CN1228045C - Fast collapsed and fast dissolved preparation for oral cavity and producing method - Google Patents
Fast collapsed and fast dissolved preparation for oral cavity and producing method Download PDFInfo
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- CN1228045C CN1228045C CN 200310107658 CN200310107658A CN1228045C CN 1228045 C CN1228045 C CN 1228045C CN 200310107658 CN200310107658 CN 200310107658 CN 200310107658 A CN200310107658 A CN 200310107658A CN 1228045 C CN1228045 C CN 1228045C
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- levalbuterol
- mannitol
- lactose
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Abstract
The present invention relates to the field of medicine preparation, and provides a preparation and a preparation method thereof. The preparation is rapidly disintegrated or dissolved in the oral cavity. The present invention takes Eudragit E-100, lactose, mannitol, low-replaced hyprolose, magnesium stearate and menthol as materials, adopts a wet granulating and tabletting method, and respectively takes salbutamol, salbutamol sulphate, salbutamol, and hydrochloride, sulfate, tartrate, oxalate, citrate, maleate, etc. of salbutamol as medicine. All the materials are made into tablets which are rapidly disintegrated and dissolved in the oral cavity. The present invention does not need particular apparatuses, adopts a common tabletting machine, and has the advantages of simple technology and low cost.
Description
Technical field: the present invention relates to field of medicine preparations, belong to the rapid release drug-supplying system, be oral rapidly disintegrating, rapid-dissolve tablet formulations and preparation method thereof.
Background technology: oral cavity quick disintegrating slice (also being oral instant-dissolving tablet) is a kind of novel dosage form that emerges rapidly in the medicament field in recent years.It has taking convenience, it is fast to absorb, bioavailability is high and to advantages such as the effect of digestive tract mucous membrane irritation are little.Water can not needed when taking, disintegrate rapidly in the 15s in the oral cavity.Though the lyophilization sheet is comparatively ripe in numerous preparation technologies, too high, the complex process of cost is very strict to the requirement of preparation condition, is difficult to be suitable for the reality of domestic pharmacy.At present oral rapidly disintegrating, instant preparation forward cost direction low, that technology is simple, mouthfeel good, quality is high develop.
Summary of the invention: for the cost that solves instant of present production oral rapidly disintegrating too high, complex process, to the very strict problem of the requirement of preparation condition, development and design of the present invention a kind of fast at Orally disintegrating or dissolving preparation and preparation method thereof, medicine is selected from albuterol, salbutamol sulfate, Levalbuterol, Levalbuterol hydrochloride, Levalbuterol sulfate, the Levalbuterol tartrate, the Levalbuterol oxalates, the Levalbuterol citrate, a kind of in the Levalbuterol maleate, with Eudragit E-100, lactose, mannitol, low-substituted hydroxypropyl cellulose, magnesium stearate, Mentholum is a pharmaceutic adjuvant, medicine and Eudragit E-100, lactose, mannitol, low-substituted hydroxypropyl cellulose, magnesium stearate, the proportioning of these pharmaceutic adjuvants of Mentholum is 1: 0.2～1.5: 20～100: 10～60: 1.0～5.0: 0.2～1.0: 0.4～2.0, utilize common tablet machine, by control process parameters, make instant of oral rapidly disintegrating.Its preparation method adopts the wet granule compression tablet method, the first step at first is dissolved in Eudragit E-100 that to make concentration in the dehydrated alcohol be 100mg/ml～300mg/ml, add medicine by proportioning then and stir coating fast, and in 20 ℃～50 ℃ dryings, it is stand-by that porphyrize is crossed 80 mesh sieves, second step crossed 80 mesh sieve mixings with the lactose and the mannitol of proportional quantity, the Mentholum ethanol solution 80mg/ml～120mg/ml that adds proportional quantity stirs, mixing, stand-by in 30 ℃～50 ℃ oven dry, the 3rd step is with the first and second step gains mix homogeneously, adding an amount of distilled water mixes, granulate with 16 mesh sieves, the granule that makes is tiled in stainless steel disc immediately puts into the baking oven baking 20～40 minutes that is warming up to 40 ℃～60 ℃, the 4th step will be dried by the fire good granule and be put to room temperature, behind the granulate, add the low-substituted hydroxypropyl cellulose and the magnesium stearate mixing of proportional quantity, select the suitable low pressure tabletting that dashes for use, with the sheet of being pressed be put in stainless steel disc 30 ℃～50 ℃ down baking promptly got instant of oral rapidly disintegrating in 3-6 hour.The mouthfeel that this oral rapidly disintegrating is instant is good, and disintegration time is at 15-30 between second.
The present invention is Orally disintegrating, solution tablet preparation, and it is main adopting water soluble adjuvant, and said preparation is disintegrate and the most of dissolving of adjuvant rapidly when running into saliva.After the medicine liquefy, with the natural swallowing act of human body, follow the saliva clothes down, need not drink water good mouthfeel, no sand feeling and bitterness sense.This tablet is taken medicine to some function of deglutition patient bad and water intaking inconvenience convenience is provided.Adopt the wet granule compression tablet method, utilize common tablet machine, the simple cost of technology is low, has vast market prospect.
Description of drawings:
Fig. 1 is a dissolution comparison diagram in instant of Levalbuterol oral rapidly disintegrating and the Levalbuterol ordinary tablet water;
Fig. 2 is a dissolution comparison diagram in instant of Levalbuterol oral rapidly disintegrating and the Levalbuterol ordinary tablet hydrochloric acid.
The specific embodiment:
Embodiment 1: the preparation that the Levalbuterol oral rapidly disintegrating is instant
Get Levalbuterol 1.25g, Eudragit E-100 0.5g, earlier Eudragit E-100 is dissolved in that to make concentration in the dehydrated alcohol be 100mg/ml～300mg/ml, add Levalbuterol then and stir coating fast, and in 40 ℃ of dryings, it is stand-by that porphyrize is crossed 80 mesh sieves, second step: get lactose 29.6g, mannitol 35.8g crosses 80 mesh sieve mixings; get Mentholum 1.0g; add 10ml absolute ethyl alcohol and stirring dissolving; the ethanol solution 100mg/ml of Mentholum is joined in the mixture of lactose and mannitol and stir; mixing, and is stand-by in 40 ℃ of oven dry, the 3rd step: with the first and second step gains mix homogeneously; add an amount of distilled water and mix; granulate with 16 mesh sieves, the granule that makes is tiled in stainless steel disc immediately puts into the baking oven baking 30 minutes that is warming up to 50 ℃, the 4th step: will dry by the fire granule well and put to room temperature; behind the granulate, adding 2.5g low-substituted hydroxypropyl cellulose and 0.5g magnesium stearate mixing.Select for use 6.0mm towards the low pressure tabletting, the sheet of being pressed is put in stainless steel disc dries by the fire 4 hours down promptly at 50 ℃.
Through the volunteer oral test, disintegration time is between the 15-30S in the oral cavity, and mouthfeel does not have bitterness well.Pharmacopeia disintegration inspection method improved method: (2000 editions two appendix XA of Chinese Pharmacopoeia) do not add jolting, survey its disintegration time between 15-25 S.
Get instant of Levalbuterol oral rapidly disintegrating, press dissolution method (2000 editions two appendix XC three therapeutic methods of traditional Chinese medicine of Chinese Pharmacopoeia), be dissolution medium with water, hydrochloric acid 0.1mol/l solution 100ml respectively, 100 rev/mins of rotating speeds, measure the drug release situation by medicine intelligence dissolution test instrument (Radio Factory of Tianjin Univ.'s product), the results are shown in Figure 1, Fig. 2, show that instant of Levalbuterol oral rapidly disintegrating compares with ordinary tablet and have tangible rapid release characteristic, can discharge at stomach, intestinal rapidly after medicine enters in the body and produce drug effect.
Embodiment 2: the preparation that the albuterol oral rapidly disintegrating is instant
Get albuterol 2.4g, Eudragit E-100 1.2g, earlier EudragitE-100 is dissolved in that to make concentration in the dehydrated alcohol be 100mg/ml～300mg/ml, add albuterol then and stir coating fast, and in 40 ℃ of dryings, it is stand-by that porphyrize is crossed 80 mesh sieves, second step: get lactose 44.5g, mannitol 30.8g crosses 80 mesh sieve mixings, gets Mentholum 1.2g, adds the dissolving of 10ml absolute ethyl alcohol and stirring.The ethanol solution (100mg/ml) of Mentholum is joined in the mixture of lactose and mannitol stir, mixing, stand-by in 40 ℃ of oven dry, the 3rd step: with the first and second step gains mix homogeneously, adding an amount of distilled water mixes, granulate with 16 mesh sieves, the granule that makes is tiled in stainless steel disc immediately puts into the baking oven baking 30 minutes that is warming up to 50 ℃, the 4th step: will dry by the fire good granule and put to room temperature, behind the granulate, add 3.8g low-substituted hydroxypropyl cellulose and 0.7g magnesium stearate mixing.Select for use 6.0mm towards the low pressure tabletting, the sheet of being pressed is put in stainless steel disc dries by the fire 4 hours down promptly at 50 ℃.
Through the volunteer oral test, disintegration time is between the 15-30S in the oral cavity, and mouthfeel does not have bitterness well.Pharmacopeia disintegration inspection method improved method: (2000 editions two appendix XA of Chinese Pharmacopoeia) do not add jolting, survey its disintegration time between 15-25 S.
Get instant of albuterol oral rapidly disintegrating, press dissolution method (2000 editions two appendix XC three therapeutic methods of traditional Chinese medicine of Chinese Pharmacopoeia), be dissolution medium with water, hydrochloric acid 0.1mol/l solution 100ml respectively, 100 rev/mins of rotating speeds, measure the drug release situation by medicine intelligence dissolution test instrument (Radio Factory of Tianjin Univ.'s product), the result shows that instant of albuterol oral rapidly disintegrating compares with ordinary tablet and have tangible rapid release characteristic, can discharge at stomach, intestinal rapidly after medicine enters in the body to produce drug effect.
Embodiment 3: Levalbuterol hydrochloride orally collapses instant preparation
Get albuterol hydrochloride 1.25g, Eudragit E-100 0.5g, earlier Eudragit E-100 is dissolved in that to make concentration in the dehydrated alcohol be 100mg/ml～300mg/ml, add Levalbuterol then and stir coating fast, and in 40 ℃ of dryings, it is stand-by that porphyrize is crossed 80 mesh sieves, second step: get lactose 29.6g, mannitol 35.8g crosses 80 mesh sieve mixings; get Mentholum 1.0g; add 10ml absolute ethyl alcohol and stirring dissolving; the ethanol solution 100mg/ml of Mentholum is joined in the mixture of lactose and mannitol and stir; mixing, and is stand-by in 40 ℃ of oven dry, the 3rd step: with the first and second step gains mix homogeneously; add an amount of distilled water and mix; granulate with 16 mesh sieves, the granule that makes is tiled in stainless steel disc immediately puts into the baking oven baking 30 minutes that is warming up to 50 ℃, the 4th step: will dry by the fire granule well and put to room temperature; behind the granulate, adding 2.5g low-substituted hydroxypropyl cellulose and 0.5g magnesium stearate mixing.Select for use 6.0mm towards the low pressure tabletting, the sheet of being pressed is put in stainless steel disc dries by the fire 4 hours down promptly at 50 ℃.
Embodiment 4: the preparation that sulphuric acid Levalbuterol oral rapidly disintegrating is instant
Get sulphuric acid Levalbuterol 1.25g, Eudragit E-100 0.5g, earlier Eudragit E-100 is dissolved in that to make concentration in the dehydrated alcohol be 100mg/ml～300mg/ml, add Levalbuterol then and stir coating fast, and in 40 ℃ of dryings, it is stand-by that porphyrize is crossed 80 mesh sieves, second step: get lactose 29.6g, mannitol 35.8g crosses 80 mesh sieve mixings; get Mentholum 1.0g; add 10ml absolute ethyl alcohol and stirring dissolving; the ethanol solution 100mg/ml of Mentholum is joined in the mixture of lactose and mannitol and stir; mixing, and is stand-by in 40 ℃ of oven dry, the 3rd step: with the first and second step gains mix homogeneously; add an amount of distilled water and mix; granulate with 16 mesh sieves, the granule that makes is tiled in stainless steel disc immediately puts into the baking oven baking 30 minutes that is warming up to 50 ℃, the 4th step: will dry by the fire granule well and put to room temperature; behind the granulate, adding 2.5g low-substituted hydroxypropyl cellulose and 0.5g magnesium stearate mixing.Select for use 6.0mm towards the low pressure tabletting, the sheet of being pressed is put in stainless steel disc dries by the fire 4 hours down promptly at 50 ℃.
Embodiment 5: the preparation that tartaric acid Levalbuterol oral rapidly disintegrating is instant
Get tartaric acid Levalbuterol 1.25g, Eudragit E-100 0.5g, earlier Eudragit E-100 is dissolved in that to make concentration in the dehydrated alcohol be 100mg/ml～300mg/ml, add Levalbuterol then and stir coating fast, and in 40 ℃ of dryings, it is stand-by that porphyrize is crossed 80 mesh sieves, second step: get lactose 29.6g, mannitol 35.8g crosses 80 mesh sieve mixings; get Mentholum 1.0g; add 10ml absolute ethyl alcohol and stirring dissolving; the ethanol solution 100mg/ml of Mentholum is joined in the mixture of lactose and mannitol and stir; mixing, and is stand-by in 40 ℃ of oven dry, the 3rd step: with the first and second step gains mix homogeneously; add an amount of distilled water and mix; granulate with 16 mesh sieves, the granule that makes is tiled in stainless steel disc immediately puts into the baking oven baking 30 minutes that is warming up to 50 ℃, the 4th step: will dry by the fire granule well and put to room temperature; behind the granulate, adding 2.5g low-substituted hydroxypropyl cellulose and 0.5g magnesium stearate mixing.Select for use 6.0mm towards the low pressure tabletting, the sheet of being pressed is put in stainless steel disc dries by the fire 4 hours down promptly at 50 ℃.
Embodiment 6: the preparation that oxalic acid Levalbuterol oral rapidly disintegrating is instant
Get oxalic acid Levalbuterol 1.25g, Eudragit E-100 0.5g, earlier Eudragit E-100 is dissolved in that to make concentration in the dehydrated alcohol be 100mg/ml～300mg/ml, add Levalbuterol then and stir coating fast, and in 40 ℃ of dryings, it is stand-by that porphyrize is crossed 80 mesh sieves, second step: get lactose 29.6g, mannitol 35.8g crosses 80 mesh sieve mixings; get Mentholum 1.0g; add 10ml absolute ethyl alcohol and stirring dissolving; the ethanol solution 100mg/ml of Mentholum is joined in the mixture of lactose and mannitol and stir; mixing, and is stand-by in 40 ℃ of oven dry, the 3rd step: with the first and second step gains mix homogeneously; add an amount of distilled water and mix; granulate with 16 mesh sieves, the granule that makes is tiled in stainless steel disc immediately puts into the baking oven baking 30 minutes that is warming up to 50 ℃, the 4th step: will dry by the fire granule well and put to room temperature; behind the granulate, adding 2.5g low-substituted hydroxypropyl cellulose and 0.5g magnesium stearate mixing.Select for use 6.0mm towards the low pressure tabletting, the sheet of being pressed is put in stainless steel disc dries by the fire 4 hours down promptly at 50 ℃.
Embodiment 7: the preparation that citric acid Levalbuterol oral rapidly disintegrating is instant
Get citric acid Levalbuterol 1.25g, Eudragit E-100 0.5g, earlier Eudragit E-100 is dissolved in that to make concentration in the dehydrated alcohol be 100mg/ml～300mg/ml, add Levalbuterol then and stir coating fast, and in 40 ℃ of dryings, it is stand-by that porphyrize is crossed 80 mesh sieves, second step: get lactose 29.6g, mannitol 35.8g crosses 80 mesh sieve mixings; get Mentholum 1.0g; add 10ml absolute ethyl alcohol and stirring dissolving; the ethanol solution 100mg/ml of Mentholum is joined in the mixture of lactose and mannitol and stir; mixing, and is stand-by in 40 ℃ of oven dry, the 3rd step: with the first and second step gains mix homogeneously; add an amount of distilled water and mix; granulate with 16 mesh sieves, the granule that makes is tiled in stainless steel disc immediately puts into the baking oven baking 30 minutes that is warming up to 50 ℃, the 4th step: will dry by the fire granule well and put to room temperature; behind the granulate, adding 2.5g low-substituted hydroxypropyl cellulose and 0.5g magnesium stearate mixing.Select for use 6.0mm towards the low pressure tabletting, the sheet of being pressed is put in stainless steel disc dries by the fire 4 hours down promptly at 50 ℃.
Embodiment 8: the preparation that maleic acid levo albuterol oral rapidly disintegrating is instant
Get maleic acid levo albuterol 1.25g, Eudragit E-100 0.5g, earlier Eudragit E-100 is dissolved in that to make concentration in the dehydrated alcohol be 100mg/ml～300mg/ml, add Levalbuterol then and stir coating fast, and in 40 ℃ of dryings, it is stand-by that porphyrize is crossed 80 mesh sieves, second step: get lactose 29.6g, mannitol 35.8g crosses 80 mesh sieve mixings; get Mentholum 1.0g; add 10ml absolute ethyl alcohol and stirring dissolving; the ethanol solution 100mg/ml of Mentholum is joined in the mixture of lactose and mannitol and stir; mixing, and is stand-by in 40 ℃ of oven dry, the 3rd step: with the first and second step gains mix homogeneously; add an amount of distilled water and mix; granulate with 16 mesh sieves, the granule that makes is tiled in stainless steel disc immediately puts into the baking oven baking 30 minutes that is warming up to 50 ℃, the 4th step: will dry by the fire granule well and put to room temperature; behind the granulate, adding 2.5g low-substituted hydroxypropyl cellulose and 0.5g magnesium stearate mixing.Select for use 6.0mm towards the low pressure tabletting, the sheet of being pressed is put in stainless steel disc dries by the fire 4 hours down promptly at 50 ℃.
Embodiment 9: the preparation that the salbutamol sulfate oral rapidly disintegrating is instant
Get salbutamol sulfate 2.4g, Eudragit E-100 1.2g, earlier Eudragit E-100 is dissolved in that to make concentration in the dehydrated alcohol be 100mg/ml～300mg/ml, add albuterol then and stir coating fast, and in 40 ℃ of dryings, it is stand-by that porphyrize is crossed 80 mesh sieves, second step: get lactose 44.5g, mannitol 30.8g crosses 80 mesh sieve mixings, gets Mentholum 1.2g, adds the dissolving of 10ml absolute ethyl alcohol and stirring.The ethanol solution 100mg/ml of Mentholum is joined in the mixture of lactose and mannitol stir, mixing, stand-by in 40 ℃ of oven dry, the 3rd step: with the first and second step gains mix homogeneously, adding an amount of distilled water mixes, granulate with 16 mesh sieves, the granule that makes is tiled in stainless steel disc immediately puts into the baking oven baking 30 minutes that is warming up to 50 ℃, the 4th step: will dry by the fire the granule of getting well and put to room temperature, behind the granulate, add 3.8g low-substituted hydroxypropyl cellulose and 0.7g magnesium stearate mixing.Select for use 6.0mm towards the low pressure tabletting, the sheet of being pressed is put in stainless steel disc dries by the fire 4 hours down promptly at 50 ℃.
Claims (1)
1. oral rapidly disintegrating rapid-dissolve tablet formulations, medicine is selected from albuterol, salbutamol sulfate, Levalbuterol, Levalbuterol hydrochloride, Levalbuterol sulfate, the Levalbuterol tartrate, the Levalbuterol oxalates, the Levalbuterol citrate, a kind of in the Levalbuterol maleate, with Eudragit E-100, lactose, mannitol, low-substituted hydroxypropyl cellulose, magnesium stearate, Mentholum is a pharmaceutic adjuvant, it is characterized in that: medicine and Eudragit E-100, lactose, mannitol, low-substituted hydroxypropyl cellulose, magnesium stearate, the proportioning of these pharmaceutic adjuvants of Mentholum is 1: 0.2～1.5: 20～100: 10～60: 1.0～5.0: 0.2～1.0: 0.4～2.0, preparation method adopts the wet granule compression tablet method, the first step at first is dissolved in Eudragit E-100 that to make concentration in the dehydrated alcohol be 100mg/ml～300mg/ml, add medicine by proportioning then and stir coating fast, and in 20 ℃～50 ℃ dryings, it is stand-by that porphyrize is crossed 80 mesh sieves, second step crossed 80 mesh sieve mixings with the lactose and the mannitol of proportional quantity, the Mentholum ethanol solution 80mg/ml～120mg/ml that adds proportional quantity stirs, mixing, stand-by in 30 ℃～50 ℃ oven dry, the 3rd step is with the first and second step gains mix homogeneously, adding an amount of distilled water mixes, granulate with 16 mesh sieves, the granule that makes is tiled in stainless steel disc immediately puts into the baking oven baking 20～40 minutes that is warming up to 40 ℃～60 ℃, the 4th step will be dried by the fire good granule and be put to room temperature, behind the granulate, the low-substituted hydroxypropyl cellulose and the magnesium stearate mixing that add proportional quantity, select the suitable low pressure tabletting that dashes for use, with the sheet of being pressed be put in stainless steel disc 30 ℃～50 ℃ down baking promptly got instant of oral rapidly disintegrating in 3-6 hour.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200310107658 CN1228045C (en) | 2003-11-03 | 2003-11-03 | Fast collapsed and fast dissolved preparation for oral cavity and producing method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200310107658 CN1228045C (en) | 2003-11-03 | 2003-11-03 | Fast collapsed and fast dissolved preparation for oral cavity and producing method |
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| CN1539408A CN1539408A (en) | 2004-10-27 |
| CN1228045C true CN1228045C (en) | 2005-11-23 |
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| CN 200310107658 Expired - Fee Related CN1228045C (en) | 2003-11-03 | 2003-11-03 | Fast collapsed and fast dissolved preparation for oral cavity and producing method |
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Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2007020204A2 (en) * | 2005-08-12 | 2007-02-22 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Hfc solution formulations for inhalation containing salbutamol hydrochloride or salbutamol citrate |
| CN107137367A (en) * | 2017-04-01 | 2017-09-08 | 重庆康刻尔制药有限公司 | Salbutamol sulfate oral disnitegration tablet and preparation method thereof |
| CN115645374B (en) * | 2022-12-25 | 2024-04-26 | 山东理工职业学院 | Preparation method of salbutamol sulfate tablet |
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