CN100444834C - Effervescence tablet for treating wind-cold type cold and preparation process thereof - Google Patents
Effervescence tablet for treating wind-cold type cold and preparation process thereof Download PDFInfo
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- CN100444834C CN100444834C CNB2005100987245A CN200510098724A CN100444834C CN 100444834 C CN100444834 C CN 100444834C CN B2005100987245 A CNB2005100987245 A CN B2005100987245A CN 200510098724 A CN200510098724 A CN 200510098724A CN 100444834 C CN100444834 C CN 100444834C
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Abstract
The present invention relates to a common cold fever reducing effervescence tablet and a preparation method thereof, which belongs to the field of traditional Chinese medicine. The effervescence tablet is composed of common cold fever reducing powdered extract, beta cyclodextrin inclusion complex, acid, an alkaline agent, a sweetening agent, a filling agent and a lubricator. 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 effervescent tablet and good effervescent effect; simultaneously, cyclodextrin is used for the clathration of volatile oil, the loss of the volatile oil is reduced, and the mouth feelings are improved. The present invention is a common cold fever reducing effervescence tablet and a preparation method thereof, and the common cold fever reducing effervescence tablet has the characteristics of high bioavailability, rapid effect taking, convenient taking, stable quality, good mouth feelings 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 effervescence tablet for treating wind-cold type cold and preparation method thereof.
Background technology
Former preparation GANMAO QINGRE KELI has expelling wind and cold, the effect of the heat clearing away of inducing sweat, and is used for anemofrigid cold, has a headache and fever aversion to cold general pain, rhinorrhea with clear discharge, the treatment of cough dry pharynx, definite effect.But its volumes of formulation is bigger, carries inconvenience, and mouthfeel is bad.And after agent changes effervescence tablet for treating wind-cold type cold into, compare with granule, volume is little, and directly takes after the effervescent dissolving, and mouthfeel is better when taking, and stores and transport more convenient, meets the modern requirement of Chinese medicine preparation.
Effervescence tablet for treating wind-cold type cold is former dosage form GANMAO QINGRE KELI to be carried out form improvement and the effervescent tablet made.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 GANMAO QINGRE KELI 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, effervescence tablet for treating wind-cold type cold of good stability and preparation method thereof.
The present invention is implemented by the following technical programs.
A kind of effervescence tablet for treating wind-cold type cold of the present invention, it is made up of cold reducing-fever extract powder, tartaric acid, sodium bicarbonate, times its cyclodextrin inclusion complex, sweeting agent, filler, lubricant, cold reducing-fever extract powder, sour agent, alkaline agent account for sheet anharmonic ratio example altogether and are 89-97.5%, and three's ratio is 2: 1.65: 1.35; Sweeting agent, lubricant, filler, times its cyclodextrin inclusion complex account for sheet anharmonic ratio example altogether and are 2-11%, and sweeting agent is 0.5-2%, and filler is 0-6%, and lubricant is 0.5-1%, and cyclodextrin inclusion complex is 1.5-2%.
Effervescent tablet of the present invention is made by the raw material of following weight parts:
Herba Schizonepetae 3.3 Herba Menthaes 1 Radix Saposhnikoviae 1.7 Radix Bupleuri 1.7 Folium Perillaes 1 Radix Puerariae 1.7
Radix Platycodonis 1 Semen Armeniacae Amarum 1.3 Radixs Angelicae Dahuricae 1 Herba Corydalis Bungeanae 3.3 Rhizoma Phragmitiss 2.7
Its preparation method can be mainly to comprise following process steps:
(1) get Herba Schizonepetae, Herba Menthae, Folium Perillae and add 10 times of water gagings, soaked 2 hours, steam distillation extracted volatile oil in 6 hours, and the aqueous solution after distillation device is in addition collected, and medicinal residues are standby; Press volatile oil-times 1: 8: 80 inclusion volatile oil of its cyclodextrin-water, 50 ℃ were stirred 1 hour, and cold preservation is spent the night, and filters, and 40 ℃ of dryings of inclusion complex are ground into fine powder, promptly get doubly its cyclodextrin inclusion complex.
(2) eight flavors such as medicinal residues and all the other Radix Saposhnikoviaes add 12 times of water gagings, decoct secondary, and each 1.5 hours, collecting decoction, filter, filtrate and the merging of above-mentioned aqueous solution are concentrated into the thick paste that is determined as 1.25-1.30 under 60 ℃ of the relative densities, drying under reduced pressure is ground into fine powder, promptly gets the cold reducing-fever extract powder.
(3) the equal 80 ℃ of oven dry of used adjuvant in the prescription, sieving for standby; Cold reducing-fever extract powder, times its cyclodextrin inclusion complex, tartaric acid, sodium bicarbonate, sweeting agent, filler are carried out proportion optimization in the ratio of above-mentioned each component of effervescent tablet, to determine optimum formula.Filler is used for regulating total amount, and sweeting agent is used for improving mouthfeel, and lubricant plays fluidizer and lubrication when tabletting.
Effervescent tablet lubricant of the present invention is selected from lubricant and is selected from a kind of in PEG6000, PEG4000, the magnesium stearate.
Effervescent tablet sweeting agent of the present invention is selected from a kind of of stevioside, betanin, Aspartane, is preferably Aspartane.
Filler of the present invention is selected from a kind of in lactose, mannitol, the xylitol, is preferably mannitol, xylitol.
Below be effervescence tablet for treating wind-cold type cold 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 result shows: the effect of prescription 1 is better, and effervescent selects tartaric acid as acid source, and sodium bicarbonate is as carbon 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 that factor is carried out experiment sieving in soda acid ratio in the ratio of shared weight of effervescent and the effervescent.
Test method: get the not commensurability medicated powder and the soda acid of different proportionings (the prescription total amount is 30g) respectively, evenly mixed, granulate with dehydrated alcohol, drying, tabletting the results are shown in Table 2.
Table 2 effervescent proportioning screening table
It is comprehensive that relatively the effervescent effect is moderate with 3,4,5,6 a little less than, further grope so fill a prescription 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 0-6% 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 recipe quantity dried cream powder 110g, doubly its cyclodextrin inclusion complex mixing that adds not commensurability tartaric acid, sodium bicarbonate and an amount of filler, sweeting agent, recipe quantity, with dehydrated alcohol granulation, drying, add lubricant, mixing, tabletting, every heavy 3.0g/ sheet the results are shown in Table 3, the consumption during the consumption of table Chinese medicine powder, acid, alkali is every.
Table 3 effervescent consumption screening table
So according to table 3 result of the test as can be known, medicated powder is that 2: 1.65: 1.35 o'clock effervescent are effective with acid, alkali ratio, and disintegration rate is fast, medicinal liquid clarification behind the effervescent, and mouthfeel is good.
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 measures appearance character, the effervescent time of its test front and back, the results are shown in Table 4.
Comparing result before and after table 4 accelerated test
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 effervescence tablet for treating wind-cold type cold principal agent of the present invention, adjuvant are formed with the proportioning selection, effervescent is effective, and medicinal liquid clarity is good behind the effervescent, volatile oil with cyclodextrin inclusion compound after, avoidable loss in the storage, and can improve slice, thin piece is risen back gained medicinal liquid at bubbly water mouthfeel.Effervescence tablet for treating wind-cold type cold preparation technology of the present invention is simple, steady quality.
The specific embodiment
The present invention is described further by embodiment.
Embodiment 1
According to the shared umber of each raw material in the effervescence tablet for treating wind-cold type cold, it is standby to get following recipe quantity raw material (by the gram number):
Herba Schizonepetae 1500g Herba Menthae 450g Radix Saposhnikoviae 750g Radix Bupleuri 750g Folium Perillae 450g
Radix Puerariae 750g Radix Platycodonis 450g Semen Armeniacae Amarum 600g Radix Angelicae Dahuricae 450g Herba Corydalis Bungeanae 1500g
Rhizoma Phragmitis 1200g
(1) get Herba Schizonepetae, Herba Menthae, Folium Perillae and add 10 times of water gagings, soaked 2 hours, steam distillation extracted volatile oil in 6 hours, and the aqueous solution after distillation device is in addition collected, and medicinal residues are standby; Press volatile oil-times 1: 8: 80 inclusion volatile oil of its cyclodextrin-water, 50 ℃ of stirrings cold preservation in 1 hour is spent the night, and filters, and 40 ℃ of dryings of inclusion complex are ground into fine powder, promptly get doubly its cyclodextrin inclusion complex.
(2) eight flavors such as medicinal residues and all the other Radix Saposhnikoviaes add 12 times of water gagings, decoct secondary, and each 1.5 hours, collecting decoction, filter, filtrate and the merging of above-mentioned aqueous solution are concentrated into the thick paste that is determined as 1.25-1.30 under 60 ℃ of the relative densities, drying under reduced pressure is ground into fine powder, promptly gets the cold reducing-fever extract powder.
(3) the equal 80 ℃ of oven dry of used adjuvant in the prescription, sieving for standby; With cold reducing-fever extract powder 1068g, doubly its cyclodextrin inclusion complex 60g, tartaric acid 881g, sodium bicarbonate 721g, Aspartane 60g, xylitol 180g mixing, to granulate with dehydrated alcohol, drying adds magnesium stearate 30g mixing, is pressed into 1000, promptly.
Embodiment 2
According to the shared umber of each raw material in the effervescence tablet for treating wind-cold type cold, it is standby to get following recipe quantity raw material (by the gram number):
Herba Schizonepetae 1500g Herba Menthae 450g Radix Saposhnikoviae 750g Radix Bupleuri 750g Folium Perillae 450g
Radix Puerariae 750g Radix Platycodonis 450g Semen Armeniacae Amarum 600g Radix Angelicae Dahuricae 450g Herba Corydalis Bungeanae 1500g
Rhizoma Phragmitis 1200g
(1) get Herba Schizonepetae, Herba Menthae, Folium Perillae and add 10 times of water gagings, soaked 2 hours, steam distillation extracted volatile oil in 6 hours, and the aqueous solution after distillation device is in addition collected, and medicinal residues are standby; Press volatile oil-times 1: 8: 80 inclusion volatile oil of its cyclodextrin-water, 50 ℃ of stirrings cold preservation in 1 hour is spent the night, and filters, and 40 ℃ of dryings of inclusion complex are ground into fine powder, promptly get doubly its cyclodextrin inclusion complex.
(2) eight flavors such as medicinal residues and all the other Radix Saposhnikoviaes add 12 times of water gagings, decoct secondary, and each 1.5 hours, collecting decoction, filter, filtrate and the merging of above-mentioned aqueous solution are concentrated into the thick paste that is determined as 1.25-1.30 under 60 ℃ of the relative densities, drying under reduced pressure is ground into fine powder, promptly gets the cold reducing-fever extract powder.
(3) the equal 80 ℃ of oven dry of used adjuvant in the prescription, sieving for standby; With cold reducing-fever extract powder 1170g, doubly its cyclodextrin inclusion complex 45g, tartaric acid 965.3g, sodium bicarbonate 789.7g, stevioside 15g mixing, to granulate with dehydrated alcohol, drying adds PEG4000 15g mixing, is pressed into 1000, promptly.
Embodiment 3
According to the shared umber of each raw material in the effervescence tablet for treating wind-cold type cold, it is standby to get following recipe quantity raw material (by the gram number):
Herba Schizonepetae 1500g Herba Menthae 450g Radix Saposhnikoviae 750g Radix Bupleuri 750g Folium Perillae 450g
Radix Puerariae 750g Radix Platycodonis 450g Semen Armeniacae Amarum 600g Radix Angelicae Dahuricae 450g Herba Corydalis Bungeanae 1500g
Rhizoma Phragmitis 1200g
(1) get Herba Schizonepetae, Herba Menthae, Folium Perillae and add 10 times of water gagings, soaked 2 hours, steam distillation extracted volatile oil in 6 hours, and the aqueous solution after distillation device is in addition collected, and medicinal residues are standby; Press volatile oil-times 1: 8: 80 inclusion volatile oil of its cyclodextrin-water, 50 ℃ of stirrings cold preservation in 1 hour is spent the night, and filters, and 40 ℃ of dryings of inclusion complex are ground into fine powder, promptly get doubly its cyclodextrin inclusion complex.
(2) eight flavors such as medicinal residues and all the other Radix Saposhnikoviaes add 12 times of water gagings, decoct secondary, and each 1.5 hours, collecting decoction, filter, filtrate and the merging of above-mentioned aqueous solution are concentrated into the thick paste that is determined as 1.25-1.30 under 60 ℃ of the relative densities, drying under reduced pressure is ground into fine powder, promptly gets the cold reducing-fever extract powder.
(3) the equal 80 ℃ of oven dry of used adjuvant in the prescription, sieving for standby; With cold reducing-fever extract powder 1134g, doubly its cyclodextrin inclusion complex 52.5g, tartaric acid 936g, sodium bicarbonate 765g, betanin 30g, mannitol 60 mixings, to granulate with dehydrated alcohol, drying adds PEG6000 22.5g mixing, is pressed into 1000, promptly.
Embodiment 4
According to the shared umber of each raw material in the effervescence tablet for treating wind-cold type cold, it is standby to get following recipe quantity raw material (by the gram number):
Herba Schizonepetae 1500g Herba Menthae 450g Radix Saposhnikoviae 750g Radix Bupleuri 750g Folium Perillae 450g
Radix Puerariae 750g Radix Platycodonis 450g Semen Armeniacae Amarum 600g Radix Angelicae Dahuricae 450g Herba Corydalis Bungeanae 1500g
Rhizoma Phragmitis 1200g
(1) get Herba Schizonepetae, Herba Menthae, Folium Perillae and add 10 times of water gagings, soaked 2 hours, steam distillation extracted volatile oil in 6 hours, and the aqueous solution after distillation device is in addition collected, and medicinal residues are standby; Press volatile oil-times 1: 8: 80 inclusion volatile oil of its cyclodextrin-water, 50 ℃ of stirrings cold preservation in 1 hour is spent the night, and filters, and 40 ℃ of dryings of inclusion complex are ground into fine powder, promptly get doubly its cyclodextrin inclusion complex.
(2) eight flavors such as medicinal residues and all the other Radix Saposhnikoviaes add 12 times of water gagings, decoct secondary, and each 1.5 hours, collecting decoction, filter, filtrate and the merging of above-mentioned aqueous solution are concentrated into the thick paste that is determined as 1.25-1.30 under 60 ℃ of the relative densities, drying under reduced pressure is ground into fine powder, promptly gets the cold reducing-fever extract powder.
(3) the equal 80 ℃ of oven dry of used adjuvant in the prescription, sieving for standby; With cold reducing-fever extract powder 1100g, doubly its cyclodextrin inclusion complex 54g, tartaric acid 907.5g, sodium bicarbonate 742.5g, Aspartane 21g, lactose 150g mixing is granulated with dehydrated alcohol, and drying adds magnesium stearate 25g mixing, is pressed into 1000, promptly.
Claims (2)
1, a kind of effervescence tablet for treating wind-cold type cold is characterized in that, this effervescent tablet is made up of cold reducing-fever extract powder, tartaric acid, sodium bicarbonate, times its cyclodextrin inclusion complex, sweeting agent, filler, lubricant;
Cold reducing-fever extract powder, tartaric acid, sodium bicarbonate account for sheet anharmonic ratio example altogether and are 89-97.5%, and three's ratio is 2: 1.65: 1.35;
Sweeting agent, lubricant, filler, times its cyclodextrin inclusion complex account for sheet anharmonic ratio example altogether and are 2-11%, and sweeting agent is 0.5-2%, and filler is 0-6%, and lubricant is 0.5-1%, and cyclodextrin inclusion complex is 1.5-2%;
The cold reducing-fever extract powder is to be made by following bulk drugs:
Herba Schizonepetae 3.3 Herba Menthaes 1 Radix Saposhnikoviae 1.7 Radix Bupleuri 1.7 Folium Perillaes 1 Radix Puerariae 1.7
Radix Platycodonis 1 Semen Armeniacae Amarum 1.3 Radixs Angelicae Dahuricae 1 Herba Corydalis Bungeanae 3.3 Rhizoma Phragmitiss 2.7;
This effervescence tablet for treating wind-cold type cold is to be prepared from by following method:
(1) get Herba Schizonepetae, Herba Menthae, Folium Perillae and add 10 times of water gagings, soaked 2 hours, steam distillation extracted volatile oil in 6 hours, and the aqueous solution after distillation device is in addition collected, and medicinal residues are standby; Press volatile oil-times 1: 8: 80 inclusion volatile oil of its cyclodextrin-water, 50 ℃ were stirred 1 hour, and cold preservation is spent the night, and filters, and 40 ℃ of dryings of inclusion complex are ground into fine powder, promptly get doubly its cyclodextrin inclusion complex.
(2) eight flavors such as medicinal residues and all the other Radix Saposhnikoviaes add 12 times of water gagings, decoct secondary, and each 1.5 hours, collecting decoction, filter, filtrate and the merging of above-mentioned aqueous solution are concentrated into the thick paste that is determined as 1.25-1.30 under 60 ℃ of the relative densities, drying under reduced pressure is ground into fine powder, promptly gets the cold reducing-fever extract powder.
(3) the equal 80 ℃ of oven dry of used adjuvant, sieving for standby; With cold reducing-fever extract powder, times its cyclodextrin inclusion complex, tartaric acid, sodium bicarbonate, sweeting agent, filler mixing, to granulate with dehydrated alcohol, drying adds the lubricant mixing, tabletting, promptly.
2, effervescence tablet for treating wind-cold type cold according to claim 1, it is characterized in that sweeting agent is selected from a kind of in stevioside, betanin, the Aspartane, filler selects a kind of in lactose, mannitol, the xylitol, lubricant to be selected from a kind of in PEG6000, PEG4000, the magnesium stearate.
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| CN108404140A (en) * | 2016-06-01 | 2018-08-17 | 湖南安邦制药有限公司 | A kind of clathrate process of volatile oil |
| CN108671143A (en) * | 2018-07-13 | 2018-10-19 | 安徽亳药千草国药股份有限公司 | A kind of Chinese herbal granules and preparation method with healthcare function |
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| CN1544065A (en) * | 2003-11-20 | 2004-11-10 | 张晴龙 | Effervescence tablet for treating cold and fever and its preparation |
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| CN1544065A (en) * | 2003-11-20 | 2004-11-10 | 张晴龙 | Effervescence tablet for treating cold and fever and its preparation |
Non-Patent Citations (2)
| Title |
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| 中华人民共和国药典1995年版第一部. 国家药典委员会，628，化学工业出版社. 1995 |
| 中华人民共和国药典1995年版第一部. 国家药典委员会，628，化学工业出版社. 1995 * |
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