CN1742776A - Flavargine effervescent tablet - Google Patents

Flavargine effervescent tablet Download PDF

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Publication number
CN1742776A
CN1742776A CN 200510019522 CN200510019522A CN1742776A CN 1742776 A CN1742776 A CN 1742776A CN 200510019522 CN200510019522 CN 200510019522 CN 200510019522 A CN200510019522 A CN 200510019522A CN 1742776 A CN1742776 A CN 1742776A
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China
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effervescent tablet
flavargine
effervescent
extract
agent
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CN100542521C (en
Inventor
罗晓健
杨世林
王跃生
饶毅
魏惠珍
王金钱
张爱玲
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Jiangxi Bencao Tiangong Technology Co Ltd
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Jiangxi Bencao Tiangong Technology Co Ltd
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Abstract

The present invention relates to a ring-shaped yinhuang effervescent tablet for effectively curing acute and chronic tonsillitis, acute and chronic laryngopharyngitis and upper respiratory tract infection. It is made up by using Chinese medicinal material lonicera flower and scutellaria root as raw material.

Description

Flavargine effervescent tablet
Technical field
The present invention relates to the technical field of Chinese patent medicine effervescent tablet, relate in particular to Flavargine effervescent tablet.
Background technology
At present, the domestic main effervescent tablet of China is health product, as vitamin C, the effervescent tablet of replenishing the calcium, 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 the silver yellow prescription is made the effervescent tablet of oral pure Chinese medicinal preparation, rarely found report.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, and rarely found report.
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.
The effect of silver yellow class Chinese patent medicine is heat clearing away, detoxifcation, and antiinflammatory is used for the acute and chronic tonsillitis, acute and chronic pharyngitis, upper respiratory tract infection.Former dosage form is a tablet.Child, the old people inconvenience of swallowing.
The raw material of Chinese medicine of YINHUANG PIAN is made up of Flos Lonicerae, Radix Scutellariae.
Conventional Chinese medicine effervescent tablet adopts the form of conventional tablet, and disintegration rate is too slow, and the time that patient waits for is oversize, easily causes impatient emotion, influences Chinese medicine effervescent tablet commercial value.The administrative provisions of Chinese medicine effervescent tablet for example, the disintegration time of effervescent tablet is higher than 5 minutes, is judged to defective.This is because of slow excessively disintegration rate, inconvenient patient's treatment.
It is long partially that the health care products effervescent dosage form of Chinese medicine effervescent dosage form and other two big classes and Western medicine effervescent dosage form are compared on disintegration time, influenced the application of Chinese medicine effervescent dosage form.
Health product effervescent dosage form contains the material that easily is dissolved in water mostly, for example easily is dissolved in the small-molecule substance and the inorganic compound of water, and disintegrate is very fast; The common dose of Western medicine is little, and easily is dissolved in water, and Western medicine only accounts for below 3% of Western medicine effervescent formulation weight usually, and all the other all can adopt acid, alkali disintegrating agent, and sour, alkali disintegrating agent can be up to more than 90%, so the disintegrate of Western medicine effervescent chance water is also very fast; Health care products effervescent dosage form and Western medicine effervescent dosage form even are finished disintegrate usually in one minute in the several seconds, therefore do not have the technical problem of poor practicability on disintegration time.And Chinese medicine is when making the effervescent dosage form, usually water is carried with alcohol extraction and is obtained multiple blended macromolecular active substance, comprise multiple stickums such as pectin class, saccharide, polysaccharide, Chinese medicine effervescent dosage form is met the influence that the water disintegrate is subjected to stickum, disintegrate is slower, on the other hand for guaranteeing curative effect, the Chinese medicine effervescent dosage form dose of monolithic is bigger, this has also influenced disintegration rate, for guaranteeing disintegrate, have to increase the consumption of adjuvant, make some effervescent tablet will accomplish the 4-5g/ sheet, not only increased cost, also made troubles to producing, transport, carry, using.After the disintegration rate of Chinese medicine effervescent reached several minutes, compare advantage with Chinese medicine granules not outstanding, limited the application of Chinese medicine effervescent.
Summary of the invention
The purpose of this invention is to provide a kind of Flavargine effervescent tablet,, satisfy needs of medical treatment better to overcome the deficiency of present dosage form.
Particularly provide a kind of disintegration rate fast silver yellow annular effervescent tablet.
Each constituent of Flavargine effervescent tablet of the present invention comprises silver yellow extract, disintegrating agent and other adjuvant, and silver yellow extract is wherein made by the following weight Chinese medicinal raw materials: Flos Lonicerae extract 80-120, Radix Scutellariae extract 20-60.
Flos Lonicerae extract prepares by following method: extracting honeysuckle decocts with water secondary, each 2 hours, collecting decoction filters, and filtrate adds lime cream and is adjusted to pH value to 10~12, leave standstill, the leaching precipitation adds suitable quantity of water, add sulphuric acid and regulate pH value to 6~7, stir evenly, filter, filtrate is concentrated into the thick paste shape, oven dry, promptly.Radix Scutellariae extract prepares by following method: get Radix Scutellariae, add to and decoct secondary in the boiling water, each 1 hour, collecting decoction filtered, and filtrate adds sulphuric acid and regulates pH value to 2, leave standstill, and the leaching precipitation, after an amount of washing of ethanol, drying, promptly.
Each constituent of Flavargine effervescent tablet of the present invention comprises YINHUANG PIAN extract, disintegrating agent and other adjuvant, and YINHUANG PIAN extract is wherein made by the following weight Chinese medicinal raw materials: Flos Lonicerae extract 100, Radix Scutellariae extract 40.
Flavargine effervescent tablet, wherein each constituent proportioning is by weight: silver yellow extract 1-50 part, disintegrating agent comprise sour agent 10-30 part, alkaline agent 10-30 part, and other adjuvant comprises binding agent 0-15 part, lubricant 0-15 part, sweeting agent 0-10 part, aromatic 0-5 part.
Flavargine effervescent tablet, wherein the effervescent tablet profile is an annular.
The annular of Flavargine effervescent tablet is made up of some bursts; Be provided with the connecting band of easy fracture between each burst.Disintegration rate can be further accelerated in the setting of connecting band between the burst.
An important feature of the present invention is that ring segment is incorporated into the Flavargine effervescent tablet preparation field, has invented silver yellow annular effervescent tablet.Contain various saccharides, polysaccharide macromolecular material in the silver yellow medical material, so the silver yellow extract that makes after the drying has very strong viscosity.After being made into Flavargine 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 outer two aspects and water effect of ring in ring, increased the contact surface with water, made effervescent tablet complete disintegrate 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 Flavargine effervescent tablet, be made into annular, but can improve disintegration rate greatly, significant, the annular Flavargine 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 common Flavargine effervescent tablet, the commercial value of annular Flavargine effervescent tablet aspect the disintegrate convenience is higher.
The acid agent can be selected from one or more in 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; Binding agent can be selected from carboxymethylstach sodium, hyprolose, carmethose, low-substituted hydroxypropyl cellulose (L-HPC), microcrystalline Cellulose (MCC), crospolyvinylpyrrolidone (PVPP), polyvinylpyrrolidone (PVP), Polyethylene Glycol (PEG) 6000, Polyethylene Glycol (PEG) 4000.
Lubricant can be selected from one or more in sodium lauryl sulphate, magnesium stearate, Pulvis Talci, the silicon dioxide.
In the additive of tablet field, materials such as Polyethylene Glycol (PEG) 6000, Polyethylene Glycol (PEG) 4000 have the effect of binding agent, lubricant simultaneously concurrently.It is divided into binding agent or lubricant all belongs to normal.
In the additive of tablet field, have the effect that binding agent, speed collapse agent simultaneously concurrently as carboxymethylstach sodium, hyprolose, carmethose, low-substituted hydroxypropyl cellulose (L-HPC), microcrystalline Cellulose (MCC), crospolyvinylpyrrolidone (PVPP), the polyvinylpyrrolidone (PVP) of binding agent.It is divided into binding agent or speed collapses agent and all belongs to normal.
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.
Effervescent tablet of the present invention was taken after every day, three times consumption was dissolved in water by each 1-3 sheet.
Being conventional substances because sour agent, alkaline agent, binding agent, lubricant, sweeting agent, aromatic, the speed in effervescent tablet field collapse the kind of agent, is not emphasis of the present invention.So the present invention does not do detailed expansion to this partial content.
Flavargine effervescent tablet of the present invention can be by following three kinds of methods preparation, and concrete steps are:
Method one: the airtight preservation of silver yellow extract that (1) drying obtains is standby; Sour agent, alkaline agent, binding 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 silver yellow extract 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, fully mixing; (5) with the 4th step gained mixed-powder tabletting, obtain required Flavargine effervescent tablet.
Method two: the airtight preservation of silver yellow extract that (1) drying obtains is standby; Sour agent, alkaline agent, binding 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 silver yellow extract 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, fully mixing; (5) with the 4th step gained hybrid particles tabletting, obtain required Flavargine effervescent tablet.
Method three: the airtight preservation of silver yellow extract that (1) drying obtains is standby; Sour agent, alkaline agent, binding 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 silver yellow extract 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, fully mixing; (5) the 4th step gained mixed-powder is added non-aqueous solution (as ethanol, isopropyl alcohol etc.) pelletizing press sheet, obtain required Flavargine effervescent tablet.
Experimental example:
The silver yellow extract 80g that the drying of learning from else's experience respectively obtains, the citric acid 50g that pulverized 100 mesh sieves, sodium bicarbonate 55g, low-substituted hydroxypropyl cellulose (L-HPC) 10g, the PEG40005g that pulverized 120 mesh sieves make the Flavargine effervescent tablet of about 4g/ sheet by above-mentioned three kinds of preparation methoies, in the preparation process control preparation ambient temperature at 25 ℃, humidity below 45%.Prepared Flavargine 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.
Check result disintegration of three kinds of preparation method gained Flavargine effervescent tablets
Method Disintegration (min)
Method one (not adding the L-HPC solid sheet) method one (adding the L-HPC solid sheet) method one (adding the L-HPC ring segment) method two (not adding the L-HPC solid sheet) method two (adding the L-HPC solid sheet) method two (adding the L-HPC ring segment) method three (not adding the L-HPC solid sheet) method three (adding the L-HPC solid sheet) method three (adding the L-HPC ring segment) 4.1±0.2 4.0±0.3 2.2±0.4 4.0±0.3 3.8±0.3 2.3±0.4 4.2±0.5 4.1±0.3 2.4±0.4
An important feature of the present invention is that the tablet speed commonly used that has added other in the pelletization collapses agent (also having the binding agent effect concurrently) as low-substituted hydroxypropyl cellulose (L-HPC), as can be seen from the table, prepare Flavargine 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.
Other gets above-mentioned raw materials, is pressed into the annular Flavargine effervescent tablet of being made up of connecting band between some bursts and the burst.Contrast disintegration with common annular Flavargine effervescent tablet:
Method Disintegration (min)
Method one (not adding the common ring segment of L-HPC) method one (not adding L-HPC with the ring segment of burst) method one (adding the common ring segment of L-HPC) method one (adding L-HPC with the ring segment of burst) 2.4±0.4 1.7±0.3 2.2±0.4 1.6±0.3
Method two (not adding the common ring segment of L-HPC) method two (not adding L-HPC with the ring segment of burst) method two (adding the common ring segment of L-HPC) method two (adding L-HPC with the ring segment of burst) 2.5±0.2 1.7±0.3 2.3±0.4 1.7±0.3
In the above-mentioned preparation method, granulating process can adopt methods such as wet granulation, dry granulation, one-step palletizing when big production.
The effervescent tablet of preparation health:
(1) it is standby to get the airtight preservation of vitamin C 10g.Citric acid 150g, sodium bicarbonate 100g, sodium carbonate 10g pulverize separately are crossed 100 mesh sieves, and airtight preservation is standby; Aspartame 8g and essence 1g pulverized 100 mesh sieves, and PEG 6000 21g pulverized 140 mesh sieves; In the preparation process control preparation ambient temperature at 25 ℃, humidity below 45%; With vitamin C and citric acid mix homogeneously, add steviosin and essence mix homogeneously by required proportioning again, granulate, get granule A; With sodium bicarbonate, sodium carbonate mix homogeneously, granulate, get granule B; Granule A is mixed with granule B, add PEG 6000, fully mixing; The gained hybrid particles is divided into identical two parts, and tabletting gets 50 of 50 of solid effervescent tablets of vitamin C and vitamin C annular effervescent tablets.
Adopt method for preparing other than ring type be that solid vitamin C effervescent tablet and vitamin C annular effervescent tablet is about the 3g/ sheet, the outer ring diameter of wherein annular effervescent dosage form is 20 millimeters, interior ring diameter is 8 millimeters.
(2) the airtight preservation of extracting lactic acid calcium 10g is standby.Citric acid 150g, sodium bicarbonate 100g, sodium carbonate 10g pulverize separately are crossed 100 mesh sieves, and airtight preservation is standby; Aspartame 8g and essence 1g pulverized 100 mesh sieves, and PEG 6000 21g pulverized 140 mesh sieves; In the preparation process control preparation ambient temperature at 25 ℃, humidity below 45%; With calcium lactate and citric acid mix homogeneously, add steviosin and essence mix homogeneously by required proportioning again, granulate, get granule A; With sodium bicarbonate, sodium carbonate mix homogeneously, granulate, get granule B; Granule A is mixed with granule B, add PEG 6000, fully mixing; The gained hybrid particles is divided into identical two parts, and tabletting gets 50 of 50 of solid effervescent tablets of calcium lactate and calcium lactate annular effervescent tablets.
Adopt method for preparing other than ring type be that solid calcium lactate effervescent tablet and calcium lactate annular effervescent tablet is about the 3g/ sheet, the outer ring diameter of wherein annular effervescent dosage form is 20 millimeters, interior ring diameter is 8 millimeters.
With reference to " 2000 editions one appendix XII A of Chinese pharmacopoeia inspection technique disintegration is checked, 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 even or clear solution in 5 minutes, it is left not have accumulative granule.Check respectively 6 all qualified, the result is up to specification.
Check result disintegration of two kinds of vitamin C effervescent tablets
Method Disintegration (min)
Solid vitamin C effervescent tablet annular vitamin C effervescent tablet 0.44±0.4 0.40±0.4
Check result disintegration of two kinds of calcium lactate effervescent tablets
Method Disintegration (min)
Solid calcium lactate effervescent tablet annular calcium lactate effervescent tablet 0.72±0.4 0.67±0.4
As can be known from the results, the vitamin C effervescent tablet of health, calcium lactate effervescent tablet, do not relate to curative effect, every contained vitamin C or calcium lactate are less, and there is not the interference of the multiple stickum such as pectin class, saccharide, polysaccharide of Chinese medicine, so disintegration rate is fast, there is not the slow technical barrier of similar Chinese medicine effervescent tablet disintegration rate.The effervescent tablet of health is prepared into the effect that annular has only novelty attractive in appearance, adopts annular and other than ring type vitamin C or calcium lactate effervescent tablet, it is limited to compare the disintegration rate raising, does not have obvious technological progress.
The dose of Western medicine is less, and is similar with vitamin C, the calcium lactate effervescent tablet of health aspect the disintegration rate raising, and annular is compared the disintegration rate raising with other than ring type Western medicine effervescent tablet limited, do not have obvious technological progress.
The present invention uses the modern pharmaceutical technology, it is carried out the dosage form process modification, thereby obtain a kind of Flavargine 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 silver yellow new formulation of taking convenience.
Each burst and connecting band can will be stamped to form after the medicated powder filling by the corresponding mould of design, and the realization of this technology can just can be finished by corresponding simple mould design.
The disintegration rate of solid Chinese medicine effervescent reaches several minutes, compare advantage with Chinese medicine granules not outstanding, its practicality is very poor, has limited the application of solid Chinese medicine effervescent, and Here it is does not see one of major reason of Chinese medicine being made oral annular effervescent dosage form report for a long time.When annular Chinese medicine effervescent dosage form was compared the obvious raising of disintegration rate with solid effervescent tablet after, its practicality improved greatly, can satisfy the demand of consumption market.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 Chinese medicine effervescent tablet, be made into annular, but can improve disintegration rate greatly, significant, the annular Chinese medicine 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 solid Chinese medicine effervescent tablet, the commercial value of annular Chinese medicine effervescent tablet aspect the disintegrate convenience is higher.
Specific embodiment
Embodiment 1
1, the preparation of silver yellow extract: extracting honeysuckle decocts with water secondary, each 2 hours, collecting decoction filters, and filtrate adds lime cream and is adjusted to pH value to 10~12, leave standstill, the leaching precipitation adds suitable quantity of water, add sulphuric acid and regulate pH value to 6~7, stir evenly, filter, filtrate is concentrated into the thick paste shape, oven dry promptly gets Flos Lonicerae extract.Get Radix Scutellariae, add to and decoct secondary in the boiling water, each 1 hour, collecting decoction filtered, and filtrate adds sulphuric acid and regulates pH value to 2, leave standstill, and the leaching precipitation, after an amount of washing of ethanol, drying promptly gets Radix Scutellariae extract.In 100 parts of Flos Lonicerae extracts: the ratio mixing that Radix Scutellariae extract is 40 parts obtains the YINHUANG PIAN extract.
2, preparation silver yellow effervescent solid sheet (100)
The prescription proportioning:
Silver yellow extract 165g citric acid 103g
Steviosin 3g essence 1g
Sodium bicarbonate 77g sodium carbonate 7g
Low-substituted hydroxypropyl cellulose 25g PEG 6000 19g
3, preparation method
The airtight preservation of silver yellow extract that drying 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 silver yellow extract 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; Be pressed into solid sheet, get 100 of Flavargine effervescent tablets.
The average sheet of gained Flavargine effervescent tablet heavily is 4.00 ± 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 6 minutes, it is left not have accumulative granule.
Embodiment 2
1, the preparation of silver yellow extract: with embodiment 1.
2, silver yellow annular effervescent tablet (100)
The prescription proportioning:
Silver yellow extract 105g tartaric acid 140g
Cyclamate 5g essence 2g
Sodium bicarbonate 80g PEG 4000 5g
Microcrystalline Cellulose 30g PVP 33g
3, preparation method
The airtight preservation of silver yellow extract that drying 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 silver yellow extract and tartaric acid mix homogeneously, add cyclamate and essence mix homogeneously by required proportioning again, get powders A 2; With the sodium 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 3% PVP, tabletting, 100 of silver yellow annular effervescent tablets.
The average sheet of gained silver yellow annular effervescent tablet heavily is 4.02 ± 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 silver yellow extract: with embodiment 1.
2, preparation silver yellow annular effervescent tablet (100)
The prescription proportioning:
Silver yellow extract 67g malic acid 38g citric acid 120g
Aspartame 5g acesulfame potassium 3g essence 2g
Sodium bicarbonate 30g potassium carbonate 90g
Crospolyvinylpyrrolidone 35g magnesium stearate 10g
3, preparation method
The airtight preservation of silver yellow extract that drying obtains is standby; Malic acid, citric 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 silver yellow extract and malic acid mix homogeneously, add aspartame, 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 silver yellow annular effervescent tablets.
The average sheet of gained Flavargine effervescent tablet heavily is 3.99 ± 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
Flavargine effervescent tablet, the composition of this effervescent tablet comprise silver yellow extract, disintegrating agent and other adjuvant.
(1) wherein the silver yellow extract is made by the following weight Chinese medicinal raw materials: extracting honeysuckle decocts with water secondary, each 2 hours, collecting decoction filters, and filtrate adds lime cream and is adjusted to pH value to 10~12, leave standstill, the leaching precipitation adds suitable quantity of water, add sulphuric acid and regulate pH value to 6~7, stir evenly, filter, filtrate is concentrated into the thick paste shape, oven dry promptly gets Flos Lonicerae extract.Get Radix Scutellariae, add to and decoct secondary in the boiling water, each 1 hour, collecting decoction filtered, and filtrate adds sulphuric acid and regulates pH value to 2, leave standstill, and the leaching precipitation, after an amount of washing of ethanol, drying promptly gets Radix Scutellariae extract.Ratio mixing in 120 parts of Flos Lonicerae extracts, 20 parts of Radix Scutellariae extracts obtains the silver yellow extract.
(2) Flavargine effervescent tablet, each constituent proportioning is by weight:
Get 50 parts of silver yellow extracts, disintegrating agent comprises 30 parts of sour agent, 30 parts of alkaline agents, 15 parts of lubricants, 10 parts of sweeting agents.
Sweeting agent is selected from 4 parts of steviosin, 2 parts of acesulfame potassiums, 4 parts of aspartames; The acid agent is selected from 14 parts of malic acids, 16 parts of anhydrous citric acids; Alkaline agent is selected from 15 parts of sodium bicarbonate, 15 parts of calcium bicarbonate; Lubricant is selected from 5 parts of sodium lauryl sulphates, 10 parts of magnesium stearate.All the other repeat embodiment 1,2,3 respectively.
Embodiment 5
(1) silver yellow extract is wherein made by the following weight Chinese medicinal raw materials: extracting honeysuckle decocts with water secondary, each 2 hours, collecting decoction filters, and filtrate adds lime cream and is adjusted to pH value to 10~12, leave standstill, the leaching precipitation adds suitable quantity of water, add sulphuric acid and regulate pH value to 6~7, stir evenly, filter, filtrate is concentrated into the thick paste shape, oven dry promptly gets Flos Lonicerae extract.Get Radix Scutellariae, add to and decoct secondary in the boiling water, each 1 hour, collecting decoction filtered, and filtrate adds sulphuric acid and regulates pH value to 2, leave standstill, and the leaching precipitation, after an amount of washing of ethanol, drying promptly gets Radix Scutellariae extract.Ratio mixing in 80 parts of Flos Lonicerae extracts, 60 parts of Radix Scutellariae extracts obtains the YINHUANG PIAN extract.
(2) Flavargine effervescent tablet, each constituent proportioning is by weight:
Get 1 part of above-mentioned stand-by silver yellow extract, disintegrating agent comprises 10 parts of sour agent, 10 parts of alkaline agents, 15 parts of binding agents, 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 6 parts of citric acids, 4 parts in tartaric acid; Alkaline agent is selected from 2 parts of potassium carbonate, 1 part of potassium bicarbonate, 4 parts of sodium carbonate, 3 parts of sodium bicarbonate; Binding agent is selected from 10 parts of microcrystalline Cellulose, 5 parts of polyvinylpyrrolidones (PVP).All the other repeat embodiment 1,2,3 respectively.
Embodiment 6
Flavargine effervescent tablet, each constituent proportioning is by weight: get 20 parts of silver yellow extracts, disintegrating agent comprises 20 parts of sour agent, 20 parts of alkaline 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 is selected from respectively 1 part of Herba Menthae essence, 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 sodium carbonate; Binding agent is selected from 1 part of microcrystalline Cellulose (MCC), 2 parts of crospolyvinylpyrrolidone (PVPP); Lubricant is selected from 3 parts of sodium lauryl sulphates, silica 1 part.All the other are with embodiment 3.
Embodiment 7
Get the Flavargine effervescent tablet of embodiment 1,2,3,4,5,6, 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 Flavargine effervescent tablet of embodiment 1,2,3,4,5,6, 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 Flavargine effervescent tablet of embodiment 1,2,3,4,5,6, it is prepared into outer ring diameter respectively is 25 millimeters, and interior ring diameter is 5 millimeters a ring segment.
Embodiment 10
Get the Flavargine effervescent tablet of embodiment 1,2,3,4,5,6, it is prepared into annular respectively forms, be provided with the ring segment of the connecting band of easy fracture between each burst by some bursts.

Claims (5)

1, a kind of Flavargine effervescent tablet is characterized in that the composition of this effervescent tablet comprises silver yellow extract, disintegrating agent and other adjuvant, and silver yellow extract is wherein made by the following weight Chinese medicinal raw materials:: Flos Lonicerae extract 80-120, Radix Scutellariae extract 20-60.
2, Flavargine effervescent tablet as claimed in claim 1 is characterized in that the silver yellow extract made by the following weight Chinese medicinal raw materials: Flos Lonicerae extract 100, Radix Scutellariae extract 40.
3, Flavargine effervescent tablet as claimed in claim 1, it is characterized in that each constituent proportioning is by weight: silver yellow extract 1-50 part, disintegrating agent comprises sour agent 10-30 part, alkaline agent 10-30 part, other adjuvant comprises binding agent 0-15 part, lubricant 0-15 part, sweeting agent 0-10 part, aromatic 0-5 part.
4,, it is characterized in that prepared effervescent tablet profile is annular as claim 1 or 2 or 3 described Flavargine effervescent tablets.
5, Flavargine effervescent tablet as claimed in claim 4 is characterized in that the annular of Flavargine effervescent tablet is made up of some bursts; Be provided with the connecting band of easy fracture between each burst.
CNB2005100195227A 2005-09-30 2005-09-30 Flavargine effervescent tablet Expired - Fee Related CN100542521C (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103623053A (en) * 2013-11-28 2014-03-12 安徽联谊药业股份有限公司 Yinhuang chewable tablet

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103623053A (en) * 2013-11-28 2014-03-12 安徽联谊药业股份有限公司 Yinhuang chewable tablet

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