CN110403911A - A kind of isosorbide mononitrate sustained release tablets and preparation method thereof - Google Patents
A kind of isosorbide mononitrate sustained release tablets and preparation method thereof Download PDFInfo
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- CN110403911A CN110403911A CN201810382434.0A CN201810382434A CN110403911A CN 110403911 A CN110403911 A CN 110403911A CN 201810382434 A CN201810382434 A CN 201810382434A CN 110403911 A CN110403911 A CN 110403911A
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- isosorbide mononitrate
- sustained release
- release tablets
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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
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
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- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
Abstract
The invention belongs to field of pharmaceutical preparations, specifically disclose a kind of big specification isosorbide mononitrate sustained release tablets and preparation method thereof, the prescription group of the sustained release tablets is divided into Isosorbide Mononitrate: lactose (6:4), hydroxypropyl methylcellulose K200M, microcrystalline cellulose, mannitol, rilanit special, silica, magnesium stearate.The combination of a certain proportion of microcrystalline cellulose, mannitol and rilanit special can be substantially improved the mobility of mixed powder by the present invention, meet production tabletting requirement.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, and in particular to a kind of isosorbide mononitrate sustained release tablets and preparation method thereof.
Background technique
Isosorbide Mononitrate is nitrate esters antianginal drug of new generation, is chief active in Isosorbide Nitrate body
Metabolin, oral absorption is fast, and absolute bioavailability is high, and individual difference is small.Its biological half-life is 4-5 hours, ordinary preparation
It needs to take daily 2-3 times, is easy to produce drug resistance after taking orally several weeks.Sustained release preparation can effectively overcome its drug resistance, and existing single nitric acid is different
Sorb ester formulation is widely used in clinic.
Patent CN200410030824 discloses a kind of isosorbide mononitrate sustained release tablets, using wet granulation, single nitric acid
Soquad is heated or is easily exploded by hitting, and heat drying is not easy to；And slow-release material used is hydroxypropyl methyl
Cellulose HPMC meets water and easily expands gelatinization, it is necessary to be pelletized with organic solvent, there are problem of solvent residual.Patent
CN201510109303 discloses a kind of isosorbide mononitrate sustained release tablets and its preparation process, using pressing after coating micro-pill is made
Piece；Patent CN201110379937 discloses a kind of isosorbide mononitrate sustained release tablets and preparation method thereof, using microballoon is made
Tabletting afterwards；The process is more complicated for two methods, is unfavorable for industrial production.Patent CN201210169963 discloses one kind with hydroxypropyl
The method that methylcellulose K4M prepares isosorbide mononitrate sustained release tablets for sustained-release matrix material, but the raw material that the method uses
For pure powder.Isosorbide Mononitrate bulk pharmaceutical chemicals are special, are heated or are easily exploded by hitting, so marketable material is mostly mixed
Powder, generally Isosorbide Mononitrate: lactose (6:4).Isosorbide Mononitrate is mostly white, needle-shaped crystals powder, leads to mixed powder
Mobility is very poor, mixes 47 ° of powder angle of repose, and larger product (120mg) is difficult to meet the requirement of production tabletting.
The specification of presently commercially available isosorbide mononitrate sustained release tablets has 40mg, 50mg and 60mg, for big specification 120mg
Isosorbide mononitrate sustained release tablets be rarely reported.When for coronary heart disease and the heavier patient with angina pectoris state of an illness, escalated dose is needed,
And this drug is used for a long time, tolerance easily occurs, so the isosorbide mononitrate sustained release tablets of urgent clinical needs large dosage specification.
However, in the prior art, the prescription and preparation method thereof of small dimension isosorbide mononitrate sustained release tablets, specification big for 120mg
For mix powder poor fluidity, tablet weight variation is big, is not able to satisfy tabletting requirement, is not easy to industrialized production.Therefore necessary
The prescription of isosorbide mononitrate sustained release tablets and preparation method thereof for providing a kind of big specification carrys out overcome the deficiencies in the prior art.
Summary of the invention
In view of the deficiencies in the prior art, the purpose of the present invention is to provide the different sorbs of single nitric acid of big specification 120mg a kind of
Ester sustained release tablets and preparation method thereof.
The object of the present invention is achieved like this:
A kind of isosorbide mononitrate sustained release tablets, which is characterized in that including following components: Isosorbide Mononitrate: lactose
(6:4), hydroxypropyl methylcellulose, filler；The hydroxypropyl methylcellulose viscosity is K200M.
The filler is the combination of microcrystalline cellulose, mannitol and rilanit special；Microcrystalline cellulose, mannitol and hydrogen
The weight fraction ratio for changing castor oil is 6:1~3:2~5；Preferably, the weight of microcrystalline cellulose, mannitol and rilanit special
Portion rate is 6:2:3.
The sustained release tablets also contain silica, magnesium stearate.
A kind of isosorbide mononitrate sustained release tablets, component ratio according to parts by weight:
Preferably, component ratio is according to parts by weight:
Invention additionally discloses a kind of preparation methods of isosorbide mononitrate sustained release tablets, specifically comprise the following steps:
(1) the hydroxypropyl methylcellulose K200M of recipe quantity, filler and silica are mixed；
(2) by Isosorbide Mononitrate: lactose (6:4) is mixed after powder crosses 20 meshes and is mixed with mixed powder obtained by step (1)；
(3) powder addition magnesium stearate mixing will be mixed obtained by step (2)；
(4) powder direct tablet compressing will be mixed obtained by step (3).
The basic prescription of the application uses hydroxypropyl methylcellulose for framework material, but prior art preparation method mostly uses
Pellet or microballoon is made in wet granulation, and granulation is difficult when batch production, therefore, selects direct tablet compressing technique.Direct tablet compressing pair
Auxiliary material is more demanding, it is desirable that mobility is good, and compressibility is good.In order to change its mobility, it is desirable to be screened to prescription.
Prescription and craft screening process:
The screening of hydroxypropyl methylcellulose viscosity: Isosorbide Mononitrate is soluble in water, in matrix tablet, should select height
The HPMC of viscosity, therefore selecting viscosity is respectively influence of K4M, K15M, K100M and K200M investigation to drug release.Prescription group
At being shown in Table 1.
1 hydroxypropyl methylcellulose viscosity of table screens prescription
By hydroxypropyl methylcellulose (K4M, K15M, K100M, K200M), microcrystalline cellulose and the silica of above-mentioned recipe quantity
It mixes spare；By Isosorbide Mononitrate: lactose (6:4) is mixed after powder crosses 20 meshes and is mixed with above-mentioned mixed powder；The hard of recipe quantity is added
Fatty acid magnesium mixing, tabletting, hardness are controlled in 90-110N.Experimental result is shown in Table 2.
2 hydroxypropyl methylcellulose viscosity the selection result of table
| Time (h) | Reference standard | Prescription 1 | Prescription 2 | Prescription 3 | Prescription 4 |
| 1 | 15-35% | 30.12% | 30.05% | 21.96% | 16.81% |
| 2 | 28-48% | 44.59% | 44.14% | 40.39% | 26.47% |
| 4 | 43-68% | 60.29% | 58.76% | 56.49% | 39.28% |
| 8 | 65-95% | 81.56% | 79.46% | 75.28% | 66.39% |
| 12 | NLT-80% | 92.59% | 88.85% | 83.35% | 75.64% |
From table 2 it can be seen that as HPMC viscosity increases big, release reduction, although 12h release does not exist in prescription 4
Within the scope of reference standard, but the dosage of adjustable HPMC improves 12h release, so that its each period release is referring to
In standard.Therefore, it is framework material that prescription, which selectes hydroxypropyl methylcellulose K200M,.
The screening of hydroxypropyl methylcellulose K200M dosage: in above-mentioned prescription, adjustment hydroxypropyl methylcellulose K200M dosage difference
It is 150 parts, 160 parts, 170 parts, 180 parts and 190 parts, investigates influence of the hydroxypropyl methylcellulose K200M dosage to drug release, place
Fang Zucheng is shown in Table 3.
3 hydroxypropyl methylcellulose K200M dosage of table screens prescription
The hydroxypropyl methylcellulose K200M, microcrystalline cellulose and silica of above-mentioned recipe quantity are mixed spare；By single nitric acid
Soquad: lactose (6:4) is mixed after powder crosses 20 meshes and is mixed with above-mentioned mixed powder；Magnesium stearate mixing, the tabletting of recipe quantity is added,
Hardness is controlled in 90-110N.Experimental result is shown in Table 4.
4 hydroxypropyl methylcellulose viscosity the selection result of table
From table 4, it can be seen that 5 hydroxypropyl methylcellulose K200M dosage of prescription discharges too fast, 9 hydroxypropyl first of prescription when being 150g
When cellulose K200M dosage is 190g, 12h release is unsatisfactory for standard requirements.Therefore, prescription selectes hydroxypropyl methylcellulose
The dosage of K200M is 160~180g.
But above prescription mobility is poor, to be made into the sustained release tablets of big specification, need to optimize filler.
Filler selects: selecting microcrystalline cellulose, lactose, mannitol, rilanit special and cyclodextrin as filling out respectively
Agent is filled, the influence to drug mobility is investigated.
5 filler of table screens prescription
The mobility that each prescription mixes powder is investigated by index of angle of repose.Isosorbide Mononitrate: lactose (6:4) is mixed into powder mistake
It is mixed after 20 meshes with unclassified stores in prescription, measurement prescription 10-14 mixes the angle of repose of powder.Test result is shown in Table 6.
6 filler of table screens prescription and mixes powder angle of repose measurement result
| Prescription | Prescription 10 | Prescription 11 | Prescription 12 | Prescription 13 | Prescription 14 |
| Angle of repose | 45.1° | 46.3° | 44.5° | 44.7° | 43.9° |
As can be seen from Table 6, the angle of repose that the above prescription mixes powder is all larger than 40 °, is not able to satisfy production tabletting needs.Invention
People attempts different auxiliary material and is applied in combination, and has been surprisingly found that different auxiliary material is applied in combination, and can reduce its angle of repose, change by test
The side's of conducting oneself well mobility.
Inventor gropes by a large number of experiments, finally determines that microcrystalline cellulose, mannitol and rilanit special combination can have
Effect reduces angle of repose, and adjusts the ratio between three, when microcrystalline cellulose, mannitol and rilanit special proportions are 6:
When 1~3:2~5, the more flowability of mixed powder may make, meet production tabletting requirement, tablet weight variation meets pharmacopoeial requirements.Invention
People continues to test determining best proportion microcrystalline cellulose: mannitol: when rilanit special (60:20:30) angle of repose being dropped to
Minimum (26.2 ° of angle of repose) farthest increases its mobility, meets production tabletting needs.
In one embodiment, prescription filler parts by weight are 90~140 parts of (microcrystalline cellulose, mannitol and hydrogenations
The mass ratio of castor oil is 6:2:3) when, the angle of repose of mixed powder is formulated less than 30 °, and mixed powder mobility is preferable, and being satisfied with production needs
It wants, the tablet weight variation of gained sustained release tablets is in ± 5.0% range；And the release of sustained release tablets is within the specified scope.
In another example, prescription filler number is 150 parts of (microcrystalline cellulose, mannitol and rilanit specials
Mass ratio is 6:2:3) when, increase when the angle of repose of mixed powder is compared with 90~140 parts of filler, the mobility of mixed powder decreases；But
Mobility when better than filler 150 parts (weight fraction ratio of microcrystalline cellulose, mannitol and rilanit special being 6:5:7).
In a preferred embodiment, a kind of isosorbide mononitrate sustained release tablets, component ratio is according to parts by weight
Meter:
The angle of repose that above-mentioned prescription mixes powder can reach 25.9 °, and the mobility for mixing powder is best, and tablet weight variation is less than ± 5.0%.
Specific embodiment
Following embodiment further describes beneficial effects of the present invention, and embodiment is only used for the purpose of illustration, does not limit this
The range of invention, while the obvious change made according to the present invention of those of ordinary skill in the art and modification are also contained in this
In invention scope.
Embodiment 1
Preparation process: (1) by the hydroxypropyl methylcellulose of recipe quantity, microcrystalline cellulose, mannitol, rilanit special and dioxy
SiClx mixes；(2) by Isosorbide Mononitrate: lactose (6:4) mixes powder and crosses 20 meshes and step (1) described mixed powder mixing；(3) add
Enter magnesium stearate mixing；(4) by the direct powder compression of above-mentioned mixing, hardness is controlled in 90-110N.
Embodiment 2
Preparation process: with embodiment 1
Embodiment 3
Preparation process: with embodiment 1
Embodiment 4
Preparation process: with embodiment 1
Embodiment 5
Preparation process: with embodiment 1
Comparative example 1
Preparation process: (1) by the hydroxypropyl methylcellulose of recipe quantity, microcrystalline cellulose, lactose, rilanit special and titanium dioxide
Silicon mixes；(2) by Isosorbide Mononitrate: lactose (6:4) mixes powder and crosses 20 meshes and step (1) described mixed powder mixing；(3) it is added
Magnesium stearate mixes；(4) by the direct powder compression of above-mentioned mixing, hardness is controlled in 90-110N.
Comparative example 2
Preparation process: (1) by the hydroxypropyl methylcellulose of recipe quantity, microcrystalline cellulose, lactose, cyclodextrin and silica are mixed
It is even；(2) by Isosorbide Mononitrate: lactose (6:4) mixes powder and crosses 20 meshes and step (1) described mixed powder mixing；(3) it is added stearic
Sour magnesium mixes；(4) by the direct powder compression of above-mentioned mixing, hardness is controlled in 90-110N.
Comparative example 3
Preparation process: (1) by the hydroxypropyl methylcellulose of recipe quantity, microcrystalline cellulose, rilanit special and silica are mixed
It is even；(2) by Isosorbide Mononitrate: lactose (6:4) mixes powder and crosses 20 meshes and step (1) described mixed powder mixing；(3) it is added stearic
Sour magnesium mixes；(4) by the direct powder compression of above-mentioned mixing, hardness is controlled in 90-110N.
Comparative example 4
Preparation process: (1) by the hydroxypropyl methylcellulose of recipe quantity, microcrystalline cellulose, mannitol and silica are mixed；
(2) by Isosorbide Mononitrate: lactose (6:4) mixes powder and crosses 20 meshes and step (1) described mixed powder mixing；(3) stearic acid is added
Magnesium mixes；(4) by the direct powder compression of above-mentioned mixing, hardness is controlled in 90-110N.
Comparative example 5
Preparation process: with 1 comparative example 6 of embodiment
Preparation process: with 1 comparative example 7 of embodiment
Preparation process: with 1 comparative example 8 of embodiment
Preparation process: with embodiment 1
Comparative example 9
Preparation process:
(1) single nitric acid acid Soquad: the mixed powder of lactose (6:4) crosses 30 meshes and the hydroxypropyl methylcellulose of recipe quantity half is mixed
80 meshes crush after conjunction, obtain mixed powder, remaining hydroxypropyl methylcellulose crosses 80 meshes, spare.
(2) dioxy of recipe quantity is added in mixed powder and remaining hydroxypropyl methylcellulose, recipe quantity microcrystalline cellulose after mixing
SiClx, lauryl sodium sulfate mix again.
(3) direct powder compression.
Verify embodiment:
1, the measurement at angle of repose
Angle of repose is calculated by the height and powder base diameter that measure powder cone, formula calculates are as follows: tan (A)=
H/0.5R, A are angle of repose, and H is the height of powder cone, and R is the diameter of powder bottom.
2, tablet weight variation measures
Inspection Check method takes test sample 20, accurately weighed total weight, after acquiring average slice weight, then accurately weighed every respectively
Weight, every sheet weight and average slice weight comparative measurements tablet weight variation, provide according to Chinese Pharmacopoeia, for average slice weight 0.30g and
Above, tablet weight variation limit is ± 5.0%.
Table 7 is formulated tablet weight variation result after the angle of repose for mixing powder and tabletting
As can be drawn from Table 7, embodiment 1-5, prescription mix the satisfaction production tabletting requirement of less than 30 ° of powder angle of repose, and tabletting
Tablet weight variation control meets pharmacopoeial requirements within ± 5.0% afterwards.Comparative example 1-4, filler are not microcrystalline celluloses,
Mannitol, the combination of rilanit special, angle of repose are greater than 40 °, and poor fluidity is not able to satisfy production tabletting requirement；Comparison is implemented
5~8 filler of example is microcrystalline cellulose, the combination of mannitol and rilanit special, but proportions are not in the model of 6:1~3:2~5
In enclosing, angle of repose is significantly increased, and the mobility for mixing powder significantly reduces, and tablet weight variation does not meet pharmacopoeial requirements.Comparative example 9 is stopped
Only angle is excessive, mixes powder poor fluidity, and tablet weight variation is greater than ± 5.0%, is not able to satisfy tabletting requirement.
3, the measurement of isosorbide mononitrate sustained release tablets release
According to release method under USP isosorbide mononitrate sustained release tablets item, using slurry processes, using water as dissolution medium (body
Product 900mL), 50 revs/min of revolving speed, release is surveyed in different time sampling, and concrete outcome is shown in Table 8.
The drug release determination result of each embodiment sample of table 8
As can be seen from Table 8: embodiment 1-5 release can control in corresponding parameter area, and highest release
Reach 98% or more, has met clinical application requirement；Although comparative example 1-8 release within the scope of relevant parameter,
Mixed powder mobility is poor, is unable to meet production tabletting requirement；Comparative example 9 discharges too fast, does not meet medication requirement.
Claims (10)
1. a kind of isosorbide mononitrate sustained release tablets, which is characterized in that including following components: Isosorbide Mononitrate: lactose (6:
4), hydroxypropyl methylcellulose, filler.
2. a kind of isosorbide mononitrate sustained release tablets according to claim 1, which is characterized in that the hydroxypropyl methylcellulose
Viscosity is K200M.
3. a kind of isosorbide mononitrate sustained release tablets according to claim 1, which is characterized in that filler is microcrystalline cellulose
The combination of element, mannitol and rilanit special.
4. a kind of isosorbide mononitrate sustained release tablets according to claim 1, which is characterized in that microcrystalline cellulose, sweet dew
The weight fraction ratio of pure and mild rilanit special is 6:1~3:2~5.
5. a kind of isosorbide mononitrate sustained release tablets according to claim 1, which is characterized in that microcrystalline cellulose, sweet dew
The weight fraction ratio of pure and mild rilanit special is 6:2:3.
6. a kind of isosorbide mononitrate sustained release tablets according to claim 1, which is characterized in that the sustained release tablets also contain
Silica, magnesium stearate.
7. a kind of isosorbide mononitrate sustained release tablets according to claim 1, which is characterized in that its component ratio is by weight
Number meter:
8. a kind of isosorbide mononitrate sustained release tablets according to claim 7, which is characterized in that its component ratio is by weight
Number meter:
9. a kind of isosorbide mononitrate sustained release tablets according to claim 8, which is characterized in that its component ratio is by weight
Number meter:
10. according to a kind of described in any item isosorbide mononitrate sustained release tablets of claim 7-9, which is characterized in that it is prepared
Method includes the following steps:
(1) the hydroxypropyl methylcellulose K200M of recipe quantity, filler and silica are mixed；
(2) by Isosorbide Mononitrate: lactose (6:4) is mixed after powder crosses 20 meshes and is mixed with mixed powder obtained by step (1)；
(3) powder addition magnesium stearate mixing will be mixed obtained by step (2)；
(4) powder direct tablet compressing will be mixed obtained by step (3).
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN112294770A (en) * | 2020-11-16 | 2021-02-02 | 仁和堂药业有限公司 | Isosorbide mononitrate compound preparation and application and preparation method thereof |
| CN113476416A (en) * | 2021-08-03 | 2021-10-08 | 北京阳光诺和药物研究股份有限公司 | Pharmaceutical composition for treating vasodilatation |
| CN114469886A (en) * | 2021-03-06 | 2022-05-13 | 鲁南贝特制药有限公司 | Isosorbide mononitrate sustained-release tablet and preparation method thereof |
| CN114522147A (en) * | 2020-11-23 | 2022-05-24 | 武汉武药科技有限公司 | Carglutamic acid solid preparation and preparation method thereof |
| CN114652691A (en) * | 2020-12-23 | 2022-06-24 | 鲁南贝特制药有限公司 | Isosorbide mononitrate sustained-release tablet and preparation method thereof |
| CN115487162A (en) * | 2022-10-13 | 2022-12-20 | 山东力诺制药有限公司 | Preparation method of isosorbide mononitrate sustained-release tablets |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN112294770A (en) * | 2020-11-16 | 2021-02-02 | 仁和堂药业有限公司 | Isosorbide mononitrate compound preparation and application and preparation method thereof |
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| CN114522147B (en) * | 2020-11-23 | 2023-08-04 | 武汉武药科技有限公司 | Solid preparation of carboglutamic acid and preparation method thereof |
| CN114652691A (en) * | 2020-12-23 | 2022-06-24 | 鲁南贝特制药有限公司 | Isosorbide mononitrate sustained-release tablet and preparation method thereof |
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| CN114469886B (en) * | 2021-03-06 | 2023-01-24 | 鲁南贝特制药有限公司 | Isosorbide mononitrate sustained-release tablet and preparation method thereof |
| CN113476416A (en) * | 2021-08-03 | 2021-10-08 | 北京阳光诺和药物研究股份有限公司 | Pharmaceutical composition for treating vasodilatation |
| CN115487162A (en) * | 2022-10-13 | 2022-12-20 | 山东力诺制药有限公司 | Preparation method of isosorbide mononitrate sustained-release tablets |
| CN115487162B (en) * | 2022-10-13 | 2023-10-13 | 山东力诺制药有限公司 | Preparation method of isosorbide mononitrate sustained release tablet |
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