CN1778297A - Phentolamine effervescent tablet and its preparation thereof - Google Patents
Phentolamine effervescent tablet and its preparation thereof Download PDFInfo
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- CN1778297A CN1778297A CN 200410052330 CN200410052330A CN1778297A CN 1778297 A CN1778297 A CN 1778297A CN 200410052330 CN200410052330 CN 200410052330 CN 200410052330 A CN200410052330 A CN 200410052330A CN 1778297 A CN1778297 A CN 1778297A
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- phentolamine
- effervescent tablet
- phentolamine mesylate
- water
- mannitol
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Abstract
An effervescent tablet of phentolamine for treating the penis erection disfunction of man and the sexual anesthesia of woman is proportionally prepared from phentolamine methylsulfonate, disintegrant, adhesive, filler, lubricant, pigment, flavouring and/or aromatic.
Description
● technical field
The present invention relates to a kind of pharmaceutical composition that contains phentolamine, more particularly, the present invention relates to a kind of phentolamine effervescent tablet.The invention still further relates to the preparation method of described phentolamine effervescent tablet.
● background technology
Effervescent tablet is a kind of novel form, just is more widely used in medicine and health product production at present, and is paid close attention to by many manufacturing enterprises and consumer.Effervescent tablet belongs to solid beverage, mean a class contain a kind of or several organic acid and a kind of or several meet inorganic salt (alkaline agent) that acid can produce carbon dioxide water-soluble as disintegrating agent, meeting that water bubbling at once produces carbon dioxide and be dissolved into can drinking beverage type tablet.General acid commonly used has citric acid, citric acid, fumaric acid, malic acid etc.; Alkaline matter is generally selected sodium bicarbonate, sodium carbonate and potassium bicarbonate etc. for use; These bronsted lowry acids and bases bronsted lowries share and are called gas-producing disintegrant, and they occupy higher ratio in effervescent tablet.The tablet that contains gas-producing disintegrant drops in the water, can " grow " bubbling at once, rolls up and down, very fast molten be one glass of good to eat beverage.The flavoring agent that adds when the organic salt that effervescent reaction generates, the carbon dioxide that dissolves in beverage, remaining organic acid and compressed tablet has stable beverage pH value and good flavored action.
Phentolamine (phentolamine) is evident in efficacy to treatment male penis erection dysfunction, what generally use is the mesylate of phentolamine, this product dosage form of exploitation both at home and abroad is conventional tablet and dispersible tablet, and Shang Weijian has the effervescent tablet and the relevant report of phentolamine mesylate.The phentolamine mesylate effervescent tablet with water dissolution after, medicinal liquid is refrigerant good to eat, and the sensation of refreshment drink is arranged, and provides to be different from the empirical experience of generally taking medicine, and makes drug administration process happier easily.In needs, it is opened with blister again drink, as having a drink, good than with other dosage form of the sensation of obviously not taking medicine, the effect that uses simultaneously, adopts oral administration solution to take, and easilier absorbed in the body, and onset is faster.Therefore, other dosage form relatively, effervescent tablet has characteristics such as taking convenience, mouthfeel are good, rapid-action, can easilier be accepted by user.
● summary of the invention
The purpose of this invention is to provide a kind of have drug solubility height, delicious, phentolamine mesylate effervescent tablet that mouthfeel is good, rapid-action and easy to use and preparation method thereof.
The present invention is achieved by following technical proposals.
Unless have in addition, percent of the present invention is weight ratio percent.
Phentolamine mesylate effervescent tablet of the present invention, every contains phentolamine mesylate 10～100mg and pharmaceutic adjuvant, and described pharmaceutic adjuvant comprises filler 10～300mg, binding agent 0～50mg, disintegrating agent 100～1000mg, lubricant 2～200mg, flavoring agent 0～100mg, toner 0～10mg and aromatic 0～50mg.Described filler is selected from a kind of in lactose, dextrin, starch or the mannitol or their mixture, and described wetting agent is selected water or ethanol or their mixture for use; Described binding agent is selected from a kind of of starch slurry, microcrystalline Cellulose, cellulose derivative (comprising hydroxypropyl emthylcellulose, methylcellulose, carboxymethyl cellulose), polyvinylpyrrolidone (PVP) or their mixture; Described disintegrating agent is selected from the soda acid disintegrating agent of citric acid or citric acid and sodium carbonate or sodium bicarbonate mixing composition; Described lubricant is selected from a kind of in fumaric acid, stearic acid U.S., Stepanol MG, sodium lauryl sulphate or the micropowder silica gel or their mixture; Described aromatic and flavoring agent are selected from a kind of in An Saimi, aspartame, stevioside or the powdered flavor or their mixture; Described toner is selected from sunset yellow or greyish purple etc.
The preferential composition of phentolamine mesylate effervescent tablet of the present invention is:
Every comprises phentolamine mesylate 10～100mg, mannitol 10～300mg, citric acid 50～500mg, sodium bicarbonate 50～500mg, PVPk30 0～50mg, fumaric acid 2～200mg, peace match close 0～50mg, aspartame 0～50mg, sunset yellow 0～5mg, greyish purple 0～10mg, sodium chloride 0～10mg and powdered flavor 0～50mg.
Preparation method of the present invention comprises the step of following order:
1, granulates preparation: by part recipe quantity mixing, is wetting agent granulate after oven dry granulate with water with phentolamine mesylate, citric acid, mannitol, sunset yellow.
2, alkali preparation of granules: by part recipe quantity mixing, is wetting agent granulate after oven dry granulate with water with sodium bicarbonate, PVP, An Saimi, aspartame, mannitol, sunset yellow, sodium chloride.
3, tabletting: with granulates, alkali granule, fumaric acid and spice by prescription requirement mixing after tabletting.Promptly get the phentolamine mesylate effervescent tablet.
The effervescent effect of phentolamine mesylate effervescent tablet of the present invention:
The phentolamine mesylate effervescent tablet is dropped in the 200ml drinking water, its suspension or fall within glass at the bottom of, and a large amount of bubbles of emerging immediately, tablet is dissolving rapidly thereupon, forms orange colour (Fructus Citri tangerinae flavor) or purple (Fructus Vitis viniferae flavor) clear solution within 3 minutes.
Phentolamine mesylate effervescent tablet of the present invention have the drug solubility height, delicious, mouthfeel is good, characteristics such as rapid-action and easy to use.
Compare with commercially available phentolamine mesylate sheet or dispersible tablet, phentolamine mesylate effervescent tablet of the present invention has following characteristics:
(1), effervescent tablet is very soluble in water, can dissolve fully in 3 minutes at ambient temperature, without boiled water, only just can take taking convenience with bottled mineral water or pure water.
(2), produce a large amount of CO during the effervescent tablet effervescent
2Tablet is seethed up and down, and surrounded by bubble group, have much interest, can satisfy people's curiosity, the easier people of allowing accepts.
(3), delicious taste, can make refreshment drink, when taking medicine, can make the people eliminate the notion of " medicine ", the also easier people of allowing accepts.
● the specific embodiment
By following specific embodiment, can further be well understood to the present invention, but they not limitation of the invention.
Embodiment 1
Take by weighing phentolamine mesylate 20g, citric acid 300g, mannitol 100g, sunset yellow 0.2g, mix homogeneously; With water is that the oven dry granulate got granulates after wetting agent was granulated.Other gets sodium carbonate 250g, PVPk30 12g, peace match close 30g, mannitol 80g, sunset yellow 0.2g, sodium chloride 4g is that the wetting agent back oven dry granulate of granulating gets the alkali granule with water.With granulates, alkali granule, magnesium stearate 100g and stevioside 10g mixing, tabletting.Make 1000 of phentolamine mesylate effervescent tablets.
Embodiment 2
Take by weighing phentolamine mesylate 20g, citric acid 320g, lactose 100g, sunset yellow 0.2g, mix homogeneously; With water is that the oven dry granulate got granulates after wetting agent was granulated.Other gets sodium bicarbonate 240g, PVPk30 10g, peace match close 30g, lactose 100g, sunset yellow 0.2g, sodium chloride 4g is that the wetting agent back oven dry granulate of granulating gets the alkali granule with water.With granulates, alkali granule, magnesium stearate 100g and stevioside 10g mixing, tabletting.Make 1000 of phentolamine mesylate effervescent tablets.
Embodiment 3
Take by weighing phentolamine mesylate 20g, citric acid 300g, mannitol 100g, sunset yellow 0.2g, greyish purple 4g, mix homogeneously; With water is that the oven dry granulate got granulates after wetting agent was granulated.Other gets sodium carbonate 250g, PVPk30 12g, aspartame 30g, mannitol 80g, sunset yellow 0.2g, sodium chloride 4g is that the oven dry granulate got the alkali granule after wetting agent was granulated with water.With granulates, alkali granule, fumaric acid 100g and powdered flavor 10g mixing, tabletting.Make 1000 of phentolamine mesylate effervescent tablets.
Embodiment 4
Take by weighing phentolamine mesylate 40g, citric acid 300g, mannitol 120g, sunset yellow 0.2g, mix homogeneously; With water is that the oven dry granulate got granulates after wetting agent was granulated.Other gets sodium carbonate 250g, PVPk30 10g, peace match close 30g, mannitol 100g, sunset yellow 0.2g, sodium chloride 5g is that the wetting agent back oven dry granulate of granulating gets the alkali granule with water.With granulates, alkali granule, sodium lauryl sulphate 100g and stevioside 10g mixing, tabletting.Make 1000 of phentolamine mesylate effervescent tablets.
Embodiment 5
Take by weighing phentolamine mesylate 40g, citric acid 300g, mannitol 120g, sunset yellow 0.2g, greyish purple 3g, mix homogeneously; With water is that the oven dry granulate got granulates after wetting agent was granulated.Other gets sodium carbonate 250g, PVPk30 10g, peace match close 30g, mannitol 100g, sunset yellow 0.2g, sodium chloride 5g is that the wetting agent back oven dry granulate of granulating gets the alkali granule with water.With granulates, alkali granule, sodium lauryl sulphate 100g and stevioside 10g mixing, tabletting.Make 1000 of phentolamine mesylate effervescent tablets.
Embodiment 6
Take by weighing phentolamine mesylate 60g, citric acid 380g, mannitol 100g, sunset yellow 2g, greyish purple 2g, mix homogeneously; With water is that the oven dry granulate got granulates after wetting agent was granulated.Other gets sodium bicarbonate 360g, PVPk30 15g, peace match close 20g, aspartame 20g, mannitol 110g, sunset yellow 2g, greyish purple 2g, sodium chloride 5g is that the wetting agent back oven dry granulate of granulating gets the alkali granule with water.With granulates, alkali granule, fumaric acid 100g and powdered flavor 10g mixing, tabletting.Make 1000 of phentolamine mesylate effervescent tablets.
Embodiment 7
Take by weighing phentolamine mesylate 60g, citric acid 350g, mannitol 100g, sunset yellow 2g, mix homogeneously; With water is that the oven dry granulate got granulates after wetting agent was granulated.Other gets sodium bicarbonate 370g, PVPk30 15g, aspartame 30g, mannitol 110g, sunset yellow 2g, sodium chloride 4g is that the oven dry granulate got the alkali granule after wetting agent was granulated with water.With granulates, alkali granule, fumaric acid 120g and powdered flavor 15g mixing, tabletting.Make 1000 of phentolamine mesylate effervescent tablets.
Embodiment 8
Take by weighing phentolamine mesylate 60g, citric acid 380g, starch 90g, sunset yellow 2g, greyish purple 2g, mix homogeneously; With water is that the oven dry granulate got granulates after wetting agent was granulated.Other gets sodium carbonate 360g, PVPk30 14g, peace match close 20g, aspartame 25g, starch 115g, sunset yellow 2g, greyish purple 2g, sodium chloride 4g is that the wetting agent back oven dry granulate of granulating gets the alkali granule with water.With granulates, alkali granule, magnesium stearate 120g and powdered flavor 12g mixing, tabletting.Make 1000 of phentolamine mesylate effervescent tablets.
Embodiment 9
Take by weighing phentolamine mesylate 60g, citric acid 360g, starch 100g, sunset yellow 2g, greyish purple 2g, mix homogeneously; With water is that the oven dry granulate got granulates after wetting agent was granulated.Other gets sodium bicarbonate 380g, PVPk30 14g, peace match close 25g, starch 115g, sunset yellow 2g, greyish purple 2g, sodium chloride 4g is that the wetting agent back oven dry granulate of granulating gets the alkali granule with water.With granulates, alkali granule, magnesium stearate 110g and stevioside 10g mixing, tabletting.Make 1000 of phentolamine mesylate effervescent tablets.
Embodiment 10
Take by weighing phentolamine mesylate 60g, citric acid 370g, mannitol 91g, sunset yellow 2g, greyish purple 2g, mix homogeneously; With water is that the oven dry granulate got granulates after wetting agent was granulated.Other gets sodium bicarbonate 360g, PVPk30 15g, peace match close 15g, aspartame 25g, mannitol 111g, sunset yellow 2g, greyish purple 2g, sodium chloride 4g is that the wetting agent back oven dry granulate of granulating gets the alkali granule with water.With granulates, alkali granule, magnesium stearate 110g and stevioside 10g mixing, tabletting.Make 1000 of phentolamine mesylate effervescent tablets.
Embodiment 11
Take by weighing phentolamine mesylate 80g, citric acid 370g, mannitol 90g, sunset yellow 0.2g, mix homogeneously; With water is that the oven dry granulate got granulates after wetting agent was granulated.Other gets sodium bicarbonate 360g, PVPk30 15g, peace match close 20g, aspartame 25g, mannitol 100g, sunset yellow 0.2g, sodium chloride 4g is that the wetting agent back oven dry granulate of granulating gets the alkali granule with water.With granulates, alkali granule, magnesium stearate 100g and stevioside 12g mixing, tabletting.Make 1000 of phentolamine mesylate effervescent tablets.
Embodiment 12
Take by weighing phentolamine mesylate 80g, citric acid 380g, mannitol 74g, sunset yellow 0.2g, mix homogeneously; With water is that the oven dry granulate got granulates after wetting agent was granulated.Other gets sodium bicarbonate 350g, PVPk30 15g, peace match close 20g, aspartame 25g, mannitol 120g, sunset yellow 0.2g, sodium chloride 4g is that the wetting agent back oven dry granulate of granulating gets the alkali granule with water.With granulates, alkali granule, fumaric acid 110g and essence 12g mixing, tabletting.Make 1000 of phentolamine mesylate effervescent tablets.
Embodiment 13
Take by weighing phentolamine mesylate 80g, citric acid 350g, mannitol 80g, sunset yellow 2g, greyish purple 2g mix homogeneously; With water is that the oven dry granulate got granulates after wetting agent was granulated.Other gets sodium carbonate 350g, PVPk30 15g, peace match close 20g, aspartame 25g, mannitol 120g, sunset yellow 2g, greyish purple 2g, sodium chloride 5g is that the wetting agent back oven dry granulate of granulating gets the alkali granule with water.With granulates, alkali granule, fumaric acid 120g and essence 14g mixing, tabletting.Make 1000 of phentolamine mesylate effervescent tablets.
Embodiment 14
Take by weighing phentolamine mesylate 80g, citric acid 360g, starch 90g, sunset yellow 2g, greyish purple 2g, mix homogeneously; With water is that the oven dry granulate got granulates after wetting agent was granulated.Other gets sodium bicarbonate 380g, PVPk30 14g, peace match close 20g, aspartame 25g, starch 95g, sunset yellow 2g, greyish purple 2g, sodium chloride 4g is that the wetting agent back oven dry granulate of granulating gets the alkali granule with water.With granulates, alkali granule, magnesium stearate 110g and stevioside 10g mixing, tabletting.Make 1000 of phentolamine mesylate effervescent tablets.
Embodiment 15
Take by weighing phentolamine mesylate 80g, citric acid 380g, starch 94g, sunset yellow 0.2g, mix homogeneously; With water is that the oven dry granulate got granulates after wetting agent was granulated.Other gets sodium bicarbonate 350g, PVPk30 15g, peace match close 20g, aspartame 25g, aspartame 25g, mannitol 120g, sunset yellow 0.2g, sodium chloride 4g is that the wetting agent back oven dry granulate of granulating gets the alkali granule with water.With granulates, alkali granule, fumaric acid 110g and essence 12g mixing, tabletting.Make 1000 of phentolamine mesylate effervescent tablets.
Embodiment 16
The effervescent effect of phentolamine mesylate effervescent tablet of the present invention:
The phentolamine mesylate effervescent tablet is dropped in the 200ml drinking water, its suspension or fall within glass at the bottom of, and a large amount of bubbles of emerging immediately, tablet is dissolving rapidly thereupon, forms orange colour (Fructus Citri tangerinae flavor) or purple (Fructus Vitis viniferae flavor) clear solution within 3 minutes.
Table 1: three batches of phentolamine mesylate effervescent tablet effervescent effect measurings
| Lot number | Dissolving (effervescent) time | Solution colour | Taste | Clarity of solution |
| 030910 | 2 minutes 42 seconds | Orange colour | The Fructus Citri tangerinae flavor | Transparency liquid |
| 030921 | 2 minutes 37 seconds | Purple | The Fructus Vitis viniferae flavor | Transparency liquid |
| 031001 | 2 minutes 45 seconds | Orange colour | The Fructus Citri tangerinae flavor | Transparency liquid |
Claims (8)
1, the effervescent tablet that contains phentolamine (phentolamine).
2, the described phentolamine effervescent tablet of claim 1 is characterized in that used phentolamine can be the salt that any one can be medicinal, as mesylate.
3, the described effervescent tablet of claim 1, every contains phentolamine mesylate 10～500mg and pharmaceutic adjuvant, and described pharmaceutic adjuvant comprises filler 10～300mg, binding agent 0～50mg, disintegrating agent 100～1000mg, lubricant 2～200mg, flavoring agent 0～100mg, toner 0～10mg and aromatic 0～50mg.
4, the described phentolamine mesylate effervescent tablet of claim 3, wherein said filler are selected from a kind of in lactose, dextrin, starch or the mannitol or their mixture, and described wetting agent is selected water or ethanol or their mixture for use; Described binding agent is selected from a kind of of starch slurry, microcrystalline Cellulose, cellulose derivative (comprising hydroxypropyl emthylcellulose, methylcellulose, carboxymethyl cellulose), polyvinylpyrrolidone (PVP) or their mixture; Described disintegrating agent is selected from the soda acid disintegrating agent of citric acid or citric acid and sodium carbonate or sodium bicarbonate mixing composition; Described lubricant is selected from a kind of in fumaric acid, stearic acid U.S., Stepanol MG, sodium lauryl sulphate or the micropowder silica gel or their mixture; Described aromatic and flavoring agent are selected from a kind of in An Saimi, aspartame, stevioside or the powdered flavor or their mixture; Described toner is selected from sunset yellow or edible pigment such as greyish purple.
5, the described phentolamine mesylate effervescent tablet of claim 4, every comprises phentolamine mesylate 10～500mg, mannitol 10～300mg, citric acid 50～500mg, sodium bicarbonate 50～500mg, PVPk300～50mg, fumaric acid 2～200mg, peace match close 0～50mg, aspartame 0～50mg, sunset yellow 0～5mg, greyish purple 0～10mg, sodium chloride 0～10mg and powdered flavor 0～50mg.
6, a kind of phentolamine mesylate effervescent tablet preparation method, this method comprises the step of following order:
6.1, granulates preparation: by part recipe quantity mixing, is the wetting agent back oven dry granulate of granulating with phentolamine mesylate, citric acid, mannitol, sunset yellow with water.
6.2, the alkali preparation of granules: by part recipe quantity mixing, is the wetting agent back oven dry granulate of granulating with sodium bicarbonate, PVP, An Saimi, aspartame, mannitol, sunset yellow, sodium chloride with water.
6.3, tabletting: with granulates, alkali granule, fumaric acid and spice by prescription requirement mixing after tabletting.Promptly get the phentolamine effervescent tablet.
7, claim 6.1 and 6.2 described parts are 0～100% of recipe quantity.
8, require prepared phentolamine effervescent tablet according to aforesaid right, be used for the treatment of male sexual disorder clinically, as the penile erectile function obstacle; And female sexual disorder, as female frigidity etc.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410052330 CN1778297A (en) | 2004-11-23 | 2004-11-23 | Phentolamine effervescent tablet and its preparation thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410052330 CN1778297A (en) | 2004-11-23 | 2004-11-23 | Phentolamine effervescent tablet and its preparation thereof |
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| Publication Number | Publication Date |
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| CN1778297A true CN1778297A (en) | 2006-05-31 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200410052330 Pending CN1778297A (en) | 2004-11-23 | 2004-11-23 | Phentolamine effervescent tablet and its preparation thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106063781A (en) * | 2016-08-01 | 2016-11-02 | 张礼 | A kind of Chinese medical concrete effervescent tablet and preparation method thereof |
| CN106606497A (en) * | 2015-10-21 | 2017-05-03 | 浙江海力生制药有限公司 | Montelukast effervescence preparation and preparing method thereof |
| CN111454234A (en) * | 2020-04-30 | 2020-07-28 | 绍兴华威化工有限公司 | Recovery process of Grignard reaction solvent |
| CN114727952A (en) * | 2019-10-17 | 2022-07-08 | Isp投资有限公司 | Stable effervescent co-processing excipient composition and preparation method thereof |
-
2004
- 2004-11-23 CN CN 200410052330 patent/CN1778297A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106606497A (en) * | 2015-10-21 | 2017-05-03 | 浙江海力生制药有限公司 | Montelukast effervescence preparation and preparing method thereof |
| CN106063781A (en) * | 2016-08-01 | 2016-11-02 | 张礼 | A kind of Chinese medical concrete effervescent tablet and preparation method thereof |
| CN114727952A (en) * | 2019-10-17 | 2022-07-08 | Isp投资有限公司 | Stable effervescent co-processing excipient composition and preparation method thereof |
| CN111454234A (en) * | 2020-04-30 | 2020-07-28 | 绍兴华威化工有限公司 | Recovery process of Grignard reaction solvent |
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