CN107028904A - A kind of preparation method of trazodone hydrochloride piece - Google Patents
A kind of preparation method of trazodone hydrochloride piece Download PDFInfo
- Publication number
- CN107028904A CN107028904A CN201710338977.8A CN201710338977A CN107028904A CN 107028904 A CN107028904 A CN 107028904A CN 201710338977 A CN201710338977 A CN 201710338977A CN 107028904 A CN107028904 A CN 107028904A
- Authority
- CN
- China
- Prior art keywords
- preparation
- prescription
- filler
- trazodone hydrochloride
- well mixed
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Classifications
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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
-
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene
-
- 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 present invention relates to a kind of preparation method of trazodone hydrochloride piece, mainly include the following steps that：（1）Trazodone hydrochloride is well mixed with a part of filler in prescription, pelletizes, obtains medicine-containing particle；（2）Remaining filler in prescription is pelletized, blank granules are obtained；（3）By step（1）And step（2）Obtained particle sieves respectively, alternating whole grain, is well mixed, tabletting is produced.The preparation method that the present invention is provided can effectively prevent the discoloration problem in production and placement process, product is more stablized, so as to ensure the validity and security of product.
Description
Technical field
The present invention relates to pharmaceutical technology field, and in particular to a kind of preparation method of trazodone hydrochloride piece.
Background technology
Trazodone hydrochloride is clinically also common to be applied to antianxiety, insomnia, erection work(mainly as antidepressant application
The illnesss such as energy obstacle.It is the medicine that a kind of therapeutic domain is wide, curative effect is good and safe.But, in the market is most common
It is very easy to metachromatism occur in formulation, i.e. trazodone hydrochloride piece, the drying process in production and in placement process, color
Pink colour is changed into by white to off-white color, and gradually deepened with the extension of tablet standing time.At present, trazodone hydrochloride
Most of manufacturer of piece improves the property of tablet by the way that coated tablet is made or adds by way of colored pellets agent is made in pigment
Shape, makes product more attractive in appearance in appearance, such as Watson Laboratories, Qualitest Pharmaceuticals and
Chemical pharmacy when coating tablet, Taiwan U.S. is made in trazodone hydrochloride piece by the companies such as Sun Pharmaceutical Industries
Jade is expressed by U.S.A of production, and pink colour is made by adding colouring agent by tablet.But, these ways are that to mask product easy to change
Essence, the problem of fundamentally not solving discoloration.And change colour and generally imply that the change of product quality and property, this change
Change may not only influence whether the curative effect of product, it is also possible to cause some adverse reactions, influence the security of product.Therefore,
The discoloration problem in production process is fundamentally solved in the urgent need to a kind of new trazodone hydrochloride piece preparation technology of exploitation, makes production
Product are more stablized, so as to ensure the validity and security of product.
The content of the invention
It is an object of the invention to provide a kind of preparation method of trazodone hydrochloride piece, it is solved in production and placement process
In discoloration problem.In order to solve the above-mentioned technical problem, the present invention is achieved through the following technical solutions.
A kind of preparation method of trazodone hydrochloride piece, it is characterised in that mainly include the following steps that：
（1）Trazodone hydrochloride is well mixed with a part of filler in prescription, pelletizes, obtains medicine-containing particle；
（2）Remaining filler in prescription is pelletized, blank granules are obtained；
（3）By step（1）And step（2）Obtained particle sieves respectively, alternating whole grain, is well mixed, tabletting is produced.
Step（1）With（2）Described in granulation can be dry granulation or wet granulation.
Step（1）With（2）Described in filler can be microcrystalline cellulose, pregelatinized starch, cornstarch, lactose,
One or more in dextrin.It is preferred that, step（1）Described in a part of filler include pregelatinized starch.
Step（1）With（2）It is additionally added appropriate adhesive.Described adhesive can be polyvinylpyrrolidone, hydroxypropyl
One kind in methylcellulose, starch, solvent is water.
The one or more in disintegrant, lubricant can also be added in each step.Described disintegrant can be
Sodium carboxymethyl starch, PVPP, crosslinked carboxymethyl fecula sodium, Ac-Di-Sol, low substitution hydroxyl
One or more in propyl cellulose；Described lubricant can be magnesium stearate, talcum powder, silica, polyethylene glycol
In one or more.
To solve the discoloration problem of trazodone hydrochloride piece, present inventor has performed substantial amounts of experimental study.In research process
It was found that, when using traditional handicraft one-step palletizing when, either select different pharmaceutic adjuvants for example filler, disintegrant, lubricant,
Adhesive etc., selection dry granulation or wet granulation or adjustment drying condition, the product of preparation are still occurred in that soon
Color is just changed into pale pink by white in metachromatism, the substantially drying process in production, prepares color after piece agent
Even more deepen with the extension of standing time.In continuous explore, inventor attempts, using the method pelletized respectively, to pass through
A part of filler in trazodone hydrochloride raw material and prescription is prepared into medicine-containing particle, be prepared by remaining filler in prescription
Into blank granules, then sieved respectively, replace whole grain, the method for well mixed rear tabletting prepares trazodone hydrochloride piece.Whole
In individual preparation process, each step is such as beneficial to the adhesive of tablet shaping, beneficial to piece always according to needing to the addition of other pharmaceutic adjuvants
The agent disintegrant of rapid solution absorption, the lubricant etc. for preventing sticking in vivo.Inventor have selected different pharmaceutic adjuvants and
Different drying conditions（Drying temperature：40-80 DEG C, drying time 3-6h）Tested, as a result shown, it is no matter other medicinal auxiliary
Material（Such as adhesive, disintegrant, lubricant）Order of addition and species how to select, how drying condition changes, as long as
Using granulation respectively（A part of filler in prescription and trazodone hydrochloride are prepared into medicine-containing particle, remaining filling
Agent is prepared into blank granules）With metachromatism in placement process in the trazodone hydrochloride piece of preparation, the drying process in production
Will be lighter than tablet prepared by traditional handicraft marumerization under equal conditions.More it was unexpected that when in medicine-containing particle preparation
When filler contains pregelatinized starch, obtained trazodone hydrochloride piece is either in the drying process or in placement process,
Do not occur metachromatism, the problem of thoroughly solving discoloration.Result of the test shows that the preparation method that the present invention is provided is made with tradition
Preparation Method is compared, and can substantially mitigate or even eliminate the metachromatism of product, is more beneficial for the stabilization of product, ensures product matter
Amount, so as to ensure the validity and security of product.
Embodiment
The present invention will be described for section Example exemplified below, but the present invention is not limited only to embodiment.
The preparation of the trazodone hydrochloride piece of embodiment 1.
Prescription is shown in Table 1, is 1000 scale consumptions.
Preparation method：。
1. the preparation of supplementary material.
Adhesive is configured in advance according to prescription standby；Trazodone hydrochloride was smashed into 100 mesh sieves standby；By its in prescription
It needs the direct mesh sieve of mistake 100 of pharmaceutic adjuvant sieved standby.
2. the preparation of medicine-containing particle.
Take a part of filler in the trazodone hydrochloride and prescription of recipe quantity（A part of filler in prescription is respectively
Refer to：Prescription 1 --- cornstarch 40g；Prescription 2 --- microcrystalline cellulose 40g+ dextrin 20g；Prescription 3 --- crystallite is fine
Tie up element 50g；Prescription 4 --- pregelatinized starch 70g；Prescription 5 --- pregelatinized starch 30g+ dextrin 20g；Prescription 6 ---
Microcrystalline cellulose 50g）Fully mix, add adhesive softwood listed in prescription, pelletized with 16 mesh sieves, 4 are dried at 80 DEG C
Hour.
3. the preparation of blank granules.
Take remaining filler in prescription（Remaining filler is referred respectively in prescription：Prescription 1 --- microcrystalline cellulose
80g；Prescription 2 --- lactose 60g；Prescription 3 --- cornstarch 25g+ dextrin 50g；Prescription 4 --- microcrystalline cellulose
50g；Prescription 5 --- microcrystalline cellulose 70g；Prescription 6 --- microcrystalline cellulose 70g）, add adhesive listed in prescription
Softwood processed, is pelletized with 16 mesh sieves, is dried 4 hours at 80 DEG C.
4. by step（1）And step（2）Obtained particle replaces whole grain with 16 mesh sieves respectively, standby.
5. adding other auxiliary materials in prescription, fully mix.
6. tabletting, obtains trazodone hydrochloride piece.
The discoloration observation of trazodone hydrochloride piece made from the Different Preparation of embodiment 2.
Prescription proportioning in embodiment 1, uses traditional handicraft marumerization（Medicine-containing particle and blank are not prepared respectively
Particle, wet granular drying condition is dry 4 hours at 80 DEG C）Trazodone hydrochloride piece is prepared, by obtained tablet and embodiment 1
It is compared using tablet made from granulation respectively, observes color change of each tablet in drying process and placement process,
As a result 2 be see the table below.
From the results, it was seen that the tablet prepared using traditional handicraft marumerization occurs in that change in the drying process
Color phenomenon, pink colour is changed into from white to off-white color, and with the extension of standing time, is changed colour more and more obvious.And equal bar
Under part, tablet metachromatism prepared by the difference granulation provided using the present invention is not obvious, and contains when in medicine-containing particle
During pregelatinized starch, do not change colour in drying process or in placement process either.The two compares, it will be apparent that
The tablet prepared with granulation respectively can preferably mitigate or even eliminate trazodone hydrochloride piece metachromatism.
Claims (9)
1. a kind of preparation method of trazodone hydrochloride piece, it is characterised in that comprise the following steps：
（1）Trazodone hydrochloride is well mixed with a part of filler in prescription, pelletizes, obtains medicine-containing particle；
（2）Remaining filler in prescription is pelletized, blank granules are obtained；
（3）By step（1）And step（2）Obtained particle sieves respectively, alternating whole grain, is well mixed, tabletting is produced.
2. preparation method according to claim 1, it is characterised in that step（1）With（2）Described in granulation can be dry
Method is pelletized or wet granulation.
3. preparation method according to claim 1 or 2, it is characterised in that step（1）With（2）Described in filler can
To be the one or more in microcrystalline cellulose, pregelatinized starch, cornstarch, lactose, dextrin.
4. preparation method according to claim 3, it is characterised in that step（1）Described in a part of filler include
Pregelatinized starch.
5. preparation method according to claim 1, it is characterised in that step（1）With（2）It is additionally added appropriate adhesive.
6. preparation method according to claim 5, it is characterised in that described adhesive can be polyvinylpyrrolidine
One kind in ketone, hydroxypropyl methylcellulose, starch, solvent is water.
7. preparation method according to claim 1 or 2, it is characterised in that can also be added in each step disintegrant,
One or more in lubricant.
8. preparation method according to claim 7, it is characterised in that described disintegrant can be sodium carboxymethyl starch,
In PVPP, crosslinked carboxymethyl fecula sodium, Ac-Di-Sol, low-substituted hydroxypropyl cellulose
It is one or more of.
9. preparation method according to claim 7, it is characterised in that described lubricant can be magnesium stearate, talcum
One or more in powder, silica, polyethylene glycol.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710338977.8A CN107028904B (en) | 2017-05-15 | 2017-05-15 | Preparation method of trazodone hydrochloride tablets |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710338977.8A CN107028904B (en) | 2017-05-15 | 2017-05-15 | Preparation method of trazodone hydrochloride tablets |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN107028904A true CN107028904A (en) | 2017-08-11 |
| CN107028904B CN107028904B (en) | 2021-05-11 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201710338977.8A Active CN107028904B (en) | 2017-05-15 | 2017-05-15 | Preparation method of trazodone hydrochloride tablets |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109364031A (en) * | 2018-10-07 | 2019-02-22 | 威海贯标信息科技有限公司 | A kind of trazodone hydrochloride tablets composition |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1765358A (en) * | 2004-10-27 | 2006-05-03 | 南京圣和药业有限公司 | Vaginal effervesce tablet of ornidazole and its preparation method |
| CN103536568A (en) * | 2012-07-12 | 2014-01-29 | 成都康弘药业集团股份有限公司 | Orally disintegrating tablets containing lurasidone and preparation method thereof |
| WO2014146775A1 (en) * | 2013-03-19 | 2014-09-25 | Pharmathen S.A. | Pharmaceutical composition comprising a fluoroquinolone antibacterial agent and method for the preparation thereof |
| CN105748421A (en) * | 2016-03-24 | 2016-07-13 | 深圳市泛谷药业股份有限公司 | Sustained-release tablet containing trazodone hydrochloride and preparation method of sustained-release tablet |
| CN106215175A (en) * | 2016-07-27 | 2016-12-14 | 中山大学 | Phycocyanin vitamin C compound effervescent tablet and preparation method thereof |
-
2017
- 2017-05-15 CN CN201710338977.8A patent/CN107028904B/en active Active
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1765358A (en) * | 2004-10-27 | 2006-05-03 | 南京圣和药业有限公司 | Vaginal effervesce tablet of ornidazole and its preparation method |
| CN103536568A (en) * | 2012-07-12 | 2014-01-29 | 成都康弘药业集团股份有限公司 | Orally disintegrating tablets containing lurasidone and preparation method thereof |
| WO2014146775A1 (en) * | 2013-03-19 | 2014-09-25 | Pharmathen S.A. | Pharmaceutical composition comprising a fluoroquinolone antibacterial agent and method for the preparation thereof |
| CN105748421A (en) * | 2016-03-24 | 2016-07-13 | 深圳市泛谷药业股份有限公司 | Sustained-release tablet containing trazodone hydrochloride and preparation method of sustained-release tablet |
| CN106215175A (en) * | 2016-07-27 | 2016-12-14 | 中山大学 | Phycocyanin vitamin C compound effervescent tablet and preparation method thereof |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109364031A (en) * | 2018-10-07 | 2019-02-22 | 威海贯标信息科技有限公司 | A kind of trazodone hydrochloride tablets composition |
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| CN107028904B (en) | 2021-05-11 |
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| EE01 | Entry into force of recordation of patent licensing contract |
Application publication date: 20170811 Assignee: SHENYANG FUNING PHARMACEUTICALS CO.,LTD. Assignor: Shenyang Pharmtech Pharmaceutical R&D Ltd. Contract record no.: X2022210000060 Denomination of invention: A preparation method of trazodone hydrochloride tablets Granted publication date: 20210511 License type: Exclusive License Record date: 20221205 |
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