CN110420192A - A kind of isosorbide mononitrate sustained release tablets and preparation method - Google Patents
A kind of isosorbide mononitrate sustained release tablets and preparation method Download PDFInfo
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- CN110420192A CN110420192A CN201810382396.9A CN201810382396A CN110420192A CN 110420192 A CN110420192 A CN 110420192A CN 201810382396 A CN201810382396 A CN 201810382396A CN 110420192 A CN110420192 A CN 110420192A
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- isosorbide mononitrate
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- 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
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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 Western medicine preparation technical field, a kind of isosorbide mononitrate sustained release tablets and preparation method thereof, the composition of the application sustained release tablets are as follows: Isosorbide Mononitrate, lactose, slow-release material, microcrystalline cellulose, glidant and lubricant are specifically provided.The formula through Isosorbide Mononitrate made from special preparation technique mix powder good fluidity be suitble to direct powder compression, and the sustained release tablet stability being prepared is good, slow release effect more preferably.
Description
Technical field
The invention belongs to pharmaceutical preparations technology field, and in particular to a kind of isosorbide mononitrate sustained release tablets and its preparation
Method.
Background technique
Isosorbide Mononitrate is nitrate esters antianginal drug of new generation, first by German Boehringer
Mannheim Gmb.h company develops, and is main active metabolites in Isosorbide Nitrate body, and oral absorption is fast, Absolute oral benefit
Expenditure is high, and individual difference is small.Its biological half-life is 4-5 hours, and ordinary preparation needs to take daily 2-3 times, is easy after taking orally several weeks
Generate drug resistance.Sustained release preparation can effectively overcome its drug resistance, and existing isosorbide mononitrate sustained release tablets agent is widely used in clinic.
Research finds that the crystal form of Isosorbide Mononitrate is brilliant white needles or crystalline powder and hardness is smaller, through crushing
It places afterwards and easily forms harder, biggish agglomeration for a period of time, poor fluidity is not easy direct using powder in formulation manufacturing processes
The technique of tabletting, generally using preparation processes such as tablettings after wet granulation；It is general using sustained release in order to achieve the purpose that slow controlled release
Then material is coated for skeleton is made sustained release tablets, is prepared into sustained release pellet, is prepared into osmotic pump type controlled release preparation etc..
Patent CN200410030824 discloses a kind of isosorbide mononitrate sustained release tablets, and using wet granulation, particle dries
After dry, whole grain, moderate lubrication agent tabletting is added；Firstly, Isosorbide Mononitrate is heated or is easily exploded by hitting, pelletize
Drying needs strict temperature control unsuitable excessively high afterwards, otherwise there is the risk of explosion；Secondly, the technics comparing is complicated, can not adopt
With mixed powder vertical compression technique, the used time is longer, it is necessary to the tabletting in second day of granulation in one day, it is inefficient.
Patent CN104644589 discloses a kind of isosorbide mononitrate sustained release tablets and preparation method thereof, and this method is first
Mesoporous carbon-Isosorbide Mononitrate compound is prepared, then using ethyl cellulose as Sustained release coating materials, with hydroxyethyl cellulose
For pore-foaming agent, bottom spray coating is carried out using fluidized bed, prepares coated sustained-release pellets, then is mixed with other pharmaceutically acceptable auxiliary materials
It closes tabletted.This method preparation process is more complicated, is unfavorable for workshop scale, mass industrial production.
Patent CN20121016996 discloses a kind of isosorbide mononitrate sustained release tablets and preparation method thereof, which uses
HPMC K4M is sustained-release matrix material, is coated using powder vertical compression and sustained release tablets are made, and selects hydroxypropyl methyl fine
Dimension element K4M is sustained-release matrix material, and the slow-release material viscosity is smaller, keeps drug-eluting rate very fast, and slow release effect is not to manage very much
Think.
Presently commercially available isosorbide mononitrate sustained release tablets small dimension is more (such as 30mg, 50mg, 60mg etc.), with trouble
The exacerbation of person's state of an illness needs to increase dosage, and single nitre sustained release tablets of research and development 120mg specification are particularly important.At present for
There are many bottlenecks for the research and development of the isosorbide mononitrate sustained release tablets of 120mg, therefore a kind of different sorb of the single nitric acid for providing 120mg
The preparation method of ester sustained release tablets is necessary.
Summary of the invention
The research and development difficult point of the drawbacks of based on the above prior art and this product, present invention generally provides a kind of easy to operate easy
Row, isosorbide mononitrate sustained release tablets that dissolution is slow and product quality is more stable and preparation method thereof.
Hydroxypropyl methyl cellulose mobility is poor, in order to guarantee the slow release effect of product and take into account the mobility of mixed powder,
The hydroxypropyl methyl cellulose model that we select viscosity big first, and optimize its dosage, reduce cost and guarantee slow release effect.
Research find hydroxypropyl methyl cellulose and rilanit special according to a certain ratio simultaneously as slow-release material, slow release effect more preferably,
And mobility can be improved.
Colloidal silicon dioxide is more fluffy, crosses 20 meshes after first mixing it with Isosorbide Mononitrate, makes it as far as possible
Be adsorbed on Isosorbide Mononitrate surface, then again with slow-release material mix after cross 20 meshes, guarantee Isosorbide Mononitrate with
Slow-release material is uniformly mixed, and was mixed 20 meshes again after lactose and microcrystalline cellulose is added, and was eventually adding talcum powder and mixes again
Even, gained mixes powder direct tablet compressing, after preparation process processing, mixes powder good fluidity, and direct tablet compressing, tablet weight variation is small, sustained release
Or result of extraction is better than former triturate, is suitble to industry mass production.
The technical solution of the present invention is as follows:
A kind of isosorbide mononitrate sustained release tablets, are made of following component: Isosorbide Mononitrate, lactose, microcrystalline cellulose
Element, slow-release material, glidant and lubricant；Wherein slow-release material is made of hydroxypropyl methylcellulose and rilanit special.
The mass ratio of the slow-release material hydroxypropyl methylcellulose and rilanit special is 1:0.55-0.82；Preferred mass ratio
For 1:0.68.
The hydroxypropyl methylcellulose is selected from HPMC K4M, hydroxypropyl methyl cellulose K15M, hydroxypropyl first
One of base cellulose K40M, hydroxypropyl methyl cellulose K100M, hydroxypropyl methyl cellulose K200M.
The hydroxypropyl methylcellulose is hydroxypropyl methyl cellulose K200M, and dosage is 90-130 parts.
The isosorbide mononitrate sustained release tablets, are made of following component: 120 parts of Isosorbide Mononitrate, lactose 50-
90 parts, slow-release material, 60-120 parts of microcrystalline cellulose, 20-35 parts and lubricant 5-15 parts of glidant；Wherein slow-release material is by hydroxyl
Third methylcellulose and rilanit special composition；The mass ratio of the slow-release material hydroxypropyl methylcellulose and rilanit special is 1:
0.55-0.82；The hydroxypropyl methylcellulose is hydroxypropyl methyl cellulose K200M, and dosage is 90-130 parts.
The isosorbide mononitrate sustained release tablets, are made of following component: 120 parts of Isosorbide Mononitrate, lactose 70
Part, slow-release material, 90 parts of microcrystalline cellulose, 25 parts and 10 parts of lubricant of glidant；Wherein slow-release material is by hydroxypropyl methylcellulose
It is formed with rilanit special；The mass ratio of the slow-release material hydroxypropyl methylcellulose and rilanit special is 1:0.68；The hydroxyl
Third methylcellulose is hydroxypropyl methyl cellulose K200M, and dosage is 90-130 parts.
The glidant is colloidal silicon dioxide.
The lubricant is talcum powder.
The isosorbide mononitrate sustained release tablets, preparation process are direct powder compression；Specifically comprise the following steps:
A. first Isosorbide Mononitrate, glidant are mixed, crosses 20 meshes；
B. powder will be mixed obtained by step (a) and slow-release material is added, mix, cross 20 mesh screens；
C. powder will be mixed obtained by step (b) and lactose and microcrystalline cellulose is added, mix, then cross 20 meshes；
D. step (c) gained is mixed powder addition lubricant to mix again, direct powder compression.
Prescription and craft screening:
The screening of hydroxypropyl methylcellulose dosage: Isosorbide Mononitrate belongs to BCS I class drug, and hydroxypropyl methylcellulose is parent
Hydrogel slow-release material mobility is poor, and dosage plays the drug release behavior of isosorbide mononitrate sustained release tablets most important
Influence, select hydroxypropyl methylcellulose K200M dosage be respectively 70 parts, 90 parts, 110 parts, 130 parts and 150 parts, investigate hydroxypropyl first
Influence of the cellulose K200M dosage to drug release.Composition is shown in Table 1.
1 hydroxypropyl methylcellulose K200M dosage of table screens prescription
It weighs the Isosorbide Mononitrate of recipe quantity, after colloidal silicon dioxide mixes, crosses 20 meshes, add above-mentioned prescription
After the hydroxypropyl methylcellulose K200M of amount is mixed, 20 meshes are crossed, the lactose of recipe quantity is added, after microcrystalline cellulose mixes, crosses 20
Talcum powder mixing, the tabletting of recipe quantity is added in mesh.Experimental result is shown in Table 2.
2 hydroxypropyl methylcellulose K200M dosage the selection result of table
With the increase of hydroxypropyl methylcellulose K200M dosage it can be seen from 2 result of table, release is gradually slack-off, but on
It states prescription and mixes powder angle of repose > 40 °, mixed powder mobility is gradually deteriorated as the dosage of hydroxypropyl methylcellulose K200M increases；Work as hydroxyl
When third methylcellulose K200M dosage is very few, mixed powder mobility meets the requirements, but release is too fast, does not meet the medication of sustained release tablets
It is required that.
Inventor pass through a large amount of creative research, have been surprisingly found that under study for action be added in slow-release material it is a certain proportion of
Rilanit special can not only improve mobility, but also can play better slow release effect, when hydroxypropyl methylcellulose and rilanit special
Mass ratio be 1:0.55-0.82, mobility can satisfy production tabletting requirement, and release can satisfy medication and want
It asks, when the mass ratio of hydroxypropyl methylcellulose and rilanit special is 1:0.68, it is best to mix powder mobility.It is further discovered that hydroxyl
When the parts by weight of third methylcellulose are 90-130 parts, the releasing effect of isosorbide mononitrate sustained release tablets is preferable.
Specific embodiment
The present invention is further illustrated below by embodiment.Should correct understanding: the embodiment of the present invention be only
It is to be provided for illustrating the present invention, rather than limiting the invention, so, to the present invention under the premise of method of the invention
Simple modifications belong to the scope of protection of present invention.
Embodiment 1
1) prescription
2) preparation process:
(1) Isosorbide Mononitrate and colloidal silicon dioxide mixing 10min of recipe quantity are accurately weighed, 20 meshes are crossed；(2)
20 meshes are crossed after hydroxypropyl methylcellulose K200M, the rilanit special mixing 15min of recipe quantity are added into mixed powder；(3) it adds
20 meshes are crossed after the lactose of recipe quantity, microcrystalline cellulose mixing 15min；(4) the talcum powder mixing 5min of recipe quantity is added again,
Tabletting to obtain the final product.
Embodiment 2
1) prescription
2) preparation process: preparation process is the same as embodiment 1.
Embodiment 3
1) prescription
2) preparation process: preparation process is the same as embodiment 1.
Embodiment 4
1) prescription
2) preparation process: preparation process is the same as embodiment 1.
Embodiment 5
1) prescription
2) preparation process: preparation process is the same as embodiment 1.
Embodiment 6
1) prescription
2) preparation process is the same as embodiment 1.
Embodiment 7
1) prescription
2) preparation process is the same as embodiment 1.
Embodiment 8
1) prescription
2) preparation process is the same as embodiment 1.
Embodiment 9
1) prescription
2) preparation process is the same as embodiment 1.
Comparative example 1
1) prescription
2) preparation process:
(1) Isosorbide Mononitrate, hydroxypropyl methyl fiber K200M, the rilanit special mixing of recipe quantity are accurately weighed
10min crosses 20 meshes；(2) microcrystalline cellulose, lactose, the silica mixing 15min of recipe quantity, rear mistake are added into mixed powder
20 meshes；(3) talcum powder of recipe quantity is added, mixes 5min again, tabletting to obtain the final product.
Comparative example 2
1) prescription
2) preparation process:
(1) Isosorbide Mononitrate, microcrystalline cellulose, lactose mixing 10min of recipe quantity are accurately weighed, 20 meshes are crossed；
(2) hydroxypropyl methyl fiber K200M, rilanit special, the silica mixing 15min of recipe quantity, rear mistake are added into mixed powder
20 meshes；(3) talcum powder of recipe quantity is added, mixes 5min again, tabletting to obtain the final product.
Comparative example 3
1) prescription
2) preparation process:
(1) Isosorbide Mononitrate, hydroxypropyl methyl fiber K200M, microcrystalline cellulose, cream of recipe quantity are accurately weighed
Sugar, rilanit special, colloidal silicon dioxide mixing 10min cross 20 meshes；(2) mixed powder is mixed into 15min again, crosses 20 meshes；
(3) talcum powder of recipe quantity is added, mixes 5min again, tabletting to obtain the final product.
Comparative example 4
1) prescription
2) preparation process:
(1) hydroxypropyl methyl fiber K200M, microcrystalline cellulose, lactose, rilanit special, the glue of recipe quantity are accurately weighed
State silica mixing 10min；(2) 20 meshes are crossed when the Isosorbide Mononitrate of recipe quantity is added, then mixed powder is mixed
15min；(3) talcum powder of recipe quantity is added, mixes 5min again, tabletting to obtain the final product.
Comparative example 5
1) prescription
2) preparation process:
(1) hydroxypropyl methyl fiber K200M, microcrystalline cellulose, lactose, rilanit special, the glue of recipe quantity are accurately weighed
State silica mixing 10min；(2) Isosorbide Mononitrate of recipe quantity is added by mixed powder mixing 15min, crosses 20 meshes；(3)
The talcum powder of recipe quantity is added, mixes 5min again, tabletting to obtain the final product.
Comparative example 6
1) prescription
2) preparation process:
(1) hydroxypropyl methyl fiber K200M, microcrystalline cellulose, lactose, rilanit special, the glue of recipe quantity are accurately weighed
State silica mixing 10min crosses 20 meshes；(2) Isosorbide Mononitrate of recipe quantity is added by mixed powder mixing 15min, mistake
20 meshes；(3) talcum powder of recipe quantity is added, mixes 5min again, tabletting to obtain the final product.
Comparative example 7
1) prescription
2) preparation process:
(1) Isosorbide Mononitrate, hydroxypropyl methyl fiber K200M, microcrystalline cellulose, cream of recipe quantity are accurately weighed
Sugar, rilanit special, colloidal silicon dioxide mixing 15min cross 20 meshes；(2) using 75% ethyl alcohol as adhesive, wet process system
, dry at 40 DEG C -80 DEG C, whole dry particl；(3) talcum powder of recipe quantity is added in dry particl, mixes 5min, tabletting again
To obtain the final product.
Comparative example 8
1) prescription
2) preparation process is the same as embodiment 1.
Comparative example 9
1) prescription
2) preparation process is the same as embodiment 1.
Comparative example 10
1) prescription
2) preparation process is the same as embodiment 1.
Comparative example 11
1) prescription
2) preparation process is the same as embodiment 1.
Verify embodiment:
Angle of repose detection method
It is measured using powder flowbility detector, principle is the height and powder base diameter meter by measuring powder cone
Angle of repose is calculated, 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 powder bottom
Diameter.
Dissolve out release detection method
Using USP lower Isosorbide Mononitrate dissolution of sustained-release tablets detection methods, it may be assumed that slurry processes are discharged by standard of water
Medium, volume 900mL, 50 revs/min of revolving speed, 37 DEG C of water temperature, release is surveyed in different time sampling.
Angle of repose is the important indicator for evaluating mixed powder mobility, to realize mixed powder direct tablet compressing must satisfy angle of repose≤
40 °, angle of repose more small preform is easier, and obtained piece tablet weight variation is smaller, more suitable for large-scale production.Specific testing result
It is shown in Table 3. embodiment data results
3. embodiment data result of table
It can be seen that 1) angle of repose < 40 ° embodiment 1-9, mobility is preferable, releases for angle of repose and release result from table 3
Degree of putting is controlled in corresponding parameter area, meets medication requirement；The preparation method of comparative example 1-7 is different, right as the result is shown
It is more excessive than implementing the angle of repose 1-6, be not suitable for mixed powder direct tablet compressing, 7 release of comparative example is undesirable；Comparative example
8,9,10 direct powder compression may be implemented, but the release of comparative example 8,9 is too fast, comparative example 10 discharged slowly；It is right
Than 11 angle of repose > 40 ° of embodiment, mobility is poor, is not suitable for mixed powder direct tablet compressing.
Claims (10)
1. a kind of isosorbide mononitrate sustained release tablets, which is characterized in that be made of following component: Isosorbide Mononitrate, lactose,
Microcrystalline cellulose, slow-release material, glidant and lubricant；Wherein slow-release material is by hydroxypropyl methylcellulose and rilanit special group
At.
2. isosorbide mononitrate sustained release tablets according to claim 1, which is characterized in that the slow-release material hydroxypropyl first is fine
The mass ratio of dimension element and rilanit special is 1:0.55-0.82.
3. isosorbide mononitrate sustained release tablets according to claim 2, which is characterized in that the slow-release material hydroxypropyl first is fine
The mass ratio of dimension element and rilanit special is 1:0.68.
4. isosorbide mononitrate sustained release tablets according to claim 1, which is characterized in that the hydroxypropyl methylcellulose is selected from
HPMC K4M, hydroxypropyl methyl cellulose K15M, hydroxypropyl methyl cellulose K40M, hydroxypropyl methyl fiber
One of plain K100M, hydroxypropyl methyl cellulose K200M.
5. isosorbide mononitrate sustained release tablets according to claim 4, which is characterized in that the hydroxypropyl methylcellulose is hydroxyl
Propyl methocel K200M, dosage are 90-130 parts.
6. isosorbide mononitrate sustained release tablets according to claim 1, which is characterized in that be made of following component: single nitre
120 parts of sour Soquad, 50-90 parts of lactose, slow-release material, 60-120 parts of microcrystalline cellulose, 20-35 parts of glidant and lubricant
5-15 parts；Wherein slow-release material is made of hydroxypropyl methylcellulose and rilanit special；The slow-release material hydroxypropyl methylcellulose and
The mass ratio of rilanit special is 1:0.55-0.82；The hydroxypropyl methylcellulose is hydroxypropyl methyl cellulose K200M, is used
Amount is 90-130 parts.
7. isosorbide mononitrate sustained release tablets according to claim 6, which is characterized in that be made of following component: single nitre
120 parts of sour Soquad, 70 parts of lactose, slow-release material, 90 parts of microcrystalline cellulose, 25 parts and 10 parts of lubricant of glidant；Wherein
Slow-release material is made of hydroxypropyl methylcellulose and rilanit special；The slow-release material hydroxypropyl methylcellulose and rilanit special
Mass ratio is 1:0.68；The hydroxypropyl methylcellulose is hydroxypropyl methyl cellulose K200M, and dosage is 90-130 parts.
8. isosorbide mononitrate sustained release tablets according to claim 1, which is characterized in that the glidant is colloidal state dioxy
SiClx.
9. isosorbide mononitrate sustained release tablets according to claim 1, which is characterized in that the lubricant is talcum powder.
10. -9 any isosorbide mononitrate sustained release tablets according to claim 1, it is characterised in that preparation process is powder
Direct tablet compressing；Specifically comprise the following steps:
A. first Isosorbide Mononitrate, glidant are mixed, crosses 20 meshes；
B. powder will be mixed obtained by step (a) and slow-release material is added, mix, cross 20 mesh screens；
C. powder will be mixed obtained by step (b) and lactose and microcrystalline cellulose is added, mix, then cross 20 meshes；
D. step (c) gained is mixed powder addition lubricant to mix again, direct powder compression.
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Cited By (4)
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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 |
| 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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| 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 |
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| CN110420192B (en) | 2022-01-28 |
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