Quick effervescent tablet of a kind of gold sense and preparation method thereof
Technical field
The invention belongs to the pharmaceutical technology field, be specifically related to quick effervescent tablet of a kind of gold sense and preparation method thereof.
Technical background
Application number is that the patent documentation of CN200410096174.9 discloses a kind of pharmaceutical composition, Its Preparation Method And Use for the treatment of flu and upper respiratory tract infection, and it is quick that this pharmaceutical composition is referred to as the gold sense.Gold sense is quick to be to be the Chinese medicine and western medicine compound preparation that feedstock production forms by aspirin, amantadine hydrochloride, caffeine, chlorphenamine, artificial Calculus Bovis, Flos Lonicerae, Folium Isatidis, effect with antipyretic-antalgic, aspirin wherein, amantadine hydrochloride, caffeine, chlorphenamine are Western medicine, effect between each composition replenishes mutually, and therapeutic effect is clear and definite; The artificial Calculus Bovis also has fine heat clearing away, antidotal effect, is traditional Chinese medical science medicine commonly used; Flos Lonicerae (Flos Lonicerae Japonicae) is caprifoliaceae plant dry flower or the first flower of opening of band of Radix Ophiopogonis, the effect that heat-clearing and toxic substances removing, wind-heat dissipating are arranged, main effective ingredient is the organic acid chemical compound based on chlorogenic acid, has effects such as analgesic, antibiotic, antiviral, antiinflammatory; Folium Isatidis (FoliunIsatidis) is the dried leaves of cruciferae isatis, clearing up internal heat by using drugs of bitter in taste and cold in nature, salty to go into blood, can removing summer-heat the noxious heat in the blood system excess-fire, especially be good at blood cooling and ecchymoses removing, be applicable to that heat goes into cards such as nutrient blood, intense heat in both QI and blood systems, maculae caused by violent heat pathogen and pharyngeal swelling aphtha, it always is the key medicine of heat-clearing and toxic substances removing, show effects such as that Folium Isatidis has is antibiotic, anticancer, antiviral, analgesic, antiinflammatory, function of gallbladder promoting, antiendotoxin and enhancing immunity, the main effective ingredient such as indigo, indirubin that contains through pharmacological evaluation.The Chinese medicine and western medicine compound preparation is used for antipyretic-antalgic, can overcome the Chinese medicine effect slowly, the Western medicine unsteady deficiency of bringing down a fever, get the length of the two, exterior heat is moved back to the greatest extent to reach, interior-heat is also clear, remove symptom, act on rapid, steady, the synergistic therapeutic purposes of bringing down a fever, and has the good clinical therapeutic effect.
Application number is that the patent documentation of CN200510134399.3 discloses a kind of gold sense sensitizing drug preparation and preparation method thereof, is the further improvement to above-mentioned patent, has improved curative effect.But the patient is good for compliance, the gold of better efficacy is felt quick novel formulation and still had demand.
Effervescent tablet is a kind of novel tablet of external in recent years Application and Development, it contains gas-producing disintegrant, after effervescent tablet is put into drinking-water, under the effect of gas-producing disintegrant, at once produce a large amount of bubbles (carbon dioxide), make rapid disintegrate of tablet and thawing, the bubble that disintegrate sometimes produces also can make tablet roll up and down in water, quickens its disintegrate and thawing.Effervescent tablet has following advantage: 1, be convenient to preserve and carry; 2, disintegrate fast, taking convenience, onset be rapid.3, bioavailability height can improve clinical efficacy.4, be specially adapted to child, old people and the patient of pill difficulty that swallows; 5, through the effervescent tablet after the seasoning, taste is better, and good medicine is no longer bitter to the taste, and patient is more taken like a shot; 6, because a large amount of foams that disintegrate produces have increased medicine contacts with the direct of diseased region, bring into play its curative effect effect better, so effervescent tablet also is used for the control medication of oral disease etc.
In data-searching, find no any report of feeling quick effervescent tablet about gold.
Summary of the invention
Based on above the deficiencies in the prior art, research worker of the present invention is developed the quick effervescent tablet of a kind of gold sense through a large amount of experiments, and it is that acid source, alkali source, binding agent and other adjuvants that principal agent preferably obtains with research worker of the present invention are prepared from.Clinical experiment is the result show, effervescent tablet of the present invention is than the better efficacy of existing peroral dosage form.
An object of the present invention is to disclose the quick effervescent tablet of a kind of gold sense.
Another object of the present invention is the preparation method that discloses above-mentioned effervescent tablet.
The quick effervescent tablet of the present invention's gold sense comprises principal agent and pharmaceutic adjuvant.
Above-mentioned pharmaceutic adjuvant comprises: acid source, alkali source, binding agent, lubricant, sweeting agent and correctives.
Above-mentioned principal agent and each pharmaceutic adjuvant consist of: principal agent 4.5-5.0 weight portion, acid source 2.0-3.0 weight portion, alkali source 7.0-8.0 weight portion, binding agent 2.0-4.0 weight portion, lubricant 0.5-1.0 weight portion, sweeting agent 1.0-1.5 weight portion, correctives 0.5-1.0 weight portion.
Above-mentioned principal agent is the mixture of aspirin, amantadine hydrochloride, caffeine, chlorphenamine, artificial Calculus Bovis, Flos Lonicerae extract, Folium Isatidis extract.
Above-mentioned acid source is a kind of in citric acid, tartaric acid, the succinic acid.
Above-mentioned alkali source is the sodium bicarbonate of coating agent parcel.
Above-mentioned coating agent is selected from polyethylene glycol 6000.
The weight portion consumption of above-mentioned acid source and alkali source is 1: 1.4-1.6.
Above-mentioned alkali source: the weight part ratio of coating agent is 1: 0.50-0.55.
Above-mentioned binding agent is selected from microcrystalline Cellulose or crospolyvinylpyrrolidone.
Above-mentioned lubricant is selected from magnesium stearate, Pulvis Talci.
Above-mentioned sweeting agent is selected from a kind of in cyclamate, stevioside, aspartame, protein sugar or the sucrose or several mixture.
Above-mentioned correctives is selected from a kind of in orange essence, flavoring orange essence, Herba Menthae essence or the Fructus Citri Limoniae essence.
The preparation method of effervescent tablet of the present invention is: get the acid source drying for standby; Get the alkali source drying, with alkali source: the coating agent weight part ratio is 1: the coating agent fusion of 0.50-0.55, add alkali source dry powder, and abundant mix homogeneously, behind the parcel, 80 mesh sieves were pulverized in cooling; Above-mentioned each component is mixed, with conventional pharmaceutical technology technology granulation, drying, granulate, tabletting, check, pack, obtain effervescent tablet of the present invention.
The principal agent prescription of effervescent tablet of the present invention is: aspirin 250g, amantadine hydrochloride 100g, caffeine 15g, chlorphenamine 2g, artificial Calculus Bovis 10g, Flos Lonicerae 500g, Folium Isatidis 500g.
Above-mentioned Flos Lonicerae extract can adopt following method preparation: the extracting honeysuckle medical material, pulverize, and cross 40 mesh sieves, add the 70-80% ethanol solution hydrochloride immersion half an hour that 4-8 doubly measures pH3-4, put into the supersound extraction jar, carry out supersound extract, time is 20-30 minute, and frequency of oscillation 30-40kHz extracts 2-3 time, merge extractive liquid,, filter, filtrate is in decompression recycling ethanol below 50 ℃, drying, pulverize, promptly get Flos Lonicerae extract.
Above-mentioned Folium Isatidis extract can adopt following method preparation: get the Folium Isatidis medical material, pulverize, cross 20 mesh sieves, add 5-8 and doubly measure the 80-90% alcohol reflux 2 times, each 1 hour, merge extractive liquid, filtered decompression filtrate recycling ethanol, drying is pulverized, and promptly gets Folium Isatidis extract.
Research worker of the present invention is found, the different in kind of principal agent is also different to the selectivity of some pharmaceutic adjuvant in the effervescent tablet.A large amount of chemicalses such as aspirin, amantadine hydrochloride had both been contained in the principal agent among the present invention, contain a large amount of Chinese medicine extract such as Flos Lonicerae extract, Folium Isatidis extract again, so only select the pharmaceutic adjuvant that is fit to principal agent character, indexs such as the outward appearance of prepared effervescent tablet, stability, disintegration just can meet quality standard, and the effervescent tablet of preparing is only qualified effervescent tablet.For this reason, research worker of the present invention has been done a large amount of experiments, and having optionally to the principal agent in the effervescent tablet of the present invention, pharmaceutic adjuvant has carried out preferably.
Research worker of the present invention finds can obviously reduce with the binding agent with disintegration the disintegration time of effervescent tablet of the present invention, so with the disintegration time is index, binder starch commonly used, modified starch, dextrin, carboxymethyl starch sodium, microcrystalline Cellulose, crospolyvinylpyrrolidone etc. are selected.
The mensuration of disintegration time, according to " two (appendix XA) inspection techniques disintegration of Chinese pharmacopoeia version in 2005 are carried out, be specially: get 1 of effervescent tablet, put in the 250ml beaker, fill 200ml water in the beaker, water temperature is 15-25 ℃, have numerous air-bubble to emit, when the gas around tablet or the fragment stopped to overflow, tablet melted or is dispersed in the water, it is left not have accumulative granule, and the record time at this moment is disintegration time.
Experimental design: principal agent is carried out proportioning with different binding agents by identical amount, and the amount of other components remains unchanged in the prescription, is pressed into effervescent tablet with identical pressure, carries out the mensuration of disintegration time.Experimental result sees Table 1.
The selection of table 1 binding agent
Form (g: g) | Disintegration time (s) |
Principal agent: starch principal agent: modified starch principal agent: dextrin principal agent: carboxymethyl starch sodium | 245 216 234 186 |
Principal agent: microcrystalline Cellulose principal agent: crospolyvinylpyrrolidone | 116 112 |
By above-mentioned experimental result as can be seen, when binding agent used microcrystalline Cellulose or crospolyvinylpyrrolidone, the disintegration time of effervescent tablet of the present invention is short, and was effective.
Alkali source commonly used has sodium carbonate and sodium bicarbonate, and sodium bicarbonate consumption wherein is little, and gas production is big, so the selection sodium bicarbonate is an alkali source.Acid source commonly used is a kind of in citric acid, tartaric acid, the succinic acid.Research worker of the present invention finds that the acid source in the effervescent tablet of the present invention and the consumption of alkali source have tangible influence for the disintegration time of effervescent tablet.So be index with the disintegration time consumption of acid source and alkali source has been carried out preferably.
Experimental design: proportioning is carried out in the design of acid source and alkali source according to the form below, and the amount of other components remains unchanged in the prescription, is pressed into effervescent tablet with identical pressure.Experimental result sees Table 2.
The selection of table 2 soda acid ratio
Acid source: alkali source (g: g) | Disintegration time (s) |
1∶1.0 1∶1.1 1∶1.2 1∶1.3 1∶1.4 1∶1.5 1∶1.6 1∶1.7 1∶1.8 1∶1.9 1∶2.0 | 140 127 114 106 95 88 92 103 108 116 128 |
By above-mentioned result of the test as can be seen, when the consumption of acid source and alkali source is about 1: during 1.4-1.6, disintegration time the best of effervescent tablet.
Macrogol 4000 and polyethylene glycol 6000 are the coating agent of alkali source in the effervescent tablet commonly used, and research worker of the present invention is index with the disintegration time, and coating agent Macrogol 4000 and polyethylene glycol 6000 are selected.
Experimental design: alkali source is carried out proportioning with different coating agents by identical amount, and the amount of other components remains unchanged in the prescription, is pressed into effervescent tablet with identical pressure, carries out the mensuration of disintegration time.Experimental result sees Table 3.
The selection of table 3 coating agent
Form (g: g) | Disintegration time (s) |
The Macrogol 4000 polyethylene glycol 6000 | Length |
By above-mentioned experimental result as can be seen, when coating agent used polyethylene glycol 6000, the disintegration time of effervescent tablet of the present invention is short, and was effective.
With polyethylene glycol 6000 the alkali source sodium bicarbonate is wrapped up, can increase the stability of effervescent tablet, but amount can impact disintegration greatly again.So with stability with to the influence of disintegration time is index, the reasonable volume of polyethylene glycol 6000 has been carried out preferably.Experimental design and the results are shown in Table 4 and table 5.
The selection of table 4 polyethylene glycol 6000 consumption
Sodium bicarbonate: polyethylene glycol 6000 (g: g) | Stability |
1∶0.20 1∶0.25 1∶0.30 1∶0.35 1∶0.40 1∶0.45 1∶0.50 1∶0.55 1∶0.60 | Slightly poor slightly poor the getting well carefully of very poor difference |
By above-mentioned experimental result as can be seen, when sodium bicarbonate: the consumption of polyethylene glycol 6000 is during greater than 1: 0.50, the good stability of effervescent tablet of the present invention.
The selection of table 5 polyethylene glycol 6000 consumption
Sodium bicarbonate: polyethylene glycol 6000 (g: g) | Influence to disintegration time |
1∶0.50 1∶0.55 1∶0.60 1∶0.65 1∶0.70 1∶0.80 | Slight greatly very big very big |
By above-mentioned experimental result as can be seen, when sodium bicarbonate: the consumption of polyethylene glycol 6000 is 1: during 0.50-0.55, the disintegration time of effervescent tablet is not almost had influence.
The quick effervescent tablet any surface finish of the present invention's gold sense, exquisiteness.A slice effervescent tablet input is filled in the 250ml beaker of 20 ℃ of drinking waters of 200ml, at the bottom of it is sunken to glass very soon, and emit a large amount of bubbles immediately, tablet is dissolving rapidly thereupon, forms clear solution in 2 minutes.
For the therapeutic effect of the quick effervescent tablet of the present invention's gold sense is described, research worker of the present invention is that the gold among the CN200510134399.3 is felt quick capsule as positive control drug with the application number, has carried out following clinical experiment.
The preparation of principal agent: aspirin 250g, amantadine hydrochloride 100g, caffeine 15g, chlorphenamine 2g, artificial Calculus Bovis 10g, Flos Lonicerae 500g, Folium Isatidis 500g.The extracting honeysuckle medical material is pulverized, and crosses 40 mesh sieves, 75% ethanol solution hydrochloride that adds 6 times of amount pH3.5 soaks half an hour, puts into the supersound extraction jar, carries out supersound extract, time is 25 minutes, and frequency of oscillation 35kHz extracts 2 times, merge extractive liquid,, filter, filtrate is in decompression recycling ethanol below 50 ℃, drying, pulverize, promptly get Flos Lonicerae extract; Get the Folium Isatidis medical material, pulverize, cross 20 mesh sieves, add 6 times of amount 85% alcohol reflux 2 times, each 1 hour, merge extractive liquid, filtered, decompression filtrate recycling ethanol, and drying is pulverized, and promptly gets Folium Isatidis extract; Flos Lonicerae extract, Folium Isatidis extract and aspirin, amantadine hydrochloride, caffeine, chlorphenamine, artificial Calculus Bovis's mixing are promptly got principal agent.
The quick capsular preparation of gold sense: with above-mentioned principal agent, add appropriate amount of starch and mix, fill, promptly get 1000 of the quick capsules of golden sense.
The preparation of the quick effervescent tablet of the present invention's gold sense: above-mentioned principal agent is mixed with pharmaceutic adjuvant, granulation, drying, granulate, tabletting, can obtain that the present invention is golden to feel 1000 of quick effervescent tablets.
Clinical settings: upper respiratory tract infection patient, 100 examples are divided into 2 groups at random, every group 50 example.Effervescent tablet medicine group male 33 examples, women's 17 examples, at 7 years old-16 years old age, 12.2 years old mean age, body temperature is 30 examples for 38.0 ℃-38.9 ℃, greater than 39.0 ℃ be 20 examples, average course of disease 1.5 ± 0.6 days; Capsule positive controls male 35 examples, women's 15 examples, at 7 years old-17 years old age, 12.5 years old mean age, body temperature is 32 examples for 38.0 ℃-38.9 ℃, greater than 39.0 ℃ be 18 examples, average course of disease 1.5 ± 0.5 days.
100 routine patients all possess following condition: in 1, the Acute onset, the course of disease 3 days; 2, body temperature is greater than 38 ℃, and is mixed with symptoms such as cough, watery nasal discharge, sneeze, hoarseness; 3, surrounding hemogram numeration of leukocyte and classification all meet the acute upper respiratory tract infection diagnostic criteria all in normal range.
Therapeutic Method: effervescent tablet group of the present invention, 7-8 year, 1/3; 9-13 year, 2/3; 13-16 year, 1; Every day 2 times, 3 days courses of treatment.Capsule positive drug group, 7-8 year, 1/3; 9-13 year, 2/3; 13-17 year, 1; Every day 2 times, 3 days courses of treatment.
Efficacy determination: the back of taking medicine is every 4 hours take temperatures and record, institute's further consultation over 4-5 days, and the improvement situation of inquiry fever time and other clinical symptoms, and make physical examination.Produce effects: recover normal after taking medicine in 24-48 hour, clinical symptoms such as cough, watery nasal discharge are clearly better or disappear; Effectively: recover normal in body temperature 48-72 hour, clinical symptoms such as cough, watery nasal discharge are clearly better; Invalid: body temperature did not recover normal in 72 hours yet, and clinical symptoms such as cough, watery nasal discharge do not have improvement.
Therapeutic outcome: effervescent tablet medicine group produce effects 29 examples of the present invention (58.0%), effective 20 examples (40.0%), invalid 1 example (2.0%); Capsule positive drug group produce effects 22 examples (44.0%), effective 25 examples (50.0%), invalid 3 examples (6.0%).As can be seen, effervescent tablet of the present invention has better therapeutical effect than existing preparation capsule.
Specific embodiment
Following specific embodiment is intended to further specify the present invention, rather than restriction the present invention.
Embodiment 1
(1) prescription: aspirin 250g, amantadine hydrochloride 100g, caffeine 15g, chlorphenamine 2g, artificial Calculus Bovis 10g, Flos Lonicerae 500g, Folium Isatidis 500g.
(2) principal agent preparation: the extracting honeysuckle medical material, pulverize, cross 40 mesh sieves, 70% ethanol solution hydrochloride that adds 4 times of amount pH3 soaks half an hour, puts into the supersound extraction jar, carries out supersound extract, time is 20 minutes, and frequency of oscillation 30kHz extracts 2 times, merge extractive liquid,, filter, filtrate is in decompression recycling ethanol below 50 ℃, drying, pulverize, promptly get Flos Lonicerae extract; Get the Folium Isatidis medical material, pulverize, cross 20 mesh sieves, add 5 times of amount 80% alcohol reflux 2 times, each 1 hour, merge extractive liquid, filtered, decompression filtrate recycling ethanol, and drying is pulverized, and promptly gets Folium Isatidis extract; Flos Lonicerae extract, Folium Isatidis extract and aspirin, amantadine hydrochloride, caffeine, chlorphenamine, artificial Calculus Bovis's mixing are promptly got principal agent 450g.
(3) preparation prescription is:
Principal agent 450g
Citric acid 200g
Sodium bicarbonate 800g
Microcrystalline Cellulose 400g
Magnesium stearate 50g
Cyclamate 100g
Orange essence 50g
(4) get the acid source drying for standby; Get the alkali source drying, with alkali source: the coating agent weight part ratio is 1: 0.50 coating agent fusion, adds alkali source dry powder, abundant mix homogeneously, and behind the parcel, 80 mesh sieves were pulverized in cooling; Above-mentioned each component is mixed, with conventional pharmaceutical technology technology granulation, drying, granulate, tabletting, check, pack, obtain 1000 of effervescent tablets of the present invention.
Embodiment 2
(1) prescription: aspirin 250g, amantadine hydrochloride 100g, caffeine 15g, chlorphenamine 2g, artificial Calculus Bovis 10g, Flos Lonicerae 500g, Folium Isatidis 500g.
(2) principal agent preparation: the extracting honeysuckle medical material, pulverize, cross 40 mesh sieves, 80% ethanol solution hydrochloride that adds 8 times of amount pH4 soaks half an hour, puts into the supersound extraction jar, carries out supersound extract, time is 30 minutes, and frequency of oscillation 40kHz extracts 3 times, merge extractive liquid,, filter, filtrate is in decompression recycling ethanol below 50 ℃, drying, pulverize, promptly get Flos Lonicerae extract; Get the Folium Isatidis medical material, pulverize, cross 20 mesh sieves, add 8 times of amount 90% alcohol reflux 2 times, each 1 hour, merge extractive liquid, filtered, decompression filtrate recycling ethanol, and drying is pulverized, and promptly gets Folium Isatidis extract; Flos Lonicerae extract, Folium Isatidis extract and aspirin, amantadine hydrochloride, caffeine, chlorphenamine, artificial Calculus Bovis's mixing are promptly got principal agent 500g.
(3) preparation prescription is:
Principal agent 500g
Tartaric acid 300g
Sodium bicarbonate 700g
Crospolyvinylpyrrolidone 200g
Pulvis Talci 100g
Stevioside 150g
Flavoring orange essence 100g
(4) get the acid source drying for standby; Get the alkali source drying, with alkali source: the coating agent weight part ratio is 1: 0.55 coating agent fusion, adds alkali source dry powder, abundant mix homogeneously, and behind the parcel, 80 mesh sieves were pulverized in cooling; Above-mentioned each component is mixed, with conventional pharmaceutical technology technology granulation, drying, granulate, tabletting, check, pack, obtain 1000 of effervescent tablets of the present invention.
Embodiment 3
(1) prescription: aspirin 250g, amantadine hydrochloride 100g, caffeine 15g, chlorphenamine 2g, artificial Calculus Bovis 10g, Flos Lonicerae 500g, Folium Isatidis 500g.
(2) principal agent preparation: the extracting honeysuckle medical material, pulverize, cross 40 mesh sieves, 75% ethanol solution hydrochloride that adds 6 times of amount pH3.5 soaks half an hour, puts into the supersound extraction jar, carries out supersound extract, time is 25 minutes, and frequency of oscillation 35kHz extracts 2 times, merge extractive liquid,, filter, filtrate is in decompression recycling ethanol below 50 ℃, drying, pulverize, promptly get Flos Lonicerae extract; Get the Folium Isatidis medical material, pulverize, cross 20 mesh sieves, add 6 times of amount 85% alcohol reflux 2 times, each 1 hour, merge extractive liquid, filtered, decompression filtrate recycling ethanol, and drying is pulverized, and promptly gets Folium Isatidis extract; Flos Lonicerae extract, Folium Isatidis extract and aspirin, amantadine hydrochloride, caffeine, chlorphenamine, artificial Calculus Bovis's mixing are promptly got principal agent 464g.
(3) preparation prescription is:
Principal agent 464g
Succinic acid 225g
Sodium bicarbonate 775g
Microcrystalline Cellulose 350g
Magnesium stearate 67g
Aspartame 115g
Herba Menthae essence 54g
(4) get the acid source drying for standby; Get the alkali source drying, with alkali source: the coating agent weight part ratio is 1: 0.53 coating agent fusion, adds alkali source dry powder, abundant mix homogeneously, and behind the parcel, 80 mesh sieves were pulverized in cooling; Above-mentioned each component is mixed, with conventional pharmaceutical technology technology granulation, drying, granulate, tabletting, check, pack, obtain 1000 of effervescent tablets of the present invention.
Embodiment 4
(1) prescription: aspirin 250g, amantadine hydrochloride 100g, caffeine 15g, chlorphenamine 2g, artificial Calculus Bovis 10g, Flos Lonicerae 500g, Folium Isatidis 500g.
(2) principal agent preparation: the extracting honeysuckle medical material, pulverize, cross 40 mesh sieves, 78% ethanol solution hydrochloride that adds 5 times of amount pH3.2 soaks half an hour, puts into the supersound extraction jar, carries out supersound extract, time is 22 minutes, and frequency of oscillation 35kHz extracts 3 times, merge extractive liquid,, filter, filtrate is in decompression recycling ethanol below 50 ℃, drying, pulverize, promptly get Flos Lonicerae extract; Get the Folium Isatidis medical material, pulverize, cross 20 mesh sieves, add 7 times of amount 88% alcohol reflux 2 times, each 1 hour, merge extractive liquid, filtered, decompression filtrate recycling ethanol, and drying is pulverized, and promptly gets Folium Isatidis extract; Flos Lonicerae extract, Folium Isatidis extract and aspirin, amantadine hydrochloride, caffeine, chlorphenamine, artificial Calculus Bovis's mixing are promptly got principal agent 488g.
(3) preparation prescription is:
Principal agent 488g
Citric acid 270g
Sodium bicarbonate 730g
Crospolyvinylpyrrolidone 250g
Pulvis Talci 85g
Protein sugar 140g
Fructus Citri Limoniae essence 87g
(4) get the acid source drying for standby; Get the alkali source drying, with alkali source: the coating agent weight part ratio is 1: 0.52 coating agent fusion, adds alkali source dry powder, abundant mix homogeneously, and behind the parcel, 80 mesh sieves were pulverized in cooling; Above-mentioned each component is mixed, with conventional pharmaceutical technology technology granulation, drying, granulate, tabletting, check, pack, obtain 1000 of effervescent tablets of the present invention.
Embodiment 5
(1) prescription: aspirin 250g, amantadine hydrochloride 100g, caffeine 15g, chlorphenamine 2g, artificial Calculus Bovis 10g, Flos Lonicerae 500g, Folium Isatidis 500g.
(2) principal agent preparation: the extracting honeysuckle medical material, pulverize, cross 40 mesh sieves, 72% ethanol solution hydrochloride that adds 7 times of amount pH3.7 soaks half an hour, puts into the supersound extraction jar, carries out supersound extract, time is 27 minutes, and frequency of oscillation 40kHz extracts 2 times, merge extractive liquid,, filter, filtrate is in decompression recycling ethanol below 50 ℃, drying, pulverize, promptly get Flos Lonicerae extract; Get the Folium Isatidis medical material, pulverize, cross 20 mesh sieves, add 6 times of amount 83% alcohol reflux 2 times, each 1 hour, merge extractive liquid, filtered, decompression filtrate recycling ethanol, and drying is pulverized, and promptly gets Folium Isatidis extract; Flos Lonicerae extract, Folium Isatidis extract and aspirin, amantadine hydrochloride, caffeine, chlorphenamine, artificial Calculus Bovis's mixing are promptly got principal agent 475g.
(3) preparation prescription is:
Principal agent 475g
Tartaric acid 245g
Sodium bicarbonate 755g
Crospolyvinylpyrrolidone 300g
Magnesium stearate 73g
Sucrose 130g
Flavoring orange essence 72g
(4) get the acid source drying for standby; Get the alkali source drying, with alkali source: the coating agent weight part ratio is 1: 0.54 coating agent fusion, adds alkali source dry powder, abundant mix homogeneously, and behind the parcel, 80 mesh sieves were pulverized in cooling; Above-mentioned each component is mixed, with conventional pharmaceutical technology technology granulation, drying, granulate, tabletting, check, pack, obtain 1000 of effervescent tablets of the present invention.
Each 1 of the quick effervescent tablet of the present invention's gold sense, every day 2 times.