CN101485673A - Roxithromycin and ambroxol hydrochloride dispersible tablets - Google Patents
Roxithromycin and ambroxol hydrochloride dispersible tablets Download PDFInfo
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- CN101485673A CN101485673A CNA200910008869XA CN200910008869A CN101485673A CN 101485673 A CN101485673 A CN 101485673A CN A200910008869X A CNA200910008869X A CN A200910008869XA CN 200910008869 A CN200910008869 A CN 200910008869A CN 101485673 A CN101485673 A CN 101485673A
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- roxithromycin
- ambroxol hydrochloride
- dispersible tablets
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Abstract
The invention relates to a roxithromycin ambroxol dispersing tablet, which comprises the following components in percentage by weight: 50 to 60 percent of roxithromycin, 10 to 20 percent of ambroxol hydrochloride, 18 to 25 percent of filling agent, 10 to 15 percent of disintegrant, 0.1 to 1 percent of adhesive, and 1 to 5 percent of lubricating agent, wherein the filling agent is microcrystalline cellulose, and the disintegrant is crosslinked polyvidone. The roxithromycin ambroxol dispersing tablet has the advantages of small tablet weight, simple process, low production cost and good safety, and has better therapeutic effect when being clinically applied to upper respiratory tract infections of human bodies.
Description
Technical field
The present invention relates to a kind of roxithromycin and ambroxol hydrochloride dispersible tablets, its active constituents of medicine is Roxithromycin and ambroxol hydrochloride, the pharmaceutic adjuvant that adds certain proportioning is prepared from, the said preparation sheet is heavy little, production cost is low, applying to human body upper respiratory tract infection disease clinically has curative effect preferably, and safety is good.
Background technology
Along with the serious day by day air pollution that the aging and the development of modern industry of social population are brought, the respiratory system disease M ﹠ M day by day increases, and the respiratory system disease sickness rate is first of any age bracket kind of disease all in the majority.Pulmonary bacterial is the commonly encountered diseases and the frequently-occurring disease of respiratory system, the general antibiotic therapies that adopt more.Roxithromycin is the outstanding macrolide antibiotics that is usually used in treating pulmonary bacterial, and is evident in efficacy, toxicity is humble, and tissue distribution is reasonable, and oral organism-absorbing availability height can enter sterilization in the cell, reaches the effect that thorough treatment is difficult for recurrence.But after the administration of Roxithromycin normal person whole body, the drug level in bronchus and the lung tissue is often far beyond blood drug level low (be same time blood drug level 1/30-1/40), and prompting has lung-blood or bronchus-alveolar-capillary barrier to exist.In the roxithromycin and ambroxol hydrochloride compound preparation, ambroxol can improve the concentration of Roxithromycin in pulmonary, and pulmonary is had the multiple protective effect.The compound preparation of Roxithromycin and ambroxol hydrochloride at above-mentioned disease, is set about from control infection and eliminating the phlegm, and can treat the various diseases due to the respiratory tract infection effectively.Roxithromycin is the antimicrobial drug of praising highly the most clinically at present, can effectively kill the various pathogenic bacterium that cause respiratory tract disease.Ambroxol hydrochloride is the most effective expectorant clinically at present, can effectively alleviate the clinical symptoms of respiratory tract disease.The two coupling will improve antibiotic curative effect, and disease controlling shortens the fever time rapidly, makes things convenient for clinical medical and nursing personnel, patient's medication.
Domestic research and development to the compound roxithromycin preparation at present are many.Wherein, with the immediate prior art of the present invention be that application number is 200610007513 patent application, a kind of compound roxithromycin dispersing tablet and preparation method thereof is disclosed, said preparation is on the basis of original ordinary tablet, adopt adjuvants such as super-disintegrant, filler, surfactant, binding agent to be prepared from, have that disintegrate is fast, dissolution is high, the bioavailability advantages of higher.But its adjuvant proportion is higher, surpasses more than 50%, the safety and the bioavailability of medicine had adverse effect, and cost is higher relatively.
Summary of the invention
Purpose of the present invention aims to provide a kind of roxithromycin and ambroxol hydrochloride dispersible tablets, and this active constituents of medicine is Roxithromycin and ambroxol hydrochloride.The characteristics of said preparation are that sheet is heavy little, and production cost is low, and safety is good, and applying to human body upper respiratory tract infection disease clinically has curative effect preferably.
Technical solution of the present invention is as follows:
The invention provides a kind of roxithromycin and ambroxol hydrochloride dispersible tablets, count by weight percentage, Roxithromycin 50～60%, ambroxol hydrochloride 10～20%, filler 18～25%, disintegrating agent 10～15%, binding agent 0.1～1%, lubricant 1～5%, and described filler is microcrystalline Cellulose, described disintegrating agent is a polyvinylpolypyrrolidone.
Further, above-mentioned described roxithromycin and ambroxol hydrochloride dispersible tablets, wherein, Roxithromycin 50～55%, ambroxol hydrochloride 10～15%, filler 18～24%, disintegrating agent 11～15%, binding agent 0.1～0.5%, lubricant 2～5%, and described filler is a microcrystalline Cellulose, and described disintegrating agent is a polyvinylpolypyrrolidone.
Wherein, described binding agent is preferably one or more the mixture in hypromellose, polyvidone, the polyvinylpyrrolidone-ethyl acetate copolymer.
Wherein, described lubricant is preferably one or more the mixture in magnesium stearate, Pulvis Talci, the micropowder silica gel.
As one of most preferred embodiment of the present invention, described roxithromycin and ambroxol hydrochloride dispersible tablets, it is characterized in that making 1000: Roxithromycin 150 grams by following component, ambroxol hydrochloride 30 grams, microcrystalline Cellulose 50 grams, polyvinylpolypyrrolidone 30 grams, 80 milliliters of 1% hypromellose, 50% alcoholic solution, Pulvis Talci 10 grams, magnesium stearate 3 grams.
The present invention also provides a kind of method of above-mentioned described roxithromycin and ambroxol hydrochloride dispersible tablets, it is characterized in that: Roxithromycin, ambroxol hydrochloride are ground into fine powder,, add binding agent and granulate with filler and disintegrating agent mix homogeneously, with lubricant mixing, tabletting, promptly.
Preferably, described method, wherein, with ambroxol hydrochloride, Roxithromycin pulverize separately, cross 100 mesh sieves earlier, more above-mentioned material is pressed recipe quantity and microcrystalline Cellulose mix homogeneously, add 1% hypromellose, 50% alcoholic solution system soft material, cross 16 mesh sieves, 50 ℃ of dryings two hours, stir frequently,, add polyvinylpolypyrrolidone with 18 mesh sieve granulate, magnesium stearate, Pulvis Talci, mixing, measure granule content, tabletting, promptly.
Roxithromycin and ambroxol hydrochloride dispersible tablets of the present invention, production technology is simple.Especially, be that 200610007513.0 disclosed dispersible tablets are compared with application number, by selecting for use microcrystalline Cellulose and polyvinylpolypyrrolidone as filler and disintegrating agent, not only significantly reduce supplementary product consumption, and do not need to add surfactant, cost greatly reduces, sheet is heavy little, taking convenience.Warp carries out the comparative study of content, related substance, dissolution and stability (acceleration, long-term) aspect with the preparation that the publication that according to application number is 200610007513.0 prepares, result of the test shows, the preparation that preparation related substance of the present invention contrasts patent obviously reduces, content and dissolution do not have significant difference, quicken to stablize, do not have obvious contrast difference with every investigation index of Journal of Sex Research steady in a long-term.For example, as shown in table 1 below, to compare with the technical scheme of 200610007513.0 patent disclosures, advantage of the present invention is obvious.
Table 1 the present invention compares with 200610007513.0 technical schemes
| The present invention | 200610007513.0 | Characteristics of the present invention |
| Do not contain surfactant | The heavy 0.5-15% of surfactant comprise sheet | Safer, economical |
| Filler: promptly the microcrystalline Cellulose consumption is few, has only the heavy 18%-24% of sheet, | Filler accounts for the heavy 40-75% of sheet | Saved cost |
| Sheet is heavy little, about 0.27-0.28g | Greater than 0.3g | Reduced cost |
| Supplementary material is crossed 100 mesh sieves and is got final product | Supplementary material needed 120 mesh sieves | Simple to operate |
The specific embodiment
Below by specific embodiment roxithromycin and ambroxol hydrochloride dispersible tablets of the present invention and preparation method thereof is described further.
Embodiment 1: preparation example
With ambroxol hydrochloride, Roxithromycin pulverize separately, cross 100 mesh sieves, get Roxithromycin 150g, ambroxol hydrochloride 30g with microcrystalline Cellulose 50g, polyvinylpolypyrrolidone 30g mix homogeneously, adds 1% hypromellose, 50% alcoholic solution 80ml system soft material, cross 16 mesh sieves, 50 ℃ of dryings two hours are stirred frequently, with 18 mesh sieve granulate, add magnesium stearate 3g, Pulvis Talci 10g, mixing, measure granule content, tabletting, promptly.
Embodiment 2: comparative test result
The inventor has made a batch sample (lot number: 071001) by oneself according to the patent of invention disclosed method of application number 200610007513.0, with sample of the present invention (embodiment 1 method, lot number: 071002), carry out the comparative study of content, related substance, dissolution and stability (acceleration, long-term) aspect, the result is as follows.
1, content, related substance, dissolution are relatively: the results are shown in Table 2.
Table 2 content, related substance, dissolution comparative test result
Result of the test shows that 071002 batch sample related substance obviously reduces than 071001 batch, and content and dissolution do not have significant difference.
2, stability test relatively: the results are shown in Table 3 and 4.
Table 3 accelerated test (40 ℃, RH75%) result
Accelerated test result indicates that the every investigation index of two batch samples does not have significant change.
Table 4 long-term stable experiment (25 ± 2 ℃, RH60 ± 10%) result
Long-term stable experiment is the result indicate, the every investigation index of two batch samples does not have significant change.
Press the as above prepared compound roxithromycin sheet of method, sheet is heavy little, and production cost is low, and safety is good, taking convenience.
The present invention is described according to preferred embodiment.Should be understood that the description of front and embodiment are just to illustrating the present invention.Under prerequisite without departing from the spirit and scope of the present invention, those skilled in the art can design multiple alternative of the present invention and improvement project, and it all should be understood to be within protection scope of the present invention.
Claims (7)
1, a kind of roxithromycin and ambroxol hydrochloride dispersible tablets, count by weight percentage, Roxithromycin 50～60%, ambroxol hydrochloride 10～20%, filler 18～25%, disintegrating agent 10～15%, binding agent 0.1～1%, lubricant 1～5%, and described filler is microcrystalline Cellulose, described disintegrating agent is a polyvinylpolypyrrolidone.
2, roxithromycin and ambroxol hydrochloride dispersible tablets according to claim 1, wherein, Roxithromycin 50～55%, ambroxol hydrochloride 10～15%, filler 18～24%, disintegrating agent 11～15%, binding agent 0.1～0.5%, lubricant 2～5%, and described filler is microcrystalline Cellulose, described disintegrating agent is a polyvinylpolypyrrolidone.
3, according to the described roxithromycin and ambroxol hydrochloride dispersible tablets of claim 1-2, wherein said binding agent is selected from one or more the mixture in hypromellose, polyvidone, the polyvinylpyrrolidone-ethyl acetate copolymer.
4, according to the described roxithromycin and ambroxol hydrochloride dispersible tablets of claim 1-3, wherein said lubricant is selected from one or more the mixture in magnesium stearate, Pulvis Talci, the micropowder silica gel.
5, roxithromycin and ambroxol hydrochloride dispersible tablets according to claim 1, it is characterized in that making 1000: Roxithromycin 150 grams by following component, ambroxol hydrochloride 30 grams, microcrystalline Cellulose 50 grams, polyvinylpolypyrrolidone 30 grams, 80 milliliters of 1% hypromellose, 50% alcoholic solution, Pulvis Talci 10 grams, magnesium stearate 3 grams.
6, a kind of method for preparing the described roxithromycin and ambroxol hydrochloride dispersible tablets of claim 1-5, it is characterized in that: Roxithromycin, ambroxol hydrochloride are ground into fine powder,, add binding agent and granulate with filler and disintegrating agent mix homogeneously, with lubricant mixing, tabletting, promptly.
7, method according to claim 6, wherein, ambroxol hydrochloride and Roxithromycin were pulverized 100 mesh sieves, again with microcrystalline Cellulose, polyvinylpolypyrrolidone mix homogeneously, add 1% hypromellose, 50% alcoholic solution system soft material, cross 16 mesh sieves, 50 ℃ of dryings two hours are stirred frequently, with 18 mesh sieve granulate, add magnesium stearate, Pulvis Talci, mixing, tabletting, promptly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910008869XA CN101485673B (en) | 2009-02-11 | 2009-02-11 | Roxithromycin and ambroxol hydrochloride dispersible tablets |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910008869XA CN101485673B (en) | 2009-02-11 | 2009-02-11 | Roxithromycin and ambroxol hydrochloride dispersible tablets |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101485673A true CN101485673A (en) | 2009-07-22 |
| CN101485673B CN101485673B (en) | 2010-08-11 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN200910008869XA Ceased CN101485673B (en) | 2009-02-11 | 2009-02-11 | Roxithromycin and ambroxol hydrochloride dispersible tablets |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101816672A (en) * | 2010-03-27 | 2010-09-01 | 海南康芝药业股份有限公司 | Composition containing roxithromycin and ambroxol and preparation method thereof |
| CN103977016A (en) * | 2014-05-19 | 2014-08-13 | 海南葫芦娃制药有限公司 | Compound roxithromycin dispersible tablet and preparation method thereof |
-
2009
- 2009-02-11 CN CN200910008869XA patent/CN101485673B/en not_active Ceased
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101816672A (en) * | 2010-03-27 | 2010-09-01 | 海南康芝药业股份有限公司 | Composition containing roxithromycin and ambroxol and preparation method thereof |
| CN103977016A (en) * | 2014-05-19 | 2014-08-13 | 海南葫芦娃制药有限公司 | Compound roxithromycin dispersible tablet and preparation method thereof |
| CN103977016B (en) * | 2014-05-19 | 2016-03-02 | 海南葫芦娃制药有限公司 | A kind of compound roxithromycin dispersing tablet and preparation method thereof |
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| Publication number | Publication date |
|---|---|
| CN101485673B (en) | 2010-08-11 |
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