CN107157946A - A kind of clopidogrel hydrogen sulfate tablet and preparation method thereof - Google Patents
A kind of clopidogrel hydrogen sulfate tablet and preparation method thereof Download PDFInfo
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- CN107157946A CN107157946A CN201710475155.4A CN201710475155A CN107157946A CN 107157946 A CN107157946 A CN 107157946A CN 201710475155 A CN201710475155 A CN 201710475155A CN 107157946 A CN107157946 A CN 107157946A
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- tablet
- hydrogen sulfate
- clopidogrel
- clopidogrel hydrogen
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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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
- A61K31/4365—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system having sulfur as a ring hetero atom, e.g. ticlopidine
-
- 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
- A61K9/2009—Inorganic compounds
Abstract
The invention discloses a kind of clopidogrel hydrogen sulfate tablet and preparation method thereof, it is made up of the material of following percentage by weight：Bisulfate clopidogrel 35% ~ 40%；Structure rafter acid 0 ~ 1%；Lactose 0 ~ 12%；Microcrystalline cellulose 0 ~ 30%；Pregelatinized starch 0 ~ 30%；Binder 2% ~ 7%；Disintegrant 3 ~ 7%；Lubricant 1.5 ~ 5%；Its preparation method comprises the following steps：The first step, 100 mesh sieves are crossed by bisulfate clopidogrel, are sealed with wax standby；Second step, 40 ~ 80 mesh sieves are crossed by lactose, microcrystalline cellulose, pregelatinized starch, Macrogol 6000, PVPP, hydroxypropyl cellulose and structure rafter acid；3rd step, bisulfate clopidogrel is well mixed with all auxiliary materials in addition to Macrogol 6000 using the equivalent method of progressively increasing；4th step, adds Macrogol 6000, and be well mixed into above-mentioned uniform mixed medicinal powder；5th step, carries out compressing tablet process to mixed powdery medicine using tablet press machine, obtains clopidogrel hydrogen sulfate tablet, and damp-prrof packing, sealing preserve.
Description
Technical field
The present invention relates to a kind of clopidogrel hydrogen sulfate tablet and preparation method thereof, belong to pharmaceutical technology field.
Background technology
Cerebral apoplexy is most common cardiovascular and cerebrovascular disease, it has also become threaten the number one killer of human health；According to statistics, it is global
Palsy of annual about 700,000 people with Xin Fa or recurrence；World's annual incidence of disease of palsy is about 2,00/,100,000, dead
Rate is close to 1,00/,100,000；Chinese annual new hair patients with cerebral apoplexy 1,500,000, existing survivor 6,000,000, wherein 75% disability,
40% severe disables；Annual directly or indirectly economic loss is up to tens billion of members；Most cerebral apoplexy (83%) is due to thrombus
What embolism that caused ischaemic is caused or due to vascular system was caused；Transient ischemia (TIAs) or small thrombus
Can voluntarily it recover at 24 hours, it is due to maladjusted nervous system caused by cerebral ischaemia；The breaking-out of Temporary ischemia is
The key factor of cerebral apoplexy is induced, because stroke onset is difficult to cure, thus the breaking-out of prevention Temporary ischemia is particularly significant；
Antiplatelet drug is the foundation stone for treating and preventing Temporary ischemia and cardiovascular thromboembolic, comprehensive in primary prevention and acute coronary
Played an important role in secondary prevention after simulator sickness and Percutaneous coronary intervention；With the sternness of cardiovascular and cerebrovascular thrombotic diseases
Reality and development trend, the application prospect of antiplatelet drug will be more wide；Oral anti-diabetic agent thing is that current research is relative
Weak link；Therefore safely and effectively antiplatelet drug is just particularly important for exploitation；Blood platelet in circulation has glutinous
The functions such as attached, deformation, secretion, release and aggregation, play an important role in physiological hemostasis and thrombosis；And hydrogen sulfate chlorine pyrrole lattice
Thunder is a kind of platelet aggregation inhibitor, can optionally suppress adenosine diphosphate (ADP)（ADP）And the combination of platelet receptor, so that
Suppress hematoblastic aggregation；And presently commercially available isomorphous bisulfate clopidogrel, due to the difference of preparation technology, it is interior in matter
Amount can be variant；The present invention demonstrates self-control clopidogrel hydrogen sulfate tablet by dissolution rate test has good dissolution rate,
It is fast compared with commercial sulfuric acid clopidogrel hydrogen tablet, be conducive to improving its bioavilability.
The content of the invention
To solve the above problems, the present invention proposes a kind of clopidogrel hydrogen sulfate tablet and preparation method thereof, develop
Stablizing effective hydrogen sulfate atmosphere adjoins Gray's piece, and patient compliance is improved while heightening the effect of a treatment.
The clopidogrel hydrogen sulfate tablet of the present invention, is made up of the material of following percentage by weight：
Bisulfate clopidogrel 35% ~ 40%；
Structure rafter acid 0 ~ 1%；
Lactose 0 ~ 12%；
Microcrystalline cellulose 0 ~ 30%；
Pregelatinized starch 0 ~ 30%；
Binder 2% ~ 7%；
Disintegrant 3 ~ 7%；
Lubricant 1.5 ~ 5%.
Further, the disintegrant includes dried starch, low-substituted hydroxypropyl cellulose, PVPP, crosslinking carboxylic first
Mixture more than one or both of base sodium cellulosate, sodium carboxymethyl starch.
As preferred embodiment, the disintegrant is PVPP, and its percentage by weight is 5%.
Further, the lubricant be 1.5% ~ 2.5% magnesium stearate including percentage by weight or percentage by weight be 2% ~
5% Macrogol 6000；It is preferred that percentage by weight be 2% magnesium stearate or percentage by weight is 3% Macrogol 6000；It is optimal
The percentage by weight of choosing is 3% Macrogol 6000.
As preferred embodiment, the binder is hydroxypropyl cellulose, and its percentage by weight is 2%.
As preferred embodiment, its weight ratio of the lactose, microcrystalline cellulose and pregelatinized starch is 1.08：3：1,
And its percentage by weight of pregelatinized starch is 10%.
It is used as preferred embodiment, in addition to glidant；The glidant be superfine silica gel powder, its percentage by weight be 0 ~
5%。
The preparation method of the clopidogrel hydrogen sulfate tablet of the present invention, comprises the following steps：
The first step, 100 mesh sieves are crossed by bisulfate clopidogrel, are sealed with wax standby；
Second step, by lactose, microcrystalline cellulose, pregelatinized starch, Macrogol 6000, PVPP, hydroxypropyl cellulose
40 ~ 80 mesh sieves are crossed with structure rafter acid；
3rd step, bisulfate clopidogrel is mixed with all auxiliary materials in addition to Macrogol 6000 using the equivalent method of progressively increasing
It is even；
4th step, adds Macrogol 6000, and be well mixed into above-mentioned uniform mixed medicinal powder；
5th step, carries out compressing tablet process to mixed powdery medicine using tablet press machine, obtains clopidogrel hydrogen sulfate tablet,
And damp-prrof packing, sealing preserve.
The preparation method of the clopidogrel hydrogen sulfate tablet of the present invention, comprises the following steps：
The first step, takes bisulfate clopidogrel to cross 60 mesh sieves；
Second step, Macrogol 6000 crosses 120 mesh sieves；
3rd step, takes the bisulfate clopidogrel after sieving to be well mixed with Macrogol 6000；
4th step, the medicine after being well mixed is mixed with microcrystalline cellulose, pregelatinized starch and lactose, uses dry granulation mechanism
Grain, control pressure is 50N；
5th step, additional PVPP, hydroxypropyl cellulose, structure rafter acid and superfine silica gel powder, compress tablet coating after being well mixed.
Further, the dissolution rate test of clopidogrel hydrogen sulfate tablet is included；The specific step of the dissolution rate test
It is rapid as follows：
A. dissolution rate test, takes clopidogrel hydrogen sulfate tablet, from 0.01 moLL-1HCl as dissolution medium, with
75r·min-1Rotating speed, operated according to dissolution method, repeat 3 ~ 5 times measure；Measurement result shows, many batches of sulfuric acid
The dissolution homogeneity of clopidogrel hydrogen tablet is good；
B. self-control clopidogrel hydrogen sulfate tablet is compared with the dissolution rate of commercial sulfuric acid clopidogrel hydrogen tablet, and hydrogen sulfate is taken respectively
Clopidogrel tablet and commercial sulfuric acid clopidogrel hydrogen tablet, carry out dissolution determination；From result, hydrogen sulfate chlorine pyrrole is made by oneself
The dissolution of Gray's tablet is fast compared with commercial sulfuric acid clopidogrel hydrogen tablet, is conducive to improving its bioavilability.
Compared with prior art, clopidogrel hydrogen sulfate tablet of the invention and preparation method thereof, addition is helped the present invention
Agent and structure rafter acid are flowed, have developed and stablize effective hydrogen sulfate atmosphere and adjoin Gray's piece, patient compliance is improved while heightening the effect of a treatment；
Test many batches of clopidogrel hydrogen sulfate tablets and self-control clopidogrel hydrogen sulfate tablet and commercial sulfuric acid hydrogen chlorine pyrrole lattice respectively simultaneously
The dissolution rate of thunder tablet, demonstrates the clopidogrel hydrogen sulfate tablet dissolution rate homogeneity of the invention prepared good and more commercially available
Clopidogrel hydrogen sulfate tablet is fast, is conducive to improving its bioavilability.
Brief description of the drawings
Fig. 1 is the dissolution rate test figure of many batches of clopidogrel hydrogen sulfate tablets of the present invention.
Fig. 2 is that the self-control clopidogrel hydrogen sulfate tablet of the present invention is surveyed with the dissolution rate of commercial sulfuric acid clopidogrel hydrogen tablet
Attempt.
Embodiment
Embodiment 1：
The clopidogrel hydrogen sulfate tablet of the present invention, is made up of the material of following percentage by weight：
Bisulfate clopidogrel 35% ~ 40%；
Structure rafter acid 0 ~ 1%；
Lactose 0 ~ 12%；
Microcrystalline cellulose 0 ~ 30%；
Pregelatinized starch 0 ~ 30%；
Binder 2% ~ 7%；
Disintegrant 3 ~ 7%；
Lubricant 1.5 ~ 5%.
The disintegrant includes dried starch, low-substituted hydroxypropyl cellulose, PVPP, cross-linked carboxymethyl cellulose
Mixture more than one or both of sodium, sodium carboxymethyl starch.
The disintegrant is PVPP, and its percentage by weight is 5%.
The lubricant is 1.5% ~ 2.5% magnesium stearate including percentage by weight or percentage by weight is 2% ~ 5% poly- second two
Alcohol 6000；It is preferred that percentage by weight be 2% magnesium stearate or percentage by weight is 3% Macrogol 6000；Most preferred weight
Percentage is 3% Macrogol 6000.
The binder is hydroxypropyl cellulose, and its percentage by weight is 2%.
Its weight ratio of the lactose, microcrystalline cellulose and pregelatinized starch is 1.08：3：1, and pregelatinized starch its weight
Percentage is 10%.
Also include glidant；The glidant is superfine silica gel powder, and its percentage by weight is 0 ~ 5%.
The preparation method of the clopidogrel hydrogen sulfate tablet of the present invention, comprises the following steps：
The first step, 100 mesh sieves are crossed by bisulfate clopidogrel, are sealed with wax standby；
Second step, by lactose, microcrystalline cellulose, pregelatinized starch, Macrogol 6000, PVPP, hydroxypropyl cellulose
40 ~ 80 mesh sieves are crossed with structure rafter acid；
3rd step, bisulfate clopidogrel is mixed with all auxiliary materials in addition to Macrogol 6000 using the equivalent method of progressively increasing
It is even；
4th step, adds Macrogol 6000, and be well mixed into above-mentioned uniform mixed medicinal powder；
5th step, carries out compressing tablet process to mixed powdery medicine using tablet press machine, obtains clopidogrel hydrogen sulfate tablet,
And damp-prrof packing, sealing preserve.
6th step, dissolution rate test, it is comprised the following steps that：
A. dissolution rate test, takes clopidogrel hydrogen sulfate tablet, from 0.01 moLL-1HCl as dissolution medium, with
75r·min-1Rotating speed, operated according to dissolution method, repeat 3 ~ 5 times measure；As shown in figure 1, measurement result table
Bright, the dissolution homogeneity of many batches of clopidogrel hydrogen sulfate tablets is good；
B. self-control clopidogrel hydrogen sulfate tablet is compared with the dissolution rate of commercial sulfuric acid clopidogrel hydrogen tablet, and hydrogen sulfate is taken respectively
Clopidogrel piece and commercial sulfuric acid clopidogrel hydrogen piece, carry out dissolution determination；As shown in Fig. 2 from result, it is molten from film-making
Go out more commercially available soon, be conducive to improving its bioavilability.
Embodiment 2：
The preparation method of the clopidogrel hydrogen sulfate tablet of the present invention, comprises the following steps：
The first step, takes bisulfate clopidogrel to cross 60 mesh sieves；
Second step, Macrogol 6000 crosses 120 mesh sieves；
3rd step, takes the bisulfate clopidogrel after sieving to be well mixed with Macrogol 6000；
4th step, the medicine after being well mixed is mixed with microcrystalline cellulose, pregelatinized starch and lactose, uses dry granulation mechanism
Grain, control pressure is 50N；
5th step, additional PVPP, hydroxypropyl cellulose, structure rafter acid and superfine silica gel powder, compress tablet coating after being well mixed.
Using the above-mentioned desirable embodiment according to the present invention as enlightenment, by above-mentioned description, relevant staff is complete
Various changes and amendments can be carried out without departing from the scope of the technological thought of the present invention' entirely.The technology of this invention
Property scope is not limited to the content on specification, it is necessary to its technical scope is determined according to right.
Claims (10)
1. a kind of clopidogrel hydrogen sulfate tablet, it is characterised in that：It is made up of the material of following percentage by weight：
Bisulfate clopidogrel 35% ~ 40%；
Structure rafter acid 0 ~ 1%；
Lactose 0 ~ 12%；
Microcrystalline cellulose 0 ~ 30%；
Pregelatinized starch 0 ~ 30%；
Binder 2% ~ 7%；
Disintegrant 3 ~ 7%；
Lubricant 1.5 ~ 5%.
2. clopidogrel hydrogen sulfate tablet according to claim 1 and preparation method thereof, it is characterised in that：The disintegrant
Including in dried starch, low-substituted hydroxypropyl cellulose, PVPP, Ac-Di-Sol, sodium carboxymethyl starch
One or more kinds of mixtures.
3. clopidogrel hydrogen sulfate tablet according to claim 1 or 2 and preparation method thereof, it is characterised in that：It is described to collapse
Solution agent is PVPP, and its percentage by weight is 5%.
4. clopidogrel hydrogen sulfate tablet according to claim 1 and preparation method thereof, it is characterised in that：The lubricant
It is 1.5% ~ 2.5% magnesium stearate including percentage by weight or percentage by weight is 2% ~ 5% Macrogol 6000；It is preferred that weight hundred
Point than being 2% magnesium stearate or percentage by weight is 3% Macrogol 6000；The polyethylene glycol that most preferred percentage by weight is 3%
6000。
5. clopidogrel hydrogen sulfate tablet according to claim 1 and preparation method thereof, it is characterised in that：The binder
For hydroxypropyl cellulose, its percentage by weight is 2%.
6. clopidogrel hydrogen sulfate tablet according to claim 1 and preparation method thereof, it is characterised in that：The lactose,
Microcrystalline cellulose and its weight ratio of pregelatinized starch are 1.08：3：1, and its percentage by weight of pregelatinized starch is 10%.
7. clopidogrel hydrogen sulfate tablet according to claim 1 and preparation method thereof, it is characterised in that：Also include helping stream
Agent；The glidant is superfine silica gel powder, and its percentage by weight is 0 ~ 5%.
8. a kind of preparation method of clopidogrel hydrogen sulfate tablet, it is characterised in that：Comprise the following steps：
The first step, 100 mesh sieves are crossed by bisulfate clopidogrel, are sealed with wax standby；
Second step, by lactose, microcrystalline cellulose, pregelatinized starch, Macrogol 6000, PVPP, hydroxypropyl cellulose
40 ~ 80 mesh sieves are crossed with structure rafter acid；
3rd step, bisulfate clopidogrel is mixed with all auxiliary materials in addition to Macrogol 6000 using the equivalent method of progressively increasing
It is even；
4th step, adds Macrogol 6000, and be well mixed into above-mentioned uniform mixed medicinal powder；
5th step, carries out compressing tablet process to mixed powdery medicine using tablet press machine, obtains clopidogrel hydrogen sulfate tablet,
And damp-prrof packing, sealing preserve.
9. a kind of preparation method of clopidogrel hydrogen sulfate tablet, it is characterised in that：Comprise the following steps：
The first step, takes bisulfate clopidogrel to cross 60 mesh sieves；
Second step, Macrogol 6000 crosses 120 mesh sieves；
3rd step, takes the bisulfate clopidogrel after sieving to be well mixed with Macrogol 6000；
4th step, the medicine after being well mixed is mixed with microcrystalline cellulose, pregelatinized starch and lactose, uses dry granulation mechanism
Grain, control pressure is 50N；
5th step, additional PVPP, hydroxypropyl cellulose, structure rafter acid and superfine silica gel powder, compress tablet coating after being well mixed.
10. clopidogrel hydrogen sulfate tablet according to claim 8 or claim 9 and preparation method thereof, it is characterised in that：Also include
The dissolution rate test of clopidogrel hydrogen sulfate tablet；The dissolution rate test is comprised the following steps that：
A. dissolution rate test, takes clopidogrel hydrogen sulfate tablet, from 0.01 moLL-1HCl as dissolution medium, with
75r·min-1Rotating speed, operated according to dissolution method, repeat 3 ~ 5 times measure；Measurement result shows, many batches of sulfuric acid
The dissolution homogeneity of clopidogrel hydrogen tablet is good；
B. self-control clopidogrel hydrogen sulfate tablet is compared with the dissolution rate of commercial sulfuric acid clopidogrel hydrogen tablet, and hydrogen sulfate is taken respectively
Clopidogrel tablet and commercial sulfuric acid clopidogrel hydrogen tablet, carry out dissolution determination；From result, hydrogen sulfate chlorine pyrrole is made by oneself
The dissolution of Gray's tablet is fast compared with commercial sulfuric acid clopidogrel hydrogen tablet.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710475155.4A CN107157946A (en) | 2017-06-21 | 2017-06-21 | A kind of clopidogrel hydrogen sulfate tablet and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710475155.4A CN107157946A (en) | 2017-06-21 | 2017-06-21 | A kind of clopidogrel hydrogen sulfate tablet and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
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| CN107157946A true CN107157946A (en) | 2017-09-15 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201710475155.4A Pending CN107157946A (en) | 2017-06-21 | 2017-06-21 | A kind of clopidogrel hydrogen sulfate tablet and preparation method thereof |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101766573A (en) * | 2010-02-05 | 2010-07-07 | 上海安必生制药技术有限公司 | Preparation process of clopidogrel bisulfate solid preparation |
| CN102247333A (en) * | 2010-05-18 | 2011-11-23 | 山东方明药业股份有限公司 | Clopidogrel hydrogen sulfate tablet and preparation method thereof |
-
2017
- 2017-06-21 CN CN201710475155.4A patent/CN107157946A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101766573A (en) * | 2010-02-05 | 2010-07-07 | 上海安必生制药技术有限公司 | Preparation process of clopidogrel bisulfate solid preparation |
| CN102247333A (en) * | 2010-05-18 | 2011-11-23 | 山东方明药业股份有限公司 | Clopidogrel hydrogen sulfate tablet and preparation method thereof |
Non-Patent Citations (2)
| Title |
|---|
| 奚念朱: "《药剂学》", 30 April 1996, 人民卫生出版社 * |
| 阚全程: "《临床药学高级教程》", 28 February 2015, 北京：人民军医出版社 * |
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Application publication date: 20170915 |