CN1736415A - Effervescence tablet of 'Shuang Huanglian' and its preparation process thereof - Google Patents
Effervescence tablet of 'Shuang Huanglian' and its preparation process thereof Download PDFInfo
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- CN1736415A CN1736415A CN 200410053811 CN200410053811A CN1736415A CN 1736415 A CN1736415 A CN 1736415A CN 200410053811 CN200410053811 CN 200410053811 CN 200410053811 A CN200410053811 A CN 200410053811A CN 1736415 A CN1736415 A CN 1736415A
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Abstract
The invention relates to an effervescent tablet of 'Shuang Huanglian' and its preparing process, wherein the constituents of the effervescent tablets comprise (by weight percent): Chinese herbs concrete powder 30-80%, effervescent agent 18-68%, flow aid 0.1-1%, lubricant 1-13%, and right amount of flavoring agent.
Description
Technical field
The present invention relates to a kind of Chinese medicine effervescent tablet, more specifically relate to a kind of double coptis effervescent tablets that contains Flos Lonicerae, Radix Scutellariae and Fructus Forsythiae three flavor Chinese medicine ingredients.
The invention still further relates to the preparation method of this effervescent tablet.
Background technology
" SHUANGHUANLIAN " prescription of being made up of Flos Lonicerae, Radix Scutellariae and Fructus Forsythiae comes from that " Chinese pharmacopoeia one one of version in 2000 is recorded " SHUANGHUANGLIAN KOUFUYE " (418 pages) and " SHUANGHUANGLIAN KELI " (420 pages), is made up of at 1: 1: 2 by mass ratio Flos Lonicerae, Radix Scutellariae and Fructus Forsythiae.Have relieving the exterior syndrome with drugs of pungent in flavor and cool in nature, the effect of heat-clearing and toxic substances removing.Be used for heating, cough, pharyngalgia that affection due to external wind and heat causes.
SHUANGHUANLIAN side's Chinese crude drug mostly is flower, root and the fruit of plant, and the water boiling and extraction thing is rich in water-soluble substanceses such as colloid, polysaccharide, polypeptide, aminoacid, organic acid and mineral, and general vacuum drying heated time is long, inefficiency; When adopting wet granulation technology to prepare granule, need to use more cane sugar powder and or dextrin, and the granule of making, because the strong viscosity under intensive water absorption of extractum and the high concentration, hindered penetrating and solute diffusion of moisture, caused granule in warm cold water, can not dissolve fully, at the bottom of having the part granule during clinical use and sticking at glass, cause taking inconvenience or actual taking dose disappearance, thereby influence drug effect.Oral liquid formulations then exists packaging volume to cause carrying shortcomings such as inconvenience more greatly.
Effervescent tablet system utilizes edible acid agent and the alkaline agent that can produce carbon dioxide, when running into water, neutralization reaction takes place, and discharges carbon dioxide (effervescence), makes rapid disintegrate of tablet and dissolved solid preparation.Effervescent tablet is not only easy to carry, and can dissolving fully in warm cold water.
Summary of the invention
The objective of the invention is to overcome SHUANGHUANGLIAN KELI and the inherent defective of SHUANGHUANGLIAN KOUFUYE dosage form, the double coptis effervescent tablets of the quick Instant Drinks of a kind of energy is provided, this effervescent tablet has better ease of use and good mouthfeel.Increase compliance of patients, thereby guarantee drug effect.
Another object of the present invention is to provide the preparation method of this effervescent tablet.
Extract powder, effervescent, fluidizer and lubricant etc. that double coptis effervescent tablets of the present invention is made by 1: 1: 2 (weight ratio) by Chinese medicine Flos Lonicerae, Radix Scutellariae and Fructus Forsythiae are formed (by weight) composed as follows of effervescent tablet of the present invention:
SHUANGHUANLIAN extract powder 30%～80%
Effervescent 18%～68%
Fluidizer 0.1%-1%
Lubricant 1%-13%
In the above-mentioned prescription, the SHUANGHUANLIAN extract powder for by Chinese medicine Flos Lonicerae, Radix Scutellariae and the Fructus Forsythiae of 1: 1: 2 (weight ratio) through decocting with water extractions, concentrated, powder that spray drying is made, the water content of SHUANGHUANLIAN extract powder should be smaller or equal to 3.5%, fineness is all can pass through 100 mesh sieves, be the disintegration rate of balance tablet and the consumption of effervescent, the preferable amount of SHUANGHUANLIAN extract powder in tablet is 50%～70% (weight ratio).
Effervescent is made up of sour agent and the edible alkaline agent that can produce carbon dioxide.The preferred content of effervescent in tablet is 25%～50% (weight ratio).
Alkaline agent is potassium and the mixed carbonate of sodium or the salt-mixture of mixed carbonic acid hydrogen salt or carbonate and bicarbonate that contains equimolar amounts, carbonate that is adopted and bicarbonate can comprise sodium bicarbonate, potassium bicarbonate, sodium carbonate, potassium carbonate, sodium glycine carbonate etc., preferred alkaline agent is the salt-mixture that Anhydrous potassium carbonate and sodium bicarbonate are formed by 1: 2 mol ratio, potassium and sodium are equimolar amounts in this alkaline agent, the balance that helps the picked-up of body's sodium potassium, simultaneously because Anhydrous potassium carbonate can play the effect of internal desiccant in effervescent tablet, can prevent migration of water residual in the Chinese medical concrete, thereby guarantee the effervescent tablet storage-stable.Among the present invention, the alkaline agent fineness is 60～100 orders, and before the use, bicarbonate was 60～80 ℃ of dryings 2～4 hours; Carbonate was 105～120 ℃ of dryings 2～4 hours.
The acid agent is the edible organic acid, adopts in citric acid, glycine citrate, monosodium citrate salt, malic acid, tartaric acid, the fumaric acid etc. one or both, and fineness is 60～100 orders, should be 105～110 ℃ of dryings 2～4 hours before using.
The proportion of composing of sour agent and alkaline agent is most important to the SOLUTION PROPERTIES that effervescent tablet dissolving back forms in the effervescent.Because the SHUANGHUANLIAN extract powder has been adjusted in preparation process near neutral, after the acid-base neutralization reaction in the effervescent, excessive acid or alkali have determined the pH value of solution, promptly acid or alkaline degree; Main effective ingredient baicalin is insoluble to pH less than in 5.5 the water in the Radix Scutellariae extract, brings bitterness but tart flavour can obviously alleviate baicalin.So in effervescent, calculate by the neutralization reaction equivalent, sour agent composition is answered excessive 3%～10% (weight ratio), preferred 5～8% (weight ratios), this moment, pH value of solution was 5.5～6.5, had good local flavor, simultaneously can cover the bitterness that baicalin brings, baicalin is not separated out substantially; When excessive 10% (weight ratio) of sour agent was above, the effective ingredient baicalin in the Radix Scutellariae extract can be separated out in a large number, and was water insoluble.
Fluidizer adopts micropowder silica gel, and its fineness is mean diameter 20-40nm; Add lubricant in lubricant comprises and add lubricant, in add lubricant and add lubricant in the material before for the system granule; Adding lubricant is to add before the tabletting, with the blended lubricant of dried granule.The fineness of lubricant is all by 100 mesh sieves, in employing polyethylene glycol 6000, fumaric acid, adipic acid, the leucine one or both, preferred polyethylene glycol 6000 and leucine (L or DL type) are united use, wherein polyethylene glycol 6000 adds lubricant in being, its preferable amount is 4～10% (weight ratios), leucine is for adding lubricant, and its preferable amount is 1～3% (weight ratio).
Can also comprise correctives in the above-mentioned according to actual needs prescription.Correctives can adopt one or both in acesulfame potassium, cyclamate or protein sugar and the aromatic (as fruit type powdered flavor and Herba Menthae powdered flavor), and the consumption of correctives is 0.5-5% (by weight), and fineness was 100 mesh sieves.
The present invention uses spray drying technology associating dry granulation prepared double coptis effervescent tablets.The key technology that the present invention prepares double coptis effervescent tablets has 2 points: one is to use spray drying process to prepare the SHUANGHUANLIAN extract.Spray drying method can be prepared into the extract micropowder with large surface area, could dissolve rapidly when effervescent tablet places water.It is block that general vacuum drying method obtains extract, because extract viscosity is bigger, is difficult to carry out mechanical activation comminution to obtain fine powder, so can not be used to prepare effervescent tablet.The 2nd, dry granulation, the extract fine powder particle diameter that the SHUANGHUANLIAN spray drying makes is little, surface area is big, volume is fluffy.Use dehydrated alcohol isopolarity nonaqueous solvent routinely during wet method system granule technology, need a large amount of organic solvents of consumption.Dry granulation then can make spray-dried extractum fine powder that makes of SHUANGHUANLIAN extract and proper auxiliary materials make the granule that makes things convenient for tabletting, avoids with an organic solvent.
The preparation method of effervescent tablet of the present invention is:
1, the preparation of SHUANGHUANLIAN extract powder: the ratio in 1: 1: 2 (weight ratio) takes by weighing Flos Lonicerae, Radix Scutellariae and Fructus Forsythiae, and Radix Scutellariae decocts extraction separately, by acid precipitation, isolates the extract based on baicalin, and is standby; Flos Lonicerae and Fructus Forsythiae be water boiling and extraction together, through concentrate, precipitate with ethanol, recovery ethanol and then be condensed into the clear paste of relative density 1.10～1.15 (60～65 ℃ of surveys), Radix Scutellariae extract is added in this clear paste, regulating the clear paste pH value with 40% sodium hydroxide solution is 6.5～7.0, make the Radix Scutellariae extract dissolving, solution spray drying method drying, 120 ℃～180 ℃ of control inlet temperatures, the best is 150 ℃, makes outlet temperature remain on 80 ℃～90 ℃.Promptly get the SHUANGHUANLIAN extract powder.
2, powder mixes: with each component pulverize on request, sieve, drying gets the raw materials ready, take by weighing each component by formula proportion then, in general mixing apparatus, added alkaline agent, sour agent, correctives, fluidizer and Nei Jia mix lubricant 5-15 minute, make mix homogeneously, add SHUANGHUANLIAN extract powder mix homogeneously then.
3, dry granulation:, under the environment of relative humidity 20～40%, use the dry granulation machine, at 2.0～2.5kg/cm 15～25 ℃ of temperature
2Pressure under 12 order granules are made in mixed powder compression, fragmentation.
4, tabletting: granule with add the lubricant mixing, 15～25 ℃ of temperature, under the environment of relative humidity 20～40%, use the punch die of 2～3 centimetres of diameters, compression moulding on tablet machine, every heavy 2.5～8 grams, preferred 3～6 grams.
Radix Scutellariae in the inventive method, the extracting method of Flos Lonicerae and Fructus Forsythiae three flavor Chinese medicines adopts conventional method, its extraction step is: the Radix Scutellariae section, water decocts three times, boiling water blanking was for the first time boiled 2 hours with the decocting of 10 times of amounts, second, three times each 8 times of water gaging decocted 1 hour, collecting decoction filters, and filtrate is concentrated into relative density 1.05～1.10 (80 ℃ of surveys), in the time of 80 ℃, add 2mol/L hydrochloric acid and regulate pH value to 1.0～2.0, be incubated 1 hour, left standstill 24 hours, filter, the precipitation wash with water to pH value be 5.0, with a small amount of 70% washing with alcohol, wave most ethanol, obtain Radix Scutellariae extract based on baicalin.Flos Lonicerae and Fructus Forsythiae add 10 times of water temperatures and soak (80 ℃) half an hour, decoct 1 hour, add 8 times of decoctings more respectively and boil 2 times, each 1 hour, gradation filters, merging filtrate, and being concentrated into relative density is 1.20～1.30 (70～80 ℃ of surveys), be chilled to 40 ℃, stir down and slowly add ethanol, make to contain the alcohol amount and reach 75%, fully stir, left standstill 12 hours, it is an amount of that leaching supernatant, residue add 75% ethanol, stirs, left standstill 12 hours, filter, merge ethanol liquid, reclaim ethanol to there not being the alcohol flavor, continue to be concentrated into the clear paste of relative density 1.10～1.15 (60～65 ℃ of surveys), obtain the mixed extract of Flos Lonicerae and Fructus Forsythiae.
The effervescent tablet that utilizes the inventive method to produce contains in the unit formulation (monolithic effervescent tablet) and is equivalent to the extract powder that 15g or 30g medicinal material extract make.Generally can make 1.8～2.3g extract powder.According to the pharmacopeia regulation, when containing the extract that is equivalent to the 15g medical material for every, every content of baicalin should be not less than 80mg; When containing the extract that is equivalent to the 30g medical material for every, every content of baicalin should be not less than 160mg.Its content employing high effective liquid chromatography for measuring (" one one 419 pages SHUANGHUANGLIAN KOUFUYE assay items of Chinese pharmacopoeia version in 2000 are the method for regulation down).
More than 2～4 steps need to be lower than 25 ℃ in temperature, relative humidity is less than 40% environment operation down.
Beneficial effect:
1, effervescent tablet of the present invention is compared with traditional granule, has convenient, fast, novel features, not limited by water temperature, cold drink, hot drink all can, no residue does not contain sucrose, the taste sweetness is pleasant, increases compliance of patients, thereby guarantees drug effect.
2, effervescent tablet of the present invention contains the sodium and the potassium of equimolar amounts, the balance that helps body's sodium potassium to take in.
3, the present invention adopts the method for spray drying technology associating dry granulation to prepare effervescent tablet, makes effervescent tablet outward appearance and various component uniformity, avoids with an organic solvent; be beneficial to environmental conservation; and technology is simple and direct efficient, and controllability is strong, is convenient to the quality control of product.
The specific embodiment:
The present invention is further elaborated below in conjunction with specific embodiment, but do not limit the present invention.
The preparation of embodiment 1 SHUANGHUANLIAN extract powder
Radix Scutellariae 37.5kg section, adding 10 times, 8 times, 8 times water gagings respectively boils three times, boiling water blanking was for the first time boiled 2 hours, second and third time each 1 hour, merge decoction liquor, filter cloth filters, filtrate is concentrated into relative density 1.08 (80 ℃ of surveys), and adding 2mol/L hydrochloric acid solution is regulated pH value to 1.5 in right amount in the time of 80 ℃, is incubated 1 hour, left standstill 24 hours, 300 order filter clothes filter, precipitation wash with water to pH value be 5.0, with 10 liter of 70% washing with alcohol, it is standby to wave most ethanol, obtains Radix Scutellariae extract 2.69kg (content of baicalin 85%); Flos Lonicerae 37.5kg, Fructus Forsythiae 75kg adds 10 times of water temperatures and soaks after (80 ℃) half an hour and decocted 1 hour, adds 8 times of water gagings more respectively and boils 2 times, each 1 hour, collecting decoction, filter cloth filters, and it is 1.20 (75 ℃ of surveys) that filtrate is concentrated into relative density, stir when being chilled to 40 ℃ and slowly add ethanol down, make to contain alcohol amount and reach 75%, fully stir, left standstill 12 hours, the leaching supernatant, residue adds 75% ethanol 75L, stirs evenly, and leaves standstill 12 hours, filter cloth filters, merge ethanol liquid, reclaiming ethanol and being concentrated into relative density is 1.11 (60 ℃), adds Radix Scutellariae extract, regulate pH value to 6.7 with 40% sodium hydroxide solution, stir evenly, with spray dryer (LPG-5 type, good the granulation drying equipment in Changzhou factory) drying, 130 ℃ of inlet temperatures, 80～90 ℃ of outlet temperatures, the extractum powder 21.7kg of light brown, water content≤3.1% (measured value).
The preparation of embodiment 2 alkaline agents
When using this effervescent tablet, human body is taken in potassium and sodium equivalent (mole), and employing Anhydrous potassium carbonate and sodium bicarbonate are pre-mixed and are the alkaline agent in the effervescent.The potassium carbonate molecular weight is 138.2, and divalent, sodium bicarbonate molecular weight are 84,1 valencys, mixes with sodium bicarbonate and is mixed base by weight taking by weighing Anhydrous potassium carbonate at 1: 1.2, and the potassium sodium mol ratio that it contains is 1: 1.When being sour agent in the effervescent with malic acid (molecular weight 134.1, divalent), soda acid equivalent mass ratio is 0.876: 1, i.e. 0.876 part of malic acid and 1 part of above-mentioned mixed base complete reaction just.
The preparation of embodiment 3 effervescent tablets
(g) sample weighting amount (200) is (g) for recipe quantity (1)
SHUANGHUANLIAN extract powder 2.2 440.6
Mixed base 0.5 100.0
Malic acid 0.47 94.04
Micropowder silica gel 0.005 1.055
Acesulfame potassium 0.04 7.931
Powdered flavor (Fructus Mali pumilae flavor) 0.03 6.062
Polyethylene glycol 6000 0.25 50.24
L-leucine 0.07 is pressed 2% of grain amount and is added
In the present embodiment, the SHUANGHUANLIAN extract powder adopts the prepared extract powder of embodiment 1.Other component raw material are commercially available pharmaceutical grade or food stage commodity.Mixed base is mixed by the Anhydrous potassium carbonate and the sodium bicarbonate of 1: 1.2 (weight ratio).The consumption of malic acid is 107.3% of a neutralization reaction aequum; Married operation carries out in HD-50 type three-dimensional mixer (the good dry dry instrument factory in Changzhou) in the effervescent tablet preparation process, and mixing velocity is that per minute 15 changes; Tabletting uses the punch die of diameter as 2.0cm, and the TDK type tablet machine of producing with the Far East, Shanghai medical machinery factory carries out compression molding.Mixing, granulation and tabletting operation are all carried out under 25 ℃, relative humidity are 40% environmental condition.
Effervescent tablet step preparation by the following method:
1, after following processing, be stored in the exsiccator each component raw material standby respectively:
The SHUANGHUANLIAN extract powder is crossed 100 mesh sieves; Anhydrous potassium carbonate is crushed to by behind 80 mesh sieves, puts 105 ℃ of aeration-dryings 3 hours; Sodium bicarbonate is crushed to by behind 80 mesh sieves, puts 75 ℃ of aeration-dryings 3 hours; Malic acid is crushed to by behind 80 mesh sieves, puts 105 ℃ of aeration-dryings 3 hours; Polyethylene glycol 6000 and L-leucine are crossed 100 mesh sieves respectively; Fructus Mali pumilae flavor powdered flavor is crossed 100 mesh sieves; Acesulfame potassium is crossed 100 mesh sieves.Airtight preservation, standby.
2, claim mixed base, malic acid, micropowder silica gel, acesulfame potassium, Fructus Mali pumilae flavor powdered flavor and polyethylene glycol 6000 to mix 10 minutes by above-mentioned formula proportion, add the SHUANGHUANLIAN extract powder again, mix and made uniform mixed-powder in 10 minutes.
3, use dry granulation machine (Zhangjagang City starts the GL-30 type that the machine-building company limited is produced), at 2.2kg/cm
2Pressure under 12 order granules are made in mixed powder compression, fragmentation.
4, dried granule is weighed, and press 2% of granular mass and add the leucine fine powder, mix homogeneously, tabletting is made effervescent tablet.The heavy 3.3g of sheet.
Preparation record: must do granule 576.2g.Add leucine fine powder 11.52g.Tabletting, the heavy 3.56g of sheet.
The result: the effervescent test, put 200ml, in 70 ℃ of water, the consoluet time is 2 minutes and 40 seconds.Solution is limpid substantially, and it is sweet to distinguish the flavor of, little hardship.
Claims (9)
1, a kind of double coptis effervescent tablets, its composition (by weight) is:
SHUANGHUANLIAN extract powder 30%～80%
Effervescent 18%～68%
Fluidizer 0.1%-1%
Lubricant 1%-13%
Wherein the SHUANGHUANLIAN extract powder for by Chinese medicine Flos Lonicerae, Radix Scutellariae and the Fructus Forsythiae of 1: 1: 2 (weight ratio) through decocting with water extractions, concentrated, powder that spray drying is made, effervescent is made up of sour agent and the edible alkaline agent that can produce carbon dioxide, said alkaline agent is potassium and the mixed carbonate of sodium or the salt-mixture of mixed carbonic acid hydrogen salt or carbonate and bicarbonate that contains equimolar amounts, calculate by the neutralization reaction equivalent, sour agent composition should excessive 3%～10% (weight ratio).
2, double coptis effervescent tablets according to claim 1, the water content that it is characterized in that the SHUANGHUANLIAN extract powder is that fineness is all to pass through 100 mesh sieves smaller or equal to 3.5%, its consumption is 50%～70% (weight ratio).
3, double coptis effervescent tablets according to claim 1, the content that it is characterized in that effervescent are 25%～50% (weight ratio).
4, double coptis effervescent tablets according to claim 1 is characterized in that alkaline agent is the salt-mixture that Anhydrous potassium carbonate and sodium bicarbonate are formed by 1: 2 mol ratio.
5, double coptis effervescent tablets according to claim 1 is characterized in that calculating by the neutralization reaction equivalent, and sour agent composition should excessive 5～8% (weight ratios).
6, double coptis effervescent tablets according to claim 1 is characterized in that comprising correctives, and its consumption is 0.5-5% (by weight), and fineness is 100 orders.
7, double coptis effervescent tablets according to claim 1, it is characterized in that lubricant adopts polyethylene glycol 6000 and leucine (L or DL type) to unite use, wherein Polyethylene Glycol adds lubricant in being, its consumption is 4～10% (weight ratios), leucine is for adding lubricant, and its consumption is 1～3% (weight ratio).
8, the preparation method of the described double coptis effervescent tablets of claim 1 is characterized in that using spray drying technology associating dry granulation technology, is made up of the following step:
(1) preparation of SHUANGHUANLIAN extract powder: the ratio in 1: 1: 2 (weight ratio) takes by weighing Flos Lonicerae, Radix Scutellariae and Fructus Forsythiae, and Radix Scutellariae decocts extraction separately, by acid precipitation, isolates the extract based on baicalin, and is standby; Flos Lonicerae and Fructus Forsythiae be water boiling and extraction together, through concentrate, precipitate with ethanol, recovery ethanol and then be condensed into the clear paste of relative density 1.10～1.15 (60～65 ℃ of surveys), Radix Scutellariae extract is added in this clear paste, regulating the clear paste pH value with 40% sodium hydroxide solution is 6.5～7.0, make the Radix Scutellariae extract dissolving, solution spray drying method drying, 120 ℃～180 ℃ of control inlet temperatures, make outlet temperature remain on 80 ℃～90 ℃, promptly get the SHUANGHUANLIAN extract powder;
(2) powder mixes: with each component pulverize on request, sieve, drying gets the raw materials ready, take by weighing each component by formula proportion then, in general mixing apparatus, add alkaline agent, sour agent, correctives, fluidizer and Nei Jia mix lubricant 5-15 minute, make mix homogeneously, add SHUANGHUANLIAN extract powder mix homogeneously then;
(3) dry granulation:, under the environment of relative humidity 20～40%, use the dry granulation machine, at 2.0～2.5kg/cm 15～25 ℃ of temperature
2Pressure under 12 order granules are made in mixed powder compression, fragmentation;
(4) tabletting: granule with add the lubricant mixing, 15～25 ℃ of temperature, under the environment of relative humidity 20～40%, use the punch die of 2～3 centimetres of diameters, compression moulding on tablet machine, every heavy 2.5～8 grams.
9, the preparation method of double coptis effervescent tablets according to claim 8 is characterized in that every heavy 3～6 grams.
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| CN200410053811A CN100577154C (en) | 2004-08-17 | 2004-08-17 | Effervescence tablet of 'Shuang Huanglian' and its preparation process thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102526208A (en) * | 2010-12-16 | 2012-07-04 | 四川科伦药物研究有限公司 | Shuanghuanglian effervescence tablet and preparation method thereof |
| CN106265945A (en) * | 2016-09-21 | 2017-01-04 | 西安乐道生物科技有限公司 | A kind of SHUANGHUANLIAN effervescent granule for animals and preparation method thereof |
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2004
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102526208A (en) * | 2010-12-16 | 2012-07-04 | 四川科伦药物研究有限公司 | Shuanghuanglian effervescence tablet and preparation method thereof |
| CN106265945A (en) * | 2016-09-21 | 2017-01-04 | 西安乐道生物科技有限公司 | A kind of SHUANGHUANLIAN effervescent granule for animals and preparation method thereof |
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| CN100577154C (en) | 2010-01-06 |
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