CN105030725A - 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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- CN105030725A CN105030725A CN201510527492.4A CN201510527492A CN105030725A CN 105030725 A CN105030725 A CN 105030725A CN 201510527492 A CN201510527492 A CN 201510527492A CN 105030725 A CN105030725 A CN 105030725A
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- nuolazan
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Abstract
The invention relates to a vonoprazan fumarate enteric-coated capsule and a preparation method thereof, particularly relates to a pellet type vonoprazan fumarate enteric-coated capsule and a preparation method thereof, and belongs to the technical field of medicines. The vonoprazan fumarate enteric-coated capsule sequentially comprises a hollow pill core, a main drug layer, an isolation layer, an enteric layer and a capsule layer from inside to outside, wherein the weight of the main drug layer is 80-130 percent of that of the hollow pill core, the weight of the isolation layer is 10-30 percent of the total weight of the hollow pill layer and the main drug layer, and the weight of the enteric layer is 30-80 percent of the total weight of the hollow pill layer, the main drug layer and the isolation layer. Each capsule contains 10-20mg of vonoprazan. By adopting the technical scheme, the dispersion of vonoprazan fumarate is improved, and the dissolution rate is increased.
Description
Technical field
The present invention relates to a kind of fumaric acid Wo Nuolazan enteric-coated composition and preparation method thereof, particularly relate to a kind of micro-pill type fumaric acid Wo Nuolazan capsule and preparation method thereof, belong to medical art.
Background technology
Fumaric acid Wo Nuolazan, its chemistry is by name: 1-[5-(2-fluorophenyl)-1-(pyridine-3-sulfonyl)-1H-pyrroles-3-base]-N-methyl methylamine fumarate, molecular formula: C
17h
16fN
3o
2sC
4h
4o
4, molecular weight: 461.4.Chemical formula is shown in formula I.
Formula I
Fumaric acid Wo Nuolazan belongs to the new class inhibitor of the competitive sour blocker (P-CAB) of potassium ion (K), there is powerful, lasting gastric acid secretion inhibitory action, simultaneously, in the final step of parietal cell gastric acid secretion, by suppressing K to H, the combination of K-ATP enzyme (proton pump), also has premature termination effect to gastric acid secretion.For erosive esophagitis, gastric ulcer, duodenal ulcer, helicobacter pylori eradication indication.
At present, commercially available fumaric acid Wo Nuolazan is the ordinary tablet discharged under one's belt, and In Vitro Dissolution experiment finds, fumaric acid Wo Nuolazan can form crystal and separate out in pH1.0 medium, and each In Vitro Dissolution acquired results is all different, illustrates that it discharges instability under one's belt.Because the pH value of adult's gastric juice is 0.9 ~ 1.5 scope, therefore, can predict, the release of fumaric acid Wo Nuolazan ordinary tablet in gastric juice is unstable, can affect the absorption of medicine, affect therapeutic effect because of the difference of gastric juice pH.At present, the report of fumaric acid Wo Nuolazan enteric coated preparation is not had.
Summary of the invention
Goal of the invention: fumaric acid Wo Nuolazan preparation providing a kind of Stable Release and preparation method thereof, discharges unstable problem to solve fumaric acid Wo Nuolazan.
For solving the problems of the technologies described above, the invention provides a kind of micro-pill type Wo Nuolazan enteric coated preparation.This enteric coated preparation can be sheet, also can be capsule.
Technical scheme of the present invention is: a kind of fumaric acid Wo Nuolazan capsule, is characterized in that, is made up of conventional capsule shell and the fumaric acid Wo Nuolazan enteric coated micropill be contained in this capsule shells, and every capsules is containing Wo Nuolazan 10-20mg.
Fumaric acid Wo Nuolazan capsule of the present invention, it is characterized in that, be followed successively by celphere, main medicament layer, sealing coat, enteric layer from inside to outside, wherein, main medicament layer weight is the 80-130% of celphere, sealing coat weight is the 10-30% of celphere and main medicament layer gross weight, and enteric layer weight is the 30-80% of celphere, main medicament layer and sealing coat gross weight.
The diameter of celphere of the present invention is 0.25-1.0 millimeter, and the granularity of fumaric acid Wo Nuolazan micropill is 14-30 order.
Celphere in technical solution of the present invention, is blank sugar pill, can makes by oneself, also can buy commercially available product.
As preferably, main medicament layer is made up of binding agent and fumaric acid Wo Nuolazan, the 60-120% that its binder dosage accounts for the 5-20% of celphere, fumaric acid Wo Nuolazan weight accounts for celphere.Be more preferably 80-110%.Wherein binding agent comprises hypromellose, hyprolose, polyvidone, carmethose and other cellulose derivatives.
As preferably, sealing coat is made up of binding agent and lubricant.Binding agent accounts for the 5-15% of celphere and main medicament layer, and lubricant accounts for the 10-15% of celphere and main medicament layer.Wherein binding agent comprises hypromellose, hyprolose, polyvidone, carmethose and other cellulose derivatives.Lubricant comprises glyceryl monostearate, silicon dioxide and Pulvis Talci.
As preferably, enteric layer is made up of enteric material, plasticizer and lubricant.The kind of enteric material is L30D-55, L100-55 or domestic acrylic resin II.Plasticizer is triethyl citrate.Lubricant comprises glyceryl monostearate, Pulvis Talci.Enteric material accounts for the 20-45% of gross weight, and triethyl citrate accounts for the 2-5% of gross weight, and lubricant accounts for the 1-2% of gross weight.
The preparation method of fumaric acid Wo Nuolazan enteric coated capsule of the present invention, is characterized in that, comprise the steps:
Step 1, prepares celphere; Preparation process: pulverized by sucrose, crosses 80 eye mesh screens.Under centrifugal granulator high speed rotating condition, spray into the binding agent adding sucrose and be made into gradually, then cross 50 mesh sieves, collect wet blank sugar pill, then drying forms;
Step 2, preparation main medicament layer, in purified water, slowly adds hypromellose under stirring.After being uniformly dispersed, add fumaric acid Wo Nuolazan, purified water is added to aequum, stir, cross 80 mesh sieves and obtain coating solution, celphere is placed in fluidized bed coating equipment and carries out the end and spray medicated bag clothing, drying, crosses 24 mesh sieves, obtains the micropill of main medicament layer;
Step 3, prepare sealing coat, in purified water, slowly add binding agent under stirring and dissolve, add lubricant again, purified water is added to aequum, stir, cross 80 mesh sieves and obtain coating solution, the micropill of coated main medicament layer is placed in fluidized bed coating equipment to carry out the end and spray sealing coat coating, drying, crosses 24 mesh sieves, obtains the micropill of sealing coat;
Step 4, prepares enteric coating layer, adds lubricant and plasticizer, stir in purified water; Add enteric material in another purified water, stir; By above-mentioned two kinds of liquid mixing, stir, cross 80 mesh sieves and obtain coating solution, the micropill of coated sealing coat is placed in fluidized bed coating equipment and carries out the end and spray enteric layer coating, dry, cross 20 mesh sieves, obtain the micropill of coated enteric layer;
Step 5, measures the content of active substance fumaric acid Wo Nuolazan in micropill;
Step 6, encapsulated, gained micropill is incapsulated in shell, obtains micro-pill type fumaric acid Wo Nuolazan enteric coated capsule.
As preferably, in step 2, the operating condition of fluid bed is: inlet temperature is 50-55 DEG C, atomizing pressure is 0.1-0.2MPa, temperature of charge is 35-40 DEG C, blower fan frequency is 15-20HZ, and peristaltic pump rotating speed is 5-10rpm, until the whole loaded of medicated layer coating solution, stop spraying, continue discharging after dry 5min.
As preferably, in step 3, the operating condition of fluid bed is: inlet temperature is 50-55 DEG C, atomizing pressure is 0.1-0.2MPa, temperature of charge is 35-40 DEG C, blower fan frequency is 15-20HZ, and peristaltic pump rotating speed is 5-10rpm, until containing the whole loaded of sealing coat coating solution, stop spraying, continue discharging after dry 5min.
As preferably, in step 4, the operating condition of fluid bed is: inlet temperature is 50-55 DEG C, atomizing pressure is 0.1-0.2MPa, temperature of charge is 35-40 DEG C, blower fan frequency is 15-20HZ, and peristaltic pump rotating speed is 5-10rpm, until containing the whole loaded of enteric layer coating solution, stop spraying, continue discharging after dry 15min.
Beneficial effect: fumaric acid Wo Nuolazan enteric coated capsule of the present invention is made up of capsule shells and the fumaric acid Wo Nuolazan micropill be contained in this capsule, making micropill is dispersed in some small circular cells by the fumaric acid Wo Nuolazan of dose, improve the dispersibility of fumaric acid Wo Nuolazan, improve dissolution, improve bioavailability, make medicine have good curative effect repeatability and less untoward reaction.Fumaric acid Wo Nuolazan micropill is followed successively by celphere, main medicament layer, sealing coat, enteric layer from inside to outside.Main medicament layer is coated on outside celphere, can increase the specific surface area of principal agent.Sealing coat can prevent enteric layer on the impact of principal agent.Enteric layer can increase the stability of principal agent in acid solution, stops it to separate out, and micropill medicine is discharged in intestinal, improves curative effect.
Detailed description of the invention
Below in conjunction with specific embodiment, embodiment of the present invention are described in detail.
Embodiment 1 prescription:
Preparation technology:
Prepare celphere
Sucrose is pulverized, crosses 80 eye mesh screens.Under centrifugal granulator high speed rotating condition, spray into the binding agent adding sucrose and be made into gradually, then cross 50 mesh sieves, collect wet blank sugar pill, then drying forms;
Prepared by medicated layer:
Slowly hypromellose is added under stirring in purified water, dissolve completely and add fumaric acid Wo Nuolazan again, purified water is added to aequum, stir, cross 60 mesh sieves and obtain coating solution, celphere is placed in fluidized bed coating equipment and carries out the end and spray medicated bag clothing, dry, cross 40 mesh sieves, obtain the micropill of main medicament layer;
Prepared by sealing coat:
Slowly add hyprolose under stirring in purified water to dissolve, add Pulvis Talci again, purified water is added to aequum, stir, cross 80 mesh sieves and obtain coating solution, the micropill of coated main medicament layer is placed in fluidized bed coating equipment and carries out the end and spray sealing coat coating, dry, cross 35 mesh sieves, obtain the micropill of sealing coat;
Prepared by enteric layer:
In purified water, add glyceryl monostearate and triethyl citrate, dispersed with stirring is even; Then with L30D-55, stir; By above-mentioned two kinds of liquid mixing, stir, cross 60 mesh sieves and obtain coating solution, the micropill of coated sealing coat is placed in fluidized bed coating equipment and carries out the end and spray enteric layer coating, dry, cross 20 mesh sieves, obtain the micropill of coated enteric layer.
Measure the content of active matter fumaric acid Wo Nuolazan in micropill.
By gained micropill according to loading in capsule shells containing Wo Nuolazan 10mg specification, obtain micro-pill type fumaric acid Wo Nuolazan enteric coated capsule.
Prepared by embodiment 2 fumaric acid Wo Nuolazan enteric coated capsule
The content preparing micropill and mensuration active matter fumaric acid Wo Nuolazan, with embodiment 1, loads the capsule into 20mg specification.
Prepared by embodiment 3 fumaric acid Wo Nuolazan enteric coated capsule
The content preparing micropill and mensuration active matter fumaric acid Wo Nuolazan, with embodiment 1, loads the capsule into 15mg specification.
Prepared by embodiment 4 fumaric acid Wo Nuolazan enteric coated capsule
The content preparing micropill and mensuration active matter fumaric acid Wo Nuolazan, with embodiment 1, loads the capsule into 10mg specification.
Prepared by embodiment 5 fumaric acid Wo Nuolazan enteric coated capsule
The content preparing micropill and mensuration active matter fumaric acid Wo Nuolazan, with embodiment 1, loads the capsule into 20mg specification.
Prepared by embodiment 6 fumaric acid Wo Nuolazan enteric coated capsule
The content preparing micropill and mensuration active matter fumaric acid Wo Nuolazan, with embodiment 1, loads the capsule into 15mg specification.
Prepared by embodiment 7 fumaric acid Wo Nuolazan enteric coated capsule
The content preparing micropill and mensuration active matter fumaric acid Wo Nuolazan, with embodiment 1, loads the capsule into 20mg specification.
Prepared by embodiment 8 fumaric acid Wo Nuolazan enteric coated capsule
The content preparing micropill and mensuration active matter fumaric acid Wo Nuolazan, with embodiment 1, loads the capsule into 10mg specification.
Prepared by embodiment 9 fumaric acid Wo Nuolazan enteric coated capsule
The content preparing micropill and mensuration active matter fumaric acid Wo Nuolazan, with embodiment 1, loads the capsule into 15mg specification.
Test example 1, investigate the stripping curve of commercially available fumaric acid Wo Nuolazan sheet in pH1.0 medium
Stripping curve assay method: 2010 editions Chinese Pharmacopoeias, two annex XC second method paddle method; Investigate the stripping curve of commercially available fumaric acid Wo Nuolazan sheet in pH1.0 medium.Result is as shown in table 1:
The stripping curve of table 1 fumaric acid Wo Nuolazan ordinary tablet in pH1.0 medium
Test proves, fumaric acid Wo Nuolazan sheet is in pH1.0 medium, and stripping prolongation is in time slowed down on the contrary.Observe and find, fumaric acid Wo Nuolazan can form crystallization in pH1.0 medium.And find through repetition test, the result of sample each stripping in pH1.0 medium of same batch is also inconsistent, cannot reappear.
The release of test example two, investigation enteric coating coating weight gain
According to the requirement of enteric coated preparation and adjuvant performance, in the certain thickness enteric coating layer of pastille micropill surface coverage, enteric coated capsule could resist the erosion of hydrochloric acid solution the long period.Embodiment one, two, three devises different enteric coating weightening finishes, and investigate the impact on release, result is as described in Table 2.
Drug release determination is according to Chinese Pharmacopoeia version in 2010 two annex XD second methods:
Burst size in acid: measure 0.1mol/L hydrochloric acid solution 750ml, inject each stripping rotor, treat that dissolution medium temperature constant is at 37 ± 0.5 DEG C, get 6 to drop in stripping rotor respectively, rotating speed is 100 turns per minute, and after 2 hours, draw solution is appropriate, filter, should complete in 30 seconds from being sampled to filtration, will measure according to high performance liquid chromatography (Chinese Pharmacopoeia version in 2010 two annex VD), calculate release;
Burst size in buffer: add the sodium radio-phosphate,P-32 solution 250ml that temperature is 37 ± 0.5 DEG C in above-mentioned acid solution, the draw solution after 30min that remains in operation is appropriate, filter, should complete in 30 seconds from being sampled to filtration, to measure according to high performance liquid chromatography (Chinese Pharmacopoeia version in 2010 two annex VD), calculate release.
The impact of enteric layer coating weight gain on release investigated by table 2
Test proves, enteric layer coating weight gain is within the scope of 30%-80%, and in the acid of fumaric acid Wo Nuolazan enteric coated capsule, burst size is all less than 10%, and in buffer, burst size all reaches more than 85%.
Test example three,
In investigation sealing coat, hyprolose consumption is on the impact of release, and drug release determination method is with test example 2.
Embodiment two, four, five devises hyprolose consumptions different in sealing coat, and investigate the impact on release, result is as described in Table 3.
Table 3 investigates different hyprolose consumption to the impact of release
Test proves, in embodiment two, four, five, hyprolose consumption does not almost affect burst size in burst size in acid and buffer.In acid, burst size is all less than 10%, and in buffer, burst size all reaches more than 85%.
Test example four, enteric material kind are on the impact of release
Embodiment two, six, seven devises different types of enteric material in enteric layer, investigates the impact on release, drug release determination method is with test example 2.Result is as described in Table 4.
Table 4 investigates different enteric material kind to the impact of release
Test proves, in embodiment two, six, seven, enteric material kind is comparatively large on burst size impact in acid, wherein especially strange L30D-55 best performance, and Eudragit L100-55 takes second place, and II is the poorest for acrylic resin.
The drug content of test example five, different proportion is on the impact of release
Embodiment six, eight, nine devises the drug content of different proportion, investigates the impact on release, drug release determination method is with test example 2.Result is as described in Table 5.
The impact of drug content on release of different proportion investigated by table 5
Test proves, in embodiment six, eight, nine, the drug content of different proportion is all less on burst size impact in burst size in acid and buffer.In acid, burst size is all less than 10%, and in buffer, burst size all reaches more than 85%.
Claims (9)
1. a fumaric acid Wo Nuolazan enteric coated capsule, is characterized in that, is made up of conventional capsule shell and the fumaric acid Wo Nuolazan enteric coated micropill be contained in this capsule shells, and every capsules is containing Wo Nuolazan 10-20mg.
2. capsule described in claim 1, it is characterized in that, be followed successively by celphere, main medicament layer, sealing coat, enteric layer from inside to outside, wherein, main medicament layer weight is the 80-130% of celphere, sealing coat weight is the 10-30% of celphere and main medicament layer gross weight, and enteric layer weight is the 30-80% of celphere, main medicament layer and sealing coat gross weight.
3. capsule described in claim 1, is characterized in that, the diameter of described celphere is 0.25-1.0 millimeter, and the granularity of fumaric acid Wo Nuolazan micropill is 14-30 order.
4. capsule described in claim 1, is characterized in that, main medicament layer is made up of binding agent and fumaric acid Wo Nuolazan, the 60-120% that its binder dosage accounts for the 5-20% of celphere, fumaric acid Wo Nuolazan weight accounts for celphere.
5. capsule described in claim 1, is characterized in that, main medicament layer is made up of binding agent and fumaric acid Wo Nuolazan, and its binder dosage accounts for the 5-20% of celphere, fumaric acid Wo Nuolazan weight accounts for celphere is 80-110%.
6. compositions described in claim 4 or 5, is characterized in that, wherein binding agent is selected from hypromellose, hyprolose, polyvidone, carmethose and other cellulose derivatives.
7. capsule described in claim 1, is characterized in that, sealing coat is made up of binding agent and lubricant, and binding agent accounts for the 5-15% of celphere and main medicament layer, and lubricant accounts for the 10-15% of celphere and main medicament layer.
8. capsule described in claim 1, is characterized in that, enteric layer is made up of enteric material, plasticizer and lubricant, wherein enteric material be selected from L30D-55, L100-55 or domestic acrylic resin II; Plasticizer is selected from triethyl citrate; Enteric material accounts for the 20-45% of gross weight, and triethyl citrate accounts for the 2-5% of gross weight, and lubricant accounts for the 1-2% of gross weight.
9. the preparation method of capsule described in claim 1, is characterized in that, comprises the steps:
Step 1, prepares celphere; Sucrose is pulverized, crosses 80 eye mesh screens; Under centrifugal granulator high speed rotating condition, spray into the binding agent adding sucrose and be made into gradually, then cross 50 mesh sieves, collect wet blank sugar pill, then drying forms;
Step 2, preparation main medicament layer, in purified water, slowly adds hypromellose under stirring; After being uniformly dispersed, add fumaric acid Wo Nuolazan, purified water is added to aequum, stir, cross 80 mesh sieves and obtain coating solution, celphere is placed in fluidized bed coating equipment and carries out the end and spray medicated bag clothing, drying, crosses 24 mesh sieves, obtains the micropill of main medicament layer;
Step 3, prepare sealing coat, in purified water, slowly add binding agent under stirring and dissolve, add lubricant again, purified water is added to aequum, stir, cross 80 mesh sieves and obtain coating solution, the micropill of coated main medicament layer is placed in fluidized bed coating equipment to carry out the end and spray sealing coat coating, drying, crosses 24 mesh sieves, obtains the micropill of sealing coat;
Step 4, prepares enteric coating layer, adds lubricant and plasticizer, stir in purified water; Add enteric material in another purified water, stir; By above-mentioned two kinds of liquid mixing, stir, cross 80 mesh sieves and obtain coating solution, the micropill of coated sealing coat is placed in fluidized bed coating equipment and carries out the end and spray enteric layer coating, dry, cross 20 mesh sieves, obtain the micropill of coated enteric layer;
Step 5, measures the content of active matter fumaric acid Wo Nuolazan in micropill;
Step 6, encapsulated, gained micropill is incapsulated in shell, obtains micro-pill type fumaric acid Wo Nuolazan enteric coated capsule.
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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 |
| WO2019013310A1 (en) * | 2017-07-10 | 2019-01-17 | Takeda Pharmaceutical Company Limited | Preparation comprising vonoprazan |
| 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 |
| CN114853728A (en) * | 2022-05-07 | 2022-08-05 | 四川制药制剂有限公司 | Vonola fumarate tablet and preparation method thereof |
| CN115175669A (en) * | 2020-02-27 | 2022-10-11 | 怡诺安有限公司 | Pharmaceutical composition comprising benzimidazole derivative compound |
| WO2024027794A1 (en) * | 2022-08-05 | 2024-02-08 | 哈尔滨市康隆药业有限责任公司 | Taste-masking microsphere, preparation process therefor, and use thereof |
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Cited By (11)
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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 |
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| US11696893B2 (en) | 2017-07-10 | 2023-07-11 | Takeda Pharmaceutical Company Limited | Preparation comprising vonoprazan |
| CN115175669A (en) * | 2020-02-27 | 2022-10-11 | 怡诺安有限公司 | Pharmaceutical composition comprising 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 |
| CN114853728A (en) * | 2022-05-07 | 2022-08-05 | 四川制药制剂有限公司 | Vonola fumarate tablet and preparation method 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 |
| WO2024027794A1 (en) * | 2022-08-05 | 2024-02-08 | 哈尔滨市康隆药业有限责任公司 | Taste-masking microsphere, preparation process therefor, and use thereof |
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