CN1803128A - Oral disintegrating tablet containing tramadol hydrochloride and acetaminopher, and its preparation method - Google Patents
Oral disintegrating tablet containing tramadol hydrochloride and acetaminopher, and its preparation method Download PDFInfo
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- CN1803128A CN1803128A CN 200510023352 CN200510023352A CN1803128A CN 1803128 A CN1803128 A CN 1803128A CN 200510023352 CN200510023352 CN 200510023352 CN 200510023352 A CN200510023352 A CN 200510023352A CN 1803128 A CN1803128 A CN 1803128A
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- granule
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- tramadol hydrochloride
- odor mask
- acetaminophen
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Abstract
The invention provides an orally disintegrating tablet containing tramadol hydrochloride and paracetamol, and the preparing process, wherein tramadol hydrochloride and paracetamol are dressed for mouth cavity use. During the dressing process, right amount of medicinal auxiliary materials are charged.
Description
Technical field
The present invention relates to a kind of preparation that contains tramadol hydrochloride and acetaminophen and preparation method thereof, particularly a kind of tramadol hydrochloride and acetaminophen oral cavity disintegration tablet and preparation method thereof of containing.
Technical background
Tramadol hydrochloride is synthetic opiates central analgesics, the part-structure of the similar endorphin of space structure, also can combine with the opiate receptor specificity, exciting receptor, produce the analgesic activity of morphine sample, but the serious adverse reaction that does not have the morphine sample, under therapeutic dose, toleration is better, and dependency is lower, because of no adrenal gland can and 5-hydroxy tryptamine can act on, respiration inhibition can not take place, constipation, dysuria, to blood vessel, hepatic and renal function, smooth muscle and striped muscle etc. also have no adverse effects, and rapid-action and persistent period and morphine are similar, and analgesic activity can be kept 4～5 hours.
This phenol of acetparaminosalol is the phenyl amines antipyretic analgesic, by suppressing the synthetic analgesic effect that reaches of central nervous system's prostaglandin, and it is very weak to suppress the synthetic effect of peripheral nervous system prostaglandin, little to GI irritation, and platelet and clotting mechanism are not had influence.This product oral absorption is complete, is evenly distributed in body fluid, and the half-life is generally 1～4 hour (average 2 hours).
The analgesic of two kinds of different mechanism of action is share, both can strengthen analgesic effect, prolong action time, can reduce dosage again, reduce the toxicity incidence rate, clinical trial proves: in the clinical trial of a management of acute pain, preparation analgesic effect of the present invention is better than the independent component of placebo and Isodose, and more rapid-action than using tramadol separately, beginning all is shorter than 1 hour action time, and it is then long than independent use acetaminophen to hold time.Therefore tramadol hydrochloride and the existing certain synergism of compound recipe that acetyl ammonia phenol is formed shorten the drug effect time, prolong analgesia and hold time, and can reduce dosage again, reduce side effect.
The ORTHO-McNEIL PHARMACEUTICAL of the U.S., INC. develops, and trade name in Nikkei drugs approved by FDA listing in Augusts 15 calendar year 2001, is not also gone public in other countries.During this compound recipe sheet indication is widely used in, the anxious acute pain of severe, as carcinous treatment of pain of surgical operation, postoperative pain and pain of joint muscle, late period.
But at present tramadol hydrochloride/acetaminophen compound recipe the sheet in the city is an ordinary tablet, needs water to swallow when taking, in case can not in time take when pain takes place, and timely alleviating pain, it need absorb by gastrointestinal tract, and bioavailability is low, and side effect is big;
Simultaneously, can't adopt conventional method to form oral cavity disintegration tablet tramadol hydrochloride and acetaminophen again because tramadol hydrochloride and or/acetaminophen all is extremely bitter medicine, does not generally make oral cavity disintegration tablet.
Summary of the invention
The technical issues that need to address of the present invention are to disclose a kind of tramadol hydrochloride and acetaminophen oral cavity disintegration tablet and preparation method thereof, to overcome the above-mentioned defective that prior art exists.
The preparation method of tramadol hydrochloride provided by the invention and acetaminophen oral cavity disintegration tablet is characterized in that comprising the steps:
(1) with correctives and filler mixing, add the binding agent of correctives and filler gross mass 1～5%, obtain the mixture of described correctives and filler, or cross 10～30 mesh sieve system wet granulars, 60～80 ℃ of oven dry get granule (I);
The weight ratio of correctives and filler is: correctives: filler=1: 2～20;
Said binding agent preferably polyethylene ketopyrrolidine;
(2) with acetaminophen and lubricant mixing, cross 60～90 mesh sieves, be that the aqueous solution of 30%～50% coating odor mask is made coating materials with mass concentration, adopt conventional method coating, granule (II);
The weight ratio of acetaminophen and lubricant is: acetaminophen: lubricant=1: 0.005～0.03;
(3) alcoholic solution of tramadol hydrochloride with the coating odor mask mixed, obtain clathrate, clathrate is pulverized, granulate, get granule (III) with the alcoholic solution coating of coating odor mask; As tramadol hydrochloride and beta-schardinger dextrin-can being added respectively in the alcoholic solution, with homogenizer high-speed stirred 2～5 hours, again the solution that stirs is layered in the glass dish, put into 50 ℃～70 ℃ baking ovens and dry, take out, with dry thing pulverize clathrate.
The weight ratio of tramadol hydrochloride and saturated coating odor mask is: tramadol hydrochloride: coating odor mask=1: 2～5;
It is 40%～60% alcoholic solution that the alcoholic solution of said coating odor mask is selected from mass percent concentration, the alcoholic solution of preferred saturated coating odor mask;
The coating pelletization is a method well known in the art;
(4) respectively with granule (II) and granule (III) mixing, granulate with the alcoholic solution coating of above-mentioned coating odor mask, get granule (IV);
Granule (II) with the weight ratio of granule (III) is: granule (II): granule (III)=1: 0.1～0.6;
(5) granule (IV) is mixed with the mixture or the granule (I) of described correctives and filler, adopt method tabletting well known in the art;
Granule (IV) and described correctives and the mixture of filler or the weight ratio of granule (I) are: granule (IV): granule (I)=1: 0.1～0.3, and in the product, the mass ratio of tramadol hydrochloride and acetaminophen is:
Tramadol hydrochloride: acetaminophen=1: 4～10.
Said coating odor mask is selected from a kind of or its mixture in acrylic resin (EUDRAGIT), hypromellose, ethyl cellulose alcoholic solution or its aqueous dispersion, gelatin, cyclodextrin or the Glyceryl Behenate, preferred coating odor mask is cyclodextrin and/or ethyl cellulose alcoholic solution, preferred especially beta-schardinger dextrin-;
Said correctives is selected from one or more in aspartame, sucrose, citric acid, tartaric acid, ethyl maltol, essence or the Herba Menthae, and preferred correctives is aspartame and/or ethyl maltol;
The aspartame of being addressed is a kind of novel amino acids high-intensity sweeteners, the dipeptide compound of being made up of L-aspartic acid and L-phenylalanine.And do not have a bitterness of other artificial sweeteners, chemistry flavor or metallic taste.Aspartame can be promoted the bitterness of the local flavor reduction coffee of fruit.Aspartame can reduce heat effectively, and can not cause tooth decay, has the metabolism similar with protein.Its chemical name is the 2-L-aspartyl-L-phenylalanine methyl ester;
Disintegrating agent is selected from one or more in polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium, sodium lauryl sulphate or the sodium alginate, and preferred disintegrating agent is a polyvinylpolypyrrolidone;
Said lubricant is selected from a kind of or its mixture in silicon dioxide or the Pulvis Talci, preferred silicon dioxide;
Filler is selected from microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, mannitol, part and gives in the gelling starch (starch1500) one or more, and preferred filler is a mannitol.
Because acetaminophen, tramadol hydrochloride taste are all bitter, and recipe quantity is very big, technology preparation by general oral cavity disintegration tablet can't be covered bitterness, therefore acetaminophen of the present invention, tramadol hydrochloride carry out the taste masking coating respectively, make its suitable orally administer, the present invention has selected for use the physicochemical property that is suitable for acetaminophen, tramadol hydrochloride to select suitable pharmaceutic adjuvant, carries out coating, last mixing tabletting.Raw material good fluidity with this prescription and taste masking coating is convenient to tabletting.After medicine is coated, taste masking substantially, add correctives again and carry out the taste adjustment this moment, is fit to orally administer.Suitable disintegrating agent and the amount that the present invention selects for use makes oral cavity disintegration tablet of the present invention can reach quickly disintegrated requirement.
The specific embodiment
Embodiment 1
325mg/37.5mg tramado hydrochloride/sheet, prescription sees Table 1.
| The component title | Component | Addition |
| Active component | Acetaminophen | 325mg |
| Active component | Tramadol hydrochloride | 37.5mg |
| The coating odor mask | Acrylic resin | 15mg |
| The coating odor mask | Beta-schardinger dextrin- | 60mg |
| The coating odor mask | Ethyl cellulose | 8mg |
| Correctives | Aspartame | 10mg |
| Essence | Fructus Citri Limoniae essence | 8mg |
| Disintegrating agent | Polyvinylpolypyrrolidone | 50mg |
| Disintegrating agent | Carboxymethyl starch sodium | 20mg |
| Filler | Mannitol | 70mg |
| Filler | Pregelatinized Starch | 30mg |
| Lubricant | Silicon dioxide | 6.0mg |
| Binding agent | Polyvinylpyrrolidone | 0.5mg |
Preparation technology:
(1) with 10mg correctives aspartame and 70mg filler mannitol mixing, add the polyvinyl pyrrolidone of 0.5mg (correctives and filler gross mass 0.6%), cross 20 mesh sieve system wet granulars, 70 ℃ of oven dry get granule (I);
Said binding agent is a polyvinylpyrrolidone;
(2) with 325mg acetaminophen and 3mg lubricant silicon dioxide mixing, cross 70 mesh sieves, be that the aqueous solution of 40% coating odor mask acrylic resin is made the coating materials coating with the 37.5mg mass concentration, must granule (II);
(3) alcoholic solution of the coating odor mask beta-schardinger dextrin-that 37.5mg tramadol hydrochloride and 180mg is saturated mixes, add tramadol hydrochloride and beta-schardinger dextrin-in the alcoholic solution respectively, with homogenizer high-speed stirred 2～5 hours, again the solution that stirs is layered in the glass dish, putting into 50～70 baking ovens dries, take out, with dry thing pulverize clathrate.
Obtain clathrate, clathrate is pulverized, granulate, get granule (III) with the alcoholic solution coating of the saturated coating odor mask ethyl cellulose of 85mg;
(4) respectively with 343mg granule (II) and 102.6mg granule (III) mixing, granulate with the alcoholic solution coating of above-mentioned coating odor mask, get granule (IV);
(5) 448.5mg granule (IV) is mixed with 80.5mg granule (I), add the abundant mixing of 8mg essence, add disintegrating agent, pregelatinized Starch and the abundant mixing of 3mg silicon dioxide of recipe quantity again, adopt method tabletting well known in the art.
Adopt tramado hydrochloride oral cavity disintegration tablet quality standard (draft) standard that the tablet that is obtained is detected, it the results are shown in Table 4.
Embodiment 2
325mg/37.5mg tramado hydrochloride/sheet, prescription sees Table 2.
Table 2
| The component title | Component | Addition |
| Active component | Acetaminophen | 325mg |
| Active component | Tramadol hydrochloride | 37.5mg |
| The coating odor mask | Acrylic resin | 8mg |
| The coating odor mask | Beta-schardinger dextrin- | 110mg |
| The coating odor mask | Ethyl cellulose | 15mg |
| Correctives | Aspartame | 5mg |
| Correctives | Ethyl maltol | 4mg |
| Essence | Fructus Citri Limoniae essence | 13mg |
| Disintegrating agent | Polyvinylpolypyrrolidone | 46mg |
| Help and collapse agent | Sodium lauryl sulphate | 10mg |
| Filler | Mannitol | 60mg |
| Lubricant | Silicon dioxide | 6.1mg |
| Binding agent | Polyvinylpyrrolidone | 0.4mg |
Preparation process is as follows:
(1) with 5mg correctives aspartame and 60mg filler mannitol mixing, add the polyvinyl pyrrolidone of 0.4mg (correctives and filler gross mass 0.6%), cross 20 mesh sieve system wet granulars, 70 ℃ of oven dry get granule (I);
Said binding agent is a polyvinylpyrrolidone;
(2) with 325mg acetaminophen and 3mg lubricant silicon dioxide mixing, cross 80 mesh sieves, be that the aqueous solution of 40% coating odor mask acrylic resin is made the coating materials coating with the 20mg mass concentration, must granule (II);
(3) alcoholic solution of the coating odor mask beta-schardinger dextrin-that 37.5mg tramadol hydrochloride and 330mg is saturated mixes, add tramadol hydrochloride and beta-schardinger dextrin-in the alcoholic solution respectively, with homogenizer high-speed stirred 2～5 hours, again the solution that stirs is layered in the glass dish, putting into 50 ℃ of baking ovens dries, take out, with dry thing pulverize clathrate.
Obtain clathrate, clathrate is pulverized, granulate, get granule (III) with the alcoholic solution coating of the saturated coating odor mask ethyl cellulose of 100mg;
(4) respectively with 336mg granule (II) and 153.5mg granule (III) mixing, granulate with the alcoholic solution coating of above-mentioned coating odor mask, get granule (IV);
(5) 498.5mg granule (IV) is mixed with 65.4mg granule (I), add 13mg essence and the abundant mixing of 4mg ethyl maltol, add the disintegrating agent and the abundant mixing of 3.1mg silicon dioxide of recipe quantity again, adopt method tabletting well known in the art.
Adopt tramado hydrochloride oral cavity disintegration tablet quality standard (draft) standard that the tablet that is obtained is detected, it the results are shown in Table 4.
Embodiment 3
325mg/37.5mg tramado hydrochloride/sheet.Prescription sees Table 3.
| The component title | Component | Addition |
| Active component | Acetaminophen | 325mg |
| Active component | Tramadol hydrochloride | 37.5mg |
| The coating odor mask | Acrylic resin | 12mg |
| The coating odor mask | Beta-schardinger dextrin- | 100mg |
| The coating odor mask | Ethyl cellulose | 15mg |
| Correctives | Aspartame | 8mg |
| Correctives | Ethyl maltol | 7mg |
| Essence | Twist lemon essence | 11mg |
| Disintegrating agent | Polyvinylpolypyrrolidone | 50mg |
| Disintegrating agent | Carboxymethyl starch sodium | 12mg |
| Filler | Mannitol | 70mg |
| Filler | Pregelatinized Starch | 30mg |
| Lubricant | Silicon dioxide | 6mg |
| Binding agent | Polyvinylpyrrolidone | 0.5mg |
Preparation process is with embodiment 1
Testing result sees Table 4.
Table 4
| Technical specification | Unit | Embodiment | ||
| 1 | 2 | 3 | ||
| Disintegration in the 2ml solution | Second | 35 | 22 | 30 |
| Content | ％ | 100 | 100 | 100 |
| Related substance | ％ | ＜1.5 | ＜1.5 | ＜1.5 |
| Mouthfeel | No grittiness | No grittiness | No grittiness | |
| Taste masking | The sense of taste is good | The sense of taste is good | The sense of taste is good | |
| Friability | 0.7 | 2.2 | 2.3 | |
Claims (17)
1. the preparation method of tramadol hydrochloride and acetaminophen oral cavity disintegration tablet is characterized in that comprising the steps:
(1) with correctives and filler mixing, add binding agent, obtain the mixture of described correctives and filler, or cross the sieve series wet granular, oven dry gets granule (I);
(2) with acetaminophen and lubricant mixing, sieve, make coating materials with the aqueous solution of coating odor mask, coating gets granule (II);
(3) alcoholic solution of tramadol hydrochloride with the coating odor mask mixed, obtain clathrate, clathrate is pulverized, granulate, get granule (III) with the alcoholic solution coating of coating odor mask;
(4) with granule (II) and granule (III) mixing, granulate with the alcoholic solution coating of above-mentioned coating odor mask, get granule (IV);
(5) granule (IV) is mixed tabletting with the mixture or the granule (I) of described correctives and filler.
2. method according to claim 1 is characterized in that, said binding agent is a polyvinylpyrrolidone.
3. method according to claim 1 is characterized in that, it is that the aqueous solution of 30%～50% coating odor mask is made coating materials that step (2) adopts mass concentration.
4. method according to claim 1 is characterized in that, it is 40%～60% alcoholic solution that the alcoholic solution of the said coating odor mask of step (3) is selected from mass percent concentration.
5. method according to claim 4 is characterized in that, adopts the alcoholic solution of saturated coating odor mask.
6. method according to claim 1 is characterized in that, the correctives of step (1) and the weight ratio of filler are: correctives: filler=1: 2～20.
7. method according to claim 1 is characterized in that, the weight ratio of step (2) acetaminophen and lubricant is: acetaminophen: lubricant=1: 0.005～0.03.
8. method according to claim 1 is characterized in that, the weight ratio of step (3) tramadol hydrochloride and saturated coating odor mask is: tramadol hydrochloride: coating odor mask=1: 2～5.
9. method according to claim 1 is characterized in that, granule (II) with the weight ratio of granule (III) is: granule (II): granule (III)=1: 0.1～0.6.
10. method according to claim 1 is characterized in that, granule (IV) and described correctives and the mixture of filler or the weight ratio of granule (I) are: granule (IV): granule (I)=1: 0.1～0.3.
11., it is characterized in that in the product, the mass ratio of tramadol hydrochloride and acetaminophen is: tramadol hydrochloride: acetaminophen=1: 4～10 according to each described method of claim 1～10.
12. according to each described method of claim 1～10, it is characterized in that said coating odor mask is selected from a kind of or its mixture in acrylic resin, hypromellose, ethyl cellulose or its aqueous dispersion, gelatin, cyclodextrin or the Glyceryl Behenate.
13., it is characterized in that said correctives is selected from one or more in aspartame, sucrose, citric acid, tartaric acid, ethyl maltol, essence or the Herba Menthae according to each described method of claim 1～10.
14., it is characterized in that disintegrating agent is selected from one or more in polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium or the sodium alginate according to each described method of claim 1～10.
15., it is characterized in that said lubricant is selected from a kind of or its mixture in silicon dioxide or the Pulvis Talci according to each described method of claim 1～10.
16., it is characterized in that filler is selected from microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, mannitol, part and gives in the gelling starch one or more according to each described method of claim 1～10.
17. the tramadol hydrochloride and the acetaminophen oral cavity disintegration tablet of each described method preparation of claim 1～16.
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| CNB200510023352XA CN100404025C (en) | 2005-01-14 | 2005-01-14 | Oral disintegrating tablet containing tramadol hydrochloride and acetaminopher, and its preparation method |
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| CNB200510023352XA CN100404025C (en) | 2005-01-14 | 2005-01-14 | Oral disintegrating tablet containing tramadol hydrochloride and acetaminopher, and its preparation method |
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| CN1803128A true CN1803128A (en) | 2006-07-19 |
| CN100404025C CN100404025C (en) | 2008-07-23 |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102458117A (en) * | 2009-05-01 | 2012-05-16 | 阿普塔利斯医药科技公司 | Orally disintegrating tablet compositions comprising combinations of non-opioid and opioid analgesics |
| WO2015044952A3 (en) * | 2013-09-30 | 2015-06-04 | Athena Drug Delivery Solutions Pvt Ltd. | Tramadol hydrochloride and paracetamol orally disintegrating composition and process for preparing the same |
| CN113694052A (en) * | 2021-09-17 | 2021-11-26 | 多多药业有限公司 | Prescription for improving bioavailability of acetaminophen and tramadol hydrochloride |
| CN113694051A (en) * | 2021-09-17 | 2021-11-26 | 多多药业有限公司 | A method for preparing coated tablet containing acetaminophen and tramadol hydrochloride |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101919803A (en) * | 2010-07-16 | 2010-12-22 | 钟术光 | A kind of controlled release preparation |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1528273A (en) * | 2003-10-21 | 2004-09-15 | 宇 周 | Analgesic tramadol hydrochloride oral disintegrating tablet and preparing method thereof |
-
2005
- 2005-01-14 CN CNB200510023352XA patent/CN100404025C/en active Active
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102458117A (en) * | 2009-05-01 | 2012-05-16 | 阿普塔利斯医药科技公司 | Orally disintegrating tablet compositions comprising combinations of non-opioid and opioid analgesics |
| CN102458117B (en) * | 2009-05-01 | 2015-11-25 | 阿普塔利斯医药科技公司 | The Orally disintegrating tablet compositions of the combination containing non-opium sample and opium sample analgesic |
| WO2015044952A3 (en) * | 2013-09-30 | 2015-06-04 | Athena Drug Delivery Solutions Pvt Ltd. | Tramadol hydrochloride and paracetamol orally disintegrating composition and process for preparing the same |
| EP3052089A4 (en) * | 2013-09-30 | 2016-08-10 | Athena Drug Delivery Solutions Pvt Ltd | Tramadol hydrochloride and paracetamol orally disintegrating composition and process for preparing the same |
| CN113694052A (en) * | 2021-09-17 | 2021-11-26 | 多多药业有限公司 | Prescription for improving bioavailability of acetaminophen and tramadol hydrochloride |
| CN113694051A (en) * | 2021-09-17 | 2021-11-26 | 多多药业有限公司 | A method for preparing coated tablet containing acetaminophen and tramadol hydrochloride |
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| CN100404025C (en) | 2008-07-23 |
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