CN101317824B - Levodropropizine lozenge and preparation method thereof - Google Patents
Levodropropizine lozenge and preparation method thereof Download PDFInfo
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- CN101317824B CN101317824B CN2008103025058A CN200810302505A CN101317824B CN 101317824 B CN101317824 B CN 101317824B CN 2008103025058 A CN2008103025058 A CN 2008103025058A CN 200810302505 A CN200810302505 A CN 200810302505A CN 101317824 B CN101317824 B CN 101317824B
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- levodropropizine
- powder
- cane sugar
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- PTVWPYVOOKLBCG-ZDUSSCGKSA-N levodropropizine Chemical compound C1CN(C[C@H](O)CO)CCN1C1=CC=CC=C1 PTVWPYVOOKLBCG-ZDUSSCGKSA-N 0.000 title claims abstract description 49
- 229960002265 levodropropizine Drugs 0.000 title claims abstract description 47
- 238000002360 preparation method Methods 0.000 title claims abstract description 24
- 239000007937 lozenge Substances 0.000 title claims description 11
- 239000000843 powder Substances 0.000 claims abstract description 40
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 38
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims abstract description 24
- 229930006000 Sucrose Natural products 0.000 claims abstract description 24
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims abstract description 21
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims abstract description 21
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims abstract description 21
- UEDUENGHJMELGK-HYDKPPNVSA-N Stevioside Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1O[C@]12C(=C)C[C@@]3(C1)CC[C@@H]1[C@@](C)(CCC[C@]1([C@@H]3CC2)C)C(=O)O[C@H]1[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O1)O)[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O UEDUENGHJMELGK-HYDKPPNVSA-N 0.000 claims abstract description 16
- 229940046011 buccal tablet Drugs 0.000 claims abstract description 8
- 239000006189 buccal tablet Substances 0.000 claims abstract description 8
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 32
- 229960004793 sucrose Drugs 0.000 claims description 23
- 239000011248 coating agent Substances 0.000 claims description 21
- 238000000576 coating method Methods 0.000 claims description 21
- 239000007788 liquid Substances 0.000 claims description 19
- 239000008187 granular material Substances 0.000 claims description 18
- 235000019359 magnesium stearate Nutrition 0.000 claims description 16
- 241000207199 Citrus Species 0.000 claims description 15
- 235000020971 citrus fruits Nutrition 0.000 claims description 15
- 239000000203 mixture Substances 0.000 claims description 13
- 239000007779 soft material Substances 0.000 claims description 12
- 239000008213 purified water Substances 0.000 claims description 7
- 238000003756 stirring Methods 0.000 claims description 7
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 7
- 238000007605 air drying Methods 0.000 claims description 6
- 238000001035 drying Methods 0.000 claims description 4
- 230000000954 anitussive effect Effects 0.000 abstract description 6
- 229940124584 antitussives Drugs 0.000 abstract description 6
- 239000003814 drug Substances 0.000 abstract description 6
- ZZVUWRFHKOJYTH-UHFFFAOYSA-N diphenhydramine Chemical compound C=1C=CC=CC=1C(OCCN(C)C)C1=CC=CC=C1 ZZVUWRFHKOJYTH-UHFFFAOYSA-N 0.000 abstract description 5
- 239000005720 sucrose Substances 0.000 abstract description 5
- 238000010521 absorption reaction Methods 0.000 abstract description 4
- 230000000857 drug effect Effects 0.000 abstract description 3
- 229940079593 drug Drugs 0.000 abstract 1
- DKXULEFCEORBJK-UHFFFAOYSA-N magnesium;octadecanoic acid Chemical compound [Mg].CCCCCCCCCCCCCCCCCC(O)=O DKXULEFCEORBJK-UHFFFAOYSA-N 0.000 abstract 1
- 210000004400 mucous membrane Anatomy 0.000 abstract 1
- 210000003800 pharynx Anatomy 0.000 abstract 1
- 238000012216 screening Methods 0.000 description 12
- 206010011224 Cough Diseases 0.000 description 10
- 239000000243 solution Substances 0.000 description 8
- 239000003795 chemical substances by application Substances 0.000 description 7
- 238000005469 granulation Methods 0.000 description 5
- 230000003179 granulation Effects 0.000 description 5
- 239000011230 binding agent Substances 0.000 description 4
- 239000000314 lubricant Substances 0.000 description 4
- 230000000694 effects Effects 0.000 description 3
- 238000005516 engineering process Methods 0.000 description 3
- 238000002474 experimental method Methods 0.000 description 3
- 210000000214 mouth Anatomy 0.000 description 3
- 210000004877 mucosa Anatomy 0.000 description 3
- 239000002245 particle Substances 0.000 description 3
- 238000007493 shaping process Methods 0.000 description 3
- 235000013599 spices Nutrition 0.000 description 3
- 238000006243 chemical reaction Methods 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 210000002345 respiratory system Anatomy 0.000 description 2
- 238000005303 weighing Methods 0.000 description 2
- PTVWPYVOOKLBCG-UHFFFAOYSA-N 3-(4-phenyl-1-piperazinyl)propane-1,2-diol Chemical compound C1CN(CC(O)CO)CCN1C1=CC=CC=C1 PTVWPYVOOKLBCG-UHFFFAOYSA-N 0.000 description 1
- 206010012335 Dependence Diseases 0.000 description 1
- 239000004375 Dextrin Substances 0.000 description 1
- 229920001353 Dextrin Polymers 0.000 description 1
- 239000008896 Opium Substances 0.000 description 1
- 235000008331 Pinus X rigitaeda Nutrition 0.000 description 1
- 235000011613 Pinus brutia Nutrition 0.000 description 1
- 241000018646 Pinus brutia Species 0.000 description 1
- 239000003434 antitussive agent Substances 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 239000013078 crystal Substances 0.000 description 1
- 235000019425 dextrin Nutrition 0.000 description 1
- 229960004722 dropropizine Drugs 0.000 description 1
- 210000001767 medulla oblongata Anatomy 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 229960001027 opium Drugs 0.000 description 1
- 230000002093 peripheral effect Effects 0.000 description 1
- DNIAPMSPPWPWGF-UHFFFAOYSA-N propylene glycol Substances CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 1
- 238000004080 punching Methods 0.000 description 1
- 208000023504 respiratory system disease Diseases 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 210000001044 sensory neuron Anatomy 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
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- Medicinal Preparation (AREA)
Abstract
The invention discloses a levodropropizine buccal tablet and a preparation method thereof. The levodropropizine buccal tablet is prepared by the levodropropizine, sucrose powder, steviosin, orange powder, 5 percent of polyvinylpyrrolidone, 75 percent of ethanol and stearic acid magnesium powder. The levodropropizine buccal tablet is peripherally acting antitussive. The levodropropizine provided by the invention is absorbed by a mouth and the mucous membrane of the pharynx and fewer factors affect the absorption of the levodropropizine, thus facilitating the absorption of the main drug for the human body and achieving better drug effect.
Description
Technical field
The present invention relates to a kind of levodropropizine preparation and preparation method thereof, relate to a kind of levodropropizine preparation that absorbs by oral cavity and pharyngeal mucosa and preparation method thereof when special.
Background technology
Cough is the common sympton of respiratory system disease, and the violent cough that continues not only brings misery to patient, also easily produces other complication, and suitable cough medicine therefore commonly used clinically comes relieving cough.
Cough medicine is commonly called as antitussive, is divided into central antitussive and periphery cough medicine two classes.Central antitussive directly suppresses to be positioned at the coughing centre of medulla oblongata and produces antitussive action, and its addiction and respiratory system untoward reaction are all bigger.The periphery cough medicine is by reducing the respiratory tract sensory nerve ending sensitivity that stimulates to be produced cough suppressing effect, there is not the untoward reaction of central antitussive thing, levodropropizine belongs to the peripheral antitussive drugs thing, is the clinical levo form of having used non-opium cough medicine dropropizine for many years.
Common name: levodropropizine
The Chinese phonetic alphabet: Zuoqiangbing paiqin
English name: Levodropropizine
Chemical name: S (-)-3-(4 phenyl-Piperazines-1-yl)-1, the 2-propylene glycol
Structural formula:
Molecular formula: C13H20N2O2
Molecular weight: 236.31
[character] this product is white crystals or crystalline powder.
Levodropropizine its curative effect of competence exertion that only is absorbed by the body, in the clinical practice of levodropropizine preparation in the past, human body is unsatisfactory to the assimilation effect of levodropropizine.
Summary of the invention
Technical problem to be solved by this invention provides a kind of Levodropropizine lozenge that absorbs by oral cavity and pharyngeal mucosa and preparation method thereof, to strengthen the absorption of human body to levodropropizine, strengthens its drug effect.
According to listed as parts by weight, Levodropropizine lozenge is to be prepared from for 4.5～5.5 parts by 25～35 parts of levodropropizines, 400～500 parts of cane sugar powders, 7～8 parts of steviosin, 2～3 parts in fragrant citrus powder, 5% polyvinylpyrrolidone+60～70 parts of 75% ethanol liquid and magnesium stearate.
Preferably, it is to be prepared from for 4.9 parts by 30 parts of levodropropizines, 450 parts of cane sugar powders, 7.5 parts of steviosin, 2.5 parts in fragrant citrus powder, 5% polyvinylpyrrolidone+65 parts of 75% ethanol liquid and magnesium stearate.
According to listed as parts by weight, the coating solution prescription of aforementioned buccal tablet is 110 parts of 20 parts of Opadries and purified water.
The preparation method of aforementioned Levodropropizine lozenge: get levodropropizine and cane sugar powder pulverize separately, steviosin is added stirring and dissolving in 5% polyvinylpyrrolidone+75% ethanol liquid, add levodropropizine and cane sugar powder, abundant mixed soft material is granulated drying, add magnesium stearate and fragrant citrus powder mix homogeneously, tabletting, coating, promptly.
Concrete, the preparation method of Levodropropizine lozenge: cross 100 mesh sieves after getting levodropropizine and cane sugar powder pulverize separately, equivalent 40 mesh sieves that progressively increased mix three times, steviosin is added stirring and dissolving in 5% polyvinylpyrrolidone+75% ethanol liquid, add levodropropizine and cane sugar powder, abundant mixed soft material, granulate with 20 mesh sieves, be lower than 60 ℃ of forced air dryings 2 hours, with 18 mesh sieve granulate, add magnesium stearate and fragrant citrus powder mix homogeneously, with diameter 12mm shallow concave punch tabletting, according to Opadry: the weight ratio preparation coating solution of purified water=20: 110, and carry out coating promptly by following parameter: 95 ℃ of inlet temperature, 43～45 ℃ of sheet bed tempertaures, atomizing pressure 3.5bar, coating pan rotating speed 5～8rpm, charging rate 3～5g/min.
The inventor has done a large amount of experiments exploring technical scheme of the present invention, and is specific as follows:
One, the screening of binding agent
Experimental technique:
After levodropropizine by 100 mesh sieves and cane sugar powder took by weighing by recipe quantity respectively, the equivalent mix homogeneously that progressively increases added binding agent system soft material, cross 16 mesh sieves, in forced air drying below 60 ℃, with 14 mesh sieve granulate, observe soft material and particulate face shaping, the results are shown in Table 1.
Table 1 binding agent screening experiment result
| The prescription number | R 1 | R 2 | R 3 |
| Levodropropizine (g) | 0.6 | 0.6 | 0.6 |
| Sucrose (g) | 9 | 9 | 9 |
| 5%PVP+95% ethanol liquid (ml) | 1.3 | - | - |
| 5%PVP+75% ethanol liquid (ml) | - | 1.3 | - |
| 5%PVP+ aqueous solution (ml) | - | - | 1.3 |
| Face shaping | Easily sieve, granule is pine, and fine powder is many | Easily sieve, shaping particles is good, and fine powder is few | Become dense thick extractum shape, can make soft material for a short time |
According to result in the table, select for use 5%PVP (polyvinylpyrrolidone)+75% ethanol liquid to make binding agent.
Two, the screening of sweeting agent
Levodropropizine, sweeting agent, dextrin by 100 mesh sieves respectively taken by weighing by table 2 recipe quantity, the equivalent mixing of progressively increasing, sweeting agent is dissolved in the 5%PVP+75% ethanol liquid respectively, is used to make soft material, granulate with 16 mesh sieves, be lower than 60 ℃ of forced air dryings 2 hours, with 14 mesh sieve granulate, add 1% magnesium stearate, behind the mix homogeneously, with Φ 12mm shallow concave punch tabletting, please at least 8 people taste the tablet mouthfeel.The results are shown in Table 2.
The screening of table 2 sweeting agent
Mouthfeel R
7＞R
5＞R
6＞R
4, decision selects for use steviosin to make sweeting agent.
Three, the screening of spice
Method is with the screening of sweeting agent.Press the granulation of table 3 prescription, tabletting, result such as following table:
The screening of table 3 spice
Mouthfeel: R
11＞R
9＞R
8＞R
10, decision selects for use the fragrant citrus powder to make spice.
Four, the screening of lubricant and fluidizer
At prescription R
11On the basis, screening lubricant and fluidizer.The results are shown in Table 4.
The screening of table 4 lubricant, fluidizer
R
13Compare R
12Mobility of particle is good, the slice, thin piece method of double differences is little, so select R for use
13, make lubricant, fluidizer with magnesium stearate.
Five, preparation technology's screening
By prescription R
13The preparation soft material with different screen sizes granulations, granulate, is measured bulk density behind the particle drying, the results are shown in Table 5
Table 5 granulation, granulate, screen size screening
Because slice, thin piece is heavier, about every 0.5g, should select the big technology of granule bulk density for use with 12mm punching pin tabletting.With the granulation of 20 mesh sieves, 18 mesh sieve granulate, grain shape is good, bulk density is big, and decision is selected for use.
Compared with prior art, levodropropizine preparation provided by the present invention absorbs by oral cavity and pharyngeal mucosa, and the factor that influence absorbs is less, more helps the absorption of human body to principal agent, better brings into play drug effect.
The specific embodiment
Embodiment 1: levodropropizine 30g, cane sugar powder 450g, steviosin 7.5g, fragrant citrus powder 2.5g, 5% polyvinylpyrrolidone+75% ethanol liquid 65g, magnesium stearate 4.9g
The preparation of coating solution: get Opadry 2kg and add among the purified water 110kg, fully dissolving, preparation coating solution.
Cross 100 mesh sieves after getting levodropropizine and sucrose pulverize separately, equivalent 40 mesh sieves that progressively increased mix three times, steviosin is added stirring and dissolving in 5% polyvinylpyrrolidone+75% ethanol liquid, add levodropropizine and cane sugar powder, abundant mixed soft material, granulate with 20 mesh sieves, be lower than 60 ℃ of forced air dryings 2 hours, with 18 mesh sieve granulate, add magnesium stearate and fragrant citrus powder mix homogeneously, with diameter 12mm shallow concave punch tabletting, make 1000, and carry out coating by following parameter and promptly get buccal tablet: 95 ℃ of inlet temperature, 40 ℃ of sheet bed tempertaures, atomizing pressure 3.5bar, coating pan rotating speed 6rpm, charging rate 4g/min.
Usage and dosage: buccal.One time 2,3 times on the one, or follow the doctor's advice.
Embodiment 2: levodropropizine 25g, cane sugar powder 500g, steviosin 7g, fragrant citrus powder 2g, 5% polyvinylpyrrolidone+75% ethanol liquid 70g and magnesium stearate 4.5g
The preparation of coating solution: get Opadry 2kg and add among the purified water 110kg, fully dissolving, preparation coating solution.
Cross 100 mesh sieves after getting levodropropizine and sucrose pulverize separately, equivalent 40 mesh sieves that progressively increased mix three times, steviosin is added stirring and dissolving in 5% polyvinylpyrrolidone+75% ethanol liquid, add levodropropizine and cane sugar powder, abundant mixed soft material, granulate with 20 mesh sieves, be lower than 60 ℃ of forced air dryings 2 hours, with 18 mesh sieve granulate, add magnesium stearate and fragrant citrus powder mix homogeneously, with diameter 12mm shallow concave punch tabletting, make 1000, and carry out coating by following parameter and promptly get buccal tablet: 95 ℃ of inlet temperature, 45 ℃ of sheet bed tempertaures, atomizing pressure 3.5bar, coating pan rotating speed 8rpm, charging rate 5g/min.
Usage and dosage: buccal.One time 2,3 times on the one, or follow the doctor's advice.
Embodiment 3: levodropropizine 35g, cane sugar powder 400g, steviosin 8g, fragrant citrus powder 3g, 5% polyvinylpyrrolidone+75% ethanol liquid 60g and magnesium stearate 5.5g
The preparation of coating solution: get Opadry 2kg and add among the purified water 110kg, fully dissolving, preparation coating solution.
Cross 100 mesh sieves after getting levodropropizine and sucrose pulverize separately, steviosin is added stirring and dissolving in 5% polyvinylpyrrolidone+75% ethanol liquid, add levodropropizine and cane sugar powder, abundant mixed soft material, add magnesium stearate and fragrant citrus powder mix homogeneously behind granulation, drying, the granulate, tabletting, make 1000, and carry out coating by following parameter and promptly get buccal tablet: 95 ℃ of inlet temperature, 43～45 ℃ of sheet bed tempertaures, atomizing pressure 3.5 bar, coating pan rotating speed 5～8rpm, charging rate 3～5g/min.
Usage and dosage: buccal.One time 2,3 times on the one, or follow the doctor's advice.
Claims (5)
1. Levodropropizine lozenge, it is characterized in that: according to listed as parts by weight, it is to be prepared from for 4.5～5.5 parts by 25～35 parts of levodropropizines, 400～500 parts of cane sugar powders, 7～8 parts of steviosin, 2～3 parts in fragrant citrus powder, 5% polyvinylpyrrolidone+60～70 parts of 75% ethanol liquid and magnesium stearate.
2. according to the described Levodropropizine lozenge of claim 1, it is characterized in that: according to listed as parts by weight, it is to be prepared from for 4.9 parts by 30 parts of levodropropizines, 450 parts of cane sugar powders, 7.5 parts of steviosin, 2.5 parts in fragrant citrus powder, 5% polyvinylpyrrolidone+65 parts of 75% ethanol liquid and magnesium stearate.
3. according to claim 1 or 2 described Levodropropizine lozenges, it is characterized in that: according to listed as parts by weight, the film-coat formula of liquid of described buccal tablet is 110 parts of 20 parts of Opadries and purified water.
4. the preparation method of the arbitrary described Levodropropizine lozenge of claim 1-3, it is characterized in that: get levodropropizine and cane sugar powder pulverize separately, steviosin is added stirring and dissolving in 5% polyvinylpyrrolidone+75% ethanol liquid, add levodropropizine and cane sugar powder, abundant mixed soft material, granulate, drying adds magnesium stearate and fragrant citrus powder mix homogeneously, tabletting, coating, promptly.
5. according to the preparation method of the described Levodropropizine lozenge of claim 4, it is characterized in that: cross 100 mesh sieves after getting levodropropizine and cane sugar powder pulverize separately, equivalent 40 mesh sieves that progressively increased mix three times, steviosin is added stirring and dissolving in 5% polyvinylpyrrolidone+75% ethanol liquid, add levodropropizine and cane sugar powder, abundant mixed soft material, granulate with 20 mesh sieves, be lower than 60 ℃ of forced air dryings 2 hours, with 18 mesh sieve granulate, add magnesium stearate and fragrant citrus powder mix homogeneously, with diameter 12mm shallow concave punch tabletting, according to Opadry: the weight ratio preparation coating solution of purified water=20: 110, and carry out coating promptly by following parameter: 95 ℃ of inlet temperature, 43～45 ℃ of sheet bed tempertaures, atomizing pressure 3.5bar, coating pan rotating speed 5～8rpm, charging rate 3～5g/min.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2008103025058A CN101317824B (en) | 2008-07-02 | 2008-07-02 | Levodropropizine lozenge and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2008103025058A CN101317824B (en) | 2008-07-02 | 2008-07-02 | Levodropropizine lozenge and preparation method thereof |
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| Publication Number | Publication Date |
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| CN101317824A CN101317824A (en) | 2008-12-10 |
| CN101317824B true CN101317824B (en) | 2011-09-07 |
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| CN103381145A (en) * | 2012-05-03 | 2013-11-06 | 贵州大学 | Method for improving levodropropizine taste by solid dispersion |
| CN105616373A (en) * | 2014-10-31 | 2016-06-01 | 康普药业股份有限公司 | Levodropropizine medicine preparation and preparation method thereof |
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