CN1861158A - Dispersing tablets of Liuwei-dihuang extract or its add-substract components, and its prepn. method - Google Patents
Dispersing tablets of Liuwei-dihuang extract or its add-substract components, and its prepn. method Download PDFInfo
- Publication number
- CN1861158A CN1861158A CN 200510070396 CN200510070396A CN1861158A CN 1861158 A CN1861158 A CN 1861158A CN 200510070396 CN200510070396 CN 200510070396 CN 200510070396 A CN200510070396 A CN 200510070396A CN 1861158 A CN1861158 A CN 1861158A
- Authority
- CN
- China
- Prior art keywords
- extract
- plus
- minus
- drugs containing
- dispersible tablet
- 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
Landscapes
- Medicines Containing Plant Substances (AREA)
Abstract
A Chinese medicine 'Dispersing tablet of six drugs including rehmannia' or its analogs containing more or less drugs is prepared from the extracts of active drugs, disintegrant, filler, lubricant, adhesive and wetting agent proportionally. Its preparing process is also disclosed.
Description
One, technical field
Six drugs containing rehmanniae or its side of plus-minus dispersible tablet and preparation method thereof relate to medical technical field.
Two, background technology
Form of Chinese drug has had significant progress in recent years, and rise the fifties, and Chinese medicinal tablet, injection, liniment, electuary, liniment and aerosol etc. are successfully used to clinical; The later stage seventies has been found large quantities of effective Chinese herbal medicine and effective site, effective ingredient, and has made tablet, injection, liniment, electuary etc. to the mid-80; From the later stage eighties so far, new dosage form continues to bring out, comprising Chinese medicine novel forms such as capsule (containing soft capsule), granule, oral liquid, pill (containing micropill, drop pill), intravenous injection emulsion and suspensoid, Chinese medicine preparation capable of permeating skin, Chinese medicine microencapsulations.The research of quick-acting preparations such as present dispersible tablet has launched in Chinese medicine preparation, but only limits to the research of Chinese medicine single component at present, for the research of Chinese medicine extract and Chinese medicine compound dispersible tablet, there is no report both at home and abroad.
Six drugs containing rehmanniae comes from the Song dynasty and cures key to Therapeutics of Children's Diseases one book that tame money Zhong Yang is shown, and is made up of Radix Rehmanniae Preparata, Fructus Corni, Rhizoma Dioscoreae, Rhizoma Alismatis, Cortex Moutan, Poria 6 flavor medical materials, has the effect of nourishing kidney yin, and Chang Zuowei treats the square substantially of deficiency of kidney yin disease.The dosage form of list marketing at present has: tablet, capsule (containing soft capsule), granule, electuary, unguentum, oral liquid, pill (containing concentrated pill, the watered pill).Tradition six drugs containing rehmanniae tablet is a coated tablet, and the coating time is long, needs adjuvant many, and anti-moisture absorption is poor, and taking dose big (each 8), prolonged disintegration (disintegration time is about 60 minutes), and onset waits shortcoming slowly.Existing six drugs containing rehmanniae oral liquid, in storage process, easy muddiness or the precipitation of producing easily gone mouldy, poor stability, volume is bigger, stores and transport and carry all inconvenient.
And dispersible tablet, than ordinary tablet, the production equipment that had both had conventional tablet is simple, is convenient to the advantage of packing, storing and transport and carry, the strong point that the taking convenience of oral liquid and granule is arranged again, available water is taken after mixing it with water, also can be directly oral, therefore, the application's research purpose is to make six drugs containing rehmanniae or reach the Tabules variation of plus-minus side, and the change mouthfeel, for clinicist and patient, particularly dysphagia provide more selection.The application's dispersible tablets of Chinese medicine has added an amount of correctives to change mouthfeel, and its dosage is accurate, and especially old man and dysphagia patients are taken like a shot.Therefore, exploitation this product is that six drugs containing rehmanniae and plus-minus formula extraction dispersible tablet have broad prospects.
Three, summary of the invention
The present invention relates to six drugs containing rehmanniae or its side of plus-minus dispersible tablet, its taking convenience, good absorbing, and long term storage steady quality.The invention still further relates to the preparation method of this dispersible tablet, this method does not have specific (special) requirements to equipment, is fit to the big production of scale.
Serve as the examination index with the dispersing uniformity of tablet in the experiment, to the main constituent in the prescription: as main filler: lactose, microcrystalline Cellulose, starch, dextrin, mannitol; Main disintegrating agent: carboxymethyl starch sodium, polyvinylpolypyrrolidone, uprightly collapse, super carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose and compatibility thereof; Main wetting agent or binding agent: 10～95% ethanol, 2～10% polyvinylpyrrolidones, the alcoholic solution of 2～10% polyvinylpyrrolidones, 2～10% hydroxypropyl emthylcelluloses and water; Main lubricant: magnesium stearate, Pulvis Talci, Stepanol MG, sodium lauryl sulphate or differential silica gel etc. screen.The result shows:
(1) dissimilar disintegrating agents to the dispersing uniformity influence of dispersible tablet are in proper order: carboxymethyl starch sodium (CMS-Na)＞polyvinylpolypyrrolidone (PPVP)＞low-substituted hydroxypropyl cellulose (L-HPC)＞cross-linking sodium carboxymethyl cellulose (SCMC-NA); The disintegrating agent consumption increases to 20% by 10%, and its dispersing uniformity descends on the contrary;
(2) water solublity of increase filler, the dispersing uniformity of tablet can increase.The filler of drafting dispersible tablet is a lactose;
(3) select water, 10～95% ethanol, 2～10% polyvinylpyrrolidones, the alcoholic solution of 2～10% polyvinylpyrrolidones, 2～10% hydroxypropyl emthylcelluloses, as wetting agent or adhesive, dispersing uniformity to dispersible tablet does not have significant difference, can take the circumstances into consideration to select for use according to kind.
(4) during the disintegrating agent coupling of variety classes and consumption, the dispersing uniformity of dispersible tablet is significantly improved.
Unified prescription be studies show that: the hardness of tablet is big more, and its disintegrate is slow more, and jitter time is long more, takes all factors into consideration the friability and the disintegration of tablet, and the hardness of drafting dispersible tablet is 3～4kg; By above analysis as can be known, the principal element that influences the dispersing uniformity of dispersible tablet is: the kind of disintegrating agent, the consumption of disintegrating agent.
Six drugs containing rehmanniae of the present invention or its side of plus-minus dispersible tablet are made up of Chinese medicine extract and adjuvant, described extract is made by six drugs containing rehmanniae or its plus-minus formula extraction, described adjuvant is disintegrating agent, filler, lubricant and 10～95% ethanol, and the prescription that optimizes is characterized in that the percentage by weight of each component is as follows:
Extract 5%～70%
Disintegrating agent 10%～50%
Filler 20%～80%
Lubricant 0%～0.5%
90% ethanol is an amount of
Above-mentioned each component sum is 100%.
Extract wherein is selected from a kind of in six drugs containing rehmanniae extract, ZHIBAIDIHUANG extract, Maiwei-dihuang extract, Lycium-rehmannia extract, Mingmu-Dihuang extract or the osmanthus attached glutinous rehmannia extract.Wherein disintegrating agent is one or more in carboxymethyl starch sodium, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, the low-substituted hydroxypropyl cellulose.Wherein filler is one or more in lactose, microcrystalline Cellulose, starch, dextrin, the mannitol.Wherein lubricant is one or more in magnesium stearate, Pulvis Talci, Stepanol MG (sodium), the micropowder silica gel.Also can select other disintegrating agents with disintegration well known in the art, other filler and other lubricant with lubrication with filling effect is used in the present invention.
Adopt wet granule compression tablet (90% ethanol is as wetting agent) and two kinds of technology film-makings of direct powder compression respectively, investigate the dispersing uniformity of tablet, experimental result shows that the dispersing uniformity of wet granulation and the prepared dispersible tablet of direct compression does not have significant difference, in order to control particulate flowability, increase the homogeneity of preparation, intend adopting wet granule compression tablet.
Adopt the technology of wet granulation as follows:
(1) each component is crossed 100 mesh sieves respectively, get extract, disintegrating agent, filler, mix homogeneously;
(2) with 90% ethanol system soft material, 18～24 mesh sieves are granulated, and wet grain is in 50～80 ℃ of dryings;
(3) 18～30 mesh sieve granulate add lubricant, tabletting, and the bag film-coat gets described dispersible tablet.
Advantage of the present invention is: the dosage form novelty, have taking convenience, and absorbability is good, and gastrointestinal irritation is littler, and the long term storage steady quality is particularly suitable for old man and dysphagia patients and uses.Preparation technology is simple, and equipment is not had specific (special) requirements, is fit to the big production of scale.
The prescription composition of six drugs containing rehmanniae and the method for making of extract are as follows:
The prescription of six drugs containing rehmanniae form, preparation method of extract
Radix Rehmanniae Preparata 160g, Fructus Corni (system) 80g, Cortex Moutan 60g, Rhizoma Dioscoreae 80g, Poria 60g, Rhizoma Alismatis 60g
Above Six-element, volatile oil is extracted in the Cortex Moutan distillation, and the aqueous solution after distillation device is in addition collected; Fructus Corni is with 70% alcohol reflux secondary, and each 2 hours, merge extractive liquid, filtered filtrate for later use.Radix Rehmanniae Preparata, Rhizoma Dioscoreae, Rhizoma Alismatis decoct with water secondary, and 2 hours for the first time, 1 hour for the second time, collecting decoction, filter, filtrate and above-mentioned aqueous solution merge, and being evaporated to relative density is the clear paste of 1.15～1.20 (50 ℃ of heat are surveyed), put cold, add ethanol and make and contain alcohol amount and reach 70%, left standstill 48 hours, get the merging of supernatant and above-mentioned Fructus Corni extracting solution, decompression recycling ethanol is to there not being the alcohol flavor, and is standby; After Poria adds water boil, in 80 ℃ of warm macerating secondaries, each 1.5 hours, merge leachate, filter, filtrate decompression is concentrated into the clear paste that relative density is 1.15～1.20 (50 ℃ of heat are surveyed), merges with above-mentioned reserve liquid, being concentrated into relative density is the thick paste of 1.30 (50 ℃ of heat are surveyed), drying under reduced pressure is ground into fine powder, adds Cortex Moutan volatile oil, mixing, promptly.
Prescription and dosage are determined: with reference to soft capsule and pill standard (WS3-B-3774-98): every day 3 times; Once take and be equivalent to raw medicinal herbs 3 grams.The dispersible tablet of making is taken 2～4 at every turn, is equivalent to raw medicinal herbs 3 grams.
The prescription of ZHIBAIDIHUANG form, preparation method of extract
Rhizoma Anemarrhenae 40g, Radix Rehmanniae 160g, Cortex Phellodendri 40g, Fructus Corni (system) 80g, Rhizoma Dioscoreae 80g, Cortex Moutan 60g, Poria 60g, Rhizoma Alismatis 60g
More than eight flavors, Rhizoma Alismatis, Poria, the Rhizoma Anemarrhenae, Cortex Phellodendri powder are broken into coarse powder, decoct with water secondary, 3 hours for the first time, 2 hours for the second time, collecting decoction filtered, filtrate is condensed into the clear paste that relative density is 1.30～1.35 (20 ℃); Get the Radix Rehmanniae Preparata section, decoct with water three times, 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, collecting decoction filtered, and filtrate is condensed into the clear paste that relative density is 1.30～1.35 (20 ℃); Get Cortex Moutan 40g, Fructus Corni 46.9g, according to the percolation under fluid extract and the extractum item (17 pages of appendix of Chinese Pharmacopoeia version in 2000), make solvent with 70% ethanol, flood after 24 hours, carry out percolation, collect the liquid of filtering, reclaim ethanol, be condensed into the clear paste of relative density 1.30～1.35 (20 ℃); Get Rhizoma Dioscoreae, remaining Fructus Corni and remaining Cortex Moutan and be ground into fine powder, with above-mentioned each clear paste mixing, promptly.
Prescription and dosage are determined: with reference to concentrated pill standard (07 WS3-B-1357-93 of Chinese medicine promulgated by the ministries or commissions of the Central Government): every day 3 times; Once take and be equivalent to raw medicinal herbs 3 grams.The dispersible tablet of making is taken 2～4 at every turn, is equivalent to raw medicinal herbs 3 grams.
The prescription of Maiwei-dihuang form, preparation method of extract
Radix Ophiopogonis 45g, Fructus Schisandrae Chinensis 30g, Radix Rehmanniae Preparata 120g, Fructus Corni (system) 60g, Cortex Moutan 45g, Rhizoma Dioscoreae 60g, Poria 45g, Rhizoma Alismatis 45g
More than eight flavors, decoct with water secondary, each 2 hours, collecting decoction filtered, filtrate is concentrated into about 3000ml, placement is spent the night, and gets supernatant, filters, filtrate continuation is concentrated into about 900ml, cold preservation 24 hours, filtration, filtrate is concentrated promptly.
Prescription and dosage are determined: with reference to oral liquid standard (WS3-B-1135-92): oral, a 10ml once takes for 2 times on the one and to be equivalent to raw medicinal herbs 3.9 grams.The dispersible tablet of making is taken the 2-4 sheet at every turn, is equivalent to raw medicinal herbs 3.9 grams.
The prescription of Lycium-rehmannia form, preparation method of extract
Fructus Lycii 33g, Flos Chrysanthemi 33g, Radix Rehmanniae Preparata 130g, Fructus Corni (system) 65g, Cortex Moutan 50g, Rhizoma Dioscoreae 65g, Poria 50g, Rhizoma Alismatis 50g
More than eight flavors, Flos Chrysanthemi, Cortex Moutan vapor distillation, it is an amount of to collect distillate, device preservation in addition; Medicinal residues decoct with water 1.5 hours, filter, and medicinal liquid is standby.Fructus Lycii, Radix Rehmanniae Preparata, Fructus Corni, Rhizoma Dioscoreae, Rhizoma Alismatis decoct with water secondary, and 2 hours for the first time, 1.5 hours for the second time, collecting decoction filtered.Filtrate and Flos Chrysanthemi, Cortex Moutan decocting liquid merge, and are concentrated into about 880ml, put coldly, add ethanol and make and contain the alcohol amount and reach 70%, stir evenly, and leave standstill 48 hours, filter recovery ethanol.Poria decocts with water secondary, and 2 hours for the first time, 1.5 hours for the second time, collecting decoction filtered, and filtrate is concentrated in right amount.Distillate and above-mentioned each medicinal liquid are merged, concentrate promptly.
Prescription and dosage are determined: (WS3-B-2146-96) is oral with reference to the oral liquid standard, and a 10ml once takes for 2 times on the one and to be equivalent to raw medicinal herbs 4.76 grams.The dispersible tablet of making is taken 2～4 at every turn, is equivalent to raw medicinal herbs 4.76 grams.
The prescription of Mingmu-Dihuang form, preparation method of extract
Radix Rehmanniae Preparata 160g, Fructus Corni (system) 80g, Cortex Moutan 60g, Rhizoma Dioscoreae 80g, Poria 60g, Rhizoma Alismatis 60g, Fructus Lycii 60g, Flos Chrysanthemi 60g, Radix Angelicae Sinensis 60g, Radix Paeoniae Alba 60g, Fructus Tribuli 60g, Concha Haliotidis (forging) 80g
More than 12 flavors, with Radix Rehmanniae Preparata section, decoct with water three times, 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, collecting decoction filtered, filtrate is condensed into the clear paste of 1.30～1.35 (20 ℃) that relative density is; Getting Fructus Corni, Cortex Moutan, the Radix Paeoniae Alba, Flos Chrysanthemi, Radix Angelicae Sinensis 40g, Fructus Tribuli, Fructus Lycii is solvent with 70% ethanol, Rhizoma Alismatis is a solvent with 45% ethanol, according to the percolation under fluid extract and the extractum item (17 pages of appendix of Chinese Pharmacopoeia version in 2000), after flooding 24 hours respectively, carry out percolation, collection merges the liquid of filtering, and reclaims ethanol, and being condensed into relative density is the clear paste of 1.30～1.35 (20 ℃); Get Rhizoma Dioscoreae, Poria, Concha Haliotidis and Radix Angelicae Sinensis 20g and be ground into fine powder, with above-mentioned each clear paste mixing, promptly.
Prescription and dosage are determined: with reference to concentrated pill standard (WS3-B-1755-94): 3 times on the one, once take and be equivalent to raw medicinal herbs 3～3.75 grams.The dispersible tablet of making is taken 2～4 at every turn, is equivalent to raw medicinal herbs 3～3.75 grams.
The prescription of osmanthus attached glutinous rehmannia form, preparation method of extract
Cortex Cinnamomi 20g, Radix Aconiti Lateralis Preparata (system) 20g, Radix Rehmanniae Preparata 160g, Fructus Corni (system) 80g, Cortex Moutan 60g, Rhizoma Dioscoreae 80g, Poria 60g, Rhizoma Alismatis 60g
More than eight flavors, Rhizoma Alismatis, Poria powder are broken into coarse powder, decoct with water secondary, 3 hours for the first time, 2 hours for the second time, collecting decoction filtered, filtrate is condensed into the clear paste that relative density is 1.30～1.35 (20 ℃); The Radix Rehmanniae Preparata section decocts with water three times, and 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, collecting decoction filtered, and filtrate is condensed into the clear paste that relative density is 1.30～1.35 (20 ℃); Fructus Corni and Cortex Moutan 40g are according to the percolation (17 pages of 2000 editions appendix of Chinese Pharmacopoeia) under fluid extract and the extractum item, with 70% ethanol is solvent, flood after 24 hours, carry out percolation, collect the liquid of filtering, reclaim ethanol, being condensed into relative density is the clear paste of 1.30～1.35 (20 ℃), three flavors such as remaining Cortex Moutan and all the other Rhizoma Dioscoreaes are ground into fine powder, with above-mentioned each clear paste mixing, promptly.
Prescription and dosage are determined: with reference to concentrated pill standard (WS3-B-1600-93): every day 3 times; Once take and be equivalent to raw medicinal herbs 3 grams.The dispersible tablet of making is taken 2～4 at every turn, is equivalent to raw medicinal herbs 3 grams.
Four, the specific embodiment
Embodiment 1:
By 1000 calculating that feed intake of preparation, the weight of raw material consists of, and is the extract 250g that raw material is made with the six drugs containing rehmanniae, lactose 120g, low-substituted hydroxypropyl cellulose 18g, crospolyvinylpyrrolidone 24g, microcrystalline Cellulose 135g, magnesium stearate 3g makes 1000 altogether.The heavy 450mg of sheet, hardness 3kg.
Get extract, the lactose of formula ratio, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose and crospolyvinylpyrrolidone, mix homogeneously; Ethanol system soft material with 10%, 24 mesh sieves are granulated, and wet grain is in 50～60 ℃ of dryings; 24 mesh sieve granulate add magnesium stearate, mixing, and tabletting, promptly.
Dispersing uniformity: get 2 of dispersible tablets, put jolting in the 100ml water, in 20 ± 1 ℃ of water, disintegrate also can be by No. 2 sieves (2000 editions two appendix IA of Chinese Pharmacopoeia) fully in 3min
Embodiment 2:
By 1000 calculating that feed intake of preparation, the weight of raw material consists of, and is the extract 225g that raw material is made with the six drugs containing rehmanniae, crospolyvinylpyrrolidone 197g, and microcrystalline Cellulose 12g, the sweet 11g of A Siba, Mentholum 2g, magnesium stearate 2g makes 1000 altogether.The heavy 450mg of sheet, hardness 3kg.
Preparation method: each component is crossed 100 mesh sieves respectively, with extract and crospolyvinylpyrrolidone, microcrystalline Cellulose, A Siba is sweet, mix homogeneously such as Mentholum, make wetting agent system soft material with 90% ethanol then, 18～24 mesh sieves are granulated, and wet granular carries out drying under 50～80 ℃ of conditions, through 18～24 mesh sieve granulate, add the magnesium stearate mixing, tabletting gets product.
Dispersing uniformity: get 2 of dispersible tablets, put jolting in the 100ml water, in 20 ± 1 ℃ of water, disintegrate also can be by No. 2 sieves (2000 editions two appendix IA of Chinese Pharmacopoeia) fully in 3min
Embodiment 3:
By 1000 calculating that feed intake of preparation, the weight of raw material consists of, and is the extract 250g that raw material is made with the six drugs containing rehmanniae, carboxymethyl starch sodium 22g, low-substituted hydroxypropyl cellulose 22g, microcrystalline Cellulose 210g, aspartame 12g, magnesium stearate 3g, micropowder silica gel 2g makes 1000 altogether.
Preparation method: each component is crossed 100 mesh sieves respectively, take by weighing extract, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, aspartame mix homogeneously earlier, make wetting agent system soft material with 90% ethanol then, 18～24 mesh sieves are granulated, wet granular carries out drying under 50～80 ℃ of conditions, through 18～24 mesh sieve granulate, add the magnesium stearate mixing, tabletting gets product.
Dispersing uniformity: get 2 of dispersible tablets, put jolting in the 100ml water, in 20 ± 1 ℃ of water, disintegrate also can be by No. 2 sieves (2000 editions two appendix IA of Chinese Pharmacopoeia) fully in 3min
Embodiment 4:
By 1000 calculating that feed intake of preparation, the weight of raw material consists of, with the extract 250g that ZHIBAIDIHUANG is made, lactose 120g, low-substituted hydroxypropyl cellulose 38g, carboxymethyl starch sodium 40g, microcrystalline Cellulose 100g, magnesium stearate 3g, micropowder silica gel 2g makes 1000 altogether.
Preparation method: each component is crossed 100 mesh sieves respectively, take by weighing extract, lactose, low-substituted hydroxypropyl cellulose earlier, carboxymethyl starch sodium, the microcrystalline Cellulose mix homogeneously is made wetting agent system soft material with 90% ethanol then, 18～24 mesh sieves are granulated, wet granular carries out drying under 50～80 ℃ of conditions, through 18～24 mesh sieve granulate, add the magnesium stearate mixing, tabletting gets product.
Dispersing uniformity: get 2 of dispersible tablets, put jolting in the 100ml water, in 20 ± 1 ℃ of water, disintegrate also can be by No. 2 sieves (2000 editions two appendix IA of Chinese Pharmacopoeia) fully in 3min
Embodiment 5:
By 1000 calculating that feed intake of preparation, the weight of raw material consists of, with the extract 250g that Maiwei-dihuang is made, lactose 120g, low-substituted hydroxypropyl cellulose 35g, cross-linking sodium carboxymethyl cellulose 50g, microcrystalline Cellulose 100g, magnesium stearate 3g, micropowder silica gel 2g makes 1000 altogether.
Preparation method: each component is crossed 100 mesh sieves respectively, take by weighing extract, lactose, low-substituted hydroxypropyl cellulose earlier, cross-linking sodium carboxymethyl cellulose, microcrystalline Cellulose mix homogeneously, make binding agent with the alcoholic solution of 2% polyvinylpyrrolidone then, the system soft material, 18～24 mesh sieves are granulated, and wet granular carries out drying under 50～80 ℃ of conditions, through 18～24 mesh sieve granulate, add the magnesium stearate mixing, tabletting gets product.
Dispersing uniformity: get 2 of dispersible tablets, put jolting in the 100ml water, in 20 ± 1 ℃ of water, disintegrate also can be by No. 2 sieves (2000 editions two appendix IA of Chinese Pharmacopoeia) fully in 3min
Embodiment 6:
By 1000 calculating that feed intake of preparation, the weight of raw material consists of, with the extract 250g that Lycium-rehmannia is made, lactose 120g, crosslinked dimension polyketone 35g, cross-linking sodium carboxymethyl cellulose 50g, microcrystalline Cellulose 100g, magnesium stearate 3g, micropowder silica gel 2g makes 1000 altogether.
Preparation method: each component is crossed 100 mesh sieves respectively, take by weighing extract, lactose, crosslinked dimension polyketone earlier, cross-linking sodium carboxymethyl cellulose, the microcrystalline Cellulose mix homogeneously uses water as wetting agent system soft material then, 18～24 mesh sieves are granulated, wet granular carries out drying under 50～80 ℃ of conditions, through 18～24 mesh sieve granulate, add the magnesium stearate mixing, tabletting gets product.
Dispersing uniformity: get 2 of dispersible tablets, put jolting in the 100ml water, in 20 ± 1 ℃ of water, disintegrate also can be by No. 2 sieve (2000 editions two appendix IA of Chinese Pharmacopoeia fully in 3min.
Embodiment 7:
By 1000 calculating that feed intake of preparation, the weight of raw material consists of, with the extract 250g that Mingmu-Dihuang is made, lactose 120g, polyvinylpolypyrrolidone 35g, cross-linking sodium carboxymethyl cellulose 50g, microcrystalline Cellulose 70g, magnesium stearate 3g, micropowder silica gel 2g makes 1000 altogether.
Preparation method: each component extract is crossed 100 mesh sieves respectively, take by weighing extract, lactose, mannitol and crospolyvinylpyrrolidone mix homogeneously earlier, make binding agent system soft material with the solution of 5% polyvinylpyrrolidone then, 18～24 mesh sieves are granulated, wet granular carries out drying under 50～80 ℃ of conditions, through 18～24 mesh sieve granulate, add the magnesium stearate mixing, tabletting gets product.
Dispersing uniformity: get 2 of dispersible tablets, put jolting in the 100ml water, in 20 ± 1 ℃ of water, disintegrate also can be by No. 2 sieve (2000 editions two appendix IA of Chinese Pharmacopoeia fully in 3min.
Embodiment 8
By 1000 calculating that feed intake of preparation, the weight of raw material consists of, with the extract 250g that osmanthus attached glutinous rehmannia is made, lactose 120g, crosslinked dimension polyketone 50g, cross-linking sodium carboxymethyl cellulose 35g, microcrystalline Cellulose 70g, magnesium stearate 3g, micropowder silica gel 2g makes 1000 altogether.
Preparation method: each component is crossed 100 mesh sieves respectively, take by weighing extract, lactose, crosslinked dimension polyketone, cross-linking sodium carboxymethyl cellulose, microcrystalline Cellulose mix homogeneously earlier, make binding agent system soft material with the alcoholic solution of 5% polyvinylpyrrolidone then, 24 mesh sieves are granulated, wet granular carries out drying under 50～80 ℃ of conditions, through 24～30 mesh sieve granulate, add the magnesium stearate mixing, tabletting gets product.
Dispersing uniformity: get 2 of dispersible tablets, put jolting in the 100ml water, in 20 ± 1 ℃ of water, disintegrate also can be by No. 2 sieves (2000 editions two appendix IA of Chinese Pharmacopoeia) fully in 3min.
Claims (15)
1. a six drugs containing rehmanniae or its side of plus-minus dispersible tablet are made up of six drugs containing rehmanniae or its plus-minus formula extraction, disintegrating agent, filler, lubricant and binding agent, it is characterized in that the percentage by weight of each component is as follows:
Extract 5%～70%
Disintegrating agent 10%～50%
Filler 20%～80%
Lubricant 0%～0.5%
Binding agent or wetting agent are an amount of
Above-mentioned each component sum is 100%.
2. six drugs containing rehmanniae according to claim 1 or its side of plus-minus dispersible tablet is characterized in that: extract wherein is selected from a kind of in six drugs containing rehmanniae extract, ZHIBAIDIHUANG extract, Maiwei-dihuang extract, Lycium-rehmannia extract, Mingmu-Dihuang extract and the osmanthus attached glutinous rehmannia extract.
3. six drugs containing rehmanniae according to claim 1 or its side of plus-minus dispersible tablet is characterized in that: disintegrating agent wherein is one or more in carboxymethyl starch sodium, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, starch and derivant thereof and the processing agar (TAG).
4. six drugs containing rehmanniae according to claim 1 or its side of plus-minus dispersible tablet is characterized in that: filler wherein is one or more in lactose, microcrystalline Cellulose, starch, dextrin, the mannitol.
5. six drugs containing rehmanniae according to claim 1 or its side of plus-minus dispersible tablet is characterized in that: lubricant wherein is one or more of magnesium stearate, Pulvis Talci, Stepanol MG, sodium lauryl sulphate and differential silica gel.
6. six drugs containing rehmanniae according to claim 1 or its side of plus-minus dispersible tablet, it is characterized in that: binding agent wherein or wetting agent are 10～95% ethanol, 2～10% polyvinylpyrrolidones, the alcoholic solution of 2～10% polyvinylpyrrolidones, a kind of in 2～10% hydroxypropyl emthylcelluloses and the water.
7. six drugs containing rehmanniae as claimed in claim 1 or 2 or its side of plus-minus dispersible tablet is characterized in that wherein the weight proportion of each component is as follows:
Six drugs containing rehmanniae or its plus-minus formula extraction 50～500
Microcrystalline Cellulose 50～150
Crospolyvinylpyrrolidone 15～400
A Siba sweet 2～20
Mentholum 1～10
Magnesium stearate 1～8
90% alcohol is an amount of.
8. six drugs containing rehmanniae as claimed in claim 7 or its side of plus-minus dispersible tablet is characterized in that: six drugs containing rehmanniae extract 225g, crospolyvinylpyrrolidone 197g, microcrystalline Cellulose 12g, the sweet 11g of A Siba, Mentholum 2g, magnesium stearate 2g.
As claim 1 and or 2 described six drugs containing rehmanniaes or its side of plus-minus dispersible tablet, it is characterized in that wherein the weight proportion of each component is as follows:
Six drugs containing rehmanniae or its plus-minus formula extraction 50～500
Lactose 0～250
Low-substituted hydroxypropyl cellulose 20～200
Carboxymethyl starch sodium 10～200
Microcrystalline Cellulose 20～300
Magnesium stearate 1～10
Micropowder silica gel 1～10.
10. six drugs containing rehmanniae as claimed in claim 9 or its side of plus-minus dispersible tablet is characterized in that: ZHIBAIDIHUANG extract 250g, lactose 120g, low-substituted hydroxypropyl cellulose 38g, carboxymethyl starch sodium 40g, microcrystalline Cellulose 100g, magnesium stearate 3g, micropowder silica gel 2g.
11. six drugs containing rehmanniae as claimed in claim 9 or its side of plus-minus dispersible tablet is characterized in that: Maiwei-dihuang extract 250g, lactose 120g, low-substituted hydroxypropyl cellulose 35g, cross-linking sodium carboxymethyl cellulose 50g, microcrystalline Cellulose 100g, magnesium stearate 3g, micropowder silica gel 2g.
12. six drugs containing rehmanniae as claimed in claim 9 or its side of plus-minus dispersible tablet is characterized in that: Lycium-rehmannia extract 250g, lactose 120g, polyvinylpolypyrrolidone 35g, cross-linking sodium carboxymethyl cellulose 50g, microcrystalline Cellulose 100g, magnesium stearate 3g, micropowder silica gel 2g.
13. the preparation method of six drugs containing rehmanniae according to claim 6 and plus-minus side's dispersible tablet thereof is characterized in that: Mingmu-Dihuang extract 250g, lactose 120g, polyvinylpolypyrrolidone 35g, cross-linking sodium carboxymethyl cellulose 50g, microcrystalline Cellulose 70g, magnesium stearate 3g, micropowder silica gel 2g.
14. the preparation method of six drugs containing rehmanniae according to claim 6 and plus-minus side's dispersible tablet thereof is characterized in that: osmanthus attached glutinous rehmannia extract 250g, lactose 120g, polyvinylpolypyrrolidone 50g, cross-linking sodium carboxymethyl cellulose 35g, microcrystalline Cellulose 70g, magnesium stearate 3g, micropowder silica gel 2g.
15. the preparation method of a six drugs containing rehmanniae as claimed in claim 1 or its side of plus-minus dispersible tablet is characterized in that comprising the steps:
(1) each component is crossed 100 mesh sieves respectively, get extract, disintegrating agent, filler, mix homogeneously;
(2) with 90% ethanol system soft material, 18～24 mesh sieves are granulated, and wet grain is in 50～80 ℃ of dryings;
(3) 18～30 mesh sieve granulate add lubricant, tabletting, and the bag film-coat gets described dispersible tablet.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510070396 CN1861158A (en) | 2005-05-09 | 2005-05-09 | Dispersing tablets of Liuwei-dihuang extract or its add-substract components, and its prepn. method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510070396 CN1861158A (en) | 2005-05-09 | 2005-05-09 | Dispersing tablets of Liuwei-dihuang extract or its add-substract components, and its prepn. method |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1861158A true CN1861158A (en) | 2006-11-15 |
Family
ID=37388744
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200510070396 Pending CN1861158A (en) | 2005-05-09 | 2005-05-09 | Dispersing tablets of Liuwei-dihuang extract or its add-substract components, and its prepn. method |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1861158A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102526547A (en) * | 2012-01-11 | 2012-07-04 | 廉波 | Medicine for treating diabetic bladder disease |
| CN103463397A (en) * | 2013-08-26 | 2013-12-25 | 荣成市科学技术情报研究所 | Traditional Chinese medicine composition for treating deficiency of kidney-yin |
-
2005
- 2005-05-09 CN CN 200510070396 patent/CN1861158A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102526547A (en) * | 2012-01-11 | 2012-07-04 | 廉波 | Medicine for treating diabetic bladder disease |
| CN103463397A (en) * | 2013-08-26 | 2013-12-25 | 荣成市科学技术情报研究所 | Traditional Chinese medicine composition for treating deficiency of kidney-yin |
| CN103463397B (en) * | 2013-08-26 | 2015-07-01 | 江军伟 | Traditional Chinese medicine composition for treating deficiency of kidney-yin |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN1726956A (en) | Extract product of general flavone of kudzuvine root, preparation method and application | |
| CN111939131B (en) | Solid dispersion for treating cervical spondylosis and application of solid dispersion in preparation of sustained-release preparation | |
| CN1226033C (en) | Method for preparing traditional Chinese medicine concentrated pill | |
| CN1861158A (en) | Dispersing tablets of Liuwei-dihuang extract or its add-substract components, and its prepn. method | |
| CN1745809A (en) | Liuwei Dihuang effervescent tablet and its preparation thereof | |
| CN1943756A (en) | A Chinese traditional medicinal composite used for treatment of hypertension and its preparation method | |
| CN100420471C (en) | Oral taking preparation of Chinese traditional medicine for nourishing the kidney and the lung | |
| CN108186821B (en) | Traditional Chinese medicine composition for treating nervous headache and preparation method and application thereof | |
| CN1233401C (en) | Agastache capsule for restoring healthy energy andits prepn and application | |
| CN1210054C (en) | Novel preparation method for ageratum zhengqi capsule | |
| CN1565501A (en) | Novel preparation method of | |
| CN1314434C (en) | Heat-clearing and detoxic medicine and its preparation method | |
| CN101062204A (en) | Method for preparing capsule made from asarum, scutellaria and so on and the capsule prepared by using said method | |
| CN1814250B (en) | Chinese medicine composition for treating liver cirrhosis ascites and preparation method thereof | |
| CN1672722A (en) | Heart-nourishing and tranquilizing medicine and its prepn process | |
| CN1310658C (en) | Chinese violet containing capsule and its preparing process | |
| CN101045099B (en) | Traditional Chinese medicine composition for treating high fever tic | |
| CN1238028C (en) | Method for preparing capsule of six drugs containing rehmannine | |
| CN1927376A (en) | Small thorowax droplet and preparation method thereof | |
| CN101313972A (en) | Technique for preparing new preparation of six ingredients with rehmannia | |
| CN1733107A (en) | Medicine for treating coronary disease and apoplexy sequelae and process for preparing the same | |
| CN1709478A (en) | Method for preparing Chinese medicine formulation for treating gynaecological disease | |
| CN1241615C (en) | Bolus of six drugs including Rehmannia | |
| CN1682798A (en) | Shenbao solid preparation good for kidney and its preparing method | |
| CN1569048A (en) | Novel method for preparing headache and vertigo treating medicine and its preparation |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Open date: 20061115 |