CN100364519C - Chewing tablet of tramado hydrochloride and its preparation method - Google Patents
Chewing tablet of tramado hydrochloride and its preparation method Download PDFInfo
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- CN100364519C CN100364519C CNB2005100415566A CN200510041556A CN100364519C CN 100364519 C CN100364519 C CN 100364519C CN B2005100415566 A CNB2005100415566 A CN B2005100415566A CN 200510041556 A CN200510041556 A CN 200510041556A CN 100364519 C CN100364519 C CN 100364519C
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- acetaminophen
- tramadol hydrochloride
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Abstract
The present invention relates to a novel preparation mode which uses a composition of tramadol hydrochloride and acetaminophen as main medicine, namely that the present invention relates to an amino-phen tramadol hydrochloride chewing tablet. The amino-phen tramadol hydrochloride chewing tablet of the present invention is an antipyretic analgesic prepared from tramadol hydrochloride, acetaminophen and medical auxiliary material, wherein the weight ratio of the tramadol hydrochloride to the acetaminophen is from 0.1:1 to 0.2:1, and the used auxiliary material is medical excipient vehicles, such as a water soluble filling agent, a disintegrating agent, a lubricating agent, corrigent and a wetting agent or an adhesive agent. The chewing tablet preparation of the medicine of the present invention tastes good, and the absorption is easy. Compared with a unilateral conventional tablet, the present invention has the advantages of rapid effect, long acting time and high analgesia intensity.
Description
Technical field
The present invention relates to a kind of is the new preparation way of principal agent with tramadol hydrochloride and acetaminophen compositions, and promptly chewing tablet of tramado hydrochloride belongs to field of medicaments.
Background technology
Acetaminophen is a ntipyretic analgesic medicine, can treat symptoms such as headache, fever, limbs pain, general malaise; Tramadol hydrochloride is the analgesics of using always, is weak opiate receptor antagonist, and both are national medical insurance medicine.Both are used the formation pharmaceutical composition, and this pharmaceutical composition is compared than the folk prescription conventional tablet, have rapid-action, long action time, the analgesia intensity big, characteristics such as no addiction.The chewable tablet preparation of this pharmaceutical composition is not arranged at present as yet, and its preparation can not generally be accepted for extensive patients.
Summary of the invention
The present invention relates to a kind of new formulation that tramadol hydrochloride and acetaminophen compositions are principal agent, the preparation way of this medicine is a chewing tablet of tramado hydrochloride, and the said preparation mouthfeel is good, easily absorb, compare, have rapid-action than the folk prescription conventional tablet, long action time, analgesia intensity is big.
The present invention also aims to provide a kind of preparation method of chewing tablet of tramado hydrochloride, comprising the tramadol hydrochloride and the acetaminophen of effective dose.
Another purpose of the present invention provides the application of this pharmaceutical preparation.
A kind of chewing tablet of tramado hydrochloride is characterized in that said preparation is that principal agent and pharmaceutic adjuvant are prepared from tramadol hydrochloride and acetaminophen, and wherein the weight ratio of tramadol hydrochloride and acetaminophen is 0.1: 1-0.2: 1.
The used pharmaceutic adjuvant of the present invention comprises: water-soluble filler, disintegrating agent, lubricant and correctives, and wetting agent or binding agent, and the percentage ratio that principal agent and each pharmaceutic adjuvant account for the raw material gross weight is:
A, principal agent 10-70%
B, water-soluble filler 10-50%
C, disintegrating agent 2-30%
D, lubricant 0.3-5%
E, correctives 0.1-20%
F, wetting agent or binding agent 0.5-20%.
Water-soluble filler selects for use erythritol, mannitol, sorbitol or xylitol or other to help the material of moisture penetration in the pharmaceutical preparation, or the mixture of above two or more material.
Disintegrating agent is selected microcrystalline Cellulose (MCC), carboxymethyl starch sodium (CMS-Na), low-substituted hydroxypropyl cellulose (L-HPC), cross-linked carboxymethyl cellulose sodium (CCNa), polyvinylpolypyrrolidone (PVPP), crosslinked carboxymethylstach sodium (CCMS-Na) for use, or the mixture of above two or more material.
Lubricant can be selected magnesium stearate, Pulvis Talci for use, or the two mixture.
In order to cover the bitterness of tramadol hydrochloride, correctives selects that Herba Menthae essence, menthol, Mentholum, refrigerant alcohol, lid gourmet powder, A Siba are sweet for use, stevioside, saccharin sodium or cyclamate, or the mixture of above two or more material.
Wetting agent and binding agent can be selected for use: the polyvidone of 5%-15% starch slurry, 5%-10% or 0.5-5%HPMC aqueous solution etc.
The preparation method of chewing tablet of tramado hydrochloride of the present invention is: the raw material of getting said ratio; with acetaminophen and tramadol hydrochloride raw material sieve (100 order); add filler, correctives and disintegrating agent; add an amount of wetting agent of people or binding agent behind the mix homogeneously and granulate, dry (50 ℃ ± 5 ℃); with lubricant and dried particles mix homogeneously, tabletting.
Chewing tablet of tramado hydrochloride of the present invention is being controlled the application that is equipped with in the treatment, in the acute and chronic pain medication of severe, especially surgical operation pain, postoperative pain, arthralgia, myalgia, headache, toothache, dysmenorrhea, neuralgia, and the application in the terminal cancer pain medication.
This dosage form adopts wet granulation technology, can use conventional tablet pharmaceutical equipment to produce, and selected adjuvant all is the adjuvants that are suitable for this tablet of preparation.
The present invention has following advantage compared to existing technology:
Chewing tablet of tramado hydrochloride of the present invention has been chosen suitable short flavor agent in order to cover the bitterness of tramadol hydrochloride, and the preparation mouthfeel is good, is more suitable for child patient and takes, for clinical application provides a kind of new selection.During said preparation is applicable to clinically, the acute and chronic pain of severe, as surgical operation, postoperative pain, arthralgia, myalgia, headache, toothache, dysmenorrhea, neuralgia, and the terminal cancer treatment of pain.Analgesic is the big class medicine that clinical practice occupies critical role.The chewable tablet preparation mouthfeel of this medicine is good, easily absorbs, and compares than the folk prescription conventional tablet, have rapid-action, long action time, analgesia intensity is big.
The specific embodiment
The preparation method of chewing tablet of tramado hydrochloride of the present invention is as described below: take by weighing acetaminophen, tramadol hydrochloride (crossing 100 mesh sieves), filler, correctives and part disintegrating agent; add an amount of wetting agent of people or binding agent behind the mix homogeneously and granulate, dry (50 ℃); with lubricant and dried particles mix homogeneously, tabletting.
Embodiment 1: the preparation chewing tablet of tramado hydrochloride
Composition weight (g) percentage by weight (%)
Tramadol hydrochloride 37.5 4.50
Acetaminophen 325 39.04
Mannitol 200 24.02
Microcrystalline Cellulose 200 24.02
Aspartame 10 1.20
Carboxymethyl starch sodium 40 4.80
Herba Menthae essence 16 1.92
Magnesium stearate 4 0.48
7% starch slurry is an amount of
Make: 1000
Preparation technology:
Take by weighing tramadol hydrochloride, acetaminophen, mannitol, microcrystalline Cellulose, aspartame, carboxymethyl starch sodium, Herba Menthae essence by above-mentioned recipe quantity; put into quick mixer granulator mixing; it is an amount of to add an amount of 7% starch slurry; the system soft material; granulate with 16 mesh sieves, 50 ℃ ± 5 ℃ aeration-drying to particle drying weightlessness are about 2.5%, and dried granule is crossed 20 mesh sieve granulate; add the magnesium stearate mix homogeneously, tabletting.
Embodiment 2: the preparation chewing tablet of tramado hydrochloride
Composition weight (g) percentage by weight (%)
Tramadol hydrochloride 50 5.90
Acetaminophen 300 35.42
Erythritol 250 29.52
Microcrystalline Cellulose 200 23.61
Stevioside 8 0.94
Polyvinylpolypyrrolidone 25 2.95
Refrigerant pure 10 1.18
Magnesium stearate 4 0.47
5% povidone solution is an amount of
Make: 1000
Preparation technology:
By above-mentioned recipe quantity take by weighing refrigerant alcohol add 10ml ethanol stir refrigerant pure alcoholic solution.Take by weighing tramadol hydrochloride, acetaminophen, erythritol, microcrystalline Cellulose, stevioside, polyvinylpolypyrrolidone by recipe quantity, put into quick mixer granulator mixing; Adding refrigerant pure alcoholic solution fully stirs; It is an amount of to add an amount of 5% povidone solution again, and the system soft material is granulated with 16 mesh sieves, and 50 ℃ ± 5 ℃ aeration-drying to particle drying weightlessness are about 2.5%, and dried granule is crossed 20 mesh sieve granulate, adds the magnesium stearate mix homogeneously, tabletting.
Embodiment 3: the preparation chewing tablet of tramado hydrochloride
Composition weight (g) percentage by weight (%)
Tramadol hydrochloride 50 6.05
Acetaminophen 350 42.32
Sorbitol 150 18.14
Microcrystalline Cellulose 230 27.81
Stevioside 8 0.97
Low-substituted hydroxypropyl cellulose 25 3.02
Mentholum 10 1.21
Magnesium stearate 4 0.48
2% hydroxypropyl emthylcellulose is an amount of
Make: 1000
Preparation technology:
Take by weighing tramadol hydrochloride, acetaminophen, sorbitol, microcrystalline Cellulose, stevioside, low-substituted hydroxypropyl cellulose, Mentholum by above-mentioned recipe quantity; put into quick mixer granulator mixing; it is an amount of to add 2% hydroxypropyl emthylcellulose again; the system soft material; granulate with 16 mesh sieves, 50 ℃ ± 5 ℃ aeration-drying to particle drying weightlessness are about 2.5%, and dried granule is crossed 20 mesh sieve granulate; add the magnesium stearate mix homogeneously, tabletting.
Embodiment 4: the preparation chewing tablet of tramado hydrochloride
Composition weight (g) percentage by weight (%)
Tramadol hydrochloride 35 4.18
Acetaminophen 350 41.77
Erythritol 250 23.87
Microcrystalline Cellulose 200 23.87
Stevioside 8 0.95
Polyvinylpolypyrrolidone 25 2.98
Herba Menthae essence 16 1.91
Magnesium stearate 4 0.48
5% povidone solution is an amount of
Make: 1000
Get above-mentioned raw materials, its preparation process is with embodiment 2.
Embodiment 5: the preparation chewing tablet of tramado hydrochloride
Composition weight (g) percentage by weight (%)
Tramadol hydrochloride 50 5.90
Acetaminophen 250 35.42
Erythritol 250 35.42
Microcrystalline Cellulose 250 29.52
Stevioside 8 0.94
Polyvinylpolypyrrolidone 25 2.95
Refrigerant pure 10 1.18
Magnesium stearate 4 0.47
5% povidone solution is an amount of
Make: 1000
Get above-mentioned raw materials, its preparation process is with embodiment 2.
Embodiment 6: the preparation chewing tablet of tramado hydrochloride
Composition weight (g) percentage by weight (%)
Tramadol hydrochloride 75 8.85
Acetaminophen 450 53.13
Erythritol 150 17.7
Microcrystalline Cellulose 125 14.7
Stevioside 8 0.94
Polyvinylpolypyrrolidone 25 2.95
Refrigerant pure 10 1.18
Magnesium stearate 4 0.47
5% povidone solution is an amount of
Make: 1000
Get above-mentioned raw materials, its preparation process is with embodiment 2.
Embodiment 7: the preparation chewing tablet of tramado hydrochloride
Composition weight (g) percentage by weight (%)
Tramadol hydrochloride 9.38 1.12
Acetaminophen 81.25 9.6
Mannitol 300 36.03
Microcrystalline Cellulose 300 36.038
Aspartame 50 6
Carboxymethyl starch sodium 60 7.2
Herba Menthae essence 27 3.24
Magnesium stearate 4 0.48
7% starch slurry is an amount of
Make: 1000
Get above-mentioned raw materials, its preparation process is with embodiment 2.
Claims (6)
1. chewing tablet of tramado hydrochloride, it is characterized in that used principal agent is tramadol hydrochloride and acetaminophen, and the weight ratio of tramadol hydrochloride and acetaminophen is 0.1: 1～0.2: 1, pharmaceutic adjuvant comprises water-soluble filler, disintegrating agent, lubricant and correctives, and wetting agent or binding agent, wherein, principal agent and each pharmaceutic adjuvant account for the percentage ratio of raw material gross weight and are:
A. principal agent 10-70%
B. water-soluble filler 10-50%
C. disintegrating agent 2-30%
D. lubricant 0.3-5%
E. correctives 0.1-20%
F. wetting agent or binding agent 0.5-20%.
2. chewing tablet of tramado hydrochloride according to claim 1 is characterized in that water-soluble filler selects erythritol, mannitol, sorbitol or xylitol for use, or the mixture of above two or more material.
3. chewing tablet of tramado hydrochloride according to claim 1, it is characterized in that disintegrating agent selects microcrystalline Cellulose, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, cross-linked carboxymethyl cellulose sodium, polyvinylpolypyrrolidone or crosslinked carboxymethylstach sodium for use, or the mixture of above two or more material.
4. chewing tablet of tramado hydrochloride according to claim 1 is characterized in that lubricant selects magnesium stearate or Pulvis Talci or magnesium stearate and talcous mixture for use.
5. chewing tablet of tramado hydrochloride according to claim 1, it is characterized in that correctives selects that Herba Menthae essence, menthol, Mentholum, refrigerant alcohol, lid gourmet powder, A Siba are sweet for use, stevioside, saccharin sodium or cyclamate, or the mixture of above two or more material.
6. the preparation method of the described chewing tablet of tramado hydrochloride of claim 1; it is characterized in that preparation process is: the raw material of getting said ratio; acetaminophen and tramadol hydrochloride are sieved; add filler, correctives and disintegrating agent; adding an amount of wetting agent or binding agent behind the mix homogeneously granulates, dries; with lubricant and dried particles mix homogeneously, tabletting.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100415566A CN100364519C (en) | 2005-08-22 | 2005-08-22 | Chewing tablet of tramado hydrochloride and its preparation method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100415566A CN100364519C (en) | 2005-08-22 | 2005-08-22 | Chewing tablet of tramado hydrochloride and its preparation method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1732910A CN1732910A (en) | 2006-02-15 |
| CN100364519C true CN100364519C (en) | 2008-01-30 |
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| CNB2005100415566A Active CN100364519C (en) | 2005-08-22 | 2005-08-22 | Chewing tablet of tramado hydrochloride and its preparation method |
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Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3052089B1 (en) * | 2013-09-30 | 2017-08-30 | Athena Drug Delivery Solutions Pvt Ltd. | Tramadol hydrochloride and paracetamol orally disintegrating composition and process for preparing the same |
| CN103719863B (en) * | 2014-01-07 | 2015-04-22 | 威海环翠楼红参科技有限公司 | Preparation method of red ginseng chewable tablets |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1600299A (en) * | 2003-09-24 | 2005-03-30 | 孙明杰 | Compound tablet of tramadol hydrochloride dispersion |
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- 2005-08-22 CN CNB2005100415566A patent/CN100364519C/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1600299A (en) * | 2003-09-24 | 2005-03-30 | 孙明杰 | Compound tablet of tramadol hydrochloride dispersion |
Non-Patent Citations (1)
| Title |
|---|
| 对乙酰氨基酚咀嚼片相对生物利用度测定. 陈秋潮等.中国临床药学杂志，第1卷. 1995 * |
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| CN1732910A (en) | 2006-02-15 |
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| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| EE01 | Entry into force of recordation of patent licensing contract |
Assignee: Nanjing Hailing Pharmaceutical Co., Ltd. of Yangtze River Pharmaceutical Group Assignor: Nanjing Hailing Chinese Medicine Pharmaceutical Technology Research Co., Ltd. Contract record no.: 2011320000101 Denomination of invention: Chewing tablet of tramado hydrochloride and its preparation method Granted publication date: 20080130 License type: Exclusive License Open date: 20060215 Record date: 20110228 |