CN101537026A - Xuesaitong dispersible tablet and preparation method thereof - Google Patents

Xuesaitong dispersible tablet and preparation method thereof Download PDF

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Publication number
CN101537026A
CN101537026A CN200910135650A CN200910135650A CN101537026A CN 101537026 A CN101537026 A CN 101537026A CN 200910135650 A CN200910135650 A CN 200910135650A CN 200910135650 A CN200910135650 A CN 200910135650A CN 101537026 A CN101537026 A CN 101537026A
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parts
dispersible tablet
microcrystalline cellulose
magnesium stearate
crospolyvinylpyrrolidone
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CN200910135650A
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Chinese (zh)
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兰玉岐
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Hebei Zhaokang Pharmacy Co Ltd
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Hebei Zhaokang Pharmacy Co Ltd
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Abstract

The invention relates to a traditional Chinese medicine, in particular to a xuesaitong dispersible tablet and a preparation method thereof. By weight, the material mixture ratios of the xuesaitong dispersible tablet are as follows: 80-100 parts of panax notoginseng saponins, 150-190 parts of microcrystalline cellulose, 8-10 parts of stevioside, 13-17 parts of crosslinked polyvinylpyrrolidone, 2-4 parts of aerosil and 1-3 parts of magnesium stearate. The preparation method comprises the steps of: taking the panax notoginseng saponins, the microcrystalline cellulose and the stevioside according to the mixture ratios and preparing soft materials by using 95% ethanol, then using a Number 3 sieve for pelletization; drying at temperature of 60 DEG C and obtaining particles after the pelletization of the Number 3 sieve; and adding the crosslinked polyvinylpyrrolidone, the aerosil and the magnesium stearate to the particles, evenly mixing, and tabletting, thus obtaining the dispersible tablet. The xuesaitong dispersible tablet has short disintegration time, fast acting property of medicaments, high bioavailability and good mouth feeling, thus being especially suitable to the use of children, old people and dysphagic patients. The invention has perfect technology and can save cost, and the quality can be controlled well.

Description

Xuesaitong dispersible tablet and preparation method thereof
Technical field:
The present invention relates to Chinese medicine, particularly a kind of Xuesaitong dispersible tablet and preparation method thereof.
Background technology:
Existing XUESAITONG PIAN has blood circulation promoting and blood stasis dispelling, it is active to promote blood circulation, anticoagulant and cerebral blood flow increasing amount, is used for the stasis of blood resistance of brain road, apoplectic hemiplegia, the resistance of the heart arteries and veins stasis of blood, obstruction of qi in the chest and cardialgia; Apoplexy sequela, angina pectoris belong to above-mentioned symptom person.For the patient that cardiovascular and cerebrovascular disease is arranged, time is life.But former dosage form is the table sugar garment piece, prolonged disintegration, and the medicine stripping is slow, can not satisfy the demand that cardio-cerebral vascular disease patient is wished the rapid onset of medicine.
Summary of the invention:
It is short that the object of the invention aims to provide a kind of disintegration time, rapid-action, the bioavailability height, and mouthfeel is good, is fit to the Xuesaitong dispersible tablet of child, old age and dysphagia patients.
Another object of the present invention is to provide the preparation technology of a kind of technical maturity, Xuesaitong dispersible tablet quality controllable, with low cost.
The objective of the invention is to be achieved through the following technical solutions: Xuesaitong dispersible tablet by weight, proportioning raw materials is: 80~100 parts of Radix Notoginseng total arasaponinss, 150~190 parts of microcrystalline Cellulose, 8~10 parts of steviosides, 13~17 parts of crospolyvinylpyrrolidone, 2~4 parts of micropowder silica gels, 1~3 part of magnesium stearate.
Optimum material proportion of the present invention is: 100 parts of Radix Notoginseng total arasaponinss, 170 parts of microcrystalline Cellulose, 10 parts of steviosides, 15 parts of crospolyvinylpyrrolidone, 3 parts of micropowder silica gels, 2 parts of magnesium stearate.
Xuesaitong dispersible tablet of the present invention is made by following raw material in 1000: Radix Notoginseng total arasaponins 100g, microcrystalline Cellulose 170g, stevioside 10g, crospolyvinylpyrrolidone 15g, micropowder silica gel 3g, magnesium stearate 2g.
Preparation technology of the present invention is: press Radix Notoginseng total arasaponins 80~100 weight portions, microcrystalline Cellulose 150~190 weight portions, stevioside 8~10 weight portions, crospolyvinylpyrrolidone 13~17 weight portions, micropowder silica gel 2~4 weight portions, magnesium stearate 1~3 weight portion batching; Get the Radix Notoginseng total arasaponins in the said ratio, microcrystalline Cellulose, stevioside are with 95% ethanol system soft material, with No. 3 sieve series grains; 60 ℃ of oven dry get granule behind No. 3 sieve granulate; Add crospolyvinylpyrrolidone in the granule, micropowder silica gel, the magnesium stearate mixing, tabletting, promptly.
Best preparation technology of the present invention is: get Radix Notoginseng total arasaponins 100g, microcrystalline Cellulose 170g, stevioside 10g are with 95% ethanol system soft material, with No. 3 sieve series grains; 60 ℃ of oven dry get granule behind No. 3 sieve granulate; Add crospolyvinylpyrrolidone 15g in the granule, micropowder silica gel 3g, magnesium stearate 2g mixing, tabletting is made 1000.
With 95% ethanol system soft material, the ethanol consumption is the 7%-8% of medicated powder weight during granulation among the present invention, and unit is ml/g.
Compared with prior art, the present invention has the following advantages and good effect:
(1) select for use crospolyvinylpyrrolidone as disintegrating agent.Compare at present widely used have carboxymethyl starch sodium, the low replacement through propyl cellulose, polyvinylpolypyrrolidone, carboxymethyl starch sodium etc., crospolyvinylpyrrolidone can make tablet meet behind the water the short as far as possible time (<3min) in the very little granule of disintegrate one-tenth and form uniform suspension.
(2) select for use microcrystalline Cellulose to make the filler of tablet.Microcrystalline Cellulose is good tablet filler and double as binding agent, and it is good to have compressibility, unilateral characteristics attractive in appearance.
(3) select for use stevioside as correctives.Stevioside is a good correctives, and consumption is low, the sugariness height, and mouthfeel is good.
(4) select for use micropowder silica gel to make fluidizer.Micropowder silica gel can improve the flowability of granule or powder effectively when pelletizing press sheet or direct powder compression, simultaneously, can significantly improve the disintegrate and the dissolution rate of advising soluble drug behind the silanol base on the silica gel surface absorption medicine.
(5) select for use magnesium stearate to make lubricant.It is the excellent lubrication agent, and easy and granule mixing reduces the frictional force between granule and the punch die, and is unilateral bright and clean attractive in appearance behind the tabletting.
(6) selecting concentration 95% ethanol system soft material is wetting agent.Wetting agent water generally commonly used, ethanol etc.Because the present invention is raw material with the Chinese medicine extract, use water as wetting agent merely, the viscosity difficulty of sieving too greatly.So consider to make wetting agent with the ethanol of variable concentrations (75%, 85%, 95%).Through the result of the test that table 1 provides, select 95% concentration of alcohol optimum.It can be seen from the table, along with the reduction of moisture, particle viscosity reduces, and the slice, thin piece compressibility strengthens.
Table 1
Concentration of alcohol The situation of sieving The granule ratio of sieving Pellet hardness
75% It is agglomerating to bond, sad sieve 60% Very hard, difficult tabletting
85% The fraction bonding is agglomerating, sad sieve 80% Harder, tabletting pressure is big
95% Easily sieve 95% Hardness is moderate, easily presses
(7) select suitable bake out temperature.The wet grain drying temperature generally is controlled at 60-80 ℃ and is advisable, and this temperature, gets final product so baking temperature is controlled at 60 ℃ because the present invention adopts 95% alcohol granulation not influence of active ingredient.
(8) the adding method of selection disintegrating agent.Adopt outer addition can reach disintegrate effect preferably (1 minute and 58 seconds).
(9) select critical relative humidity.Through the result of the test that table 2 provides, it is suitable that the relative humidity of environment is controlled at below 60%.
Table 2
Figure A20091013565000051
The specific embodiment:
Embodiment 1: get Radix Notoginseng total arasaponins 100g, microcrystalline Cellulose 170g, stevioside 10g are with 95% ethanol system soft material, with No. 3 sieve series grains; 60 ℃ of oven dry get granule behind No. 3 sieve granulate; Add crospolyvinylpyrrolidone 15g in the granule, micropowder silica gel 3g, magnesium stearate 2g mixing, tabletting is made 1000.Oral, a 50~100mg, 3 times on the one.
Embodiment 2: get Radix Notoginseng total arasaponins 80g, microcrystalline Cellulose 160g, stevioside 10g are with 95% ethanol system soft material, with No. 3 sieve series grains; 60 ℃ of oven dry get granule behind No. 3 sieve granulate; Add crospolyvinylpyrrolidone 13g in the granule, micropowder silica gel 3g, magnesium stearate 2g mixing, tabletting is made 1000.Oral, a 50~100mg, 3 times on the one.

Claims (6)

1, a kind of Xuesaitong dispersible tablet is characterized in that, by weight, proportioning raw materials is: 80~100 parts of Radix Notoginseng total arasaponinss, 150~190 parts of microcrystalline Cellulose, 8~10 parts of steviosides, 13~17 parts of crospolyvinylpyrrolidone, 2~4 parts of micropowder silica gels, 1~3 part of magnesium stearate.
2, Xuesaitong dispersible tablet according to claim 1 is characterized in that, by weight, proportioning raw materials is: 100 parts of Radix Notoginseng total arasaponinss, 170 parts of microcrystalline Cellulose, 10 parts of steviosides, 15 parts of crospolyvinylpyrrolidone, 3 parts of micropowder silica gels, 2 parts of magnesium stearate.
3, Xuesaitong dispersible tablet according to claim 1 is characterized in that, Xuesaitong dispersible tablet is in 1000, make by following raw material: Radix Notoginseng total arasaponins 100g, microcrystalline Cellulose 170g, stevioside 10g, crospolyvinylpyrrolidone 15g, micropowder silica gel 3g, magnesium stearate 2g.
4, preparation is according to the technology of the said Xuesaitong dispersible tablet of claim 1, it is characterized in that, press Radix Notoginseng total arasaponins 80~100 weight portions, microcrystalline Cellulose 150~190 weight portions, stevioside 8~10 weight portions, crospolyvinylpyrrolidone 13~17 weight portions, micropowder silica gel 2~4 weight portions, magnesium stearate 1~3 weight portion batching; Get the Radix Notoginseng total arasaponins in the said ratio, microcrystalline Cellulose, stevioside are with 95% ethanol system soft material, with No. 3 sieve series grains; 60 ℃ of oven dry get granule behind No. 3 sieve granulate; Add crospolyvinylpyrrolidone in the granule, micropowder silica gel, the magnesium stearate mixing, tabletting, promptly.
5, preparation is characterized in that according to the technology of the said Xuesaitong dispersible tablet of claim 4 get Radix Notoginseng total arasaponins 100g, microcrystalline Cellulose 170g, stevioside 10g are with 95% ethanol system soft material, with No. 3 sieve series grains; 60 ℃ of oven dry get granule behind No. 3 sieve granulate; Add crospolyvinylpyrrolidone 15g in the granule, micropowder silica gel 3g, magnesium stearate 2g mixing, tabletting is made 1000.
6, preparation is characterized in that according to the technology of the said Xuesaitong dispersible tablet of claim 5 with 95% ethanol system soft material, the ethanol consumption is the 7%-8% of medicated powder weight during granulation, and unit is ml/g.
CN200910135650A 2009-04-24 2009-04-24 Xuesaitong dispersible tablet and preparation method thereof Pending CN101537026A (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102627680A (en) * 2012-03-21 2012-08-08 浙江维康药业有限公司 Ginsenoside Rg1 compound and pharmaceutical composition containing the same
CN105055476A (en) * 2015-08-24 2015-11-18 江苏红瑞制药有限公司 Radix notoginseng saponin dispersible tablet and preparing method thereof
CN113069426A (en) * 2021-04-09 2021-07-06 海南海力制药有限公司 Preparation method of Xuesaitong dispersion tablet and Xuesaitong dispersion tablet

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102627680A (en) * 2012-03-21 2012-08-08 浙江维康药业有限公司 Ginsenoside Rg1 compound and pharmaceutical composition containing the same
CN102627680B (en) * 2012-03-21 2013-04-03 浙江维康药业有限公司 Ginsenoside Rg1 compound and pharmaceutical composition containing the same
CN105055476A (en) * 2015-08-24 2015-11-18 江苏红瑞制药有限公司 Radix notoginseng saponin dispersible tablet and preparing method thereof
CN105055476B (en) * 2015-08-24 2019-01-15 江苏红瑞制药有限公司 A kind of Xuesaitong dispersible tablet and preparation method thereof
CN113069426A (en) * 2021-04-09 2021-07-06 海南海力制药有限公司 Preparation method of Xuesaitong dispersion tablet and Xuesaitong dispersion tablet

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Open date: 20090923