CN101536991A - Pentoxyverine voltoide and preparation method thereof - Google Patents
Pentoxyverine voltoide and preparation method thereof Download PDFInfo
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- CN101536991A CN101536991A CN200910103639A CN200910103639A CN101536991A CN 101536991 A CN101536991 A CN 101536991A CN 200910103639 A CN200910103639 A CN 200910103639A CN 200910103639 A CN200910103639 A CN 200910103639A CN 101536991 A CN101536991 A CN 101536991A
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- pentoxyverine
- ammonium chloride
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- citrate
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Abstract
The invention discloses a pentoxyverine voltoide and a preparation method thereof. The tablet uses citric acid pentoxyverine dipping pill as a tablet core, and adopts a dry pressure coating technology to press ammonium chloride, the citric acid pentoxyverine dipping pill and an excipient to a coated tablet. The weight ratio of the ammonium chloride to the citric acid pentoxyverine in the tablet is 12:1, and the balance is the excipient. The invention solves the technical problem of sticky punch in tabletting and leads the whole tabletting process to be easier to realize, and the tabletted tablet has reliable quality and is beautiful. The pentoxyverine voltoide can be clinically used for treating coughing and sputum including acute and chronic bronchitis and pneumonia, and the like caused by various reasons.
Description
Technical field
The present invention relates to the pharmaceutical preparation of pentoxyverine ammonium chloride, be specially a kind of pentoxyverine voltoide and preparation method thereof.
Background technology
Respiratory tract diseases such as cough, expectoration are a kind of common diseases of current society, have a strong impact on people's life and health.Along with developing rapidly of global economy, the continuous increase of industrial and civilian polluter, serious day by day atmospheric pollution, environmental improvement is weak in addition, make the sickness rate of various respiratory tract diseases be growing on and on the mountain,, its mortality rate that causes also rises year by year, and respiratory tract disease has become one of human several big " killers " at present.As the important component part of respiratory system disease, the market of cough-relieving and phlegm-eliminating medicine also increases year by year, and average annual growth rate is more than 10%.Therefore develop relieving cough and expelling phlegm class medicine, its social benefit and economic benefit highly significant.
Ministry of Public Health " antitussive, suppressing panting calming medicine clinical research guideline " emphasis is pointed out: violent cough can cause severe complication and increase patient's misery, but cough and eliminate the phlegm and be respiratory tract defensive enginery inalienable part, ideal antitussive medicine should have cough-relieving concurrently, eliminate the phlegm, and does not have side effect such as obvious respiration inhibition and sleep.Pentoxyverine citrate has maincenter and periphery antitussive effect, its antitussive intensity is 1/3 of codeine, except that the respiratory center to oblongata has the direct repression, also have slight atropine-like effect, can make the bronchial smooth muscle of spasm loose, lower airway resistance; Ammonium chloride can increase the secretion of respiratory mucosa body of gland in reflexive ground, thereby makes sputum be easy to discharge, and helps the removing of sticking expectorant.Both compatibility of drugss use can realize good cough-relieving, phlegm-dispelling functions, and side effect is little, is good cough-relieving and phlegm-eliminating medicine.
The dosage form that domestic listing is produced is a pentoxyverine ammonium chloride syrup, exist and take, carry, transport inconvenience, the shortcoming that sugar content is high, particularly person in middle and old age's respiratory tract disease patient also are diabeticss simultaneously, can not take and contain sugared medicine, also add antiseptic and coloring agent etc. in the syrup.And the pentoxyverine voltoide has overcome the deficiency of above-mentioned dosage form, and it is little, stable and controllable for quality to have a volume of taking, and suitable crowd is advantage widely.
But the pentoxyverine citrate fusing point is low, is 88～93 ℃, in tabletting was produced, the metal die transient temperature that produces that runs up far surpassed 100 ℃, was attached on the punch die after making the pentoxyverine citrate fusing, cause the tabletting difficulty, the tablet of extrusion is uneven.Ammonium chloride is water miscible white crystalline powder, has strong to draw moistly, and tabletting can stick and dash separately, is difficult for tabletting.If pentoxyverine citrate and ammonium chloride are mixed, the hygroscopicity of mixture sharply increases, and fusing point significantly reduces, unsuitable compression moulding tablet.So the compound tablet of pentoxyverine citrate and ammonium chloride has open defect, can not suppress in flakes.
Summary of the invention
The objective of the invention is to overcome the above-mentioned deficiency of prior art, a kind of pentoxyverine citrate drop pill pentoxyverine voltoide as the sheet heart and outsourcing ammonium chloride layer and preparation method thereof is provided.
The technical scheme that technical solution problem of the present invention is adopted is:
The characteristics of pentoxyverine voltoide of the present invention are to adopt unique prescription, and the weight ratio of active component pentoxyverine citrate, ammonium chloride is 12: 1, and excipient accounts for the 15%-25% of pentoxyverine citrate and ammonium chloride total amount.
The characteristics of pentoxyverine voltoide of the present invention also are pentoxyverine citrate is made drop pill, and are the sheet heart with the drop pill, adopt dry pressing coated technology, preparation pentoxyverine ammonium chloride bag heart sheet.
The sheet heart of pentoxyverine voltoide of the present invention is the pentoxyverine citrate drop pill, comprise pentoxyverine citrate in the prescription of drop pill, and in the adjuvant substrate Polyethylene Glycol, stearic acid, octadecanol, glyceryl monostearate, sorbitol, pregelatinized Starch, microcrystalline Cellulose, polysorbate-80 (tween 80) one or more.The weight ratio of pentoxyverine citrate and substrate is 1～2.5: 1.
The sheet heart skin of pentoxyverine voltoide of the present invention is the ammonium chloride layer, comprise ammonium chloride in the prescription of ammonium chloride layer, and in the excipient starch, pregelatinized Starch, dextrin, sucrose, carboxymethylstach sodium, low-substituted hydroxypropyl methylcellulose, magnesium stearate, Pulvis Talci one or more.
Foregoing invention has solved the glutinous technical problem of dashing of tabletting by unique recipe design.The present invention makes spherical drop pill to low-melting medicine pentoxyverine citrate by solid dispersion technology, and it is accurate that drop pill is decided dosage, and the medicine stripping is fast.In tablet tabletting process, adopt special-purpose bag heart tablet machine, the drop pill bag is by in the sheet heart, sheet heart skin wraps up the ammonium chloride layer again, such benefit is that pentoxyverine citrate does not contact with punch die, not can because of moment high temperature melt; And the contact surface of ammonium chloride layer and drop pill reduces, and drop pill substrate has also been avoided the effect with ammonium chloride, makes the easier realization of whole tabletting process at last, and the tablet quality that sheet goes out is attractive in appearance, reliable.
The preparation method of pentoxyverine voltoide of the present invention has following steps:
A. the preparation of pentoxyverine citrate drop pill: by the prescription batching, take by weighing one or more substrate in pentoxyverine citrate raw material and Polyethylene Glycol, stearic acid, octadecanol, the glyceryl monostearate, heating and melting in 100 ℃ of water-baths, to solution be clear liquid; Add one or more substrate in sorbitol, pregelatinized Starch, microcrystalline Cellulose and/or the polyoxyethylene sorbitan monoleate (tween 80) again, be stirred into suspension, to drip the system temperature and be controlled at 96-98 ℃, open the system switch system of dripping of dripping of drop pill machine, the water dropper internal diameter is 3.6～4.2mm, condensed fluid is simethicone or liquid paraffin, collects the drop pill sample, oil suction, drying; The inspection drop pill is up-to-standard;
B. ammonium chloride particle preparation: take by weighing one or more excipient in ammonium chloride and starch, pregelatinized Starch, dextrin, sucrose, carboxymethylstach sodium, low-substituted hydroxypropyl methylcellulose, magnesium stearate and/or the Pulvis Talci by prescription, adopt wet granulation technology, after mixing, granulation, drying, granulate and total mixing, make uniform ammonium chloride particle, as the clothing layer granule of dry-pressing coating.
C. ammonium chloride particle assay.
D. install, debugged dry-pressing coating tablet machine, the punch die diameter is 8～10mm.The pentoxyverine citrate drop pill is added in the sheet heart conveyer device of tablet machine, ammonium chloride particle is packed in another magazine attachment, open tablet machine, the compacting sample.The pentoxyverine citrate drop pill should be in the central authorities of tablet, coated outside one deck ammonium chloride particle of drop pill, and the sample of Xing Chenging is a white tablets at last, the sheet heart is the compound tablet of drop pill.
E detects intermediate products.
F. aluminum-plastic packaged: as the pentoxyverine voltoide to be added in the hopper of Aluminium-coating Packer, carry out the plastic-aluminum inner packing.
G. plastic bottle packing, outer package, product inspection.
Pentoxyverine voltoide of the present invention compared with prior art mainly contains following excellent results:
1. owing to adopted drop pill bag heart pressed-disc technique, low-melting pentoxyverine citrate is made drop pill, the ammonium chloride layer is as the coatings tabletting, and the tablet compression molding is good, appearance looks elegant, and the similar preparation of mass ratio is outstanding.
The different pentoxyverine ammonium chloride of table 1 dosage form quality situation
As can be seen from the above table, pentoxyverine voltoide (the bag heart) all is better than conventional tablet on important quality index such as outward appearance, content, disintegration, friability, weight differential; Compare with syrup, bag heart sheet uses more convenient, and quality is more stable.
2. compare with other bag heart sheets, characteristics of the present invention are that the bag heart partly is drop pill, and the bag heart of other bag heart sheets partly is a tabloid.Bag heart drop pill has the advantages that as domestic exclusive dosage form rate of release is fast, medicine is stable, pentoxyverine citrate is made drop pill after, medicine stability is improved, drug release is rapider.
The different pentoxyverine voltoide of table 2 mass ratio
3. this technology is compared with common bag heart tablet, the technology uniqueness, and medicine is more stable.Pentoxyverine citrate is wrapped in and makes drop pill in the inert base, and medicine stability improves, and the medicine disintegrate is fast, discharges rapider.
The specific embodiment
Product of the present invention prepares as stated above, and its detailed component is provided by the following example, but protection scope of the present invention is not limited to this.
Embodiment 1
1000 consumptions of component (gram)
Pentoxyverine citrate 25
Ammonium chloride 300
Octadecanol 8
Pregelatinized Starch 9
Starch 22
Dextrin 15
Carboxymethylstach sodium 8
Magnesium stearate 3.5
Pulvis Talci 3.5
Example 2
1000 consumptions of component (gram)
Pentoxyverine citrate 25
Ammonium chloride 300
Stearic acid 8
Pregelatinized Starch 6.5
Carboxymethylstach sodium 12
Tween 80 0.43
Starch 32
Dextrin 15
Magnesium stearate 3.5
Pulvis Talci 3.5
Example 3
1000 consumptions of component (gram)
Pentoxyverine citrate 25
Ammonium chloride 300
Glyceryl monostearate 9
Sorbitol 1
Microcrystalline Cellulose 5
Carboxymethylstach sodium 8
Starch 20
Dextrin 20
Sucrose 5.5
Magnesium stearate 3.5
Pulvis Talci 3.5
Example 4
1000 consumptions of component (gram)
Pentoxyverine citrate 25
Ammonium chloride 300
Octadecanol 9
Sorbitol 1
Microcrystalline Cellulose 5
Carboxymethylstach sodium 8
Low-substituted hydroxypropyl cellulose 20
Starch 12
Dextrin 15
Magnesium stearate 3.5
Pulvis Talci 3.5
Example 5
1000 consumptions of component (gram)
Pentoxyverine citrate 25
Ammonium chloride 300
Polyethylene glycol 6000 5
Glyceryl monostearate 10
Microcrystalline Cellulose 10
Low-substituted hydroxypropyl cellulose 20
Starch 40
Dextrin 15
Magnesium stearate 3.5
Pulvis Talci 3.5
Example 6
1000 consumptions of component (gram)
Pentoxyverine citrate 25
Ammonium chloride 300
Polyethylene glycol 6000 8
Macrogol 4000 4
Microcrystalline Cellulose 4
Low-substituted hydroxypropyl cellulose 20
Starch 12
Dextrin 15
Magnesium stearate 3.5
Pulvis Talci 3.5
Example 7
1000 consumptions of component (gram)
Pentoxyverine citrate 25
Ammonium chloride 300
Glyceryl monostearate 5
Polyethylene glycol 6000 5
Microcrystalline Cellulose 5
Starch 40
Dextrin 15
Magnesium stearate 3.5
Pulvis Talci 3.5
Example 8
1000 consumptions of component (gram)
Pentoxyverine citrate 25
Ammonium chloride 300
Polyethylene glycol 6000 11
Stearic acid 2
Tween 80 0.5
Low-substituted hydroxypropyl cellulose 20
Starch 12
Dextrin 15
Magnesium stearate 3.5
Pulvis Talci 3.5
The preparation technology of above embodiment pentoxyverine voltoide is:
1. the preparation of pentoxyverine citrate drop pill: by prescription batching, (use octadecanol as example 1, example 2 is used stearic acid to take by weighing one or more substrate in pentoxyverine citrate raw material and Polyethylene Glycol, stearic acid, octadecanol, the glyceryl monostearate; Example 3 is used glyceryl monostearate; Example 4 is used octadecanol; Example 5 usefulness polyethylene glycol 6000 and glyceryl monostearates; Example 6 usefulness Macrogol 4000 and polyethylene glycol 6000s; Example 7 polyethylene glycol 6000s and glyceryl monostearate; Example 8 usefulness polyethylene glycol 6000 and stearic acid), heating and melting in 100 ℃ of water-baths, to solution be clear liquid; Add one or more substrate in sorbitol, pregelatinized Starch, microcrystalline Cellulose and/or the polyoxyethylene sorbitan monoleate (tween 80) again, (use pregelatinized Starch as example 1, example 2 usefulness pregelatinized Starch and tween 80s; Example 3 usefulness microcrystalline Cellulose and sorbitol; Example 4 usefulness microcrystalline Cellulose and sorbitol; Example 5 is used microcrystalline Cellulose; Example 6 is used microcrystalline Cellulose; Example 7 is used microcrystalline Cellulose; Example 8 is used tween 80), be stirred into suspension, will drip the system temperature and be controlled at 96-98 ℃, open the system switch system of dripping of dripping of drop pill machine, the water dropper internal diameter is 3.6～4.2mm, condensed fluid is simethicone or liquid paraffin, collects the drop pill sample, oil suction, drying; The inspection drop pill is up-to-standard; 2. ammonium chloride particle preparation: take by weighing ammonium chloride and excipient by prescription, (as embodiment 1 usefulness starch, dextrin, carboxymethylstach sodium, magnesium stearate, Pulvis Talci, example 2 usefulness starch, dextrin, carboxymethylstach sodium, magnesium stearate, Pulvis Talci; Example 3 usefulness starch, dextrin, carboxymethylstach sodium, sucrose, magnesium stearate, Pulvis Talci; Example 4 usefulness starch, dextrin, carboxymethylstach sodium, low-substituted hydroxypropyl cellulose, magnesium stearate, Pulvis Talci; Example 5 usefulness starch, dextrin, low-substituted hydroxypropyl cellulose, magnesium stearate, Pulvis Talci; Example 6 usefulness starch, dextrin, low-substituted hydroxypropyl cellulose, magnesium stearate, Pulvis Talci; Example 6 usefulness starch, dextrin, low-substituted hydroxypropyl cellulose, magnesium stearate, Pulvis Talci; Example 7 usefulness starch, dextrin, magnesium stearate, Pulvis Talci; Example 8 usefulness starch, dextrin, low-substituted hydroxypropyl cellulose, magnesium stearate, Pulvis Talci), adopt wet granulation technology, after mixing, granulation, drying, granulate and total mixing, make uniform ammonium chloride particle, as the clothing layer granule of dry-pressing coating.
3. ammonium chloride particle assay.
4. install, debugged dry-pressing coating tablet machine, the punch die diameter is 8～10mm.The pentoxyverine citrate drop pill is added in the sheet heart conveyer device of tablet machine, ammonium chloride particle is packed in another magazine attachment, open tablet machine, the compacting sample.The pentoxyverine citrate drop pill should be in the central authorities of tablet, coated outside one deck ammonium chloride particle of drop pill, and the sample of Xing Chenging is a white tablets at last, the sheet heart is the compound tablet of drop pill.
5 detect intermediate products.
6. aluminum-plastic packaged: the pentoxyverine voltoide is added in the hopper of Aluminium-coating Packer, carry out the plastic-aluminum inner packing, packing specification is 10/plate, 12/plate, 20/plate.
7. plastic bottle packing: the pentoxyverine voltoide is added in the hopper of full automatic plastic bottle packer, carry out the plastic bottle inner packing, packing specification is 50 slices/bottle, 100 slices/bottle.
8. outer package, product inspection.
Claims (7)
1. pentoxyverine ammonium chloride tablet, it is characterized in that doing the sheet heart by the pentoxyverine citrate drop pill, adopt dry pressing coated technology, ammonium chloride, pentoxyverine citrate drop pill and at least a pharmaceutically acceptable excipient suppressed together form, the weight proportion of described pentoxyverine citrate and ammonium chloride is 12: 1, and excipient accounts for the 15%-25% of pentoxyverine citrate and ammonium chloride total amount.
2. according to the described pentoxyverine ammonium chloride of claim 1 tablet, it is characterized in that the pentoxyverine citrate drop pill adopts the dropping preparation method system of dripping to form, described pentoxyverine citrate drop pill is made up of pentoxyverine citrate and substrate, the weight ratio of described pentoxyverine citrate and substrate is 1～2.5: 1, and the condensed fluid that drips system adopts simethicone or liquid paraffin.
3. pentoxyverine ammonium chloride tablet according to claim 1 and 2 is characterized in that: described excipient is starch, pregelatinized Starch, dextrin, sucrose, carboxymethylstach sodium, low-substituted hydroxypropyl methylcellulose, magnesium stearate and/or Pulvis Talci.
4. according to right 2 described pentoxyverine ammonium chloride tablets, it is characterized in that: the substrate of described pentoxyverine citrate drop pill is Polyethylene Glycol, stearic acid, octadecanol, glyceryl monostearate, sorbitol, pregelatinized Starch, microcrystalline Cellulose and/or polyoxyethylene sorbitan monoleate.
5. according to right 4 described pentoxyverine ammonium chloride tablets, it is characterized in that: described substrate is selected octadecanol, glyceryl monostearate, sorbitol, pregelatinized Starch, microcrystalline Cellulose.
6. the preparation method of claim 1 or 2 described pentoxyverine ammonium chloride tablets may further comprise the steps:
A. the preparation of pentoxyverine citrate drop pill: by the prescription batching, take by weighing one or more substrate in pentoxyverine citrate raw material and Polyethylene Glycol, stearic acid, octadecanol, the glyceryl monostearate, heating and melting in 100 ℃ of water-baths, to solution be clear liquid; Add one or more substrate in sorbitol, pregelatinized Starch, microcrystalline Cellulose and/or the polyoxyethylene sorbitan monoleate again, be stirred into suspension, to drip the system temperature and be controlled at 96-98 ℃, open the system switch system of dripping of dripping of drop pill machine, the water dropper internal diameter is 3.6～4.2mm, condensed fluid is simethicone or liquid paraffin, collects the drop pill sample, oil suction, drying; The inspection drop pill is up-to-standard;
The weight ratio of described pentoxyverine citrate and substrate is 1～2: 1;
B. ammonium chloride particle preparation: take by weighing ammonium chloride and excipient by prescription, adopt wet granulation technology, after mixing, granulation, drying, granulate and total mixing, make uniform ammonium chloride particle, as the clothing layer granule of dry-pressing coating;
C. ammonium chloride particle assay;
D. install, debugged dry-pressing coating tablet machine, the punch die diameter is 8～10mm; The pentoxyverine citrate drop pill is added in the sheet heart conveyer device of tablet machine, ammonium chloride particle is packed in another magazine attachment, open tablet machine, the compacting sample; The pentoxyverine citrate drop pill should be in the central authorities of tablet, coated outside one deck ammonium chloride particle of drop pill, and the sample of Xing Chenging is a white tablets at last, the sheet heart is the compound tablet of drop pill;
E detects intermediate products;
F. aluminum-plastic packaged: as the pentoxyverine voltoide to be added in the hopper of Aluminium-coating Packer, carry out the plastic-aluminum inner packing;
G. plastic bottle packing, outer package again, product inspection;
The weight proportion of described pentoxyverine citrate and ammonium chloride is 12: 1, and excipient accounts for the 15%-25% of pentoxyverine citrate and ammonium chloride total amount.
7. the preparation method of pentoxyverine voltoide according to claim 6 is characterized in that described excipient is starch, pregelatinized Starch, dextrin, sucrose, carboxymethylstach sodium, low-substituted hydroxypropyl methylcellulose, magnesium stearate and/or Pulvis Talci.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910103639A CN101536991A (en) | 2009-04-20 | 2009-04-20 | Pentoxyverine voltoide and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910103639A CN101536991A (en) | 2009-04-20 | 2009-04-20 | Pentoxyverine voltoide and preparation method thereof |
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| CN101536991A true CN101536991A (en) | 2009-09-23 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112315931A (en) * | 2020-11-19 | 2021-02-05 | 濮阳市汇元药业有限公司 | Pentoxyverine citrate tablet and preparation method thereof |
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2009
- 2009-04-20 CN CN200910103639A patent/CN101536991A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112315931A (en) * | 2020-11-19 | 2021-02-05 | 濮阳市汇元药业有限公司 | Pentoxyverine citrate tablet and preparation method thereof |
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Open date: 20090923 |