CN109078007A - The preparation method of sodium rabeprazole enteric-coated sustained-release micro-spheres and oral solid formulation containing sodium rabeprazole enteric-coated sustained-release micro-spheres - Google Patents
The preparation method of sodium rabeprazole enteric-coated sustained-release micro-spheres and oral solid formulation containing sodium rabeprazole enteric-coated sustained-release micro-spheres Download PDFInfo
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- CN109078007A CN109078007A CN201811010986.5A CN201811010986A CN109078007A CN 109078007 A CN109078007 A CN 109078007A CN 201811010986 A CN201811010986 A CN 201811010986A CN 109078007 A CN109078007 A CN 109078007A
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- sodium
- spheres
- release micro
- rabeprazole
- coated sustained
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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
- A61K31/4427—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
- A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
Abstract
Oral solid formulation the invention discloses a kind of preparation method of sodium rabeprazole enteric-coated sustained-release micro-spheres and containing sodium rabeprazole enteric-coated sustained-release micro-spheres；This method is to dissolve RABEPRAZOLE SODIUM and Utech with solvent, obtains mixed solution, is then spray-dried to mixed solution, then vacuum dried obtains sodium rabeprazole enteric-coated sustained-release micro-spheres；The oral solid formulation is made of sodium rabeprazole enteric-coated sustained-release micro-spheres and pharmaceutically acceptable auxiliary material.By special process enteric slow release microballoon is made in RABEPRAZOLE SODIUM by the present invention, which has preferable acid-resistant strength and higher encapsulation rate, has good sustained releasing character, and this method is easy to operate, lower production costs are suitable for industrialized production；The dissolution rate in vitro and dissolution rate of RABEPRAZOLE SODIUM can be effectively delayed using pharmaceutical preparation made from sodium rabeprazole enteric-coated sustained-release micro-spheres produced by the present invention, to improve the bioavilability of drug, there is commercialized feasibility.
Description
Technical field
The invention belongs to technical field of medicine, and in particular to a kind of preparation side of sodium rabeprazole enteric-coated sustained-release micro-spheres
Method and oral solid formulation containing sodium rabeprazole enteric-coated sustained-release micro-spheres.
Background technique
Disease of digestive system is common one of frequently-occurring disease, wherein based on peptic ulcer, be often accompanied by it is serious simultaneously
Disease, such as gastric ulcer, duodenal ulcer meeting upper digestive tract bleeding complicated, perforation are sent out, is brought great pain to patients, seriously
Threaten people's health.
RABEPRAZOLE SODIUM is the benzimidazole substituent of new generation after Omeprazole, Lansoprazole, for parietal cell tip point
The potent inhibitor of film inner proton pump is secreted, RABEPRAZOLE SODIUM specifically inhibits H+-K+The activity of ATP enzyme, to basic gastric acid and by
Gastric acid secretion caused by stimulating has inhibiting effect.RABEPRAZOLE SODIUM is suitable for gastric ulcer, duodenal ulcer, erosive stomach-food
Pipe reflux disease, helicobacter pylori syndrome etc..
The chemical name of RABEPRAZOLE SODIUM are as follows: [{ 4- (3- methoxy propoxy) -3- picoline -2- base }-methyl is sub- by 2-
Sulfonyl] -1 hydrogen-benzimidazole sodium salt.Structural formula is as follows:
。
Since RABEPRAZOLE SODIUM is to wet, light and heat are unstable, it is very fast to meet acid degradation.Using thunder shellfish made from conventional method
Draw azoles sodium oral solid preparation there are acid resistances poor, the lower deficiency of encapsulation rate.
Summary of the invention
It is an object of the present invention to solving the above problems, provide that a kind of acid resistance is preferable, the higher thunder shellfish of encapsulation rate
Draw the preparation method of azoles sodium enteric slow release microballoon.
The second object of the present invention is to solve the above problems, and provides a kind of containing sodium rabeprazole enteric-coated sustained-release micro-spheres
Oral solid formulation.
Realizing the technical solution of one of the object of the invention is: a kind of preparation method of sodium rabeprazole enteric-coated sustained-release micro-spheres,
It has follow steps:
1. RABEPRAZOLE SODIUM and Utech are dissolved with solvent, mixed solution is obtained；
2. 1. mixed solution that step obtains is spray-dried, then it is vacuum dried obtain it is sodium rabeprazole enteric-coated sustained release it is micro-
Ball.
Above-mentioned steps 1. described in Utech be selected from Utech L 100-55, Utech L 30D-55, Utech L 100,
One of Utech S 100 is two or more (containing two kinds).
Above-mentioned steps 1. described in solvent be one of ethyl alcohol, water, isopropanol or two or more (contain two kinds).
In order to assign the preferable acid resistance of RABEPRAZOLE SODIUM and higher encapsulation rate, above-mentioned steps 1. described in Rabeprazole
The weight ratio of sodium and the Utech is 1: 1~1: 4, preferably 1: 2.
Realizing two technical solution of the object of the invention is: containing sodium rabeprazole enteric-coated slow made from above-mentioned any means
Release the oral solid formulation of microballoon.
It the oral solid formulation sodium rabeprazole enteric-coated sustained-release micro-spheres as made from above-mentioned any means and can pharmaceutically connect
The auxiliary material received is made.
The oral solid formulation is tablet, granule or capsule.
The pharmaceutically acceptable auxiliary material includes but is not limited to filler, adhesive, disintegrating agent, lubricant.
The filler is lactose, microcrystalline cellulose, magnesia, mannitol, sucrose, starch, cornstarch, the pre- glue in part
Change one of starch, calcium monohydrogen phosphate, calcium dihydrogen phosphate or two or more (containing two kinds)；Preferably lactose, microcrystalline cellulose,
One of magnesia, mannitol are two or more (containing two kinds).
Described adhesive is polyvinylpyrrolidone, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, hydroxyethyl methyl fibre
Tie up element, hydroxyethyl cellulose, hydroxymethyl cellulose, methylcellulose, copolyvidone, starch syrup, potato starch, part in advance
One of gelling starch is two or more (containing two kinds)；Preferably polyvinylpyrrolidone, hydroxypropyl methyl cellulose, hydroxyl
One of propyl cellulose is two or more (containing two kinds).
The disintegrating agent is low-substituted hydroxypropyl cellulose, crospovidone, calcium carboxymethylcellulose, carboxymethyl cellulose
One of sodium, croscarmellose sodium, sodium carboxymethyl starch are two or more (containing two kinds)；Preferably low substitution hydroxyl
One of propyl cellulose, crospovidone, calcium carboxymethylcellulose are two or more (containing two kinds).
The lubricant is one of talcum powder, magnesium stearate, colloidal silicon dioxide or two or more (contain two kinds).
The good effect that the present invention has:
(1) by special process enteric slow release microballoon is made in RABEPRAZOLE SODIUM by the present invention, which has preferable
Acid-resistant strength and higher encapsulation rate, there is good sustained releasing character, and this method is easy to operate, lower production costs, fits
Together in industrialized production.
(2) thunder can be effectively delayed using pharmaceutical preparation made from sodium rabeprazole enteric-coated sustained-release micro-spheres produced by the present invention
Shellfish draws the dissolution rate in vitro and dissolution rate of azoles sodium, to improve the bioavilability of drug, has commercialized feasibility.
Detailed description of the invention
Fig. 1 is the SEM figure of sodium rabeprazole enteric-coated sustained-release micro-spheres made from example 2.
Specific embodiment
(example 1)
The sodium rabeprazole enteric-coated sustained-release micro-spheres of this example the preparation method is as follows:
1. by 300g RABEPRAZOLE SODIUM and 300g Utech L 100(weight ratio 1: 1) being dissolved in the medicinal alcohol of 2400g, obtain
To mixed solution.
2. setting 100 DEG C of inlet temperature of spray dryer (Yamato DL410), atomizing pressure 0.1MPa, air quantity 0.8m3/
Min is spray-dried above-mentioned mixed solution, and the powder after spray drying is dried in vacuo again, obtains Rabeprazole
Sodium enteric slow release microballoon.
(embodiment 1)
Capsule is made using sodium rabeprazole enteric-coated sustained-release micro-spheres made from example 1, formula is shown in Table 1.
Table 1
| Ingredient | Single dose mg/ | Specifications and models | Weight percent |
| Sodium rabeprazole enteric-coated sustained-release micro-spheres made from example 1 | 20 | / | 16.7% |
| Magnesia | 40 | / | 33.3% |
| Lactose | 30 | 200 mesh | 25.0% |
| Polyvinylpyrrolidone | 5 | K30 | 4.2% |
| Hydroxypropyl cellulose | 11 | NISSO HPC-SL | 9.2% |
| Crospovidone | 12 | XL | 10.0% |
| Magnesium stearate | 2 | / | 1.7% |
| Gross weight | 120 | / | / |
The preparation method is as follows: weighing sodium rabeprazole enteric-coated sustained-release micro-spheres, magnesia, cream made from example 1 by recipe quantity
Ethanol in proper amount is added as wetting agent in sugar, polyvinylpyrrolidone, hydroxypropyl cellulose and crospovidone after mixing
Softwood processed, the granulation of 24 meshes set 50 ± 5 DEG C of drying in baking oven, cross 24 mesh sieves, magnesium stearate is then added, be uniformly mixed,
Particulate matter is obtained, filling 2# capsule, every intragranular is tolerant to nearly weigh 120mg.
(example 2)
The sodium rabeprazole enteric-coated sustained-release micro-spheres of this example the preparation method is as follows:
1. by 300g RABEPRAZOLE SODIUM and 600g Utech S 100(weight ratio 1: 2) being dissolved in the purified water of 2400g, obtain
Mixed solution.
2. setting 100 DEG C of inlet temperature of spray dryer (Yamato DL410), atomizing pressure 0.1MPa, air quantity 0.8m3/
Min is spray-dried above-mentioned mixed solution, and the powder after spray drying is dried in vacuo again, obtains Rabeprazole
Sodium enteric slow release microballoon.
Electron microscope observation, the result is shown in Figure 1 are scanned to sodium rabeprazole enteric-coated sustained-release micro-spheres made from this example.
(embodiment 2)
Tablet is made using sodium rabeprazole enteric-coated sustained-release micro-spheres made from example 2, formula is shown in Table 2.
Table 2
| Ingredient | Single dose mg/ piece | Specifications and models | Weight percent |
| Sodium rabeprazole enteric-coated sustained-release micro-spheres made from example 2 | 30 | / | 25.0% |
| Magnesia | 30 | / | 25.0% |
| Mannitol | 20.8 | / | 17.3% |
| Hydroxypropyl cellulose | 17 | NISSO HPC-SSL | 14.2% |
| Low-substituted hydroxypropyl cellulose | 16 | LH-21 | 13.3% |
| Calcium carboxymethylcellulose | 5 | / | 4.2% |
| Magnesium stearate | 1.2 | / | 1.0% |
| Gross weight | 120 | / | / |
The preparation method is as follows: weighing sodium rabeprazole enteric-coated sustained-release micro-spheres made from example 2, magnesia, sweet by recipe quantity
Reveal alcohol, hydroxypropyl cellulose and low-substituted hydroxypropyl cellulose, it is soft as wetting agent system that ethanol in proper amount is added after mixing
Material, the granulation of 24 meshes set 60 ± 5 DEG C of drying in baking oven, cross 24 mesh sieves, calcium carboxymethylcellulose and stearic acid is then added
Magnesium is uniformly mixed, and obtains particulate matter, the circle stamping of Φ 6.5mm scrobicula, every nearly weighs 120mg.
(example 3)
The sodium rabeprazole enteric-coated sustained-release micro-spheres of this example the preparation method is as follows:
1. by 100g RABEPRAZOLE SODIUM, 200g Utech L 30D-55 and 100g Utech S 100(weight ratio 1: 3) being dissolved in
In the isopropanol of 2600g, mixed solution is obtained.
2. setting 100 DEG C of inlet temperature of spray dryer (Yamato DL410), atomizing pressure 0.1MPa, air quantity 0.8m3/
Min is spray-dried above-mentioned mixed solution, and the powder after spray drying is dried in vacuo again, obtains Rabeprazole
Sodium enteric slow release microballoon.
(embodiment 3)
Granule is made using sodium rabeprazole enteric-coated sustained-release micro-spheres made from example 3, formula is shown in Table 3.
Table 3
| Ingredient | Mg/ parts of single dose | Specifications and models | Weight percent |
| Sodium rabeprazole enteric-coated sustained-release micro-spheres made from example 3 | 40 | / | 33.3% |
| Magnesia | 20 | / | 16.7% |
| Microcrystalline cellulose | 39 | PH 101 | 32.5% |
| Hydroxypropyl methyl cellulose | 11 | E 5 | 9.2% |
| Low-substituted hydroxypropyl cellulose | 10 | LH-21 | 8.3% |
| Gross weight | 120 | / | / |
The preparation method is as follows: weighing sodium rabeprazole enteric-coated sustained-release micro-spheres made from example 3, magnesia, micro- by recipe quantity
Ethanol in proper amount is added as profit in crystalline cellulose, hydroxypropyl methyl cellulose and low-substituted hydroxypropyl cellulose after mixing
60 ± 5 DEG C of drying in baking oven are set in humectant softwood, the granulation of 24 meshes, cross 24 mesh sieves to get sodium rabeprazole enteric-coated sustained release
Microsphere particle agent.
(example 4)
The sodium rabeprazole enteric-coated sustained-release micro-spheres of this example the preparation method is as follows:
1. by 100g RABEPRAZOLE SODIUM and 400g Utech L 100-55(weight ratio 1: 4) being dissolved in 1500g concentration is 80wt%'s
In ethanol solution, mixed solution is obtained.
2. setting 100 DEG C of inlet temperature of spray dryer (Yamato DL410), atomizing pressure 0.1MPa, air quantity 0.8m3/
Min is spray-dried above-mentioned mixed solution, and the powder after spray drying is dried in vacuo again, obtains Rabeprazole
Sodium enteric slow release microballoon.
(embodiment 4)
Tablet is made using sodium rabeprazole enteric-coated sustained-release micro-spheres made from example 4, formula is shown in Table 4.
Table 4
| Ingredient | Single dose mg/ piece | Specifications and models | Weight percent |
| Sodium rabeprazole enteric-coated sustained-release micro-spheres made from example 4 | 50 | / | 41.7% |
| Lactose | 35 | 200 mesh | 29.2% |
| Mannitol | 20 | / | 16.7% |
| Hydroxypropyl cellulose | 8 | NISSO HPC-SL FP | 6.7% |
| Crospovidone | 6 | XL-10 | 5.0% |
| Magnesium stearate | 1 | / | 0.8% |
| Gross weight | 120 | / | / |
The preparation method is as follows: weighing sodium rabeprazole enteric-coated sustained-release micro-spheres, lactose, sweet dew made from example 4 by recipe quantity
Ethanol in proper amount is added as wetting agent softwood, 24 mesh Shai Zhi in alcohol, hydroxypropyl cellulose and crospovidone after mixing
Grain sets 60 ± 5 DEG C of drying in baking oven, crosses 24 mesh sieves, magnesium stearate is then added, is uniformly mixed, obtains particulate matter, Φ
6.5mm scrobicula justifies stamping, and every nearly weighs 120mg.
(test case 1)
Acid-resistant strength measurement is carried out to sodium rabeprazole enteric-coated sustained-release micro-spheres made from 1~example of example 4.
Measuring method: precision weighs sodium rabeprazole enteric-coated sustained-release micro-spheres (thunder containing 10mg made from 1~example of example 4
Shellfish draws azoles sodium), referring to the second method method 1 in four 0931 dissolution methods of general rule of " Chinese Pharmacopoeia " version in 2015, with
0.1mol/L hydrochloric acid solution 700mL is dissolution medium, and revolving speed 100r/min is operated according to methods, and is dissolved out when measuring 120min, as a result
It is shown in Table 5.
(test case 2)
Entrapment efficiency determination is carried out to sodium rabeprazole enteric-coated sustained-release micro-spheres made from 1~example of example 4.
Measuring method: precision weighs sodium rabeprazole enteric-coated sustained-release micro-spheres 0.10g made from 1~example of example 4, is placed in
In 100mL measuring bottle, add purified water constant volume, shake up, dissolve non-encapsulated RABEPRAZOLE SODIUM, is centrifuged, supernatant is taken (to filter when necessary
Cross), the hydrochloric acid of 1mL, 1mol/L is then added, is used as test sample after standing 15min, separately takes the conduct pair of RABEPRAZOLE SODIUM standard items
According to product.According to ultraviolet-visible spectrophotometry, the absorbance of test solution, reference substance solution is measured respectively, is recorded data, is pressed
External standard method calculates the amount of dissolution.Another precision weighs sodium rabeprazole enteric-coated sustained-release micro-spheres 0.10g made from 1~example of example 4, with pH
=7.0 buffer solution is measured in the same method absorbance, calculates RABEPRAZOLE SODIUM total amount in microsphere sample.Encapsulation rate %=(total drug containing
Amount-do not encapsulate RABEPRAZOLE SODIUM)/total content of dispersion × 100%.As a result 5 are still shown in Table.
(test case 3)
Particle size determination is carried out to sodium rabeprazole enteric-coated sustained-release micro-spheres made from 1~example of example 4.
Measuring method: precision weighs sodium rabeprazole enteric-coated sustained-release micro-spheres 1.0g made from 1~example of example 4, uses
Malvern particle instrument measures partial size, and measuring method is dry method, and D90 result is still shown in Table 5.
Table 5
| Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | |
| 120min dissolution | 8% | 1% | 9% | 2% |
| Encapsulation rate | 92% | 96% | 94% | 97% |
| D90 partial size | 77.6μm | 49.3μm | 58.2μm | 81.9μm |
As can be seen from Table 5: sodium rabeprazole enteric-coated sustained-release micro-spheres acid-resistant strength produced by the present invention is preferable, in acid
The dissolution of 120min is no more than 10%, it is ensured that and it is non-degradable in gastric acid after taking, reach enteric effect.Drug encapsulation simultaneously
Rate is greater than 90%, and drugloading rate is high, and microspherulite diameter narrow range.
(test case 4)
Dissolution determination is carried out to oral solid formulation made from 1~embodiment of embodiment 4.
Measuring method is referring to the second method method in four 0931 dissolution methods of general rule of " Chinese Pharmacopoeia " version in 2015
1, dissolution medium is the phosphate buffer of pH=6.8, and revolving speed 50r/min operates according to methods, respectively at 5min, 10min,
Dissolution rate is measured by sampling when 15min, 20min, 30min and 45min, the results are shown in Table 6.
Table 6
| Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | |
| 5min | 0% | 0% | 0% | 0% |
| 10min | 4% | 0% | 7% | 12% |
| 15min | 45% | 33% | 51% | 54% |
| 20min | 71% | 65% | 77% | 75% |
| 30min | 85% | 82% | 89% | 90% |
| 45min | 96% | 98% | 92% | 94% |
As can be seen from Table 6, RABEPRAZOLE SODIUM produced by the present invention can effectively delay drug dissolution rate in vitro and
Dissolution rate has commercialized feasibility to improve the bioavilability of drug.
Claims (9)
1. a kind of preparation method of sodium rabeprazole enteric-coated sustained-release micro-spheres, it is characterised in that have follow steps:
1. RABEPRAZOLE SODIUM and Utech are dissolved with solvent, mixed solution is obtained；
2. 1. mixed solution that step obtains is spray-dried, then it is vacuum dried obtain it is sodium rabeprazole enteric-coated sustained release it is micro-
Ball.
2. the preparation method of sodium rabeprazole enteric-coated sustained-release micro-spheres according to claim 1, it is characterised in that: above-mentioned steps
Utech described in 1. in Utech L 100-55, Utech L 30D-55, Utech L 100, Utech S 100 one
Kind is two or more.
3. the preparation method of sodium rabeprazole enteric-coated sustained-release micro-spheres according to claim 1, it is characterised in that: above-mentioned steps
1. solvent described in is one of ethyl alcohol, water, isopropanol or two or more.
4. the preparation method of sodium rabeprazole enteric-coated sustained-release micro-spheres according to claim 1, it is characterised in that: above-mentioned steps
1. the weight ratio of RABEPRAZOLE SODIUM described in and the Utech is 1: 1~1: 4.
5. the preparation method of sodium rabeprazole enteric-coated sustained-release micro-spheres according to claim 4, it is characterised in that: above-mentioned steps
1. the weight ratio of RABEPRAZOLE SODIUM described in and the Utech is 1: 2.
6. a kind of oral administration solid containing sodium rabeprazole enteric-coated sustained-release micro-spheres made from one of claim 1 to 5 the method
Preparation.
7. oral solid formulation according to claim 6, it is characterised in that: the oral solid formulation is tablet, granule
Or capsule.
8. oral solid formulation according to claim 6, it is characterised in that: the oral solid formulation is by RABEPRAZOLE SODIUM intestines
Molten sustained-release micro-spheres and pharmaceutically acceptable auxiliary material are made；The pharmaceutically acceptable auxiliary material include but is not limited to filler,
Adhesive, disintegrating agent, lubricant.
9. oral solid formulation according to claim 8, it is characterised in that:
The filler is one of lactose, microcrystalline cellulose, magnesia, mannitol or two or more；
Described adhesive is polyvinylpyrrolidone, hydroxypropyl methyl cellulose, one of hydroxypropyl cellulose or two kinds
More than；
The disintegrating agent is one of low-substituted hydroxypropyl cellulose, crospovidone, calcium carboxymethylcellulose or two kinds
More than；
The lubricant is one of talcum powder, magnesium stearate, colloidal silicon dioxide or two or more.
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| CN201811010986.5A CN109078007A (en) | 2018-08-31 | 2018-08-31 | The preparation method of sodium rabeprazole enteric-coated sustained-release micro-spheres and oral solid formulation containing sodium rabeprazole enteric-coated sustained-release micro-spheres |
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR101845665B1 (en) * | 2017-06-30 | 2018-04-04 | 롯데정밀화학 주식회사 | Oral solid formulation composition comprising proton pump inhibitor, oral solid formulation comprising the same and manufacturing method thereof |
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2018
- 2018-08-31 CN CN201811010986.5A patent/CN109078007A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR101845665B1 (en) * | 2017-06-30 | 2018-04-04 | 롯데정밀화학 주식회사 | Oral solid formulation composition comprising proton pump inhibitor, oral solid formulation comprising the same and manufacturing method thereof |
Non-Patent Citations (4)
| Title |
|---|
| R. P. RAFFIN ET AL: "Powder Characteristics of Pantoprazole Delivery Systems Produced in Different Spray-Dryer Scales", 《DRYING TECHNOLOGY》 * |
| 刘文: "《药用高分子材料学》", 30 June 2017, 北京：中国中医药出版社 * |
| 杨宗发主编: "《药物制剂设备》", 30 April 2012, 北京：人民军医出版社 * |
| 邹品文等: "质子泵抑制剂研究进展和研究方向", 《中国药业》 * |
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Application publication date: 20181225 |