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CN100496515C - Ring form effervescence dosage and preparation method thereof - Google Patents

Ring form effervescence dosage and preparation method thereof Download PDF

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Publication number
CN100496515C
CN100496515C CNB2004100131856A CN200410013185A CN100496515C CN 100496515 C CN100496515 C CN 100496515C CN B2004100131856 A CNB2004100131856 A CN B2004100131856A CN 200410013185 A CN200410013185 A CN 200410013185A CN 100496515 C CN100496515 C CN 100496515C
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parts
annular
effervescent tablet
agent
effervescent
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CN1698663A (en
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罗晓健
吕爱平
曾志斌
饶小勇
游剑
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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 invention relates to a ring form effervescence dosage and preparation method, wherein a physical method is employed, by altering the external form of the tablets, the disintegrating speed of the Chinese medicinal effervescent tablets can be increased substantially, while not influencing the medicinal effect, the consumption of the disintegrating agent is reduced, and reducing the production costs, increasing the medicament release speed in human body. The invention also has the advantages of increased biological availability, and convenience in carrying and administration.

Description

A kind of annular effervescent dosage form and preparation method thereof
Technical field
The present invention relates to a kind of annular effervescent dosage form and preparation method thereof, particularly relate to a kind of annular Chinese medicine effervescent tablet and preparation method thereof.
Background technology
The effervescent dosage form often occurs with the form of tablet, and 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 bubble is less.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, Shang Weijian makes Chinese medicine the report of oral annular effervescent dosage form.
The Chinese medicine effervescent tablet is a kind of new dosage form, has that drug release rate is fast, dosage is little, divided dose accurately, take, advantage such as easy to carry, and the oral administration effervescing sheet is specially adapted to the swallow patient of solid preparations such as tablet, capsule of child, old people and inconvenience.
But 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 it is few to be prepared into the required excipient of effervescent dosage form, and it is also very fast that small-sized effervescent is met the water disintegrate; 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 yet.
Summary of the invention
The object of the present invention is to provide a kind of annular effervescent dosage form and preparation method thereof,, satisfy needs of medical treatment better to overcome the deficiency of existing dosage form.Adopt annular to improve drug release rate.
The composition of the present invention's annular effervescent dosage form comprises Chinese medicine medicine, 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, also can add western medicine composition, to increase drug effect.
Each constituent proportioning of annular Chinese medicine effervescent dosage form is by weight: Chinese medicine medicine 10-50 part, disintegrating agent comprises sour agent 10-30 part, alkaline agent 10-30 part and auxiliary disintegrating agent 0-30 part, and other adjuvant comprises binding agent 0-6 part, lubricant 2-10 part, sweeting agent 0-10 part, aromatic 0-5 part.
Disintegrating agent is made up of sour agent and alkaline agent; 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.
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.
Another important feature of the present invention is that ring segment is incorporated into the effervescent tablet preparation field, has invented annular effervescent tablet.Contain multiple pectin class, saccharide, polysaccharide macromolecular material in the Chinese medicine, so the extract powder that makes after the Chinese medicine extract drying has very strong viscosity.After being made into 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.Be provided with the connecting band of easy fracture between each burst, also help quick disintegrate to become a plurality of small pieces, improve disintegration rate.
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 disintegration rate raising 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 Chinese medicine root 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 the Chinese medicine effervescent tablet, the commercial value of annular isatis root effervescence tablet aspect the disintegrate convenience is higher.
Technical scheme of the present invention can realize with three kinds of methods:
First kind is: (A) the airtight preservation of Chinese medicine or water medicine powder is standby; Sour agent in the disintegrating 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%; (B) press required proportioning with Chinese medicine or water medicine powder and sour agent mix homogeneously, or add sweeting agent again or/and the aromatic mix homogeneously gets powders A 1; (C), get powder B1 with the alkaline agent mix homogeneously; (D) powders A 1 is mixed with powder B1, add lubricant, fully mixing; (E), obtain required annular Chinese medicine effervescent dosage form with above-mentioned gained mixed-powder tabletting.
Second kind is: (A) the airtight preservation of Chinese medicine or water medicine powder is standby; Sour agent in the disintegrating 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%; (B) press required proportioning with Chinese medicine or water medicine powder and sour agent mix homogeneously, or add sweeting agent again, get granule A2 or/and the aromatic mix homogeneously is granulated; (C), granulate with the alkaline agent mix homogeneously; Get granule B2; (D) granule A2 is mixed with granule B23, add lubricant, fully mixing; (E), obtain required annular Chinese medicine effervescent dosage form with above-mentioned gained hybrid particles tabletting.
The third is: (A) the airtight preservation of Chinese medicine or water medicine powder is standby; Sour agent in the disintegrating 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%; (B) press required proportioning with Chinese medicine or water medicine powder and sour agent mix homogeneously, or add sweeting agent again or/and the aromatic mix homogeneously gets powders A 3; (C), get powder B3 with the alkaline agent mix homogeneously; (D) powders A 3 is mixed with powder B3, add lubricant, fully mixing; (E) above-mentioned gained mixed-powder is added non-aqueous solution (as ethanol, isopropyl alcohol etc.) pelletizing press sheet, obtain required annular Chinese medicine effervescent dosage form.
Annular effervescent tablet of the present invention is to form by the compression mold compacting, internal diameter 3-8mm, external diameter 20-30mm, the heavy 2-4g of sheet is with reference to " 2000 editions one appendix XII A of Chinese pharmacopoeia inspection technique disintegration is checked, 25 ℃ of effervescent tablet inputs of the present invention is filled in the 250ml beaker of 200ml water, there are a large amount of bubbles to emit immediately, tablet dissolves rapidly, is scattered in the water, forms transparent or uniform solution in 3 minutes or in 1 to 2 minute, and it is left not have accumulative granule.And pharmacopeia requires is disintegrate fully in five minutes, and conventional effervescent tablet is many after four minutes, have in addition do not reach this requirement.The present invention can effectively improve the disintegration rate of Chinese medicine effervescent tablet, satisfies needs of medical treatment.
Annular effervescent tablet profile of the present invention can be annular, oval ring, also can be made up of some bursts; Be provided with the connecting band of easy fracture between each burst.
The invention has the advantages that: use physical method,, significantly improve the disintegration rate of Chinese medicine effervescent tablet by changing the external form of tablet, to not influence of ingredient, promptly can not influence drug effect, need not change original production technology simultaneously, need not add other adjuvants, even can reduce the consumption of adjuvant, thereby reduced production cost, improved medicine, improved bioavailability at the intravital rate of release of people, carry, taking convenience, satisfy the actual demand of broad masses of the people's medication.
Describe the present invention in detail below in conjunction with embodiment:
Description of drawings
Fig. 1 is the flat structural representation towards annular effervescent tablet of band connecting band of the present invention.
Fig. 2 is the structural representation of the parabola shaped annular effervescent tablet of the present invention.
Fig. 3 is the structural representation of annular effervescent tablet of the present invention.
Fig. 4 is the structural representation of oval ring effervescent tablet of the present invention.
Specific embodiment:
Embodiment 1
With " the 474th page of contained KANGKAN KELI of Chinese pharmacopoeia version in 2000 is made common effervescent tablet and annular effervescent tablet.
Raw material: Flos Lonicerae 210 grams, Radix Paeoniae Rubra 210 grams, Rhizoma Dryopteris Crassirhizomatis 70 grams.
Production technology:
Flos Lonicerae, Radix Paeoniae Rubra, Rhizoma Dryopteris Crassirhizomatis three flavors decoct with water twice, each 1.5 hours, collecting decoction filters, and filtrate is concentrated into 250ml, add ethanol and reach 50% to containing the alcohol amount, stir evenly, placement is spent the night, filter, filtrate recycling ethanol, and be concentrated into the clear paste that relative density is 1.28~1.30 (50 ℃), be dried to extract powder, get 50g, airtight preservation is standby.Citric acid 100g, sodium bicarbonate 80g, sodium carbonate 30g pulverize separately are crossed 100 mesh sieves, and airtight preservation is standby; Steviosin 4g and essence 1g pulverized 100 mesh sieves, and PEG600035g pulverized 140 mesh sieves; In the preparation process control preparation ambient temperature at 25 ℃, humidity below 45%; With extract powder 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 PEG6000, fully mixing; The gained hybrid particles is divided into identical two parts, and tabletting must resist 50 of 50 of sense effervescent tablets and the annular effervescent tablets of anti-sense.
Adopt the anti-sense effervescent tablet and the annular effervescent tablet of anti-sense of method for preparing to be about the 3g/ sheet, the outer ring diameter of wherein annular effervescent dosage form is 25 millimeters, and interior ring diameter is 6 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, but both exist than big-difference on disintegration time, see Table 1.
Check result disintegration of two kinds of anti-sense effervescent tablets of table 1
Figure C200410013185D00061
As can be known from the results, resist more easy disintegrating of the annular effervescent tablet of sense.
Although this paper describes preferred implementation of the present invention in detail, it should be understood that the present invention is not limited in this embodiment, wherein can carry out various changes and improvements under the scope of the invention not deviating from.
Embodiment 2
With " the 374th page of contained xiao'er ganmao granules of Chinese pharmacopoeia version in 2000 is made common effervescent tablet and annular effervescent tablet.
Raw material: Herba Pogostemonis 75 grams, Flos Chrysanthemi 75 grams, Fructus Forsythiae 75 grams, Folium Isatidis 125 grams, Radix Isatidis 75 grams, Radix Rehmanniae 75 grams, Cortex Lycii 75 grams, Radix Cynanchi Atrati 75 grams, Herba Menthae 50 grams, Gypsum Fibrosum 125 grams.
Production technology:
Radix Rehmanniae, Radix Cynanchi Atrati, Cortex Lycii, Gypsum Fibrosum (100 gram) decoct with water twice, and 3 hours for the first time, 1 hour for the second time, collecting decoction filtered; Flos Chrysanthemi, Folium Isatidis hot dipping secondary, 2 hours for the first time, 1 hour for the second time, merge leachate, filter; Herba Pogostemonis, Herba Menthae, Fructus Forsythiae extract volatile oil, and its aqueous solution filters, and filtrate and above two liquid merge, and being concentrated into relative density is the clear paste of 1.30~1.35 (50 ℃), is dried to extract powder, get 72g, and airtight preservation is standby; Gypsum Fibrosum 25 grams, Radix Isatidis powder are broken into fine powder, and airtight preservation is standby. and malic acid 50g, sodium bicarbonate 40g, potassium carbonate 10g pulverize separately are crossed 100 mesh sieves, and airtight preservation is standby; Acesulfame potassium 3g and essence 1g pulverized 100 mesh sieves, and PEG 4000 24g pulverized 140 mesh sieves; In the preparation process control preparation ambient temperature at 25 ℃, humidity below 45%; With extract powder, fine powder and malic acid mix homogeneously, add acesulfame potassium and essence mix homogeneously by required proportioning again, get powders A; With sodium bicarbonate, potassium carbonate mix homogeneously, get powder B; Powders A is mixed with powder B, add PEG 4000, add the abundant mixing of volatile oil; The gained mixed-powder is divided into identical two parts, and all direct compression gets 50 of 50 of effervescent tablet for child common cold and infantile common cold annular effervescent tablets.
Adopt the effervescent tablet for child common cold and the infantile common cold annular effervescent tablet of method for preparing to be about the 3g/ sheet, the outer ring diameter of wherein annular effervescent dosage form is 24 millimeters, and interior ring diameter is 5 millimeters.
With reference to " 2000 editions one appendix XIIA inspection technique disintegration of Chinese pharmacopoeia 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, but both exist than big-difference on disintegration time, see Table 2.
Check result disintegration of two kinds of effervescent tablet for child common cold of table 2
Figure C200410013185D00071
As can be known from the results, infantile common cold annular effervescent tablet easy disintegrating more.
Although this paper describes preferred implementation of the present invention in detail, it should be understood that the present invention is not limited in this embodiment, wherein can carry out various changes and improvements under the scope of the invention not deviating from.
Embodiment 3
" ministry standard " the 20th is contained, and the Danxiyupingfeng granule is made common effervescent tablet and annular effervescent tablet.
Raw material: the Radix Astragali 100 grams, Radix Saposhnikoviae 100 grams, the Rhizoma Atractylodis Macrocephalae (parched with bran) 200 grams.
Production technology:
More than three flavors decoct with water twice, 2 hours for the first time, 1 hour for the second time, collecting decoction filtered, filtrate is concentrated into the clear paste that relative density is 1.30 (80~85 ℃), is dried to extract powder, 37g, airtight preservation is standby; Tartaric acid 70g, potassium bicarbonate 60g pulverize separately are crossed 100 mesh sieves, and airtight preservation is standby; Cyclamate 2g and essence 1g pulverized 100 mesh sieves, and magnesium stearate 30g pulverized 140 mesh sieves; In the preparation process control preparation ambient temperature at 25 ℃, humidity below 35%; With extract powder, fine powder and tartaric acid mix homogeneously, add cyclamate and essence mix homogeneously by required proportioning again, get powders A; With the potassium bicarbonate mix homogeneously, get powder B; Powders A is mixed with powder B, add the abundant mixing of magnesium stearate; The gained mixed-powder is divided into identical two parts, and all direct compression gets 50 of 50 of Danxiyupingfeng effervescent tablets and Danxiyupingfeng annular effervescent tablets.
Adopt the Danxiyupingfeng effervescent tablet and the Danxiyupingfeng annular effervescent tablet of method for preparing to be about the 2g/ sheet, the outer ring diameter of wherein annular effervescent dosage form is 22 millimeters, and interior ring diameter is 7 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, but both exist than big-difference on disintegration time, see Table 3.
Check result disintegration of two kinds of Danxiyupingfeng effervescent tablets of table 3
As can be known from the results, Danxiyupingfeng annular effervescent tablet easy disintegrating more.
Although this paper describes preferred implementation of the present invention in detail, it should be understood that the present invention is not limited in this embodiment, wherein can carry out various changes and improvements under the scope of the invention not deviating from.
Embodiment 4
" ministry standard " 15 contained XIASANGJU KELI are made common effervescent tablet and annular effervescent tablet.
Raw material: Spica Prunellae 500g, Flos Chrysanthemi Indici 80g, Folium Mori 175g.
Production technology:
More than three the flavor, decoct with water secondary, each 1.5 hours, collecting decoction filters, and filtrate is concentrated into 1/2 (V/W) of crude drug amount, 95% ethanol that adds 2 times of amounts fully stirs standing over night, filter, filtrate recycling ethanol, being evaporated to relative density is 1.25~1.26 (30 ℃), is dried to extract powder, get 64g, airtight preservation is standby.Tartaric acid 50g, sodium bicarbonate 45g, sodium carbonate 15g pulverize separately are crossed 100 mesh sieves, and airtight preservation is standby; Acesulfame potassium 2g and essence 1g pulverized 100 mesh sieves, and sodium lauryl sulphate 23g pulverized 140 mesh sieves; In the preparation process control preparation ambient temperature at 25 ℃, humidity below 45%; With extract powder, fine powder and tartaric acid mix homogeneously, add acesulfame potassium and essence mix homogeneously by required proportioning again, get powders A; With sodium bicarbonate, sodium carbonate mix homogeneously, get powder B; Powders A is mixed with powder B, add sodium lauryl sulphate, add the abundant mixing of volatile oil; The gained mixed-powder is divided into identical two parts, and all direct compression gets 50 of 50 of summer Sang Ju Yin effervescent tablets and summer Sang Ju Yin annular effervescent tablets.
Adopt the summer Sang Ju Yin effervescent tablet of method for preparing and the summer Sang Ju Yin annular effervescent tablet of catching a cold to be about the 2g/ sheet, the outer ring diameter of wherein annular effervescent dosage form is 22 millimeters, and interior ring diameter is 7 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, but both exist than big-difference on disintegration time, see Table 4.
Check result disintegration of two kinds of summers of table 4 Sang Ju Yin effervescent tablet
Figure C200410013185D00082
As can be known from the results, summer Sang Ju Yin annular effervescent tablet easy disintegrating more.
Although this paper describes preferred implementation of the present invention in detail, it should be understood that the present invention is not limited in this embodiment, wherein can carry out various changes and improvements under the scope of the invention not deviating from.
Embodiment 5
The effervescent tablet of preparation health:
Get vitamin C 3g, sucrose 47g, airtight preservation is standby. and citric acid 100g, sodium bicarbonate 80g, sodium carbonate 30g pulverize separately are crossed 100 mesh sieves, and airtight preservation is standby; Steviosin 4g and essence 1g pulverized 100 mesh sieves, and PEG 6000 35g 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 vitamin C effervescent tablets and vitamin C annular effervescent tablets.
Adopt the vitamin C effervescent tablet and the vitamin C annular effervescent tablet of method for preparing to be about the 3g/ sheet, the outer ring diameter of wherein annular effervescent dosage form is 26 millimeters, and interior ring diameter is 4 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, but both exist than big-difference on disintegration time, see Table 1.
Check result disintegration of two kinds of vitamin C effervescent tablets of table 1
Figure C200410013185D00092
As can be known from the results, the vitamin C effervescent tablet of health does not relate to curative effect, and every contained vitamin C is less, so disintegration rate is fast, does not have 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 to compare disintegration rate with the other than ring type vitamin C effervescent tablet and improve limited.
The dose of Western medicine is less, and is similar with the vitamin C effervescent tablet of health aspect the disintegration rate raising, and annular is compared disintegration rate and improved limited with other than ring type Western medicine effervescent tablet.
Embodiment 6
Get Flos Lonicerae, Radix Paeoniae Rubra, the anti-sense of the Rhizoma Dryopteris Crassirhizomatis extract powder of embodiment 1 gained and make annular effervescent tablet.
Raw material: Flos Lonicerae, Radix Paeoniae Rubra, Rhizoma Dryopteris Crassirhizomatis resist 50 parts of sense extract powders, and disintegrating agent comprises 30 parts of sour agent, 30 parts of alkaline agents, 5 parts of lubricants, 5 parts of aromatic.Aromatic wherein is selected from 4 parts of orange essences, 1 part of flavoring orange essence.The acid agent is selected from 5 parts of citric acid, 10 parts in tartaric acid, 15 parts of sodium dihydrogen citrate salt; Alkaline agent is selected from 5 parts of potassium carbonate, 5 parts of potassium bicarbonates, 6 parts of sodium carbonate, 4 parts of sodium bicarbonate, 2 parts of calcium carbonate, 8 parts of calcium bicarbonate; Lubricant is selected from 4000,0.5 parts of sodium lauryl sulphates of 6000,0.5 parts of Polyethylene Glycol of 0.5 part of Polyethylene Glycol (PEG) (PEG), 0.5 part of magnesium stearate, 1 part of Pulvis Talci, 2 parts of silicon dioxide.All the other make outer ring diameter by embodiment 1 method is 30 millimeters, and interior ring diameter is 3 millimeters an annular effervescent tablet.This effervescent dosage form profile is an annular 1.
Embodiment 7
Get Flos Lonicerae, Radix Paeoniae Rubra, the anti-sense of the Rhizoma Dryopteris Crassirhizomatis extract powder of embodiment 1 gained and make annular effervescent tablet.Raw material: 10 parts of the anti-sense of Flos Lonicerae, Radix Paeoniae Rubra, Rhizoma Dryopteris Crassirhizomatis extract powders, disintegrating agent comprise 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 2 parts of cyclamates, 1 part of steviosin, 2 parts of acesulfame potassiums, 1 part of aspartame, 2 parts of protein sugar, 1 part of sucrose, 1 part of saccharin sodium; The acid agent is selected from 1 part of malic acid, 1 part of fumaric acid, 8 parts of anhydrous citric acid one sodium salts; Alkaline agent is selected from 2 parts of sodium bicarbonate, 8 parts of calcium bicarbonate; Auxiliary disintegrating agent can be selected from 15 parts of low-substituted hydroxypropyl celluloses (L-HPC), 5 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 make outer ring diameter by embodiment 1 method is 20 millimeters, and interior ring diameter is 8 millimeters an annular effervescent tablet.This effervescent dosage form profile is an annular.
Embodiment 8
Get Flos Lonicerae, Radix Paeoniae Rubra, the anti-sense of the Rhizoma Dryopteris Crassirhizomatis extract powder of embodiment 1 gained and make annular effervescent tablet.
Raw material: 30 parts of the anti-sense of Flos Lonicerae, Radix Paeoniae Rubra, Rhizoma Dryopteris Crassirhizomatis extract powders, disintegrating agent comprise 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 1 part of steviosin, 4 parts of sucrose, 4 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 12 parts in tartaric acid, 8 parts of citric acids; Alkaline agent is selected from 5 parts of sodium bicarbonate, 15 parts of calcium bicarbonate; Auxiliary disintegrating agent is selected from 15 parts of microcrystalline Cellulose (MCC), 5 parts of crospolyvinylpyrrolidone (PVPP); Binding agent is selected from 3 parts of polyvinylpyrrolidones (PVP), and lubricant is selected from 2 parts of 2 parts of the sodium lauryl sulphates, silicon dioxide.All the other make outer ring diameter by embodiment 1 method is 24 millimeters, and interior ring diameter is 5 millimeters an annular effervescent tablet.This effervescent dosage form profile is an oval ring.And the connecting band 3 that outer ring width is 1 millimeter easy fracture is set, connecting band 3 is provided with six, and whole annular effervescent tablet is divided into six bursts 2.
Embodiment 9
Get the infantile common cold extract powder that the Herba Pogostemonis, Flos Chrysanthemi, Fructus Forsythiae, Folium Isatidis, Radix Isatidis, Radix Rehmanniae, Cortex Lycii, Radix Cynanchi Atrati, Herba Menthae, Gypsum Fibrosum of embodiment 2 gained form and make annular effervescent tablet.
Raw material: 50 parts of the infantile common cold extract powders that Herba Pogostemonis, Flos Chrysanthemi, Fructus Forsythiae, Folium Isatidis, Radix Isatidis, Radix Rehmanniae, Cortex Lycii, Radix Cynanchi Atrati, Herba Menthae, Gypsum Fibrosum are formed.Disintegrating agent comprises 30 parts of sour agent, 30 parts of alkaline agents, 5 parts of lubricants, 5 parts of aromatic.Aromatic wherein is selected from 4 parts of orange essences, 1 part of flavoring orange essence.The acid agent is selected from 5 parts of citric acid, 10 parts in tartaric acid, 15 parts of sodium dihydrogen citrate salt; Alkaline agent is selected from 5 parts of potassium carbonate, 5 parts of potassium bicarbonates, 6 parts of sodium carbonate, 4 parts of sodium bicarbonate, 2 parts of calcium carbonate, 8 parts of calcium bicarbonate; Lubricant is selected from 4000,0.5 parts of sodium lauryl sulphates of 6000,0.5 parts of Polyethylene Glycol of 0.5 part of Polyethylene Glycol (PEG) (PEG), 0.5 part of magnesium stearate, 1 part of Pulvis Talci, 2 parts of silicon dioxide.All the other make outer ring diameter by embodiment 2 methods is 30 millimeters, and interior ring diameter is 3 millimeters an annular effervescent tablet.This effervescent dosage form profile is an annular 1.
Embodiment 10
Get the infantile common cold extract powder that the Herba Pogostemonis, Flos Chrysanthemi, Fructus Forsythiae, Folium Isatidis, Radix Isatidis, Radix Rehmanniae, Cortex Lycii, Radix Cynanchi Atrati, Herba Menthae, Gypsum Fibrosum of embodiment 2 gained form and make annular effervescent tablet.
Raw material: 10 parts of the infantile common cold extract powders that Herba Pogostemonis, Flos Chrysanthemi, Fructus Forsythiae, Folium Isatidis, Radix Isatidis, Radix Rehmanniae, Cortex Lycii, Radix Cynanchi Atrati, Herba Menthae, Gypsum Fibrosum are formed.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 2 parts of cyclamates, 1 part of steviosin, 2 parts of acesulfame potassiums, 1 part of aspartame, 2 parts of protein sugar, 1 part of sucrose, 1 part of saccharin sodium; The acid agent is selected from 1 part of malic acid, 1 part of fumaric acid, 8 parts of anhydrous citric acid one sodium salts; Alkaline agent is selected from 2 parts of sodium bicarbonate, 8 parts of calcium bicarbonate; Auxiliary disintegrating agent can be selected from 15 parts of low-substituted hydroxypropyl celluloses (L-HPC), 5 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 make outer ring diameter by embodiment 2 methods is 20 millimeters, and interior ring diameter is 8 millimeters an annular effervescent tablet.This effervescent dosage form profile is an annular.
Embodiment 11
Get the infantile common cold extract powder that the Herba Pogostemonis, Flos Chrysanthemi, Fructus Forsythiae, Folium Isatidis, Radix Isatidis, Radix Rehmanniae, Cortex Lycii, Radix Cynanchi Atrati, Herba Menthae, Gypsum Fibrosum of embodiment 2 gained form and make annular effervescent tablet.
Raw material: 25 parts of the infantile common cold extract powders that Herba Pogostemonis, Flos Chrysanthemi, Fructus Forsythiae, Folium Isatidis, Radix Isatidis, Radix Rehmanniae, Cortex Lycii, Radix Cynanchi Atrati, Herba Menthae, Gypsum Fibrosum are formed.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 1 part of steviosin, 4 parts of sucrose, 4 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 12 parts in tartaric acid, 8 parts of citric acids; Alkaline agent is selected from 5 parts of sodium bicarbonate, 15 parts of calcium bicarbonate; Auxiliary disintegrating agent is selected from 15 parts of microcrystalline Cellulose (MCC), 5 parts of crospolyvinylpyrrolidone (PVPP); Binding agent is selected from 3 parts of polyvinylpyrrolidones (PVP), and lubricant is selected from 2 parts of 2 parts of the sodium lauryl sulphates, silicon dioxide.All the other make outer ring diameter by embodiment 2 methods is 25 millimeters, and interior ring diameter is 5 millimeters an annular effervescent tablet.This effervescent dosage form profile is an oval ring.And the connecting band 3 that outer ring width is 1 millimeter easy fracture is set, connecting band 3 is provided with six, and whole annular effervescent tablet is divided into six bursts 2.
Embodiment 12
Get the Danxiyupingfeng extract powder that the Radix Astragali, Radix Saposhnikoviae, the Rhizoma Atractylodis Macrocephalae of embodiment 3 gained form and make annular effervescent tablet.
Raw material: 50 parts of the Danxiyupingfeng extract powders that the Radix Astragali, Radix Saposhnikoviae, the Rhizoma Atractylodis Macrocephalae are formed, disintegrating agent comprises 30 parts of sour agent, 30 parts of alkaline agents, 5 parts of lubricants, 5 parts of aromatic.Aromatic wherein is selected from 4 parts of orange essences, 1 part of flavoring orange essence.The acid agent is selected from 5 parts of citric acid, 10 parts in tartaric acid, 15 parts of sodium dihydrogen citrate salt; Alkaline agent is selected from 5 parts of potassium carbonate, 5 parts of potassium bicarbonates, 6 parts of sodium carbonate, 4 parts of sodium bicarbonate, 2 parts of calcium carbonate, 8 parts of calcium bicarbonate; Lubricant is selected from 4000,0.5 parts of sodium lauryl sulphates of 6000,0.5 parts of Polyethylene Glycol of 0.5 part of Polyethylene Glycol (PEG) (PEG), 0.5 part of magnesium stearate, 1 part of Pulvis Talci, 2 parts of silicon dioxide. and all the other make outer ring diameter by embodiment 3 methods is 30 millimeters, and interior ring diameter is 3 millimeters an annular effervescent tablet.This effervescent dosage form profile is an annular 1.
Embodiment 13
Get the Danxiyupingfeng extract powder that the Radix Astragali, Radix Saposhnikoviae, the Rhizoma Atractylodis Macrocephalae of embodiment 3 gained form and make annular effervescent tablet.
Raw material: 10 parts of the Danxiyupingfeng extract powders that the Radix Astragali, Radix Saposhnikoviae, the Rhizoma Atractylodis Macrocephalae are formed.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 2 parts of cyclamates, 1 part of steviosin, 2 parts of acesulfame potassiums, 1 part of aspartame, 2 parts of protein sugar, 1 part of sucrose, 1 part of saccharin sodium; The acid agent is selected from 1 part of malic acid, 1 part of fumaric acid, 8 parts of anhydrous citric acid one sodium salts; Alkaline agent is selected from 2 parts of sodium bicarbonate, 8 parts of calcium bicarbonate; Auxiliary disintegrating agent can be selected from 15 parts of low-substituted hydroxypropyl celluloses (L-HPC), 5 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 make outer ring diameter by embodiment 3 methods is 20 millimeters, and interior ring diameter is 8 millimeters an annular effervescent tablet.This effervescent dosage form profile is an annular.
Embodiment 14
Get the Danxiyupingfeng extract powder that the Radix Astragali, Radix Saposhnikoviae, the Rhizoma Atractylodis Macrocephalae of embodiment 3 gained form and make annular effervescent tablet.
Raw material: 20 parts of the Danxiyupingfeng extract powders that the Radix Astragali, Radix Saposhnikoviae, the Rhizoma Atractylodis Macrocephalae are formed.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 1 part of steviosin, 4 parts of sucrose, 4 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 12 parts in tartaric acid, 8 parts of citric acids; Alkaline agent is selected from 5 parts of sodium bicarbonate, 15 parts of calcium bicarbonate; Auxiliary disintegrating agent is selected from 15 parts of microcrystalline Cellulose (MCC), 5 parts of crospolyvinylpyrrolidone (PVPP); Binding agent is selected from 3 parts of polyvinylpyrrolidones (PVP), and lubricant is selected from 2 parts of 2 parts of the sodium lauryl sulphates, silicon dioxide.All the other make outer ring diameter by embodiment 3 methods is 25 millimeters, and interior ring diameter is 5 millimeters an annular effervescent tablet.This effervescent dosage form profile is an oval ring.And the connecting band 3 that outer ring width is 1 millimeter easy fracture is set, connecting band 3 is provided with six, and whole annular effervescent tablet is divided into six bursts 2.
Embodiment 15
Add the annular Chinese medicine effervescent tablet of Western medicine: in the raw material that embodiment 8 provides, add 0.03 part of benorylate, benorylate and Chinese medical concrete powder and citric acid mix homogeneously among the preparation technology, all the other are with embodiment 8.
Embodiment 16
Add the annular Chinese medicine effervescent tablet of Western medicine: in the raw material that embodiment 11 provides, add 0.0002 part of chlorphenamine, chlorphenamine and Chinese medical concrete powder and citric acid mix homogeneously among the preparation technology, all the other are with embodiment 11.
Embodiment 17
Add the annular Chinese medicine effervescent tablet of Western medicine: in the raw material that embodiment 8 provides, add 0.003 part of pseudoephedrine hydrochloride, benorylate and Chinese medical concrete powder and citric acid mix homogeneously among the preparation technology, all the other are with embodiment 8.

Claims (4)

1, annular Chinese medicine effervescent tablet is characterized in that: each constituent proportioning is by weight: Chinese medicine medicine 10-50 part, disintegrating agent comprise 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 0-10 part, aromatic 0-5 part; This effervescent tablet profile is an annular (1).
2, annular Chinese medicine effervescent tablet as claimed in claim 1 is characterized in that: this effervescent tablet type profile is an annular.
3, annular Chinese medicine effervescent tablet as claimed in claim 1 is characterized in that: this effervescent tablet type profile is an oval ring.
4, annular Chinese medicine effervescent tablet as claimed in claim 1, the outer ring diameter that it is characterized in that annular Chinese medicine effervescent tablet is the 20-30 millimeter, interior ring diameter is the 3-8 millimeter.
CNB2004100131856A 2004-05-21 2004-05-21 Ring form effervescence dosage and preparation method thereof Expired - Lifetime CN100496515C (en)

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Publication number Priority date Publication date Assignee Title
CN101125130B (en) * 2006-08-14 2010-12-22 北京四环科宝制药有限公司 Indian chrysanthemum effervescent preparation and preparation method thereof
CN102100902B (en) * 2011-02-15 2012-03-28 江西本草天工科技有限责任公司 Sini Effervescent Tablets
CN102697873A (en) * 2012-06-07 2012-10-03 佛山科学技术学院 Compound Chinese medicinal preparation for preventing and treating swine influenza viruses
CN103526639B (en) * 2012-07-03 2016-01-27 金东纸业(江苏)股份有限公司 Lubricant and apply the coating of this lubricant
CN110368371A (en) * 2014-04-08 2019-10-25 越洋医药开发(广州)有限公司 A kind of novel controlled release piece
CN105079391A (en) * 2015-08-31 2015-11-25 青岛海之源智能技术有限公司 Effervescent tablets for preventing oral ulcer and preparation method therefor
CN108685855A (en) * 2018-07-13 2018-10-23 安徽亳药千草国药股份有限公司 A kind of preparation method of annular effervescent with health role
CN113081979A (en) * 2021-03-30 2021-07-09 天圣制药集团股份有限公司 Instant tea for treating common cold in children and production process thereof

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Assignee: BEIJING ASIA-EAST BIO-PHARMACEUTICAL Co.,Ltd.

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Denomination of invention: Ring form effervescence dosage and preparation method thereof

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