CN101406457A - Process for the manufacture of a pharmaceutical product - Google Patents
Process for the manufacture of a pharmaceutical product Download PDFInfo
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- CN101406457A CN101406457A CNA2007101860236A CN200710186023A CN101406457A CN 101406457 A CN101406457 A CN 101406457A CN A2007101860236 A CNA2007101860236 A CN A2007101860236A CN 200710186023 A CN200710186023 A CN 200710186023A CN 101406457 A CN101406457 A CN 101406457A
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- potassium bicarbonate
- diameter
- granular size
- sodium picosulfate
- particulate
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/009—Sachets, pouches characterised by the material or function of the envelope
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Zoology (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
A process for the preparation of a pharmaceutical composition comprising a homogeneous or substantially homogeneous mixture of citric acid, magnesium oxide, potassium bicarbonate and sodium picosulphate and, optionally, saccharin sodium and/or orange flavour; products, intermediate products, and uses thereof.
Description
The present invention relates to a kind of improved method that is used to prepare drug products, and the product that obtains by described method.
Background technology
Selling at present a kind of drug products that was used to clean intestinal before X-radiological survey X, splanchnoscopy or operation, commodity are called PICOLAX
TMDescribed drug products is a kind of white powder, and it is made solution (in water) and takes.The character that needs is that it is easy good to eat strong cathartic.Described drug products comprises sodium picosulfate (PS), a kind of irritant laxative; And anhydrous citric acid (CA) and magnesium oxide (MgO, lightweight), they form citrate of magnesia together in solution, a kind of osmotic laxative treatments with strong defecating feces excretion.
The dosage form that is used for oral delivery is a fine-grained form.The term particulate comprises loose granule (such as the granule that can generally be called powder, comprising the discrete particles of the powder form of conduct known in the art " Orally administered powder ") herein.Described product is 6 kinds of raw-material physical mixtures; These are citric acid (for example, anhydrous citric acid or citric acid monohydrate), magnesium oxide (for example, light magnesium oxide), potassium bicarbonate (KHCO
3), sodium picosulfate (NaPIC), saccharin sodium and orange flavor." lightweight " magnesium oxide means the magnesium oxide with apparent volume in this article, accounts for 75-180ml such as 15g, and for example, 15g accounts for the volume of 150ml.
Preparation PICOLAX
TMKnown method can comprise the steps.The particulate of magnesium oxide and citric acid is produced by these two kinds of materials are mixed---and this is called " elementary mixture ".In another step, with potassium bicarbonate, sodium picosulfate and water mixing or fusion and produce moistening " premix ", be dried then.In another step, with flavoring ingredients, orange flavor (orangeflavour) and saccharin sodium and premix and elementary mixture are blended together.There is correlative questions in described known method.
At first, blend step may cause uneven problem in the final sum intermediate product.On the one hand, when with in this application the time, term " inhomogeneities " and " shortage uniformity " be meant the shortage active substance---uniformity of sodium picosulfate content---for example, in end product, lack described uniformity.It also is meant and is lacking uniformity aspect the physics of intermediate product and/or end product particulate and the morphological properties, described character such as granular size (diameter) or granular size scope or distribution.The intermediate product particulate is meant, for example, and elementary mixing particulate or premixing particulate.
Suspected that uniformity is to guarantee the quality of end product and at least a key factor of performance, and it is believed that the uniformity (with inhomogeneities) of product is relevant with used mixed method.Therefore, in the first step of described known method, because low binding characteristic between citric acid and the magnesium oxide particle or agglomeration characteristic are (for example, cause by the difference of these two kinds of material densities), so discordance (disparities) may occur in particulate size and the distribution (that is, may cause inhomogeneities).In addition, the magnesium oxide cylinder, blade etc. that are retained in blender are gone up (rather than mix with citric acid).Therefore, in described known method, in raw material, comprise excessive magnesium oxide (" excessive "), with the loss of compensation in whipping process.Excessively be typically greater than 10%.This causes economic loss in longer period and in the situation of producing bigger amount.In addition, processing time that must be longer, and in whipping process, may produce the dust of insalubrity amount.
In pre-blend step, it may be to cause owing to some potassium bicarbonates are dissolved in the pelletize WATER AS FLOW MEDIUM that the particulate of acquisition lacks uniformity, and owing to the mechanical degradation (pulverizing) of granule in mixed process causes.This may have illeffects for end product.In addition, finish processing time and the multistep rapid (it typically needs 15-24 hour) that described method need be grown.
Therefore, existence is for the demand of improved preparation method.
Summary of the invention
The applicant has developed the method that can alleviate the some or all of problems of art methods, and for example, improved products is provided and/or significantly reduces preparation time.
Therefore, according to one aspect of the present invention, the invention provides a kind of method of pharmaceutical compositions, described pharmaceutical composition comprises uniformly or the basically mixture uniformly of citric acid, magnesium oxide, potassium bicarbonate and sodium picosulfate and optional saccharin sodium and/or orange flavor, and described method comprises:
A) dry blending citric acid and magnesium oxide;
B) sodium picosulfate solution is administered on (for example, being sprayed to) potassium bicarbonate; And dry described sodium picosulfate and potassium bicarbonate; With
C) product of near small part step a) and part steps b at least) product mix, and randomly, mix with saccharin sodium and/or orange flavor.
In an example, described method comprises another step d), it mixes product of step c) with the following product of amount in addition: the mixture that forms by dry blending citric acid and magnesium oxide [for example, some or all remaining products of the method that defines of step a)]; And/or by sodium picosulfate solution being administered on (for example, being sprayed to) potassium bicarbonate; And dry described sodium picosulfate and potassium bicarbonate and the product that forms [for example, some or all remaining products of the method for step b) definition].
Therefore, on the one hand, the invention provides a kind of method of pharmaceutical compositions, described pharmaceutical composition comprises citric acid, magnesium oxide, potassium bicarbonate and sodium picosulfate and the uniformly or basically mixture uniformly of saccharin sodium and/or orange flavor randomly, and described method comprises:
A) dry blending citric acid and magnesium oxide;
B) sodium picosulfate solution is administered on (for example, being sprayed to) potassium bicarbonate; And dry described sodium picosulfate and potassium bicarbonate;
C) product of near small part step a) and part steps b at least) product mix, and randomly, mix with saccharin sodium and/or orange flavor; With
D) with some or all remaining products of the method for the product of step c) and step a) definition; And/or some or all remaining products of the method for step b) definition mix mutually.
Described product, citric acid, magnesium oxide, potassium bicarbonate and sodium picosulfate and optional saccharin sodium and/or orange flavor uniformly or basically uniformly mixture can be the particulate dosage form.Described particulate can have granular size (diameter) scope or the distribution between about 100 μ m and the about 900 μ m, for example, and between about 150 μ m and the 875 μ m, for example, between about 250 μ m and the about 850 μ m.Described pharmaceutical composition can be the particulate dosage form, for example granular size (diameter) scope or be distributed in about 100 μ m and about 900 μ m between, for example, between about 150 μ m and 875 μ m, for example, between about 250 μ m and about 850 μ m.
According to the present invention; on the other hand; the invention provides one or more particulates or pharmaceutical composition, it comprises uniformly or the basically mixture uniformly of citric acid, magnesium oxide, potassium bicarbonate and sodium picosulfate and optional saccharin sodium and/or orange flavor.Pharmaceutical composition of the present invention can be used to clean intestinal before X-radiological survey X, splanchnoscopy or operation.Described particulate can have granular size (diameter) scope or the distribution between about 100 μ m and about 900 μ m, for example, and between about 150 μ m and 875 μ m, for example, between about 250 μ m and about 850 μ m.
Described particulate or pharmaceutical composition can be used as the pouch preparation and provide.
The uniformity of the content of active substance sodium picosulfate in end product particulate or pharmaceutical composition can have meansigma methods between about 0.0559 weight % and 0.068 weight %, and (the 9.0-11.0mg/ agent is based on 16.1g PICOLAX
TMDosage).
Method of the present invention (for example can comprise a step or multistep separation, handle, for example screening) step, for example, use (for example, spraying) obtain before suitable size and/or size distribution potassium bicarbonate---for example granular size (diameter) scope is for example between about 100 μ m and about 900 μ m, for example, between about 150 μ m and 875 μ m, for example, between about 250 μ m and about 850 μ m.Method of the present invention (for example can comprise a step or multistep separation, handle, for example screening) step, for example, with the citric acid that obtains suitable size and/or size distribution before magnesium oxide mixes---for example granular size (diameter) scope for example between about 100 μ m and about 900 μ m, for example, between about 150 μ m and 875 μ m, for example, between about 250 μ m and about 850 μ m.
The present invention also provides the method for pharmaceutical compositions, described pharmaceutical composition comprises uniformly or the basically mixture uniformly of citric acid, magnesium oxide, potassium bicarbonate and sodium picosulfate and optional saccharin sodium and/or orange flavor, (and/or preparation comprises citric acid and magnesian method for compositions), described method (for example comprises the steps: dry blending citric acid and magnesium oxide, light magnesium oxide), use a kind of device (such as Multidimensional and Hybrid device or three-dimensional hybrid device) preparation to have the uniform mixture of the chemical compound of remarkable different densities.Described device can use three-dimensional motion and mix (for example, it is known as Paul Schatz principle).Described device can use the three-dimensional motion of being made up of 8 fonts motions and rotation and mix, this make material in agitator with rhythmical, clocklike move and move.Described device can strengthen the agglomeration process between citric acid and the magnesium oxide.Described device (for example, Multidimensional and Hybrid device or three-dimensional hybrid device) can seal in mixed process, and this can prevent dust or pollution.Described device (for example, Multidimensional and Hybrid device or three-dimensional hybrid device) can mix by such effect, wherein mixer stirs or moves (for example, rotation) with three-dimensional motion, rather than by using blade or oar (as in agitator routine, planetary) at internal tank.Three-dimensional motion can reduce the granule relevant with conventional stirring technique and damage (with uneven product size)---for example, causes by the frictional force between blade or oar and mixer sidewall.
Before adding magnesium oxide,, citric acid for example can be gone up sample in described device (such as Multidimensional and Hybrid device or three-dimensional hybrid device) with single batch in order to form uniformly or the basically mixture uniformly of chemical compound with remarkable different densities.Magnesium oxide can mix between each batch of adding with for example 2-6 batch as 4 batches of addings.With small batch MgO is joined in the full dose citric acid, and the mixing between the adding of each batch MgO, can strengthen the agglomeration process between citric acid and the magnesium oxide, and/or the uniformity of product mixtures, and/or reduce the MgO loss.
Described method can comprise a step or multistep separation (for example processing, for example screening) step, for example, with the citric acid that obtains suitable size and/or size distribution before magnesium oxide mixes---for example, granular size (diameter) scope for example between about 100 μ m and about 900 μ m, for example, between about 150 μ m and 875 μ m, for example, between about 250 μ m and about 850 μ m.Described method randomly comprises a step or more multistep separation (for example, screening) step, for example to obtain the product compositions/particulate of suitable size (diameter) and/or size distribution.
Described (product) compositions/particulate can have such granular size (diameter) and/or granular size (diameter) distributes, promptly, its granular size or particle size distribution with premix is consistent, perhaps with sodium picosulfate be administered on (for example, being sprayed to) potassium bicarbonate and the product unanimity of exsiccant step.
According to another aspect of the present invention, (for example the invention provides citric acid and magnesian particulate, particulate for agglomerated particle), it has the particle size distribution between about 100 μ m and the about 900 μ m, for example, between about 150 μ m and 875 μ m, for example, between about 250 μ m and about 850 μ m.Described particulate can have such granular size (diameter) and distribute, promptly, wherein greater than 85%, for example greater than 90%, for example have granular size (diameter) between about 100 μ m and the about 900 μ m greater than 92% granule, for example, between about 150 μ m and 875 μ m, for example, between about 250 μ m and about 850 μ m.Described particulate can have such granular size (diameter) and distribute, and, wherein is lower than 5% that is, for example is lower than 2%, for example is lower than 1% granule and has granular size (diameter) greater than about 850 μ m; And/or wherein be lower than 5%, and for example be lower than 2%, for example be lower than 1% granule and have granular size (diameter) less than about 250 μ m.Described particulate can have such granular size (diameter) and distribute, and, wherein is lower than 5% that is, for example is lower than 2%, for example is lower than 1% granule and has granular size (diameter) greater than about 875 μ m; And/or wherein be lower than 5%, and for example be lower than 2%, for example be lower than 1% granule and have granular size (diameter) less than about 150 μ m.Described particulate can have such granular size (diameter) and distribute, and, wherein is lower than 5% that is, for example is lower than 2%, for example is lower than 1% granule and has granular size (diameter) greater than about 900 μ m; And/or wherein be lower than 5%, and for example be lower than 2%, for example be lower than 1% granule and have granular size (diameter) less than about 100 μ m.Described particulate can have such granular size (diameter) scope, for example, and between about 100 μ m and about 900 μ m, for example, between about 150 μ m and 875 μ m, for example, between about 250 μ m and about 850 μ m.Described particulate can have such size or size distribution, that is, its with sodium picosulfate solution is administered on (for example, being sprayed to) potassium bicarbonate; And (for example the product mixed phase of step b) is consistent for the step of dry sodium picosulfate and potassium bicarbonate.Described particulate can comprise the magnesium oxide layer that is coated on the citric acid.
On the other hand, the invention provides the method for pharmaceutical compositions, described pharmaceutical composition comprises uniformly or the basically mixture uniformly of citric acid, magnesium oxide, potassium bicarbonate and sodium picosulfate and optional saccharin sodium and/or orange flavor, (and/or preparation comprises the method for compositions of potassium bicarbonate and sodium picosulfate), described method comprises the steps; Sodium picosulfate solution is administered on (for example, being sprayed to) potassium bicarbonate; And dry sodium picosulfate and potassium bicarbonate.
Described potassium bicarbonate can have granular size (diameter) scope between for example about 100 μ m and the about 900 μ m, for example, and between about 150 μ m and 875 μ m, for example, between about 250 μ m and about 850 μ m.Described method (for example can comprise a step or multistep separation, screening) step, to obtain the potassium bicarbonate of suitable size and/or size distribution---granular size (diameter) scope for example, for example, between about 100 μ m and about 900 μ m, for example, between about 150 μ m and 875 μ m, for example, between about 250 μ m and about 850 μ m.
Sodium picosulfate can be in aqueous solution.Sodium picosulfate in the solution: the part by weight of water can be between 1: 1 and 1: 3, for example, and between 1: 1.3 and 1: 2.5, for example between about 1: 1.5 and 1: 2.Sodium picosulfate solution---for example aqueous solution---can be used (for example, spraying), preferably 10-12ml/min with the speed of 1-20ml/min.
In an example, sodium picosulfate is in aqueous solution.Described solution---for example, aqueous solution---can be applied to (for example, being sprayed to) for example potassium bicarbonate particulate or particulate surface.Described solution---for example, aqueous solution---can be used as for example little drop and use (for example, spraying).
Potassium bicarbonate can heat (for example, before sodium picosulfate solution being administered on (for example, being sprayed to) potassium bicarbonate) in advance, for example is heated to the temperature between 30 °-100 ℃, and for example 30 ℃-70 ℃, for example, 30 ℃-50 ℃.Sodium picosulfate and potassium bicarbonate can carry out drying in for example temperature between 30 °-100 ℃, and for example 30 ℃-70 ℃, for example 30 ℃-50 ℃, for example 45 ℃.Drying can be by using [for example, using for example air blast] warm or hot-air (for example, the temperature between 30 °-100 ℃, for example 30 ℃-70 ℃, for example 30 ℃-50 ℃).Drying can be carried out in using (for example spraying) process, and/or carries out immediately immediately or basically after using (for example spraying).Can exist one or many (for example, 2,3,4 times or more times) to use (for example, spraying) sodium picosulfate solution, sodium picosulfate and potassium bicarbonate are in each (spraying) application or carry out drying afterwards immediately or afterwards basically immediately.
For example, described using (for example spraying) and drying can be carried out in roll coating machine or other coating machine known to the skilled (for example, fluidized-bed coating machine).
Therefore, the using of sodium picosulfate and potassium bicarbonate (for example, spraying) and dry can in a step using same coating machine, finishing, rather than need two or more separately (stirring, drying) step, and/or two or more machine that separates.
Described process can be control automatically.Therefore, can avoid manual operations, allow the minimizing of whole preparation time again.
Described method (for example can comprise one or more separation, screening) step, to obtain the product of suitable size and/or size distribution---for example, granular size (diameter) scope is between for example about 100 μ m and about 900 μ m, for example, between about 150 μ m and 875 μ m, for example, between about 250 μ m and about 850 μ m.
Described (product) compositions that comprises potassium bicarbonate and sodium picosulfate can have such granular size (diameter) and/or granular size (diameter) distributes, that is, its granular size or particle size distribution with the product of elementary mixture or dry blending citric acid and magnesium oxide step is consistent.Described (product) compositions that comprises potassium bicarbonate and sodium picosulfate can have such granular size (diameter) and distribute, promptly, wherein greater than 85%, for example greater than 90%, for example have granular size (diameter) between about 100 μ m and the about 900 μ m greater than 92% granule, for example, between about 150 μ m and 875 μ m, for example, between about 250 μ m and about 850 μ m.Described (product) compositions that comprises potassium bicarbonate and sodium picosulfate can have such granular size (diameter) and distribute, and, wherein is lower than 5% that is, for example is lower than 2%, for example is lower than 1% granule and has granular size (diameter) greater than about 850 μ m; And/or wherein be lower than 5%, and for example be lower than 2%, for example be lower than 1% granule and have granular size (diameter) less than about 250 μ m.Described (product) compositions that comprises potassium bicarbonate and sodium picosulfate can have such granular size (diameter) and distribute, and, wherein is lower than 5% that is, for example is lower than 2%, for example is lower than 1% granule and has granular size (diameter) greater than about 875 μ m; And/or wherein be lower than 5%, and for example be lower than 2%, for example be lower than 1% granule and have granular size (diameter) less than about 150 μ m.Described (product) compositions that comprises potassium bicarbonate and sodium picosulfate can have such granular size (diameter) and distribute, and, wherein is lower than 5% that is, for example is lower than 2%, for example is lower than 1% granule and has granular size (diameter) greater than about 900 μ m; And/or wherein be lower than 5%, and for example be lower than 2%, for example be lower than 1% granule and have granular size (diameter) less than about 100 μ m.Described (product) compositions that comprises potassium bicarbonate and sodium picosulfate can have for example about 100 and about 900 μ m between granular size (diameter) scope or distribution, for example, between about 150 μ m and the 875 μ m, for example, between about 250 μ m and the about 850 μ m.
By sodium picosulfate solution being administered on (for example, being sprayed to) potassium bicarbonate and dry and product or compositions that form can be inhomogeneity particulate or the particle form with raising.
According to another aspect of the present invention, the invention provides the premixing particulate of sodium picosulfate and potassium bicarbonate, it has granular size (diameter) scope or distribution between about 100 μ m and the about 900 μ m, for example, between about 150 μ m and the 875 μ m, for example, between about 250 μ m and the about 850 μ m.
According to another aspect of the present invention, the invention provides one or more particulates that comprise one deck sodium picosulfate that is coated on the potassium bicarbonate.Described particulate can have such granular size (diameter) and distribute, promptly, wherein greater than 85%, for example greater than 90%, for example have granular size (diameter) between about 100 μ m and the about 900 μ m greater than 92% granule, for example, between about 150 μ m and 875 μ m, for example, between about 250 μ m and about 850 μ m.Described particulate can have such granular size (diameter) and distribute, and, wherein is lower than 5% that is, for example is lower than 2%, for example is lower than 1% granule and has granular size (diameter) greater than about 850 μ m; And/or wherein be lower than 5%, and for example be lower than 2%, for example be lower than 1% granule and have granular size (diameter) less than about 250 μ m.Described particulate can have such granular size (diameter) and distribute, and, wherein is lower than 5% that is, for example is lower than 2%, for example is lower than 1% granule and has granular size (diameter) greater than about 875 μ m; And/or wherein be lower than 5%, and for example be lower than 2%, for example be lower than 1% granule and have granular size (diameter) less than about 150 μ m.Described particulate can have such granular size (diameter) and distribute, and, wherein is lower than 5% that is, for example is lower than 2%, for example is lower than 1% granule and has granular size (diameter) greater than about 900 μ m; And/or wherein be lower than 5%, and for example be lower than 2%, for example be lower than 1% granule and have granular size (diameter) less than about 100 μ m.Described particulate can have granular size (diameter) scope of for example about 100 μ m and about 900 μ m, for example, and between about 150 μ m and the 875 μ m, for example, between about 250 μ m and the about 850 μ m.
The premixing particulate of producing by the inventive method can have the content of uniform sodium picosulfate (mg dosage), and it helps the uniformity of end product.The present invention can provide a kind of intermediate composition or premix; it comprises potassium bicarbonate and sodium picosulfate; dosage form with particulate; it has the uniform certain content of sodium picosulfate (mg dosage); and granular size (diameter) scope between about 100 μ m and about 900 μ m; for example between about 150 μ m and 875 μ m, for example between about 250 μ m and about 850 μ m, described specific content consistent with the uniformity of end product particulate or pharmaceutical composition (referring to above).
Should be appreciated that just for simplicity, the treatment step of this paper can be called step a), b), c) etc.; There is not requirement clear and definite or that infer in order about step.Therefore, for example, the step a) process can be before step b), finish simultaneously with step b) afterwards or basically.
Detailed Description Of The Invention
Described product P ICOLAX
TMBe six kinds of raw-material physical mixtures; These raw materials are citric acid (anhydrous), light magnesium oxide, potassium bicarbonate (KHCO
3), sodium picosulfate, saccharin sodium and orange flavor.
At preparation PICOLAX
TMThe first step of known method in, as discussed above, at first produce " the elementary mixture " that comprises magnesium oxide and citric acid.Calculate extra magnesium oxide (" excessive "), as the part of feed with the loss of compensation in mixed process.In second step, potassium bicarbonate, sodium picosulfate and water are mixed or stirring, to produce " premix ".Dry then premixed granule.In third step, with the flavoring agent composition, orange flavor and saccharin sodium and premix and elementary mixture mix.
According to the present invention, in some respects, described method also needs several steps.
Elementary mixing
In art methods, obviously because low binding characteristic or agglomeration characteristic between citric acid and the magnesium oxide particle find that aspect granular size and distribution discordance takes place.As if applied prior-art devices, it is tumble mixer or planetary dry blending device typically, promotes the separation of these two kinds of compositions and for example magnesian loss of raw material of fine powder form.Use known method, need add unnecessary magnesium oxide (" excessive ") and recover damage typically to be higher than 10% amount based on conventional basis, this causes economic loss along with the more volume of longer cycle and production.In addition, production time that must be longer, and in whipping process, may produce the MgO dust of insalubrity amount.Art methods may cause the cleaning difficulty, and/or the control of the difference of product particulate/granular size and distribution.
A stage of the present invention or step comprise dry blending citric acid (CA) and magnesium oxide, to produce " elementary mixture ".Different with existing method, obtain agglomeration better mixing thing by for example using Multidimensional and Hybrid device or three-dimensional hybrid device that citric acid and magnesium oxide are mixed.Excessive significantly less.The three-dimensional hybrid device is known, and can obtain from the Laval Lab Inc. of for example U.S..The container that stirs moves (being known as Paul Schatz principle) with three-dimensional motion, and described three-dimensional motion is in conjunction with motion of 8 fonts and rotation, make the material of internal mixer with rhythmical, clocklike move and move.This motion can mix the powder and the granule of Different Weight, size and flow behavior.
Do not exist under the blade, the Multidimensional and Hybrid device uses strong physical force to come compounding substances, rather than uses mechanical agitation blender (as in planetary dry agitator).This can reduce the granule that is caused by the frictional force between mixing arm or oar and the stirred vessel sidewall and damage (with uneven granular size).It also reduces the dust (it is believed that it influences the uniformity of end product) that damages from granule, and/or adheres to the dust on the stirred vessel inwall.In addition, owing to only exist slick inner surface to need cleaning (do not stir agitator and need cleaning), so cleaning is much easier.
The use of Multidimensional and Hybrid device or three-dimensional hybrid device is followed operating parameter, adds the suitable adjustment of frequency such as rotary speed, mixing time and material.
Therefore, new method is removed or has significantly been reduced the problem that runs in the existing method.
Premixing
In second step of existing method, when producing premix, sodium picosulfate and potassium bicarbonate wet mixing are closed.Close in the process in wet mixing, a part of potassium bicarbonate dissolving, and part is stirred the agitator pulverizing; These effects cause dry back to have the fine-powder of excessive potassium bicarbonate in premix.It is believed that the inhomogeneity loss of product is caused by this, reason is that excessive granule or particulate comprise very few sodium picosulfate, and the meticulous granule of dry mixture or particulate comprise too much sodium picosulfate; It is believed that these extremely influence the uniformity of product.Known method also needed the dry significantly long time of wet mixture.Known method also needs some manual steps, has incident danger and the worry that increases operator's safety to contamination of products.
According to one or more aspects of the present invention, described method comprises sodium picosulfate solution is administered on (for example, being sprayed to) potassium bicarbonate; And the step of dry sodium picosulfate and potassium bicarbonate.
This mixed process can be regarded the coating process that is similar to as.Mixing/coating process can use the coating machine that rolls automatically to carry out, and for example, suitably adjusts the operating parameter of control coating level.
Therefore, sodium picosulfate solution (for example, aqueous solution) can be sprayed on the potassium bicarbonate; And described sodium picosulfate and potassium bicarbonate (that is the premix particulate of coating) can be dry in same equipment.This can cause the significantly production time of minimizing; For example, " premix " of sodium picosulfate and potassium bicarbonate can produce [rather than use has about 15-24 hour of method now] in about 3 hours.
In addition, the applicant finds can have significant minimizing on the particulate inhomogeneities of product, as following.Sodium picosulfate solution can be sprayed to KHCO very equably
3The surface of particulate, and use (for example, spraying) dry immediately afterwards, and can reduce the amount of fine-powder.For example, particulate unlikely by for example in the production of types of coatings the pulverizing to granule/particulate reduce.In addition, because the particulate of coating can be dry immediately or dry immediately basically, for example, use the warm air drying, powder in small, broken bits and dust can reduce significantly.
Subsequently, method of the present invention can comprise mixes saccharin sodium, orange flavor, the elementary mixture of part and premix, subsequently in conjunction with the elementary mixture (and mixing) of surplus, so that final bulk products uniformly to be provided.
Therefore, invention of the present disclosure can provide the remarkable improvement of a step, two steps or the multistep of mixed process.It can provide more effective production, improves the quality and repeatability (for example, the uniformity of active substance).It can provide reduces risk of pollution and/or significant loss, and/or manual method still less.It can provide the method that causes the production time significantly to reduce.
Can improve the uniformity of the intermediate product of elementary mixture and premix blend step and the uniformity of end product according to method of the present invention.
With reference now to following case description the present invention.
Embodiment 1-method
Potassium bicarbonate is sieved on the filter screen with 250 μ m and 600 μ m slot sizes.The purified water of weighing, and sodium picosulfate is dissolved in forms sodium picosulfate solution in the water, be used for pre-blend step.By using rolling type coating machine (such coating machine is well known in the art), sodium picosulfate solution and potassium bicarbonate are formed particulate.The potassium bicarbonate particulate is filled in the coating machine, and in coating machine operation, with the surface of true quantitative sodium picosulfate solution spray to described particulate.Pass through the granule of warm air dry coationg then.After the Cotton seeds, obtain exsiccant premixing particulate in conjunction with sodium picosulfate and potassium bicarbonate.
By using three-dimensional dry mixed device, magnesium oxide and citric acid are mixed, form elementary mixture particulate.Citric acid is filled in the blender, and adds light magnesium oxide.By the routine operation method material in the blender is mixed.
The elementary mixture of orange flavor and saccharin sodium and premix and known quantity is mixed together, to form flavouring mixture.Then with the elementary mixture combination of flavouring mixture and surplus and mix.Use methods known in the art, the final mixture powder that makes up is filled in the paper tinsel type pouch, and is packaged in the carton.
Note the amount of product as required, the amount of (for example, in fairly large production process) reactant of the required usefulness of technical ability personnel's easy to understand.
Embodiment 2-preparation
Following preparation passes through method for preparing.Each paper tinsel type pouch comprises following ingredients.
| Reagent | Embodiment 2a | Embodiment 2b (16.1g pouch) | Embodiment 2c |
| Sodium picosulfate | 9mg | 10mg | 11mg |
| Potassium bicarbonate | 0.45g | 0.5g | 0.55g |
| Light magnesium oxide | 3.15g | 3.5g | 3.85g |
| Citric acid | 10.8g | 12g | 13.2 |
| Saccharin sodium | 54mg | 60mg | 66mg |
| Orange flavor * | 54mg | 60mg | 66mg |
*Natural spray-dired orange flavor, it comprises butylated hydroxyanisol
Claims (41)
1. the method for a pharmaceutical compositions, described pharmaceutical composition comprises uniformly or the basically mixture uniformly of citric acid, magnesium oxide, potassium bicarbonate and sodium picosulfate and optional saccharin sodium and/or orange flavor, described method comprises sodium picosulfate solution is administered on (for example, being sprayed to) potassium bicarbonate; And the step of dry sodium picosulfate and potassium bicarbonate.
2. one kind prepares the method for compositions that comprises potassium bicarbonate and sodium picosulfate, and described method comprises sodium picosulfate solution is administered on (for example, being sprayed to) potassium bicarbonate; And the step of dry sodium picosulfate and potassium bicarbonate.
3. according to the method for claim 1 or 2, wherein said potassium bicarbonate has granular size (diameter) scope between about 100 μ m and the about 900 μ m.
4. according to the method for claim 1,2 or 3, wherein said potassium bicarbonate is preheated before sodium picosulfate solution being administered on (for example, being sprayed to) potassium bicarbonate.
5. according to the method for arbitrary aforementioned claim, wherein said sodium picosulfate and the potassium bicarbonate temperature drying between 30 °-100 ℃.
6. according to the method for arbitrary aforementioned claim, wherein said drying is to use in (for example, spraying) process, and/or uses (for example, spraying) immediately or carry out immediately basically afterwards.
7. according to the method for arbitrary aforementioned claim, wherein there be twice of sodium picosulfate solution or repeatedly use, sodium picosulfate and potassium bicarbonate are in each application or carry out drying after using immediately or basically immediately at every turn.
8. according to the method for arbitrary aforementioned claim, wherein by sodium picosulfate solution being administered on (for example, being sprayed to) potassium bicarbonate and dry and product or compositions that form are particulate or particulate form.
9. according to the method for claim 8, wherein said particulate or granule have such granular size (diameter) and distribute, and, wherein have granular size (diameter) between about 100 μ m and the about 900 μ m greater than 85% granule that is.
10. according to the method for claim 8 or 9, wherein said particulate or granule have such granular size (diameter) and distribute, that is, wherein be lower than 5% granule and have granular size (diameter) greater than about 900 μ m; And/or wherein be lower than 5% granule and have granular size (diameter) less than about 100 μ m.
11. according to the method for arbitrary aforementioned claim, wherein said sodium picosulfate is in aqueous solution.
12. a compositions that comprises potassium bicarbonate and sodium picosulfate, it is by making according to each method in the claim 2 to 11.
13. a compositions that comprises the particulate of sodium picosulfate and potassium bicarbonate, it has granular size (diameter) scope or distribution between about 100 μ m and about 900 μ m.
14. one or more particulates, it comprises one deck sodium picosulfate that is coated on the potassium bicarbonate.
15. according to the particulate of claim 14, it has such granular size (diameter) and distributes, and, wherein has granular size (diameter) between about 100 μ m and the about 900 μ m greater than 85% granule that is.
16. according to the particulate of claim 14 or 15, it has such granular size (diameter) and distributes, that is, wherein be lower than 5% granule and have granular size (diameter) greater than about 900 μ m; And/or wherein be lower than 5% granule and have granular size (diameter) less than about 100 μ m.
17. the method for a pharmaceutical compositions, described pharmaceutical composition comprises uniformly or the basically mixture uniformly of citric acid, magnesium oxide, potassium bicarbonate and sodium picosulfate and optional saccharin sodium and/or orange flavor, described method comprises uses a kind of device dry blending citric acid and magnesian step, and described device is used for the uniform mixture of the compound formation with remarkable different densities.
18. one kind prepares and comprises citric acid and magnesian method for compositions, it comprises a kind of device dry blending citric acid of use and magnesian step, and described device is used for the uniform mixture of the compound formation with remarkable different densities.
19. according to the method for claim 17 or claim 18, the wherein said device that is used for having the uniform mixture of compound formation of remarkable different densities is Multidimensional and Hybrid device or three-dimensional hybrid device.
20. according to the method for claim 17,18 or 19, wherein said device strengthens the agglomeration process between citric acid and the magnesium oxide.
21. according to each method in the claim 17 to 20, wherein said citric acid before adding magnesium oxide with single batch on sample to the described compound formation that is used for having the remarkable different densities device of mixture uniformly uniformly or basically.
22. according to the method for claim 21, wherein said magnesium oxide joins in single batch the citric acid in batches, mixes adding between each batch magnesium oxide.
23. according to the method for claim 17-22, wherein said citric acid has granular size (diameter) scope between about 100 μ m and the about 900 μ m.
24. a compositions that comprises particulate, described particulate are citric acid and magnesian agglomerated particle.
25. according to the compositions of claim 24, wherein said particulate has granular size (diameter) scope between about 100 μ m and the about 900 μ m.
26. according to claim 24 or 25 each compositionss, wherein said particulate has such granular size (diameter) and distributes, and, wherein has granular size (diameter) between about 100 μ m and the about 900 μ m greater than 85% granule that is.
27. according to each compositions in the claim 24 to 26, wherein said particulate has such granular size (diameter) and distributes, that is, wherein be lower than 5% granule and have granular size (diameter) greater than about 900 μ m; And/or wherein be lower than 5% granule and have granular size (diameter) less than about 100 μ m.
28. one kind comprises citric acid and magnesian compositions, it is by making according to each method in the claim 18 to 23.
29. the method for a pharmaceutical compositions, described pharmaceutical composition comprise citric acid, magnesium oxide, potassium bicarbonate and sodium picosulfate and the uniformly or basically mixture uniformly of saccharin sodium and/or orange flavor randomly, described method comprises:
A) dry blending citric acid and magnesium oxide;
B) sodium picosulfate solution is administered on (for example, being sprayed to) potassium bicarbonate; And dry described sodium picosulfate and potassium bicarbonate; With
C) product of near small part step a) and part steps b at least) product mix, and randomly, mix with saccharin sodium and/or orange flavor.
30. according to the method for claim 29, wherein step (a) comprises according to each method among the claim 18-23.
31. according to the method for claim 29 or claim 30, wherein step (b) comprises according to each method in the claim 3 to 11.
32. the method according to each pharmaceutical compositions in the claim 29 to 31, described method also comprises step d): with the product of step c) and the mixture of measuring in addition that passes through dry blending citric acid and magnesium oxide formation; And/or with mix mutually by the product that sodium picosulfate solution is administered on (for example, being sprayed to) potassium bicarbonate and dry described sodium picosulfate is made with potassium bicarbonate.
33. according to the method for claim 32, the citric acid of wherein said other amount and magnesian mixture comprise step (a) product some or all and/or by making according to each method in the claim 18 to 23.
34. method according to claim 32 or 33, wherein said by sodium picosulfate solution is administered on (for example, being sprayed to) potassium bicarbonate and the dry and product other amount made comprise step (b) product some or all and/or by making according to each method in the claim 3 to 11.
35. a pharmaceutical composition, it comprises uniformly or the basically mixture uniformly of citric acid, magnesium oxide, potassium bicarbonate and sodium picosulfate and optional saccharin sodium and/or orange flavor.
36. according to the pharmaceutical composition of claim 35, wherein said particulate has granular size (diameter) scope between about 100 μ m and the about 900 μ m.
37. according to the pharmaceutical composition of claim 35 or claim 36, wherein said particulate has the uniformity of the sodium picosulfate content of meansigma methods between about 0.0559 weight % and 0.068 weight %.
38. a pharmaceutical composition, its by or can be by obtaining according to each method in the claim 29 to 34.
39. according to claim 35, each pharmaceutical composition in 36,37 or 38, it is as cathartic.
40. according to the compositions of claim 24, wherein said particulate comprises the magnesium oxide that is coated on the citric acid.
41. a method, its basically as preamble with reference to as described in one or more embodiment.
Priority Applications (23)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| HUE08837670A HUE038174T2 (en) | 2007-10-12 | 2008-10-10 | Process for the manufacure of a pharmaceutical product comprising citric acid, magnesium oxide, potassium bicarbonate and sodium picosulfate, pharmaceutical composition comprising granules obtained by such process and intermediate products thereof |
| PCT/IB2008/003199 WO2009047633A2 (en) | 2007-10-12 | 2008-10-10 | Process for the manufacure of a pharmaceutical product comprising citric acid, magnesium oxide, potassium bicarbonate and sodium picosulfate, pharmaceutical composition comprising granules obtained by such process and intermediate |
| LTEP08837670.2T LT2207526T (en) | 2007-10-12 | 2008-10-10 | Process for the manufacure of a pharmaceutical product comprising citric acid, magnesium oxide, potassium bicarbonate and sodium picosulfate, pharmaceutical composition comprising granules obtained bysuch process and intermediate products thereof |
| CA2702152A CA2702152A1 (en) | 2007-10-12 | 2008-10-10 | Process for the manufacture of a pharmaceutical product |
| ES08837670.2T ES2659716T3 (en) | 2007-10-12 | 2008-10-10 | Process for the manufacture of a pharmaceutical product comprising citric acid, magnesium oxide, potassium bicarbonate and sodium picosulfate, pharmaceutical composition comprising granules obtained by such process and intermediate products thereof |
| AU2008309287A AU2008309287B2 (en) | 2007-10-12 | 2008-10-10 | Process for the manufacure of a pharmaceutical product comprising citric acid, magnesium oxide, potassium bicarbonate and sodium picosulfate, pharmaceutical composition comprising granules obtained by such process and intermediate |
| SI200831915T SI2207526T1 (en) | 2007-10-12 | 2008-10-10 | Process for the manufacure of a pharmaceutical product comprising citric acid, magnesium oxide, potassium bicarbonate and sodium picosulfate, pharmaceutical composition comprising granules obtained by such process and intermediate products thereof |
| KR1020107007932A KR101330096B1 (en) | 2007-10-12 | 2008-10-10 | Process for the manufacture of a pharmaceutical product comprising citric acid, magnesium oxide, potassium bicarbonate and sodium picosulfate, pharmaceutical composition comprising granules obtained by such process and intermediate |
| PT88376702T PT2207526T (en) | 2007-10-12 | 2008-10-10 | Process for the manufacure of a pharmaceutical product comprising citric acid, magnesium oxide, potassium bicarbonate and sodium picosulfate, pharmaceutical composition comprising granules obtained by such process and intermediate products thereof |
| KR1020137023315A KR101381263B1 (en) | 2007-10-12 | 2008-10-10 | Process for the manufacture of a pharmaceutical product comprising citric acid, magnesium oxide, potassium bicarbonate and sodium picosulfate, pharmaceutical composition comprising granules obtained by such process and intermediate |
| EP08837670.2A EP2207526B1 (en) | 2007-10-12 | 2008-10-10 | Process for the manufacure of a pharmaceutical product comprising citric acid, magnesium oxide, potassium bicarbonate and sodium picosulfate, pharmaceutical composition comprising granules obtained by such process and intermediate products thereof |
| BRPI0818541A BRPI0818541B8 (en) | 2007-10-12 | 2008-10-10 | pharmaceutical composition comprising granules including sodium picosulfate and potassium bicarbonate and its process for preparation |
| PL08837670T PL2207526T3 (en) | 2007-10-12 | 2008-10-10 | Process for the manufacure of a pharmaceutical product comprising citric acid, magnesium oxide, potassium bicarbonate and sodium picosulfate, pharmaceutical composition comprising granules obtained by such process and intermediate products thereof |
| JP2010528503A JP5654873B2 (en) | 2007-10-12 | 2008-10-10 | Method of manufacturing a medicine |
| RU2010112483/15A RU2473332C2 (en) | 2007-10-12 | 2008-10-10 | Method of manufacturing pharmaceutical product, containing citric acid, magnesium oxide, potassium bicarbonate and sodium picosulfate, pharmaceutical compositions, containing thus obtained granules and intermediate compound |
| US12/677,857 US8481083B2 (en) | 2007-10-12 | 2008-10-10 | Granular compositions of magnesium oxide and citric acid and uses thereof |
| NZ583899A NZ583899A (en) | 2007-10-12 | 2008-10-10 | Process for the manufacure of a pharmaceutical product comprising citric acid, magnesium oxide, potassium bicarbonate and sodium picosulfate, pharmaceutical composition comprising granules obtained by such process and intermediate |
| DK08837670.2T DK2207526T3 (en) | 2007-10-12 | 2008-10-10 | PROCEDURE FOR THE PREPARATION OF A PHARMACEUTICAL PRODUCT CONTAINING CITRIC ACID, MAGNESIUM OXIDE, POTASSIUM BICARBONATE AND SODIUM PICOSULPHATE, PHARMACEUTICAL COMPOSITION EXCEPTING VARIOUS VARIETIES EXCEEDING THE VARIOUS VARIETIES AVAILABLE FROM THE VARIOUS VARIETIES AVAILABLE FROM THE VARIOUS VARIETIES AVAILABLE. |
| MX2010003588A MX2010003588A (en) | 2007-10-12 | 2008-10-10 | Process for the manufacture of a pharmaceutical product. |
| IL204500A IL204500A (en) | 2007-10-12 | 2010-03-15 | Process for the manufacture of a composition or pharmaceutical composition comprising spray coating a layer of sodium picosulphate on a core of potassium bicarbonate |
| ZA2010/02131A ZA201002131B (en) | 2007-10-12 | 2010-03-25 | Process for the manufacture of a pharmaceutical product comprising citric acid,magnesium oxide,potassium bicarbonate and sodium picosulfate,pharmaceutical composition comprising granules obtained by such process and intermediate |
| US13/246,739 US8450338B2 (en) | 2007-10-12 | 2011-09-27 | Granular compositions of sodium picosulphate and potassium bicarbonate and uses thereof |
| HRP20180215TT HRP20180215T1 (en) | 2007-10-12 | 2018-02-05 | Process for the manufacure of a pharmaceutical product comprising citric acid, magnesium oxide, potassium bicarbonate and sodium picosulfate, pharmaceutical composition comprising granules obtained by such process and intermediate products thereof |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP07254049 | 2007-10-12 | ||
| EP07254049.5 | 2007-10-12 | ||
| US60/980,549 | 2007-10-17 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101406457A true CN101406457A (en) | 2009-04-15 |
Family
ID=39672123
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA2007101860236A Pending CN101406457A (en) | 2007-10-12 | 2007-11-09 | Process for the manufacture of a pharmaceutical product |
Country Status (2)
| Country | Link |
|---|---|
| CN (1) | CN101406457A (en) |
| SA (1) | SA08290670B1 (en) |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104797244A (en) * | 2012-07-27 | 2015-07-22 | 红山生物医药有限公司 | Formulations and methods of manufacturing formulations for use in colonic evacuation |
| CN105228634A (en) * | 2013-05-17 | 2016-01-06 | 协和化学工业株式会社 | For inorganic agent and the processing method of large intestine inspection or operation |
| CN105456264A (en) * | 2015-12-03 | 2016-04-06 | 广州瑞尔医药科技有限公司 | Double-effect laxative drug composition and preparing method thereof |
| CN110638786A (en) * | 2019-10-09 | 2020-01-03 | 杭州百诚医药科技股份有限公司 | Pharmaceutical composition of sodium picosulfate, citric acid and magnesium oxide and preparation method thereof |
| CN115040512A (en) * | 2022-07-28 | 2022-09-13 | 苏州中化药品工业有限公司 | Pharmaceutical composition and preparation method thereof |
| CN115337271A (en) * | 2022-09-30 | 2022-11-15 | 山东创新药物研发有限公司 | Sodium picosulfate granular preparation and preparation process thereof |
-
2007
- 2007-11-09 CN CNA2007101860236A patent/CN101406457A/en active Pending
-
2008
- 2008-10-22 SA SA08290670A patent/SA08290670B1/en unknown
Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104797244A (en) * | 2012-07-27 | 2015-07-22 | 红山生物医药有限公司 | Formulations and methods of manufacturing formulations for use in colonic evacuation |
| CN104797244B (en) * | 2012-07-27 | 2018-03-09 | 红山生物医药有限公司 | Preparation and preparation of preparation method for colon emptying |
| CN108175773A (en) * | 2012-07-27 | 2018-06-19 | 红山生物医药有限公司 | For colon emptying preparation and prepare formulation method |
| US10493065B2 (en) | 2012-07-27 | 2019-12-03 | Redhill Biopharma Ltd. | Formulations and methods of manufacturing formulations for use in colonic evacuation |
| CN105228634A (en) * | 2013-05-17 | 2016-01-06 | 协和化学工业株式会社 | For inorganic agent and the processing method of large intestine inspection or operation |
| CN105456264A (en) * | 2015-12-03 | 2016-04-06 | 广州瑞尔医药科技有限公司 | Double-effect laxative drug composition and preparing method thereof |
| CN105456264B (en) * | 2015-12-03 | 2018-07-10 | 广州瑞尔医药科技有限公司 | Pharmaceutical composition of economic benefits and social benefits laxative and preparation method thereof |
| CN110638786A (en) * | 2019-10-09 | 2020-01-03 | 杭州百诚医药科技股份有限公司 | Pharmaceutical composition of sodium picosulfate, citric acid and magnesium oxide and preparation method thereof |
| CN115040512A (en) * | 2022-07-28 | 2022-09-13 | 苏州中化药品工业有限公司 | Pharmaceutical composition and preparation method thereof |
| CN115337271A (en) * | 2022-09-30 | 2022-11-15 | 山东创新药物研发有限公司 | Sodium picosulfate granular preparation and preparation process thereof |
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|---|---|
| SA08290670B1 (en) | 2014-03-02 |
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