CN105030725B - Vonoprazan fumarate enteric-coated composition and preparation method thereof - Google Patents
Vonoprazan fumarate enteric-coated composition and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a Vonoprazan fumarate enteric-coated capsule and a preparation method thereof, in particular to a pellet type Vonoprazan fumarate capsule and a preparation method thereof, belonging to the technical field of medicines. The vonoprazan fumarate capsule sequentially comprises a blank pill core, a main medicine layer, an isolation layer, an enteric-coated layer and a capsule shell from inside to outside, wherein the weight of the main medicine layer is 80-130% of that of the blank pill core, the weight of the isolation layer is 10-30% of the total weight of the blank pill core and the main medicine layer, and the weight of the enteric-coated layer is 30-80% of that of the blank pill core, the main medicine layer and the isolation layer. Each capsule contains 10-20mg of Vonoprazan. The technical scheme of the invention improves the dispersibility of the vonoprazan fumarate and improves the dissolution rate.
Description
Technical Field
The invention relates to a Vonoprazan fumarate enteric-coated composition and a preparation method thereof, in particular to a pellet type Vonoprazan fumarate capsule and a preparation method thereof, and belongs to the technical field of medicines.
Background
vonoprazan fumarate, the chemical name of which is 1- [5- (2-fluorophenyl) -1- (pyridine-3-sulfonyl) -1H-pyrrole-3-yl ] -N-methyl methylamine fumarate, the molecular formula is C 17 H 16 FN 3 O 2 S.C 4 H 4 O 4, the molecular weight is 461.4, the chemical formula is shown in formula I.
Formula I
Vonoprazan fumarate belongs to a new inhibitor of potassium ion (K) competitive acid retarder (P-CAB), has strong and durable gastric acid secretion inhibition effect, and simultaneously has early termination effect on gastric acid secretion by inhibiting the combination effect of K on H, K-ATP enzyme (proton pump) in the last step of gastric acid secretion of gastric parietal cells. Can be used for treating erosive esophagitis, gastric ulcer, duodenal ulcer, and helicobacter pylori eradication indication.
At present, the commercially available vonoprazan fumarate is a common tablet released in the stomach, and in-vitro dissolution experiments show that the vonoprazan fumarate can form crystal precipitation in a medium with the pH value of 1.0, and the obtained results of each in-vitro dissolution are different, which indicates that the release in the stomach is unstable. Since the pH value of the adult gastric juice is 0.9-1.5, it can be expected that the release of the vonoprazan fumarate ordinary tablet in the gastric juice is unstable, and the absorption of the drug and the treatment effect are influenced due to different pH values of the gastric juice. At present, no report is made on vonoprazan fumarate enteric-coated preparation.
Disclosure of Invention
The purpose of the invention is as follows: provides a stable release Vonoprazan fumarate preparation and a preparation method thereof, so as to solve the problem of unstable release of Vonoprazan fumarate.
In order to solve the technical problems, the invention provides a pellet type Vonoprazan enteric-coated preparation. The enteric preparation can be tablets or capsules.
The technical scheme of the invention is as follows: the Vonoprazan fumarate capsule is characterized by consisting of a common capsule shell and Vonoprazan fumarate enteric-coated pellets contained in the capsule shell, wherein each capsule contains 10-20mg of Vonoprazan.
The Vonoprazan fumarate capsule is characterized by sequentially comprising a blank pill core, a main medicine layer, an isolating layer and an enteric layer from inside to outside, wherein the weight of the main medicine layer is 80-130% of that of the blank pill core, the weight of the isolating layer is 10-30% of the total weight of the blank pill core and the main medicine layer, and the weight of the enteric layer is 30-80% of that of the blank pill core, the main medicine layer and the isolating layer.
The blank pellet core has the diameter of 0.25-1.0 mm, and the granularity of the Vonoprazan fumarate pellet is 14-30 meshes.
The blank pill core in the technical scheme of the invention is a blank sugar pill, can be prepared by self and can also be purchased as a commercial product.
Preferably, the main medicine layer consists of a binder and Vonoprazan fumarate, wherein the dosage of the binder is 5-20% of the weight of the Vonoprazan fumarate is 60-120% of the weight of the Vonoprazan fumarate. More preferably 80 to 110%. Wherein the binder comprises hypromellose, hyprolose, povidone, sodium carboxymethylcellulose and other cellulose derivatives.
Preferably, the release layer consists of a binder and a lubricant. The adhesive is filled in the core of white pill and 5-15% of the main medicine layer, and the lubricant is filled in the core of white pill and 10-15% of the main medicine layer. Wherein the binder comprises hypromellose, hyprolose, povidone, sodium carboxymethylcellulose and other cellulose derivatives. The lubricant comprises glyceryl monostearate, silica and talc powder.
Preferably, the enteric layer is composed of an enteric material, a plasticizer and a lubricant. The enteric material is L30D-55, L100-55 or domestic polypropylene resin II. The plasticizer is triethyl citrate. The lubricant comprises glyceryl monostearate and pulvis Talci. The enteric material accounts for 20-45% of the total weight, the triethyl citrate accounts for 2-5% of the total weight, and the lubricant accounts for 1-2% of the total weight.
The preparation method of the vonoprazan fumarate enteric-coated capsule is characterized by comprising the following steps:
Step 1, preparing a blank pellet core; the preparation process comprises the following steps: pulverizing sucrose, and sieving with 80 mesh sieve. Gradually spraying an adhesive prepared by adding sucrose in a centrifugal granulator under the condition of high-speed rotation, then sieving by a 50-mesh sieve, collecting wet blank sugar pills, and then drying to obtain the sugar pills;
And 2, preparing a main medicine layer, and slowly adding hydroxypropyl methylcellulose into purified water under stirring. After the dispersion is uniform, adding Vonoprazan fumarate, supplementing purified water to the required amount, stirring uniformly, sieving with a 80-mesh sieve to obtain a coating solution, placing the blank pellet core in a fluidized bed coating device for bottom spraying of a medicine coating, drying, and sieving with a 24-mesh sieve to obtain pellets of a main medicine layer;
Step 3, preparing an isolation layer, adding an adhesive slowly to dissolve in purified water under stirring, adding a lubricant, adding the purified water to a required amount, uniformly stirring, sieving by a 80-mesh sieve to obtain a coating solution, placing the pellets coated with the main drug layer in a fluidized bed coating device for bottom spraying of an isolation layer coating, drying, and sieving by a 24-mesh sieve to obtain pellets of the isolation layer;
Step 4, preparing an enteric coating layer, adding a lubricant and a plasticizer into purified water, and uniformly stirring; adding enteric material into another purified water, and stirring; mixing the two liquids, stirring, sieving with 80 mesh sieve to obtain coating solution, coating the pellet coated with the isolating layer in a fluidized bed coating device, spraying enteric layer coating, drying, and sieving with 20 mesh sieve to obtain pellet coated with enteric layer;
Step 5, determining the content of the active substance vonoprazan fumarate in the pellets;
And 6, encapsulating, namely encapsulating the obtained pellets into a capsule shell to obtain the pellet type Vonoprazan fumarate enteric-coated capsule.
preferably, the operating conditions of the fluidized bed in step 2 are: the air inlet temperature is 50-55 deg.C, the atomization pressure is 0.1-0.2MPa, the material temperature is 35-40 deg.C, the fan frequency is 15-20HZ, the rotation speed of the peristaltic pump is 5-10rpm, until the coating liquid of the medicine-containing layer is completely loaded, the atomization is stopped, and the material is discharged after drying for 5 min.
Preferably, the operating conditions of the fluidized bed in step 3 are: the air inlet temperature is 50-55 deg.C, the atomization pressure is 0.1-0.2MPa, the material temperature is 35-40 deg.C, the fan frequency is 15-20HZ, the rotation speed of the peristaltic pump is 5-10rpm, until the coating liquid containing the isolation layer is completely loaded, stopping spraying, and continuously drying for 5 min.
Preferably, the operating conditions of the fluidized bed in step 4 are: the air inlet temperature is 50-55 deg.C, the atomization pressure is 0.1-0.2MPa, the material temperature is 35-40 deg.C, the fan frequency is 15-20HZ, the peristaltic pump rotation speed is 5-10rpm, until the enteric layer coating liquid is completely loaded, stopping spraying, and continuously drying for 15 min.
has the advantages that: the vonoprazan fumarate enteric-coated capsule consists of a capsule shell and vonoprazan fumarate pellets contained in the capsule, and the pellets are prepared by uniformly dispersing vonoprazan fumarate in a single dose in a plurality of tiny round chambers, so that the dispersibility of the vonoprazan fumarate is improved, the dissolution rate is improved, the bioavailability is improved, and the medicament has better curative effect reproducibility and smaller adverse reaction. The Vonoprazan fumarate pellet comprises a blank pellet core, a main medicine layer, an isolating layer and an enteric-coated layer from inside to outside in sequence. The main medicine layer is coated outside the blank pill core, so that the specific surface area of the main medicine can be increased. The isolating layer can prevent the influence of the enteric layer on the main medicine. The enteric layer can increase the stability of the main drug in acid liquor, prevent the main drug from being separated out, release the pellet drug in the intestinal tract and improve the curative effect.
Detailed Description
The embodiments of the present invention will be described in detail with reference to specific examples.
Example 1 recipe:
The preparation process comprises the following steps:
Preparing blank pill core
Pulverizing sucrose, and sieving with 80 mesh sieve. Gradually spraying an adhesive prepared by adding sucrose in a centrifugal granulator under the condition of high-speed rotation, then sieving by a 50-mesh sieve, collecting wet blank sugar pills, and then drying to obtain the sugar pills;
Preparing a medicine-containing layer:
Slowly adding hydroxypropyl methylcellulose into purified water under stirring, adding Vonoprazan fumarate after complete dissolution, supplementing the purified water to a required amount, stirring uniformly, sieving with a 60-mesh sieve to obtain a coating solution, spraying a blank pellet core into a fluidized bed coating device for bottom spraying, coating, drying, and sieving with a 40-mesh sieve to obtain a pellet of a main drug layer;
Preparing an isolation layer:
Slowly adding hydroxypropyl cellulose into purified water under stirring for dissolving, adding pulvis Talci, adding purified water to required amount, stirring, sieving with 80 mesh sieve to obtain coating solution, coating the pellet coated with main drug layer in fluidized bed coating device, spraying with isolating layer for coating, drying, and sieving with 35 mesh sieve to obtain pellet with isolating layer;
Preparing an enteric layer:
Adding glyceryl monostearate and triethyl citrate into purified water, and stirring and dispersing uniformly; then evenly stirring the mixture with L30D-55; mixing the two liquids, stirring, sieving with 60 mesh sieve to obtain coating solution, coating the pellet coated with the isolating layer in a fluidized bed coating device, spraying enteric layer coating, drying, and sieving with 20 mesh sieve to obtain pellet coated with enteric layer.
and determining the content of the active substance vonoprazan fumarate in the pellets.
And filling the obtained pellets into a capsule shell according to the specification of containing 10mg of Vonoprazan to obtain the pellet type Vonoprazan fumarate enteric-coated capsule.
Example 2 preparation of Vonoprazan fumarate enteric capsules
Pellets were prepared and the active substance vonoprazan fumarate was measured as in example 1 and filled into capsules of 20mg size.
example 3 preparation of Vonoprazan fumarate enteric capsules
pellets were prepared and the active substance vonoprazan fumarate was measured as in example 1, filled into capsules of 15mg size.
Example 4 preparation of Vonoprazan fumarate enteric capsules
Pellets were prepared and the active substance vonoprazan fumarate was measured as in example 1, filled into capsules of 10mg size.
Example 5 preparation of Vonoprazan fumarate enteric capsules
Pellets were prepared and the active substance vonoprazan fumarate was measured as in example 1 and filled into capsules of 20mg size.
Example 6 preparation of Vonoprazan fumarate enteric capsules
Pellets were prepared and the active substance vonoprazan fumarate was measured as in example 1, filled into capsules of 15mg size.
Example 7 preparation of Vonoprazan fumarate enteric capsules
Pellets were prepared and the active substance vonoprazan fumarate was measured as in example 1 and filled into capsules of 20mg size.
example 8 preparation of Vonoprazan fumarate enteric capsules
Pellets were prepared and the active substance vonoprazan fumarate was measured as in example 1, filled into capsules of 10mg size.
Example 9 preparation of Vonoprazan fumarate enteric capsules
pellets were prepared and the active substance vonoprazan fumarate was measured as in example 1, filled into capsules of 15mg size.
test example 1 examination of the dissolution Profile of a commercially available Vonoprazan fumarate tablet in a medium having a pH of 1.0
The dissolution curve measuring method comprises the following steps: XC second law-paddle method which is an annex of the second part of the 2010 version of Chinese pharmacopoeia; the dissolution curve of the commercial vonoprazan fumarate tablet in a medium with pH1.0 is examined. The results are shown in table 1:
TABLE 1 dissolution Profile of Vonoprazan fumarate Normal tablets in pH1.0 media
Experiments prove that in the medium with the pH value of 1.0, the dissolution of the Vonoprazan fumarate tablet is rather slowed down along with the time. It is observed that vonoprazan fumarate forms crystal precipitates in a medium with a pH value of 1.0. Further, it was found through repeated experiments that the dissolution results of the same batch of samples in the medium of pH1.0 were not consistent and could not be reproduced.
Test example two, examination of the Release Rate of enteric coating weight gain
According to the requirements of the enteric-coated preparation and the auxiliary material, the surface of the drug-containing pellet is covered with an enteric-coated layer with a certain thickness, and the enteric-coated capsule can resist the erosion of hydrochloric acid solution for a long time. Examples one, two and three designed different enteric coating weight gains and examined the effect on release, the results are shown in table 2.
The measurement of the release rate is carried out according to the second method of the second appendix XD of the 2010 edition of Chinese pharmacopoeia:
Release amount in acid: measuring 750ml of 0.1mol/L hydrochloric acid solution, injecting into each dissolution cup, taking 6 granules when the temperature of a dissolution medium is constant at 37 +/-0.5 ℃, respectively putting into the dissolution cups at the rotating speed of 100 revolutions per minute, sucking a proper amount of solution after 2 hours, filtering, finishing sampling and filtering within 30 seconds, and measuring according to a high performance liquid chromatography (appendix VD in the second part of 2010 edition of Chinese pharmacopoeia), and calculating the release degree;
Release amount in buffer: adding 250ml of sodium phosphate solution with the temperature of 37 +/-0.5 ℃ into the acid liquor, continuously operating for 30min, sucking a proper amount of solution, filtering, completing the filtering within 30 seconds from sampling, and measuring according to a high performance liquid chromatography (second appendix VD of 2010 edition of Chinese pharmacopoeia), and calculating the release degree.
table 2 examination of the effect of weight gain of enteric layer coating on Release
Tests prove that the weight of the enteric-coated layer coating is increased within the range of 30-80%, the release amount of the acid in the vonoprazan fumarate enteric-coated capsule is less than 10%, and the release amount of the acid in the buffer solution is more than 85%.
Test example III,
the influence of the amount of hydroxypropylcellulose in the isolation layer on the release rate was examined, and the release rate was determined in the same manner as in test example 2.
examples two, four and five designed different amounts of hydroxypropylcellulose in the barrier layer and examined the effect on release, the results are shown in table 3.
Table 3 shows the influence of different amounts of hydroxypropylcellulose on the release rate
Tests prove that the dosage of the hydroxypropyl cellulose in the second, fourth and fifth examples has little influence on the release amount of acid and the release amount of the buffer solution. The release amount of acid is less than 10%, and the release amount of the buffer solution is more than 85%.
Test example four Effect of enteric Material type on Release degree
examples two, six and seven different enteric materials in the enteric layer were designed, and the influence on the release rate was examined, and the method for measuring the release rate was the same as in test example 2. The results are shown in Table 4.
table 4 examines the effect of different enteric material types on the release degree
Tests prove that the types of the enteric-coated materials in the second, sixth and seventh examples have larger influence on the release amount of acid, wherein the performance of the Ewing L30D-55 is the best, the performance of the Ewing L100-55 is the second, and the polypropylene resin II is the worst.
Test example five, the influence of the content of the main drugs in different proportions on the release degree
In the sixth, eighth and ninth examples, the contents of the main drugs in different proportions are designed, the influence on the release rate is examined, and the method for measuring the release rate is the same as that in test example 2. The results are shown in Table 5.
Table 5 examines the influence of different proportions of main drug content on the release rate
Experiments prove that the main drug contents in different proportions in the sixth, eighth and ninth examples have small influence on the release amount in acid and the release amount in buffer. The release amount of acid is less than 10%, and the release amount of the buffer solution is more than 85%.
Claims (6)
1. A Vonoprazan fumarate enteric-coated capsule comprises a common capsule shell and Vonoprazan fumarate enteric-coated pellets contained in the capsule shell, wherein each capsule contains 10-20mg of Vonoprazan, it is characterized in that the capsule comprises a blank pill core, a main medicine layer, an isolating layer and an enteric-coated layer from inside to outside in sequence, wherein, the main medicine layer consists of adhesive and Vonoprazan fumarate, the dosage of the adhesive is 5-20% of the blank pill core, the weight of the Vonoprazan fumarate is 60-120% of the blank pill core, the weight of the main medicine layer is 80-130% of the blank pill core, the weight of the isolating layer is 10-30% of the total weight of the blank pill core and the main medicine layer, the weight of the enteric coating layer is 30-80% of the total weight of the blank pill core, the main medicine layer and the isolating layer, the diameter of the blank pellet core is 0.25-1.0 mm, and the granularity of the Vonoprazan fumarate pellet is 14-30 meshes.
2. The vonoprazan fumarate enteric capsule of claim 1, wherein the main drug layer is composed of a binder and vonoprazan fumarate, and the binder is used in an amount of 5-20% of the weight of the vonoprazan fumarate and 80-110% of the weight of the vonoprazan fumarate.
3. Vonoprazan fumarate enteric capsule according to claim 1, wherein the binder is selected from hypromellose, hyprolose, povidone, sodium carboxymethylcellulose and other cellulose derivatives.
4. the vonoprazan fumarate enteric capsule of claim 1, wherein the separating layer is composed of a binder and a lubricant, the binder is 5-15% of the blank pellet core and the main drug layer, and the lubricant occupies 10-15% of the blank pellet core and the main drug layer.
5. The vonoprazan fumarate enteric capsule of claim 1, wherein the enteric layer is composed of enteric materials, plasticizers and lubricants, wherein the enteric materials are selected from the group consisting of L30D-55, L100-55 or domestic polypropylene resin II; the plasticizer is selected from triethyl citrate; the enteric material accounts for 20-45% of the total weight, the triethyl citrate accounts for 2-5% of the total weight, and the lubricant accounts for 1-2% of the total weight.
6. the method for preparing vonoprazan fumarate enteric capsule as claimed in claim 1, which comprises the following steps:
Step 1, preparing a blank pellet core; pulverizing sucrose, and sieving with 80 mesh sieve; gradually spraying an adhesive prepared by adding sucrose in a centrifugal granulator under the condition of high-speed rotation, then sieving by a 50-mesh sieve, collecting wet blank sugar pills, and then drying to obtain the sugar pills;
Step 2, preparing a main medicine layer, and slowly adding hydroxypropyl methylcellulose into purified water under stirring; after the dispersion is uniform, adding Vonoprazan fumarate, supplementing purified water to the required amount, stirring uniformly, sieving with a 80-mesh sieve to obtain a coating solution, placing the blank pellet core in a fluidized bed coating device for bottom spraying of a medicine coating, drying, and sieving with a 24-mesh sieve to obtain pellets of a main medicine layer;
step 3, preparing an isolation layer, adding an adhesive slowly to dissolve in purified water under stirring, adding a lubricant, adding the purified water to a required amount, uniformly stirring, sieving by a 80-mesh sieve to obtain a coating solution, placing the pellets coated with the main drug layer in a fluidized bed coating device for bottom spraying of an isolation layer coating, drying, and sieving by a 24-mesh sieve to obtain pellets of the isolation layer;
Step 4, preparing an enteric coating layer, adding a lubricant and a plasticizer into purified water, and uniformly stirring; adding enteric material into another purified water, and stirring; mixing the two liquids, stirring, sieving with 80 mesh sieve to obtain coating solution, coating the pellet coated with the isolating layer in a fluidized bed coating device, spraying enteric layer coating, drying, and sieving with 20 mesh sieve to obtain pellet coated with enteric layer;
Step 5, determining the content of the active substance vonoprazan fumarate in the pellets;
And 6, encapsulating, namely encapsulating the obtained pellets into a capsule shell to obtain the pellet type Vonoprazan fumarate enteric-coated capsule.
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| RU2779057C2 (en) * | 2017-07-10 | 2022-08-31 | Такеда Фармасьютикал Компани Лимитед | Preparation containing vonoprazan |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN106074431A (en) * | 2016-06-12 | 2016-11-09 | 佛山市腾瑞医药科技有限公司 | A kind of Vonoprazan fumarate preparation and application thereof |
| SG11202000136YA (en) * | 2017-07-10 | 2020-02-27 | Takeda Pharmaceuticals Co | Preparation comprising vonoprazan |
| UY39094A (en) * | 2020-02-27 | 2021-07-30 | Hk Inno N Corp | PHARMACEUTICAL COMPOSITION INCLUDING BENZIMIDAZOLE DERIVATIVE COMPOUND |
| CN112353802A (en) * | 2020-11-26 | 2021-02-12 | 山东诚创蓝海医药科技有限公司 | Vonola fumarate taste masking composition and application thereof |
| CN114853728B (en) * | 2022-05-07 | 2023-11-07 | 四川制药制剂有限公司 | Vonopraz fumarate tablet and preparation method thereof |
| CN117503707A (en) * | 2022-08-05 | 2024-02-06 | 哈尔滨市康隆药业有限责任公司 | Taste-masking microsphere and preparation process and application thereof |
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Effective date of registration: 20210826 Address after: No.1 Qingdao South Road, Weihai Economic and Technological Development Zone, Shandong Province Patentee after: DISHA PHARMACEUTICAL GROUP Co.,Ltd. Address before: No.1 Qingdao South Road, Weihai Economic and Technological Development Zone, Shandong Province Patentee before: DISHA PHARMACEUTICAL GROUP Co.,Ltd. Patentee before: Dijia Pharmaceutical Group Co.,Ltd. |
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| PE01 | Entry into force of the registration of the contract for pledge of patent right | ||
| PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: Vorolazan fumarate enteric coated composition and its preparation method Effective date of registration: 20220721 Granted publication date: 20191210 Pledgee: Bank of China Limited Weihai Branch Pledgor: DISHA PHARMACEUTICAL GROUP Co.,Ltd. Registration number: Y2022980010828 |