CN105663095A - Preparation method of (R)-lansoprazole sustained-release capsule - Google Patents
Preparation method of (R)-lansoprazole sustained-release capsule Download PDFInfo
- Publication number
- CN105663095A CN105663095A CN201510981088.4A CN201510981088A CN105663095A CN 105663095 A CN105663095 A CN 105663095A CN 201510981088 A CN201510981088 A CN 201510981088A CN 105663095 A CN105663095 A CN 105663095A
- Authority
- CN
- China
- Prior art keywords
- enteric
- coat
- layer
- micropill
- slow releasing
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- 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
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
- A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
Abstract
The invention relates to an (R)-lansoprazole sustained-release capsule and a preparation method thereof and belongs to the field of sustained-release preparations, and particularly relates to a preparation method of an acid-sensitive proton pump inhibitor sustained-release enteric-coated pellets. The capsule is filled with two kinds of pellets of which the releasing speed are different, one is enteric-coated quick-release pellets and the other one is enteric-coated sustained-release pellets. In the invention, damage on the (R)-lansoprazole is avoided and the (R)-lansoprazole is orientedly released in intestinal tracts, so that the capsule is quick in action, is prolonged in medicine effect and is improved in bioavailability, and is mainly improved significantly in stability of medicine active molecules in the preparation.
Description
Technical field
The present invention is the preparation method of a kind of R-lansoprazole slow releasing capsule, the preparation method being specifically related to a kind of R-lansoprazole enteric sustained-release pellet, belongs to sustained-release preparation technical field.
Background technology
R-lansoprazole (dexlansoprazole) chemical structural formula is as follows:
Its molecular formula is: C16H14F3N3O2S
Its chemical name is: (+)-2-[(R)-[[3-methyl-4-(2,2,2-trifluoro ethoxy)-2-pyridine radicals] methyl] sulfinyl]-1H-benzimidazole.
U.S. FDA is in esophagitis treatment new drug R-lansoprazole (the general Dexlansoprazole by name) listing of Takeda Pharmaceutical Company Limited of approval on January 30th, 2009 Japan research and development. Belonging to proton pump inhibitor class (PPIS) antiulcerative, it acts on the H+/K+-ATP enzyme of parietal cell, closes gastric much acid pump and reduces the generation of gastric acid. Clinically for treating the heartburn relevant to Non-erosive gastroesophageal reflux disease and erosive esophagitis in various degree, such as duodenal ulcer, gastric ulcer, reflux esophagitis, the first from left Chinese mugwort (Zollinger-Ellison) syndromic treatment etc., evident in efficacy.
This time listing dosage form is for providing the proton pump inhibitor class slow releasing capsule of point dual controlled release of 2 releases, medicine can be made 1-2 hour and two peak plasma concentrations occur after 4-5 hour respectively upon administration, and administration time unable to take food thing and the impact of meal time, can in the daytime or accompany night the gastroesophageal reflux disease of heartburn symptom to provide the Acidinhibitor up to 24 hours and lasting remission effect.
R-lansoprazole is the optical voidness medicine of racemization lansoprazole, there is the chemical constitution of sulfinyl benzimidazole in its structure, is subject to light, heavy metal ion, oxidisability and reproducibility and becomes the impact of grading factors to make stability reduce. Especially in acid condition, can there is destructive change in its chemical constitution, variable color and polymerism occur. In dosage form, R-lansoprazole interacts with other adjunct ingredients in preparation and makes stability reduce, and produces at preparation and variable color and decomposition be can be observed in storage. It addition, unstable in the solution of slant acidity, after oral administration, it is subject to gastric acid and destroys and reduce drug effect speed and bioavailability.
For increasing the stability of this class medicine, generally the materials such as medicine and alkaline, inorganic salts are mixed with, to provide the alkaline microenvironment of drug substance stable, outer layer is enteric coated, avoid degraded under one's belt, but, the subacidity of enteric-coating material own, the degraded of acid labile drug can be caused, thus causing that in enteric coated process or in storage, medicated layer surface color changes. Therefore, how to avoid this phenomenon, be the critical process in this preparation method.
Summary of the invention:
The object of the invention, for providing a kind of R-lansoprazole slow releasing capsule and preparation method thereof, is advantageous in that and can either ensure drug effect, can be obviously enhanced again R-lansoprazole active component stability in this dosage form.
The present invention adopts below scheme:
The capsule that human body compliance is higher, includes enteric-coated quick releasing micropill and enteric sustained-release pellet two kinds, has following specific sequential layer: celphere, medicated layer, sub-coat, sealing coat, enteric layer. Two kinds of micropill mass ratioes are 1:1-1.5, R-lansoprazole active component mass ratio 1:2.5-3.5.
Wherein, enteric coated micropill medicated layer, sub-coat preparation method be the medicine-feeding of celphere coating pan, bag sub-coat, this medicine-feeding method is low for equipment requirements, and efficiency is high, and yield is high, and micropill roundness is high. The enteric layers of micropill outer layer is that PH relies on the polymeric material dissolved, and intestinal location release can quickly be absorbed by the body, and effectively raises bioavailability, extends drug effect.
It is magnesium hydroxide that adjuvant used in the preparation of each sequential layer of micropill includes stabilizer, magnesium carbonate, sodium carbonate, sodium hydroxide, sodium dihydrogen phosphate etc., filler is microcrystalline Cellulose, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, mannitol, starch, dextrin, sucrose, lactose, pre-paying starch etc., adhesive is hydroxypropyl methylcellulose, hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose, polyvidone, polyvinylpolypyrrolidone, polyvinylpyrrolidone, methylcellulose, starch slurry, syrup etc., lubricant is magnesium stearate, Pulvis Talci, micropowder silica gel, one or more in Polyethylene Glycol, opacifier is titanium dioxide, solvent is purified water, 75%-95% ethanol. coating materials is methacrylic acid-acrylic acid polymerizable methacrylate thing, methacrylic acid-methyl methacrylate polymer etc., and plasticizer is triethyl citrate, Polyethylene Glycol, dibutyl phthalate, propylene glycol etc.
Wherein, R-lansoprazole micropill sub-coat weightening finish 30-40%, the weightening finish of R-lansoprazole micropill sealing coat is 5%-15%, and the weightening finish of R-lansoprazole micropill enteric layer is 10%-40%. Micropill water content is less than 3%.
The preparation method of R-lansoprazole micropill, concrete operation step is as follows:
A. two kinds of micropills all adopt celphere method of the round as a ball medicine-feeding of coating pan under adhesive effect, prepare pellet core.
B. two kinds of micropills all adopt pellet core coating pan under adhesive effect round as a ball on the method for powder, prepare sub-coat micropill.
C. two kinds of micropills all adopt fluid bed by method to sub-coat capsule core coating of the insulating liquid that stirs, prepare sealing coat micropill.
D. two kinds of micropills all adopt fluid bed by method to sealing coat capsule core coating of the enteric liquid that stirs, prepare the enteric coated micropill of two kinds of different release Mechanisms.
E. by the micropill of two kinds of prepared release Mechanisms, by the mass ratio of 1:1-1.5, make active component content ratio for 1:2.5-3.5, add moderate lubrication agent, mix homogeneously, fill capsule, prepare R-lansoprazole slow releasing capsule.
Detailed description of the invention
Embodiment 1:
The preparation (centrifugal coating pan medicine-feeding) of enteric-coated quick releasing micropill pellet core:
Preparation technology:
A. each supplementary material, mix homogeneously are weighed in proportion.
B. adhesive is got out. Adjusting coating pan rotating disk 300r/min, hydrojet 7-15r/min, atomizing pressure 0-0.5mpa, air feed 30hz carries out the preparation of pellet core.
C. dry, make pellet core water content lower than 3%.
D. the pellet core collecting 30-40 order of sieving is standby.
Embodiment 2:
The preparation (centrifugal coating pan medicine-feeding) of enteric sustained-release pellet pellet core:
Preparation technology:
A. each supplementary material, mix homogeneously are weighed in proportion.
B. adhesive is got out.
C. adjusting coating pan rotating disk 300r/min, hydrojet 7-15r/min, atomizing pressure 0-0.5mpa, air feed 30hz carries out the preparation of pellet core.
D. dry, make pellet core water content lower than 3%.
E. the pellet core collecting 30-40 order of sieving is standby.
Embodiment 3:
The preparation that enteric coated micropill sub-coat capsule core (includes rapid release with slow release):
Preparation technology:
A. each adjuvant, mix homogeneously are weighed in proportion.
B. adhesive 50% syrup is got out.
C. adjusting coating pan rotating disk 300r/min, hydrojet 7-15r/min, atomizing pressure 0.1-0.4mpa, air feed 30hz carries out the preparation of sub-coat capsule core.
D. dry, make sub-coat capsule core water content lower than 3%.
E. the sub-coat capsule core collecting 20-30 order of sieving is standby.
Embodiment 4:
The preparation of sealing coat capsule core that enteric coated micropill (includes rapid release and slow release):
Preparation technology:
A. weigh each adjuvant in proportion, appropriate purified water stirs.
B. adjusting fluid bed blower fan 25-35hz, hydrojet 10-15hz, atomizing pressure 0.1-0.4mpa, inlet temperature 50 DEG C, carry out the preparation of isolation capsule core, sealing coat weightening finish is 5%-15%.
C. dry, make sealing coat capsule core water content lower than 3%.
D. the sealing coat capsule core collecting 20-30 order of sieving is standby.
Embodiment 5:
The preparation of enteric-coated quick releasing micropill:
Preparation technology:
A. weigh each adjuvant in proportion, appropriate purified water stirs.
B. adjusting fluid bed blower fan 25-35hz, hydrojet 10-20hz, atomizing pressure 0.1-0.4mpa, inlet temperature 45 DEG C, carry out the preparation of enteric-coated quick releasing micropill, the weightening finish of fast release micropill enteric layer is 10%-20%.
C. dry, make fast release micropill water content lower than 3%.
D. the enteric-coated quick releasing micropill collecting 20-30 order that sieves is standby.
Embodiment 6:
The preparation of enteric sustained-release pellet:
Preparation technology:
A. weigh each adjuvant in proportion, appropriate 75%-95% ethanol stirs.
B. adjusting fluid bed blower fan 25-35hz, hydrojet 10-25hz, atomizing pressure 0.1-0.4mpa, inlet temperature 40 DEG C, carry out the preparation of enteric sustained-release pellet, the weightening finish of slow-release micro-pill enteric layer is 20%-40%.
C. dry, make slow-release micro-pill water content lower than 3%.
D. the enteric sustained-release pellet collecting 20-30 order that sieves is standby.
Embodiment 7:
Taking R-lansoprazole fast release micropill and slow-release micro-pill, weigh by 1:1-1.5, making R-lansoprazole active component mass ratio is 1:2.5-3.5, and three-dimensional mixer mixes, No. 3 capsule fills.
So far, R-lansoprazole slow releasing capsule completes.
Quality control:
By prepared R-lansoprazole slow releasing capsule being carried out standard test, character, differentiating, have the equal conformance with standard of index such as related substance, uniformity of dosage units, dissolution, loss on drying, assay.
Study on the stability:
Place 9 months under acceleration environment after taking R-lansoprazole slow releasing capsule dummy packages, preserve 15 months under long-term conditions, be periodically subject to product stability respectively and investigate, investigate result in Table 1.
Table 1 R-lansoprazole slow releasing capsule study on the stability result
The to sum up result of stability study, the R-lansoprazole slow releasing capsule demonstrating the present invention has the stability of excellence, and all experimental datas under long-term storage conditions all meet the requirements of the standard, and the stability data between each batch is showed no notable difference. By contrasting, the stability of the present invention is better than commercially available product. It is enough to demonstrate the interpolation sub-coat contribution to this dosage form stability.
The explanation of above example is only intended to help to understand method and the core concept thereof of the present invention.It should be pointed out that, for those skilled in the art, under the premise without departing from the principles of the invention, it is also possible to the present invention carries out some improvement and modification, these improve and modify in the protection domain also falling into the claims in the present invention.
Claims (14)
1. a R-lansoprazole slow releasing capsule, it is characterised in that: capsule is built with two kinds of micropills, and one is enteric-coated quick releasing micropill, and one is enteric sustained-release pellet.
2. slow releasing capsule according to claim 1; it is characterized in that; enteric-coated quick releasing micropill and slow-release micro-pill; there is following specific sequential layer: celphere, medicated layer, sub-coat, sealing coat, enteric layer; the sub-coat increased together with sealing coat higher intensity intercepted contacting of acidic enteric layer and basic activated medicine layer; protect medicine layer; make that enteric layer is more effective has kept out the gastric acid environment destruction to active component simultaneously, enhance active constituents of medicine stability in this dosage form significantly.
3. the slow releasing capsule according to any one of claim 1-2, it is characterised in that wherein, R-lansoprazole micropill sub-coat weightening finish 30-40%, the weightening finish of R-lansoprazole micropill sealing coat is 5%-15%, and the weightening finish of R-lansoprazole micropill enteric layer is 10%-40%.
4. the slow releasing capsule according to any one of claim 1-3, it is characterised in that enteric coated micropill medicated layer is obtained by the medicine-feeding of celphere coating pan rolling manipulation.
5. the slow releasing capsule according to any one of claim 1-4, it is characterised in that the enteric layer of micropill outer layer is that pH relies on the acrylic polymer materials dissolved, the release of intestinal location effectively raises bioavailability, extends drug effect.
6. the slow releasing capsule according to any one of claim 1-5, it is characterised in that also including adjuvant in each sequential layer of micropill, described adjuvant includes one or more in stabilizer, filler, adhesive, lubricant, opacifier, coating materials, plasticizer.
7. the slow releasing capsule according to any one of claim 1-6, it is characterized in that, described stabilizer is magnesium carbonate, sodium carbonate, one or more in sodium dihydrogen phosphate, filler is microcrystalline Cellulose, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, mannitol, starch, sucrose, one or more in pre-paying starch, adhesive is hydroxypropyl methylcellulose, hydroxypropyl cellulose, polyvidone, copolyvidone, polyvinylpyrrolidone, one or more in methylcellulose, lubricant is magnesium stearate, Pulvis Talci, one or more in micropowder silica gel, opacifier is titanium dioxide, coating materials is methacrylic acid-acrylic acid polymerizable methacrylate thing, one or more in methacrylic acid-methyl methacrylate polymer, plasticizer is triethyl citrate, Polyethylene Glycol, dibutyl phthalate, one or more in propylene glycol.
8. the slow releasing capsule according to any one of claim 1-7, it is characterised in that activity capsule core is prepared by the mixed powder of celphere and medicine layer, the mixed powder of described medicine layer includes active component R-lansoprazole, stabilizer, filler, adhesive, disintegrating agent, lubricant.
9. the slow releasing capsule according to any one of claim 1-8, it is characterised in that sub-coat capsule core is by activity capsule core, and the mixed powder of sub-coat and the centrifugal coating pan coating of adhesive obtain.
10. the slow releasing capsule according to any one of claim 1-9, it is characterised in that sealing coat capsule core is obtained by sub-coat capsule core and sealing coat coating solution fluidized bed coating, and wherein sealing coat coating solution includes adhesive, cosolvent, lubricant, opacifier.
11. the slow releasing capsule according to any one of claim 1-10, it is characterised in that rapid release enteric layer coating solution includes polymer 50-100 part, plasticizer 10-20 part, cosolvent 10-20 part, lubricant 20-30 part.
12. the slow releasing capsule according to any one of claim 1-11, it is characterised in that enteric-coated sustained release coating solution includes polymer 150-170 part, plasticizer 10-20 part, lubricant 50-80 part.
13. the preparation method of the slow releasing capsule according to any one of claim 1-12, it is characterised in that concrete operation step is as follows:
A. the preparation of activity capsule core: taking celphere mass parts is 300 parts, containing mixing mixed 1000 parts of the powder of uniform medicine layer, wherein active component R-lansoprazole 100-120 part, stabilizer 80-100 part, filler 500-550 part, adhesive 10-20 part, disintegrating agent 80-100 part, lubricant 10-30 part, under adhesive effect, centrifugal coating pan medicine-feeding;
B. the preparation of sub-coat capsule core: take activity capsule core 300 parts, sub-coat mixes powder 150-180 part, adhesive 10-20 part, centrifugal coating pan coating;
C. the preparation of sealing coat capsule core: take sub-coat capsule core 100 parts, sealing coat coating solution 200 parts, wherein adhesive 30-60 part, cosolvent 10-20 part, lubricant 10-20 part, opacifier 10-20 part, stir, fluidized bed coating;
D. the preparation of enteric coated micropill: take sealing coat micropill 100 parts, enteric layer coating solution 300 parts, stir, fluidized bed coating;
E. two kinds of micropills are weighed mixing in 1:1-1.5 ratio, and active component mass ratio is 1::2.5-3.5, fill capsule.
14. the method described in claim 13, rapid release enteric layer coating solution includes polymer 50-100 part, plasticizer 10-20 part, cosolvent 10-20 part, lubricant 20-30 part; Enteric-coated sustained release coating solution includes polymer 150-170 part, plasticizer 10-20 part, lubricant 50-80 part.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510981088.4A CN105663095A (en) | 2015-12-24 | 2015-12-24 | Preparation method of (R)-lansoprazole sustained-release capsule |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510981088.4A CN105663095A (en) | 2015-12-24 | 2015-12-24 | Preparation method of (R)-lansoprazole sustained-release capsule |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN105663095A true CN105663095A (en) | 2016-06-15 |
Family
ID=56189611
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510981088.4A Pending CN105663095A (en) | 2015-12-24 | 2015-12-24 | Preparation method of (R)-lansoprazole sustained-release capsule |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN105663095A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109316466A (en) * | 2017-07-31 | 2019-02-12 | 深圳翰宇药业股份有限公司 | A kind of body of Pramipexole dihydrochloride sustained release preparation and preparation method thereof |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103202820A (en) * | 2012-01-11 | 2013-07-17 | 浙江亚太药业股份有限公司 | Stable enteric lansoprazole capsule and preparation method thereof |
| US8563034B2 (en) * | 2010-05-05 | 2013-10-22 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Dual release oral tablet compositions of dexlansoprazole |
| CN104523654A (en) * | 2014-12-15 | 2015-04-22 | 北京红太阳药业有限公司 | Dexlansoprazole sustained-release capsule and preparation method thereof |
| CN104940169A (en) * | 2015-06-26 | 2015-09-30 | 山东省药学科学院 | Dexlansoprazole sustained release capsule and preparation method thereof |
-
2015
- 2015-12-24 CN CN201510981088.4A patent/CN105663095A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8563034B2 (en) * | 2010-05-05 | 2013-10-22 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Dual release oral tablet compositions of dexlansoprazole |
| CN103202820A (en) * | 2012-01-11 | 2013-07-17 | 浙江亚太药业股份有限公司 | Stable enteric lansoprazole capsule and preparation method thereof |
| CN104523654A (en) * | 2014-12-15 | 2015-04-22 | 北京红太阳药业有限公司 | Dexlansoprazole sustained-release capsule and preparation method thereof |
| CN104940169A (en) * | 2015-06-26 | 2015-09-30 | 山东省药学科学院 | Dexlansoprazole sustained release capsule and preparation method thereof |
Non-Patent Citations (2)
| Title |
|---|
| 周丽娟等: "兰索拉唑肠溶微丸的制备及其在犬体内药动学", 《中国医院药学杂志》 * |
| 张倩等: "兰索拉唑肠溶微丸胶囊的制备", 《中国药房》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109316466A (en) * | 2017-07-31 | 2019-02-12 | 深圳翰宇药业股份有限公司 | A kind of body of Pramipexole dihydrochloride sustained release preparation and preparation method thereof |
| CN109316466B (en) * | 2017-07-31 | 2022-04-05 | 深圳翰宇药业股份有限公司 | Pramipexole dihydrochloride sustained-release preparation and preparation method thereof |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CA2307037C (en) | Oral pharmaceutical preparation comprising an antiulcer activity compound, and process for its production | |
| CN104606146B (en) | A kind of esomeprazole enteric capsules preparation and preparation method thereof | |
| JP5052051B2 (en) | Enteric granules and method for producing the same | |
| CN1964704A (en) | Stable pharmaceutical composition comprising an acid labile drug | |
| US20070218140A1 (en) | Slow-Release Preparations And Their Method Of Production | |
| CZ291943B6 (en) | Pharmaceutical preparation | |
| JP2001524131A (en) | Stable oral pharmaceutical dosage form | |
| JPWO2005084649A1 (en) | Stable capsule | |
| CN111012756B (en) | Dabigatran etexilate pharmaceutical composition and preparation method thereof | |
| CN104922086A (en) | Preparation method of proton pump inhibitor enteric-coated tablet | |
| CN103356489B (en) | Proton pump inhibitor enteric coated pellet and preparation and preparation method thereof | |
| CN104414978A (en) | Enteric-coated micropellet containing esomeprazole magnesium | |
| WO2009002416A1 (en) | Controlled release tamsulosin hydrochloride formulation | |
| CN103784414A (en) | Esomeprazole enteric-coated tablets and preparation method thereof | |
| CN105560206A (en) | Preparation of Pradaxa capsule | |
| CN111214457A (en) | Esomeprazole magnesium enteric-coated pellet preparation and preparation method thereof | |
| CN105106168B (en) | A kind of esomeprazole magnesium intestines capsule and preparation method thereof | |
| US20230048354A1 (en) | Dosage form for use in treating or preventing of a disease | |
| CN105663095A (en) | Preparation method of (R)-lansoprazole sustained-release capsule | |
| CN104188935A (en) | Lansoprazole enteric-coated tablet and preparation method thereof | |
| CZ302388B6 (en) | Multiparticulate controlled release selective serotonin reuptake inhibitor formulation and the use thereof | |
| CN104940168A (en) | Dextrorotation lansoprazole diphasic spansule preparation and preparing method thereof | |
| JP2000212085A (en) | Highly stable oral medicinal preparation containing omeprazole or othrer analog, and production thereof | |
| CN103705483A (en) | Stable, uniform and efficient lansoprazole enteric-coated tablets and preparation method thereof | |
| CN103393615B (en) | Duloxetine enteric pellet and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20160615 |
|
| RJ01 | Rejection of invention patent application after publication |