CN101138554B - Effervescence dispersible tablet - Google Patents
Effervescence dispersible tablet Download PDFInfo
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- CN101138554B CN101138554B CN200610048659XA CN200610048659A CN101138554B CN 101138554 B CN101138554 B CN 101138554B CN 200610048659X A CN200610048659X A CN 200610048659XA CN 200610048659 A CN200610048659 A CN 200610048659A CN 101138554 B CN101138554 B CN 101138554B
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Abstract
The present invention relates to a new preparation of a Chinese medicine. The present invention particularly relates to a novel preparation of a drug with the effervescent tablet property and the dispersing agent property. In the effervescent dispersing tablet of the present invention, the weight ratio of each components are as following, which comprises 5 percentage to 60 percentage of effervescent agent, 3 percentage to 30 percentage of effervescing agent, 3 percentage to 30 percentage of disintegrant, 3 percentage to 30 percentage of excipient of the hydrophilic medicine, 1 percentage to 5 percentage of correctant. The effervescent dispersing tablet of the present invention is a novel preparation of the Chinese medicine, which has the effervescent tablet property and the dispersing agent property. The present medicine is a tablet, which can produce the gas in the water, which can disaggregate quickly and disperse evenly. The present invention is a novel preparation of the medicine, which can generate the gas; as a result the medicine can disaggregate more quickly. The drug loading dosage of the agent is large, which is beneficial for improving the dispersion uniformity, the dissolution and the bioavailability of the medicine. The present invention has the characteristics of convenience for oral administration and small dose. The present invention can sufficiently display the drug efficacy in order to meet the drug requirement of the patients.
Description
Technical field
The present invention relates to a kind of novel form of Chinese medicine, especially existing effervescent tablet feature, again the novel pharmaceutical formulation of dispersant feature arranged.
Technical background
Effervescent tablet is a kind of dosage form of Chinese medicine, in that " existing clearly regulation in the Chinese pharmacopoeia 2005 editions, effervescent tablet mean and contain sodium bicarbonate and organic acid, meets that water can produce gas and the tablet that is the effervescent shape.Obtained extensive use in Chinese medicine in the dosage form, as summer Sang Ju Yin effervescent tablet, gingkgo vitamin C effervescent tablets, infantile asthma effervescent tablet, double coptis effervescent tablets etc., it is 120 multinomial that only relevant patent just has.Dispersible tablet is a kind of Western medicine dosage form, in that " existing clearly regulation in the Chinese pharmacopoeia 2005 editions, dispersible tablet mean in water disintegrate and homodisperse tablet rapidly.In the form of Chinese drug exploitation, also see the appearance that a large amount of Chinese medicine disperses dosage form, as Yixin ketone dispersing tablets, XUESHUANTONG dispersible tablet, cough-relieving dispersible tablet, breviscapine dispersible tablet, Naoxinqing Chinese medicine dispersible tablet etc., it is 170 multinomial that only relevant patent just has, and national Bureau of Drugs Supervision medicine was evaluated the new Chinese medicine application that 342 relevant dispersible tablets been have just have been accepted at the center in 2005.This shows the fierce degree of Chinese medicine novel form competition exploitation.Effervescent tablet is to utilize foam theory to quicken the medicine disintegrate, and dispersible tablet is to quicken the disintegrate of medicine by the swelling of special adjuvant in solution.No matter be effervescent tablet or dispersible tablet, they all are in order to accelerate the disintegrate of medicine, to improve the dissolubility and the bioavailability of medicament of medicine.But along with the component difference of medicine, these two kinds of dosage forms all can not adapt to the specific requirement of all medicines again, as drug loading problem, the high-leveled and difficult scattering problem of Chinese medicine extract viscosity, the low problem of drug solubility.Chinese medicine dispersant drug loading generally is no more than 30%, and effervescent tablet sheet heavy generally all heavier (have even reach 4～5 gram sheets heavy).This exploitation to novel pharmaceutical formulation is disadvantageous, and the suffered restriction of developer is too many.
Summary of the invention
The objective of the invention is to overcome the defective of prior art, a kind of have simultaneously foaming and swelling function are provided, can quicken the disintegrate of medicine better, increase the dissolubility of medicine, improve bioactive new pharmaceutical dosage form---the effervescence dispersible tablet of medicine.
Effervescence dispersible tablet of the present invention is made up of medicine, effervescent, disintegrating agent, hydrophilic pharmaceutic adjuvant and correctives.
Described medicine can be single composition, also the mixture of multiple components; Can be Western medicine, plant amedica, Chinese medicine and their compound recipe, the also extract of plant amedica, Chinese medicine.Described medicine can be ease of solubility or ease of solubility not.
Described effervescent is made up of sour agent and alkaline agent, sour agent: the weight ratio of alkaline agent is 0.8: 1.4, and sour agent can be selected from one or more in citric acid, tartaric acid, dextrotartaric acid, fumaric acid, malic acid, anhydrous citric acid, the sodium dihydrogen citrate.Alkaline agent is one or more in sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, calcium carbonate, the calcium bicarbonate.
The optional self-crosslinking polyvinylpyrrolidone of described disintegrating agent (PVPP), carboxymethyl starch sodium (CMS-Na), low-substituted hydroxypropyl cellulose (L-HPC), microcrystalline Cellulose (MCC), crosslinked carboxymethyl fecula sodium (cCMS-Na), 30 POVIDONE K 30 BP/USP
30In one or more.
Described correctives can be selected from one or more in sucrose, aspartame, acesulfame-K, hesperidin dihydrochalcone, the sweet peptide factor, the fruity flavor.
Described hydrophilic pharmaceutic adjuvant is optional takes from lactose (lactose), sucrose (sucrose), mannitol (mannitol), Polyethylene Glycol (PEG) 6000, Polyethylene Glycol (PEG) 4000, sodium lauryl sulphate, dextrin, the soluble starch one or more.
In the effervescence dispersible tablet of the present invention, the percentage by weight of each component is: medicine 5～60%, effervescent 3～30%, disintegrating agent 3～30%, hydrophilic pharmaceutic adjuvant 3～30%, correctives 1～5%.
Effervescence dispersible tablet of the present invention is a kind of novel form of Chinese medicine, and the feature of its existing effervescent tablet has the dispersant feature again, be that a kind of chance water can produce gas, and disintegrate rapidly, and finely dispersed tablet, produce with bubble simultaneously, quicken the novel drugs dosage form of its disintegrate.Effervescence dispersible tablet has overcome the Chinese medicine effervescent can only be with the water soluble ingredient of medical material, and the shortcoming that liposoluble constituent is less utilizes the advantage of tablet formulation can fully use each active component of Chinese medicine.The high-leveled and difficult dispersion of Chinese medicine extract viscosity utilizes effervescent dosage form foaming characteristics, helps improving the dispersibility of dope.This dosage form drug loading is bigger, helps improving dispersing uniformity, dissolution and the bioavailability of medicine, and has and be easy to orally, and characteristics such as dosage is little can be given full play to the curative effect of medicine, satisfy the medication demand of extensive patients.
Effervescence dispersible tablet is realized by following method.
Method one:
1. medicine (as Chinese medicine extract), sour agent, disintegrating agent, pharmaceutic adjuvant and correctives are crossed mix homogeneously behind 100 orders, the 30 POVIDONE K 30 BP/USP with 10% respectively
30Solution impregnation adds the medicinal adjuvant system soft material that is mixed, and makes the granule of 50 mesh sieves;
2. medicine (as Chinese medicine extract), alkaline agent, disintegrating agent, pharmaceutic adjuvant and correctives are crossed mix homogeneously behind 100 orders, the 30 POVIDONE K 30 BP/USP with 10% respectively
30Solution impregnation adds the medicinal adjuvant system soft material that is mixed, and makes the granule of 50 mesh sieves;
3. above two kinds of granule mix homogeneously, tabletting promptly gets effervescence dispersible tablet.
Method two:
1. medicine (as Chinese medicine extract), sour agent, disintegrating agent, pharmaceutic adjuvant and correctives are crossed mix homogeneously behind 100 orders, the 30 POVIDONE K 30 BP/USP with 10% respectively
30Solution impregnation adds the medicinal adjuvant system soft material that is mixed, and makes the granule of 50 mesh sieves;
2. alkaline agent is crossed 100 order mix homogeneously, the 30 POVIDONE K 30 BP/USP with 10%
30Solution impregnation was made the granule of 50 mesh sieves;
3. above two kinds of granule mix homogeneously, tabletting promptly gets effervescence dispersible tablet.
Method three:
1. medicine (as Chinese medicine extract), sour agent, disintegrating agent, pharmaceutic adjuvant and correctives are crossed mix homogeneously behind 100 orders respectively;
2. alkaline agent is crossed 100 order mix homogeneously, the 30 POVIDONE K 30 BP/USP with 10%
30Solution impregnation was made the granule of 50 mesh sieves;
3. above two kinds of powder mix homogeneously, tabletting promptly gets effervescence dispersible tablet.
In the preparation process, use sour agent and medicament mixed, mix with alkaline agent again; Use alkaline agent and medicament mixed, mix with sour agent again; Use sour agent, alkaline agent respectively with medicament mixed, add speed afterwards again and collapse agent (before or after granulating); As requested, make tablet, a tears agent, capsule etc.
Importantly, in novel form of the present invention, comprise effervescent and disintegrating agent, made this dosage form have the feature of effervescent dosage form and dispersion dosage form simultaneously.
The specific embodiment
Embodiment 1:
1. Chinese medicine Radix Glycyrrhizae effervescence dispersible tablet
Radix Glycyrrhizae extractum medicine 112.5g
Citric acid 10g
Sodium bicarbonate 13g
Crospolyvinylpyrrolidone (PVPP) 10g
Microcrystalline Cellulose (MCC) 20g
Acesulfame-K 8g
Lactose 22.5g
30 POVIDONE K 30 BP/USP
304g
More than prescription is by aforementioned three kinds of methods preparation respectively, can make 1000 of the Radix Glycyrrhizae effervescence dispersible tablets of the heavy 0.2g of sheet.
2. the sample dispersion uniformity detects
The examination criteria of the dispersing uniformity of effervescence dispersible tablet is: get 2 effervescence dispersible tablets, put in 20 ℃ ± 1 ℃ the 100ml water, jolting 3 minutes, all disintegrate and can cross No. two and sieve.Radix Glycyrrhizae effervescence dispersible tablet sample detection the results are shown in Table 1.
Table 1. distinct methods prepares Radix Glycyrrhizae effervescence dispersible tablet dispersing uniformity experimental result
Embodiment 2:
1. Chinese medicine SANHUANG effervescence dispersible tablet
Radix Et Rhizoma Rhei 300g, berberine hydrochloride 5g, Radix Scutellariae extractum 21g.Radix Et Rhizoma Rhei adds 30% alcohol reflux three times, filters, and merging filtrate reclaims ethanol and concentrating under reduced pressure, makes powder, berberine hydrochloride, Radix Scutellariae extractum mix homogeneously, and it is standby to get 100g extractum powder.
SANHUANG extractum powder 100g
Tartaric acid 30g
Sodium bicarbonate 36g
Carboxymethyl starch sodium (CMS-Na) 20g
Low-substituted hydroxypropyl cellulose (L-HPC) 40g
Aspartame 10g
Lactose (lactose) 28g
Mannitol (mannitol) 28g
30 POVIDONE K 30 BP/USP
308g
More than prescription is by aforementioned three kinds of methods preparation respectively, can make 1000 of the SANHUANG effervescence dispersible tablets of every heavy 0.3g.
2. the sample dispersion uniformity detects
The examination criteria of the dispersing uniformity of effervescence dispersible tablet is: get 2 effervescence dispersible tablets, put in 20 ℃ ± 1 ℃ the 100ml water, jolting 3 minutes, all disintegrate and can cross No. two and sieve.SANHUANG effervescence dispersible tablet sample detection the results are shown in Table 2.
Table 2. distinct methods prepares SANHUANG effervescence dispersible tablet dispersing uniformity experimental result
Fact Example 3:
1. Western medicine famotidine effervescence dispersible tablet
Famotidine 20g
Anhydrous citric acid 9g
Sodium bicarbonate 12g
Carboxymethyl starch sodium (CMS-Na) 7g
Low-substituted hydroxypropyl cellulose (L-HPC) 14g
Aspartame 1.2g
Dextrin 86.8g
30 POVIDONE K 30 BP/USP
302g
More than prescription is by aforementioned three kinds of methods preparation respectively, can make 1000 of the famotidine effervescence dispersible tablets of every heavy 0.15g.
2. the sample dispersion uniformity detects
The examination criteria of the dispersing uniformity of effervescence dispersible tablet is: get 2 effervescence dispersible tablets, put in 20 ℃ ± 1 ℃ the 100ml water, jolting 3 minutes, all disintegrate and can cross No. two and sieve.Method not the results are shown in Table 3 for the effervescence dispersible tablet sample detection.
Table 3. distinct methods prepares famotidine effervescence dispersible tablet dispersing uniformity experimental result
Embodiment 4:
1. plant amedica Radix Lamiophlomidis Rotatae effervescence dispersible tablet
Get Radix Lamiophlomidis Rotatae 1000g, pulverize, decoct with water three times, each 1 hour, collecting decoction filtered, and filtrate is concentrated, dry, gets the 120g extract powder.
Radix Lamiophlomidis Rotatae 120g
Malic acid 12.5g
Sodium bicarbonate 16g
Crospolyvinylpyrrolidone (PVPP) 20g
Microcrystalline Cellulose (MCC) 40g
Aspartame 2g
Mannitol (mannitol) 9.5g
30 POVIDONE K 30 BP/USP
3030g
More than prescription is by aforementioned three kinds of methods preparation respectively, can make 1000 of the Radix Lamiophlomidis Rotatae effervescence dispersible tablets of every heavy 0.25g.
2. the sample dispersion uniformity detects
The examination criteria of the dispersing uniformity of effervescence dispersible tablet is: get 2 effervescence dispersible tablets, put in 20 ℃ ± 1 ℃ the 100ml water, jolting 3 minutes, all disintegrate and can cross No. two and sieve.Radix Lamiophlomidis Rotatae effervescence dispersible tablet sample detection the results are shown in Table 4.
Table 4. distinct methods prepares Radix Lamiophlomidis Rotatae effervescence dispersible tablet dispersing uniformity experimental result
Claims (2)
1. effervescence dispersible tablet, it is characterized in that being made up of medicine, effervescent, disintegrating agent, hydrophilic pharmaceutic adjuvant and correctives, its weight proportion is as follows: Radix Lamiophlomidis Rotatae extract powder 120g, malic acid 12.5g, sodium bicarbonate 16g, crospolyvinylpyrrolidone 20g, microcrystalline Cellulose 40g, aspartame 2g, mannitol 9.5g, 30 POVIDONE K 30 BP/USP
3030g, described 120g Radix Lamiophlomidis Rotatae extract powder are the 1000g Radix Lamiophlomidis Rotataes through pulverizing, and decoct with water three times, and each 1 hour, collecting decoction filtered, and filtrate concentrates, dry and make.
2. effervescence dispersible tablet, it is characterized in that being made up of medicine, effervescent, disintegrating agent, hydrophilic pharmaceutic adjuvant and correctives, its weight proportion is as follows: Radix Glycyrrhizae extractum medicine 112.5g, citric acid 10g, sodium bicarbonate 13g, crospolyvinylpyrrolidone 10g, microcrystalline Cellulose 20g, acesulfame-K 8g, lactose 22.5g, 30 POVIDONE K 30 BP/USP
304g.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN200610048659XA CN101138554B (en) | 2006-09-05 | 2006-09-05 | Effervescence dispersible tablet |
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| Application Number | Priority Date | Filing Date | Title |
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| CN200610048659XA CN101138554B (en) | 2006-09-05 | 2006-09-05 | Effervescence dispersible tablet |
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| CN101138554A CN101138554A (en) | 2008-03-12 |
| CN101138554B true CN101138554B (en) | 2010-09-29 |
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| CN105941862A (en) * | 2008-06-16 | 2016-09-21 | 希尔氏宠物营养品公司 | Composition for being added to drinking water |
| CN102309461B (en) * | 2010-07-09 | 2013-08-14 | 重庆医科大学 | Pyridostigmine bromide odor masking dispersible tablets and preparation method thereof |
| CN102813628A (en) * | 2012-08-23 | 2012-12-12 | 江阴天江药业有限公司 | Method for improving dissolubility of phlegm-contained traditional Chinese medicine formula granule |
| CN104147041B (en) * | 2014-08-17 | 2017-02-22 | 山西振东安特生物制药有限公司 | Dispersion preparation containing colloidal bismuth pectin and preparation method thereof |
| CN105679378A (en) * | 2016-04-01 | 2016-06-15 | 杨溢 | Housing capable of automatically floating after falling into water |
| CN105878340A (en) * | 2016-05-04 | 2016-08-24 | 河南师范大学 | Alfalfa effervescent tablets and preparation method thereof |
| CN105878367A (en) * | 2016-05-04 | 2016-08-24 | 河南师范大学 | Herba salviae plebeiae extract effervescent tablets and preparation method thereof |
| CN105997923A (en) * | 2016-07-07 | 2016-10-12 | 驻马店华中正大有限公司 | Tylosin tartrate effervescent tablets and preparation method thereof |
| CN106265833A (en) * | 2016-08-01 | 2017-01-04 | 遵义医学院 | A kind of Flos Lonicerae effervescent tablet and preparation method thereof |
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| CN101138554A (en) | 2008-03-12 |
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