CN108096363A - A kind of doxepin hydrochloride piece and preparation method thereof - Google Patents
A kind of doxepin hydrochloride piece and preparation method thereof Download PDFInfo
- Publication number
- CN108096363A CN108096363A CN201810094716.0A CN201810094716A CN108096363A CN 108096363 A CN108096363 A CN 108096363A CN 201810094716 A CN201810094716 A CN 201810094716A CN 108096363 A CN108096363 A CN 108096363A
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- CN
- China
- Prior art keywords
- doxepin hydrochloride
- piece
- mesh
- hydrochloride piece
- doxepin
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Links
- BUDQDWGNQVEFAC-UHFFFAOYSA-N C1COC=CC1 Chemical compound C1COC=CC1 BUDQDWGNQVEFAC-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/79—Schisandraceae (Schisandra family)
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/57—Magnoliaceae (Magnolia family)
-
- 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
-
- 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
Abstract
The invention belongs to medicine and medical production technical fields, and in particular to a kind of doxepin hydrochloride piece and preparation method thereof.By the way that Schisandra chinens P.E, binding agent and lubricant and doxepin hydrochloride are combined tablet, so that Schisandra chinens P.E acts synergistically with doxepin hydrochloride, tablet obtained has good effect to treatment depression, and can reduce the side effect of doxepin hydrochloride.
Description
Technical field
The invention belongs to medicine and medical production technical fields, and in particular to a kind of doxepin hydrochloride piece and its preparation side
Method.
Background technology
Depression is a kind of common mental handicape, can be caused by many reasons, is so that notable and lasting mental state is low
Main clinical characteristics.Patients with depression clinically there are about 30%~50% is invalid or curative effect is endless using anti depressant medication
Entirely.
Doxepin hydrochloride chemical name:N, N- dimethyl -3- dibenzo (b, e)-evil English in heptan -11 (6H) subunit -1- propylamine
Hydrochlorate cis-trans-isomer mixture, chemical structural formula are:
It is a kind of tricyclic antidepressant, for treating depression and anxiety neurosis, its role is to inhibit maincenter
Nervous system is to the reuptake of serotonin and norepinephrine, so that two kinds of concentration of neurotransmitters of this in synaptic cleft increase
It is high and play antidepressant effect, it may have antianxiety and sedation.
But taking doxepin hydrochloride piece, there are more serious side reactions, such as hidrosis, dry, dizziness, blurred vision.It is accidental
Bone marrow suppression or toxic hepatic damage.
The content of the invention
In order to reduce the side effect of doxepin hydrochloride piece, the present invention provides a kind of doxepin hydrochloride piece and its preparation sides
Method.
Doxepin hydrochloride piece provided by the invention, is prepared by the following raw material:
The doxepin hydrochloride piece is preferably to be prepared by the following raw material:
Wherein, the Schisandra chinens P.E is commercially available that active ingredient is lignanoids such as schizandrin A, Schisandra chinensis second
Element, schizandrin, wuweizi alcohol B, schisandrin C, schisantherin are first-class, also containing a variety of volatile oil such as firpene and lemon
The organic acids compound such as acid, malic acid, tartaric acid.
The binding agent is one kind in starch, dextrin or ethyl cellulose.
The lubricant is one kind in magnesium stearate, superfine silica gel powder, talcum powder or calcium stearate.
The present invention also provides a kind of preparation method of the doxepin hydrochloride piece, the preparation method step is as follows:
(1) Schisandra chinens P.E, doxepin hydrochloride, binding agent and lubricant are weighed in proportion;
(2) Schisandra chinens P.E, doxepin hydrochloride, binding agent and lubricant are crossed into 80 mesh sieves;
(3) Schisandra chinens P.E, binding agent and doxepin hydrochloride after step (2) is sieved, which are placed in mixer, mixes 10
~15 minutes, then a small amount of spray concentration was 75% ethyl alcohol every time, and constantly stirs, when mixed-powder has all moistened,
Manufactured softwood hand is pinched agglomerating, and light pressure is easily scattered, and by the mixture after wetting by the sieve of 18~22 mesh, obtains
Grain;
(4) particle that step (3) obtains is placed in baking oven heating, temperature rises to 40~60 DEG C, and maintenance cools down after five minutes;
(5) lubricant is added in after step (4) dried particle to be crossed to the sieve progress whole grain of 18~22 mesh, is placed in mixing
It is uniformly mixed in machine;
(6) granule content is detected, after determining piece again after the pressure lower sheeting of 5KN~15KN, obtained doxepin hydrochloride piece
It is packed.
Wherein, incorporation time is preferably 10 minutes in step (3) mixer;Mixture after wetting is preferably by 18 mesh
Sieve.
Baking oven heating temperature is preferably 50 DEG C in step (4).
Step (5) dried particle was preferably that the sieve of 18 mesh carries out whole grain.
The pressure of step (6) tabletting is preferably 10KN.
Advantageous effect:
Doxepin hydrochloride piece is made in doxepin hydrochloride and Schisandra chinens P.E by the present invention, in the collaboration of Schisandra chinens P.E
Under effect, tablet obtained can preferably play antidepression, antianxiety and the quelling effect of doxepin hydrochloride, and can have
The side effect of the reduction doxepin hydrochloride of effect, material strictly sieves during processing, ensure that the size of particle, enables its functional component
It is preferably fully absorbed by human body, drug effect is contributed to preferably to play.
Specific embodiment
The present invention is described in further detail with reference to embodiment:
Embodiment 1
Prescription:1000 amounts
(1) Schisandra chinens P.E, doxepin hydrochloride, talcum powder and starch are weighed in proportion;
(2) Schisandra chinens P.E, doxepin hydrochloride, starch and talcum powder are crossed into 80 mesh sieves;
(3) Schisandra chinens P.E, doxepin hydrochloride and starch are placed in mixer and mixed 10 minutes, it is then a small amount of every time
The ethyl alcohol of sprinkling 75%, and is constantly stirred, and when mixed-powder has all moistened, manufactured softwood hand is pinched agglomerating, gently presses fugitive
It opens, the mixture after wetting is passed through to the sieve of 18 mesh, obtains granular product;
(4) granular product that step (3) obtains is placed in constant temperature oven, temperature rises to 50 DEG C, and maintenance is dropped after five minutes
Temperature;
(5) talcum powder is added in after step (4) dried particle to be crossed to the sieve progress whole grain of 22 mesh, is placed in mixer
It is uniformly mixed;
(6) granule content is detected, in the pressure lower sheeting of 10KN after determining piece again, is wrapped after doxepin hydrochloride piece is made
Dress.
Embodiment 2
Prescription:1000 amounts
(1) Schisandra chinens P.E, doxepin hydrochloride, talcum powder and dextrin are weighed in proportion;
(2) Schisandra chinens P.E, doxepin hydrochloride, dextrin and talcum powder are crossed into 80 mesh sieves;
(3) Schisandra chinens P.E, doxepin hydrochloride and dextrin are placed in mixer and mixed 10 minutes, it is then a small amount of every time
The ethyl alcohol of sprinkling 75%, and is constantly stirred, and when mixed-powder has all moistened, manufactured softwood hand is pinched agglomerating, gently presses fugitive
It opens, the mixture after wetting is passed through to the sieve of 20 mesh, obtains granular product;
(4) granular product that step (3) obtains is placed in constant temperature oven, temperature rises to 40 DEG C, and maintenance is dropped after five minutes
Temperature;
(5) talcum powder is added in after step (4) dried particle to be crossed to the sieve progress whole grain of 20 mesh, is placed in mixer
It is uniformly mixed;
(6) granule content is detected, in the pressure lower sheeting of 10KN after determining piece again, is wrapped after doxepin hydrochloride piece is made
Dress.
Embodiment 3
Prescription:1000 amounts
(1) Schisandra chinens P.E, doxepin hydrochloride, calcium stearate and ethyl cellulose are weighed in proportion;
(2) Schisandra chinens P.E, doxepin hydrochloride, ethyl cellulose and calcium stearate are crossed into 80 mesh sieves;
(3) Schisandra chinens P.E, doxepin hydrochloride and ethyl cellulose are placed in mixer and mix 15 minutes, then often
The ethyl alcohol of secondary a small amount of sprinkling 75%, and is constantly stirred, when mixed-powder has all moistened, manufactured softwood hand pinch it is agglomerating, gently
Pressure is easily scattered, and the mixture after wetting is passed through to the sieve of 22 mesh, obtains granular product;
(4) granular product that step (3) obtains is placed in constant temperature oven, temperature rises to 60 DEG C, and maintenance is dropped after five minutes
Temperature;
(5) calcium stearate is added in after step (4) dried particle to be crossed to the sieve progress whole grain of 20 mesh, is placed in mixer
In be uniformly mixed;
(6) granule content is detected, in the pressure lower sheeting of 10KN after determining piece again, is wrapped after doxepin hydrochloride piece is made
Dress.
Embodiment 4
Prescription:1000 amounts
(1) Schisandra chinens P.E, doxepin hydrochloride, magnesium stearate and starch are weighed in proportion;
(2) Schisandra chinens P.E, doxepin hydrochloride, starch and magnesium stearate are crossed into 80 mesh sieves;
(3) Schisandra chinens P.E, doxepin hydrochloride and starch are placed in mixer and mixed 12 minutes, it is then a small amount of every time
The ethyl alcohol of sprinkling 75%, and is constantly stirred, and when mixed-powder has all moistened, manufactured softwood hand is pinched agglomerating, gently presses fugitive
It opens, the mixture after wetting is passed through to the sieve of 20 mesh, obtains granular product;
(4) granular product that step (3) obtains is placed in constant temperature oven, temperature rises to 50 DEG C, and maintenance is dropped after five minutes
Temperature;
(5) magnesium stearate is added in after step (4) dried particle to be crossed to the sieve progress whole grain of 20 mesh, is placed in mixer
In be uniformly mixed;
(6) granule content is detected, in the pressure lower sheeting of 10KN after determining piece again, is wrapped after doxepin hydrochloride piece is made
Dress.
Comparative example 1
Prescription:1000 amounts
Doxepin hydrochloride 10g
Starch 184g
Talcum powder 6g
(1) doxepin hydrochloride, talcum powder and starch are weighed in proportion;
(2) doxepin hydrochloride, starch and talcum powder are crossed into 80 mesh sieves;
(3) doxepin hydrochloride and starch are placed in mixer and mixed 10 minutes, then spray 75% second on a small quantity every time
Alcohol, and constantly stirring, when mixed-powder has all moistened, manufactured softwood hand is pinched agglomerating, and light pressure is easily scattered, and will be soaked
Mixture afterwards passes through the sieve of 18 mesh, obtains granular product;
(4) granular product that step (3) obtains is placed in constant temperature oven, temperature rises to 50 DEG C, and maintenance is dropped after five minutes
Temperature;
(5) talcum powder is added in after step (4) dried particle to be crossed to the sieve progress whole grain of 22 mesh, is placed in mixer
It is uniformly mixed;
(6) granule content is detected, in the pressure lower sheeting of 10KN after determining piece again, is wrapped after doxepin hydrochloride piece is made
Dress.
Due to no addition Schisandra chinens P.E, there are serious side reactions for doxepin hydrochloride sector-meeting obtained.
Comparative example 2
Prescription:1000 amounts
Schisandra chinens P.E 144g
Starch 50g
Talcum powder 6g
(1) Schisandra chinens P.E, talcum powder and starch are weighed in proportion;
(2) Schisandra chinens P.E, starch and talcum powder are crossed into 80 mesh sieves;
(3) Schisandra chinens P.E and starch are placed in mixer and mixed 10 minutes, then spray 75% on a small quantity every time
Ethyl alcohol, and constantly stirring, when mixed-powder has all moistened, manufactured softwood hand is pinched agglomerating, and light pressure is easily scattered, and will be moistened
Mixture after wet passes through the sieve of 18 mesh, obtains granular product;
(4) granular product that step (3) obtains is placed in constant temperature oven, temperature rises to 50 DEG C, and maintenance is dropped after five minutes
Temperature;
(5) talcum powder is added in after step (4) dried particle to be crossed to the sieve progress whole grain of 22 mesh, is placed in mixer
It is uniformly mixed;
(6) granule content is detected, in the pressure lower sheeting of 10KN after determining piece again, it is laggard that Schisandra chinens P.E tablet is made
Row packaging.
Tablet obtained without the synergistic effect of doxepin hydrochloride, can seriously affect its therapeutic effect.
Claims (8)
1. a kind of doxepin hydrochloride piece, it is characterised in that:The doxepin hydrochloride piece is prepared by the following raw material:
2. doxepin hydrochloride piece as described in claim 1, it is characterised in that:The doxepin hydrochloride piece is prepared by the following raw material
It forms:
3. doxepin hydrochloride piece as described in claim 1, it is characterised in that:The Schisandra chinens P.E is commercially available.
4. doxepin hydrochloride piece as described in claim 1, it is characterised in that:The binding agent is starch, dextrin or ethyl are fine
One kind in dimension element.
5. doxepin hydrochloride piece as described in claim 1, it is characterised in that:The lubricant for magnesium stearate, superfine silica gel powder,
One kind in talcum powder or calcium stearate.
6. a kind of preparation method of doxepin hydrochloride piece as described in claim 1, it is characterised in that:The preparation method step
It is as follows:
(1) Schisandra chinens P.E, doxepin hydrochloride, binding agent and lubricant are weighed in proportion;
(2) Schisandra chinens P.E, doxepin hydrochloride, binding agent and lubricant are crossed into 80 mesh sieves;
(3) Schisandra chinens P.E, binding agent and doxepin hydrochloride after step (2) is sieved, which are placed in mixer, mixes 10~15
Minute, then a small amount of spray concentration is 75% ethyl alcohol every time, and constantly stirs, and when mixed-powder has all moistened, is made
Softwood hand pinch agglomerating, light pressure is easily scattered, and by the mixture after wetting by the sieve of 18~22 mesh, obtains particle;
(4) particle that step (3) obtains is placed in baking oven heating, temperature rises to 40~60 DEG C, and maintenance cools down after five minutes;
(5) lubricant is added in after step (4) dried particle to be crossed to the sieve progress whole grain of 18~22 mesh, is placed in mixer
It is uniformly mixed;
(6) granule content is detected, in the pressure lower sheeting of 5KN~15KN after determining piece again, is carried out after doxepin hydrochloride piece is made
Packaging.
7. the preparation method of doxepin hydrochloride piece as claimed in claim 6, it is characterised in that:In step (3) described mixer
Incorporation time is 10 minutes;Mixture after wetting passes through the sieve of 18 mesh;Baking oven heating temperature is 50 DEG C in step (4).
8. the preparation method of doxepin hydrochloride piece as claimed in claim 6, it is characterised in that:Step (5) dried particle
The sieve for crossing 18 mesh carries out whole grain;The pressure of step (6) tabletting is 10KN.
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CN201810094716.0A CN108096363A (en) | 2018-01-31 | 2018-01-31 | A kind of doxepin hydrochloride piece and preparation method thereof |
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CN201810094716.0A CN108096363A (en) | 2018-01-31 | 2018-01-31 | A kind of doxepin hydrochloride piece and preparation method thereof |
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
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CN109512793A (en) * | 2018-12-25 | 2019-03-26 | 哈尔滨珍宝制药有限公司 | A kind of paroxetine hydrochloride preparation and preparation method thereof and paroxetine hydrochloride composition |
CN110575444A (en) * | 2019-10-08 | 2019-12-17 | 苏州弘森药业股份有限公司 | Preparation method of doxepin hydrochloride membrane controlled release preparation |
CN114344288A (en) * | 2022-01-25 | 2022-04-15 | 深圳技术大学 | Application of doxepin hydrochloride in preparation of antiviral drugs |
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US20090074862A1 (en) * | 2007-04-13 | 2009-03-19 | Luigi Schioppi | Low-dose doxepin formulations and methods of making and using the same |
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN109512793A (en) * | 2018-12-25 | 2019-03-26 | 哈尔滨珍宝制药有限公司 | A kind of paroxetine hydrochloride preparation and preparation method thereof and paroxetine hydrochloride composition |
CN109512793B (en) * | 2018-12-25 | 2021-06-11 | 哈尔滨珍宝制药有限公司 | Paroxetine hydrochloride preparation, preparation method thereof and paroxetine hydrochloride composition |
CN110575444A (en) * | 2019-10-08 | 2019-12-17 | 苏州弘森药业股份有限公司 | Preparation method of doxepin hydrochloride membrane controlled release preparation |
CN114344288A (en) * | 2022-01-25 | 2022-04-15 | 深圳技术大学 | Application of doxepin hydrochloride in preparation of antiviral drugs |
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Application publication date: 20180601 |