CN1799578A - Effervescence tablet with sowthistle tasselflower herb and spreading hedryotis herb and method for preparing the same - Google Patents
Effervescence tablet with sowthistle tasselflower herb and spreading hedryotis herb and method for preparing the same Download PDFInfo
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- CN1799578A CN1799578A CN 200510032074 CN200510032074A CN1799578A CN 1799578 A CN1799578 A CN 1799578A CN 200510032074 CN200510032074 CN 200510032074 CN 200510032074 A CN200510032074 A CN 200510032074A CN 1799578 A CN1799578 A CN 1799578A
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Abstract
The invention relates to a pharmaceutical effervescent tablet and process for preparation, wherein the effervescent tablet comprises tasselblower, oldenlandia, Urena lobata Linn., Mallotus, root of Fructus Rosae Laevigatae, spatholobus stem and right amount of adjuvant.
Description
Invention field
The present invention relates to a kind of medicine effervescent tablet and preparation method thereof, particularly a kind of premium effervescent tablet and preparation method thereof.
Background technology
HUAHONG PIAN belongs to the preferable gynecological's good medicine of curative effect; Has clearing away heat-damp and promoting diuresis, stasis-dispelling and pain-killing.The disease such as women's leukorrhagia, menoxenia, dysmenorrhea that is used for damp-heat type, and endometritis, adnexitis, pelvic inflammatory disease.The process clinical verification: HUAHONG PIAN has significantly antibiotic, antiinflammation, is the ideal Chinese herbal and crude drugs preparationses of gynecological inflammation such as treatment female pelvic inflammation, adnexitis, gynecological inflammation due to humid-heat stagnation is had better curative effect, no obvious toxic-side effects.Existing production and sales dosage form has: conventional tablet, capsule, granule, and have that dissolving is slow rapidly, bioavailability is low, take and carry problem such as inconvenience, seriously fettered applying of HUAHONG PIAN.Develop a kind of determined curative effect, cheap, mouthfeel good, the preparation that is fit to China's national situation, carries taking convenience, have no side effect, have important theoretical meaning and value for clinical application, and will produce good economic benefit and social benefit.
Summary of the invention
One object of the present invention is to disclose a kind of premium effervescent tablet; Another object of the present invention is to disclose a kind of preparation method of premium effervescent tablet.
The raw material of medicine effervescent tablet of the present invention is formed and proportioning following (by weight):
Herba Duchesneae Indicae 750-1500 part Herba Hedyotidis Diffusae 550-1050 part Radix Urenae Lobatae 750-1500 part
The white back of the body is feared 550-1050 part Radix Rhodomyrti 750-1500 part Caulis Spatholobi 750-1250 part
Herba Thlaspis 550-1050 part
The adjuvant of medicine effervescent tablet of the present invention is composed as follows: filler is lactose, microcrystalline Cellulose, mannitol, acid source is citric acid, tartaric acid, fumaric acid, malic acid, carbon dioxide source is sodium carbonate, sodium bicarbonate, stevioside, polyethylene glycol 6000, magnesium stearate, ethanol.
The adjuvant of medicine effervescent tablet of the present invention is preferably formed proportioning following (by weight):
Lactose 230-320 part tartaric acid 45-135 part ethanol 220-290 part
Stevioside 10-38 part magnesium stearate 2-15 part sodium bicarbonate 45-120 part
Polyethylene glycol 6000 12-95 part
The raw material of medicine effervescent tablet of the present invention is preferably formed proportioning and is (by weight):
1250 parts of 750 parts of Radix Urenae Lobataes of 1250 parts of Herba Hedyotidis Diffusaes of Herba Duchesneae Indicae
The white back of the body is feared 1000 parts of 1250 portions of Caulis Spatholobis of 750 parts of Radix Rhodomyrtis
90 parts in 280 parts of tartaric acid of 750 parts of lactose of Herba Thlaspis
260 parts of 8 parts of ethanol of 24 parts of magnesium stearate of stevioside
40 parts of 80 parts of polyethylene glycol 6000s of sodium bicarbonate
The preparation method of said medicine effervescent tablet:
With Herba Duchesneae Indicae, Herba Hedyotidis Diffusae, Radix Urenae Lobatae, the white back of the body is feared, Radix Rhodomyrti, Caulis Spatholobi, seven flavor Chinese crude drugs such as Herba Thlaspis decoct with water secondary, add 8 times of water gagings for the first time and decoct 2 hours, add for the second time 6 times of water gagings and decocted 1.5 hours, collecting decoction filters, filtrate is condensed into clear paste, add ethanol and make and contain alcohol amount and reach 6596, stir evenly, left standstill 24 hours, filter, decompression filtrate recycling ethanol also is condensed into clear paste, and vacuum drying (temperature 65-70 ℃, vacuum is-0.08-0.09Mpa), get dry extract, add the Herba Duchesneae Indicae fine powder, add lactose, tartaric acid, stevioside mixes, and is ground into fine powder, with ethanol system soft material, 18 mesh sieves are granulated, 60 ℃ of dryings, 20 mesh sieve granulate.Taking polyethylene glycol-6000 fusion in addition adds sodium bicarbonate, stirs, and is ground into fine powder after the cooling, crosses 80 mesh sieves, with above-mentioned granulates, magnesium stearate (crossing 80 mesh sieves) mixing, tabletting, promptly.
The premium medicine is made the premium effervescent tablet by the present invention, have taking convenience, be easy to transportation and preservation, mouthfeel is good, steady quality, determined curative effect, disintegration is short, good absorbing, instant effect, the bioavailability height, and contain low sugar, not limited by sugar avoiding patient, adiposis patient and hyperlipemic patients, be specially adapted to middle-aged and elderly people and the patient of the solid preparation of can not swallowing, can satisfy clinical different levels medication demand better, more patients are received benefits.
Following experiment is used to further specify the present invention:
Experimental example 1: filler kind and consumption are selected
According to the character of dried cream powder, serve as the examination index with granule qualification rate, hydroscopicity, adjuvants such as lactose, microcrystalline Cellulose, mannitol are selected test.
1. 100 order dried cream powder 15g were got in sample preparation, added Herba Duchesneae Indicae fine powder 12.8g, added tartaric acid 9g, made binding agent by the proportioning of table 6 design with alcoholic solution, the system soft material is crossed 18 mesh sieves and is granulated, and wet granular is dry below 60 ℃, 20 mesh sieve granulate are measured the granule recovery rate, the results are shown in Table 2.
Table 1 adjuvant and consumption thereof are selected the design of test
The prescription number | 1 | 2 | 3 | 4 | 5 | 6 |
Dried cream powder (g) tartaric acid (g) microcrystalline Cellulose (g) lactose (g) mannitol (g) | 27.8 9 28 | 27.8 9 28 | 27.8 9 28 | 27.8 9 18 | 27.8 9 18 | 27.8 9 18 |
2. the mensuration of hydroscopicity glass exsiccator that the bottom is filled the sodium chloride supersaturated solution is put into 250 ℃ constant incubator constant temperature 24 hours, and the relative humidity in this moment exsiccator is 75%.Put into the above-mentioned sample of thick about 2mm respectively in the weighing botle bottom of constant weight, the glass exsiccator interior (the weighing bottle cap is opened) of accurately weighing and being placed on the NaCl supersaturated solution is preserved weighing after 72 hours in 25 ℃ of constant incubators, be calculated as follows the moisture absorption percentage rate, the results are shown in Table 2.
Table 2 adjuvant is selected result of the test
Numbering | Granule recovery rate (%) | Hydroscopicity (%) | The granulation situation | Substrate hardness (kg/mm 2) | Disintegration (min) | Tabletting situation and outward appearance |
1 2 3 4 5 6 | 87 92 91 75 88 85 | 12.11 9.65 13.97 14.02 12.23 13.74 | A small amount of bonding; Entirely not sieving sieves the substantially entirely sticking sieve that substantially entirely sieves; Entirely do not sieve and bond on a small quantity; Entirely do not sieve and glue sieve, entirely do not sieve | 7.34 7.26 6.25 4.34 5.54 4.85 | 18 12 14 28 20 22 | Sticking not, the slice, thin piece smooth in appearance is sticking not, the slice, thin piece smooth in appearance is sticking not, slice, thin piece smooth in appearance sticking, the sheet sticking looses, the rough sticking of slice, thin piece appearance, slice, thin piece is rough |
Above result shows that selecting the 28g lactose is that filler is better.
Experimental example 2: the selection of gas-producing disintegrant kind and consumption
The most frequently used acid source is citric acid, tartaric acid, fumaric acid, malic acid, carbon dioxide source is sodium carbonate, sodium bicarbonate etc., get the dried cream powder 27.8g that contains the crude drug powder, add the 28g lactose, add the above-mentioned acid source of 9g and granulate, be numbered 1,2,3, No. 4, add 9g sodium bicarbonate mixing respectively, add 1% magnesium stearate, tabletting, observe to granulate and the tabletting situation, and measure hydroscopicity and disintegration (with reference to " an appendix XIIA of Chinese pharmacopoeia version in 2000 effervescent tablet).The results are shown in Table 3.
Table 3 adjuvant is selected result of the test
Numbering | Recovery rate (%) | Hydroscopicity (%) | The granulation situation | Disintegration (min) | Tabletting situation and outward appearance |
Prescription 1 prescription 2 prescriptions 3 prescriptions 4 | 75 92 93 - | 18.24 11.89 12.08 - | Bonding, the bonding of sieving substantially entirely of sieving substantially entirely of not sieving entirely can't be granulated | 6 2 8 - | Sticking, diffusing sheet is sticking not, smooth in appearance is sticking not, smooth in appearance- |
Above result shows, selects No. 2 prescriptions preferable, and promptly tartaric acid is as acid source.
Experimental example 3: the selection of soda acid ratio and consumption
Select tartaric acid and sodium bicarbonate to make gas-producing disintegrant, consumption through groping gas-producing disintegrant is to contain the extract powder 55%, 60% of crude drug powder and at 65% o'clock, through granulation, mixing, tabletting, measure gas release, 55% consumption gas release does not reach requirement as a result, 60% and 65% consumption gas release is more or less the same, and it is few more good more with supplementary product consumption to select, so select 60% consumption.
After adjusting the ratio of tartaric acid and sodium bicarbonate, investigate the dried cream adding gas-producing disintegrant that contains the crude drug powder, the influence to its acidity, gas release and disintegration time the results are shown in Table 4.
Table 4 bubble disintegrating agent ratio and consumption are selected
Tartaric acid: sodium bicarbonate | PH value | Gas release (ml) | Disintegration (s) |
0.76∶1 0.88∶1 1∶1 1∶0.88 1∶0.76 | 8.5 7.7 7.0 6.4 5.8 | 9 14 14 14 8 | 128 115 105 98 122 |
Above result shows, when the ratio of tartaric acid and sodium bicarbonate was 1: 1 or 1: 0.88, its gas release, disintegration all met the requirements, but acidity is undesirable when ratio is 1: 1, and mouthfeel is relatively poor, so select 1: 0.88 ratio.
Embodiment:
Prescription one:
Herba Duchesneae Indicae 1122g
Herba Hedyotidis Diffusae 750g
Radix Urenae Lobatae 1250g
The white back of the body is feared 750g
Radix Rhodomyrti 1250g
Caulis Spatholobi 1000g
Herba Thlaspis 750g
Keep within bounds dried cream 150g
The medical material of prescription one is decocted with water secondary, add 8 times of water gagings for the first time and decocted 2 hours, add 6 times of water gagings for the second time and decocted 1.5 hours, collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.18~1.23 (80 ℃), adding ethanol makes and contains alcohol amount and reach 65%, stir evenly, left standstill 24 hours, filter, decompression filtrate recycling ethanol also is concentrated into the clear paste that relative density is 1.25~1.30 (80 ℃), vacuum drying (temperature 65-70 ℃, vacuum is-0.08-0.09Mpa), about 150g gets dry extract.
Prescription two:
The about 150g of dried cream (write out a prescription one and produce)
The about 128g of Herba Duchesneae Indicae
The about 280g of lactose
The about 90g of tartaric acid
The about 24g of stevioside
The about 80g of sodium bicarbonate
The about 40g of polyethylene glycol 6000
The about 8g of magnesium stearate
The about 260ml of ethanol
Make 1000 approximately
With prescription one prepared dried cream and two the Herba Duchesneae Indicae of writing out a prescription, be ground into fine powder, add lactose, tartaric acid, stevioside mixing, add alcohol granulation, 50~600C drying, granulate; Taking polyethylene glycol-6000 40g fusion in addition adds sodium bicarbonate 80g, stirs, and is ground into fine powder after the cooling, crosses 80 mesh sieves, with above-mentioned granulates, magnesium stearate 8g (crossing 80 mesh sieves) mixing, tabletting, promptly.
Claims (6)
1, a kind of medicine effervescent tablet is characterized in that the Chinese medicine that it is made by weight ratio with following Chinese crude drug:
Herba Duchesneae Indicae 750-1500 part Herba Hedyotidis Diffusae 550-1050 part Radix Urenae Lobatae 750-1500 part
The white back of the body is feared 550-1050 part Radix Rhodomyrti 750-1500 part Caulis Spatholobi 750-1250 part
Herba Thlaspis 550-1050 part.
2, medicine effervescent tablet as claimed in claim 1, it is characterized in that this medicine effervescent tablet is the Chinese medicine made from following adjuvant: filler is lactose, microcrystalline Cellulose, mannitol, acid source is citric acid, tartaric acid, fumaric acid, malic acid, carbon dioxide source is sodium carbonate, sodium bicarbonate, stevioside, polyethylene glycol 6000, magnesium stearate, ethanol.
3,, it is characterized in that this medicine effervescent tablet is the Chinese medicine of making by weight ratio with following adjuvant as claim 1,2 described medicine effervescent tablets:
Lactose 230-320 part tartaric acid 45-135 part ethanol 220-290 part
Stevioside 10-38 part magnesium stearate 2-15 part sodium bicarbonate 45-120 part
Polyethylene glycol 6000 12-95 part.
4,, it is characterized in that this medicine effervescent tablet is to make with the raw material of following weight parts as claim 1,2,3 described medicine effervescent tablets:
1250 parts of 750 parts of Radix Urenae Lobataes of 1250 parts of Herba Hedyotidis Diffusaes of Herba Duchesneae Indicae
The white back of the body is feared 1000 parts of 1250 portions of Caulis Spatholobis of 750 parts of Radix Rhodomyrtis
90 parts in 280 parts of tartaric acid of 750 parts of lactose of Herba Thlaspis
260 parts of 8 parts of ethanol of 24 parts of magnesium stearate of stevioside
40 parts of 80 parts of polyethylene glycol 6000s of sodium bicarbonate.
5, as claim 1,2,3,4 described medicine effervescent tablets, it is characterized in that: 1122 parts of Herba Duchesneae Indicae, 750 parts of Herba Hedyotidis Diffusaes, 1250 parts of Radix Urenae Lobataes, the white back of the body is feared 750 parts, 1250 parts of Radix Rhodomyrtis, 1000 parts of Caulis Spatholobis, 750 parts of grades of Herba Thlaspis, seven flavors, decoct with water secondary, adding for the first time 8 times of water gagings decocted 2 hours, adding for the second time 6 times of water gagings decocted 1.5 hours, collecting decoction, filter, filtrate is concentrated into the clear paste that relative density is 1.18~1.23 (80 ℃), adding ethanol makes and contains alcohol amount and reach 65%, stir evenly, left standstill 24 hours, filter, decompression filtrate recycling ethanol also is concentrated into the clear paste that relative density is 1.25~1.30 (80 ℃), vacuum drying (temperature 65-70 ℃, vacuum is-0.08-0.09Mpa), get dry extract 100 parts to 200 parts.
6, as claim 1,2,3,4 described medicine effervescent tablets, it is characterized in that: claim 5 is described and dried cream and 128 parts of Herba Duchesneae Indicae that obtain are ground into fine powder, add lactose, tartaric acid, stevioside mixing, add alcohol granulation, 50~60 ℃ of dryings, granulate; Taking polyethylene glycol-600040 part fusion in addition adds 80 parts of sodium bicarbonate, stirs, and is ground into fine powder after the cooling, crosses 80 mesh sieves, with above-mentioned granulates, 8 parts of (crossing 80 mesh sieves) mixings of magnesium stearate, tabletting, promptly.
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN104096204A (en) * | 2014-07-23 | 2014-10-15 | 重庆大学 | Children lung cough effervescent tablet and preparation method thereof |
CN112546081A (en) * | 2021-01-26 | 2021-03-26 | 吉林农业科技学院 | Ginseng effervescent tablet and preparation method thereof |
CN113679753A (en) * | 2021-08-12 | 2021-11-23 | 云南植物药业有限公司 | Oral effervescent tablet for regulating blood fat and blood pressure and improving immunity and preparation method thereof |
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2005
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN104096204A (en) * | 2014-07-23 | 2014-10-15 | 重庆大学 | Children lung cough effervescent tablet and preparation method thereof |
CN104096204B (en) * | 2014-07-23 | 2017-10-13 | 重庆大学 | Lungs of Children coughs effervescent tablet and preparation method thereof |
CN112546081A (en) * | 2021-01-26 | 2021-03-26 | 吉林农业科技学院 | Ginseng effervescent tablet and preparation method thereof |
CN113679753A (en) * | 2021-08-12 | 2021-11-23 | 云南植物药业有限公司 | Oral effervescent tablet for regulating blood fat and blood pressure and improving immunity and preparation method thereof |
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