CN1943586A - Oral disintegrating tablet using roxithromycin and ambroxol hydrochloride as active component and its preparing method and use - Google Patents
Oral disintegrating tablet using roxithromycin and ambroxol hydrochloride as active component and its preparing method and use Download PDFInfo
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- CN1943586A CN1943586A CN 200610140552 CN200610140552A CN1943586A CN 1943586 A CN1943586 A CN 1943586A CN 200610140552 CN200610140552 CN 200610140552 CN 200610140552 A CN200610140552 A CN 200610140552A CN 1943586 A CN1943586 A CN 1943586A
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- cavity disintegration
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Abstract
The invention relates to an orally disintegrating tablet comprising roxithromycin id and ambroxol hydrochloride as active ingredients and its preparation method and uses. Said invention is a medical compound resulting from mixing roxithromycin id and ambroxol hydrochloride as active ingredients and auxiliary material acceptable by pharmacology and for treatment of infection of the upper respiratory tract. Said invention provides means for covering bitter from roxithromycin id and ambroxol hydrochloride and preparation method for orally disintegrating tablets of said medical compound.
Description
Technical field
The present invention relates to a kind of is oral cavity disintegration tablet of active component and preparation method thereof, purposes with Roxithromycin and ambroxol hydrochloride, belongs to medical technical field.
Background technology
Roxithromycin is a macrolide antibiotics of new generation, mainly acts on gram positive bacteria, anaerobe, chlamydia and mycoplasma etc.Its vitro antibacterial activity and erythromycin are similar, to the activity of streptococcus, haemophilus ducreyi, chlamydia trachomatis, mycoplasma pneumoniae, oral cavity or vagina anaerobe etc. and erythromycin series seemingly; Effect to Campylobacter, bordetella pertussis and hemophilus influenza is not so good as erythromycin series; Mycobacterium tuberculosis, most of atypical mycobacteria, campylobacter jejuni, diphtheria corynebacterium, pasteurella multocida also there is inhibitory action; The G bacterium there is not antibiotic activity.Some antibacterial has cross resistance to erythromycin and this product, and this product is effective especially to mycoplasma, chlamydia and infection with legionella.Vivo bacteria corrosion action is stronger 1～4 times than erythromycin.
Ambroxol hydrochloride has effect that promotes the mucus eliminating and the characteristic of dissolving secretions.Can promote the discharge of thick secretions in the respiratory tract and reduce mucous delay, thereby significantly promote expectoration, improve breath state.When using the ambroxol treatment, the mucous secretion of patient can return to normal condition.Cough and amount of expectoration usually significantly reduce, the surfactant on the respiratory mucosa thereby can bring into play its normal defencive function.LD50 in the acute toxicity test: mice, oral 300mg/kg; Quiet notes 140mg/kg.The poison exponent of ambroxol is very low.Ambroxol does not have mutagenicity (Ames and micronucleus test).Carcinogenecity for mice and rat studies show that, the ambroxol non-carcinogenesis.
Oral cavity disintegration tablet is a kind of new pharmaceutical dosage forms, English " Orally disintegratingtables " by name.Be that a kind of water that do not need in the oral cavity can disintegrate or dissolved tablet.It can be in the oral cavity rapidly disintegrate, no grittiness, good mouthfeel, swallow easily, to the oral mucosa nonirritant.Have absorb fast, bioavailability is high; Instructions of taking does not need water; Intestinal is residual few, few side effects; Avoid the characteristics such as first pass effect of liver sausage.Therefore make things convenient for groups of people group's medication after medication preparation being become oral cavity disintegration tablet, as the patient's medication under old man, child, dysphagia or the special environment.U.S. FDA has been ratified this dosage form listing.
The compound preparation of Roxithromycin ambroxol hydrochloride goes on the market in India.But be ordinary preparation.Dissolubility is extremely low in the Roxithromycin water, and is water-soluble hardly, and the deficiency that stripping is slow, bioavailability is low often appears in therefore general general formulation easily.Therefore, this compound recipe is prepared into oral cavity disintegration tablet, can makes rapid stripping of medicine and absorption, help improving the Roxithromycin bioavailability.
But Roxithromycin flavor is extremely bitter, the ambroxol hydrochloride bitter in the mouth, and desire is prepared into oral cavity disintegration tablet with it, two kinds of principal agents is carried out taste masking and flavoring handle extremely importantly, and this also is the key technology place of this compound recipe of research and development oral cavity disintegration tablet.
Summary of the invention
The invention provides a kind of good taste, medicine stripping preparation method of compound roxithromycin Orally disintegrating tablet of ambroxol rapidly that has, and provide Roxithromycin and ambroxol are carried out method and the technology that taste masking and flavoring are handled, and the preparation method of oral cavity disintegration tablet.
The consumption of Roxithromycin is 25mg-300mg for per unit dosage among the present invention.Be preferably 50mg-150mg.The consumption of described ambroxol hydrochloride is 10mg-90mg for per unit dosage.Be preferably 15-30mg.The weight ratio of Roxithromycin and ambroxol hydrochloride is 5: 1 or 10: 3.
Specifically, preparation unit dose of the present invention contains the active constituents of medicine of following consumption: Roxithromycin 50mg+ ambroxol hydrochloride 15mg, or Roxithromycin 150mg+ ambroxol hydrochloride 30mg.
Because oral cavity disintegration tablet requires disintegrate rapidly in the oral cavity, good mouthfeel, to the oral mucosa nonirritant.Therefore the selection to supplementary product kind and performance thereof is the key of preparation oral cavity disintegration tablet.Selection of odor mask, correctives that wherein the most key is and the various supplementary product kinds of this preparation, the selection of the selection of proportioning, especially disintegrating agent.
The present invention is through selecting, found the pharmaceutic adjuvant of suitable oral cavity disintegration tablet of the present invention, wherein filler selects to be used for increasing the weight and volume of oral cavity disintegration tablet, so that the molding of preparation and divided dose, preferred one or more in lactose, mannitol, pregelatinized Starch, sorbitol, xylitol of filler among the present invention.
The adding of binding agent and lubricant is for the ease of the preparation of preparation and molding.Binding agent is selected from one or more the mixture in syrup, starch slurry, carboxymethylcellulose sodium solution, the povidone solution.Lubricant is selected from one or more the mixture in micropowder silica gel, magnesium stearate, the Pulvis Talci.
The kind of disintegrating agent and the selection of consumption are for can this preparation disintegrate be most important fully at the appointed time.Disintegrating agent of the present invention one of is selected to comprise in low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium, corn starch, carboxymethylcellulose calcium, the carboxymethyl starch sodium or wherein several mixture.
In oral cavity disintegration tablet, can add an amount of effervescent, help the disintegrate of tablet, and an amount of acid can also be regulated taste.Acid source is selected from one or more the mixture in citric acid, tartaric acid, four caproic acids, lysine, the arginine in the effervescent that the present invention selects, or alkali source is selected from one or more mixture wherein such as sodium bicarbonate, sodium carbonate, potassium carbonate, potassium bicarbonate.
Because the taste of Roxithromycin and ambroxol is all bitter, must carries out a series of taste masking and handle.Bibliographical information is arranged with acrylic resin L and R or MC, EC wrap up or capsuleization medicine, but, not only need to consider how to carry out taste masking and handle, also must consider the problem that the medicine disintegrate discharges rapidly as oral cavity disintegration tablet.Therefore must selection can in water, dissolve rapidly or dissolved material wraps up or capsuleization medicine in gastric juice.Through screening, odor mask of the present invention comprises one or more the mixture in acrylic resin copolymer (gastric solubility), HPMC, PEG macromolecule series (as 1500,6000,10000,15000), polyvinyl alcohol (PVA), gelatin, melon glue, the arabic gum.
The method that taste masking is handled can be: medicine is fully mixed lyophilization with odor mask; Medicine and taste masking material are formed eutectic, pulverize again; With medicine dissolution or be dispersed in the solution of lapping, carry out drying, pulverization process again.
Sometimes, be subjected to the unit formulation quantitative limitation, carry out must using some correctivess when taste masking is handled, these correctivess one of are selected from Rhizoma et radix valerianae, Fructus Pruni pseudocerasi, Fructus Vitis viniferae, Fructus Citri tangerinae, Fructus Citri Limoniae, Herba Menthae, Fructus Fragariae Ananssae, Fructus Musae, Fructus Ananadis comosi, honey peach essence, maltose alcohol, saccharin sodium, protein sugar, sucrose, Mentholum, aspartame, stevioside, the acesulfame-K or wherein several mixture.
Oral cavity disintegration tablet of the present invention can be by freeze-drying or direct powder compression or granulating tabletting process preparation.
Adopt freeze-drying to prepare oral cavity disintegration tablet, adjuvant can be chosen filler, disintegrating agent, correctives and odor mask, principal agent can be mixed with various adjuvants, add the suitable quantity of water dilution, behind the mix homogeneously, place suitable sheet shape mould, lyophilization, being shaped to the material lyophilizing gets final product.
Adopt direct powder compression to prepare oral cavity disintegration tablet, adjuvant can be chosen filler, disintegrating agent, effervescent, lubricant, correctives and odor mask, after principal agent carried out certain taste masking and handle again with various adjuvant mix homogeneously after, direct powder compression gets final product.
Adopt granulating tabletting process to prepare oral cavity disintegration tablet, adjuvant can be chosen filler, disintegrating agent, binding agent, lubricant, correctives and odor mask.After principal agent carried out certain taste masking and handle,, add binding agent system soft material, granulate again with the partial supplementary material mix homogeneously, dry, granulate, the disintegrating agent and the lubricant of adding surplus, behind the mix homogeneously, tabletting gets final product.
The specific embodiment
Come Roxithromycin of the present invention and ambroxol hydrochloride preparation done further specifying by following example, but be not limited in following example.
Embodiment 1
Prescription:
Roxithromycin 50g
Ambroxol hydrochloride 15g
Pregelatinized Starch 15g
Mannitol 20g
Guar gum 32g
Arabic gum 48g
Xylitol 30g
Microcrystalline Cellulose 15g
Fructus Citri Limoniae essence 2g
Make 1000 altogether
Preparation method:
Roxithromycin and ambroxol hydrochloride are joined in guar gum and the arabic gum mixed liquor, after stirring, add mannitol, pregelatinized Starch, xylitol, microcrystalline Cellulose, Fructus Citri Limoniae essence, after the limit edged stirs and makes into even suspension, be poured in the suitable mould, lyophilization, press seal, packing.。
Embodiment 2:
Prescription:
Amounts of components
Roxithromycin 50g
Ambroxol hydrochloride 15g
PEG6000 130g
L-HPC 6g
PPVP 24g
Lactose 40g
Mannitol 50g
Protein sugar 8g
Micropowder silica gel 20g
Honey peach essence 4g
Preparation method:
Roxithromycin, ambroxol hydrochloride are crossed 80 mesh sieves respectively, behind the mix homogeneously, join among the fused PEG6000, stir, cool off eutectic rapidly, pulverize, fine particle between the screening 40-80 order, standby, other gets adjuvants such as other mannitol mix homogeneously with it, and direct powder compression carries out tabletting.
Embodiment 3:
Prescription:
Amounts of components
Roxithromycin 75g
Ambroxol hydrochloride 15g
Eudragit EPO 90g
PPVP 16g
L-HPC 6g
Microcrystalline Cellulose 120g
Mentholum 4g
Fructus Citri sinensis powdered flavor 4g
Micropowder silica gel 2g
Dehydrated alcohol is an amount of
Make 1000 altogether
Preparation method:
Eudragit EPO is dissolved in the dehydrated alcohol, adds Roxithromycin, the ambroxol suspendible is even, drying under reduced pressure is pulverized, screening 40-80 purpose granule standby (yield is about 90%); Other gets microcrystalline Cellulose etc. and crosses 80 mesh sieves respectively, behind the mix homogeneously, adds above-mentioned granule, and dry granulation is pulverized, and granulate adds disintegrating agent PPVP, L-HPC and fluidizer micropowder silica gel, tabletting behind the mix homogeneously, promptly.
Embodiment 4:
Prescription:
Amounts of components
Roxithromycin 150g
Ambroxol hydrochloride 30g
HPMC 30g
Microcrystalline Cellulose 60g
Lactose 60g
Crospolyvinylpyrrolidone 8.5g
Sodium bicarbonate 12g
Citric acid 15g
Honey peach essence 10g
Stevioside 10g
Dehydrated alcohol is an amount of
Pulvis Talci 2g
Preparation method:
Get HPMC, add the solution that 90% alcoholic solution is prepared into debita spissitudo, add Roxithromycin and ambroxol mixing, the low-temperature reduced-pressure drying is pulverized, and the granule of getting the 40-80 mesh sieve is standby; With mix homogeneously such as microcrystalline Cellulose, lactose, sodium bicarbonate, citric acid, with dehydrated alcohol system soft material, 24 mesh sieves are granulated in addition, 20 mesh sieve granulate, add medicine parcel powder, the Pulvis Talci of honey peach essence, stevioside, screening again, behind the mix homogeneously, tabletting promptly.
Embodiment 5:
Below only carry out taste, disintegration and the investigation of external stripping curve, with fast, the medicine stripping release characteristics rapidly of good mouthfeel, disintegrate that this preparation is described with regard to the embodiment of the invention 3 prepared oral cavity disintegration tablet and conventional tablets.
1. investigate external disintegration
Get each 6 of this sample and common compound recipe sheets respectively, place 37 ℃ ± 1 ℃ 2ml water respectively, adopt the counter-rotating determination of tube method, and, write down its disintegration, the results are shown in Table 12 all by 20 mesh sieves.
Table one: external disintegration comparing result
| Group | 1 | 2 | 3 | 4 | 5 | 6 | On average |
| Oral cavity disintegration tablet | 38 seconds | 34 seconds | 33 seconds | 41 seconds | 36 seconds | 36 seconds | 36 seconds |
| Conventional tablet | 49 minutes | 54 minutes | 51 minutes | 52 minutes | 56 minutes | 47 minutes | 52 minutes |
Know by above-mentioned result of the test, all fully disintegrates in 1min of oral cavity disintegration tablet,, and conventional tablet disintegrate is very slow with this understanding, significant difference between the two.
2. dissolution determination (only measuring Roxithromycin)
Getting test sample, according to dissolution method (two appendix XC second methods of Chinese Pharmacopoeia version in 2005), is solvent with the hydrochloric acid solution 500ml of 0.1mol/L, and rotating speed is every 100r/min, and operation in accordance with the law during 30min, is got solution and filtered, and measures.
Table two: dissolution in vitro comparing result
| Group | 1min | 2min | 5min | 10min | 20min | 30min |
| Conventional tablet (%) | 1.5 | 4.7 | 25.4 | 36.7 | 61.2 | 77.1 |
| Oral cavity disintegration tablet (%) | 89.4 | 99.4 | 102.1 | 100.5 | 100.1 | 99.1 |
Result of the test shows that oral cavity disintegration tablet can significantly improve the dissolution in vitro of insoluble medicine Roxithromycin, and burst size surpasses the burst size in the conventional tablet 30min in its 1min, and difference is extremely remarkable.
3. the Orally disintegrating test is investigated
With through the Roxithromycin raw material that taste masking is handled and non-taste masking is handled, be prepared into oral cavity disintegration tablet respectively, find 12 volunteers, be divided into two groups at random, carry out mouth and collapse test according to identical preparation method.The result is as follows for record.
Table three is investigated the result for examination oral cavity disintegration tablet mouthfeel
| Investigate index | 1 | 2 | 3 | 4 | 5 | 6 | Satisfaction |
| Have or not grittiness that non-stimulated mouthfeel is arranged | Do not have | Do not have good | Do not have | Do not have better | Do not have slightly hot cool general | Do not have | 100％ 100％ 83％ |
Table four contrast oral cavity disintegration tablet mouthfeel is investigated the result
| Investigate index | 1 | 2 | 3 | 4 | 5 | 6 | Satisfaction |
| Have or not grittiness that non-stimulated mouthfeel is arranged | Non-stimulated, can't swallow extremely bitter | Non-stimulated, can't swallow extremely bitter | Non-stimulated, can't swallow extremely bitter | Non-stimulated, can't swallow extremely bitter | Non-stimulated, can't swallow extremely bitter | Non-stimulated, can't swallow extremely bitter | 100％ 0％ 0％ |
Above result shows: handling through taste masking has tangible effect for the bad mouthfeel of improving Roxithromycin, ambroxol, and this taste masking method does not hinder the rapid stripping and the release of medicine.
Claims (9)
- The present invention for a kind of be the oral cavity disintegration tablet of active component with Roxithromycin and ambroxol hydrochloride, it is characterized in that it is a Roxithromycin and the active component of ambroxol hydrochloride formation, with the Pharmaceutical composition of mixing acceptable accessories formation.
- 2. oral cavity disintegration tablet as claimed in claim 1, wherein the consumption of Roxithromycin is 25mg-300mg for per unit dosage.Be preferably 50mg-150mg.The consumption of described ambroxol hydrochloride is 10mg-90mg for per unit dosage.Be preferably 15-30mg.The weight ratio of Roxithromycin and ambroxol hydrochloride is 5: 1 or 10: 3.
- 3. oral cavity disintegration tablet as claimed in claim 1, its single dosage unit active component most preferably are Roxithromycin 50mg+ ambroxol hydrochloride 15mg, or Roxithromycin 150mg+ ambroxol hydrochloride 30mg.
- 4. oral cavity disintegration tablet as claimed in claim 1 is characterized in that described acceptable accessories is selected from filler, disintegrating agent, effervescent, correctives, odor mask, binding agent or lubricant.
- 5. oral cavity disintegration tablet as claimed in claim 4 is characterized in that, described filler is selected from one or more the mixture in lactose, mannitol, pregelatinized Starch, sorbitol, the xylitol.Described disintegrating agent is selected from a kind of or wherein several mixture in low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium, corn starch, carboxymethylcellulose calcium, the carboxymethyl starch sodium.Acid source is selected from one or more the mixture in citric acid, tartaric acid, four caproic acids, lysine, the arginine in the described effervescent, and alkali source is selected from one or more mixture wherein such as sodium bicarbonate, sodium carbonate, potassium carbonate, potassium bicarbonate.Described binding agent is selected from one or more the mixture in syrup, starch slurry, carboxymethylcellulose sodium solution, the povidone solution.Described lubricant is selected from one or more the mixture in micropowder silica gel, magnesium stearate, the Pulvis Talci.
- 6. oral cavity disintegration tablet as claimed in claim 4 in preparation process of the present invention, must carry out certain taste masking or flavoring and handle.Described odor mask must can be in water or in gastric juice rapid dissolved material.Odor mask of the present invention comprises one or more the mixture in acrylic resin copolymer (gastric solubility), HPMC, PEG macromolecule series (as 1500,6000,10000,15000), polyvinyl alcohol (PVA), gelatin, melon glue, the arabic gum.
- 7. oral cavity disintegration tablet as claimed in claim 6, in the present invention prepared to become, the method that taste masking is handled can be: medicine is fully mixed lyophilization with odor mask; Medicine and taste masking material are formed eutectic, pulverize again; With medicine dissolution or be dispersed in the solution of lapping, carry out drying, pulverization process again.
- 8. oral cavity disintegration tablet as claimed in claim 6, in the present invention prepared to become, also must use correctives where necessary, described correctives one of is selected from Rhizoma et radix valerianae, Fructus Pruni pseudocerasi, Fructus Vitis viniferae, Fructus Citri tangerinae, Fructus Citri Limoniae, Herba Menthae, Fructus Fragariae Ananssae, Fructus Musae, Fructus Ananadis comosi, honey peach essence, maltose alcohol, saccharin sodium, protein sugar, sucrose, aspartame, stevioside, the acesulfame-K or wherein several mixture.
- 9. the preparation method of the oral cavity disintegration tablet of claim 1 is characterized in that, adopts the preparation of freeze-drying or direct powder compression or granulating tabletting process.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610140552 CN1943586A (en) | 2006-02-23 | 2006-10-17 | Oral disintegrating tablet using roxithromycin and ambroxol hydrochloride as active component and its preparing method and use |
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|---|---|---|---|
| CN200610007938 | 2006-02-23 | ||
| CN200610007938.1 | 2006-02-23 | ||
| CN 200610140552 CN1943586A (en) | 2006-02-23 | 2006-10-17 | Oral disintegrating tablet using roxithromycin and ambroxol hydrochloride as active component and its preparing method and use |
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| CN1943586A true CN1943586A (en) | 2007-04-11 |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102935078A (en) * | 2012-11-21 | 2013-02-20 | 北京润德康医药技术有限公司 | Ibuprofen oral dispersing film agent |
| CN102940616A (en) * | 2012-11-21 | 2013-02-27 | 北京润德康医药技术有限公司 | Ambroxol hydrochloride oral cavity dispersion membrane agent |
| CN102940617A (en) * | 2012-11-21 | 2013-02-27 | 北京润德康医药技术有限公司 | Desloratadine oral dispersible film |
| CN103301467A (en) * | 2013-06-20 | 2013-09-18 | 北京阜康仁生物制药科技有限公司 | Stable taste-masking ambroxol hydrochloride compound and preparation method thereof |
| CN104174023A (en) * | 2014-08-15 | 2014-12-03 | 河北菲尼斯生物技术有限公司 | Pharmaceutical composition capable of improving stability of ambroxol hydrochloride |
| CN104382869A (en) * | 2014-10-23 | 2015-03-04 | 温州芳植生物科技有限公司 | Orally disintegrating tablet with functions of oral cavity paralysis and taste masking and preparation method of orally disintegrating tablet |
-
2006
- 2006-10-17 CN CN 200610140552 patent/CN1943586A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102935078A (en) * | 2012-11-21 | 2013-02-20 | 北京润德康医药技术有限公司 | Ibuprofen oral dispersing film agent |
| CN102940616A (en) * | 2012-11-21 | 2013-02-27 | 北京润德康医药技术有限公司 | Ambroxol hydrochloride oral cavity dispersion membrane agent |
| CN102940617A (en) * | 2012-11-21 | 2013-02-27 | 北京润德康医药技术有限公司 | Desloratadine oral dispersible film |
| CN103301467A (en) * | 2013-06-20 | 2013-09-18 | 北京阜康仁生物制药科技有限公司 | Stable taste-masking ambroxol hydrochloride compound and preparation method thereof |
| CN104174023A (en) * | 2014-08-15 | 2014-12-03 | 河北菲尼斯生物技术有限公司 | Pharmaceutical composition capable of improving stability of ambroxol hydrochloride |
| CN104382869A (en) * | 2014-10-23 | 2015-03-04 | 温州芳植生物科技有限公司 | Orally disintegrating tablet with functions of oral cavity paralysis and taste masking and preparation method of orally disintegrating tablet |
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