CN108619103A - A kind of clozapine and preparation method thereof - Google Patents
A kind of clozapine and preparation method thereof Download PDFInfo
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- CN108619103A CN108619103A CN201810375413.6A CN201810375413A CN108619103A CN 108619103 A CN108619103 A CN 108619103A CN 201810375413 A CN201810375413 A CN 201810375413A CN 108619103 A CN108619103 A CN 108619103A
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- clozapine
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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
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
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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
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
- A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
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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
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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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
- 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
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
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Abstract
The invention discloses a kind of clozapine and preparation method thereof, concrete operation step is：The major ingredient ingredient and mass parts of the clozapine be：25 parts of Clozapine, 61.2 parts of microcrystalline cellulose, 3.8 parts of lactose, appropriate povidone, 0.5 part of magnesium stearate, 1.4 parts of talcum powder, 0.4 part of silica；Wherein, the preparation method of the clozapine includes the following steps：Step 1：Clozapine is sieved with 100 mesh sieve, it is spare；Step 2：By the recipe quantity in claim 1 weigh Clozapine, microcrystalline cellulose, lactose be collectively disposed in wet mixing pelletizer be uniformly mixed；Step 3：Suitable povidone is weighed, is dissolved in water and is configured to aqueous solution；Step 4：Suitable softwood is made in the suitable adhesive of addition in mixed powder in one step up.The present invention solves existing prescription poor compressibility, tablet hardness is bad, there are problems that sliver phenomenon in transportational process more using existing customary adjuvant by being optimized to prescription and production technology.
Description
Technical field
The present invention relates to medicine and medical production technical field, more particularly to a kind of clozapines and preparation method thereof.
Background technology
Mental disease refers to that cerebral function activity incidence is random, leads to the cerebrations such as understanding, emotion, behavior and will not
With the general name of the disease of degree obstacle.Pathogenic factor has various aspects：Congenital heredity, personal characteristics and physical factors, device quality factor,
Social environmental factor etc..Many mental patients have vain hope, illusion, illusion, the disturbance of emotion, cry and laugh by turns, without any apparent reason, talk to onself, behavior
Strange, hypobulia, most humans lack insight, do not recognize that oneself is ill, do not seek the help of doctor actively.Commonly
People is not there is also oneself ill phenomenon is recognized, so cannot not recognize using shortage insight and that oneself is ill as determining mental disease
Foundation.Common mental disease has：Schizophrenia, manic-depressive psychosis, involutional psychosis, paranoid psychosis and
The mental disease etc. that various organic diseases occur together.Patient and family members should actively coordinate with psychiatrist, early hospital treatment.
Existing therapy adds complementary therapy mostly based on doctor trained in Western medicine, and the Western medicine of doctor trained in Western medicine diagnosis of complex, common treatment has：
Ziprasidone, Clozapine, perphenazine, chlorpromazine, Risperidone, haloperidol, quetiapine fumarate, Sulpiride, Trimetozine, Austria
Nitrogen equality.Wherein, clozapine is drug of Novartis production in the U.S.'s for schizophrenia treatment, and the prior art mostly uses wet
Legal system grain technique productions clozapine, and use much starch as filler, prescription compressibility is bad, and tablet hardness is bad,
There is sliver phenomenon in transportational process more.
Therefore, it is necessary to solve the above problems to invent a kind of clozapine and preparation method thereof.
Invention content
The purpose of the present invention is to provide a kind of clozapines and preparation method thereof, using existing customary adjuvant, by right
Prescription and production technology optimize, and bad to solve prescription compressibility mentioned above in the background art, tablet hardness is bad,
There are problems that sliver phenomenon in transportational process more.
To achieve the above object, the present invention provides the following technical solutions：A kind of clozapine and preparation method thereof, the chlorine
The major ingredient ingredient and mass parts of nitrogen plain film be：25 parts of Clozapine, 61.2 parts of microcrystalline cellulose, 3.8 parts of lactose, appropriate povidone,
0.5 part of magnesium stearate, 1.4 parts of talcum powder, 0.4 part of silica；
Wherein, the preparation method of the clozapine includes the following steps：
Step 1：Clozapine is sieved with 100 mesh sieve, it is spare；
Step 2：Weighing Clozapine, microcrystalline cellulose, lactose by the recipe quantity in claim 1, to be collectively disposed at wet method mixed
It closes in granulator and is uniformly mixed；
Step 3：Suitable povidone is weighed, is dissolved in water and is configured to aqueous solution；
Step 4：The suitable adhesive of addition is made suitable softwood in mixed powder in one step up, and through waving
As for dry in baking oven after grain mechanism grain；
Step 5：Particle after drying is subjected to whole grain, and adds extraneous component, it is total mixed；
Step 6：Tabletting.
Preferably, in the step 3 povidone solution a concentration of 3~5%.
Preferably, the adhesive in the step 4 is using amylum adhesive, and the amylum adhesive is by Shui Hedian
Powder is made, and the ratio of each component is water 80% and starch 20%, and wherein uncooked amylum accounts for 85%, and ripe starch accounts for 15%, institute
It is 25~35% to state the dosage of amylum adhesive in tablets.
Preferably, the drying temperature in the step 4 is 70~90 DEG C.
Preferably, the extraneous component in the step 5 is except magnesium stearate, talcum powder and the silica in formulation ingredients
Outside, further include having suitable external application disintegrant.
Preferably, the external application disintegrant forms sediment using sodium carboxymethyl starch or low substituted cellulose, the carboxymethyl
The dosage of powder sodium and low substituted cellulose in tablets is generally respectively 4~8% and 2~5%.
Preferably, the ratio of the external application disintegrant and interior microcrystalline cellulose is 1:3.
The technique effect and advantage of the present invention：Using existing customary adjuvant, by optimization to prescription and production technology into
Row optimization, solves prescription poor compressibility, the bad problem of tablet hardness, and auxiliary material used in said preparation is cheap and easy to get, to people
Body safety, In Vitro Dissolution grinds product with original has higher similitude.
Description of the drawings
Fig. 1 stripping curve similitude figures in pH4.0 media compared with reference for clozapine of the invention；
The correction data and commercially available product correction data table that Fig. 2 is the embodiment of the present invention 1-3.
Specific implementation mode
Following will be combined with the drawings in the embodiments of the present invention, and technical solution in the embodiment of the present invention carries out clear, complete
Site preparation describes, it is clear that described embodiments are only a part of the embodiments of the present invention, instead of all the embodiments.It is based on
Embodiment in the present invention, it is obtained by those of ordinary skill in the art without making creative efforts every other
Embodiment shall fall within the protection scope of the present invention.
Embodiment 1：
The present invention provides a kind of clozapine and preparation method thereof, the major ingredient ingredient and mass parts of the clozapine
For：25 parts of Clozapine, 61.2 parts of microcrystalline cellulose, 3.8 parts of lactose, appropriate povidone, 0.5 part of magnesium stearate, talcum powder 1.4
Part, 0.4 part of silica；
Wherein, the preparation method of the clozapine includes the following steps：
Step 1：Clozapine is sieved with 100 mesh sieve, it is spare；
Step 2：Weighing Clozapine, microcrystalline cellulose, lactose by the recipe quantity in claim 1, to be collectively disposed at wet method mixed
It closes in granulator and is uniformly mixed；
Step 3：Weigh suitable povidone, be dissolved in water be configured to it is a concentration of be less than 3% aqueous solution；
Step 4：Suitable softwood, the shallow lake is made in the suitable amylum adhesive of addition in mixed powder in one step up
Powder adhesive is made of water and starch, and the ratio of each component is water 80% and starch 20%, and wherein uncooked amylum accounts for 85%, and
Ripe starch accounts for 15%, and the dosage of the amylum adhesive in tablets is less than 25% and after oscillating granulator is pelletized as baking
Dry in case, drying temperature is 70~90 DEG C；
Step 5：Particle after drying is subjected to whole grain, and stiffened fatty acid magnesium, talcum powder, silica and external application are collapsed
Agent is solved, it is total mixed, wherein external application disintegrant is using sodium carboxymethyl starch, the sodium carboxymethyl starch and use in tablets
Amount is typically less than 4%；
Step 6：Tabletting.
Further, in the above-mentioned technical solutions, the ratio of the external application disintegrant and interior microcrystalline cellulose is 1:
3。
Embodiment 2：
The present invention provides a kind of clozapine and preparation method thereof, the major ingredient ingredient and mass parts of the clozapine
For：25 parts of Clozapine, 61.2 parts of microcrystalline cellulose, 3.8 parts of lactose, appropriate povidone, 0.5 part of magnesium stearate, talcum powder 1.4
Part, 0.4 part of silica；
Wherein, the preparation method of the clozapine includes the following steps：
Step 1：Clozapine is sieved with 100 mesh sieve, it is spare；
Step 2：Weighing Clozapine, microcrystalline cellulose, lactose by the recipe quantity in claim 1, to be collectively disposed at wet method mixed
It closes in granulator and is uniformly mixed；
Step 3：Weigh suitable povidone, be dissolved in water be configured to a concentration of 3~5% aqueous solution；
Step 4：Suitable softwood, the shallow lake is made in the suitable amylum adhesive of addition in mixed powder in one step up
Powder adhesive is made of water and starch, and the ratio of each component is water 80% and starch 20%, and wherein uncooked amylum accounts for 85%, and
Ripe starch accounts for 15%, and the dosage of the amylum adhesive in tablets is 25~35% and after oscillating granulator is pelletized as baking
Dry in case, drying temperature is 70~90 DEG C；
Step 5：Particle after drying is subjected to whole grain, and stiffened fatty acid magnesium, talcum powder, silica and external application are collapsed
Agent is solved, it is total mixed, wherein external application disintegrant is using sodium carboxymethyl starch, the sodium carboxymethyl starch and use in tablets
Amount generally 4~8%；
Step 6：Tabletting.
Embodiment 3：
The present invention provides a kind of clozapine and preparation method thereof, the major ingredient ingredient and mass parts of the clozapine
For：25 parts of Clozapine, 61.2 parts of microcrystalline cellulose, 3.8 parts of lactose, appropriate povidone, 0.5 part of magnesium stearate, talcum powder 1.4
Part, 0.4 part of silica；
Wherein, the preparation method of the clozapine includes the following steps：
Step 1：Clozapine is sieved with 100 mesh sieve, it is spare；
Step 2：Weighing Clozapine, microcrystalline cellulose, lactose by the recipe quantity in claim 1, to be collectively disposed at wet method mixed
It closes in granulator and is uniformly mixed；
Step 3：Weigh suitable povidone, be dissolved in water be configured to it is a concentration of be more than 5% aqueous solution；
Step 4：Suitable softwood, the shallow lake is made in the suitable amylum adhesive of addition in mixed powder in one step up
Powder adhesive is made of water and starch, and the ratio of each component is water 80% and starch 20%, and wherein uncooked amylum accounts for 85%, and
Ripe starch accounts for 15%, and the dosage of the amylum adhesive in tablets is more than 35% and after oscillating granulator is pelletized as baking
Dry in case, drying temperature is 70~90 DEG C；
Step 5：Particle after drying is subjected to whole grain, and stiffened fatty acid magnesium, talcum powder, silica and external application are collapsed
Agent is solved, it is total mixed, wherein external application disintegrant is using sodium carboxymethyl starch, the sodium carboxymethyl starch and use in tablets
Amount typically greater than 8%；
Step 6：Tabletting.
Embodiment 4：
From implement unlike power 1-3, the external application disintegrant used in the step is low substituted cellulose, and it is in piece
Dosage in agent is generally 2~5%.
With reference to Figure of description 2, from the data in the table：
(1) and if only if povidone concentration of aqueous solution be 3~5%, the dosage of amylum adhesive in tablets be 25~
35% and sodium carboxymethyl starch dosage in tablets when being 4~8%, for the tablet hardness of clozapine is compared with commercially available product,
There is the raising of apparent amplitude；
(2) unlike conclusion 1, other conditions are constant, and the dosage of low substituted cellulose in tablets is 2~5%, chlorine
For the tablet hardness of nitrogen plain film is compared with commercially available product, the raising of equal magnitude can be reached.
In addition, using this technology prepare clozapine, compared with reference in pH4.0 media stripping curve similitude ratio
Compared with result referring to Figure of description 1, from the similarity curve in figure：
The clozapine prepared using this technology stripping curve similitude in pH4.0 media is preferable.
Finally it should be noted that：The foregoing is only a preferred embodiment of the present invention, is not intended to restrict the invention,
Although the present invention is described in detail referring to the foregoing embodiments, for those skilled in the art, still may be used
With technical scheme described in the above embodiments is modified or equivalent replacement of some of the technical features,
All within the spirits and principles of the present invention, any modification, equivalent replacement, improvement and so on should be included in the present invention's
Within protection domain.
Claims (7)
1. a kind of clozapine and preparation method thereof, it is characterised in that：The major ingredient ingredient and mass parts of the clozapine be：Chlorine
Nitrogen is 25 parts flat, 61.2 parts of microcrystalline cellulose, 3.8 parts of lactose, appropriate povidone, 0.5 part of magnesium stearate, 1.4 parts of talcum powder, dioxy
0.4 part of SiClx；
Wherein, the preparation method of the clozapine includes the following steps：
Step 1：Clozapine is sieved with 100 mesh sieve, it is spare；
Step 2：Clozapine, microcrystalline cellulose, lactose, which are weighed, by the recipe quantity in claim 1 is collectively disposed at wet-mixing system
It is uniformly mixed in grain machine；
Step 3：Suitable povidone is weighed, is dissolved in water and is configured to aqueous solution；
Step 4：Suitable softwood is made in the suitable adhesive of addition in mixed powder in one step up, and through oscillating granulator
As for dry in baking oven after granulation；
Step 5：Particle after drying is subjected to whole grain, and adds extraneous component, it is total mixed；
Step 6：Tabletting.
2. a kind of preparation method of clozapine according to claim 1, it is characterised in that：Povidone in the step 3
A concentration of the 3~5% of solution.
3. a kind of preparation method of clozapine according to claim 1, it is characterised in that：Bonding in the step 4
Agent is made using amylum adhesive, the amylum adhesive of water and starch, and the ratio of each component is water 80% and forms sediment
Powder 20%, wherein uncooked amylum account for 85%, and ripe starch accounts for 15%, and the dosage of the amylum adhesive in tablets is 25~35%.
4. a kind of preparation method of clozapine according to claim 1, it is characterised in that：Drying in the step 4
Temperature is 70~90 DEG C.
5. a kind of preparation method of clozapine according to claim 1, it is characterised in that：It is additional in the step 5
Component further includes having suitable external application disintegrant in addition to magnesium stearate, talcum powder and silica in formulation ingredients.
6. a kind of preparation method of clozapine according to claim 5, it is characterised in that：The external application disintegrant uses
Be sodium carboxymethyl starch or low substituted cellulose, the dosage one of the sodium carboxymethyl starch and low substituted cellulose in tablets
As be respectively 4~8% and 2~5%.
7. a kind of preparation method of clozapine according to claim 5, it is characterised in that：The external application disintegrant with it is interior
The ratio of microcrystalline cellulose is 1:3.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810375413.6A CN108619103A (en) | 2018-04-24 | 2018-04-24 | A kind of clozapine and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810375413.6A CN108619103A (en) | 2018-04-24 | 2018-04-24 | A kind of clozapine and preparation method thereof |
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| CN108619103A true CN108619103A (en) | 2018-10-09 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201810375413.6A Pending CN108619103A (en) | 2018-04-24 | 2018-04-24 | A kind of clozapine and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109030684A (en) * | 2018-10-29 | 2018-12-18 | 湖南洞庭药业股份有限公司 | Clozaril pharmaceutical composition and preparation method |
| CN113975239A (en) * | 2021-11-04 | 2022-01-28 | 寿光富康制药有限公司 | Preparation method and equipment of clozapine dispersible tablets |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RU2441651C1 (en) * | 2010-12-23 | 2012-02-10 | Маргарита Алексеевна Морозова | Method for production of clozapine pharmaceutical composition in form of tablets and pharmaceutical composition |
| CN105327287A (en) * | 2015-12-05 | 2016-02-17 | 翔宇药业股份有限公司 | Pharmaceutical composition for treating psychosis and preparation technology thereof |
| CN105769789A (en) * | 2016-03-14 | 2016-07-20 | 山东仁和堂药业有限公司 | Clozapine tablets for treating schizophrenia and preparation method thereof |
-
2018
- 2018-04-24 CN CN201810375413.6A patent/CN108619103A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RU2441651C1 (en) * | 2010-12-23 | 2012-02-10 | Маргарита Алексеевна Морозова | Method for production of clozapine pharmaceutical composition in form of tablets and pharmaceutical composition |
| CN105327287A (en) * | 2015-12-05 | 2016-02-17 | 翔宇药业股份有限公司 | Pharmaceutical composition for treating psychosis and preparation technology thereof |
| CN105769789A (en) * | 2016-03-14 | 2016-07-20 | 山东仁和堂药业有限公司 | Clozapine tablets for treating schizophrenia and preparation method thereof |
Non-Patent Citations (2)
| Title |
|---|
| 国家食品药品监督管理总局执业药师资格认证中心: "《药学专业知识 1 第7版 2017版》", 28 February 2017, 中国医药科技出版社 * |
| 未知: "CLOZARIL", 《CLOZARIL®(CLOZAPINE) TABLETS》 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109030684A (en) * | 2018-10-29 | 2018-12-18 | 湖南洞庭药业股份有限公司 | Clozaril pharmaceutical composition and preparation method |
| CN109030684B (en) * | 2018-10-29 | 2021-06-15 | 湖南洞庭药业股份有限公司 | Clozapine tablet pharmaceutical composition and preparation method thereof |
| CN113975239A (en) * | 2021-11-04 | 2022-01-28 | 寿光富康制药有限公司 | Preparation method and equipment of clozapine dispersible tablets |
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