CN1279896C - Tramadol hydrochloride oral disintegration tablets, and prepn. method therefor - Google Patents
Tramadol hydrochloride oral disintegration tablets, and prepn. method therefor Download PDFInfo
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- CN1279896C CN1279896C CN 200410005680 CN200410005680A CN1279896C CN 1279896 C CN1279896 C CN 1279896C CN 200410005680 CN200410005680 CN 200410005680 CN 200410005680 A CN200410005680 A CN 200410005680A CN 1279896 C CN1279896 C CN 1279896C
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- tramadol hydrochloride
- microcrystalline cellulose
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- oral cavity
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Abstract
The present invention relates to a tramadol hydrochloride oral disintegration tablet and a preparation method thereof. The tramadol hydrochloride oral disintegration tablet comprises an effective dose of tramadol hydrochloride and medicinal excipient capable of quickly disintegrating and releasing medicines in the mouth cavity, wherein the medicinal excipient is a water soluble filling agent, a disintegrating agent, a lubricating agent, a wetting agent or an adhesive. The tramadol hydrochloride oral disintegration tablet has the advantages of quick disintegration, quick effect, little residue in the intestinal tract, full absorption, low side effect, convenient medication and good taste.
Description
Technical field
The present invention relates to a kind of tramadol hydrochloride oral cavity disintegration tablet and preparation method thereof.
Technical background
Tramadol hydrochloride is a kind of synthetic non-morphine class nervus centralis analgesic, it is a racemization mixture, its positive enantiomer acts on opiate receptor, negative enantiomer then suppresses the reuptake of synapse to norepinephrine, and the outer 5-hydroxy tryptamine concentration of increase neuron, thereby influence pain sensation transmission and produce analgesic activity.The effect of morphine sample is arranged as analgesia and antitussive, but the apnea inhibitory action, no constipation.Cardiovascular and hepatic and renal function there is not obvious influence.There are not glad, hallucination and histamine release effect yet.Do not cause contracted pupil, do not cause sphincterismus yet.A little less than toleration and the addicted generation slowly and, be analgesic safely and effectively.
The tramadol hydrochloride structural formula is as follows:
The dosage form of the tramadol hydrochloride of clinical practice at present has tablet, injection, and injection must use by medical personnel, and tablet need use water delivery service, and dysphagia or the inconvenient patient of water intaking are taken medicine has certain difficulty; So these dosage forms can't satisfy patient's medication needs fully.In order to expand the range of application of tramadol hydrochloride, we consider to be made into oral cavity disintegration tablet.Oral cavity quick disintegrating slice is the novel solid quick releasing formulation of foreign study exploitation in recent ten years.This dosage form mainly is to select suitable fast disintegrant, by the existing certain rigidity of its tablet of making, certain sedimentation is arranged again.Can not need the water assisting deglutition when taking, can be in the oral cavity in the 15s rapidly disintegrate become fine grained, only several swallowing acts can be finished drug administration process.Its more common solid orally ingestible absorbs fast, the bioavailability height, and the gastrointestinal mucosal stimulation is little, and taking convenience, as a kind of novel solid quick releasing formulation, the research and the product of these dosage forms such as existing abroad antiulcerative, anti-inflammatory agent.
Summary of the invention
The object of the present invention is to provide a kind of novel form that can overcome the insufficient tramadol hydrochloride of above-mentioned dosage form and preparation method thereof.
The present invention relates to a kind of tramadol hydrochloride oral cavity disintegration tablet, comprising the tramadol hydrochloride of effective dose and can be in the oral cavity rapidly disintegrate discharge the pharmaceutically acceptable excipient of medicine.
The tramadol hydrochloride oral cavity disintegration tablet contains principal agent tramadol hydrochloride, water-soluble filler, disintegrating agent, lubricant, also contains wetting agent or binding agent, various main materials and auxiliary materials weight shares prescription in the gross weight shared ratio as follows:
A, principal agent 10～50%
B, water-soluble filler 10～70%
C, disintegrating agent 5～70%
D, lubricant 0.3～5%
E, wetting agent or binding agent 0.5～10%.
Water-soluble filler selects for use erythrose, mannitol, sorbitol, 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), 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.
Can also contain gas-producing disintegrant in the above-mentioned disintegrating agent, as citric acid, tartaric acid, fumaric acid, sodium bicarbonate, sodium glycine carbonate, Glycine sodium fumarate.
Lubricant can be selected magnesium stearate, Pulvis Talci for use, or the two mixture.
The optional water of wetting agent, ethanol, or the mixture of the two.
Binding agent can be selected starch slurry, polyvidone or various cellulose family for use, or the mixture of above two or more material.
In order to cover the bitterness of tramadol hydrochloride, can also add the correctives that accounts for prescription gross weight 2～10% in the present invention, aspartame, saccharin sodium, cyclamate and various essence etc.
This dosage form adopts wet granulation technology, can use conventional tablet pharmaceutical equipment to produce.
Selected adjuvant all is the adjuvants that are suitable for this tablet of preparation.Water-soluble filler such as erythrose, mannitol can dissolve rapidly in mouth, absorbs heat during dissolving, and cool taste is little sweet, and is very little to the disintegrate influence, is suitable for the preparation of oral cavity disintegration tablet.Microcrystalline Cellulose is that filler has effect with the collaborative disintegrate of disintegrating agent again, and its compressibility gets final product compression moulding when pressure is very little fortunately, because it is porous tubular structured, is beneficial to moisture content and enters tablet inside and impel the slice, thin piece disintegrate.Selected disintegrating agent mostly is efficient disintegrating agent, uses the disintegrate effect that can reach good on a small quantity, and gas-producing disintegrant contacts a spot of moisture content just can produce the disintegrate that a large amount of bubbles promote slice, thin piece.Various disintegrating agents are united use, can reach the purpose that makes the rapid disintegrate of slice, thin piece.Tramadol hydrochloride raw material hardship is share with aspartame and each essence correctives and can be improved its bitterness, makes the mouthfeel of slice, thin piece suitable.
Concrete preparation method is as described below:
Take by weighing tramadol hydrochloride (crossing 100 mesh sieves), filler, correctives and part disintegrating agent; add an amount of wetting agent or binding agent behind the mix homogeneously and granulate, dry (50 ℃); to remain disintegrating agent and dried particles mix homogeneously, the adding lubricant that is up to the standards, mix homogeneously tabletting.
The tramadol hydrochloride oral cavity disintegration tablet is little sweet in cool taste, runs in the oral cavity after the saliva rapidly that disintegrate becomes fine particle, swallows conveniently.This dosage form has following advantage:
First disintegrate is rapid, and drug effect is fast.Tablet of the present invention can be in one minute in mouth disintegrate fast, be beneficial to the rapid stripping of medicine, shorten dissolution time, accelerate its absorption, make medicine bring into play curative effect rapidly.At the particularity of this kind disintegrate, we have formulated corresponding dissolve scattered time limit and molten shot degree detection method, and concrete detection method and result are as follows.
The detection of dissolve scattered time limit: get this product a slice, put in the glass dish, getting the scale dropper measures 37 ℃ of water of 1ml and directly drips on unilateral, and the control rate of addition was finished timing simultaneously, inspection during to 45 seconds in 30 seconds, this product Ying Rong clears entirely, do not clear entirely as molten, get hard paper and scratch, hard core must not be arranged.Get 6 of this product, operation is all up to specification in accordance with the law.
The detection of molten shot degree: get this product a slice, shine inspection technique disintegration (two appendix X of Chinese Pharmacopoeia version in 2000 A) lower device requirement, and hanging basket bottom screen cloth is replaced by 26 eye mesh screens.This product is put in the disintegration tester hanging basket, regulate the hanging basket height, make the bottom screen cloth concordant, and when this product contact water surface, pick up counting, in the time of 60 seconds, mention the hanging basket inspection, should all pass through screen cloth with the water surface.Get 6 of this product, operation is all up to specification in accordance with the law.
Second drug absorption is abundant.The present invention is disintegrate before reaching gastrointestinal tract, is dispersed into fine particle at gastrointestinal tract, and medicine distributes in the gastrointestinal tract large tracts of land, makes the absorption of medicine more abundant, so also helps improving bioavailability of medicament.
The 3rd taking convenience, good mouthfeel.The present invention needn't use water delivery service, and saliva can make its disintegrate or be partly dissolved, and mouthful in no foreign body sensation owing to wherein add suitable filler and the correctives cool taste sweet compliance that the patient takes medicine that helps improving of distinguishing the flavor of.This kind tablet can place the mouth water delivery service, also can be placed in the water and take after the disintegrate, can also directly place to swallow after the mouth disintegrate and take, for taking medicine, the patient provides very big convenience, compare with liquid preparation and have dosage advantage accurately, the present invention can guarantee that medicine is in time taken, dosage is accurate and curative effect is rapid.
The present invention preferably resolves deficiency of the prior art as gastrointestinal drug disintegrate and masking agents bitterness or disagreeable taste rapidly, to some old peoples, child or gulp down and be undoubtedly Gospel when the inconvenient patient of medicine takes medicine.This pharmaceutical dosage form is the compacting preparation with suitable stiffness, and its suitable stiffness is meant can disruptive enough hardness in preparation and transportation.When taking, medicine is contained in the mouth mustn't be moisture with regard to fully disintegrate in the oral cavity, and the time of its disintegrate just can finish in second about 1-40.The generation of above-mentioned effect be because, it is described: erythrose is the comparatively ideal filler of tablet, and is mobile, cohesive is all good, no hygroscopicity, the tablet that is pressed into is bright and clean attractive in appearance.Microcrystalline Cellulose plays dual parts to fill and disintegrate in this test recipe, it has spongiform porous tubular structured, during pressurized, loose structure is by disorderly and unsystematic and become linear array, plastic deformation in addition, make it meet water after, hydrone enters tablet inside, destroy the hydrogen bond between the crystallite, impel disintegration of tablet; Low-substituted hydroxypropyl cellulose L-HPC has good hygroscopicity, meets water-soluble expanding and microcrystalline Cellulose when being used, and can play the disintegrate effect of the best.Citric acid contacts low amounts of water with sodium bicarbonate just can produce a large amount of bubbles, has helped the disintegrate of tablet more.Saccharin sodium is the novel sweetener of white mealy crystal, and sugariness is 50 times of sucrose, and stable in properties is soluble in water, nonhygroscopic, is suitable for the correctives as medicine; Mentholum because of its have local anesthetic action shelter for bitterness also effective, so itself and saccharin sodium are share as correctives to reach the flavoring effect; Talcum is white, fine and smooth, light powder, and lubricity is strong, has good tack, and is unilateral bright and clean attractive in appearance, most widely used behind the tabletting.
The specific embodiment
Tramadol hydrochloride oral cavity disintegration tablet of the present invention contains principal agent, water-soluble filler, disintegrating agent, lubricant, also contains wetting agent or binding agent, the main materials and auxiliary materials weight share prescription in the total amount shared preferred proportion as follows:
Principal agent 20～40%
Water-soluble filler 20～60%
Disintegrating agent 10～60%
Lubricant 0.5～3%
Wetting agent 1～5%.
Preferred erythrose of water-soluble filler and mannitol.
Disintegrating agent preferably microcrystalline cellulose (MCC), low-substituted hydroxypropyl cellulose (L-HPC), citric acid and sodium bicarbonate.
The preferred cyclamate of correctives.
Wetting agent or binding agent preferred alcohol solution.
Lubricant preferably talc powder.
With following embodiment the present invention is described.
Embodiment 1: preparation tramadol hydrochloride oral cavity disintegration tablet
Prescription: 1000
| Component | Weight | Percentage by weight |
| Tramadol hydrochloride sweet mellow wine saccharin sodium microcrystalline cellulose L-HPC citric acid sodium acid carbonate talcum powder menthol | 50 grams, 100 grams, 1 gram, 96 grams, 12.6 grams, 6 grams, 2 grams, 2.7 grams, 0.4 gram | 18.47％ 36.94％ 0.37％ 35.46％ 4.65％ 2.22％ 0.74％ 1.00％ 0.15％ |
| Gross weight: | 270.7 gram | |
Preparation technology:
Take by weighing tramadol hydrochloride by recipe quantity, mannitol, saccharin sodium, citric acid, the part microcrystalline Cellulose, put into the mixer mixing, add 50% alcoholic solution as wetting agent, stirred 5 minutes, granulate with 40 mesh sieves, 50 ℃ ± 5 ℃ aeration-dryings, dried granule is crossed 40 mesh sieve granulate, particle weight done in record, and calculate with this and to add microcrystalline cellulose excipients, low-substituted hydroxypropyl cellulose, sodium bicarbonate, Pulvis Talci, the Mentholum consumption, by amount of calculation take by weighing add adjuvant and the abundant mix homogeneously of dried granule after, sample examination, qualified tabletting, two aluminum packings in the qualified back of finished product detection and dress box.
Embodiment 2: preparation tramadol hydrochloride oral cavity disintegration tablet
Prescription: 1000
| Component | Weight | Percentage by weight |
| Tramadol hydrochloride antierythrite saccharin sodium microcrystalline cellulose Ac-Di-Sol citric acid sodium acid carbonate dolomol menthol | 50 grams, 50 grams, 1 gram, 85.4 grams, 20 grams, 9 grams, 3 grams, 2.2 grams, 0.4 gram | 22.62％ 22.62％ 0.45％ 38.64％ 9.05％ 4.07％ 1.36％ 1.00％ 0.18％ |
| Gross weight: | 221 grams | |
Preparation technology:
Take by weighing tramadol hydrochloride by recipe quantity, erythritol, saccharin sodium, citric acid, the part microcrystalline Cellulose, put into the mixer mixing, add an amount of 5% polyvidone, 95% alcoholic solution, stirred 5 minutes, granulate with 40 mesh sieves, 50 ℃ ± 5 ℃ aeration-dryings, dried granule is crossed 40 mesh sieve granulate, and particle weight done in record, and calculates with this and to add microcrystalline cellulose excipients, low-substituted hydroxypropyl cellulose, sodium bicarbonate, magnesium stearate, the Mentholum consumption, by amount of calculation take by weighing add adjuvant and the abundant mix homogeneously of dried granule after, sample examination, qualified tabletting, two aluminum packings in the qualified back of finished product detection and dress box.
Embodiment 3: preparation tramadol hydrochloride oral cavity disintegration tablet
Prescription: 1000
| Component | Weight | Percentage by weight |
| Tramadol hydrochloride antierythrite saccharin sodium microcrystalline cellulose L-HPC citric acid sodium acid carbonate talcum powder dolomol menthol | 50 grams, 81.8 grams, 2 grams, 95.4 grams, 10.6 grams, 9 grams, 3 grams, 1 gram, 1 gram, 0.5 gram | 19.66％ 32.17％ 0.79％ 37.51％ 4.17％ 3.54％ 1.18％ 0.39％ 0.39％ 0.20％ |
| Gross weight: | 254.3 gram | |
Preparation technology:
Take by weighing tramadol hydrochloride by recipe quantity, erythritol, saccharin sodium, citric acid, the part microcrystalline Cellulose, put into the mixer mixing, add 50% alcoholic solution as wetting agent, stirred 5 minutes, granulate with 40 mesh sieves, 50 ℃ ± 5 ℃ aeration-dryings, dried granule is crossed 40 mesh sieve granulate, particle weight done in record, and calculate with this and to add microcrystalline cellulose excipients, low-substituted hydroxypropyl cellulose, sodium bicarbonate, Pulvis Talci, magnesium stearate, the Mentholum consumption, by amount of calculation take by weighing add adjuvant and the abundant mix homogeneously of dried granule after, sample examination, qualified tabletting, two aluminum packings in the qualified back of finished product detection and dress box.
Embodiment 4: preparation tramadol hydrochloride oral cavity disintegration tablet
Prescription: 1000
| Component | Weight | Percentage by weight |
| Tramadol hydrochloride antierythrite saccharin sodium microcrystalline cellulose L-HPC tartaric acid sodium acid carbonate talcum powder dolomol menthol | 50 grams, 25 grams, 2 grams, 95.4 grams, 14.6 grams, 9 grams, 3 grams, 0.5 gram, 0.5 gram, 0.5 gram | 24.94％ 12.47％ 1.00％ 47.58％ 7.28％ 4.49％ 1.50％ 0.25％ 0.25％ 0.25％ |
| Gross weight: | 200.5 gram | |
Preparation technology:
Take by weighing tramadol hydrochloride by recipe quantity, erythritol, saccharin sodium, tartaric acid, the part microcrystalline Cellulose, put into the mixer mixing, add 50% alcoholic solution as wetting agent, stirred 5 minutes, granulate with 40 mesh sieves, 50 ℃ ± 5 ℃ aeration-dryings, dried granule is crossed 40 mesh sieve granulate, particle weight done in record, and calculate with this and to add microcrystalline cellulose excipients, low-substituted hydroxypropyl cellulose, sodium bicarbonate, Pulvis Talci, magnesium stearate, the Mentholum consumption, by amount of calculation take by weighing add adjuvant and the abundant mix homogeneously of dried granule after, sample examination, qualified tabletting, two aluminum packings in the qualified back of finished product detection and dress box.
Embodiment 5: preparation tramadol hydrochloride oral cavity disintegration tablet
Prescription: 1000
| Component | Weight | Percentage by weight |
| Tramadol hydrochloride antierythrite saccharin sodium microcrystalline cellulose L-HPC tartaric acid sodium acid carbonate talcum powder dolomol menthol | 50 grams, 140 grams, 2 grams, 35 grams, 5 grams, 3 grams, 1.5 grams, 1 gram, 0.5 gram, 0.5 gram | 20.96％ 58.70％ 0.84％ 14.68％ 2.10％ 1.26％ 0.63％ 0.42％ 0.21％ 0.21％ |
| Gross weight: | 238.5 gram | |
Preparation technology:
Take by weighing tramadol hydrochloride by recipe quantity, erythritol, saccharin sodium, tartaric acid, the part microcrystalline Cellulose, put into the mixer mixing, add 50% alcoholic solution as wetting agent, stirred 5 minutes, granulate with 40 mesh sieves, 50 ℃ ± 5 ℃ aeration-dryings, dried granule is crossed 40 mesh sieve granulate, particle weight done in record, and calculate with this and to add microcrystalline cellulose excipients, low-substituted hydroxypropyl cellulose, sodium bicarbonate, Pulvis Talci, magnesium stearate, the Mentholum consumption, by amount of calculation take by weighing add adjuvant and the abundant mix homogeneously of dried granule after, sample examination, qualified tabletting, two aluminum packings in the qualified back of finished product detection and dress box.
Claims (3)
1, a kind of tramadol hydrochloride oral cavity disintegration tablet, tramadol hydrochloride, erythrose, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose and other adjuvants by effective dose are formed, and it is characterized in that weight share proportion in the prescription total amount is: tramadol hydrochloride 19.66～24.94%, erythrose 12.47～58.70%, microcrystalline Cellulose and low-substituted hydroxypropyl cellulose 16.78～54.86%.
2, tramadol hydrochloride oral cavity disintegration tablet according to claim 1 is characterized in that containing proper amount of lubricating agent, correctives, wetting agent or binding agent.
3, preparation method according to the described tramadol hydrochloride oral cavity disintegration tablet of claim 2, it is characterized in that weight share proportion in the prescription total amount takes by weighing tramadol hydrochloride, erythrose, saccharin sodium, tartaric acid, the part microcrystalline Cellulose, put into the mixer mixing, add 50% alcoholic solution as wetting agent, stirred 5 minutes, granulate with 40 mesh sieves, 50 ℃ ± 5 ℃ aeration-dryings, dried granule is crossed 40 mesh sieve granulate, particle weight done in record, and calculate with this and to add microcrystalline cellulose excipients, low-substituted hydroxypropyl cellulose, sodium bicarbonate, Pulvis Talci, magnesium stearate, the Mentholum consumption, by amount of calculation take by weighing add adjuvant and the abundant mix homogeneously of dried granule after, sample examination, qualified tabletting.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410005680 CN1279896C (en) | 2004-02-27 | 2004-02-27 | Tramadol hydrochloride oral disintegration tablets, and prepn. method therefor |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410005680 CN1279896C (en) | 2004-02-27 | 2004-02-27 | Tramadol hydrochloride oral disintegration tablets, and prepn. method therefor |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1559388A CN1559388A (en) | 2005-01-05 |
| CN1279896C true CN1279896C (en) | 2006-10-18 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200410005680 Expired - Lifetime CN1279896C (en) | 2004-02-27 | 2004-02-27 | Tramadol hydrochloride oral disintegration tablets, and prepn. method therefor |
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Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100335055C (en) * | 2005-04-29 | 2007-09-05 | 邢为藩 | Pitavastatin soluble tablet composition and preparation method thereof |
| JP5409382B2 (en) * | 2007-11-21 | 2014-02-05 | 大日本住友製薬株式会社 | Orally disintegrating tablets |
| CN102451164B (en) * | 2010-10-22 | 2015-11-25 | 量子高科（北京）研究院有限公司 | A kind of analgesic oral cavity disintegrating tablet and preparation method thereof |
| CN110101673A (en) * | 2019-05-07 | 2019-08-09 | 安徽金太阳生化药业有限公司 | A kind of preparation method of tramadol hydrochloride dispersible tablets |
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2004
- 2004-02-27 CN CN 200410005680 patent/CN1279896C/en not_active Expired - Lifetime
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| CN1559388A (en) | 2005-01-05 |
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Owner name: SYSCAN MICRO PHOTOELECTRIC TECHNOLOGY (SHENZHEN) C Free format text: FORMER NAME OR ADDRESS: SYSCAN MICRO PHOTOELECTRIC TECHNOLOGY (SHENZHEN) CO., LTD.; OUYI PHARMACEUTICAL INDUSTRY CO., LTD., SHIJIAZHUANG PHARMACEUTICAL GROUP |
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Address after: 050051 No. 276 West Zhongshan Road, Hebei, Shijiazhuang Co-patentee after: SHIJIAZHUANG OUYI PHARMA Co.,Ltd. Patentee after: CSPC ZHONGQI PHARMACEUTICAL TECHNOLOGY (SHIJIAZHUANG) Co.,Ltd. Address before: 050051 No. 276 West Zhongshan Road, Hebei, Shijiazhuang Co-patentee before: Shijiazhuang Pharmaceutical Group Ouyl Pharma. Co.,Ltd. Patentee before: CSPC ZHONGQI PHARMACEUTICAL TECHNOLOGY (SHIJIAZHUANG) Co.,Ltd. |
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Granted publication date: 20061018 |
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