CN1887315A - Fukean disperser tablet and its prepn - Google Patents

Fukean disperser tablet and its prepn Download PDF

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Publication number
CN1887315A
CN1887315A CN 200610081182 CN200610081182A CN1887315A CN 1887315 A CN1887315 A CN 1887315A CN 200610081182 CN200610081182 CN 200610081182 CN 200610081182 A CN200610081182 A CN 200610081182A CN 1887315 A CN1887315 A CN 1887315A
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adjuvant
disperser
fukean
tablet
silica gel
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CN 200610081182
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Chinese (zh)
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张嵩
张对良
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Individual
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Individual
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Abstract

The present invention discloses Fukean disperser tablet prepared with amplexicaul jasmine leaf, Chinese knotweed, holly bark, plantain and pomegranate bark and including also pelletizing supplementary material, corrective, adhesive and tabletting supplementary material. The present invention also provides the preparation process of the disperser tablet. The Fukean disperser tablet can disintegrated fast and homogeneously to make the medicine components act fast. The disperser tablet has simple preparation process.

Description

Fukean disperser tablet and preparation method thereof
Technical field
The present invention relates to a kind of Fukean disperser tablet and preparation method thereof.
Background technology
Dispersible tablet, changes dosage form and manages as new drug research according to the relevant laws and regulations of China's drug control as a kind of pharmaceutical dosage form.Dosage forms such as the original conventional tablet of Fukean disperser tablet, oneself lists the national drug standards in.
The technology features of existing conventional tablet is that filtrate recycling ethanol is condensed into thick paste with after the medicinal material extract in the prescription, and cold drying after the pulverizing, adds suitable adjuvant, advances into granule, is pressed into tablet and sugar coating after the drying.
Also there is prolonged disintegration in existing conventional tablet, and dispersed homogeneous degree is poor, influences shortcomings such as medicine plays a role rapidly.
Summary of the invention
Technical problem to be solved by this invention is to propose the dispersive Fukean disperser tablet of the rapid disintegrate of a kind of energy, and the preparation method of Fukean disperser tablet, and can overcome the above-mentioned disadvantage of prior art, and improve the quality and the curative effect of product, satisfy needs of medical treatment better.
Technical scheme provided by the present invention is: a kind of Fukean disperser tablet, main component are Herba Oxalidis strictae, Herb Polygoni Chinensis, Cortex Ilicis Rotundae, Herba Plantaginis, Pericarpium Granati, and this dispersible tablet also includes granulation adjuvant, correctives, binding agent and tabletting adjuvant, wherein:
This granulation adjuvant is a kind of or not of the same race combination in lactose, calcium sulfate, mannitol, xylitol, starch, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, carboxymethyl starch sodium, sodium carboxymethyl cellulose, micropowder silica gel, the microcrystalline Cellulose;
This correctives is that lactose, mannitol, Bath are sweet, a kind of or not of the same race combination in the essence;
This binding agent is that the alcoholic solution of polyvidone k30 is or/and aqueous solution;
This tabletting adjuvant is a kind of or not of the same race combination in micropowder silica gel, magnesium stearate, the Pulvis Talci.
Further, described granulation adjuvant is 10% microcrystalline Cellulose, 25% low-substituted hydroxypropyl cellulose, 5% polyvinylpolypyrrolidone and 2% carboxymethyl starch sodium.
Further, described binding agent is the alcoholic solution of 5% polyvidone k30.
Further, described tabletting adjuvant is 1% micropowder silica gel, 1% magnesium stearate and 12% Pulvis Talci.
The preparation method step of above-mentioned Fukean disperser tablet is:
(1) get main constituent, corresponding percentage by weight is: Herba Oxalidis strictae 30.03%, Herb Polygoni Chinensis 30.03%, Cortex Ilicis Rotundae 20.12%, Herba Plantaginis 9.91%, Pericarpium Granati 9.91%;
(2) get above five tastes medical material, decoct with water secondary, each 2 hours, filter, it is 1.18~1.20 clear paste that filtrate is concentrated into relative density, adds ethanol and reaches 65% to containing the alcohol amount, left standstill 24 hours, and filtered, residue with 65% washing with alcohol once, leave standstill, filter, merge secondary ethanol liquid, reclaim ethanol, be condensed into thick paste, cold drying, be ground into dried cream powder, standby;
(3) with the dried cream powder of step (2) gained, add granulation adjuvant and correctives, mix homogeneously adds binding agent system soft material, granulates drying;
Wherein, the used adjuvant of granulating is: a kind of or not of the same race combination in lactose, calcium sulfate, mannitol, xylitol, starch, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, carboxymethyl starch sodium, sodium carboxymethyl cellulose, micropowder silica gel, the microcrystalline Cellulose etc.;
Correctives is: lactose, mannitol, Bath are sweet, a kind of or not of the same race combination in the essence;
Binding agent is: the alcoholic solution of polyvidone k30 or its aqueous solution;
(4) the granular medicine by step (3) gained adds tabletting adjuvant, mix homogeneously, tabletting again;
Tabletting adjuvant and consumption are: a kind of or not of the same race combination in micropowder silica gel, magnesium stearate, the Pulvis Talci.
The present invention has following advantage: add corresponding auxiliary material in existing Fukean disperser tablet, promoted that the Fukean disperser tablet disintegrate is rapid, the dispersed homogeneous degree height can promptly play a role medicine.The processing technology of this dispersible tablet is simple, is suitable for applying.
The specific embodiment
Describe the present invention in detail below in conjunction with embodiment.
Preparing 1000 Fukean disperser tablets is example:
Example 1: specification: 0.5g/ sheet
Herba Oxalidis strictae 1000g, Herb Polygoni Chinensis 1000g, Cortex Ilicis Rotundae 670g, Herba Plantaginis 330g, Pericarpium Granati 330g
Low-substituted hydroxypropyl cellulose 125g
Microcrystalline Cellulose 50g
Lactose 228g
Polyvinylpolypyrrolidone 25g
Micropowder silica gel 5g
Magnesium stearate 5g
Polyvidone k30 2g
Flavoring orange essence 1ml
Ethanol 80ml
Water 120ml
Make 1000
(1) gets above five tastes medical material, decoct with water secondary, each 2 hours, filter, filtrate is concentrated into the clear paste that relative density is 1.18~1.20 (85~90 ℃), adds ethanol and reaches 65% to containing the alcohol amount, left standstill 24 hours, and filtered, residue with 65% washing with alcohol once, leave standstill, filter, merge secondary ethanol liquid, reclaim ethanol, be condensed into thick paste, cold drying, be ground into dried cream powder, cross the 80-120 mesh sieve, standby;
(2) with granulation adjuvant lactose, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, microcrystalline Cellulose, pulverize, cross 80-120 mesh sieve, mix homogeneously respectively;
(3) ethanol is mixed with water, stir, add polyvidone k30 stirring and dissolving;
(4), add (3) and make soft material, granulation, 60-100 ℃ drying 1.5 hours, granulate with (1) and (2) mix homogeneously;
(5) with (4) and micropowder silica gel, magnesium stearate, flavoring orange essence mix homogeneously, tabletting
Sampling, detection level, disintegration, appearance character all meet corresponding drug standard, see Table 1
Table 1 three batch sample testing results
Lot number appearance character dispersing uniformity content
The disintegrate in 1.6 minutes of 20060216 pale brown color chips is by No. 2 sieves 97.6%
The disintegrate in 1.9 minutes of 20060217 pale brown color chips is by No. 2 sieves 98.1%
The disintegrate in 1.5 minutes of 20060218 pale brown color chips is by No. 2 sieves 97.2%
Example 2 specifications: 0.5g/ sheet
Herba Oxalidis strictae 1000g, Herb Polygoni Chinensis 1000g, Cortex Ilicis Rotundae 670g, Herba Plantaginis 330g, Pericarpium Granati 330g
Low-substituted hydroxypropyl cellulose 125g
Carboxymethyl starch sodium 10g
Microcrystalline Cellulose 50g
Lactose 218g
Polyvinylpolypyrrolidone 25g
Micropowder silica gel 5g
Magnesium stearate 5g
Polyvidone k30 2g
Flavoring orange essence 1ml
Ethanol 80ml
Water 120ml
Make 1000
(1) gets above five tastes medical material, decoct with water secondary, each 2 hours, filter, filtrate is concentrated into the clear paste that relative density is 1.18~1.20 (85~90 ℃), adds ethanol and reaches 65% to containing the alcohol amount, left standstill 24 hours, and filtered, residue with 65% washing with alcohol once, leave standstill, filter, merge secondary ethanol liquid, reclaim ethanol, be condensed into thick paste, cold drying, be ground into dried cream powder, cross the 80-120 mesh sieve, standby;
(2) with granulation adjuvant lactose, low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, polyvinylpolypyrrolidone, microcrystalline Cellulose, pulverize, cross 80-120 mesh sieve, mix homogeneously respectively;
(3) ethanol is mixed with water, stir, add polyvidone k30 stirring and dissolving;
(4), add (3) and make soft material, granulation, 60-100 ℃ drying 1.5 hours, granulate with (1) and (2) mix homogeneously;
(5) with (4) and micropowder silica gel, magnesium stearate, flavoring orange essence mix homogeneously, tabletting
Sampling, detection level, disintegration, appearance character all meet corresponding drug standard, see Table 2
Table 2 three batch sample testing results
Lot number appearance character dispersing uniformity content
The disintegrate in 2.3 minutes of 20060219 pale brown color chips is by No. 2 sieves 99.3%
The disintegrate in 2.5 minutes of 20060220 pale brown color chips is by No. 2 sieves 98.1%
The disintegrate in 2.2 minutes of 20060221 pale brown color chips is by No. 2 sieves 99.0%
Example 3 specifications: 0.25g/ sheet
Herba Oxalidis strictae 1000g, Herb Polygoni Chinensis 1000g, Cortex Ilicis Rotundae 670g, Herba Plantaginis 330g, Pericarpium Granati 330g
Low-substituted hydroxypropyl cellulose 62.5g
Microcrystalline Cellulose 25g
Lactose 84g
Polyvinylpolypyrrolidone 12.5g
Micropowder silica gel 2.5g
Magnesium stearate 2.5g
Polyvidone k30 1g
Flavoring orange essence 0.5ml
Ethanol 40ml
Water 60ml
Make 1000
(1) gets above five tastes medical material, decoct with water secondary, each 2 hours, filter, filtrate is concentrated into the clear paste that relative density is 1.18~1.20 (85~90 ℃), adds ethanol and reaches 65% to containing the alcohol amount, left standstill 24 hours, and filtered, residue with 65% washing with alcohol once, leave standstill, filter, merge secondary ethanol liquid, reclaim ethanol, be condensed into thick paste, cold drying, be ground into dried cream powder, cross the 80-120 mesh sieve, standby;
(2) with granulation adjuvant lactose, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, microcrystalline Cellulose, pulverize, cross 80-120 mesh sieve, mix homogeneously respectively;
(3) ethanol is mixed with water, stir, add polyvidone k30 stirring and dissolving;
(4), add (3) and make soft material, granulation, 60-100 ℃ drying 1.5 hours, granulate with (1) and (2) mix homogeneously;
(5) with (4) and micropowder silica gel, magnesium stearate, flavoring orange essence mix homogeneously, tabletting
Sampling, detection level, disintegration, appearance character all meet corresponding drug standard, see Table 3
Table 3 three batch sample testing results
Lot number appearance character dispersing uniformity content
The disintegrate in 1.5 minutes of 20060222 pale brown color chips is by No. 2 sieves 100.3%
The disintegrate in 1.7 minutes of 20060223 pale brown color chips is by No. 2 sieves 101.1%
The disintegrate in 1.3 minutes of 20060224 pale brown color chips is by No. 2 sieves 100.5%
Example 4 specifications: 0.25g/ sheet
Herba Oxalidis strictae 1000g, Herb Polygoni Chinensis 1000g, Cortex Ilicis Rotundae 670g, Herba Plantaginis 330g, Pericarpium Granati 330g
Low-substituted hydroxypropyl cellulose 62.5g
Carboxymethyl starch sodium 5g
Microcrystalline Cellulose 25g
Lactose 79g
Polyvinylpolypyrrolidone 12.5g
Micropowder silica gel 2.5g
Magnesium stearate 2.5g
Polyvidone k30 1g
Flavoring orange essence 1ml
Ethanol 80ml
Water 120ml
Make 1000
(1) gets above five tastes medical material, decoct with water secondary, each 2 hours, filter, filtrate is concentrated into the clear paste that relative density is 1.18~1.20 (85~90 ℃), adds ethanol and reaches 65% to containing the alcohol amount, left standstill 24 hours, and filtered, residue with 65% washing with alcohol once, leave standstill, filter, merge secondary ethanol liquid, reclaim ethanol, be condensed into thick paste, cold drying, be ground into dried cream powder, cross the 80-120 mesh sieve, standby;
(2) with granulation adjuvant lactose, low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, polyvinylpolypyrrolidone, microcrystalline Cellulose, pulverize, cross 80-120 mesh sieve, mix homogeneously respectively;
(3) ethanol is mixed with water, stir, add polyvidone k30 stirring and dissolving;
(4), add (3) and make soft material, granulation, 60-100 ℃ drying 1.5 hours, granulate with (1) and (2) mix homogeneously;
(5) with (4) and micropowder silica gel, magnesium stearate, flavoring orange essence mix homogeneously, tabletting
Sampling, detection level, disintegration, appearance character all meet corresponding drug standard, see Table 4
Table 4 three batch sample testing results
Lot number appearance character dispersing uniformity content
The disintegrate in 2.8 minutes of 20060225 pale brown color chips is by No. 2 sieves 100.5%
The disintegrate in 2.9 minutes of 20060226 pale brown color chips is by No. 2 sieves 99.9%
The disintegrate in 2.6 minutes of 20060227 pale brown color chips is by No. 2 sieves 101.1%
Example 5 specifications: 1.0g/ sheet
Herba Oxalidis strictae 1000g, Herb Polygoni Chinensis 1000g, Cortex Ilicis Rotundae 670g, Herba Plantaginis 330g, Pericarpium Granati 330g
Low-substituted hydroxypropyl cellulose 250g
Microcrystalline Cellulose 100g
Lactose 516g
Polyvinylpolypyrrolidone 50g
Micropowder silica gel 10g
Magnesium stearate 10g
Polyvidone k30 4g
Flavoring orange essence 1ml
Ethanol 80ml
Water 120ml
Make 1000
(1) gets above five tastes medical material, decoct with water secondary, each 2 hours, filter, filtrate is concentrated into the clear paste that relative density is 1.18~1.20 (85~90 ℃), adds ethanol and reaches 65% to containing the alcohol amount, left standstill 24 hours, and filtered, residue with 65% washing with alcohol once, leave standstill, filter, merge secondary ethanol liquid, reclaim ethanol, be condensed into thick paste, cold drying, be ground into dried cream powder, cross the 80-120 mesh sieve, standby;
(2) with granulation adjuvant lactose, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, microcrystalline Cellulose, pulverize, cross 80-120 mesh sieve, mix homogeneously respectively;
(3) ethanol is mixed with water, stir, add polyvidone k30 stirring and dissolving;
(4), add (3) and make soft material, granulation, 60-100 ℃ drying 1.5 hours, granulate with (1) and (2) mix homogeneously;
(5) with (4) and micropowder silica gel, magnesium stearate, flavoring orange essence mix homogeneously, tabletting
Sampling, detection level, disintegration, appearance character all meet corresponding drug standard, see Table 5
Table 5 three batch sample testing results
Lot number appearance character dispersing uniformity content
The disintegrate in 2.3 minutes of 20060301 pale brown color chips is by No. 2 sieves 98.5%
The disintegrate in 2.6 minutes of 20060302 pale brown color chips is by No. 2 sieves 98.8%
The disintegrate in 2.5 minutes of 20060303 pale brown color chips is by No. 2 sieves 97.9%
Example 6 specifications: 1.0g/ sheet
Herba Oxalidis strictae 1000g, Herb Polygoni Chinensis 1000g, Cortex Ilicis Rotundae 670g, Herba Plantaginis 330g, Pericarpium Granati 330g
Low-substituted hydroxypropyl cellulose 250g
Carboxymethyl starch sodium 20g
Microcrystalline Cellulose 100g
Lactose 496g
Polyvinylpolypyrrolidone 50g
Micropowder silica gel 10g
Magnesium stearate 10g
Polyvidone k30 4g
Flavoring orange essence 1ml
Ethanol 80ml
Water 120ml
Make 1000
(1) gets above five tastes medical material, decoct with water secondary, each 2 hours, filter, filtrate is concentrated into the clear paste that relative density is 1.18~1.20 (85~90 ℃), adds ethanol and reaches 65% to containing the alcohol amount, left standstill 24 hours, and filtered, residue with 65% washing with alcohol once, leave standstill, filter, merge secondary ethanol liquid, reclaim ethanol, be condensed into thick paste, cold drying, be ground into dried cream powder, cross the 80-120 mesh sieve, standby;
(2) with granulation adjuvant lactose, low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, polyvinylpolypyrrolidone, microcrystalline Cellulose, pulverize, cross 80-120 mesh sieve, mix homogeneously respectively;
(3) ethanol is mixed with water, stir, add polyvidone k30 stirring and dissolving;
(4), add (3) and make soft material, granulation, 60-100 ℃ drying 1.5 hours, granulate with (1) and (2) mix homogeneously;
(5) with (4) and micropowder silica gel, magnesium stearate, flavoring orange essence mix homogeneously, tabletting
Sampling, detection level, disintegration, appearance character all meet corresponding drug standard, see Table 6
Table 6 three batch sample testing results
Lot number appearance character dispersing uniformity content
The disintegrate in 1.3 minutes of 20060304 pale brown color chips is by No. 2 sieves 99.0%
The disintegrate in 1.2 minutes of 20060305 pale brown color chips is by No. 2 sieves 98.6%
The disintegrate in 1.3 minutes of 20060306 pale brown color chips is by No. 2 sieves 99.7%

Claims (5)

1, a kind of Fukean disperser tablet, main component is Herba Oxalidis strictae, Herb Polygoni Chinensis, Cortex Ilicis Rotundae, Herba Plantaginis, Pericarpium Granati, it is characterized in that: this dispersible tablet also includes granulation adjuvant, correctives, binding agent and tabletting adjuvant, wherein:
This granulation adjuvant is a kind of or not of the same race combination in lactose, calcium sulfate, mannitol, xylitol, starch, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, carboxymethyl starch sodium, sodium carboxymethyl cellulose, micropowder silica gel, the microcrystalline Cellulose;
This correctives is that lactose, mannitol, Bath are sweet, a kind of or not of the same race combination in the essence;
This binding agent is that the alcoholic solution of polyvidone k30 is or/and aqueous solution;
This tabletting adjuvant is a kind of or not of the same race combination in micropowder silica gel, magnesium stearate, the Pulvis Talci.
2, Fukean disperser tablet according to claim 1 is characterized in that: described granulation adjuvant is 10% microcrystalline Cellulose, 25% low-substituted hydroxypropyl cellulose, 5% polyvinylpolypyrrolidone and 2% carboxymethyl starch sodium.
3, Fukean disperser tablet according to claim 1 is characterized in that: described binding agent is the alcoholic solution of 5% polyvidone k30.
4, Fukean disperser tablet according to claim 1 is characterized in that: described tabletting adjuvant is 1% micropowder silica gel, 1% magnesium stearate and 12% Pulvis Talci.
5, a kind of preparation may further comprise the steps as the preparation method of claim 1,2,3 or 4 described Fukean disperser tablets:
(1) get main constituent, corresponding percentage by weight is: Herba Oxalidis strictae 30.03%, Herb Polygoni Chinensis 30.03%, Cortex Ilicis Rotundae 20.12%, Herba Plantaginis 9.91%, Pericarpium Granati 9.91%;
(2) get above five tastes medical material, decoct with water secondary, each 2 hours, filter, it is 1.18~1.20 clear paste that filtrate is concentrated into relative density, adds ethanol and reaches 65% to containing the alcohol amount, left standstill 24 hours, and filtered, residue with 65% washing with alcohol once, leave standstill, filter, merge secondary ethanol liquid, reclaim ethanol, be condensed into thick paste, cold drying, be ground into dried cream powder, standby;
(3) with the dried cream powder of step (2) gained, add granulation adjuvant and correctives, mix homogeneously adds binding agent system soft material, granulates drying;
Wherein, the used adjuvant of granulating is: a kind of or not of the same race combination in lactose, calcium sulfate, mannitol, xylitol, starch, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, carboxymethyl starch sodium, sodium carboxymethyl cellulose, micropowder silica gel, the microcrystalline Cellulose etc.;
Correctives is: lactose, mannitol, Bath are sweet, a kind of or not of the same race combination in the essence;
Binding agent is: the alcoholic solution of polyvidone k30 or its aqueous solution;
(4) the granular medicine by step (3) gained adds tabletting adjuvant, mix homogeneously, tabletting again;
Tabletting adjuvant and consumption are: a kind of or not of the same race combination in micropowder silica gel, magnesium stearate, the Pulvis Talci.
CN 200610081182 2006-05-24 2006-05-24 Fukean disperser tablet and its prepn Pending CN1887315A (en)

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101919919B (en) * 2009-06-09 2012-02-08 张嵩 Fukean dispersible tablet and preparation method thereof
CN103655744A (en) * 2013-12-06 2014-03-26 山东中大药业有限公司 Preparation method for Fukean tablet and application of Fukean tablet in preparation of drug used for inhibiting proliferation of mouse lymphoma cell YAC-1
CN103655743A (en) * 2013-12-06 2014-03-26 山东中大药业有限公司 Preparation method for Fukean tablets and application of Fukean tablets to prepare medicaments for inhibiting mice lymphoma cell BL4 cell proliferation
CN103655742A (en) * 2013-12-06 2014-03-26 山东中大药业有限公司 Preparation method of fukean tablet and application of fukean tablet in preparation of drugs for inhibition of cell proliferation of mouse embryonic carcinoma cell P19
CN111000819A (en) * 2020-01-06 2020-04-14 一力制药股份有限公司 Fukean film-coated tablet and preparation process thereof

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101919919B (en) * 2009-06-09 2012-02-08 张嵩 Fukean dispersible tablet and preparation method thereof
CN103655744A (en) * 2013-12-06 2014-03-26 山东中大药业有限公司 Preparation method for Fukean tablet and application of Fukean tablet in preparation of drug used for inhibiting proliferation of mouse lymphoma cell YAC-1
CN103655743A (en) * 2013-12-06 2014-03-26 山东中大药业有限公司 Preparation method for Fukean tablets and application of Fukean tablets to prepare medicaments for inhibiting mice lymphoma cell BL4 cell proliferation
CN103655742A (en) * 2013-12-06 2014-03-26 山东中大药业有限公司 Preparation method of fukean tablet and application of fukean tablet in preparation of drugs for inhibition of cell proliferation of mouse embryonic carcinoma cell P19
CN103655744B (en) * 2013-12-06 2015-06-10 丛宁 Preparation method for Fukean tablet and application of Fukean tablet in preparation of drug used for inhibiting proliferation of mouse lymphoma cell YAC-1
CN103655742B (en) * 2013-12-06 2015-07-15 刘梅 Preparation method of fukean tablet and application of fukean tablet in preparation of drugs for inhibition of cell proliferation of mouse embryonic carcinoma cell P19
CN103655743B (en) * 2013-12-06 2015-07-29 刘梅 A kind of preparation method of fukean tablet and the application in preparation suppression mouse lymphoma cell BL4 cell proliferation thereof
CN111000819A (en) * 2020-01-06 2020-04-14 一力制药股份有限公司 Fukean film-coated tablet and preparation process thereof

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