦门宇净环保科技有限公司 | Catalyst for removing formaldehyde through catalytic oxidation at indoor temperature and preparation method thereof |
-
2012
- 2012-09-20 CN CN201210348873.2A patent/CN102836172B/en active Active
Non-Patent Citations (2)
| Title |
|---|
| 胡荣峰: "《工业药剂学》", 30 August 2010, 中国中医药出版社 * |
| 韩树荣: "《铁路红十字救护员培训教材》", 31 January 2010, 中国铁道出版社 * |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103610692A (en) * | 2013-12-05 | 2014-03-05 | 厦门恩成制药有限公司 | Preparation method of low-permeability oral rehydration salt |
| CN103610692B (en) * | 2013-12-05 | 2015-11-18 | 厦门恩成制药有限公司 | A kind of preparation method of low-permeability oral rehydration salt |
| CN105457654A (en) * | 2015-12-14 | 2016-04-06 | 厦门宇净环保科技有限公司 | Catalyst for removing formaldehyde through catalytic oxidation at indoor temperature and preparation method thereof |
| 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 |
Also Published As
| Publication number | Publication date |
|---|---|
| CN102836172B (en) | 2015-04-29 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN102824362B (en) | Medicine composition of oral rehydration salt | |
| CN101766648B (en) | Polyethylene glycol electrolyte granular preparation and production method | |
| CN101252920A (en) | Stable fixed-dose unitary formulations containing tenofovir, a surfactant, efavirenz and emtricitabine | |
| CN103610692B (en) | A kind of preparation method of low-permeability oral rehydration salt | |
| CN106667952A (en) | Palbociclib pharmaceutical composition and preparation method thereof | |
| CN102133225A (en) | Compound polyethylene glycol electrolyte pulvis and preparation method thereof | |
| CN106580887A (en) | Marbofloxacin soluble pulvis | |
| CN102836172B (en) | Powder combination containing glucose | |
| CN102824361B (en) | Composition containing glucose | |
| CN104434847A (en) | Choline fenofibric acid sustained release pellets and preparation method thereof | |
| CN102824360B (en) | Powder composition containing glucose and preparation method thereof | |
| CN108836973A (en) | Metformin-glibenclamide capsule and preparation method thereof | |
| CN102488667B (en) | Glimepiride tablet and preparation method thereof | |
| CN107028912A (en) | A kind of preparation method of Irbesartan Capsules | |
| EP2915526B1 (en) | Pharmaceutical compositions comprising anagrelide | |
| CN114366757A (en) | Compound polyethylene glycol electrolyte and preparation method thereof | |
| CN107375225B (en) | Level release formulation of a kind of succinic acid furan Luo Qu and preparation method thereof | |
| CN109966262A (en) | Lenalidomide pharmaceutical composition | |
| CN104352472A (en) | Guanfacine hydrochloride sustained release tablets and preparation method thereof | |
| Jain et al. | Formulation and evaluation of fast dissolving tablet of ondansetron by utilizing liquisolid compact technique | |
| CN102641253A (en) | Valsartan sustained release tablet and preparation method thereof | |
| CN102319220A (en) | Preparation method of oral sustained controlled-release particle system | |
| CN107569465A (en) | A kind of Nifedipine sustained release tablets and preparation method thereof | |
| CN101474167A (en) | Preparation method of estradiol capsule for vagina | |
| CN106265731A (en) | The preparation method of ferrous sulfate matrix type sustained-release dropping pill |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| ASS | Succession or assignment of patent right |
Owner name: XI AN ANJIAN PHARMACEUTICAL CO., LTD. Free format text: FORMER OWNER: WANG WEI Effective date: 20150909 |
|
| C41 | Transfer of patent application or patent right or utility model | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20150909 Address after: 710400 Shaanxi city of Xi'an Province pharmaceutical Zhouzhi County Road No. 1 Patentee after: Xi'an Anjian Pharmaceutical Co., Ltd. Address before: 510200 No. 40, Po Gang straight street, Haizhuqu District, Guangdong, Guangzhou Patentee before: Wang Wei |