CN1887315A - Fukean dispersible tablet and preparation method thereof - Google Patents
Fukean dispersible tablet and preparation method thereof Download PDFInfo
- 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
- Authority
- CN
- China
- Prior art keywords
- adjuvant
- fukean
- silica gel
- tabletting
- disperser
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 239000007919 dispersible tablet Substances 0.000 title claims abstract description 10
- 238000002360 preparation method Methods 0.000 title claims abstract description 9
- 238000005469 granulation Methods 0.000 claims abstract description 21
- 230000003179 granulation Effects 0.000 claims abstract description 21
- 239000003814 drug Substances 0.000 claims abstract description 13
- -1 lso Species 0.000 claims abstract description 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 90
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 36
- 239000002671 adjuvant Substances 0.000 claims description 27
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 22
- 239000000203 mixture Substances 0.000 claims description 22
- 239000000741 silica gel Substances 0.000 claims description 22
- 229910002027 silica gel Inorganic materials 0.000 claims description 22
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 20
- 239000008101 lactose Substances 0.000 claims description 20
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 20
- 239000003826 tablet Substances 0.000 claims description 19
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 18
- 238000001035 drying Methods 0.000 claims description 18
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 claims description 18
- 235000019359 magnesium stearate Nutrition 0.000 claims description 18
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 18
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 18
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 18
- 239000001253 polyvinylpolypyrrolidone Substances 0.000 claims description 18
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims description 18
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims description 18
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 18
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 18
- 229920002472 Starch Polymers 0.000 claims description 16
- 239000008107 starch Substances 0.000 claims description 16
- 235000019698 starch Nutrition 0.000 claims description 16
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims description 12
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims description 12
- 239000011734 sodium Substances 0.000 claims description 12
- 229910052708 sodium Inorganic materials 0.000 claims description 12
- 239000011230 binding agent Substances 0.000 claims description 10
- 239000006071 cream Substances 0.000 claims description 10
- 239000000843 powder Substances 0.000 claims description 10
- 239000000706 filtrate Substances 0.000 claims description 9
- 239000008187 granular material Substances 0.000 claims description 9
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims description 8
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 8
- 229930195725 Mannitol Natural products 0.000 claims description 8
- OSGAYBCDTDRGGQ-UHFFFAOYSA-L calcium sulfate Chemical compound [Ca+2].[O-]S([O-])(=O)=O OSGAYBCDTDRGGQ-UHFFFAOYSA-L 0.000 claims description 8
- 239000007788 liquid Substances 0.000 claims description 8
- 239000000594 mannitol Substances 0.000 claims description 8
- 235000010355 mannitol Nutrition 0.000 claims description 8
- 239000012567 medical material Substances 0.000 claims description 8
- 239000007779 soft material Substances 0.000 claims description 8
- 235000019640 taste Nutrition 0.000 claims description 8
- 238000005406 washing Methods 0.000 claims description 8
- 230000001476 alcoholic effect Effects 0.000 claims description 6
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 claims description 6
- 239000000243 solution Substances 0.000 claims description 6
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims description 4
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 4
- 239000007864 aqueous solution Substances 0.000 claims description 4
- 235000011132 calcium sulphate Nutrition 0.000 claims description 4
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 4
- 235000009508 confectionery Nutrition 0.000 claims description 4
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims description 4
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims description 4
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims description 4
- 239000000811 xylitol Substances 0.000 claims description 4
- 235000010447 xylitol Nutrition 0.000 claims description 4
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims description 4
- 229960002675 xylitol Drugs 0.000 claims description 4
- 239000000470 constituent Substances 0.000 claims description 2
- 239000000463 material Substances 0.000 abstract description 5
- 241000283690 Bos taurus Species 0.000 abstract 1
- 241000209035 Ilex Species 0.000 abstract 1
- 235000003332 Ilex aquifolium Nutrition 0.000 abstract 1
- 235000002296 Ilex sandwicensis Nutrition 0.000 abstract 1
- 235000002294 Ilex volkensiana Nutrition 0.000 abstract 1
- 241000207840 Jasminum Species 0.000 abstract 1
- 235000003805 Musa ABB Group Nutrition 0.000 abstract 1
- 240000008790 Musa x paradisiaca Species 0.000 abstract 1
- 240000003109 Persicaria chinensis Species 0.000 abstract 1
- 235000015266 Plantago major Nutrition 0.000 abstract 1
- 244000294611 Punica granatum Species 0.000 abstract 1
- 235000014360 Punica granatum Nutrition 0.000 abstract 1
- 239000000853 adhesive Substances 0.000 abstract 1
- 230000001070 adhesive effect Effects 0.000 abstract 1
- 239000006185 dispersion Substances 0.000 abstract 1
- 239000000796 flavoring agent Substances 0.000 abstract 1
- 235000013355 food flavoring agent Nutrition 0.000 abstract 1
- 238000003756 stirring Methods 0.000 description 12
- 229940079593 drug Drugs 0.000 description 8
- 238000001514 detection method Methods 0.000 description 6
- 238000005070 sampling Methods 0.000 description 6
- 239000002552 dosage form Substances 0.000 description 3
- 238000005516 engineering process Methods 0.000 description 3
- 235000015424 sodium Nutrition 0.000 description 3
- 230000000694 effects Effects 0.000 description 1
- 239000002547 new drug Substances 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 238000010298 pulverizing process Methods 0.000 description 1
- 238000004064 recycling Methods 0.000 description 1
- 238000009495 sugar coating Methods 0.000 description 1
- 238000009492 tablet coating Methods 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
Abstract
The invention discloses a Fukean dispersible tablet, which mainly comprises the components of Jasminum Amplexicaule, Chinese knotweed herb, ovate leaf holly bark, plantain herb and pomegranate rind, and also comprises granulation auxiliary materials, flavoring agents, adhesives and tabletting auxiliary materials; also provides a preparation process of the dispersible tablet. The invention adds corresponding auxiliary materials into the prior Fukean dispersible tablet, promotes the Fukean dispersible tablet to disintegrate quickly, has high dispersion uniformity and ensures that the medicine can play a role quickly. The preparation process of the dispersible tablet is simple and is suitable for popularization and application.
Description
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.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610081182 CN1887315A (en) | 2006-05-24 | 2006-05-24 | Fukean dispersible tablet and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610081182 CN1887315A (en) | 2006-05-24 | 2006-05-24 | Fukean dispersible tablet and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1887315A true CN1887315A (en) | 2007-01-03 |
Family
ID=37576596
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200610081182 Pending CN1887315A (en) | 2006-05-24 | 2006-05-24 | Fukean dispersible tablet and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1887315A (en) |
Cited By (5)
| 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 |
-
2006
- 2006-05-24 CN CN 200610081182 patent/CN1887315A/en active Pending
Cited By (8)
| 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 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN1036763C (en) | Pharmaceutical composition pharmaceutical granulate and process for their preparation | |
| CN1390594A (en) | Mixture for improving blood circulation | |
| CN1929821A (en) | Pharmaceutical composition comprising pimobendan | |
| CN1887315A (en) | Fukean dispersible tablet and preparation method thereof | |
| CN101028254A (en) | Sustaining agent of Duosuo theosine and its preparation | |
| CN1868463A (en) | Slow-release prepn. contg. alpha-lipoic acid or its derivatives, and preparing method therefor | |
| CN1628662A (en) | Medicine with abirritation | |
| CN1762357A (en) | Oral medicinal formulation of moxifloxacin and its preparation method | |
| CN1194956C (en) | Extraction and purification process of general rhubarb anthraquinone and its application in preparing kidney hypofuction-treating medicine | |
| CN1301108C (en) | Metadoxine dispersible tablet and preparation method thereof | |
| CN1166402C (en) | Composite Chinese medicine with health care function | |
| CN1823805A (en) | Ground erythromycin enteric micropill and its preparation method | |
| CN1723998A (en) | Compound red-rooted salvia prepn., and its prepn. method | |
| CN100340239C (en) | Andrographolide dispersing tablets | |
| CN1698668A (en) | Motherwort extract dispersed tablet and preparation method of motherwort extract | |
| CN1923182A (en) | Lacidipine tablets disintegrating in oral cavity and process for producing same | |
| CN101057866A (en) | Method for preparing 'kelike' capsule | |
| CN1626211A (en) | Astragalus-leech preparation of lowering blood sugar for treating diabetes and syndrome and preparation method | |
| CN1287800C (en) | Medicine for regulating nerve system, treating epilepsia disease | |
| CN1814129A (en) | Compound black-bone chicken tablet, its preparing method and quality control method | |
| CN1309398C (en) | Orally disintegrating tablet for treating cardiovascular diseases and its preparing process | |
| CN1206991C (en) | Preparation containing Cetirizine Hydrochloride and hydrochloric pseudoephedrine and its prepn. method | |
| CN100346791C (en) | Controlled and released preparation of kurarinone detained in stomach | |
| CN1875950A (en) | Compound capsule of glycyrrhzin and preparation method thereof | |
| CN1915116A (en) | Gingko milk beverage and preparation method |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C12 | Rejection of a patent application after its publication | ||
| RJ01 | Rejection of invention patent application after publication |