CN105476972A - Paroxetine hydrochloride sustained release tablet and preparation method thereof - Google Patents
Paroxetine hydrochloride sustained release tablet and preparation method thereof Download PDFInfo
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- CN105476972A CN105476972A CN201510881435.6A CN201510881435A CN105476972A CN 105476972 A CN105476972 A CN 105476972A CN 201510881435 A CN201510881435 A CN 201510881435A CN 105476972 A CN105476972 A CN 105476972A
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- paroxetine hydrochloride
- hypromellose
- sustained release
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- release tablet
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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
- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
- A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
- A61K31/4525—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with oxygen as a ring hetero atom
-
- 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
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
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- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
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- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
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- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a paroxetine hydrochloride sustained release tablet and a preparation method thereof. The paroxetine hydrochloride sustained release tablet is prepared from paroxetine hydrochloride, hydroxypropyl methylcellulose and a lubricating agent through the processing steps including preparing materials, mixing, pelleting, total blending, tabletting and packaging by aluminum plastic. The paroxetine hydrochloride sustained release tablet is mainly used for treating symptoms relevant to depression. A novel sustained release preparation is adopted, wherein sustained release refers to the means of delaying the release rate of medicines from the preparation, and reducing the absorption rate after the medicines enter the body, so that relatively stable treatment effect is achieved; the effective blood concentration is kept within relatively long time, the toxic and side effects of the medicines are reduced, and the administration safety is improved. The paroxetine hydrochloride sustained release tablet is convenient to take, and is particularly suitable for patients with chronic diseases who take medicines for a long term, and the compliance of the patients is improved. The paroxetine hydrochloride sustained release tablet has the advantages of good stability, and conveniences in packaging, transportation and storage; the preparation method is simple and feasible, and suitable for industrial production.
Description
Technical field
The invention belongs to chemical medicine slow releasing preparation field, be specifically related to a kind of paroxetine hydrochloride slow releasing tablet and preparation method thereof.
Background technology
Depression is also known as depressive disorder, low for main clinical characteristics with remarkable and lasting mental state, is the main Types of mood disorders.Clinical visible mental state is low unbecoming with its situation, and the downhearted of emotion can from depressed to extremely grieved, and depression of feeling oneself inferior is even pessimistic and worldweary, can have suicidal attempt or behavior; Even occur numb; Some cases have obvious anxiety and mobility intense; The psychotic symptoms such as hallucination, vain hope can be there is in severe patient.Even each outbreak continues at least 2 weeks more than, elder's several years, majority of cases has the tendency of recurrent exerbation, and each outbreak great majority can be alleviated, and part can have residual symptoms or transfer to chronic.
At present, on market in the related indication paroxetine hydrochloride medicine of Cure of depression, there is drug release stablizing effect low, large to gastrointestinal irritation, bioavailability is low, packaging, transport, storage inconvenience, and the deficiency such as preparation method is complicated.
Summary of the invention
The object of this invention is to provide one to have and be applicable to depression related symptoms, drug release stablizing effect is good, little to gastrointestinal irritation, and bioavailability is high, pack, transport, preserve conveniently, a kind of paroxetine hydrochloride slow releasing tablet of the advantages such as preparation method is simple and preparation method thereof.
In order to realize object of the present invention, the present invention is achieved by the following technical solutions: a kind of paroxetine hydrochloride slow releasing tablet, it is characterized in that: be made up of the raw material of following weight: 20mg paroxetine hydrochloride, 50-195mg hypromellose, 3-20mg lubricant.
In described raw material, preferred weight proportion is: 20mg paroxetine hydrochloride, 92mg hypromellose, 5mg lubricant.
Described hypromellose can be one or both compositions of following model:
75hd100cr hypromellose, 75hd4000cr hypromellose, 75hd15000cr hypromellose, 100000cr hypromellose.
Described lubricant is one or both in magnesium stearate, Pulvis Talci, silicon dioxide.
Its manufacture method comprises following operation:
Step 1: get the raw materials ready: by above-mentioned quality proportioning, use pulverizer to pulverize paroxetine hydrochloride, crosses 100 mesh sieves;
Step 2: mixing: take paroxetine hydrochloride according to above-mentioned quality proportioning, hypromellose put into three-dimensional mixer mixing 30 minutes, make Drug Component, take out for subsequent use;
Step 3: granulate: the supplementary material fine powder mixed is put into wet granulator, and binding agent puts into feed tank, opens machine, and adjustment parameter, starts to add wetting agent, opens simultaneously and shears fly cutter, 2-5 minute, discharging; Use oscillating granulator, granulate with 20 order nylon screens; Rear use fluid bed dryer is dried, and first uses cool breeze dry, after epidermis parches, opens Hot-blast Heating, and inlet temperature, at 50-55 degree Celsius, uses the swing collator granulate of 18 order nylon screen after drying, for subsequent use.
Step 4: always mix: by the granule made, puts into three-dimension type mixer, and adds the lubricant of recipe quantity, and total mixed 30 minutes, discharging was for subsequent use.
Step 5: tabletting: use 35 to rush high-speed rotary tabletting machine.
Step 6: plastic-aluminum: above-mentioned plain sheet is used aluminium-plastic bubble plate packing machine, is packaged into aluminium-plastic panel, packed products.
In described step 3: granulation mode is replaceable is: the supplementary material fine powder mixed is put into fluidised bed granulator, binding agent puts into feed tank, open machine, adjustment parameter, after goods fluid is in good condition, open spraying, adjustment inlet temperature, liquid supply speed, air inducing frequency, atomizing pressure, Real Time Observation, stops spraying after granular size is moderate; Open Hot-blast Heating, inlet temperature, at 50-55 degree Celsius, uses the swing collator granulate of 18 order nylon screen after drying, for subsequent use.
Beneficial effect of the present invention: paroxetine hydrochloride slow releasing tablet of the present invention, is mainly used in improving various types of depressions such as various obsession (OCD), generalized anxiety disorder (GAD), panic disorder, human communication disorders, posttraumatic stress disorder (PTSD).Slow release-refer to by delaying medicine from the rate of releasing drug this dosage form, reduces the absorption rate that medicine enters body, thus plays more stable therapeutic effect; The more novel slow releasing preparation that the present invention adopts, the blood drug level that can remain valid in a long time, can also reduce the toxic and side effects of medicine, improves the safety of medication.Facilitate medication, be specially adapted to the chronic of Long-term taking medicine, improve the compliance of patient.The advantages such as it is good that the present invention has medicine stability, packaging, transport, and storage is convenient, its preparation method is simple, is applicable to commercial production.
The present invention is through two groups of clinical verifications, and wherein one group is that treatment group uses the present invention, and every day uses once, within 7 days, be a course for the treatment of, another group contrast uses existing tamsulosin hydrochloride cotrolled-releasing tablet, every group selection outpatient 90 example, wherein man 52 example, female 28 example, measures 56 years old large age, minimal ages 26 years old, every day uses once, within 30 days, is a course for the treatment of, clinical manifestation is weak, sleep disorder, lacks interest and joyful sense, loss of appetite, table one is for taking the contrasting data after the course for the treatment of:
Table 1 is taken front and back and is compared (unit: people) two groups of courses for the treatment of
There were significant differences for treatment group and matched group, thus can find out that the present invention's application clinically has significant curative effect.
Process characteristic of the present invention: 1, select raw material science, production technology is advanced, and its product is conveniently deposited and used; 2, product Chinese medicine composition is easily absorbed by the body; 3, raw material sources are extensive, add process line short, the easy processing and manufacturing of product.
Detailed description of the invention:
Embodiment 1
A kind of paroxetine hydrochloride slow releasing tablet, is characterized in that: be made up of the raw material of following weight: 20mg paroxetine hydrochloride, 50-195mg hypromellose, 3-20mg lubricant.
In described raw material, preferred weight proportion is: 20mg paroxetine hydrochloride, 92mg hypromellose, 5mg lubricant.
Described hypromellose can be one or both compositions of following model:
75hd100cr hypromellose, 75hd4000cr hypromellose, 75hd15000cr hypromellose, 100000cr hypromellose.
Described lubricant is one or both in magnesium stearate, Pulvis Talci, silicon dioxide.
Its manufacture method comprises following operation:
Step 1: get the raw materials ready: by above-mentioned quality proportioning, use pulverizer to pulverize paroxetine hydrochloride, crosses 100 mesh sieves;
Step 2: mixing: take paroxetine hydrochloride according to above-mentioned quality proportioning, hypromellose put into three-dimensional mixer mixing 30 minutes, make Drug Component, take out for subsequent use;
Step 3: granulate: the supplementary material fine powder mixed is put into wet granulator, and binding agent puts into feed tank, opens machine, and adjustment parameter, starts to add wetting agent, opens simultaneously and shears fly cutter, 2-5 minute, discharging; Use oscillating granulator, granulate with 20 order nylon screens; Rear use fluid bed dryer is dried, and first uses cool breeze dry, after epidermis parches, opens Hot-blast Heating, and inlet temperature, at 50-55 degree Celsius, uses the swing collator granulate of 18 order nylon screen after drying, for subsequent use.
Step 4: always mix: by the granule made, puts into three-dimension type mixer, and adds the lubricant of recipe quantity, and total mixed 30 minutes, discharging was for subsequent use.
Step 5: tabletting: use 35 to rush high-speed rotary tabletting machine.
Step 6: plastic-aluminum: above-mentioned plain sheet is used aluminium-plastic bubble plate packing machine, is packaged into aluminium-plastic panel, packed products.
In described step 3: granulation mode is replaceable is: the supplementary material fine powder mixed is put into fluidised bed granulator, binding agent puts into feed tank, open machine, adjustment parameter, after goods fluid is in good condition, open spraying, adjustment inlet temperature, liquid supply speed, air inducing frequency, atomizing pressure, Real Time Observation, stops spraying after granular size is moderate; Open Hot-blast Heating, inlet temperature, at 50-55 degree Celsius, uses the swing collator granulate of 18 order nylon screen after drying, for subsequent use.
Embodiment 2
Indication: PX effectively can improve various types of depressions such as various obsession (OCD), generalized anxiety disorder (GAD), panic disorder, human communication disorders, posttraumatic stress disorder (PTSD).Comprise the depression with anxiety and reactive depression.Common depressive symptom: weak, sleep disorder, lacks interest and joyful sense to daily routines, loss of appetite.After treatment satisfactory effect, continue to take the recurrence that these product can prevent depression.
Embodiment 3
Drug interaction:
(1) these product and tryptophan share, and can cause high serotonin syndrome, show as restless, uneasy and gastrointestinal symptom.Moreover can occur hypermyotonia, Gao Re or disturbance of consciousness, therefore these product should not share with tryptophan.
(2) the derivant of the medicine enzyme of liver enzyme or inhibitor, metabolism and the pharmacokinetic property of these product can be affected, when these product and known drug metabolism inhibitor share, answer the lower bound of using dosage scope, and when share with known enzyme inducer, need not consider to adjust predose.
(3) the patient taking these product should avoid drinking.
(4) take before and after these product and can not use oxidase inhibitor in 2 weeks, in inactive oxidase inhibitor after 2 weeks, starting to take this medicine should be prudent, and dosage should increase gradually.
(5) should be prudent when these product and lithium salts share, note monitoring blood lithium concentration.
(6) when share with phenytoin Sodium and other anticonvulsants, the blood drug level of this medicine can be reduced, and the generation of untoward reaction can be increased.
(7) these product and warfarin share, and can cause hemorrhage increase.
(8) these product and tricyclic antidepressant amitriptyline, imipramine share, and the blood concentration of the latter can be made to increase.
(9) these product obviously can increase the blood plasma level of procyclidine, if should reduce the dosage of procyclidine when there is cholinolytic effect.
Embodiment 4
Pharmacological toxicology
These product of pharmacological action belong to antidepressant, are potent, high selectivity serotonin reuptake inhibitor, 5-hydroxy tryptamine concentration in synaptic space can be made to raise, strengthen maincenter 5-hydroxy tryptamine function of nervous system.The only re uptake of faint suppression norepinephrine and dopamine, with muscarine 1,2 receptor or adrenoceptor, dopamine 2 receptor, 5-hydroxy tryptamine 1,2 receptor and histamine H1-receptor almost do not have affinity.Inhibitory action is not had to monoamine oxidase, MAO yet.Toxicological study genetoxic: the test of paroxetine mutant bacteria, the outer DNA synthetic test of mouse lymph lymphoma mutant test, degree, Chromosome Aberration In Human Lymphocytes test, Micronuclei In The Mouse Bone Marrow test and rat dominant lethal test result are feminine gender.Genotoxicity: to paroxetine 15mg/kg/ days (calculating with mg/m, is 2.9 times of the clinical recommended dose of Cure of depression), the pregnancy rate of rat declined.In the toxicity research in 2 to 52 weeks, find male rat reproductive tract irreversible damage (during 50mg/kg/ days visible epididymal duct epithelium cavity, with the testis atrophy of vas deferens that spermatogenesis suppresses during 25mg/kg/ days).Period of organogenesis rat and rabbit give paroxetine 50mg/kg/ days and 6mg/kg/ days (calculate with mg/m, be equivalent to 9.7 and 2.2 times of the clinical recommended dose of Cure of depression respectively) respectively, do not demonstrate Teratogenesis toxicity.But after Rat Pregnancy three months and whole age of sucking successive administration, first 4 days of age of sucking, young Mus death increases, and this effect occurs in 1mg/kg/ days, and the cause of death it be unclear that.Fail to determine to cause the no-effect level of rat children mouse death.Carcinogenecity: in rodent administration (feedstuff incorporation methods) the carcinogenecity research of 2 years, Mouse and rat dosage reaches 25mg/kg/ days respectively and (calculates with mg/m for 20mg/kg/ days, be equivalent to 2.4 and 3.9 times of the clinical recommended dose of Cure of depression respectively), result high dose group male rat skein cell tumor significantly increases (contrast, low, in and high dose group be respectively 1/100,0/50,0/50, with 4/50), lymphatic reticular endothelial cell tumor is with dosage escalation.Female rats is unaffected.Increase although number of tumors presents dosage correlation in mice, the increase of the mice with tumor quantity not having medicine to be correlated with.These find to it be unclear that with the dependency of the mankind.Dependency: do not have the systematic study data about the abuse of paroxetine animal or human, tolerance or drug dependence at present.
Embodiment 5
Pharmacokinetics
The oral rear easy absorption of these product, is not subject to the impact of antiacid medicine and food.Chinese healthy male volunteer oral 40mg paroxetine hydrochloride, T1/2Ke is 19.74 hours, and peak reaching time of blood concentration is 5.30 hours, and peak concentration is 31.01ng/ml, AUC (0-Tn) for 727.93ng/ml*h, AUC (0-inf) be 873.17ng/ml*h.Oral hydrochloride paroxetine 30mg according to the literature, mostly can reach stable state in 10 days, and peak reaching time of blood concentration is 5.2 hours, and peak concentration is 61.7ng/ml, and plasma protein binding rate is 95%, is distributed to each histoorgan, comprises central nervous system.These product removing half-life is generally 24 hours.At liver metabolism, about 2% with prototype by urinating discharge, all the other with metabolite form from urine discharge, on a small quantity by defecate.
Claims (6)
1. a paroxetine hydrochloride slow releasing tablet, is characterized in that: be made up of the raw material of following weight: 20mg paroxetine hydrochloride, 50-195mg hypromellose, 3-20mg lubricant.
2. a kind of paroxetine hydrochloride slow releasing tablet according to claim 1, is characterized in that: in described raw material, preferred weight proportion is: 20mg paroxetine hydrochloride, 92mg hypromellose, 5mg lubricant.
3. a kind of paroxetine hydrochloride slow releasing tablet according to claim 1, is characterized in that: described hypromellose can be one or both compositions of following model: 75hd100cr hypromellose, 75hd4000cr hypromellose, 75hd15000cr hypromellose, 100000cr hypromellose.
4. a kind of paroxetine hydrochloride slow releasing tablet according to claim 1-2, is characterized in that: described lubricant is one or both in magnesium stearate, Pulvis Talci, silicon dioxide.
5. the preparation method of a kind of paroxetine hydrochloride slow releasing tablet according to claim 1-2, is characterized in that: comprise following operation:
Step 1: get the raw materials ready: by above-mentioned quality proportioning, use pulverizer to pulverize paroxetine hydrochloride, crosses 100 mesh sieves;
Step 2: mixing: take paroxetine hydrochloride according to above-mentioned quality proportioning, hypromellose put into three-dimensional mixer mixing 30 minutes, make Drug Component, take out for subsequent use;
Step 3: granulate: the supplementary material fine powder mixed is put into wet granulator, and binding agent puts into feed tank, opens machine, and adjustment parameter, starts to add wetting agent, opens simultaneously and shears fly cutter, 2-5 minute, discharging; Then use oscillating granulator, granulate with 20 order nylon screens; Rear use fluid bed dryer is dried, and first uses cool breeze dry, after epidermis parches, opens Hot-blast Heating, and inlet temperature, at 50-55 degree Celsius, uses the swing collator granulate of 18 order nylon screen after drying, for subsequent use;
Step 4: always mix: by the granule made, puts into three-dimension type mixer, and adds the lubricant of recipe quantity, and total mixed 30 minutes, discharging was for subsequent use;
Step 5: tabletting: use 35 to rush high-speed rotary tabletting machine;
Step 6: plastic-aluminum: above-mentioned plain sheet is used aluminium-plastic bubble plate packing machine, is packaged into aluminium-plastic panel, packed products.
6. the preparation method of a kind of paroxetine hydrochloride slow releasing tablet according to claim 5, it is characterized in that: in described step 3: granulation mode is replaceable is: the supplementary material fine powder mixed is put into fluidised bed granulator, binding agent puts into feed tank, open machine, adjustment parameter, after goods fluid is in good condition, open spraying, adjustment inlet temperature, liquid supply speed, air inducing frequency, atomizing pressure, Real Time Observation, stops spraying after granular size is moderate; Open Hot-blast Heating, inlet temperature, at 50-55 degree Celsius, uses the swing collator granulate of 18 order nylon screen after drying, for subsequent use.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510881435.6A CN105476972A (en) | 2015-12-07 | 2015-12-07 | Paroxetine hydrochloride sustained release tablet and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510881435.6A CN105476972A (en) | 2015-12-07 | 2015-12-07 | Paroxetine hydrochloride sustained release tablet and preparation method thereof |
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| CN105476972A true CN105476972A (en) | 2016-04-13 |
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| CN201510881435.6A Pending CN105476972A (en) | 2015-12-07 | 2015-12-07 | Paroxetine hydrochloride sustained release tablet and preparation method thereof |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2005107716A1 (en) * | 2004-03-25 | 2005-11-17 | Cadila Healthcare Limited | Controlled release paroxetine-containing tablets based on a core and a coating |
| CN102525966A (en) * | 2010-12-13 | 2012-07-04 | 江苏万全特创医药生物技术有限公司 | Tablet containing paroxetine and preparation method thereof |
| CN102670548A (en) * | 2011-03-14 | 2012-09-19 | 北京天衡药物研究院 | Paroxetine hydrochloride osmotic pump type enteric controlled release tablet |
-
2015
- 2015-12-07 CN CN201510881435.6A patent/CN105476972A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2005107716A1 (en) * | 2004-03-25 | 2005-11-17 | Cadila Healthcare Limited | Controlled release paroxetine-containing tablets based on a core and a coating |
| CN102525966A (en) * | 2010-12-13 | 2012-07-04 | 江苏万全特创医药生物技术有限公司 | Tablet containing paroxetine and preparation method thereof |
| CN102670548A (en) * | 2011-03-14 | 2012-09-19 | 北京天衡药物研究院 | Paroxetine hydrochloride osmotic pump type enteric controlled release tablet |
Non-Patent Citations (1)
| Title |
|---|
| 温玉琴: ""盐酸帕罗西汀肠溶缓释制剂的研制"", 《中国优秀硕士学位论文全文数据库 医药卫生科技辑》 * |
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Application publication date: 20160413 |