CN1698665A - Defervesce effervescence tablet for treating cold and preparation method thereof - Google Patents
Defervesce effervescence tablet for treating cold and preparation method thereof Download PDFInfo
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- CN1698665A CN1698665A CNA2004100131875A CN200410013187A CN1698665A CN 1698665 A CN1698665 A CN 1698665A CN A2004100131875 A CNA2004100131875 A CN A2004100131875A CN 200410013187 A CN200410013187 A CN 200410013187A CN 1698665 A CN1698665 A CN 1698665A
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Abstract
The invention relates to a defervesce effervescence tablet for treating cold and preparation process, wherein the medicament is prepared from clerodendroa cyrtophyllum, isatic root, capsule of weeping forsythia and bistort through specific processes. The tablet has the effects of heat clearing and detoxicating, and can be used for treating upper respiratory tract infection, acute tonsillitis laryngitis. The invention has the advantages of improved biological availability, easy oral administration, small amount of administration, and easiness in carrying. The selected auxiliary material and ring-shaped effervescent tablet can make the effervescent tablet disintegrate rapidly.
Description
Technical field
The present invention relates to the preparation method technical field of Chinese patent medicine effervescent tablet, relate in particular to influenza defervesce effervescent tablet and preparation method.
Background technology
At present, the domestic main effervescent tablet of China is health product, as vitamin C effervescent tablet, also has plenty of the effervescent tablet of gynecological external use medicine, as JIEERYIN PAOTENGPIAN, and metronidazole vagina effervescent tablet etc., but the oral Chinese medicine effervescent formulation is less.And influenza defervesce prescription is made the effervescent tablet of oral pure Chinese medicinal preparation, do not appear in the newspapers as yet.In addition, ring segment early has application in food industry, but less in the field of medicaments application, particularly in the effervescent tablet preparation field, does not appear in the newspapers as yet.
The Chinese medicine effervescent tablet is a kind of new dosage form, have that drug release rate is fast, dosage is little, divided dose is accurate, take, advantage such as easy to carry, and the oral administration effervescing sheet is specially adapted to the patient of child, old people and the solid preparation of can not swallowing.Influenza defervesce class Chinese patent medicine is to have heat-clearing toxin-expelling functions, the common medicine that is used for upper respiratory tract infection, acute tonsillitis, pharyngolaryngitis, former dosage form have flu Antifebrile oral liquor (recording in the Drug Standard of Ministry of Public Health of the Peoples Republic of China new Chinese medicine), GANMAO TUIRE KELI (recording in one one of 2000 editions Chinese Pharmacopoeia), influenza defervesce capsule (recording in the Drug Standard of Ministry of Public Health of the Peoples Republic of China new Chinese medicine).
All there are some shortcomings in original dosage form, the shortcoming of oral liquid be medical material through the decocting in water precipitate with ethanol, add correctives again, fill forms, though solved the problem of difficult clothes, in order to keep clarity, in the precipitate with ethanol process, lost many effective ingredient, thereby influenced curative effect.The shortcoming of granule is to take after mixing it with hot water, and dissolving is not exclusively normal, easily produce precipitation, and taking dose is big.The shortcoming of capsule is generally to be not suitable for child and old man's medication because of the inconvenience of swallowing.
Summary of the invention
The purpose of this invention is to provide a kind of influenza defervesce effervescent tablet and preparation method,, satisfy needs of medical treatment better to overcome the deficiency of present dosage form.
The composition of influenza defervesce effervescent tablet of the present invention comprises influenza defervesce extract powder, disintegrating agent and other adjuvant.Other adjuvant comprises lubricant, can add binding agent, sweeting agent and/or aromatic again in other adjunct ingredient, to improve taste and mouthfeel.
Another important feature of the present invention is that ring segment is incorporated into influenza defervesce effervescent tablet preparation field, has invented influenza defervesce annular effervescent tablet.Contain various saccharides, polysaccharide macromolecular material in the influenza defervesce medical material, so the extract powder that makes after the influenza defervesce extract drying has very strong viscosity.After being made into the influenza defervesce effervescent tablet, these materials form one deck adhesive film in tablet surface easily when effervescent tablet is met the water disintegrate, influence the disintegration rate of effervescent tablet.After being made into ring segment, increased the contact surface of disintegrating agent and water, made disintegrating agent from about two aspects and water effect.Effervescent tablet is easy to rupture after being subjected to the power of both direction, thereby has increased the contact surface with water more, makes effervescent tablet disintegrate fully in the short time.
Because health care products effervescent dosage form and Western medicine effervescent dosage form are very fast because of self Material Characteristics disintegrate, health care products effervescent dosage form and Western medicine effervescent dosage form are made the technical meaning that ring segment further improves disintegration rate do not give prominence to.But to the influenza defervesce effervescent tablet, be made into annular, but can improve disintegration rate greatly, significant, the annular influenza defervesce effervescent tablet of disintegrate had both met national standard in two minutes even in one minute, can satisfy patient's demand easy to use again; Need the disintegrate of 4-5 minute ability to compare with the common cold effervescent tablet of bringing down a fever, the commercial value of annular influenza defervesce effervescent tablet aspect the disintegrate convenience is higher.
Each constituent proportioning (mass percent) of influenza defervesce effervescent tablet of the present invention is: influenza defervesce extract powder 15-50 part, disintegrating agent comprises sour agent 10-30 part, alkaline agent 10-30 part and auxiliary disintegrating agent 0-30 part, binding agent 0-6 part, lubricant 2-10 part, sweeting agent 0-5 part, aromatic 0-5 part.
Usually, every 100g influenza defervesce extract powder is equivalent to influenza defervesce prescription medical material 600-1300g.
The acid agent can be selected from one or more in citric acid, tartaric acid, malic acid, fumaric acid, anhydrous citric acid, citric acid or the sodium dihydrogen citrate salt; Alkaline agent can be selected from one or more in potassium carbonate, potassium bicarbonate, sodium carbonate, sodium bicarbonate, calcium carbonate, the calcium bicarbonate; Other disintegrating agent can be selected from one or more of low-substituted hydroxypropyl cellulose (L-HPC), microcrystalline Cellulose (MCC), crospolyvinylpyrrolidone (PVPP).
The optional non-aqueous solution (as ethanol, isopropyl alcohol etc.) of binding agent from polyvinylpyrrolidone (PVP) variable concentrations.
Optional in Polyethylene Glycol (PEG) 6000, Polyethylene Glycol (PEG) 4000, sodium lauryl sulphate, magnesium stearate, Pulvis Talci, silicon dioxide one or more of lubricant.
Sweeting agent can be selected from one or more in cyclamate, steviosin, acesulfame potassium, aspartame, protein sugar, sucrose, the saccharin sodium (calcium) etc.
Aromatic can be selected from one or more among orange essence, flavoring orange essence, Herba Menthae essence or Fructus Citri Limoniae essence, the flavoring banana essence etc.
Influenza defervesce effervescent tablet of the present invention can be by following three kinds of methods preparation, and concrete steps are:
Method one: (1) spray-dried airtight preservation of influenza defervesce extract powder that obtains is standby; Sour agent, alkaline agent, other disintegrating agent pulverize separately are crossed the 80-100 mesh sieve, and airtight preservation is standby; Sweeting agent and aromatic were pulverized the 100-120 mesh sieve, and lubricant was pulverized the 140-200 mesh sieve; In the preparation process control preparation ambient temperature at 25 ℃, humidity below 45%; (2) press required proportioning with influenza defervesce extract powder and sour agent mix homogeneously, or add sweeting agent again or/and the aromatic mix homogeneously gets powders A 1; (3), get powder B1 with the alkaline agent mix homogeneously; (4) powders A 1 is mixed with powder B1, add lubricant, add or do not add other disintegrating agent, fully mixing; (5) with the 4th step gained mixed-powder tabletting, obtain required influenza defervesce effervescent tablet.
Method two: (1) spray-dried airtight preservation of influenza defervesce extract powder that obtains is standby; Sour agent, alkaline agent, other disintegrating agent pulverize separately are crossed the 80-100 mesh sieve, and airtight preservation is standby; Sweeting agent and aromatic were pulverized the 100-120 mesh sieve, and lubricant was pulverized the 140-200 mesh sieve; In the preparation process control preparation ambient temperature at 25 ℃, humidity below 45%; (2) press required proportioning with influenza defervesce extract powder and sour agent mix homogeneously, or add sweeting agent again, get granule A2 or/and the aromatic mix homogeneously is granulated; (3), granulate with the alkaline agent mix homogeneously; Get granule B2; (4) granule A2 is mixed with granule B2, add lubricant, add or do not add other disintegrating agent, fully mixing; (5) with the 4th step gained hybrid particles tabletting, obtain required influenza defervesce effervescent tablet.
Method three: (1) spray-dried airtight preservation of influenza defervesce extract powder that obtains is standby; Sour agent, alkaline agent, other disintegrating agent pulverize separately are crossed the 80-100 mesh sieve, and airtight preservation is standby; Sweeting agent and aromatic were pulverized the 100-120 mesh sieve, and lubricant was pulverized the 140-200 mesh sieve; In the preparation process control preparation ambient temperature at 25 ℃, humidity below 45%; (2) press required proportioning with influenza defervesce extract powder and sour agent mix homogeneously, or add sweeting agent again or/and the aromatic mix homogeneously gets powders A 3; (3), get powder B3 with the alkaline agent mix homogeneously; (4) powders A 3 is mixed with powder B3, add lubricant, add or do not add other disintegrating agent, fully mixing; (5) the 4th step gained mixed-powder is added non-aqueous solution (as ethanol, isopropyl alcohol etc.) pelletizing press sheet, obtain required influenza defervesce effervescent tablet.
The profile of influenza defervesce effervescent tablet done circularize.
The influenza defervesce extract powder 105g that the spray drying of learning from else's experience respectively obtains, the malic acid 35g that pulverized 100 mesh sieves, sodium bicarbonate 45g, low-substituted hydroxypropyl cellulose (L-HPC) 13g, the PEG4000 2g that pulverized 140 mesh sieves make the influenza defervesce effervescent tablet of about 2g/ sheet by above-mentioned three kinds of preparation methoies, in the preparation process control preparation ambient temperature at 25 ℃, humidity below 45%.Prepared influenza defervesce effervescent tablet is with reference to " 2000 editions one appendix XII A of Chinese pharmacopoeia inspection technique disintegration detects, and the result is up to specification, sees Table 1.
Check result disintegration of three kinds of preparation method gained of table 1 influenza defervesce effervescent tablet
Method disintegration (min)
Method one (not adding L-HPC) 4.6 ± 0.3
Method one (adding L-HPC) 4.0 ± 0.5
Method one (adding the L-HPC ring segment) 2.6 ± 0.6
Method two (not adding L-HPC) 4.3 ± 0.4
Method two (adding L-HPC) 3.7 ± 0.4
Method two (adding the L-HPC ring segment) 2.1 ± 0.5
Method three (not adding L-HPC) 4.5 ± 0.4
Method three (adding L-HPC) 3.9 ± 0.6
Method three (adding the L-HPC ring segment) 2.4 ± 0.5
Another important feature of the present invention is to have added in the pelletization other tablet disintegrating agent commonly used such as low-substituted hydroxypropyl cellulose (L-HPC), as can be seen from the table, prepare the influenza defervesce effervescent tablet by above-mentioned three kinds of methods, the effervescent tablet that adds L-HPC is shorter than the effervescent tablet disintegration time that does not add L-HPC, and can significantly improve disintegration rate after making annular effervescent tablet.In three kinds of methods, the same terms adopts the influenza defervesce effervescent tablet disintegration time of method two preparation the shortest down, is preferred technology.
In the above-mentioned preparation method, granulating process can adopt methods such as wet granulation, dry granulation, one-step palletizing when big production.
The used influenza defervesce extract powder of said method prepares by the following method: the proportioning of crude drug is (by weight): 2 parts of Folium Isatidiss, 2 parts of Radix Isatidis, 1 part of Fructus Forsythiae, 1 part of Rhizoma Bistortae; Above four Chinese medicine is cleaned respectively, remove impurity, it is standby to be up to the standards: get Folium Isatidis, Radix Isatidis, Fructus Forsythiae, Rhizoma Bistortae is ground into fine powder/be ground into coarse powder/be cut into decoction pieces, decoct with water 2-3 time, each 1-3 hour, collecting decoction filtered, filtrate is concentrated to relative density and is about 1.00-1.20 (80-95 ℃), room temperature to be chilled to adds the ethanol that 1-2 doubly measures and makes precipitation, leaves standstill 6-24 hour, get supernatant concentration to relative density 1.10-1.30 (50-60 ℃), add the water that 1-3 doubly measures, stir, left standstill 6-18 hour, get supernatant soln and be condensed into the clear paste that relative density is 1.00-1.20 (60-65 a ℃), be dried to extract powder.
To adopt be drying under reduced pressure or spray drying to the drying of extract in the technology.The drying under reduced pressure temperature is controlled at 50-80 ℃, and the best is 60 ℃.
The present invention uses the modern pharmaceutical technology, it is carried out the dosage form process modification, thereby obtain a kind of influenza defervesce effervescent tablet, many weak points of original dosage form have been remedied, and make it become a kind of production technology by optimization more to become fully rationally, quality is easy to control, and drug release rate is fast, the bioavailability height carries, the influenza defervesce new formulation of taking convenience.
Specific embodiment
Embodiment 1
1, the preparation of influenza defervesce extract powder
(1) proportioning of crude drug is:
Folium Isatidis 3400g Radix Isatidis 3400g Fructus Forsythiae 1700g Rhizoma Bistortae 1700g
(2) above four Chinese medicine is cleaned respectively, remove impurity, it is standby to be up to the standards: get Folium Isatidis, Radix Isatidis, Fructus Forsythiae, Rhizoma Bistortae is ground into fine powder/be ground into coarse powder/be cut into decoction pieces, decoct with water 2 times, each 2 hours, collecting decoction filtered, filtrate is concentrated to relative density and is about 1.10 (80-95 ℃), room temperature to be chilled to, the ethanol that adds 2 times of amounts makes precipitation, leaves standstill 12 hours, get supernatant concentration to relative density 1.20 (50-60 ℃), the water that adds 1 times of amount stirs, and leaves standstill 8 hours, get supernatant soln and be condensed into the clear paste that relative density is 1.10 (60-65 ℃), be dried to extract powder.Obtain influenza defervesce extract powder 1030g altogether, yield 10.1%.
2, preparation influenza defervesce effervescent tablet (100)
The prescription proportioning:
Influenza defervesce extract powder 105g citric acid 30g
Steviosin 2g essence 1g
Sodium bicarbonate 30g sodium carbonate 5g
Low-substituted hydroxypropyl cellulose 15g PEG 6000 12g
3, preparation method
The spray-dried airtight preservation of influenza defervesce extract powder that obtains is standby; Citric acid, sodium bicarbonate, sodium carbonate, low-substituted hydroxypropyl cellulose pulverize separately are crossed 100 mesh sieves, and airtight preservation is standby; Steviosin and essence were pulverized 100 mesh sieves, and PEG 6000 pulverized 140 mesh sieves; In the preparation process control preparation ambient temperature at 25 ℃, humidity below 45%; With influenza defervesce extract powder and citric acid mix homogeneously, add steviosin and essence mix homogeneously by required proportioning again, get powders A 1; With sodium bicarbonate, sodium carbonate mix homogeneously, get powder B1; Powders A 1 is mixed with powder B1, add low-substituted hydroxypropyl cellulose, PEG 6000, fully mixing; Tabletting gets 100 of influenza defervesce effervescent tablets.
The average sheet of gained influenza defervesce effervescent tablet heavily is 2.00 ± 0.04g, any surface finish, exquisiteness.With reference to " 2000 editions one appendix XII A of Chinese pharmacopoeia inspection technique disintegration is checked this product, 25 ℃ of a slice effervescent tablet inputs are filled in the 250ml beaker of 200ml water, there are a large amount of bubbles to emit immediately, tablet dissolves, is scattered in the water rapidly, formed light yellow transparent solution in 5 minutes, it is left not have accumulative granule.Check 6 all qualified, the result is up to specification.
Embodiment 2
1, the preparation of influenza defervesce extract powder: with embodiment 1.
2, influenza defervesce annular effervescent tablet (100)
The prescription proportioning:
Influenza defervesce extract powder 105g tartaric acid 26g
Cyclamate 2g essence 1g
Potassium bicarbonate 32g PEG 4000 17g
Microcrystalline Cellulose 16g PVP 1g
3, preparation method
The spray-dried airtight preservation of influenza defervesce extract powder that obtains is standby; Tartaric acid, sodium bicarbonate, microcrystalline Cellulose pulverize separately are crossed 100 mesh sieves, and airtight preservation is standby; Cyclamate and essence were pulverized 100 mesh sieves, and PEG 4000 pulverized 140 mesh sieves; In the preparation process control preparation ambient temperature at 25 ℃, humidity below 45%; With influenza defervesce extract powder and tartaric acid mix homogeneously, add cyclamate and essence mix homogeneously by required proportioning again, get powders A 2; With the potassium bicarbonate mix homogeneously, get powder B2; Powders A 2 is mixed with powder B2, add microcrystalline Cellulose, PEG 4000, fully mixing; The gained mixed-powder is granulated with the alcoholic solution of 5% PVP, tabletting, 100 of influenza defervesce annular effervescent tablets.
The average sheet of gained influenza defervesce annular effervescent tablet heavily is 1.99 ± 0.03g, any surface finish, exquisiteness.With reference to " 2000 editions one appendix XII A of Chinese pharmacopoeia inspection technique disintegration is checked this product, 25 ℃ of a slice effervescent tablet inputs are filled in the 250ml beaker of 200ml water, there are a large amount of bubbles to emit immediately, tablet dissolves, is scattered in the water rapidly, formed light yellow transparent solution in 5 minutes, it is left not have accumulative granule.Check 6 all qualified, the result is up to specification.
Embodiment 3
1, the preparation of influenza defervesce extract powder: with embodiment 1.
2, preparation influenza defervesce annular effervescent tablet (100)
The prescription proportioning:
Influenza defervesce extract powder 105g malic acid 30g
Acesulfame potassium 2g essence 1g
Sodium bicarbonate 24g potassium carbonate 8g
Crospolyvinylpyrrolidone 20g magnesium stearate 10g
3, preparation method
The spray-dried airtight preservation of influenza defervesce extract powder that obtains is standby; Malic acid, sodium bicarbonate, potassium carbonate, crospolyvinylpyrrolidone pulverize separately are crossed 100 mesh sieves, and airtight preservation is standby; Acesulfame potassium and essence were pulverized 100 mesh sieves, and magnesium stearate was pulverized 140 mesh sieves; In the preparation process control preparation ambient temperature at 25 ℃, humidity below 45%; With influenza defervesce extract powder and malic acid mix homogeneously, add acesulfame potassium and essence mix homogeneously by required proportioning again, granulate, get granule A3; With sodium bicarbonate, potassium carbonate mix homogeneously, granulate, get granule B3; Granule A3 is mixed with granule B3, add crospolyvinylpyrrolidone, magnesium stearate, fully mixing; Tabletting gets 100 of influenza defervesce annular effervescent tablets.
The average sheet of gained influenza defervesce effervescent tablet heavily is 1.99 ± 0.04g, any surface finish, exquisiteness.With reference to " 2000 editions one appendix XII A of Chinese pharmacopoeia inspection technique disintegration is checked this product, 25 ℃ of a slice effervescent tablet inputs are filled in the 250ml beaker of 200ml water, there are a large amount of bubbles to emit immediately, tablet dissolves, is scattered in the water rapidly, formed light yellow transparent solution in 5 minutes, it is left not have accumulative granule.Check 6 all qualified, the result is up to specification.
Embodiment 4
Get 2 parts of Folium Isatidiss, 2 parts of Radix Isatidis, 1 part of Fructus Forsythiae, 1 part of Rhizoma Bistortae; Above four Chinese medicine is cleaned respectively, remove impurity, it is standby to be up to the standards: get Folium Isatidis, Radix Isatidis, Fructus Forsythiae, Rhizoma Bistortae is ground into fine powder/be ground into coarse powder/be cut into decoction pieces, decoct with water 2 times, each 1 hour, collecting decoction filtered, filtrate is concentrated to relative density and is about 1.00 (80-95 ℃), room temperature to be chilled to, the ethanol that adds 1 times of amount makes precipitation, leaves standstill 6 hours, get supernatant concentration to relative density 1.10 (50-60 ℃), the water that adds 1 times of amount stirs, and leaves standstill 6 hours, get supernatant soln and be condensed into the clear paste that relative density is 1.00 (60-65 ℃), be dried to extract powder.
15 parts of influenza defervesce extract powders, disintegrating agent comprise 30 parts of sour agent, 30 parts of alkaline agents, 10 parts of lubricants, 5 parts of aromatic.
Aromatic wherein is selected from 2 parts of orange essences, 3 parts of flavoring orange essences.The acid agent is selected from 10 parts of citric acid, 10 parts in tartaric acid, 10 parts of sodium dihydrogen citrate salt; Alkaline agent is selected from 10 parts of potassium carbonate, 4 parts of potassium bicarbonates, 6 parts of sodium carbonate, 3 parts of sodium bicarbonate, 2 parts of calcium carbonate, 5 parts of calcium bicarbonate; Lubricant is selected from 4000,0.5 parts of sodium lauryl sulphates of 6000,5 parts of Polyethylene Glycol of 3 parts of Polyethylene Glycol (PEG) (PEG), 0.5 part of magnesium stearate, 0.5 part of Pulvis Talci, 0.5 part of silicon dioxide.All the other are with embodiment 1.
Embodiment 5
Get 2 parts of Folium Isatidiss, 2 parts of Radix Isatidis, 1 part of Fructus Forsythiae, 1 part of Rhizoma Bistortae; Above four Chinese medicine is cleaned respectively, remove impurity, it is standby to be up to the standards: get Folium Isatidis, Radix Isatidis, Fructus Forsythiae, Rhizoma Bistortae is ground into fine powder/be ground into coarse powder/be cut into decoction pieces, decoct with water 2 times, each 2 hours, collecting decoction filtered, filtrate is concentrated to relative density and is about 1.12 (80-95 ℃), room temperature to be chilled to, the ethanol that adds 1.5 times of amounts makes precipitation, leaves standstill 15 hours, get supernatant concentration to relative density 1.20 (50-60 ℃), the water that adds 2 times of amounts stirs, and leaves standstill 12 hours, get supernatant soln and be condensed into the clear paste that relative density is 1.10 (60-65 ℃), be dried to extract powder.
Get 50 parts of influenza defervesce extract powders, disintegrating agent comprises 30 parts of 10 parts of sour agent, 10 parts of alkaline agents and auxiliary disintegrating agents, 6 parts of binding agents, 2 parts of lubricants, 10 parts of sweeting agents.
Sweeting agent is selected from 1 part of cyclamate, 1 part of steviosin, 2 parts of acesulfame potassiums, 2 parts of aspartames, 1 part of protein sugar, 2 parts of sucrose, 1 part of saccharin sodium; The acid agent is selected from 1 part of malic acid, 5 parts of fumaric acid, 4 parts of anhydrous citric acid one sodium salts; Alkaline agent is selected from 5 parts of sodium bicarbonate, 5 parts of calcium bicarbonate; Auxiliary disintegrating agent can be selected from 10 parts of low-substituted hydroxypropyl celluloses (L-HPC), 10 parts of microcrystalline Cellulose (MCC), 10 parts of crospolyvinylpyrrolidone (PVPP); Binding agent is selected from 6 parts of polyvinylpyrrolidones (PVP), and lubricant is selected from 2 parts of Polyethylene Glycol (PEG) 6000.All the other are with embodiment 1.
Embodiment 6
Get 2 parts of Folium Isatidiss, 2 parts of Radix Isatidis, 1 part of Fructus Forsythiae, 1 part of Rhizoma Bistortae; Above four Chinese medicine is cleaned respectively, remove impurity, it is standby to be up to the standards: get Folium Isatidis, Radix Isatidis, Fructus Forsythiae, Rhizoma Bistortae is ground into fine powder/be ground into coarse powder/be cut into decoction pieces, decoct with water 3 times, each 3 hours, collecting decoction filtered, filtrate is concentrated to relative density and is about 1.20 (80-95 ℃), room temperature to be chilled to, the ethanol that adds 2 times of amounts makes precipitation, leaves standstill 24 hours, get supernatant concentration to relative density 1.30 (50-60 ℃), the water that adds 3 times of amounts stirs, and leaves standstill 18 hours, get supernatant soln and be condensed into the clear paste that relative density is 1.20 (60-65 ℃), be dried to extract powder.
Get 20 parts of influenza defervesce extract powders, disintegrating agent comprises 20 parts of 20 parts of sour agent, 20 parts of alkaline agents and auxiliary disintegrating agents, 3 parts of binding agents, 4 parts of lubricants, 6 parts of sweeting agents, 3 parts of aromatic.
Sweeting agent is selected from 2 parts of steviosin, 2 parts of sucrose, 2 parts of Calcium o-benzolsulfimides; Aromatic wherein is selected from each 1 part of Herba Menthae essence or Fructus Citri Limoniae essence, flavoring banana essence; The acid agent is selected from 10 parts in tartaric acid, 10 parts of malic acids; Alkaline agent is selected from 15 parts of sodium bicarbonate, 5 parts of calcium bicarbonate; Auxiliary disintegrating agent is selected from 10 parts of microcrystalline Cellulose (MCC), 10 parts of crospolyvinylpyrrolidone (PVPP); Binding agent is selected from 3 parts of polyvinylpyrrolidones (PVP), and lubricant is selected from 3 parts of sodium lauryl sulphates, silica 1 part.All the other are with embodiment 1.
Embodiment 7
Get the influenza defervesce effervescent tablet of embodiment 1,2,3, it is prepared into outer ring diameter respectively is 30 millimeters, and interior ring diameter is 3 millimeters a ring segment.
Embodiment 8
Get the influenza defervesce effervescent tablet of embodiment 1,2,3, it is prepared into outer ring diameter respectively is 20 millimeters, and interior ring diameter is 8 millimeters a ring segment.
Embodiment 9
Get the influenza defervesce effervescent tablet of embodiment 1,2,3, it is prepared into outer ring diameter respectively is 25 millimeters, and interior ring diameter is 5 millimeters a ring segment.
Claims (10)
1, a kind of influenza defervesce effervescent tablet is characterized in that the composition of this effervescent tablet comprises influenza defervesce extract powder, disintegrating agent and other adjuvant.
2, influenza defervesce effervescent tablet as claimed in claim 1, it is characterized in that each constituent proportioning is by weight: influenza defervesce extract powder 15-50 part, disintegrating agent comprises sour agent 10-30 part, alkaline agent 10-30 part and auxiliary disintegrating agent 0-30 part, other adjuvant comprises binding agent 0-6 part, lubricant 2-10 part, sweeting agent 0-10 part, aromatic 0-5 part.
3, influenza defervesce effervescent tablet as claimed in claim 2 is characterized in that wherein sweeting agent is selected from one or more in cyclamate, steviosin, acesulfame potassium, aspartame, protein sugar, sucrose, the saccharin sodium (calcium) etc.; Aromatic wherein is selected from one or more among orange essence, flavoring orange essence, Herba Menthae essence or Fructus Citri Limoniae essence, the flavoring banana essence etc.
4, influenza defervesce effervescent tablet as claimed in claim 2 is characterized in that wherein sour agent is selected from one or more in citric acid, tartaric acid, malic acid, fumaric acid, anhydrous citric acid, citric acid or the sodium dihydrogen citrate salt; Alkaline agent is selected from one or more in potassium carbonate, potassium bicarbonate, sodium carbonate, sodium bicarbonate, calcium carbonate, the calcium bicarbonate; Auxiliary disintegrating agent can be selected from one or more in low-substituted hydroxypropyl cellulose (L-HPC), microcrystalline Cellulose (MCC), the crospolyvinylpyrrolidone (PVPP); Binding agent is selected from the non-aqueous solution (as ethanol, isopropyl alcohol etc.) of polyvinylpyrrolidone (PVP) variable concentrations, and lubricant is selected from one or more in Polyethylene Glycol (PEG) 6000, Polyethylene Glycol (PEG) 4000, sodium lauryl sulphate, magnesium stearate, Pulvis Talci, the silicon dioxide.
5, influenza defervesce effervescent tablet as claimed in claim 2 is characterized in that every 100g influenza defervesce extract powder wherein is equivalent to influenza defervesce prescription medical material 600-1300g.
6, influenza defervesce effervescent tablet as claimed in claim 2 is characterized in that prepared effervescent tablet profile is annular.
7, the preparation method of the described any influenza defervesce effervescent tablet of claim 1 to 6, concrete steps comprise: (1) spray-dried airtight preservation of influenza defervesce extract powder that obtains is standby; Sour agent, alkaline agent pulverize separately are crossed the 80-100 mesh sieve, and airtight preservation is standby; Sweeting agent and aromatic were pulverized the 100-120 mesh sieve, and lubricant was pulverized the 140-200 mesh sieve; In the preparation process control preparation ambient temperature at 25 ℃, humidity below 45%; (2) press required proportioning with influenza defervesce extract powder and sour agent mix homogeneously, or add sweeting agent again or/and the aromatic mix homogeneously gets powders A 1; (3), get powder B1 with the alkaline agent mix homogeneously; (4) powders A 1 is mixed with powder B1, add lubricant, add or do not add other disintegrating agent, fully mixing; (5) with the 4th step gained mixed-powder tabletting, obtain required influenza defervesce effervescent tablet.
8, the preparation method of the described any influenza defervesce effervescent tablet of claim 1 to 6, concrete steps comprise: (1) spray-dried airtight preservation of influenza defervesce extract powder that obtains is standby; Sour agent, alkaline agent pulverize separately are crossed the 80-100 mesh sieve, and airtight preservation is standby; Sweeting agent and aromatic were pulverized the 100-120 mesh sieve, and lubricant was pulverized the 140-200 mesh sieve; In the preparation process control preparation ambient temperature at 25 ℃, humidity below 45%; (2) press required proportioning with influenza defervesce extract powder and sour agent mix homogeneously, or add sweeting agent again, get granule A2 or/and the aromatic mix homogeneously is granulated; (3), granulate with the alkaline agent mix homogeneously; Get granule B2; (4) granule A2 is mixed with granule B2, add lubricant, add or do not add other disintegrating agent, fully mixing; (5) with the 4th step gained hybrid particles tabletting, obtain required influenza defervesce effervescent tablet.
9, the preparation method of the described any influenza defervesce effervescent tablet of claim 1 to 6, concrete steps comprise: (1) spray-dried airtight preservation of influenza defervesce extract powder that obtains is standby; Sour agent, alkaline agent pulverize separately are crossed the 80-100 mesh sieve, and airtight preservation is standby; Sweeting agent and aromatic were pulverized the 100-120 mesh sieve, and lubricant was pulverized the 140-200 mesh sieve; In the preparation process control preparation ambient temperature at 25 ℃, humidity below 45%; (2) press required proportioning with influenza defervesce extract powder and sour agent mix homogeneously, or add sweeting agent again or/and the aromatic mix homogeneously gets powders A 3; (3), get powder B3 with the alkaline agent mix homogeneously; (4) powders A 3 is mixed with powder B3, add lubricant, add or do not add other disintegrating agent, fully mixing; (5) the 4th step gained mixed-powder is added non-aqueous solution (as ethanol, isopropyl alcohol etc.) pelletizing press sheet, obtain required influenza defervesce effervescent tablet.
10, described any one the influenza defervesce effervescent tablet preparation method of claim 1 to 6 is characterized in that wherein used influenza defervesce extract powder prepares by the following method: the proportioning of crude drug is (by weight): 2 parts of Folium Isatidiss, 2 parts of Radix Isatidis, 1 part of Fructus Forsythiae, 1 part of Rhizoma Bistortae; Above four Chinese medicine is cleaned respectively, remove impurity, it is standby to be up to the standards: get Folium Isatidis, Radix Isatidis, Fructus Forsythiae, Rhizoma Bistortae is ground into fine powder/be ground into coarse powder/be cut into decoction pieces, decoct with water 2-3 time, each 1-3 hour, collecting decoction filtered, filtrate is concentrated to relative density and is about 1.00-1.20 (80-95 ℃), room temperature to be chilled to adds the ethanol that 1-2 doubly measures and makes precipitation, leaves standstill 6-24 hour, get supernatant concentration to relative density 1.10-1.30 (50-60 ℃), add the water that 1-3 doubly measures, stir, left standstill 6-18 hour, get supernatant soln and be condensed into the clear paste that relative density is 1.00-1.20 (60-65 a ℃), be dried to extract powder.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101194944B (en) * | 2006-12-05 | 2011-03-16 | 凌沛学 | Technique of preparing medicament for treating upper respiratory tract infection and quality control method |
| CN107510747A (en) * | 2017-08-04 | 2017-12-26 | 上海中华药业南通有限公司 | A kind of effervescent tablet for rinsing mouth and preparation method thereof |
| CN109588605A (en) * | 2018-11-26 | 2019-04-09 | 安徽迎春草生物科技有限公司 | A kind of heat-clearing is welcomed spring careless effervescent tablet and preparation method thereof |
| CN110755521A (en) * | 2019-11-22 | 2020-02-07 | 扬子江药业集团江苏制药股份有限公司 | Weisu effervescent tablet and preparation method thereof |
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2004
- 2004-05-21 CN CNB2004100131875A patent/CN100551361C/en active Active
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101194944B (en) * | 2006-12-05 | 2011-03-16 | 凌沛学 | Technique of preparing medicament for treating upper respiratory tract infection and quality control method |
| CN107510747A (en) * | 2017-08-04 | 2017-12-26 | 上海中华药业南通有限公司 | A kind of effervescent tablet for rinsing mouth and preparation method thereof |
| CN109588605A (en) * | 2018-11-26 | 2019-04-09 | 安徽迎春草生物科技有限公司 | A kind of heat-clearing is welcomed spring careless effervescent tablet and preparation method thereof |
| CN110755521A (en) * | 2019-11-22 | 2020-02-07 | 扬子江药业集团江苏制药股份有限公司 | Weisu effervescent tablet and preparation method thereof |
| CN110755521B (en) * | 2019-11-22 | 2022-02-18 | 扬子江药业集团江苏龙凤堂中药有限公司 | Weisu effervescent tablet and preparation method thereof |
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| CN100551361C (en) | 2009-10-21 |
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