CN1806800A - Pharmaceutical composition making pregabalin as active ingredient, its preparation method and uses - Google Patents
Pharmaceutical composition making pregabalin as active ingredient, its preparation method and uses Download PDFInfo
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- CN1806800A CN1806800A CN 200610007943 CN200610007943A CN1806800A CN 1806800 A CN1806800 A CN 1806800A CN 200610007943 CN200610007943 CN 200610007943 CN 200610007943 A CN200610007943 A CN 200610007943A CN 1806800 A CN1806800 A CN 1806800A
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- lyrica
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- active component
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Abstract
The invention relates to a medicinal composition with pregabalin as the active constituent, its preparing process and use, which comprises pregabalin as the medicinal active constituent, as well as pharmaceutically acceptable auxiliary materials, The composition can be used for treating peripheral nerve pain and epilepsy, and can be prepared into the forms of tablets, capsules, dispersible tablets, granules, soft capsules, chewable tablets, buccal tablets, buccal tablets or other oral preparations.
Description
Technical field
The present invention relates to a kind of is Pharmaceutical composition and preparation method thereof, the purposes of active component with the lyrica, belongs to medical technical field.
Background technology
Epilepsy is the discharge of cerebral neuron paroxysmal abnormality, causes a kind of chronic disease of of short duration cerebral disorder.Owing to the related position difference of paradoxical discharge neuron, can show as motion, sensation, vegetative nerve, consciousness and the mental disorder of outbreak.It is one of clinical common symptom of causing of multiple reason.According to domestic Epidemiological study, its sickness rate is about crowd's 1 ‰, and prevalence is about crowd's 5 ‰.
The chemical name of lyrica is that (3S)-3-(Aminomethyl)-its chemical structural formula of 5-methylhexanoic acid is
Experiment finds that lyrica can combine with the α 2 γ-subunit gabapentin binding site on the calcium channel, increases neuron γ-GABA content.In the experiment of the synapse cornea of the neural cortex of rat, this medicine can suppress the activity of casein kinase, obviously strengthens with respect to gabapentin, can strengthen the activity of glutamate decarboxylase simultaneously.This chemical compound all shows antiepileptic pharmaceutically active in many animal epileptic models.Its effect is similar with gabapentin, but dosage than the low 3-10 of gabapentin doubly, and acting duration is the former 2 times.
In addition, this medicine is studies show that aspect the treatment neuropathic pain, in the mouse model of various neuropathic pains, comprise intrathecal injection P-or-NMDA neuronal acceptor, carrageenin and the inductive pain model of formalin, the lenitive effect of lyrica is 2 times of gabapentin at least, but does not have sedation.
As psychotherapeutic drugs, lyrica all has therapeutical effect preferably to generalization anxiety, social anxiety, bipolar imbalance, terrified etc., and rapid-action, safety is good, has research and development and is worth.
Summary of the invention
Having the purpose of this invention is to provide a kind of is the Pharmaceutical composition and uses thereof of active component with the lyrica.The present invention for a kind of be the Pharmaceutical composition of active component with the lyrica, it is characterized in that it is the active component that lyrica forms, the Pharmaceutical composition that forms with mixing acceptable accessories.
Above-mentioned a kind of be the Pharmaceutical composition of active component with the lyrica, it is characterized in that the consumption of described lyrica is 5mg-900mg for per unit dosage.
Above-mentioned a kind of be the Pharmaceutical composition of active component with the lyrica, it is characterized in that the consumption of described lyrica is preferably 10mg-600mg for per unit dosage.
Above-mentioned a kind of be the Pharmaceutical composition of active component with the lyrica, it is characterized in that the consumption of described lyrica is preferably 25mg-300mg more of per unit dosage.
Described a kind of be the Pharmaceutical composition of active component with the lyrica, it is characterized in that the Pharmaceutical composition of described lyrica is an oral formulations.
Described a kind of be the Pharmaceutical composition of active component with the lyrica, it is characterized in that described oral formulations can be made into tablet, capsule, dispersible tablet, soft capsule, chewable tablet, oral cavity disintegration tablet, buccal tablet, drop pill etc.
Described a kind of be the Pharmaceutical composition of active component with the lyrica, can be used for the treatment of peripheral nervous pain and epilepsy partial seizure.
The specific embodiment
Come lyrica preparation of the present invention done further specifying by following example, but be not limited in following example.
Embodiment 1 lyrica tablet
Prescription:
| Component | Consumption |
| Lyrica microcrystalline cellulose pregelatinized starch CMS-Na superfine silica gel powder dolomol 95% ethanol is made altogether | An amount of 1000 of 25g 60g 30g 5.0g 2.5g 2.5g |
Preparation method:
Guo 80 mesh sieves with lyrica, microcrystalline Cellulose, pregelatinized Starch, behind the mix homogeneously, add 95% ethanol and make soft material in right amount, 20 mesh sieves are granulated, drying, 18 mesh sieve granulate, add CMS-Na, micropowder silica gel, magnesium stearate, adopt suitable punch die compressed tablets behind the mix homogeneously, promptly.
Embodiment 2: the lyrica capsule
Prescription:
| Component | Consumption |
| Lyrica starch | 50g 30g |
| Dextrin 5%PVP-k 30 alcoholic solution PPVP Pulvis Talci | An amount of 2.0g 2.0g of 10g |
Preparation method:
Lyrica, starch, dextrin are crossed 80 mesh sieves respectively, behind the mix homogeneously, add 5%PVP-k 30 alcoholic solution (about 60 milliliters) and make soft material in right amount, 24 mesh sieves are granulated, drying, 24 mesh sieve granulate, the PPVP, the Pulvis Talci that add recipe quantity, in the suitable capsule shells of packing into behind the mix homogeneously promptly.
Embodiment 3: the lyrica dispersible tablet
Prescription:
| Component | Consumption |
| Lyrica microcrystalline cellulose sweet mellow wine CMS-Na PPVP lemon extract Aspartame talcum powder 50% ethanol is made altogether | An amount of 1000 of 75g 80g 120 18g 3g 6g 3g 2.5g |
Preparation method:
Lyrica, microcrystalline Cellulose, mannitol are crossed 80 mesh sieves respectively, behind the mix homogeneously, add 50% alcoholic solution and make soft material in right amount, 24 mesh sieves are granulated, drying, 20 mesh sieve granulate add disintegrating agent CMS-Na, PPVP, Fructus Citri Limoniae essence, aspartame, Pulvis Talci, tabletting behind the mix homogeneously, promptly.
Embodiment 4: the lyrica soft capsule
Prescription:
| Component | Consumption |
| Lyrica soybean oil tween 80 lecithin Cera Flava is made altogether | 1000 of 100g 150g 15g 5g 2.5g |
Preparation method:
Earlier lyrica is pulverized, crossed 200 mesh sieves, join in the recipe quantity soybean oil and stir, add tween 80, lecithin while stirring, evenly the back adds in 60-70 ℃ of fused Cera Flava, makes it to obtain the oil solution of even suspendible.Adjust content weight, the compacting soft capsule, promptly.
Embodiment 5: the lyrica chewable tablet
Prescription
| Component | Consumption |
| The sweet flavoring orange essence 1%PVP-K30 of lyrica xylitol sorbierite sweet mellow wine A Siba ethanolic solution is made altogether | An amount of 1000 of 125g 140g 60g 60g 6g 8g |
Preparation method:
To all cross lyrica, xylitol, sorbitol, the mannitol mix homogeneously of 80 mesh sieves, with 1%PVP-K30 alcoholic solution system soft material, 16 mesh sieves are granulated, and dry, 12 mesh sieve granulate add sweet, the flavoring orange essence of A Siba, mix homogeneously, and tabletting gets final product.
Embodiment 6: the lyrica oral cavity disintegration tablet
Prescription
| Component | Consumption |
| Lyrica microcrystalline Cellulose PPVP L-HPC stevioside Fructus Citri Limoniae essence | 150g 158g 24.5g 10.5g 3.5g 3.5g |
| Dehydrated alcohol is made altogether | An amount of 1000 |
Preparation method:
After all crossing the lyrica, microcrystalline Cellulose mix homogeneously of 80 mesh sieves, with an amount of ethanol solution system soft material, the granulation of 16 mesh sieves, drying, 12 mesh sieve granulate add PPVP, L-HPC, stevioside, Fructus Citri Limoniae essence, mix homogeneously, adjust pressure, tabletting gets final product.
Embodiment 7: the lyrica buccal tablet
Prescription
| Component | Consumption |
| Lyrica sweet mellow wine xylitol stevioside menthol sunset yellow 95% ethanol is made altogether | An amount of 1000 of 300g 150g 40g 5g 5g |
Preparation method:
To all cross lyrica, mannitol, the xylitol mix homogeneously of 80 mesh sieves, with the 95% alcoholic solution system soft material that is dissolved with sunset yellow, 16 mesh sieves are granulated, and dry, 12 mesh sieve granulate add recipe quantity stevioside, Mentholum, mix homogeneously, and tabletting gets final product.
Embodiment 8: the lyrica drop pill
Prescription
| Component | Consumption |
| Lyrica PEG4000 S-40 makes altogether | 1000 of 100g 150g 40g |
Preparation method:
Lyrica is crossed 80 mesh sieves, standby; In addition with PEG4000, S-40 mixings post-heating extremely about 60 ℃ make fusion; Lyrica is heated in the fused solution stirs, move in the dropping funnel, be incubated about 60 ℃, regulate the water dropper size, serves as the cooling phase with-20 ℃ dimethicones, the system of dripping, and ball is washed, selects in filtration, gets final product.
Claims (7)
- The present invention for a kind of be the Pharmaceutical composition of active component with the lyrica, it is characterized in that it is to be medicinal active ingredient with the lyrica, the Pharmaceutical composition that forms with mixing acceptable accessories.
- 2. as claimed in claim 1 a kind of be the Pharmaceutical composition of active component with the lyrica, it is characterized in that the consumption of described lyrica is 5mg-900mg for per unit dosage.
- 3. as claimed in claim 1 a kind of be the Pharmaceutical composition of active component with the lyrica, it is characterized in that the consumption of described lyrica is preferably 10mg-600mg for per unit dosage.
- 4. as claimed in claim 1 a kind of be the Pharmaceutical composition of active component with the lyrica, it is characterized in that the consumption of described lyrica is preferably 25mg-300mg more of per unit dosage.
- 5. as claimed in claim 1 a kind of be the Pharmaceutical composition of active component with the lyrica, it is characterized in that the Pharmaceutical composition of described lyrica is an oral formulations.
- 6. as claimed in claim 5 a kind of be the Pharmaceutical composition of active component with the lyrica, it is characterized in that described oral formulations can be made into tablet, capsule, dispersible tablet, granule, soft capsule, chewable tablet, oral cavity disintegration tablet, buccal tablet, drop pill etc.
- Claim 1-6 described a kind of be the Pharmaceutical composition of active component with the lyrica, can be used for the treatment of peripheral nervous pain and epilepsy partial seizure.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610007943 CN1806800A (en) | 2006-02-23 | 2006-02-23 | Pharmaceutical composition making pregabalin as active ingredient, its preparation method and uses |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610007943 CN1806800A (en) | 2006-02-23 | 2006-02-23 | Pharmaceutical composition making pregabalin as active ingredient, its preparation method and uses |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1806800A true CN1806800A (en) | 2006-07-26 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200610007943 Pending CN1806800A (en) | 2006-02-23 | 2006-02-23 | Pharmaceutical composition making pregabalin as active ingredient, its preparation method and uses |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1806800A (en) |
Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102465157A (en) * | 2010-11-04 | 2012-05-23 | 浙江九洲药业股份有限公司 | Preparation of pregabalin chiral intermediate with bio-enzyme method |
| CN103271888A (en) * | 2013-06-18 | 2013-09-04 | 上海奥科达生物医药科技有限公司 | Pregabalin orally disintegrating tablet and dispersible tablet and preparation method thereof |
| CN103494796A (en) * | 2013-09-30 | 2014-01-08 | 浙江华义医药有限公司 | Stable pharmaceutical composition of pregabalin and preparation method thereof |
| CN105055371A (en) * | 2015-07-15 | 2015-11-18 | 江苏阿尔法药业有限公司 | Oral pregabalin preparation |
| CN109125287A (en) * | 2018-10-25 | 2019-01-04 | 千辉药业（安徽）有限责任公司 | A kind of Pregabalin tablet and preparation method thereof |
| WO2019146642A1 (en) * | 2018-01-24 | 2019-08-01 | 大原薬品工業株式会社 | METHOD FOR IMPROVING CHEMICAL STABILITY OF γ-AMINOBUTYRIC ACID DERIVATIVE- CONTAINING TABLET |
| JP2019142834A (en) * | 2017-07-31 | 2019-08-29 | 大原薬品工業株式会社 | Solid formulations containing pregabalin and suitable excipients |
| CN112107550A (en) * | 2019-06-19 | 2020-12-22 | 北京万全德众医药生物技术有限公司 | Pregabalin orally disintegrating tablet preparation and preparation method thereof |
| CN112121020A (en) * | 2019-06-24 | 2020-12-25 | 北京万全德众医药生物技术有限公司 | Preparation method of pregabalin orally disintegrating tablet |
| CN115581686A (en) * | 2022-10-20 | 2023-01-10 | 成都恒瑞制药有限公司 | Preparation method of pregabalin capsule and pregabalin capsule |
-
2006
- 2006-02-23 CN CN 200610007943 patent/CN1806800A/en active Pending
Cited By (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102465157B (en) * | 2010-11-04 | 2014-11-26 | 浙江九洲药业股份有限公司 | Preparation of pregabalin chiral intermediate with bio-enzyme method |
| CN102465157A (en) * | 2010-11-04 | 2012-05-23 | 浙江九洲药业股份有限公司 | Preparation of pregabalin chiral intermediate with bio-enzyme method |
| CN103271888A (en) * | 2013-06-18 | 2013-09-04 | 上海奥科达生物医药科技有限公司 | Pregabalin orally disintegrating tablet and dispersible tablet and preparation method thereof |
| CN103494796A (en) * | 2013-09-30 | 2014-01-08 | 浙江华义医药有限公司 | Stable pharmaceutical composition of pregabalin and preparation method thereof |
| CN103494796B (en) * | 2013-09-30 | 2016-01-20 | 浙江华义医药有限公司 | Pharmaceutical composition that lyrica is stable and preparation method thereof |
| CN105055371A (en) * | 2015-07-15 | 2015-11-18 | 江苏阿尔法药业有限公司 | Oral pregabalin preparation |
| JP2019142834A (en) * | 2017-07-31 | 2019-08-29 | 大原薬品工業株式会社 | Solid formulations containing pregabalin and suitable excipients |
| JPWO2019146642A1 (en) * | 2018-01-24 | 2020-12-10 | 大原薬品工業株式会社 | How to improve the chemical stability of tablets containing γ-aminobutyric acid derivatives |
| WO2019146642A1 (en) * | 2018-01-24 | 2019-08-01 | 大原薬品工業株式会社 | METHOD FOR IMPROVING CHEMICAL STABILITY OF γ-AMINOBUTYRIC ACID DERIVATIVE- CONTAINING TABLET |
| JP7138666B2 (en) | 2018-01-24 | 2022-09-16 | 大原薬品工業株式会社 | METHOD FOR IMPROVING CHEMICAL STABILITY OF TABLETS CONTAINING γ-AMINOBUTYRIC ACID DERIVATIVES |
| CN109125287A (en) * | 2018-10-25 | 2019-01-04 | 千辉药业（安徽）有限责任公司 | A kind of Pregabalin tablet and preparation method thereof |
| CN112107550A (en) * | 2019-06-19 | 2020-12-22 | 北京万全德众医药生物技术有限公司 | Pregabalin orally disintegrating tablet preparation and preparation method thereof |
| CN112121020A (en) * | 2019-06-24 | 2020-12-25 | 北京万全德众医药生物技术有限公司 | Preparation method of pregabalin orally disintegrating tablet |
| CN115581686A (en) * | 2022-10-20 | 2023-01-10 | 成都恒瑞制药有限公司 | Preparation method of pregabalin capsule and pregabalin capsule |
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Open date: 20060726 |