CN1302772C - Orally disintegrated sodium ferulate tablet and its prepn process - Google Patents
Orally disintegrated sodium ferulate tablet and its prepn process Download PDFInfo
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- CN1302772C CN1302772C CNB2005100261411A CN200510026141A CN1302772C CN 1302772 C CN1302772 C CN 1302772C CN B2005100261411 A CNB2005100261411 A CN B2005100261411A CN 200510026141 A CN200510026141 A CN 200510026141A CN 1302772 C CN1302772 C CN 1302772C
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Abstract
The present invention relates to a sodium ferulate orally disintegrating tablet and a preparation method thereof, which belongs to the technical field of medicinal preparations. The table contains 10 to 50 wt% of sodium ferulate active ingredient and 50 to 90 wt% of pharmaceutically acceptable auxiliary materials, wherein the auxiliary materials comprise 2 to 30 wt% of disintegrating agent, 10 to 90 wt% of filling agent, 1 to 5 wt% of adhesive, at most 5 wt% of lubricating agent and 0.1 to 20 wt% of corrigent; the preparation method can adopt a freeze drying method, a direct powder compression method and a wet granulation and tabletting method; according to different preparation methods, relevant auxiliary materials in the components can be selected; the preparation of the present invention overcomes the defects of slow dissolution, inconvenient swallow, etc. of common sodium ferulate tablets; the tablet has the advantages of no stimulation to the feelmouth mucosa, good taste and no sand feel and is especially suitable for senile patients with dysphagia.
Description
Technical field
The present invention relates to technical field of medicine, is a kind of Orally disintegrated sodium ferulate tablet and preparation method thereof.
Background technology
Sodium ferulate (sodium ferulate) is the sodium salt of Chinese medicine extract main component ferulic acids such as Radix Angelicae Sinensis and Rhizoma Chuanxiong, claims angelicin or Rhizoma Chuanxiong element again, is mainly used in the treatment of diseases such as coronary heart disease, cerebrovascular, vasculitis and migraine.Determined curative effect, its listing peroral dosage form is a conventional tablet.But the sodium ferulate sheet is indissoluble under one's belt, by " Chinese pharmacopoeia version in 2005 is carried out the dissolution experiment to the sodium ferulate sheet and found, commercially available sodium ferulate sheet (ChengDu HengDa Pharmacy Co., Ltd, lot number 040804) 45 minutes doses of stripping 10% only in simulated gastric fluid, this influences in the medicine body and absorbs, and drug effect is slow.Clinical use object that it should be noted that the sodium ferulate sheet mostly is specific groups such as old age of needing long-term prescription, bed, and these patients tend to take place dysphagia, and tablet is easy to take place physical blockage.Up-to-date epidemiology finds that only common gerontal patient just has 35% can gulp down the medicine difficulty approximately.
Oral cavity disintegration tablet is a kind of novel solid preparation of foreign study exploitation over past ten years, refers in the oral cavity not water in addition or with seldom water, internal energy quick disintegrate in 1 minute or dissolved tablet.This dosage form mainly is to select the disintegrating property excellent disintegrating agent, and tablet places on patient's tongue, meets saliva dissolving or disintegrate rapidly, and medicine borrows swallowing act to go into the stomach onset.Oral cavity disintegration tablet is compared with conventional tablet, and a kind of new method of administration is provided, and can make things convenient for patient's medication, especially is fit to the old people and waits the dysphagia patients medication, prevents to suffocate because of the tablet physical blockage.Simultaneously, owing to used the disintegrating property excellent disintegrating agent, tablet is disintegrate rapidly in the oral cavity, has accelerated the medicine stripping, makes medicine fast Absorption and onset.But relevant Orally disintegrated sodium ferulate tablet of Shang Weijian and relevant research report thereof at present.
Summary of the invention
The invention provides a kind ofly swallow conveniently, rapid-action Orally disintegrated sodium ferulate tablet and preparation method thereof.
Orally disintegrated sodium ferulate tablet of the present invention, component comprises sodium ferulate active component and medicinal acceptable auxiliary, the percentage by weight of sodium ferulate is 10～50%, the percentage by weight of adjuvant is 50～90%, adjuvant comprises disintegrating agent, filler, also can contain binding agent, lubricant, correctives.The percentage by weight of disintegrating agent is 2～30%, and the percentage by weight of filler is 10～90%, and the percentage by weight of binding agent is 1～5%, and the percentage by weight of lubricant is no more than 5%, and the percentage by weight of correctives is 0.1～20%.According to the difference of preparation method, can select relevant auxiliary materials for use.
Described disintegrating agent is selected from polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, can select wherein one or more simultaneously for use.
Described filler is selected from lactose, pregelatinized Starch, mannitol, sorbitol, xylitol, erythritol, can select wherein one or more simultaneously for use.
Described binding agent is selected from syrup, starch slurry, sodium carboxymethyl cellulose, hydroxypropyl emthylcellulose, polyvidone, can select wherein one or more simultaneously for use.
Described lubricant is selected from micropowder silica gel, magnesium stearate, Pulvis Talci, can select wherein one or more simultaneously for use.
Described correctives comprises sweeting agent, flavouring agent and effervescent.Sweeting agent is selected from saccharin sodium, sucrose, aspartame, cyclamate,, can select wherein one or more simultaneously for use, percentage by weight is 1～5%; Flavouring agent is selected from Rhizoma et radix valerianae, Fructus Pruni pseudocerasi, Fructus Vitis viniferae, Fructus Citri tangerinae, Fructus Citri Limoniae, Herba Menthae, blue berry, Fructus Musae, Fructus Ananadis comosi, honey peach, maltose essence, and percentage by weight is 0.1～1%; Effervescent is selected from the mixture of sodium bicarbonate and tartaric acid or citric acid or fumaric acid, and percentage by weight is no more than 15%.
The preparation method of Orally disintegrated sodium ferulate tablet can be selected freeze-drying or direct powder compression or wet granule compression tablet method for use.
1. freeze-drying: step be by proportioning with sodium ferulate and disintegrating agent, filler, correctives mix homogeneously, add the suitable quantity of water dilution, fully mixing places the respective tablets mould, puts into the freeze dryer lyophilization, is shaped to the material bone dry.
2. direct powder compression: step is by proportioning sodium ferulate, disintegrating agent, filler, correctives to be sieved, and mix homogeneously adds the lubricant mixing, and direct compression is shaped.
3. wet granule compression tablet method: step be by proportioning earlier with sodium ferulate and filler, correctives and part disintegrating agent mix homogeneously, add binding agent and make soft material, granulate, oven dry, granulate adds surplus disintegrating agent and lubricant at last, the tabletting shaping.
Through dissolution experiment, the sodium ferulate dissolution is greater than 90% in the oral cavity disintegration tablet of the present invention 5 minutes, thereby oral back drug effect is fast.Do not need water when oral cavity disintegration tablet of the present invention is taken, only relying on saliva in the oral cavity is disintegrate in 1 minute, and oral mucosa is not had zest, good mouthfeel, and acidity, sugariness are suitable, and no grittiness is specially adapted to the gerontal patient of dysphagia.Orally disintegrating piece preparation method of the present invention is simple, is suitable for industrial-scale production.
Description of drawings
Fig. 1 is Orally disintegrated sodium ferulate tablet and the dissolution curve chart of commercially available ordinary tablet in simulated gastric fluid
Fig. 2 is Orally disintegrated sodium ferulate tablet and the dissolution curve chart of commercially available ordinary tablet in water
The specific embodiment
Describe the present invention below in conjunction with embodiment and accompanying drawing, but the present invention is not construed as limiting.
In the specific implementation, reach the difference of preparation method as required, can select different adjuvants for use in the component.
Embodiment 1 freeze-drying prepares Orally disintegrated sodium ferulate tablet
Component and proportioning (w/w%)
Sodium ferulate 40
Lactose 23
Aspartame 1.5
Orange flavor 0.5
Preparation method:
With sodium ferulate and carboxymethyl starch sodium, microcrystalline Cellulose, lactose, sucrose, aspartame, orange flavor, be suspended in the suitable quantity of water, stirred 1 hour, make suspension, be poured in the tablet mould, carry out lyophilization, the lyophilizing back press seal that is shaped, packing.
The obtained freeze-drying article construction is loose, puts acidity on the tongue, sugariness is suitable, and no grittiness, disintegration time are 5 seconds, and 100% dissolution time is 4 minutes.
Embodiment 2 freeze-dryings prepare Orally disintegrated sodium ferulate tablet
Component and proportioning (w/w%)
Sodium ferulate 15
Low-substituted hydroxypropyl cellulose 10
Lactose 33.8
Pregelatinized Starch 20
Cyclamate 1
Cherry essence 0.2
Preparation method:
With sodium ferulate and low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, lactose, pregelatinized Starch, cyclamate, cherry essence, be suspended in the suitable quantity of water, stirred 1 hour, make suspension, be poured in the tablet mould, carry out lyophilization, press seal after lyophilizing is shaped, packing.
The obtained freeze-drying article construction is loose, puts acidity on the tongue, sugariness is suitable, and no grittiness, disintegration time are 5 seconds, and 100% dissolution time is 4 minutes.
Embodiment 3 direct powder compressions prepare Orally disintegrated sodium ferulate tablet
Component and proportioning (w/w%)
Sodium ferulate 25
Polyvinylpolypyrrolidone 8
Lactose 19
Mannitol 23.5
Micropowder silica gel 2
Magnesium stearate 1
Aspartame 1
Orange flavor 0.5
Preparation method:
Sodium ferulate and polyvinylpolypyrrolidone, microcrystalline Cellulose, lactose, mannitol are crossed 80 mesh sieves, and with micropowder silica gel, magnesium stearate, aspartame, the orange flavor equivalent mix homogeneously that progressively increases, direct compression is shaped, packing.
The gained oral cavity disintegration tablet is put refrigerant sense on the tongue, acidity, sugariness suit, and no grittiness, disintegration time are 47 seconds, and 100% dissolution time is 10 minutes, all meets the pharmacopeia regulation.
Embodiment 4 direct powder compressions prepare Orally disintegrated sodium ferulate tablet
Component and proportioning (w/w%)
Sodium ferulate 22
Carboxymethyl starch sodium 3
Microcrystalline Cellulose 18
Mannitol 28
Sodium bicarbonate 2
Citric acid 2.5
Micropowder silica gel 2
Magnesium stearate 0.5
Aspartame 1.5
Fructus Citri Limoniae essence 0.5
Preparation method:
Sodium ferulate and carboxymethyl starch sodium, microcrystalline Cellulose, lactose, mannitol, sodium bicarbonate, citric acid are crossed 80 mesh sieves, and with micropowder silica gel, magnesium stearate, aspartame, the Fructus Citri Limoniae essence equivalent mix homogeneously that progressively increases, direct compression is shaped, packing.
The gained oral cavity disintegration tablet is put effervescent on the tongue, refrigerant sense, and acidity, sugariness suit, and no grittiness, disintegration time are 32 seconds, and 100% dissolution time is 8 minutes, all meets the pharmacopeia regulation.
Component and proportioning (w/w%)
Sodium ferulate 30
Cross-linking sodium carboxymethyl cellulose 5
Lactose 11.5
Mannitol 28
Tartaric acid 6
Micropowder silica gel 2
Magnesium stearate 0.5
Aspartame 1.5
Fructus Citri Limoniae essence 0.5
Preparation method:
Sodium ferulate and cross-linking sodium carboxymethyl cellulose, microcrystalline Cellulose, lactose, mannitol, sodium bicarbonate, tartaric acid are crossed 80 mesh sieves, and with micropowder silica gel, magnesium stearate, aspartame, the Fructus Citri Limoniae essence equivalent mix homogeneously that progressively increases, direct compression is shaped, packing.
The gained oral cavity disintegration tablet is put effervescent on the tongue, refrigerant sense, and acidity, sugariness suit, and no grittiness, disintegration time are 30 seconds, and 100% dissolution time is 8 minutes, all meets the pharmacopeia regulation.
Embodiment 6 wet granule compression tablet legal systems are equipped with Orally disintegrated sodium ferulate tablet
Component and proportioning (w/w%)
Sodium ferulate 30
Cross-linking sodium carboxymethyl cellulose 5
Mannitol 30
Sodium bicarbonate 2
Fumaric acid 2.5
Micropowder silica gel 2
Magnesium stearate 2
Aspartame 1
Fructus Citri tangerinae essence 0.5
Preparation method:
With sodium ferulate and cross-linking sodium carboxymethyl cellulose, microcrystalline Cellulose, lactose, mannitol, sodium bicarbonate, fumaric acid, micropowder silica gel, aspartame mix homogeneously, granulate with 1% polyvidone alcoholic solution, 50 ℃ of oven dry, spray into Fructus Citri tangerinae essence behind the granulate, add magnesium stearate, tabletting is shaped, packing.
The gained oral cavity disintegration tablet is put effervescent on the tongue, refrigerant sense, and acidity, sugariness suit, and no grittiness, disintegration time are 49 seconds, and 100% dissolution time is 10 minutes, all meets the pharmacopeia regulation.
Oral cavity disintegration tablet that embodiment 3 is made and commercially available sodium ferulate sheet (ChengDu HengDa Pharmacy Co., Ltd, lot number 040804) by " Chinese pharmacopoeia version in 2005 carry out respectively in simulated gastric fluid and the water dissolution relatively, the results are shown in Figure 1, Fig. 2.As seen from the figure, the dissolution rate of oral cavity disintegration tablet of the present invention in simulated gastric fluid and water is significantly higher than ordinary tablet.Thereby show that from experiment in vitro oral cavity disintegration tablet of the present invention is convenient to oral, and instant effect.
Claims (5)
1. an Orally disintegrated sodium ferulate tablet comprises sodium ferulate active component and medicinal acceptable auxiliary, and adjuvant comprises disintegrating agent, filler, correctives; Wherein disintegrating agent is selected from carboxymethyl starch sodium, microcrystalline Cellulose, can select wherein a kind of or two kinds simultaneously for use; Filler is a lactose; Correctives comprises sweeting agent and flavouring agent, and sweeting agent is sucrose and aspartame, and flavouring agent is an orange flavor, it is characterized in that component and proportioning (w/w/%) are as follows:
Sodium ferulate 40
Carboxymethyl starch sodium 5
Microcrystalline Cellulose 10
Lactose 23
Sucrose 20
Aspartame 1.5
Orange flavor 0.5.
2. an Orally disintegrated sodium ferulate tablet comprises sodium ferulate active component and medicinal acceptable auxiliary, and adjuvant comprises disintegrating agent, filler, lubricant, correctives; Wherein disintegrating agent is selected from polyvinylpolypyrrolidone, microcrystalline Cellulose, can select wherein a kind of or two kinds simultaneously for use; Filler is lactose and mannitol; Lubricant is micropowder silica gel and magnesium stearate; Correctives comprises sweeting agent and flavouring agent, and sweeting agent is an aspartame, and flavouring agent is an orange flavor, it is characterized in that component and proportioning (w/w/%) are as follows:
Sodium ferulate 25
Polyvinylpolypyrrolidone 8
Microcrystalline Cellulose 20
Lactose 19
Mannitol 23.5
Micropowder silica gel 2
Magnesium stearate 1
Aspartame 1
Orange flavor 0.5.
3. an Orally disintegrated sodium ferulate tablet comprises sodium ferulate active component and medicinal acceptable auxiliary, and adjuvant comprises disintegrating agent, filler, binding agent, lubricant, correctives; Wherein disintegrating agent is selected from cross-linking sodium carboxymethyl cellulose, microcrystalline Cellulose, can select wherein a kind of or two kinds simultaneously for use; Filler is lactose, mannitol; Lubricant is micropowder silica gel, magnesium stearate; Correctives comprises sweeting agent, flavouring agent, effervescent, and sweeting agent is an aspartame, and flavouring agent is a Fructus Citri tangerinae essence, and effervescent is sodium bicarbonate and fumaric acid, it is characterized in that component and proportioning (w/w/%) are as follows:
Sodium ferulate 30
Cross-linking sodium carboxymethyl cellulose 5
Microcrystalline Cellulose 15
Lactose 10
Mannitol 30
Sodium bicarbonate 2
Fumaric acid 2.5
Micropowder silica gel 2
Magnesium stearate 2
Aspartame 1
Fructus Citri tangerinae essence 0.5.
4. the preparation method of the described Orally disintegrated sodium ferulate tablet of claim 1, step is as follows: by proportioning with sodium ferulate and disintegrating agent, filler, correctives mix homogeneously, and add suitable quantity of water dilution, abundant mixing, place the respective tablets mould, put into the freeze dryer lyophilization, be shaped to the material bone dry.
5. the preparation method of the described Orally disintegrated sodium ferulate tablet of claim 2, step is as follows: by proportioning sodium ferulate, disintegrating agent, filler, correctives are sieved, mix homogeneously adds the lubricant mixing again, and direct compression is shaped.
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| Application Number | Priority Date | Filing Date | Title |
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| CNB2005100261411A CN1302772C (en) | 2005-05-24 | 2005-05-24 | Orally disintegrated sodium ferulate tablet and its prepn process |
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| Application Number | Priority Date | Filing Date | Title |
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| CNB2005100261411A CN1302772C (en) | 2005-05-24 | 2005-05-24 | Orally disintegrated sodium ferulate tablet and its prepn process |
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| CN1302772C true CN1302772C (en) | 2007-03-07 |
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Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN100411621C (en) * | 2006-01-09 | 2008-08-20 | 深圳致君制药有限公司 | Cefixime oral disintegration tablet and its preparation method |
| CN101077338B (en) * | 2006-05-24 | 2012-06-20 | 天津大学 | Nano lanthanum carbonate and orally disintegrating tablet and preparation method |
| CN101138554B (en) * | 2006-09-05 | 2010-09-29 | 云南白药集团股份有限公司 | Effervescence dispersible tablet |
| TWI468167B (en) * | 2007-11-16 | 2015-01-11 | 威佛（國際）股份有限公司 | Pharmaceutical compositions |
| CN103191069A (en) * | 2013-03-25 | 2013-07-10 | 海南卫康制药(潜山)有限公司 | Rapid disintegration tabella and chill-pressing method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1476826A (en) * | 2003-07-30 | 2004-02-25 | 北京中西经纬释药技术有限公司 | Oral disintegrant tablet and its preparation method |
| CN1634014A (en) * | 2004-12-01 | 2005-07-06 | 北京科信必成医药科技发展有限公司 | Sodium ferulate oral disintegrating tablet and its preparation process |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1476826A (en) * | 2003-07-30 | 2004-02-25 | 北京中西经纬释药技术有限公司 | Oral disintegrant tablet and its preparation method |
| CN1634014A (en) * | 2004-12-01 | 2005-07-06 | 北京科信必成医药科技发展有限公司 | Sodium ferulate oral disintegrating tablet and its preparation process |
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Granted publication date: 20070307 |