CN107744509A - Mosapride Citrate Tablets agent and preparation method thereof - Google Patents
Mosapride Citrate Tablets agent and preparation method thereof Download PDFInfo
- Publication number
- CN107744509A CN107744509A CN201711001305.4A CN201711001305A CN107744509A CN 107744509 A CN107744509 A CN 107744509A CN 201711001305 A CN201711001305 A CN 201711001305A CN 107744509 A CN107744509 A CN 107744509A
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- Prior art keywords
- mosapride citrate
- preparation
- citrate tablets
- lactose
- mosapride
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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
- A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
- A61K31/5375—1,4-Oxazines, e.g. morpholine
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- 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
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
Abstract
The application is related to a kind of Mosapride Citrate Tablets agent and preparation method thereof, belongs to the medical pharmaceutical product technical field containing organic effective component.Using mosapride citrate as raw material, lactose, starch, hydroxypropyl methylcellulose are equipped with auxiliary agent, Mosapride Citrate Tablets agent are obtained using wet granulation and tabletting as auxiliary material.The application is applied to the preparation of medicine for stomach dynamic, has the advantages that dissolution is rapid, stability is good, preparation technology is simple, is easy to industrialized production.
Description
Technical field
The application is related to a kind of Mosapride Citrate Tablets agent and preparation method thereof, belongs to medical containing organic effective component
Pharmaceutical product technical field.
Background technology
Mosapride citrate is the third generation medicine for stomach dynamic of Nihon Pharmaceutical Co., Ltd.'s exploitation, is a kind of selective 5-
HT4 receptor stimulating agents, belong to third generation medicine for stomach dynamic, be mainly used in treating functional dyspepsia FD and GERD.Should
Medicine can be obviously improved the symptom such as turn sour, be heartburn of patients with functional dyspepsia, and can accelerate gastric emptying, promote stomach and 12 refer to
Bowel movement.Simultaneously without the side effect such as the outer system reaction of cone and diarrhoea, and tolerance is good.
The chemical name of mosapride citrate be (±) -4- amino -5- chloro-2-ethoxies-N- [4- (4- luorobenzyls) -
2- morphines base] methyl } toluamide citrate dihydrate, its molecular formula is:C21H25ClFN3O3·C6H8O7·2H2O, point
Son amount is 650.05, and structural formula is:
The formulation of existing mosapride citrate has sustained-release tablet, spansule, oral administration solution.Although these technologies compared with
For maturation, but still suffer from many shortcomings.Mosapride Citrate Tablets were ratified to list in 1999 in China, and Clinical practice specification has
2.5mg and 5mg.After oral solid formulation enters in vivo, it is both needed to be absorbed by organisms through biomembrane by process in leaching.It is existing
Provided in row national standard WSI- (X-287) -2003Z, Mosapride Citrate Tablets are in 30min in 0.1mol/L hydrochloric acid solutions
Dissolution rate is not less than 75%;Import drugs registered standard JX20080288 provided in pH6.8 phosphate buffered saline solution, citron
Sour Mosapride 45min dissolution rates are not less than 80%.But because mosapride citrate is the class medicines of BCS II, it is in water
Solubility it is extremely low, it is low or even do not conform to that dissolution rate is frequently encountered in the actual production of Mosapride citrate oral solid pharmaceutical preparation
The problem of lattice.Solve the problems, such as insoluble drug bioavilability caused by dissolubility is poor, dissolution rate is slow it is low be very
There is realistic meaning.
Publication No. CN101273973B Chinese patent disclose it is a kind of with direct powder compression prepare contain citron
Pharmaceutical composition of sour Mosapride and preparation method thereof.Tablet prepared by the patented technology can fater disintegration, but for indissoluble
For property medicine, after fater disintegration, medicine, which also differs, to be surely dissolved in dissolution medium.
Publication No. CN102335154A Chinese patent discloses a kind of Mosapride citrate sustained-release tablet, the sustained release tablets
With the slow releasing function of 12 hours, the sustained release tablets by mosapride citrate, slow-release material, diluent, adhesive, lubricant and
Coating material forms.It is stressed during sustained-release tablet tabletting, the influence of the factors such as powder flowbility, to later stage optimised process
Investigation brings many difficulties.
Based on this, the application is made.
The content of the invention
In view of the deficiencies in the prior art, the application provides that a kind of technique is simple, dissolution is rapid, the citron of steady quality first
Sour Mosapride tablet.
To achieve the above object, the technical scheme that the application takes is as follows:
Mosapride Citrate Tablets, it is made up of the component of following parts by weight:
Further, as preferred:
Described lactose is Lactis Anhydrous.
Described lubricant is selected from glyceryl palmitostearate, Compritol 888 ATO, glycerin monostearate, tristearin
One or more in acid, magnesium stearate, preferably magnesium stearate.
The one kind or more of described disintegrant in low-substituted hydroxypropyl cellulose, microcrystalline cellulose, PVPP
Kind, preferably low-substituted hydroxypropyl cellulose.
Described glidant is the one or more in talcum powder, superfine silica gel powder, preferably superfine silica gel powder.
The preparation method of Mosapride Citrate Tablets as characterized above, using mosapride citrate as raw material, lactose,
Starch, hydroxypropyl methylcellulose are equipped with the preparation that auxiliary agent carries out following steps as auxiliary material:
1) supplementary material is weighed according to recipe quantity, auxiliary material crosses 60 mesh sieves, standby;
2) purified water of recipe quantity is weighed, adds the hydroxypropyl methylcellulose of recipe quantity, stirring and dissolving forms hypromellose
The plain aqueous solution;
3) sequentially by lactose, API (i.e. raw materials:Mosapride citrate), starch and hydroxypropyl methylcellulose water
Wet granulation after solution premix;
4) 30 mesh sieve whole grains will be crossed after the particle drying of step (3) shaping, and auxiliary agent is added and always mixed;
5) tabletting.
Further, as preferred:
In step (2), the addition mass ratio of purified water and hydroxypropyl methylcellulose is 6-10:1.In process of production, we
It is found surprisingly that:Hydroxypropyl methylcellulose is dissolved in water, using this aqueous solution as adhesive, there is good bonding effect,
Especially when hydroxypropyl methylcellulose mesh number is no more than 60 mesh, purified water and the control of hydroxypropyl methylcellulose mixing ratio 8:When 1, due to
The hydroxypropyl methylcellulose aqueous solution has surface-active, assigns its good dispersiveness and caking property, carries out on this basis follow-up
Pelletize, dry, whole grain, tabletting, you can obtain the stable Mosapride Citrate Tablets agent of the property of medicine.
Described auxiliary agent includes lubricant, disintegrant and glidant, the setting of auxiliary agent, for adjusting the overall uniform of tablet
Property and dispersiveness.
More preferably:
Described lubricant is selected from glyceryl palmitostearate, Compritol 888 ATO, glycerin monostearate, tristearin
One or more in acid, magnesium stearate, preferably magnesium stearate.
One or more of the described disintegrant in low-substituted hydroxypropyl cellulose, microcrystalline cellulose, PVPP,
Preferably low-substituted hydroxypropyl cellulose.Selected disintegrant, especially low-substituted hydroxypropyl cellulose have larger table
Area and porosity, therefore the quick water swelling of energy, when the tabletting processing for the application tablet, tablet fater disintegration can be made,
And have between its coarse structure and medicine and particle it is larger inlay, tablet hardness can be significantly improved, while do not influence to be disintegrated, from
And accelerate the dissolution rate of medicine, improve bioavilability.
Described glidant is the one or more in talcum powder, superfine silica gel powder, preferably superfine silica gel powder.Glidant can be with
The frictional force between particle and particle, tablet and nib wall is reduced, the characteristic of tablet surface smooth and beautiful appearance is assigned, from talcum
The mixture of one or both of powder, superfine silica gel powder is as glidant, during especially from superfine silica gel powder as glidant, no
The mobility of particle can only be improved, assign the effect of piece table smooth and beautiful appearance, when its water absorption reaches deadweight 40%, also remain to protect
Hold pulverulence, remain to effectively be thickened in the medium of nonpolar and low polarity, improve pharmaceutical activity of parcel in it into
The stability divided.
Therefore, compared with prior art, Mosapride Citrate Tablets agent provided herein has the following advantages that and shown
Write progressive:
(1) drug-eluting is rapid, steady quality.Mosapride Citrate Tablets agent prepared by the application mainly by raw material,
Auxiliary material and auxiliary agent three parts are formed, and raw material exists as active constituents of medicine, and in auxiliary material, hydroxypropyl methylcellulose is made after being mixed with water
Mixed for adhesive with raw material and other components, by with lactose (therefore lactose is preferably Lactis Anhydrous), starch
Under cooperation, assign tablet inner core good physical stability and property of medicine stability;The particle that then raw material and auxiliary material are formed again with
Auxiliary agent carries out always mixing, tabletting, and tabletting its cooperation with inner core, also ensure that tablet while smooth tablet, hardness is kept
Good stripping property.
(2) preparation method is simple, and granularity requirements are not harsh, it is not necessary to complicated preparation equipment, is easy to industrialized production.
In the preparation process of tablet, four steps are broadly divided into:The premixing and granulation of the water-soluble of hydroxypropyl methylcellulose, raw material and auxiliary material
Always the mixing of (formation inner core), inner core and auxiliary agent, tabletting, in addition to auxiliary material and particle have mesh number requirement, other components to dynamics not
Do rigors, involved equipment also only only has the wet granulator and tabletting work of granulation process in whole process
The tablet press machine of sequence, it is therefore not necessary to complicated check-in equipment, therefore, the universality of technique is stronger, is advantageous to industrialization expansion life
Production.
Brief description of the drawings
Fig. 1 is pH6.8 stripping curve figures.
Embodiment
It is further described, but is only illustrated herein with most preferably scheme, the application with reference to embodiment
Content be not limited thereto.
Wherein, in following each embodiments, mosapride citrate is purchased from Shandong Xinshidai Pharmaceutical Industry Co., Ltd., specification 15
μm;Lactose is purchased from DFE Pharma, and specification is 200 mesh;Starch is purchased from Jiaxing whitecap starch-based product Co., Ltd, is formed sediment for corn
Powder;Low-substituted hydroxypropyl cellulose is purchased from Anhui Shanhe Medicinal Subsidiary Material Co., Ltd.;Hydroxypropyl methylcellulose is purchased from Japanese Cao
Up to Co., Ltd., model LF;Purified water is made by Zhejiang Ang Likang Pharmacy stock Co., Ltd;Magnesium stearate is purchased from An Huishan
River pharmaceutic adjuvant limited company;Superfine silica gel powder is purchased from Anhui Shanhe Medicinal Subsidiary Material Co., Ltd..
Wet granulator:Yingge Granulating Covering Technology Co., Ltd., Chongqing, model EMG2-6.
Embodiment 1
Mosapride citrate 26.50g
Lactose 295.00g
Starch 160.00g
Low-substituted hydroxypropyl cellulose 140.00g
Hydroxypropyl methylcellulose 12.00g
Purified water 188.00g
Magnesium stearate 6.50g
Superfine silica gel powder 8.25g.
Preparation method:
1) supplementary material is weighed respectively according to above-mentioned recipe quantity, auxiliary material crosses 60 mesh sieves;
2) purified water of recipe quantity is weighed, adds the hydroxypropyl methylcellulose of recipe quantity, stirring and dissolving, stirring and dissolving forms hydroxyl
The third methylcellulose aqueous solution;
3) sequentially the hydroxypropyl methylcellulose aqueous solution that lactose, API, starch and step (2) are formed is transferred to
In wet granulator, wet granulation after premix;
4) 30 mesh sieve whole grains are crossed after drying and are carried out low-substituted hydroxypropyl cellulose, magnesium stearate and superfine silica gel powder total
It is mixed;
5) tabletting.
Embodiment 2
Mosapride citrate 26.50g
Lactose 300.00g
Starch 150.00g
Low-substituted hydroxypropyl cellulose 155.00g
Hydroxypropyl methylcellulose 15.00g
Purified water 188.00g
Magnesium stearate 6.50g
Superfine silica gel powder 8.00g.
Preparation method:
1) supplementary material is weighed respectively according to above-mentioned recipe quantity, auxiliary material crosses 60 mesh sieves;
2) purified water of recipe quantity is weighed, adds the hydroxypropyl methylcellulose of recipe quantity, stirring and dissolving forms hypromellose
The plain aqueous solution;
3) sequentially the hydroxypropyl methylcellulose aqueous solution that lactose, API, starch and step (2) are formed is transferred to
In wet granulator, wet granulation after premix;
4) 30 mesh sieve whole grains are crossed after drying and are carried out low-substituted hydroxypropyl cellulose, magnesium stearate and superfine silica gel powder total
It is mixed;5) tabletting.
Comparative example 1
Mosapride citrate 75.00g
Lactose 315.00g
Superfine silica gel powder 37.50g
Microcrystalline cellulose 780.00g
Low-substituted hydroxypropyl cellulose 217.50g
Crospovidone 60.00g
Magnesium stearate 15.00g.
Mosapride Citrate Tablets are prepared with reference to the technical scheme of specification embodiment 4 in CN105769872A, it is prepared
Method is:
Mosapride citrate and superfine silica gel powder are added into the crushing that rotating speed is 3000r/min jointly according to above-mentioned prescription
Machine, composition is made after co-grinding 20s, obtained composition is mixed with lactose, add microcrystalline cellulose, low take
Mixed for hydroxypropylcellulose, Crospovidone, cross 40 mesh sieves and disperse 1 time, added magnesium stearate and always mix, mix, tabletting, produce.
Dissolution Rate Testing
Sample 1 (embodiment 1), sample 2 (embodiment 2), sample 3 (comparative example 1) and reference preparation (SUMITOMO CHEMICAL system
The Mosapride piece of medicine Co., Ltd production) in medium in pH=6.8 mosapride citrate dissolution rate referring to table 1,
Shown in table 2, table 3 and table 4.
The dissolution rate situation table of the embodiment 1 of table 1
The dissolution rate situation table of the embodiment 2 of table 2
The dissolution rate situation table of the reference preparation of table 3
The dissolution rate situation table of the comparative example 1 of table 4
The dissolution rate of the finished product of above-mentioned two embodiment under the conditions of pH6.8 is drawn, it is shown in Figure 1.From table 1, table
2nd, the Mosapride Citrate Tablets agent that table 3, table 4 and Fig. 1 can be seen that the application starts after dissolution time is 10min
Quick dissolution, its dissolution rate rapidly reach more than 60%, and comparative example dissolution rate is also close to 60%;The citron of the application
For sour Mosapride tablet when dissolution time reaches 20min, stripping quantity alreadys exceed 80%, and reaches import drugs registered standard
JX20080288 requirements, and the dissolution rate of comparative example is less than 70%;Continue to extend dissolution time, when dissolution time reaches
During 30min, the Mosapride Citrate Tablets agent dissolution rate of the application reaches 90%, and basically reaches maximum stripping quantity, the dissolution
Degree coincide substantially with reference preparation, especially the tablet under the conditions of embodiment 1, and its dissolving out capability is even better than being used as import all the time
The reference preparation of medicine, and from cost, the application is then far below import medicament, the implementation of the application, has broken imported medicine
Agent makes to have more universality with the even more excellent effect medicine for stomach dynamic of same effect to the monopoly of the type medicine.
Stability test:
Test specimen:The Mosapride piece that embodiment 1~2 (sample 1~2) produces with SUMITOMO CHEMICAL pharmaceutical Co. Ltd
(being denoted as reference preparation).
Test method:Placed six months under the conditions of accelerated stability test respectively, with mosapride citrate and relevant
Material is the change of index determining content, is detected respectively at the 0th, 1,3, sampling in June, referring specifically to shown in table 5.
The stability parameter table of comparisons under 5 different implementation conditions of table
As can be seen from Table 5, after the time of 6 months is placed, whether embodiment 1, or its content drop of embodiment 2
For low rate below 0.5%, the shelf stability of product is preferable.
Above content be with reference to the invention preferred embodiment provided technical scheme is made it is further detailed
Describe in detail bright, it is impossible to assert that the invention specific implementation is confined to these above-mentioned explanations, for the affiliated technology of the invention
For the those of ordinary skill in field, without departing from the concept of the premise of the invention, some simple deductions can also be made
Or replace, it should all be considered as belonging to the protection domain of the invention.
Claims (10)
1. Mosapride Citrate Tablets, it is characterised in that be made up of the component of following parts by weight:
Mosapride citrate 2-5
Lactose 40-50
Starch 20-30
Disintegrant 20-30
Hydroxypropyl methylcellulose 1-3
Lubricant 0.5-10
Glidant 0.5-2.
2. Mosapride Citrate Tablets as claimed in claim 1, it is characterised in that:Described lactose is Lactis Anhydrous.
3. Mosapride Citrate Tablets as claimed in claim 1, it is characterised in that:Described lubricant is selected from stearic acid palm
One or more in acid glyceride, Compritol 888 ATO, glycerin monostearate, stearic acid, magnesium stearate.
4. Mosapride Citrate Tablets as claimed in claim 1, it is characterised in that:Described disintegrant is selected from low-substituted hydroxypropyl
One or more in cellulose, microcrystalline cellulose, PVPP.
5. Mosapride Citrate Tablets as claimed in claim 1, it is characterised in that:Described glidant is talcum powder, micro mist
The mixture of one or both of silica gel.
6. the preparation method of Dispersible Mosapride citrate tablets as claimed in claim 1, it is characterised in that with citric acid Mo Shabi
Profit is used as raw material, and lactose, starch, hydroxypropyl methylcellulose are equipped with the preparation that auxiliary agent carries out following steps as auxiliary material:
1)Supplementary material is weighed according to recipe quantity, auxiliary material crosses 60 mesh sieves;
2)The purified water of recipe quantity is weighed, adds the hydroxypropyl cellulose of recipe quantity, stirring and dissolving;
3)Wet granulation after sequentially premixing lactose, API, starch and the hydroxypropyl methylcellulose aqueous solution;
4)30 mesh sieve whole grains are crossed after drying, and auxiliary agent is added and always mixed;
5)Tabletting.
7. the preparation method of Dispersible Mosapride citrate tablets as claimed in claim 6, it is characterised in that:Step(2)In, it is pure
The addition mass ratio for changing water and hydroxypropyl methylcellulose is 6-10:1.
8. the preparation method of Dispersible Mosapride citrate tablets as claimed in claim 6, it is characterised in that:Described lactose is
Lactis Anhydrous.
9. the preparation method of Dispersible Mosapride citrate tablets as claimed in claim 6, it is characterised in that:Step(4)In, institute
The auxiliary agent stated includes lubricant, disintegrant and glidant.
10. the preparation method of Dispersible Mosapride citrate tablets as claimed in claim 9, it is characterised in that:Described lubrication
The one kind of agent in glyceryl palmitostearate, Compritol 888 ATO, glycerin monostearate, stearic acid, magnesium stearate
It is or a variety of;One or more of the disintegrant in low-substituted hydroxypropyl cellulose, microcrystalline cellulose, PVPP;Glidant
For the mixture of one or both of talcum powder, superfine silica gel powder.
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CN201711001305.4A CN107744509B (en) | 2017-10-24 | 2017-10-24 | Mosapride citrate tablet and preparation method thereof |
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CN107744509B CN107744509B (en) | 2020-06-12 |
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN111514111A (en) * | 2020-05-07 | 2020-08-11 | 福建海西新药创制有限公司 | Pharmaceutical composition containing mosapride citrate and preparation method thereof |
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CN101273973A (en) * | 2007-03-28 | 2008-10-01 | 成都康弘科技实业(集团)有限公司 | Pharmaceutical combination containing Mosapride citrate and method of preparing the same |
CN102988372A (en) * | 2011-09-13 | 2013-03-27 | 广东九明制药有限公司 | Screening and composition of main auxiliary materials of compound aspirin tablet, and preparation method of compound aspirin sheet |
CN105560249A (en) * | 2014-10-10 | 2016-05-11 | 成都康弘药业集团股份有限公司 | Pharmaceutical composition containing mosapride citrate |
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Patent Citations (5)
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CN1359680A (en) * | 2001-12-26 | 2002-07-24 | 成都康弘制药有限公司 | Prescription of preparing moxapride citrate |
WO2006011159A2 (en) * | 2004-06-21 | 2006-02-02 | Torrent Pharmaceuticals Limited | Stabilized pharmaceutical composition containing rabeprazole sodium with improved bioavailability |
CN101273973A (en) * | 2007-03-28 | 2008-10-01 | 成都康弘科技实业(集团)有限公司 | Pharmaceutical combination containing Mosapride citrate and method of preparing the same |
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Denomination of invention: Mosapride citrate tablet and its preparation method Effective date of registration: 20230601 Granted publication date: 20200612 Pledgee: Bank of Ningbo Co.,Ltd. Shaoxing Branch Pledgor: ZHEJIANG ANGLIKANG PHARMACEUTICAL Co.,Ltd. Registration number: Y2023980042571 |