CN106265585A - A kind of Zaltoprofen stomach dissolution type pellet tablet and preparation method thereof - Google Patents
A kind of Zaltoprofen stomach dissolution type pellet tablet and preparation method thereof Download PDFInfo
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- CN106265585A CN106265585A CN201610827731.2A CN201610827731A CN106265585A CN 106265585 A CN106265585 A CN 106265585A CN 201610827731 A CN201610827731 A CN 201610827731A CN 106265585 A CN106265585 A CN 106265585A
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- zaltoprofen
- dissolution type
- micropill
- stomach dissolution
- tablet
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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
- A61K31/38—Heterocyclic compounds having sulfur as a ring hetero atom
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
- A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a kind of Zaltoprofen pellet tablet and preparation method thereof, first principal agent Zaltoprofen is prepared as stomach dissolution type coated micropill with fluidized bed coating technique by this medicine, prepares stomach dissolution type tablet with compressing dry granulation technology after then being mixed with filler, disintegrating agent, binding agent, plasticizer, lubricant etc. by coated micropill.This tablet can directly be swallowed, it is also possible in water, rapid disintegrate becomes micropill, conveniently swallows inconvenient patient particularly children taking.It is that one both can guarantee that dosage was accurate, the dosage form of safety, taking convenience again.
Description
Technical field
The invention belongs to pharmaceutical field, relate to a kind of pellet tablet, be specifically related to a kind of Zaltoprofen stomach dissolution type pellet tablet
And preparation method thereof.
Background technology
By the exploitation of Chemiphar company of Japan, in 1993 in the Japan potent non-steroidal anti-inflammatory of one of Initial Public Offering, town
Bitterly, antipyretic this product selectively acting in inflammation part, and to other organ such as harmonization of the stomach kidney without effect, with similar drugs such as Nabumetone
Raw, ibuprofen is compared, and has efficient, stomach
The features such as side effect is little, thus quite by favorable comment on Japan Clinic.
This product analgesic activity and relatively strong to acute inflammation effect, and more weak to chronic inflammatory disease effect.Mechanism of action is system
The activity of epoxidase, makes prostaglandin synthesis reduce, block inflammatory mediator and work.Oral gastrointestinal absorption is good, in blood plasma
Drug level linearly increases, and peak time is 1～1.5h.Repetitively administered has no medicine savings property.The last reign of a dynasty medicine original shape medicine
Thing is about the 1%～3% of dosage, is about 82% including the total excretion rate of metabolite.Digestive tract ulcer, hematopathy, serious hepatic and renal function
Obstacle, severe cardiac functional defect, this product and aspirin-sensitive person are disabled.Having digestive tract to burst history, hematopathy, hepatic and renal function is not
Quan Zhe, has allergies bronchial asthma person to be cautious use of.To chronic disease, long term administration should periodically carry out hematuria routine and liver function inspection
Look into.Acute patient should
By this product, if desired with antimicrobial drug using.
This product oral absorption is good, and peak time is 1-1.5 hour.Repetitively administered has no drug accumulation.Medicine prototype
Accounting for the 1-3% of dosage, the total excretion rate including metabolite is about 82%.
Animal experiment shows, this medicine cause harmonization of the stomach mucous membrane of small intestine produce untoward reaction probability the least, about pula
Ibuprofen and 1/10th of indomethacin.General pharmacology test confirms, this product and metabolite thereof to central nervous system, breathing and
Blood circulation and smooth muscle etc. will not produce obvious harmful effect.
And use after listing before Japan lists in the 8190 example patients of this product, have 450 example patients to create untoward reaction,
Incidence rate is 5.49%, mainly shows as the gastrointestinal symptoms (3.48%) such as stomach upset, stomachache, belch, dysentery, dermexanthesis, erythra
Deng allergic symptom (0.45%).The great untoward reaction that this medicine is likely to occur has acute renal insufficiency, hepatic insufficiency, digestion
Property ulcer etc., but the incidence rate of these untoward reaction is not clear or the lowest (＜ 0.1%).
In sum, this product is a kind of safe and effective NSAID (non-steroidal anti-inflammatory drug), this medication effect height, alternative suppression inflammation
The generation of disease position prostaglandin.Gastrointestinal side effect can be significantly reduced compared with tradition anti-inflammatory agent.Its curative effect and safety
Property is better than the domestic preferable diclofenac of current sale, ibuprofen etc., and therefore developing this medical instrument has good market prospect.
Summary of the invention
The invention provides a kind of steady quality, evident in efficacy, the Zaltoprofen stomach used particular for child patient
Molten type pellet tablet.
The pellet tablet of the present invention can rapid disintegrate be micropill in water, facilitates the child patient of dysphagia to take, and improves
Safety, it is ensured that medication dose is accurate.
The pellet tablet of the present invention, is first prepared as stomach dissolution type coating with fluidized bed coating technique by principal agent Zaltoprofen micro-
Ball, with compressing dry granulation technology system after then mixing coated micropill with filler, disintegrating agent, binding agent, plasticizer, lubricant etc.
Standby one-tenth stomach dissolution type pellet tablet.
Zaltoprofen stomach dissolution type pellet tablet of the present invention, composed of the following components:
| Zaltoprofen | 2-80 part |
| Filler | 100-300 part |
| Disintegrating agent | 15-50 part |
| Binding agent | 15-50 part |
| Lubricant | 1-10 part |
| Macromolecule coating material | 2-6 part |
| Plasticizer | 1-4 part |
| Antitackiness agent | 1-4 part |
| Pigment | 2-5 part |
Wherein, Zaltoprofen micropill, composed of the following components:
| Zaltoprofen | 20-80 part |
| Fine pellet core | 100-200 part |
| Binding agent | 15-30 part |
| Antitackiness agent | 1-3 part |
| Stomach dissolution type coating powder | 10-20 part |
Wherein, the one or several during described fine pellet core is starch ball, sugar pill, microcrystalline Cellulose ball, lactose, dicalcium phosphate
Kind；
Wherein, described filler is starch, sucrose, dextrin, lactose, pregelatinized Starch, microcrystalline Cellulose, mannitol, inorganic calcium
One or more in salt, xylitol, sorbitol, glucose, erithritol；
Wherein, described disintegrating agent is dried starch, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, crosslinked polyethylene pyrrolidine
One or more in ketone, cross-linking sodium carboxymethyl cellulose；
Wherein, described binding agent be water, ethanol, starch slurry, sodium carboxymethyl cellulose, hypromellose, methylcellulose and
One or more in ethyl cellulose, cross-linking sodium carboxymethyl cellulose；
Wherein, one or more during described lubricant is magnesium stearate, Pulvis Talci, polyethylene glycols, differential silica gel；
Wherein, described plain edition macromolecule coating material is hypromellose, hydroxypropylcellulose, methylcellulose, ethoxy
One or more in cellulose；
Wherein, the one or several during described plasticizer is glycerol, Polyethylene Glycol, propylene glycol, Semen Maydis oil, Oleum Ricini, liquid Paraffin
Kind；
Wherein, one or more during described antitackiness agent is Pulvis Talci, magnesium stearate, differential silica gel；
Wherein, one or more during described pigment is yellow ferric oxide, red ferric oxide.
In composition described above, part is weight portion, if in grams, composition described above can be made into 1000 compositions lists of compositions
Position, described compositions unit refers to, the final product composition having made, and is 1000 as made tablet, is 1000 as made capsule,
Make granule 1000.
Preferably, Zaltoprofen stomach dissolution type pellet tablet of the present invention, (percentage by weight) composed of the following components:
| Zaltoprofen | 2-80 part |
| Microcrystalline Cellulose | 100-300 part |
| Low-substituted hydroxypropyl cellulose | 15-50 part |
| Magnesium stearate | 1-5 part |
| Hypromellose | 2-10 part |
| Ferrum oxide | 2-6 part |
| Pulvis Talci | 1-4 part |
| Polyethylene glycol 6000 | 1-4 part |
Wherein, Zaltoprofen micropill, (percentage by weight) composed of the following components:
| Zaltoprofen | 20-80 part |
| Fine pellet core | 100-200 part |
| Hypromellose | 6-20 part |
| Pulvis Talci | 1-3 part |
| Stomach dissolution type coating powder | 10-20 part |
Further object is that the preparation method that Zaltoprofen stomach dissolution type pellet tablet is provided, comprise the following steps:
1) being added to the water by binding agent, heating makes it be completely dissolved, and cooling adds Zaltoprofen, after it is completely dissolved, and will
Antitackiness agent is dispersed in this solution；
2) fine pellet core is placed in fluid bed, then by step 1) in solution fluidized bed plant be uniformly sprayed at fine pellet core table
Face, makes Zaltoprofen micropill；
3) stomach dissolution type film coating powder is dissolved in ethanol so that it is dispersed；
4) Zaltoprofen micropill is placed in fluid bed, then stomach dissolution type film coating solution fluidized bed plant is wrapped
Clothing；
5) uniform to Zaltoprofen coated micropill, filler, disintegrating agent, mix lubricant；
6) being pressed into the sheet of 0.1～0.5g weight, slice, thin piece shape can be polygon, capsule shape, circle, annular and all rational shapes
Shape；
7) plain edition macromolecule coating material, plasticizer, antitackiness agent, pigment are added in ethanol so that it is dispersed；
8) sheet weighed up is put in coating pan, by step 7) in solution be uniformly sprayed on Zaltoprofen pellet tablet,.
The Zaltoprofen relatively conventional tablet of stomach dissolution type pellet tablet of the present invention has the following characteristics that
This stomach dissolution type pellet tablet is possible not only to directly swallow, and for the patient of dysphagia, can be dissolved in water first
Row disintegrate is that micropill takes down again, is difficult to adhere on chamber wall, it is ensured that dosage is accurate, improves patient and takes medicine and comply with
Property.
Zaltoprofen stomach dissolution type pellet tablet of the present invention, also has the advantages that
(1) dosage is mainly for children, taking convenience, it is simple to carry；
(2) Zaltoprofen has bitterness, and coating can cover bitterness, and drug compliance is good；
(3) tablet disintegrate can become micropill, convenient for children to swallow rapidly in water, is discharged by principal agent rapidly in gastric juice, biological profit
Expenditure is high；
(4) principal agent micropill improves medicine stability after stomach dissolution type film coating liquid coating, it is simple to storage.
Detailed description of the invention
By specific examples below, the present invention is further illustrated, but not as the restriction of the present invention.
Prepared by embodiment 1 Zaltoprofen stomach dissolution type pellet tablet
1.1 prescription
A, Zaltoprofen stomach dissolution type micropill
| Zaltoprofen | 80g |
| Starch capsule core | 250g |
| Hypromellose | 10g |
| Pulvis Talci | 3g |
| Stomach dissolution type coating powder | 10g |
| Purified water | 200g |
| Ethanol | 100g |
B, Zaltoprofen stomach dissolution type pellet tablet
1.2 methods preparing above-mentioned prescription Zaltoprofen stomach dissolution type pellet tablet, follow the steps below:
1) being added to the water by hypromellose, heating makes it be completely dissolved, and cooling adds Zaltoprofen, treats that it is the most molten
Xie Hou, is dispersed in Pulvis Talci in this solution；
2) starch capsule core is placed in fluid bed, then " 1) " will uniformly be sprayed at starch capsule core table by solution fluidized bed plant
Face, makes Zaltoprofen micropill；
3) stomach dissolution type film coating powder is dissolved in ethanol so that it is dispersed；
4) Zaltoprofen micropill is placed in fluid bed, then stomach dissolution type film coating solution fluidized bed plant is wrapped
Clothing；
5) Zaltoprofen coated micropill, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate mix homogeneously；
6) sheet of 0.1～0.8g weight it is pressed into.Slice, thin piece shape can be polygon, capsule shape, circle, annular and all rational shapes
Shape；
7) hypromellose, polyethylene glycol 6000, Pulvis Talci, yellow ferric oxide are added in ethanol so that it is be uniformly dispersed；
8) sheet weighed up is put in coating pan, will " 7) " in solution be uniformly sprayed on Zaltoprofen pellet tablet so that it is table
Face is smooth, color even.
Prepared by embodiment 2 Zaltoprofen stomach dissolution type pellet tablet
2.1 prescription
A, Zaltoprofen stomach dissolution type micropill
| Zaltoprofen | 40g |
| Starch capsule core | 200g |
| Hypromellose | 10g |
| Pulvis Talci | 3g |
| Stomach dissolution type coating powder | 7g |
| Purified water | 150g |
| Ethanol | 80g |
B, Zaltoprofen stomach dissolution type pellet tablet
2.2 methods preparing above-mentioned prescription Zaltoprofen stomach dissolution type pellet tablet, follow the steps below:
1) being added to the water by hypromellose, heating makes it be completely dissolved, and cooling adds Zaltoprofen, treats that it is the most molten
Xie Hou, is dispersed in Pulvis Talci in this solution；
2) starch capsule core is placed in fluid bed, then " 1) " will uniformly be sprayed at starch capsule core table by solution fluidized bed plant
Face, makes Zaltoprofen micropill；
3) stomach dissolution type film coating powder is dissolved in ethanol so that it is dispersed；
4) Zaltoprofen micropill is placed in fluid bed, then stomach dissolution type film coating solution fluidized bed plant is wrapped
Clothing；
5) Zaltoprofen coated micropill, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate mix homogeneously；
6) sheet of 0.1～0.8g weight it is pressed into.Slice, thin piece shape can be polygon, capsule shape, circle, annular and all rational shapes
Shape；
7) hypromellose, polyethylene glycol 6000, Pulvis Talci, yellow ferric oxide are added in ethanol so that it is be uniformly dispersed；
8) sheet weighed up is put in coating pan, will " 7) " in solution be uniformly sprayed on Zaltoprofen pellet tablet so that it is table
Face is smooth, color even.
Prepared by embodiment 3 Zaltoprofen stomach dissolution type pellet tablet
3.1 prescription
A, Zaltoprofen stomach dissolution type micropill
| Zaltoprofen | 20g |
| Starch capsule core | 80g |
| Hypromellose | 6g |
| Pulvis Talci | 3g |
| Stomach dissolution type coating powder | 10g |
| Purified water | 160g |
| Ethanol | 100g |
B, Zaltoprofen stomach dissolution type pellet tablet
3.2 methods preparing above-mentioned prescription Zaltoprofen stomach dissolution type pellet tablet, follow the steps below:
1) being added to the water by hypromellose, heating makes it be completely dissolved, and cooling adds Zaltoprofen, treats that it is the most molten
Xie Hou, is dispersed in Pulvis Talci in this solution；
2) starch capsule core is placed in fluid bed, then " 1) " will uniformly be sprayed at starch capsule core table by solution fluidized bed plant
Face, makes Zaltoprofen micropill；
3) stomach dissolution type film coating powder is dissolved in ethanol so that it is dispersed；
4) Zaltoprofen micropill is placed in fluid bed, then stomach dissolution type film coating solution fluidized bed plant is wrapped
Clothing；
5) Zaltoprofen coated micropill, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate mix homogeneously；
6) sheet of 0.1～0.8g weight it is pressed into.Slice, thin piece shape can be polygon, capsule shape, circle, annular and all rational shapes
Shape；
7) hypromellose, polyethylene glycol 6000, Pulvis Talci, yellow ferric oxide are added in ethanol so that it is be uniformly dispersed；
8) sheet weighed up is put in coating pan, will " 7) " in solution be uniformly sprayed on Zaltoprofen pellet tablet so that it is table
Face is smooth, color even.
Claims (3)
1. a Zaltoprofen stomach dissolution type pellet tablet, composed of the following components:
Pellet tablet described in accordance with the above, it is characterised in that Zaltoprofen micropill, composed of the following components:
Pellet tablet in accordance with the above, it is characterised in that
Wherein, the one or several during described fine pellet core is starch ball, sugar pill, microcrystalline Cellulose ball, lactose, dicalcium phosphate
Kind；
Wherein, described filler is starch, sucrose, dextrin, lactose, pregelatinized Starch, microcrystalline Cellulose, mannitol, inorganic calcium
One or more in salt, xylitol, sorbitol, glucose, erithritol；
Wherein, described disintegrating agent is dried starch, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, crosslinked polyethylene pyrrolidine
One or more in ketone, cross-linking sodium carboxymethyl cellulose；
Wherein, described binding agent be water, ethanol, starch slurry, sodium carboxymethyl cellulose, hypromellose, methylcellulose and
One or more in ethyl cellulose, cross-linking sodium carboxymethyl cellulose；
Wherein, one or more during described lubricant is magnesium stearate, Pulvis Talci, polyethylene glycols, differential silica gel；
Wherein, described plain edition macromolecule coating material is hypromellose, hydroxypropylcellulose, methylcellulose, ethoxy
One or more in cellulose；
Wherein, the one or several during described plasticizer is glycerol, Polyethylene Glycol, propylene glycol, Semen Maydis oil, Oleum Ricini, liquid Paraffin
Kind；
Wherein, one or more during described antitackiness agent is Pulvis Talci, magnesium stearate, differential silica gel；
Wherein, one or more during described pigment is yellow ferric oxide, red ferric oxide.
Pellet tablet the most according to claim 1, it is characterised in that composed of the following components:
Pellet tablet according to claim 1, it is characterised in that Zaltoprofen micropill, composed of the following components:
Pellet tablet according to claim 1, it is characterised in that every weight is 0.1～0.8g.
Pellet tablet the most according to claim 1, it is characterised in that composed of the following components:
In, Zaltoprofen micropill consists of the following composition:
The preparation method of the pellet tablet described in claim 1, it is characterised in that comprise the following steps:
1) being added to the water by binding agent, heating makes it be completely dissolved, and cooling adds Zaltoprofen, after it is completely dissolved, and will
Antitackiness agent is dispersed in this solution；
2) fine pellet core is placed in fluid bed, then by step 1) in solution fluidized bed plant be uniformly sprayed at fine pellet core table
Face, makes Zaltoprofen micropill；
3) stomach dissolution type film coating powder is dissolved in ethanol so that it is dispersed；
4) Zaltoprofen micropill is placed in fluid bed, then stomach dissolution type film coating solution fluidized bed plant is wrapped
Clothing；
5) uniform to Zaltoprofen coated micropill, filler, disintegrating agent, mix lubricant；
6) being pressed into the sheet of 0.1～0.5g weight, slice, thin piece shape can be polygon, capsule shape, circle, annular and all rational shapes
Shape；
7) plain edition macromolecule coating material, plasticizer, antitackiness agent, pigment are added in ethanol so that it is dispersed；
8) sheet weighed up is put in coating pan, by step 7) in solution be uniformly sprayed on Zaltoprofen pellet tablet, i.e.
Can.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610827731.2A CN106265585A (en) | 2016-09-18 | 2016-09-18 | A kind of Zaltoprofen stomach dissolution type pellet tablet and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610827731.2A CN106265585A (en) | 2016-09-18 | 2016-09-18 | A kind of Zaltoprofen stomach dissolution type pellet tablet and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN106265585A true CN106265585A (en) | 2017-01-04 |
Family
ID=57711972
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610827731.2A Pending CN106265585A (en) | 2016-09-18 | 2016-09-18 | A kind of Zaltoprofen stomach dissolution type pellet tablet and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107982254A (en) * | 2017-12-06 | 2018-05-04 | 佛山市腾瑞医药科技有限公司 | A kind of Zaltoprofen preparation and its application |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2001089370A (en) * | 1999-09-24 | 2001-04-03 | Nippon Chemiphar Co Ltd | Medicine for hepatic failure |
| CN105663064A (en) * | 2016-03-31 | 2016-06-15 | 河南蓝图制药有限公司 | Imatinib mesylate gastric-soluble pellet tablet and preparation method thereof |
-
2016
- 2016-09-18 CN CN201610827731.2A patent/CN106265585A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2001089370A (en) * | 1999-09-24 | 2001-04-03 | Nippon Chemiphar Co Ltd | Medicine for hepatic failure |
| CN105663064A (en) * | 2016-03-31 | 2016-06-15 | 河南蓝图制药有限公司 | Imatinib mesylate gastric-soluble pellet tablet and preparation method thereof |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107982254A (en) * | 2017-12-06 | 2018-05-04 | 佛山市腾瑞医药科技有限公司 | A kind of Zaltoprofen preparation and its application |
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