CN106937945A - Fluoxetine hydrochloride enteric coatel tablets and preparation method thereof - Google Patents
Fluoxetine hydrochloride enteric coatel tablets and preparation method thereof Download PDFInfo
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- CN106937945A CN106937945A CN201710189449.0A CN201710189449A CN106937945A CN 106937945 A CN106937945 A CN 106937945A CN 201710189449 A CN201710189449 A CN 201710189449A CN 106937945 A CN106937945 A CN 106937945A
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- CN
- China
- Prior art keywords
- parts
- fluoxetine hydrochloride
- separation layer
- label
- coatel tablets
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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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
-
- 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
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
-
- 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 present invention proposes a kind of Fluoxetine hydrochloride enteric coatel tablets and preparation method thereof, including the label containing Fluoxetine hydrochloride, separation layer and enteric layer, the separation layer is the polymer spacer containing titanium dioxide and polyethylene glycol, and polymer is hydroxypropyl methylcellulose or polyvinylpyrrolidone；Enteric layer includes following auxiliary material：0.5~2 part of 5~8 parts of hydroxypropyl methylcellulose acetate succinate, 6~15 parts of cellulose acetate phthalate, 0.5~2 part of triethyl citrate and talcum powder.Preparation method, comprises the following steps：1) label is prepared：2) polymer of titanium dioxide and polyethylene glycol is prepared into coating solution, gives label bag separation layer；3) hydroxypropyl methylcellulose acetate succinate, cellulose acetate phthalate, triethyl citrate and talcum powder are well mixed, coating solution are made with acetone solution, by step 2) obtain coated cores be coated, you can.Said preparation can reduce gastrointestinal stimulation symptom, facilitate patient to be administered.
Description
Technical field
The invention belongs to antidepressant preparation technique field, and in particular to a kind of Fluoxetine hydrochloride enteric coatel tablets and its preparation
Method.
Background technology
Prozac, i.e. N- methyl -3- (p- 4-trifluoromethylphenopendant sheet) -3- phenylpropylamines, are a kind of antidepressants.Fluorine
Xi Ting chemical combination medicine and its salt is disclosed in United States Patent (USP) 4314081 and 46266549, and the active constituent of current commercialized product is salt
Sour Prozac.Prozac and its salt have antidepressant effect, can suppress reuptake of the central nervous system to 5-HT, clinical practice
In treatment depression and its relevant anxiety symptom, treatment bulimia nervosa and besetment and conduct disorder are also applied to.
It has been found that due to the long half time of Prozac, other dosage regimens in addition to being administered daily be also it is effective, it is right
In maintaining, administration is especially true.For example, Burke etc., Psychopharmacol.Bull., 31 (3), 524 (1995) are reported
(it is administered daily after 8 weeks) during maintaining treatment, weekly administration 60mg fluoxetine hydrochlorides and daily administration 20mg effect phase
Together.Montgomery etc., Eur.Arch.PsychiatryClin.Neuroscience, 244 (4), 211 (1994) are reported often
Administration 120mg Fluoxetine in Treatment recurrence in two weeks it is of short duration depressed when it is invalid.Benazzi etc., Pharmacopsychiatry, 27
(6), 246 (1994) suggestion is weekly using 20mg Prozacs to reduce sex dysfunction side effect.Although being used in the studies above
The treatment specified with providing of capsule of one or several 20mg ground, but also use in such as South Africa 60mg fluoxetine hydrochloride capsule
Treat bulimia nerovsa.
Prozac has strong bitter taste and other tastes beastly, and oral ordinary solid preparation influences patient's taste
Feel, the side effects such as Nausea and vomiting are caused in the too high stimulation gastric mucosa of stomach local concentration, therefore, clinically Prozac administration is normal
Include capsule, conventional tablet and the solution just used recently with pharmaceutical dosage form, all there is a series of limitations and unfavorable factor.
The content of the invention
The present invention proposes a kind of Fluoxetine hydrochloride enteric coatel tablets, and said preparation can reduce gastrointestinal stimulation symptom, facilitate patient to
Medicine.
The technical proposal of the invention is realized in this way：
A kind of Fluoxetine hydrochloride enteric coatel tablets, including the label containing Fluoxetine hydrochloride, separation layer and enteric layer, the isolation
Layer is the polymer spacer containing titanium dioxide and polyethylene glycol, and polymer is hydroxypropyl methylcellulose or polyvinyl pyrrole
Alkanone；In parts by weight, enteric layer includes following auxiliary material：5~8 parts of hydroxypropyl methylcellulose acetate succinate,
0.5~2 part of 6~15 parts of cellulose acetate phthalate, 0.5~2 part of triethyl citrate and talcum powder.
Further, in parts by weight, label includes following supplementary material：
30~40 parts of Fluoxetine hydrochloride, 6~15 parts of starch, 30~50 parts of lactose, 10~20 parts of hydroxypropyl cellulose and
1~3 part of lubricant.
Further, lubricant is magnesium stearate or talcum powder.
Further, the content of separation layer is 6~15 parts.
It is a further object to provide a kind of preparation method of Fluoxetine hydrochloride enteric coatel tablets, comprise the following steps：
1) label is prepared：
2) polymer of titanium dioxide and polyethylene glycol is prepared into coating solution, gives label bag separation layer；
3) by hydroxypropyl methylcellulose acetate succinate, cellulose acetate phthalate, triethyl citrate with
Talcum powder be well mixed, coating solution is made with acetone solution, by step 2) obtain coated cores be coated, you can.
Label is entered to be coated using the polymer spacer containing titanium dioxide and polyethylene glycol, activity can be effectively controlled
The release of composition.
There is series of advantages compared with the known formulation (capsule, conventional tablet and solution) of Prozac, it is as follows：1) it is applied to
Treatment is had any problem patient to taking solid dosage forms (capsule)；2) it is applied to diabetes patients with depression, it is sweet that reason is free from sucrose
Taste agent；3) special sense of oral administered bitter free, it is to avoid the sense of discomfort that general formulation is brought, patient is subjected to；4) avoid stomach local
Concentration is excessive, eliminates the side effect, good patient compliance such as Nausea and vomiting caused by the viscous stimulation of stomach；5) stability is more preferable, the intestines
Molten clothing has superior moisture-resistant effect, and its shape, big I are loaded into cryptomere aluminium-plastic panel, are easy to carry and are taken, can be really
Patient is protected to complete to treat and improve curative effect；6) danger of oral solution overdose is eliminated, makes its safer, is especially fitted
Together in children or gerontal patient.
Embodiment
Embodiment 1
A kind of Fluoxetine hydrochloride enteric coatel tablets, including the label containing Fluoxetine hydrochloride, separation layer and enteric layer；According to weight
Number is calculated, and label includes following supplementary material：
2 parts of 35 parts of Fluoxetine hydrochloride, 48 parts of starch, 32 parts of lactose, 14 parts of hydroxypropyl cellulose and magnesium stearate.
Separation layer is the polymer spacer containing titanium dioxide and polyethylene glycol, and polymer is hydroxypropyl methylcellulose,
The content of separation layer is 10 parts.
In parts by weight, enteric layer includes following auxiliary material：7 parts of hydroxypropyl methylcellulose acetate succinate,
0.5 part of 10 parts of cellulose acetate phthalate, 0.5 part of triethyl citrate and talcum powder.
Preparation method, comprises the following steps：
1) label is prepared：
2) polymer of titanium dioxide and polyethylene glycol is prepared into coating solution, gives label bag separation layer；
3) by hydroxypropyl methylcellulose acetate succinate, cellulose acetate phthalate, triethyl citrate with
Talcum powder be well mixed, coating solution is made with acetone solution, by step 2) obtain coated cores be coated, you can.
Embodiment 2
A kind of Fluoxetine hydrochloride enteric coatel tablets, including the label containing Fluoxetine hydrochloride, separation layer and enteric layer；
In parts by weight, label includes following supplementary material：
1 part of 30 parts of Fluoxetine hydrochloride, 40 parts of starch, 32 parts of lactose, 10 parts of hydroxypropyl cellulose and talcum powder.
Separation layer is the polymer spacer containing titanium dioxide and polyethylene glycol, and polymer is polyvinylpyrrolidone,
The content of separation layer is 9 parts.
In parts by weight, enteric layer includes following auxiliary material：5 parts of hydroxypropyl methylcellulose acetate succinate,
0.5 part of 6 parts of cellulose acetate phthalate, 0.5 part of triethyl citrate and talcum powder.
Preparation method is same as Example 1, and difference is in supplementary material composition and content.
Embodiment 3
A kind of Fluoxetine hydrochloride enteric coatel tablets, including the label containing Fluoxetine hydrochloride, separation layer and enteric layer；
In parts by weight, label includes following supplementary material：
1.2 parts of 37 parts of Fluoxetine hydrochloride, 52 parts of starch, 30 parts of lactose, 17 parts of hydroxypropyl cellulose and magnesium stearate.
Separation layer is the polymer spacer containing titanium dioxide and polyethylene glycol, and polymer is hydroxypropyl methylcellulose,
The content of separation layer is 12 parts.
In parts by weight, enteric layer includes following auxiliary material：8 parts of hydroxypropyl methylcellulose acetate succinate,
2 parts of 8 parts of cellulose acetate phthalate, 2 parts of triethyl citrate and talcum powder.
Preparation method is same as Example 1, and difference is in supplementary material composition and content.
Embodiment 4
A kind of Fluoxetine hydrochloride enteric coatel tablets, including the label containing Fluoxetine hydrochloride, separation layer and enteric layer；
In parts by weight, label includes following supplementary material：
3 parts of 40 parts of Fluoxetine hydrochloride, 60 parts of starch, 48 parts of lactose, 20 parts of hydroxypropyl cellulose and magnesium stearate.
Separation layer is the polymer spacer containing titanium dioxide and polyethylene glycol, and polymer is hydroxypropyl methylcellulose,
The content of separation layer is 13 parts.
In parts by weight, enteric layer includes following auxiliary material：5 parts of hydroxypropyl methylcellulose acetate succinate,
1 part of 13 parts of cellulose acetate phthalate, 1 part of triethyl citrate and talcum powder.
Preparation method is same as Example 1, and difference is in supplementary material composition and content.
Tablet is prepared according to examples detailed above, quality control is carried out by 2000 editions enteric coated tablet quality standards of Chinese Pharmacopoeia
System, and study on the stability is carried out by stability test principle, as a result show, tablet stability is good.
Experiment is also shown that the tablet 2 hours inner sheet shapes in gastric juice are intact, can when touching the general condition of small intestine
The rapid contained Prozac of release.By the Chinese Pharmacopoeia paddle method of 2000 editions, 100 turns, in 750ml water in 37 DEG C ± 0.5 DEG C and
In Vitro Dissolution experiment, 2 hours release≤10% are carried out under conditions of pH=1.2；Add pH=12.5's after 2 hours
250ml Na3PO4The aqueous solution, to obtain pH=6.8 buffer solution, 45min release >=75%.
Presently preferred embodiments of the present invention is the foregoing is only, is not intended to limit the invention, all essences in the present invention
God is with principle, and any modifications, equivalent substitutions and improvements made etc. should be included within the scope of the present invention.
Claims (5)
1. a kind of Fluoxetine hydrochloride enteric coatel tablets, it is characterised in that including the label containing Fluoxetine hydrochloride, separation layer and enteric
Layer, the separation layer be the polymer spacer containing titanium dioxide and polyethylene glycol, polymer be hydroxypropyl methylcellulose or
Person's polyvinylpyrrolidone；In parts by weight, enteric layer includes following auxiliary material：Hydroxypropylmethylcellulose acetate methyl cellulose succinate
0.5~2 part of 5~8 parts of acid esters, 6~15 parts of cellulose acetate phthalate, 0.5~2 part of triethyl citrate and talcum powder.
2. Fluoxetine hydrochloride enteric coatel tablets according to claim 1, it is characterised in that in parts by weight, label bag
Include following supplementary material：
30~40 parts of Fluoxetine hydrochloride, 6~15 parts of starch, 30~50 parts of lactose, 10~20 parts of hydroxypropyl cellulose and lubrication
1~3 part of agent.
3. Fluoxetine hydrochloride enteric coatel tablets according to claim 2, it is characterised in that lubricant is magnesium stearate or talcum
Powder.
4. Fluoxetine hydrochloride enteric coatel tablets according to claim 2, it is characterised in that the content of separation layer is 6~15 parts.
5. the preparation method of Fluoxetine hydrochloride enteric coatel tablets as claimed in claim 1, it is characterised in that comprise the following steps：
1) label is prepared：
2) polymer of titanium dioxide and polyethylene glycol is prepared into coating solution, gives label bag separation layer；
3) by hydroxypropyl methylcellulose acetate succinate, cellulose acetate phthalate, triethyl citrate and talcum
Powder be well mixed, coating solution is made with acetone solution, by step 2) obtain coated cores be coated, you can.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710189449.0A CN106937945A (en) | 2017-03-27 | 2017-03-27 | Fluoxetine hydrochloride enteric coatel tablets and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710189449.0A CN106937945A (en) | 2017-03-27 | 2017-03-27 | Fluoxetine hydrochloride enteric coatel tablets and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN106937945A true CN106937945A (en) | 2017-07-11 |
Family
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| Application Number | Title | Priority Date | Filing Date |
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| CN201710189449.0A Pending CN106937945A (en) | 2017-03-27 | 2017-03-27 | Fluoxetine hydrochloride enteric coatel tablets and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111643506A (en) * | 2020-06-15 | 2020-09-11 | 重庆医药高等专科学校 | Olanzapine fluoxetine compound capsule preparation and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1541644A (en) * | 2003-04-29 | 2004-11-03 | 常州市第四制药厂有限公司 | Fluoxetine enteric coated tablet |
| CN101190208A (en) * | 2006-11-30 | 2008-06-04 | 石药集团中奇制药技术（石家庄）有限公司 | Medicinal preparations containing duloxetine hydrochloride and preparation method thereof |
| CN103705483A (en) * | 2013-12-30 | 2014-04-09 | 湖北华世通潜龙药业有限公司 | Stable, uniform and efficient lansoprazole enteric-coated tablets and preparation method thereof |
-
2017
- 2017-03-27 CN CN201710189449.0A patent/CN106937945A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1541644A (en) * | 2003-04-29 | 2004-11-03 | 常州市第四制药厂有限公司 | Fluoxetine enteric coated tablet |
| CN101190208A (en) * | 2006-11-30 | 2008-06-04 | 石药集团中奇制药技术（石家庄）有限公司 | Medicinal preparations containing duloxetine hydrochloride and preparation method thereof |
| CN103705483A (en) * | 2013-12-30 | 2014-04-09 | 湖北华世通潜龙药业有限公司 | Stable, uniform and efficient lansoprazole enteric-coated tablets and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 范新华等: "盐酸氟西汀肠溶片的研制", 《中国医药工业杂志》 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111643506A (en) * | 2020-06-15 | 2020-09-11 | 重庆医药高等专科学校 | Olanzapine fluoxetine compound capsule preparation and preparation method thereof |
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| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20170711 |
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| RJ01 | Rejection of invention patent application after publication |