CN109432038A - A kind of enteric coated tablet and preparation method thereof containing sertraline hydrochloride - Google Patents
A kind of enteric coated tablet and preparation method thereof containing sertraline hydrochloride Download PDFInfo
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- CN109432038A CN109432038A CN201811625263.6A CN201811625263A CN109432038A CN 109432038 A CN109432038 A CN 109432038A CN 201811625263 A CN201811625263 A CN 201811625263A CN 109432038 A CN109432038 A CN 109432038A
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- sertraline hydrochloride
- enteric
- coated tablet
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- plain piece
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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
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
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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
-
- 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
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
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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
- A61P25/24—Antidepressants
Abstract
The invention discloses a kind of enteric coated tablet and preparation method thereof containing sertraline hydrochloride.The tablet is made of plain piece and enteric coating film.The plain piece is added filler, disintegrating agent, adhesive, lubricant direct tablet compressing by sertraline hydrochloride and is prepared.The weight gain of enteric coating film is 2-4%, it is ensured that it generates adverse reaction in the insoluble release of stomach, while quickly dissolving release in duodenum, guarantees curative effect of medication.In addition, increasing methacrylic acid copolymer content in enteric coating film to guarantee stability of the sertraline hydrochloride tablet in enteron aisle and also reducing the content of Tween 80.Enteric coated tablet of the invention has the characteristics that dissolution rate is good, stability is high, body absorption is good, individual difference is small, and side effect is lower.The enteric coated tablet also has preparation process simple, the advantage suitable for industrial mass production.
Description
Technical field
The invention belongs to technical field of medicine, and in particular to a kind of enteric coated tablet and its system containing sertraline hydrochloride
Preparation Method.
Background technique
Sertraline hydrochloride piece is mainly used for treating the related symptoms of depression, including adjoint anxiety, with or without manic history
Depression.Its main component is sertraline hydrochloride, its chemical name is: (1S- is cis-) -4- (3,4- dichlorophenyl) -1,2,3,
4- tetrahydro-N-methyl -1- naphthyridines amine hydrochlorate, structural formula are as follows:
Sertraline hydrochloride piece (trade name: Zoloft) is researched and developed by Pfizer, and nineteen ninety lists in Britain first.1991
Zoloft in December obtains FDA approval, lists in the U.S. within 1992, oneself lists in countries and regions, 96, the world so far, in antidepression
Still the position that do not replace is occupied in pharmaceutical market.Sertraline hydrochloride includes at present 25mg, 50mg in the specification of U.S.'s sale
With the oral concentrating agents (20mg/mL) of every bottle of the 60mL of the film coating tablet and multi-dose of 100mg (with Sertraline meter).
Japanese approval sertraline hydrochloride oral disintegrating tablet in 2014, specification 25mg, 50mg and 100mg (with Sertraline meter).
Influence because of sertraline hydrochloride to stomach is also easy to produce the adverse reactions such as diarrhea/loose stools, indigestion and nausea.Salt
Sour Sertraline is larger for the gastrointestinal stimulations such as patients with gastric disease and children and the elderly.Existing commercial product dosage form is tablet, divides
Discrete piece and capsule, these products are larger to gastric irritation, are also easy to produce adverse reaction.
In order to reduce other side reactions such as gastrointestinal tract, patent CN1261793A discloses small to 40mgA/ with 1mgA/ hours
When rate release Sertraline sustained release preparation.The Sertraline sustained release preparation reduces pair by controlling the rate of release of Sertraline
Reaction: during the initial delay phase, Sertraline is discharged with the rate lower than 1mgA/ hours.But the Sertraline sustained release preparation
Still there is biggish side effect, and dissolution rate and stability are relatively low, in addition the technique of the Sertraline sustained release preparation is more complex, required
Auxiliary material requires high, price height.
Summary of the invention
It is an object of the invention to overcome the deficiencies in the prior art, and provide a kind of enteric coated tablet containing sertraline hydrochloride
And preparation method thereof.Enteric coated tablet is made in Sertraline by the present invention, is reducing gastrointestinal side effect simultaneously, can guarantee that it is preferable
Stripping property, stability, and its preparation process is simply suitable for mass production.
Specifically, the purpose of the present invention is be achieved through the following technical solutions:
A kind of enteric coated tablet containing sertraline hydrochloride, including plain piece and enteric coating film；The enteric coating film cladding
In plain piece surface；By mass, the plain piece includes following component:
The enteric coating film consists of the following compositions:
Preferably, the enteric coating film gain in weight is 2~4% (w/w) of plain piece quality.
Preferably, the disintegrating agent is selected from crospovidone, low-substituted hydroxypropyl cellulose, cross-linked carboxymethyl cellulose
One of sodium and sodium carboxymethyl starch are a variety of.
Preferably, the filler is selected from one of microcrystalline cellulose, lactose, calcium carbonate and dicalcium phosphate dihydrate
Or it is a variety of.
Preferably, the adhesive is selected from one of hydroxypropylcellulose, hydroxypropyl methylcellulose and pregelatinized starch
Or it is a variety of.
Preferably, the lubricant is in magnesium stearate, talcum powder, sodium stearyl fumarate and colloidal silicon dioxide
It is one or more.
The present invention also provides the preparation methods of the enteric coated tablet containing sertraline hydrochloride, include the following steps:
(1) sertraline hydrochloride is uniformly mixed in mixing machine with filler, disintegrating agent, adhesive and lubricant, is obtained
Mix rear center body；
(2) rear center body tabletting will be mixed, plain piece is made；
(3) methacrylic acid copolymer, triethyl citrate, Tween 80 and talcum powder are dissolved in mass fraction is 80%
Ethanol water obtains the coating solution that concentration is 8%, and coating solution is added in seed-coating machine；
(4) coating solution is sprayed to plain piece with seed-coating machine, so that plain piece surface is coated enteric coating film, and control enteric coating film
Gain in weight is 2~4% (w/w) of plain piece quality；Finally obtain the enteric coated tablet containing sertraline hydrochloride.
The present invention in terms of existing technologies, has the advantages that
Conventional enteric coating membrane is to guarantee that drug is not discharged in stomach stabilization, and general gain in weight is 8-12%.Hydrochloric acid house
Bent woods major absorption site is duodenum, and between stomach and jejunum, conventional coating weight gain can guarantee the insoluble explanation of its stomach
It puts, but discharge position to extend to small intestine and later, curative effect of medication is caused to reduce.Enteric coating weight gain of the present invention is 2-4%, both
Guarantee that it generates adverse reaction in the insoluble release of stomach, while can quickly dissolve release in duodenum again, guarantees that drug is treated
Effect.Simultaneously to guarantee stability of the sertraline hydrochloride tablet in enteron aisle, invention increases metering systems in enteric coating film
Acid copolymer content reduces Tween 80 content.Enteric coated tablet drug dissolution provided by the present invention containing sertraline hydrochloride
Degree was high, and through test in 6 months, still with good stability in the environment of 40 DEG C of relative humidity 75%.Human body is pre-
BE test indicates that comparison its adverse reaction of Pfizer's Zoloft significantly reduces.And the enteric of the invention containing sertraline hydrochloride
The simple process of tablet, auxiliary material price are low.
Specific embodiment
The present invention is further elaborated and is illustrated With reference to embodiment.Each embodiment in the present invention
Technical characteristic can carry out the corresponding combination under the premise of not conflicting with each other.
Embodiment 1:
Preparation method is
(1) by the lactose of the sertraline hydrochloride of recipe quantity and recipe quantity, dicalcium phosphate dihydrate, cross-linked carboxymethyl cellulose
Sodium, hydroxypropyl methylcellulose and magnesium stearate mix 10min in mixing machine, obtain total mix rear center body；
(2) total mix rear center body is pressed into theoretical slice weight tabletting, plain piece is made；
(3) methacrylic acid copolymer of recipe quantity, triethyl citrate, Tween 80 and talcum powder are dissolved in 80% ethyl alcohol
In, the coating solution of compound concentration 8%；And coating solution is added in seed-coating machine；
(4) sertraline hydrochloride plain piece is put into coating pan, preheated, when piece bed tempertaure is up to 40 DEG C, whitewashing, control sheet bed tempertaure
About 40 DEG C, coating flow velocity is 40g/min, coats enteric coating film on plain piece surface.It finally obtains containing sertraline hydrochloride
Enteric coated tablet.
Embodiment 2:
Preparation method is
(1) by the microcrystalline cellulose of the sertraline hydrochloride of recipe quantity and recipe quantity, calcium carbonate, cross-linked carboxymethyl cellulose
Sodium, hydroxypropyl methylcellulose and magnesium stearate mix 10min in mixing machine, obtain total mix rear center body；
(2) total mix rear center body is pressed into theoretical slice weight tabletting, plain piece is made；
(3) methacrylic acid copolymer of recipe quantity, triethyl citrate, Tween 80 and talcum powder are dissolved in 80% ethyl alcohol
In, the coating solution of compound concentration 8%；And coating solution is added in seed-coating machine；
(4) sertraline hydrochloride plain piece is put into coating pan, preheated, when piece bed tempertaure is up to 40 DEG C, whitewashing, control sheet bed tempertaure
About 40 DEG C, coating flow velocity is 40g/min, coats enteric coating film on plain piece surface.It finally obtains containing sertraline hydrochloride
Enteric coated tablet.
Embodiment 3:
Preparation method is
(1) by the microcrystalline cellulose of the sertraline hydrochloride of recipe quantity and recipe quantity, microcrystalline cellulose, cross-linked carboxymethyl fiber
Plain sodium, hydroxypropyl methylcellulose and magnesium stearate mix 10min in mixing machine, obtain total mix rear center body；
(2) total mix rear center body is pressed into theoretical slice weight tabletting, plain piece is made；
(3) methacrylic acid copolymer of recipe quantity, triethyl citrate, Tween 80 and talcum powder are dissolved in 80% ethyl alcohol
In, the coating solution of compound concentration 8%；And coating solution is added in seed-coating machine；
(4) sertraline hydrochloride plain piece is put into coating pan, preheated, when piece bed tempertaure is up to 40 DEG C, whitewashing, control sheet bed tempertaure
About 40 DEG C, coating flow velocity is 40g/min, coats enteric coating film on plain piece surface.It finally obtains containing sertraline hydrochloride
Enteric coated tablet.
Comparative example 1:
Preparation method is
(1) by the lactose of the sertraline hydrochloride of recipe quantity and recipe quantity, dicalcium phosphate dihydrate, cross-linked carboxymethyl cellulose
Sodium, hydroxypropyl methylcellulose and magnesium stearate mix 10min in mixing machine, obtain total mix rear center body；
(2) total mix rear center body is pressed into theoretical slice weight tabletting, plain piece is made；
(3) methacrylic acid copolymer of recipe quantity, triethyl citrate, Tween 80 and talcum powder are dissolved in 80% ethyl alcohol
In, the coating solution of compound concentration 8%；And coating solution is added in seed-coating machine；
(4) sertraline hydrochloride plain piece is put into coating pan, preheated, when piece bed tempertaure is up to 40 DEG C, whitewashing, control sheet bed tempertaure
About 40 DEG C, coating flow velocity is 40g/min, coats enteric coating film on plain piece surface.It finally obtains containing sertraline hydrochloride
Enteric coated tablet.
Comparative example 2:
Preparation method is
(1) by the lactose of the sertraline hydrochloride of recipe quantity and recipe quantity, dicalcium phosphate dihydrate, cross-linked carboxymethyl cellulose
Sodium, hydroxypropyl methylcellulose and magnesium stearate mix 10min in mixing machine, obtain total mix rear center body；
(2) total mix rear center body is pressed into theoretical slice weight tabletting, plain piece is made；
(3) methacrylic acid copolymer of recipe quantity, triethyl citrate, Tween 80 and talcum powder are dissolved in 80% ethyl alcohol
In, the coating solution of compound concentration 8%；And coating solution is added in seed-coating machine；
(4) sertraline hydrochloride plain piece is put into coating pan, preheated, when piece bed tempertaure is up to 40 DEG C, whitewashing, control sheet bed tempertaure
About 40 DEG C, coating flow velocity is 40g/min, coats enteric coating film on plain piece surface.It finally obtains containing sertraline hydrochloride
Enteric coated tablet.
The following are the dissolutions using the enteric coated tablet containing sertraline hydrochloride obtained by embodiment 1-3 and comparative example 1-2
Degree, dissolution curve and stability test and the pre- BE test of human body.Wherein the sample of control group uses the commercially available medicine Zoloft of import
(specification 50mg, Pfizer pharmaceutical Co. Ltd, abbreviation original are ground).
Embodiment 4: dissolution detection
The present embodiment is held in strict accordance with dissolution rate and drug release determination method general rule (0,931 second method of " Chinese Pharmacopoeia " general rule)
Row.Its specific experiment method are as follows:
(1) the hydrochloric acid solution 900ml of pH1.0 as dissolution medium and is added in digestion instrument first.When hydrochloric acid solution
When temperature stabilizes to 37 DEG C ± 0.5 DEG C, then sample to be tested is put into dissolution medium.50 turns of digestion instrument revolutions per minute of control,
Appropriate solution is taken when 45min and is filtered, and obtains filtrate, dissolution fluid when as pH1.0.
(2) (sodium acetate 3g, acetic acid 1.6ml on the rocks is taken to be diluted with water to 1000ml, necessity with pH4.5 sodium-acetate buffer
When glacial acetic acid to adjust pH to 4.5) 900ml be dissolution medium and to be added in digestion instrument.When dissolution medium stabilizes to 37 DEG C ± 0.5
DEG C when, then sample to be tested is put into dissolution medium.50 turns of digestion instrument revolutions per minute of control, through taking appropriate solution when 45min
And it filters, and obtain filtrate, dissolution fluid when as pH4.5.
(3) it as dissolution medium and is added in digestion instrument using the phosphate solution 900ml of pH6.8.When dissolution medium stabilizes to
At 37 DEG C ± 0.5 DEG C, then sample to be tested is put into dissolution medium.50 turns of digestion instrument revolutions per minute of control, through being taken when 45min
Appropriate solution simultaneously filters, and obtains filtrate, dissolution fluid when as pH6.8.
(4) the pure sertraline hydrochloride reference substance of precision weighing is appropriate, it is dissolved with a small amount of methanol.The vinegar of pH4.5 is used again
Sour sodium buffer is diluted to the middle sertraline hydrochloride solution that concentration is 50 μ g/ml, as standard solution.
(5) it according to above-mentioned steps, is made obtained by embodiment 1-3 and comparative example 1-2 respectively and contains sertraline hydrochloride
Enteric coated tablet, there are also dissolution fluid of the Zoloft (original is ground) at pH1.0,4.5 and 6.8.
(6) 18 kinds obtained above different dissolution fluids are analyzed using liquid chromatograph.
The analysis condition of liquid chromatograph is as follows:
Final dissolution rate is as shown in the table:
From the experimental result of upper table it is found that when enteric coating film uses conventional proportions and gain in weight, i.e. comparative example 1,
It is not dissolved under acid condition although can guarantee, 30.6% is only dissolved out in pH4.5, it cannot be guaranteed that duodenal site drug
Effectively absorb.Comparative example 2 is to reduce the comparative example of enteric coating film gain in weight, and the dissolution rate in pH1.0 is up to 83.4%,
Goal-selling cannot be reached completely, cannot effectively prevent stomach adverse reaction.Increase methacrylic acid copolymer in enteric coating film
Object content reduces the enteric coated tablet containing sertraline hydrochloride of the embodiment 1-3 preparation of Tween 80 content in pH1.0 medium simultaneously
In hardly dissolve out, drug can be discharged rapidly in pH4.5 medium.This example demonstrates that using the enteric coatel tablets of the proportion in stomach
Portion does not discharge substantially, can be disintegrated release rapidly at duodenum road position, ensure that curative effect of medication while reducing side effect.
It is unable to meet demand due to being proved comparative example 1,2 in embodiment 4, is predominantly compared in following embodiment real
An advantage for 1-3 comparison Zoloft (original is ground) is applied, no longer comparative example 1,2 is detected.
Embodiment 5: dissolution rate Detection of Stability
The present embodiment is held in strict accordance with dissolution rate and drug release determination method general rule (0,931 second method of " Chinese Pharmacopoeia " general rule)
Row.Its specific experiment method are as follows:
(1) (sodium acetate 3g, acetic acid 1.6ml on the rocks is taken to be diluted with water to 1000ml, necessity with pH4.5 sodium-acetate buffer
When glacial acetic acid to adjust pH to 4.5) 900ml be dissolution medium and to be added in digestion instrument.When dissolution medium stabilizes to 37 DEG C ± 0.5
DEG C when, then sample to be tested is put into dissolution medium.50 turns of digestion instrument revolutions per minute of control, through taking appropriate solution when 45min
And it filters, and obtain filtrate, dissolution fluid when as pH4.5.
(2) it is appropriate to weigh sertraline hydrochloride reference substance for precision, and is dissolved with a small amount of methanol.PH4.5 sodium acetate buffer is used again
Liquid dilution be made concentration be 50 μ g/ml sertraline hydrochloride solution as standard solution.
(3) according to above-mentioned steps, embodiment 1-3 and the dissolution fluid of Zoloft (original is ground) in pH4.5 are made respectively.
(4) dissolution fluid obtained above is analyzed using liquid chromatograph.
The analysis condition of liquid chromatograph is as follows:
As a result as shown in the table:
| Sample source | 0 day | 40 DEG C of 75%RH accelerate 6 months |
| Embodiment 1 | 93.1 | 92.8 |
| Embodiment 2 | 92.4 | 91.7 |
| Embodiment 3 | 91.8 | 92.0 |
| Zoloft (original is ground) | 88.6 | 86.9 |
It is found that the dissolution of the enteric coated tablet containing sertraline hydrochloride of 1-3 of embodiment of the present invention preparation from upper table result
It is consistent with non-Acceleration study to spend the dissolution rate after Acceleration study, remains that higher level or even dissolution rate are higher than Zoloft
(original is ground).This example demonstrates that high using Dissolution of Tablet stability prepared by this method.
Embodiment 6: the related goods and materials detection of sample stability
Specific experiment method are as follows:
(1) it takes sample to be tested to be ground into fine powder, weighs in right amount, and mobile phase is added and makes it dissolve, and the hydrochloric acid in solution
Sertraline content is 0.5mg/ml.Solution is filtered again, and obtains solution to be measured.
(2) the accurate 1ml solution to be measured that measures is diluted to scale using mobile phase, shakes up as right into 100ml volumetric flask
According to solution.
(3) the accurate 5ml contrast solution that measures is diluted to scale with mobile phase, shakes up as sensitive into 100ml volumetric flask
Spend solution.
(4) according to above-mentioned steps, configure in order the solution to be measured of embodiment 1-3 and Zoloft (original is ground), contrast solution and
Sensitivity solution.
(5) above-mentioned solution is analyzed using liquid chromatograph.
The analysis condition of liquid chromatograph is as follows:
As a result as shown in the table:
Embodiment 6 illustrates Examples 1 to 3 it is found that Examples 1 to 3 related substance variation is smaller and be substantially better than original and grind
Stability of drug products is more preferable.
Embodiment 7: the pre- BE test of human body.
Normal adults are respectively adopted in the sample of 1~3 formula preparation according to embodiments of the present invention and carry out pharmacokinetics
Test, while using Zoloft (original is ground) as control, 12h fasting before 20 subjects's (number 1 to 20) are administered, during test
Free water.Difference 0,0.25,0.5,1,1.5,2.0,3.0,4.0,5.0,6.0,8.0,12,24,36,48h takes after administration
Venous blood 4ml (takes blood vessel that heparin is added), sets in 4 DEG C of refrigerators, after placing 30min, is centrifuged (5000r/min, 10min), takes
Purify the blood slurry.With the concentration of Sertraline in LCMS/MS method detection blood plasma, it is as follows to statistically analyze mean serum pharmacokinetic parameter result
Table: (wherein AUC0-tFor area under the drug-time curve, TmaxFor peak reaching time of blood concentration, CmaxFor blood peak concentration of drug, RSD is opposite
Standard deviation)
From the experimental result of upper table it is found that the embodiment of the present invention 1~3 prepare sertraline hydrochloride enteric coated tablet in vivo
It absorbs and is ground unanimously with original, and individual difference is small, bioavilability is apparently higher than original and grinds, and reason is with sertraline hydrochloride enteric coatel tablets
Agent can help to absorb in duodenal site uniformly disintegration release rapidly.
In 20 subjects, only there are the adverse reaction of nausea, gastric disorder causing nausea, other subjects in two subjects of number 1 and 3
Do not occur adverse reaction, the results showed that the enteric coatel tablets can improve the side effect of Sertraline.
Above-mentioned embodiment is only a preferred solution of the present invention, so it is not intended to limiting the invention.Have
The those of ordinary skill for closing technical field can also make various changes without departing from the spirit and scope of the present invention
Change and modification.Therefore all mode technical solutions obtained for taking equivalent substitution or equivalent transformation, all fall within guarantor of the invention
It protects in range.
Claims (7)
1. a kind of enteric coated tablet containing sertraline hydrochloride, which is characterized in that including plain piece and enteric coating film；The enteric packet
Clothing film is coated on plain piece surface；By mass, the plain piece includes following component:
The enteric coating film consists of the following compositions:
2. the enteric coated tablet according to claim 1 containing sertraline hydrochloride, it is characterised in that: the enteric coating film increases
Weight is 2~4% (w/w) of plain piece quality.
3. the enteric coated tablet according to claim 1 containing sertraline hydrochloride, it is characterised in that: the disintegrating agent is selected from
One of crospovidone, low-substituted hydroxypropyl cellulose, croscarmellose sodium and sodium carboxymethyl starch are a variety of.
4. the enteric coated tablet according to claim 1 containing sertraline hydrochloride, it is characterised in that: the filler is selected from
One of microcrystalline cellulose, lactose, calcium carbonate and dicalcium phosphate dihydrate are a variety of.
5. the enteric coated tablet according to claim 1 containing sertraline hydrochloride, it is characterised in that: the adhesive is selected from
One of hydroxypropylcellulose, hydroxypropyl methylcellulose and pregelatinized starch are a variety of.
6. the enteric coated tablet according to claim 1 containing sertraline hydrochloride, it is characterised in that: the lubricant is selected from
One of magnesium stearate, talcum powder, sodium stearyl fumarate and colloidal silicon dioxide are a variety of.
7. a kind of preparation method of the enteric coated tablet according to claim 1 containing sertraline hydrochloride, which is characterized in that packet
Include following steps:
(1) sertraline hydrochloride is uniformly mixed in mixing machine with filler, disintegrating agent, adhesive and lubricant, is mixed
Rear center body；
(2) rear center body tabletting will be mixed, plain piece is made；
(3) methacrylic acid copolymer, triethyl citrate, Tween 80 and talcum powder are dissolved in the ethyl alcohol that mass fraction is 80%
Aqueous solution obtains the coating solution that concentration is 8%, and coating solution is added in seed-coating machine；
(4) coating solution is sprayed to plain piece with seed-coating machine, plain piece surface is made to coat enteric coating film, and control the weight gain of enteric coating film
Amount is 2~4% (w/w) of plain piece quality；Finally obtain the enteric coated tablet containing sertraline hydrochloride.
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| CN201811625263.6A CN109432038A (en) | 2018-12-28 | 2018-12-28 | A kind of enteric coated tablet and preparation method thereof containing sertraline hydrochloride |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201811625263.6A CN109432038A (en) | 2018-12-28 | 2018-12-28 | A kind of enteric coated tablet and preparation method thereof containing sertraline hydrochloride |
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Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1999001121A1 (en) * | 1997-07-01 | 1999-01-14 | Pfizer Inc. | Sertraline salts and sustained-release dosage forms of sertraline |
| CN1261273A (en) * | 1997-07-01 | 2000-07-26 | 辉瑞产品公司 | Delayed-release dosage forms of sertraline |
| CN1823749A (en) * | 1997-07-01 | 2006-08-30 | 美国辉瑞有限公司 | Sertraline salts and sustained-release dosage forms of sertraline |
| CN104997741A (en) * | 2015-06-24 | 2015-10-28 | 万特制药(海南)有限公司 | Orally disintegrating tablet containing sertraline and preparation method thereof |
| CN106109432A (en) * | 2016-07-28 | 2016-11-16 | 北京万全德众医药生物技术有限公司 | A kind of containing sertraline hydrochloride taste masking oral cavity disintegration tablet and preparation method thereof |
-
2018
- 2018-12-28 CN CN201811625263.6A patent/CN109432038A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1999001121A1 (en) * | 1997-07-01 | 1999-01-14 | Pfizer Inc. | Sertraline salts and sustained-release dosage forms of sertraline |
| CN1261273A (en) * | 1997-07-01 | 2000-07-26 | 辉瑞产品公司 | Delayed-release dosage forms of sertraline |
| CN1823749A (en) * | 1997-07-01 | 2006-08-30 | 美国辉瑞有限公司 | Sertraline salts and sustained-release dosage forms of sertraline |
| CN104997741A (en) * | 2015-06-24 | 2015-10-28 | 万特制药(海南)有限公司 | Orally disintegrating tablet containing sertraline and preparation method thereof |
| CN106109432A (en) * | 2016-07-28 | 2016-11-16 | 北京万全德众医药生物技术有限公司 | A kind of containing sertraline hydrochloride taste masking oral cavity disintegration tablet and preparation method thereof |
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Application publication date: 20190308 |
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