CN111214457A - Esomeprazole magnesium enteric-coated pellet preparation and preparation method thereof - Google Patents
Esomeprazole magnesium enteric-coated pellet preparation and preparation method thereof Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
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- 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
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- 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
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- 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
- A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
- A61K9/5089—Processes
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- 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
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Abstract
The invention discloses a preparation method of esomeprazole magnesium enteric-coated pellets, belonging to the field of pharmaceutical preparations, wherein the preparation method comprises the steps of (1) preparing a drug-containing pellet core, and carrying out spray coating on 80-300 parts by weight of sucrose pellet core by using a bottom spraying mode in a fluidized bed to form a drug-containing pellet core; (2) coating the isolating coating layer, and performing isolating coating on the pill-containing core in a fluidized bed by bottom spraying. (3) Coating the enteric coating layer, and coating the enteric coating layer on the drug-containing pellet core coated with the isolation coating in a bottom spraying manner in a fluidized bed to obtain the enteric coated pellet with 18-20 meshes. The enteric coating material is Eudragit series acrylic resin, has good moldability and plasticity, is colorless and tasteless, has good flexibility and good crack resistance, and shows good stability under the conditions of heat, light, air and certain humidity. Compared with L30D-55 used traditionally, the coating material has the characteristics of high viscosity, small dosage, suitability for quick coating and good color reproducibility. The coating material is applied to the enteric coating of esomeprazole magnesium pellets for the first time.
Description
Technical Field
The invention belongs to the technical field of pharmaceutical preparations, relates to a pharmaceutical preparation taking esomeprazole magnesium as an active ingredient, and particularly relates to an esomeprazole magnesium enteric-coated pellet preparation and a preparation method thereof.
Technical Field
Esomeprazole (Esomeprazole) is the levorotatory isomer of omeprazole, the first global isomer Proton Pump Inhibitor (PPI) developed by the company asikang, and is used for treating gastroesophageal reflux disease (GERD), Helicobacter Pylori (HP) positive peptic ulcer and gastric acid-related digestive system disorder mainly by specifically inhibiting the proton pump of parietal cells and further reducing gastric acid secretion. Compared with omeprazole, esomeprazole, a new generation product of omeprazole, which is introduced by the original research company in 2002, has the advantages of lower liver metabolic rate, higher blood concentration and bioavailability and stronger acid inhibition effect.
However, esomeprazole drug substance is unstable in acidic and neutral media and degrades particularly rapidly in acidic environments. At the same time, moisture, heat, organic solvents and to some extent light also have an influence on the stability of the active compounds. Thus, most of the marketed oral formulations block direct contact of esomeprazole with gastric fluid by means of a means and mostly take the form of a hydrate of its pharmaceutically acceptable salt, e.g. esomeprazole magnesium trihydrate, formula C34H36N6O6S2 Mg.3H 2O, chemical name 5-methoxy-2- [ (S) - [ (4-methoxy-3, 5-dimethylpyridin-2-yl) methyl ] sulfinyl ] -benzimidazole magnesium salt (2: 1) trihydrate.
The Chinese invention patent CN102100671A discloses an esomeprazole magnesium enteric-coated pellet and a preparation method thereof, wherein an active pellet core of the enteric-coated pellet consists of esomeprazole magnesium and other medicinal excipients, and the enteric-coated pellet is finally prepared by coating an isolation layer and an enteric layer by layer. However, the isolating layer of the pellet does not contain an acid-base regulator, and when the active ingredient migrates to the isolating layer from inside to outside along with the prolonged storage time, the active ingredient is decomposed by contacting with an acidic enteric material (methacrylic acid), thereby reducing the curative effect of the drug.
The Chinese invention patent CN102670521A discloses an esomeprazole magnesium enteric-coated pellet and a preparation method thereof, wherein pH values of the enteric-coated pellet are respectively adjusted by using an acid-base regulator in a drug-containing layer and an isolating layer, so that the stability of esomeprazole magnesium is enhanced. In addition, the components such as solubilizer, medicinal talcum powder, adhesive and the like are used for ensuring the quick release and the high-efficiency absorption of esomeprazole magnesium in a human body. However, the addition of the alkalizer to the drug-containing layer leads to a decrease in drug-loading efficiency, and at the same time, the coating time is too long, which wastes manpower and material resources.
Disclosure of Invention
Aiming at the technical problems, the esomeprazole magnesium enteric-coated pellet preparation with high release degree and strong stability is obtained by improving the production formula process and repeated experimental demonstration, so that the defects of the conventional process are overcome, and the large-scale production requirements of enterprises at the present stage are met.
In particular to an application of Eudragit series acrylic resin in the preparation of esomeprazole magnesium enteric-coated pellets. The whole process adopts the bottom spraying mode of a fluidized bed coating machine for coating, so that the content uniformity of the drug coating is better, and the problem of uneven coating of an extrusion spheronizer and a centrifugal coating machine is solved. The enteric coating material adopted by the invention is a novel polyacrylic resin emulsion, has good moldability and plasticity, and the obtained enteric coating is colorless, tasteless, good in flexibility, good in crack resistance and good in stability under the conditions of heat, light, air and certain humidity. Compared with L30D-55 used traditionally, the coating material has the characteristics of high viscosity, small dosage, suitability for quick coating and good color reproducibility. The coating material is applied to the enteric coating of the esomeprazole magnesium pellet for the first time, and magnesium oxide is added into the coating of the isolating layer to serve as an acid-base regulator, so that the drug loading efficiency is improved.
The preparation method of the esomeprazole magnesium enteric-coated pellet comprises the following steps:
a) preparation of drug-containing pellet core
Firstly dispersing 2-10 parts by weight of povidone in 50-200 parts by weight of medicinal ethanol, adding 50-100 parts by weight of purified water, adding 30 parts by weight of 20 mu m esomeprazole magnesium trihydrate after the povidone is completely swelled to prepare a drug-containing coating liquid, and carrying out spray coating on the drug-containing coating liquid in a bottom spraying manner in a fluidized bed to form a drug-containing pellet core on 250 parts by weight of 180-one sugar pellet core.
b) Isolating layer coating
Adding HPMC E5 into a proper amount of 65% ethanol, slowly stirring in a water bath at 50-60 deg.C to fully dissolve, adding pulvis Talci into the rest 65% ethanol, homogenizing with a high-shear homogenizer for 10min (rotation speed is 3500 rpm), slowly pouring the pulvis Talci suspension into HPMC solution, stirring, sieving with 80 mesh sieve to obtain coating solution for the isolating layer, and coating the drug-containing pellet core with the isolating layer by bottom-spraying in a fluidized bed.
c) Enteric layer coating
Dissolving Eudragit L30D-55 in a proper amount of water, then adding talcum powder, titanium dioxide and triethyl citrate into the rest of water, homogenizing for 10min by using a high-shear homogenizer (the rotating speed is 3500 rpm), slowly pouring the suspension of the talcum powder, the titanium dioxide and the triethyl citrate into the Eudragit L30D-55 solution, fully stirring, sieving by using a 80-mesh sieve to obtain an enteric-coated coating solution, and coating the drug-containing pellet cores coated with the barrier coats in a bottom spraying manner in a fluidized bed to obtain the esomeprazole magnesium enteric-coated pellets.
Furthermore, povidone is used as a binder in the drug-containing pellet core.
Furthermore, in the pill-containing core, a sucrose pill core is used as a blank pill core.
Further, the gastric-soluble film coating premix coated by the isolating layer is hydroxypropyl methylcellulose, talcum powder and magnesium oxide, and an acid value regulator magnesium oxide is particularly added to inhibit the reduction of the curative effect of the medicament.
Further, the film forming agent used for the enteric layer coating is Eudragit series acrylic resin.
Furthermore, the enteric coating also comprises lubricant talcum powder, opacifier titanium dioxide and plasticizer polyethylene glycol.
Further, a fluidized bed coating machine is adopted for preparing the pill-containing core, and the parameters are preheating to 40 ℃, the air inlet temperature is 50-55 ℃, the rotation speed of a peristaltic pump is 50 r/min, the air quantity is 30HZ, the pressure of a needle valve is 1.6bar, and the bottom spraying pressure is 2.5 bar; the barrier coat coating adopts a fluidized bed coating machine, and the parameters are preheating to 45 ℃, the air inlet temperature is 50 ℃, the rotating speed of a peristaltic pump is 5.5-7.5 r/min, the air quantity is 30-38HZ, the pressure of a needle valve is 2.2bar, and the bottom spraying pressure is 3 bar; the enteric coating adopts a fluidized bed coating machine, and the parameters are preheating to 40 ℃, the air inlet temperature is 35-40 ℃, the rotating speed of a peristaltic pump is 25-35 r/min, the air quantity is 35-40HZ, the pressure of a needle valve is 2bar, and the bottom spray pressure is 2.5-3 bar.
Compared with the prior art, the invention adopting the technical scheme has the following advantages:
the acid-base regulator in the drug-loaded layer is removed, the coating efficiency is improved, the coating time is reduced, and the waste of manpower and material resources is avoided.
And secondly, an acid-base regulator magnesium oxide is added into the isolation layer, so that the drug loading efficiency is well improved.
And thirdly, coating is carried out by adopting a bottom spraying mode of a fluidized bed coating machine, so that the content uniformity of the medicament coating is better, and the problem of uneven coating of an extrusion spheronizer and a centrifugal coating machine is solved.
And the Eudragit series acrylic resin is used as a film forming agent, so that the bioavailability is improved, the safety and the effectiveness of the medicine are guaranteed, the safety, the energy saving and the pollution prevention are realized, the time and the labor are saved, and the cost is low.
Detailed Description
Example 1
Firstly dispersing 2 parts by weight of povidone into 50 parts by weight of medicinal ethanol, adding 50 parts by weight of purified water, stirring and adding 30 parts by weight of 20 mu m esomeprazole magnesium trihydrate after the povidone is completely swelled to prepare the drug-containing coating liquid. Spraying and coating the drug-containing coating liquid to 180 parts by weight of sucrose pellet cores in a bottom spraying manner in a fluidized bed to form drug-containing pellet cores;
adding HPMC E5 into a proper amount of 65% ethanol, slowly stirring in a water bath at 50-60 ℃ to fully dissolve the HPMC, then adding talcum powder into the rest 65% ethanol, homogenizing by a high-shear homogenizer for 10min (the rotation speed is 3500 rpm), slowly pouring the talcum powder suspension into the HPMC solution, fully stirring, sieving by a 80-mesh sieve to obtain an isolating layer coating solution, and carrying out isolating coating on the drug-containing pill cores in a fluidized bed in a bottom spraying manner.
Dissolving Eudragit L30D-55 in a proper amount of water, then adding talcum powder, titanium dioxide and triethyl citrate into the rest water, homogenizing for 10min by a high-shear homogenizer (the rotating speed is 3500 rpm), slowly pouring the suspension of the talcum powder, the titanium dioxide and the triethyl citrate into the Eudragit L30D-55 solution, fully stirring, sieving by a 80-mesh sieve to obtain an enteric-coated coating solution, and coating the drug-containing pellet cores coated with the isolating coat by using the enteric-coated coating solution in a bottom spraying manner in a fluidized bed to obtain the enteric-coated pellets with 18-20 meshes.
Example 2
Firstly, dispersing 5 parts by weight of povidone in 100 parts by weight of medicinal ethanol, adding 70 parts by weight of purified water, stirring and adding 30 parts by weight of 20 mu m esomeprazole magnesium trihydrate after the povidone is completely swelled to prepare the drug-containing coating liquid. Spraying and coating the drug-containing coating liquid to 180 parts by weight of sucrose pellet cores in a bottom spraying manner in a fluidized bed to form drug-containing pellet cores;
adding HPMC E5 into a proper amount of 65% ethanol, slowly stirring in a water bath at 50-60 ℃ to fully dissolve the HPMC, then adding talcum powder into the rest 65% ethanol, homogenizing by a high-shear homogenizer for 10min (the rotation speed is 3500 rpm), slowly pouring the talcum powder suspension into the HPMC solution, fully stirring, sieving by a 80-mesh sieve to obtain an isolating layer coating solution, and carrying out isolating coating on the drug-containing pill cores in a fluidized bed in a bottom spraying manner.
Dissolving Eudragit L30D-55 in a proper amount of water, then adding talcum powder, titanium dioxide and triethyl citrate into the rest water, homogenizing for 10min by a high-shear homogenizer (the rotating speed is 3500 rpm), slowly pouring the suspension of the talcum powder, the titanium dioxide and the triethyl citrate into the Eudragit L30D-55 solution, fully stirring, sieving by a 80-mesh sieve to obtain an enteric-coated coating solution, and coating the drug-containing pellet cores coated with the isolating coat by using the enteric-coated coating solution in a bottom spraying manner in a fluidized bed to obtain the enteric-coated pellets with 18-20 meshes.
Example 3
Firstly, dispersing 10 parts by weight of povidone into 200 parts by weight of medicinal ethanol, adding 100 parts by weight of purified water, stirring and adding 30 parts by weight of 20 mu m esomeprazole magnesium trihydrate after the povidone is completely swelled to prepare the drug-containing coating liquid. Spraying and coating the drug-containing coating liquid to 180 parts by weight of sucrose pellet cores in a bottom spraying manner in a fluidized bed to form drug-containing pellet cores;
adding HPMC E5 into a proper amount of 65% ethanol, slowly stirring in a water bath at 50-60 ℃ to fully dissolve the HPMC, then adding talcum powder into the rest 65% ethanol, homogenizing by a high-shear homogenizer for 10min (the rotation speed is 3500 rpm), slowly pouring the talcum powder suspension into the HPMC solution, fully stirring, sieving by a 80-mesh sieve to obtain an isolating layer coating solution, and carrying out isolating coating on the drug-containing pill cores in a fluidized bed in a bottom spraying manner.
Dissolving Eudragit L30D-55 in a proper amount of water, then adding talcum powder, titanium dioxide and triethyl citrate into the rest water, homogenizing for 10min by a high-shear homogenizer (the rotating speed is 3500 rpm), slowly pouring the suspension of the talcum powder, the titanium dioxide and the triethyl citrate into the Eudragit L30D-55 solution, fully stirring, sieving by a 80-mesh sieve to obtain an enteric-coated coating solution, and coating the drug-containing pellet cores coated with the isolating coat by using the enteric-coated coating solution in a bottom spraying manner in a fluidized bed to obtain the enteric-coated pellets with 18-20 meshes.
The detection of the three examples shows that the quality reproducibility of the three batches of products is good, and the process is safe and reliable.
The stability test results are as follows
Compared with the patent CN105193767, the acid-base blender is added into the isolation layer, so that the tolerance is more stable; compared with patent CN104606146, the whole process adopts the bottom spraying mode of a fluidized bed coating machine to coat, so that the uniformity of the coating content of the medicine is better, and the problem of uneven coating of an extrusion spheronizer and a centrifugal coating machine is solved.
Claims (7)
1. A preparation method of esomeprazole magnesium enteric-coated pellets comprises the following steps of sequentially preparing a drug-containing pellet core, an isolation coating layer and an enteric coating layer from inside to outside:
(1) preparation of drug-containing pellet core
Dispersing 2-10 parts by weight of povidone into 50-200 parts by weight of medicinal ethanol, adding 50-100 parts by weight of purified water, adding 30 parts by weight of 20 mu m esomeprazole magnesium trihydrate after the povidone is completely swelled to prepare a drug-containing coating liquid, and carrying out spray coating on the drug-containing coating liquid in a bottom spraying manner in a fluidized bed until the drug-containing coating liquid is coated on 250 parts by weight of sucrose cores by 180-250 parts by weight to form drug-containing cores;
(2) isolating layer coating
Adding HPMC E5 into a proper amount of 65% ethanol, slowly stirring in a water bath at 50-60 ℃ to fully dissolve the HPMC, then adding talcum powder into the rest 65% ethanol, homogenizing by a high-shear homogenizer for 10min (the rotating speed is 3500 rpm), slowly pouring the talcum powder suspension into the HPMC solution, fully stirring, sieving by a 80-mesh sieve to obtain an isolating layer coating solution, and coating the drug-containing pellet core by an isolating layer in a bottom spraying manner in a fluidized bed;
(3) enteric layer coating
Dissolving Eudragit L30D-55 in a proper amount of water, then adding talcum powder, titanium dioxide and triethyl citrate into the rest of water, homogenizing for 10min by using a high-shear homogenizer (the rotating speed is 3500 rpm), slowly pouring the suspension of the talcum powder, the titanium dioxide and the triethyl citrate into the Eudragit L30D-55 solution, fully stirring, sieving by using a 80-mesh sieve to obtain an enteric-coated coating solution, and coating the drug-containing pellet cores coated with the barrier coats in a bottom spraying manner in a fluidized bed to obtain the esomeprazole magnesium enteric-coated pellets.
2. The process for preparing esomeprazole magnesium enteric pellets according to claim 1, wherein povidone is used as a binder in the core of the drug-containing pellets.
3. The process for preparing esomeprazole magnesium enteric pellets according to claim 1, wherein the drug-containing pellet core is a sucrose pellet core as a blank pellet core.
4. The process for preparing esomeprazole magnesium enteric pellets as claimed in claim 1, wherein the gastric-soluble film-coated premix coated with the isolating layer is hydroxypropyl methylcellulose, talc, magnesium oxide, and especially, the acid value modifier magnesium oxide is added to inhibit the decrease of the therapeutic effect of the drug.
5. The process for preparing esomeprazole magnesium enteric pellets according to claim 1, wherein the film forming agent used for coating the enteric layer is Eudragit series acrylic resin.
6. The process for preparing esomeprazole magnesium enteric pellets as claimed in claim 1, wherein the enteric layer coating further comprises lubricant talc, opacifier titanium dioxide, plasticizer polyethylene glycol.
7. The preparation method of esomeprazole magnesium enteric-coated pellets as claimed in claim 1, wherein the preparation of the drug-containing pellet cores adopts a fluidized bed coating machine, and the parameters are preheating to 40 ℃, air inlet temperature of 50-55 ℃, 50 r/min of the rotation speed of a peristaltic pump, air volume of 30HZ, needle valve pressure of 1.6bar, bottom spraying pressure of 2.5 bar; the barrier coat coating adopts a fluidized bed coating machine, and the parameters are preheating to 45 ℃, the air inlet temperature is 50 ℃, the rotating speed of a peristaltic pump is 5.5-7.5 r/min, the air quantity is 30-38HZ, the pressure of a needle valve is 2.2bar, and the bottom spraying pressure is 3 bar; the enteric coating adopts a fluidized bed coating machine, and the parameters are preheating to 40 ℃, the air inlet temperature is 35-40 ℃, the rotating speed of a peristaltic pump is 25-35 r/min, the air quantity is 35-40HZ, the pressure of a needle valve is 2bar, and the bottom spray pressure is 2.5-3 bar.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111991367A (en) * | 2020-09-21 | 2020-11-27 | 青岛吉达巴尔国际贸易有限公司 | Esomeprazole magnesium pulse pellet capsule and preparation method thereof |
| CN113101276A (en) * | 2021-03-11 | 2021-07-13 | 浙江康德药业集团股份有限公司 | Esciprazole magnesium enteric-coated pellet and capsule and preparation method thereof |
| CN114948898A (en) * | 2022-03-28 | 2022-08-30 | 深圳善康医药科技股份有限公司 | Naltrexone hydrochloride pellet for treating tumors and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104606146A (en) * | 2015-02-11 | 2015-05-13 | 苏州大学 | Esomeprazole enteric coated pellet preparation and preparation method thereof |
| CN105193767A (en) * | 2015-08-25 | 2015-12-30 | 江苏中邦制药有限公司 | Preparation method of esomeprazole magnesium enteric-coated pellets |
| CN108371657A (en) * | 2018-02-27 | 2018-08-07 | 苏州逸纪杰电子科技有限公司 | A kind of preparation method of esomeprazole enteric capsules |
-
2020
- 2020-03-31 CN CN202010241938.8A patent/CN111214457A/en not_active Withdrawn
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104606146A (en) * | 2015-02-11 | 2015-05-13 | 苏州大学 | Esomeprazole enteric coated pellet preparation and preparation method thereof |
| CN105193767A (en) * | 2015-08-25 | 2015-12-30 | 江苏中邦制药有限公司 | Preparation method of esomeprazole magnesium enteric-coated pellets |
| CN108371657A (en) * | 2018-02-27 | 2018-08-07 | 苏州逸纪杰电子科技有限公司 | A kind of preparation method of esomeprazole enteric capsules |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111991367A (en) * | 2020-09-21 | 2020-11-27 | 青岛吉达巴尔国际贸易有限公司 | Esomeprazole magnesium pulse pellet capsule and preparation method thereof |
| CN113101276A (en) * | 2021-03-11 | 2021-07-13 | 浙江康德药业集团股份有限公司 | Esciprazole magnesium enteric-coated pellet and capsule and preparation method thereof |
| CN114948898A (en) * | 2022-03-28 | 2022-08-30 | 深圳善康医药科技股份有限公司 | Naltrexone hydrochloride pellet for treating tumors and preparation method thereof |
| CN114948898B (en) * | 2022-03-28 | 2024-04-30 | 深圳善康医药科技股份有限公司 | Naltrexone hydrochloride pellets for treating tumors and preparation method thereof |
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Application publication date: 20200602 |