CN101428030A - Compound dipyridamole/acetophen sustained-release capsule and preparation thereof - Google Patents
Compound dipyridamole/acetophen sustained-release capsule and preparation thereof Download PDFInfo
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- CN101428030A CN101428030A CNA2007101579666A CN200710157966A CN101428030A CN 101428030 A CN101428030 A CN 101428030A CN A2007101579666 A CNA2007101579666 A CN A2007101579666A CN 200710157966 A CN200710157966 A CN 200710157966A CN 101428030 A CN101428030 A CN 101428030A
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- dipyridamole
- aspirin
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- sustained release
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Abstract
The invention relates to compound dipyridamole/aspirin sustained-release capsules and a preparation technique thereof. The invention is characterized in that sustained-release mircropill technique is applied to prepare two components: sustained-release dipyridamole and quick acting aspirin into compound preparation which is used for treating cardiovascular and cerebrovascular diseases. Different dosage at different times and multiple taking of the two medicines are changed into twice a day, thereby being convenient for the patient to take. Aspirin can reduce the dosage of dipyridamole and reduce the side effect thereof of blood pressure decrease; dipyridamole can improve the bioavailability of aspirin, and increase the efficacy on preventing and treating cardiovascular and cerebrovascular diseases. By combining dipyridamole and aspirin, the effects of the two medicines on inhibition of platelet aggregation and thrombosis in different links can be completely exerted. The efficacy of the compound preparation is obviously superior to that of single prescription preparation.
Description
Technical field:
The present invention relates to a kind of compound slow-releasing preparation and preparation technology thereof, compound recipe dipyridamole/aspirin sustained release capsule specifically is provided, contained active ingredient is delayed release dipyridamole and quick-acting aspirin.Particularly the slow-release micro-pill technical matters of this medicine has been carried out preferably.
Background technology:
Aspirin, chemical name 2-(acetoxyl group) benzoic acid, under alkalescence or weak basic condition easily and actual effect.Still all there is the control of limiting the quantity of to its catabolite free salicylic acid in state to aspirin and preparation thereof.After aspirin and double density reach not mixed pressuring plate, because the chemical instability of aspirin itself, between the storage life of tablet, can quicken aspirin decomposition generation free salicylic acid because of the influence that double density reaches not, be difficult to reach quality control standard to free water poplar acid content in the aspirin.
Aspirin and the double density developed by German Boehringer-Ingelheim company reach not compound preparation, and commodity are called Aggrenox
TM, go on the market by the FDA approval in March, 1999.Aggrenox
TMBe the capsule that is used for oral administration, the interior slow-release micro-pill that is reached not by the sugar coated tablet and the double density of aspirin of capsule is formed.This complex process, and need corresponding special equipment.
Summary of the invention: this patent technical problem to be solved is: provide a kind of new dosage form structure, quality to be easy to control, and the easy aspirin double density of making reaches not slow releasing capsule and technology thereof.It is characterized in that: described dipyridamole/aspirin sustained release capsules preparation technique wherein dipyridamole is the slow release composition, and aspirin is the rapid release composition.So dipyridamole and aspirin are made micropill respectively, dipyridamole is made slow-release micro-pill, and aspirin is made the common quick release micropill, and remix fill capsule promptly gets this product; Its technological operation is simple, utilizes the existing equipment in market, can reach the purpose of large-scale production.
The specific embodiment:
Preparation technology
1. dipyridamole extended-release micropill
1.1 system micropill
(1) get dipyridamole, microcrystalline Cellulose, porphyrize is crossed 100 mesh sieves respectively, and is standby.
(2) take by weighing dipyridamole, the microcrystalline Cellulose mix homogeneously of prescription ratio, must supply powder mixture.
(3) in the main frame rotating disk, add 40~60 purpose starch ball hearts, adjust air quantity, rotary speed and spray pump rotating speed to the technological requirement value.
(4) check that whiff pressure and flow whether at institute's required value, spray the atomization slurry of 2% an amount of hypromellose (HPMC pharmacoat606) aqueous solution then.Beginning moistening master batch notes not making the master batch bonding.
(5) after the suitable moistening of master batch, begin for powder.Along with the increasing of master batch size, progressively improve for powder speed and hydrojet flow.In this process, when containing more powder between the granule, strengthen the hydrojet flow.Otherwise granule is too wet, when adhesion or sticking pot are arranged, reduces the hydrojet flow, improves for powder speed.
(6) when granular size reaches necessary requirement, stop to open discharging opening, discharging for powder, whitewashing and jet.
(7) the pastille micropill mixture that makes is dry down in 55 ℃.It is standby that sieve is got 20~30 purpose micropills.
1.2 coating
(1) get the main frame rotating disk that 20~30 purpose micropills place the centrifugal coating granulator of BZJ-360MII type, hot blast temperature transfers to temperature required, regularly sprays coating solution and drying, repeated multiple times.
(2) get dried coated micropill, sieve, sieve is got 20~30 order micropills, surveys release.Promptly get the dipyridamole extended-release micropill.
(3) measure the slow-release micro-pill content of dispersion, calculate the capsule loading amount.
2. aspirin fast release micropill
2.1 rise female
(1) get aspirin, pregelatinized Starch, tartaric acid is evenly mixed, pulverizes 100 mesh sieves.
(2) take by weighing aspirin, pregelatinized Starch and tartaric acid by recipe quantity, mix homogeneously, mother in the centrifugal coating granulator of BZJ-360MII type, dry under 35 ℃, sieve is got 40~60 orders, and is standby.
2.2 system micropill
With 40~60 purpose aspirin granules is master batch system micropill, and dry under 35 ℃, other technologies are the same.
2.3 coating
With 20~30 purpose aspirin micropills is master batch, carries out coating, and technology is the same.The control loss on drying must not cross 2%.Sieve is got 20~30 order coated micropills, promptly gets the aspirin fast release micropill.Measure aspirin fast release micropill content of dispersion, calculate the capsule loading amount.
3. aspirin-dipyridomole sustained-release capsule
(1) gets the dipyridamole extended-release micropill and the aspirin fast release micropill of recipe quantity, be filled in respectively in No. 0 capsulae vacuus.
(2) carry out quality testing, it is qualified to detect, and promptly gets aspirin-dipyridomole sustained-release capsule.
Claims (6)
1, a kind of compound recipe dipyridamole/aspirin sustained release capsule and preparation technology thereof is characterized in that: use the slow-release micro-pill technology delayed release dipyridamole and two kinds of compositions of quick-acting aspirin are made compound preparation, be used for the treatment of cardiovascular and cerebrovascular disease.
2, according to the described dipyridamole of claim 1/aspirin sustained release capsule, it is characterized in that: described dipyridamole be clinical in stronger coronary artery expander, can increase coronary flow significantly enduringly, increase the myocardial oxygen delivery amount, be mainly used to prevent thrombosis.
3, according to the described dipyridamole of claim 1/aspirin sustained release capsule, it is characterized in that: described aspirin has antiplatelet aggregative activity, is widely used in prevention and treatment unstable angina pectoris, coronary heart disease and cerebral ischemia migraine.
4, according to the described dipyridamole of claim 1/aspirin sustained release capsule, it is characterized in that: described dipyridamole/aspirin sustained release capsule is repeatedly taken two kinds of medicines in the different time various dose and is changed 2 times on the one into.
5, according to the described dipyridamole of claim 4/aspirin sustained release capsule, it is characterized in that: aspirin can reduce the dipyridamole consumption and alleviate the side effect of its blood pressure lowering; Dipyridamole can improve the bioavailability of aspirin, increases the curative effect of the control heart, cerebrovascular disease.Dipyridamole and aspirin share, and can give full play to two medicines in different link anticoagulant and thrombotic effect.The drug effect of this compound preparation obviously is better than single preparations of ephedrine.
6, according to the described dipyridamole of claim 1/aspirin sustained release capsule, it is characterized in that: described dipyridamole/aspirin sustained release capsules preparation technique wherein dipyridamole is the slow release composition, and aspirin is the rapid release composition.So dipyridamole and aspirin are made micropill respectively, dipyridamole is made slow-release micro-pill, and aspirin is made the common quick release micropill, and remix fill capsule promptly gets this product.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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CNA2007101579666A CN101428030A (en) | 2007-11-06 | 2007-11-06 | Compound dipyridamole/acetophen sustained-release capsule and preparation thereof |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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CNA2007101579666A CN101428030A (en) | 2007-11-06 | 2007-11-06 | Compound dipyridamole/acetophen sustained-release capsule and preparation thereof |
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CN101428030A true CN101428030A (en) | 2009-05-13 |
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CNA2007101579666A Pending CN101428030A (en) | 2007-11-06 | 2007-11-06 | Compound dipyridamole/acetophen sustained-release capsule and preparation thereof |
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102058558A (en) * | 2010-12-14 | 2011-05-18 | 张瑞琛 | Method for preparing aspirin dipyridamole double-layer tablets |
CN102210693A (en) * | 2010-04-10 | 2011-10-12 | 山东新华制药股份有限公司 | Method for preparing aspirin and dipyridamole multilayer tablets |
CN102961418A (en) * | 2012-11-02 | 2013-03-13 | 山西大同大学 | Compound Hippophae rhamnoides dipyridamole tablet and preparation method thereof |
CN104013634A (en) * | 2013-03-01 | 2014-09-03 | 天津药物研究院 | Capsule containing aspirin enteric part and dipyridamole quick-releasing part and preparation method thereof |
-
2007
- 2007-11-06 CN CNA2007101579666A patent/CN101428030A/en active Pending
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102210693A (en) * | 2010-04-10 | 2011-10-12 | 山东新华制药股份有限公司 | Method for preparing aspirin and dipyridamole multilayer tablets |
CN102210693B (en) * | 2010-04-10 | 2013-10-09 | 山东新华制药股份有限公司 | Method for preparing aspirin and dipyridamole multilayer tablets |
CN102058558A (en) * | 2010-12-14 | 2011-05-18 | 张瑞琛 | Method for preparing aspirin dipyridamole double-layer tablets |
CN102961418A (en) * | 2012-11-02 | 2013-03-13 | 山西大同大学 | Compound Hippophae rhamnoides dipyridamole tablet and preparation method thereof |
CN104013634A (en) * | 2013-03-01 | 2014-09-03 | 天津药物研究院 | Capsule containing aspirin enteric part and dipyridamole quick-releasing part and preparation method thereof |
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Open date: 20090513 |