CN1315500C - Effervescence tablet of Chinese globeflower and its preparation process - Google Patents
Effervescence tablet of Chinese globeflower and its preparation process Download PDFInfo
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- CN1315500C CN1315500C CNB2005100987207A CN200510098720A CN1315500C CN 1315500 C CN1315500 C CN 1315500C CN B2005100987207 A CNB2005100987207 A CN B2005100987207A CN 200510098720 A CN200510098720 A CN 200510098720A CN 1315500 C CN1315500 C CN 1315500C
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Abstract
The present invention relates to a tropaeolum eEffervescence tablet and a preparation method thereof, which belongs to the field of traditional Chinese medicine. The effervescence tablet is composed of tropaeolum powdered extract, acid, an alkaline agent, a sweetening agent, a filling agent and a lubricant agent. The present invention has the advantages of rational matching of the kinds and the dosage of auxiliary materials and basic remedies, simple preparation process, stable quality of the effervescence tablet and good effervescence effect; the present invention is a tropaeolum eEffervescence tablet and a preparation method thereof, and the tropaeolum eEffervescence tablet has the characteristics of high bioavailability, rapid effect taking, convenient taking, stable quality, good mouth feel and convenient transportation and carrying.
Description
Technical field
The invention belongs to field of traditional Chinese medicine pharmacy, more specifically relate to a kind of Flos Trollii effervescent tablet and preparation method thereof.
Background technology
Former preparation tropaeolum oral liquid is used for wind-heat evil toxin and attacks lung, the upper respiratory tract infection that dominance of heat in the interior causes, pharyngitis, tonsillitis, and curative effect is better, is subjected to very much the welcome of extensive patients, and the market sales volume is bigger.But oral liquid is in that the aspect such as to transport, carry all inconvenient, and mouthfeel is also bad; And liquid preparation less stable often, also might microbiological contamination produce sour aerogenesis and problem such as set off an explosion has limited the use to it.
The Flos Trollii effervescent tablet changes former dosage form tropaeolum oral liquid and forms through agent.The oral administration effervescing sheet is to be the novel quick-release tablet of disintegrating agent with the effervescent, effervescent is dissolved in hot water but both have, but effervescent is dissolved in the advantage of directly taking behind the cold water again, and onset is rapid, bioavailability is high, and mouthfeel is good, is suitable for child especially, the old man takes.With tropaeolum oral liquid make into effervescent tablet both can keep former dosage form be easy to oral, absorb characteristics rapidly, simultaneously again because it is a solid preparation, transportation, easy to carry, steady quality, overcome the shortcoming that former preparation is preserved, carried inconvenience, meet the modern requirement of Chinese medicine preparation, have vast market prospect.Chinese medicine effervescent tablet Chinese medicine extractum proportion is very big, difficult point is the selection of drug extract powder and pharmaceutic adjuvant kind and ratio, selected proper supplementary material and appropriate ratio, can reduce supplementary product consumption, preparation technology is simple, easy-formation, be difficult for moisture absorption, effervescent speed is fast, and effervescent is effective, medicinal liquid clarity is good behind the effervescent, no granule.
Summary of the invention
For solving not easy-formation of Chinese medicine effervescent tablet, disintegrate is slow, and clarity is bad, and problems such as poor stability the invention provides a kind of principal agent, supplementary product kind reasonable mixture ratio, forming, good stability, Flos Trollii effervescent tablet that clarity is good after the disintegrate and preparation method thereof.
The present invention is implemented by the following technical programs.
A kind of Flos Trollii effervescent tablet of the present invention, it is made up of Flos Trollii extract powder, tartaric acid, sodium bicarbonate, sweeting agent, filler, lubricant, and the ratio of each component is:
Flos Trollii extract powder, tartaric acid, sodium bicarbonate be 92-99 part altogether, lubricant 0.5-1 part, and sweeting agent 0.5-2 part,
Filler 0-5 part, wherein Flos Trollii extract powder: tartaric acid: sodium bicarbonate is 2: 1.5: 1.5.
Wherein said Flos Trollii extract powder by Flos Trollii by weight 1 part make.
Sweeting agent is selected from a kind of in stevioside, betanin, the Aspartane, is preferably Aspartane; Filler is selected from a kind of in lactose, mannitol, the xylitol, is preferably mannitol, xylitol; Lubricant is selected from a kind of in PEG6000, PEG4000, the magnesium stearate.
Its preparation method can be mainly to comprise following process steps:
(1) the depletion Flos Nelumbinis adds 12 times of water gagings decoctions three times, and each 1.5 hours, collecting decoction filtered, filtrate decompression concentrates, and leaves standstill 24 hours, gets supernatant, filters, filtrate is concentrated into 60 ℃ of thick pastes that are determined as 1.25-1.30 of relative density, and drying under reduced pressure is ground into fine powder, gets the Flos Trollii extract powder.
(2) the equal 80 ℃ of oven dry of used adjuvant in the prescription, sieving for standby; Flos Trollii extractum fine powder and sour agent, alkaline agent, sweeting agent, filler are carried out proportion optimization by the umber of above-mentioned each component of effervescent tablet, to determine optimum formula.Filler is used for adjustment sheet heavily, and sweeting agent is used for improving mouthfeel, and lubricant plays fluidizer and lubrication when tabletting.
Below be Flos Trollii effervescent tablet prescription screening experiment:
One, the selection of sour agent and alkaline agent
In the selection of effervescent, sodium bicarbonate is as alkali source, and consumption is few, and gas production is big, and the present invention adopts sodium bicarbonate as alkali source.Because the easy moisture absorption of Chinese medical concrete powder, viscosity is big, so the selection of acid source is very important.Take by weighing a certain amount of medicated powder and mix evenly, granulate, carry out different preparations shaping prescriptions and screen, the results are shown in Table 1 with dehydrated alcohol with acid, alkali.
The screening of the different preparations shaping soda acid of table 1 prescription
| The prescription number | Medicated powder (g) | Acid kind (g) | Alkali kind (g) | The result |
| 1 2 3 4 5 6 | 20 20 20 20 20 20 | Tartaric acid 14.5 adipic acids 14.5 succinic acid 14.5 malic acids 14.5 fumaric acid 14.5 citric acids 14.5 | Sodium bicarbonate 14.5 sodium bicarbonate 14.5 sodium bicarbonate 14.5 sodium bicarbonate 14.5 sodium bicarbonate 14.5 sodium bicarbonate 14.5 | The all good effervescent of granulation, tabletting, effervescent is too slow, the bad moisture absorption of effect, the moisture absorption of can't granulating, can't granulate better, effervescent lumps slowly, can't granulate |
The result shows: the effect of prescription 1 is better, and promptly effervescent selects tartaric acid as acid source, and sodium bicarbonate is as alkali source.
Two, medicated powder, the screening of effervescent proportioning
To effervescent tablet quality influence maximum in the Chinese medicine effervescent tablet is soda acid ratio in effervescent and drug ratios and the effervescent, be screening formula, based on above-mentioned prescription 1, be factor in soda acid ratio in the ratio of shared weight of effervescent and the effervescent, do 4 horizontal comprehensive tests.
Test method: get the not commensurability medicated powder and the soda acid of different proportionings (the prescription total amount is 50g) respectively, evenly mixed, granulate with dehydrated alcohol, drying, tabletting the results are shown in Table 2.
Table 2 medicated powder, effervescent proportioning screening table
| Sequence number | Medicated powder accounts for sheet anharmonic ratio example | Effervescent accounts for sheet anharmonic ratio example | Acid accounts for the effervescent ratio | The effervescent effect | Disintegration time |
| 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 | 2/5 2/5 2/5 2/5 1/2 1/2 1/2 1/2 3/5 3/5 3/5 3/5 2/3 2/3 2/3 2/3 | 3/5 3/5 3/5 3/5 1/2 1/2 1/2 1/2 2/5 2/5 2/5 2/5 1/3 1/3 1/3 1/3 | 40％ 45％ 50％ 55％ 40％ 45％ 50％ 55％ 40％ 45％ 50％ 55％ 40％ 45％ 50％ 55％ | +++ +++ ++++ ++++ +++ +++ ++ ++ + + + + ± ± ± ± | 1 minute 28 seconds 1 minute 20 seconds 1 minute 50 seconds 1 minute 48 seconds 4 minutes 28 seconds 4 minutes 38 seconds 4 minutes 45 seconds 4 minutes 52 seconds 58 minutes 62 minutes 60 minutes 68 minutes 75 minutes 76 minutes 74 minutes 77 minutes |
It is comprehensive that relatively the effervescent effect is better with 3,4,5,6,7,8 also can, 3,4 is moderate, 5,6 a little less than, 1,2 gas releases are too big, further grope so choosing is filled a prescription to 3,4.
Three, effervescent consumption screening
Know according to above-mentioned result of the test, effervescent tablet of the present invention is promptly plastic without filler, different batches Chinese crude drug paste-forming rate is variant in considering to produce, need there be 0-5% filler space to regulate total amount, simultaneously for improving mouthfeel, the sweeting agent that can add 0.5-2%, particulate flowability when increasing tabletting can add the lubricant of 0.5-1%.
Test method: every group of test all feeds intake by 100, take by weighing prescription dried cream powder 94g, add not commensurability tartaric acid, sodium bicarbonate and an amount of filler, sweeting agent mixing, with dehydrated alcohol granulation, drying, add lubricant, mixing, tabletting, every heavy 2.5g/ sheet the results are shown in following table, the consumption during the consumption of table Chinese medicine powder, acid, alkali is every.
Table 3 effervescent consumption screening table
| Sequence number | Medicated powder (g) | Acid (g) | Alkali (g) | Disintegration time | Medicinal liquid evaluation behind the effervescent |
| 1234 | 0.94 0.94 0.94 0.94 | 0.68 0.71 0.74 0.78 | 0.74 0.71 0.68 0.64 | 2 minutes 2 minutes 3 seconds 2 minutes 38 seconds 3 minutes 40 seconds | Medicinal liquid has a small amount of floccule, and mouthfeel is poor.The medicinal liquid clarification, mouthfeel is good.Medicinal liquid is muddy slightly, and mouthfeel is general.Some muddiness of medicinal liquid, mouthfeel is general. |
Table 3 result of the test shows that the optimal proportion of prescription Chinese medicine powder and soda acid is 2: 1.5: 1.5.
Four, preparation stabilization Journal of Sex Research
In order to investigate the stability of moulding process, we place 40 ℃, relative humidity with the effervescent tablet of two aluminum laminated films packings is 75% climatic chamber, places 1 month, takes out, and appearance character, effervescent time of measuring its test front and back the results are shown in Table 4.
Comparing result before and after table 4 accelerated test
| Sample | Appearance character | The effervescent time |
| After testing before the test | The agent of yellow tablet erotic film | 1 minute 55 seconds 1 minute 42 seconds |
The result shows: this medicine has no significant change at aspects such as appearance color, physical behavior, effervescent times before and after the accelerated test, illustrates that this medicine is basicly stable, and moulding process is reasonable.
It is reasonable that Flos Trollii effervescent tablet principal agent of the present invention, adjuvant are formed with the proportioning selection, and effervescent is effective, and medicinal liquid clarity is good behind the effervescent.The Flos Trollii effervescent tablet preparation technology who makes by the present invention is simple, steady quality.
The specific embodiment
The present invention is described further by embodiment
Embodiment 1
Flos Trollii effervescent tablet preparation method comprises following process steps:
(1) depletion Flos Nelumbinis 4.5Kg adds 12 times of water gagings and decocts each 1.5 hours three times, collecting decoction, filter, filtrate decompression concentrates, and leaves standstill 24 hours, get supernatant, filter, filtrate is concentrated into 60 ℃ of thick pastes that are determined as 1.25-1.30 of relative density, drying under reduced pressure, be ground into fine powder, get Flos Trollii extract powder 920g.
(2) the equal 80 ℃ of oven dry of used adjuvant in the prescription, sieving for standby; With recipe quantity Flos Trollii extractum fine powder 920g and tartaric acid 690g, sodium bicarbonate 690g, A Sibapatan 50g, lactose 125g mixing, with dehydrated alcohol granulate, drying, add the PEG400025g mixing, be pressed into 1000, promptly.
Embodiment 2
Flos Trollii effervescent tablet preparation method comprises following process steps:
(1) depletion Flos Nelumbinis 4.5Kg adds 12 times of water gagings and decocts each 1.5 hours three times, collecting decoction, filter, filtrate decompression concentrates, and leaves standstill 24 hours, get supernatant, filter, filtrate is concentrated into 60 ℃ of thick pastes that are determined as 1.25-1.30 of relative density, drying under reduced pressure, be ground into fine powder, get Flos Trollii extract powder 990g.
(2) the equal 80 ℃ of oven dry of used adjuvant in the prescription, sieving for standby; With recipe quantity Flos Trollii extractum fine powder 990g and tartaric acid 742.5g, sodium bicarbonate 742.5g, betanin 12.5g mixing, with dehydrated alcohol granulate, drying, add magnesium stearate 12.5g mixing, be pressed into 1000, promptly.
Embodiment 3
Flos Trollii effervescent tablet preparation method comprises following process steps:
(1) depletion Flos Nelumbinis 4.5Kg adds 12 times of water gagings and decocts each 1.5 hours three times, collecting decoction, filter, filtrate decompression concentrates, and leaves standstill 24 hours, get supernatant, filter, filtrate is concentrated into 60 ℃ of thick pastes that are determined as 1.25-1.30 of relative density, drying under reduced pressure, be ground into fine powder, get Flos Trollii extract powder 984g.
(2) the equal 80 ℃ of oven dry of used adjuvant in the prescription, sieving for standby; With recipe quantity Flos Trollii extractum fine powder 984g and tartaric acid 738g, sodium bicarbonate 738g, Aspartane 16g, xylitol 8g mixing, with dehydrated alcohol granulate, drying, add the PEG600016g mixing, be pressed into 1000, promptly.
Embodiment 4
Flos Trollii effervescent tablet preparation method comprises following process steps:
(1) depletion Flos Nelumbinis 4.5Kg adds 12 times of water gagings and decocts each 1.5 hours three times, collecting decoction, filter, filtrate decompression concentrates, and leaves standstill 24 hours, get supernatant, filter, filtrate is concentrated into 60 ℃ of thick pastes that are determined as 1.25-1.30 of relative density, drying under reduced pressure, be ground into fine powder, get Flos Trollii extractum 950g.
(2) the equal 80 ℃ of oven dry of used adjuvant in the prescription, sieving for standby; With recipe quantity Flos Trollii extractum fine powder 950g and tartaric acid 712.5g, sodium bicarbonate 712.5g, A Sibapatan 25g, mannitol 81.2g mixing, with dehydrated alcohol granulate, drying, add PEG4000 18.8g mixing, be pressed into 1000, promptly.
Embodiment 5
Flos Trollii effervescent tablet preparation method comprises following process steps:
(1) depletion Flos Nelumbinis 4.5Kg adds 12 times of water gagings and decocts each 1.5 hours three times, collecting decoction, filter, filtrate decompression concentrates, and leaves standstill 24 hours, get supernatant, filter, filtrate is concentrated into 60 ℃ of thick pastes that are determined as 1.25-1.30 of relative density, drying under reduced pressure, be ground into fine powder, get Flos Trollii extractum 970g.
(2) the equal 80 ℃ of oven dry of used adjuvant in the prescription, sieving for standby; With recipe quantity Flos Trollii extractum fine powder 970g and tartaric acid 727.5g, sodium bicarbonate 727.5g, stevioside 41.25g, lactose 12.5g mixing, with dehydrated alcohol granulate, drying, add magnesium stearate 21.25g mixing, be pressed into 1000, promptly.
Claims (4)
1, a kind of Flos Trollii effervescent tablet is characterized in that this effervescent tablet is made up of following components by part by weight:
Flos Trollii extract powder, tartaric acid, sodium bicarbonate be 92-99 part altogether, lubricant 0.5-1 part, sweeting agent 0.5-2 part, filler 0-5 part, Flos Trollii extract powder wherein: tartaric acid: sodium bicarbonate is 2: 1.5: 1.5, wherein said Flos Trollii extract powder prepares as follows: the depletion Flos Nelumbinis adds 12 times of water gagings and decocts three times, and each 1.5 hours, collecting decoction, filter, filtrate decompression concentrates, and leaves standstill 24 hours, gets supernatant, filter, filtrate is concentrated into 60 ℃ of thick pastes that are determined as 1.25-1.30 of relative density, and drying under reduced pressure is ground into fine powder.
2, Flos Trollii effervescent tablet according to claim 1, sweeting agent is selected from a kind of in stevioside, betanin, the Aspartane, filler is selected from a kind of in lactose, mannitol, the xylitol, and lubricant is selected from a kind of in PEG6000, PEG4000, the magnesium stearate.
3, according to the Flos Trollii effervescent tablet of claim 1, it is characterized in that 0.204-0.220 weight portion Flos Trollii extract powder by Flos Trollii by weight 1 part make the Flos Trollii extract powder by Flos Trollii by weight 1 part make.
4, according to the preparation method of the Flos Trollii effervescent tablet of claim 1 or 2 or 3, it is characterized in that comprising following process steps:
The equal 80 ℃ of oven dry of used adjuvant in the prescription, sieving for standby; With Flos Trollii extractum fine powder and tartaric acid, sodium bicarbonate, sweeting agent, filler mixing, with dehydrated alcohol granulate, drying, add the lubricant mixing, tabletting, promptly.
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| Application Number | Priority Date | Filing Date | Title |
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| CNB2005100987207A CN1315500C (en) | 2005-09-07 | 2005-09-07 | Effervescence tablet of Chinese globeflower and its preparation process |
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| CNB2005100987207A CN1315500C (en) | 2005-09-07 | 2005-09-07 | Effervescence tablet of Chinese globeflower and its preparation process |
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| CN1315500C true CN1315500C (en) | 2007-05-16 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101606989B (en) * | 2009-04-21 | 2012-03-21 | 王平 | Novel preparation method of trollius chinensis granular preparation |
| CN105582077A (en) * | 2016-02-19 | 2016-05-18 | 承德天原药业股份有限公司 | Trollius chinensis bunge effervescent granules and preparation method thereof |
| CN106420656B (en) * | 2016-11-25 | 2018-10-02 | 广东大鹏医药科技有限公司 | A kind of trollflower effervescent tablet and preparation method thereof |
| CN108619257B (en) * | 2018-06-13 | 2021-08-06 | 广东大鹏医药科技有限公司 | Trollflower coated 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 |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1660367A (en) * | 2005-01-31 | 2005-08-31 | 北京正大绿洲医药科技有限公司 | Drop pills of canary-creeper and preparing method |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1660367A (en) * | 2005-01-31 | 2005-08-31 | 北京正大绿洲医药科技有限公司 | Drop pills of canary-creeper and preparing method |
Non-Patent Citations (1)
| Title |
|---|
| 中华人民共和国药典委员会 中华人民共和国卫生部药品标准 中药成方制剂 第17册 1998 * |
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