CN104473905A - Trimetazidine hydrochloride sustained-release capsule and preparation method thereof - Google Patents
Trimetazidine hydrochloride sustained-release capsule and preparation method thereof Download PDFInfo
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- CN104473905A CN104473905A CN201410663900.4A CN201410663900A CN104473905A CN 104473905 A CN104473905 A CN 104473905A CN 201410663900 A CN201410663900 A CN 201410663900A CN 104473905 A CN104473905 A CN 104473905A
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- trimetazidine
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Abstract
The invention discloses a trimetazidine hydrochloride sustained-release capsule and a preparation method thereof, belonging to the technical field of medicines. The sustained-release capsule is prepared by filling sustained-release pellets containing trimetazidine in capsules, wherein the sustained-release pellets are a framework control preparation. The trimetazidine hydrochloride sustained-release capsule prepared by the preparation method is simple in process and low in cost. As the capsule is in a multiunit control release system of drug, the user does not need to worry about abrupt release of drug. Compared with preparations such as sustained release tablets, the trimetazidine hydrochloride sustained-release capsule is safe and reliable in medication and high in medication compliance.
Description
Technical field
The present invention relates to slow release formulation of antianginal cardiovascular drug and preparation method thereof, relate to a kind of trimetazidine hydrochloride sustained-release capsule and preparation method particularly, belong to medical art.
Background technology
Angina pectoris is a kind of common cardiovascular disease, due to coronary atherosclerosis, narrow, cause coronary insufficiency, cardiac muscle ischemia and anoxia caused by, take precordialgia as one group of syndrome of main clinical manifestation, be the one of the coronary heart disease that incidence rate is the highest, the Health and Living of the mankind in serious threat.It is mainly divided into stable angina pectoris and unstable angina pectoris.Angina pectoris can show effect any time at 24 hours, but in the majority to the morning with early morning, and ariant angina is many in timing outbreak at night.Therefore, require that medicine can maintain in 24h always and effectively treat concentration, to ensure effectiveness, the safety and stability for the treatment of.Trimetazidine Hydrochloride belongs to other class antianginal cardiovascular drugses, is first and acts on metabolism of myocardium, playing direct cytoprotection and be widely used in antianginal medicine by making cardiac energy metabolism rationalize.Trimetazidine Hydrochloride has taken in Europe, Japanese Pharmacopoeia, is 3-ketone Acyl-CoA thiolase inhibitor (3-KAT), and during myocardial ischemia, it can by suppressing fatty acid oxidation, stimulate glucose oxidase, and metabolism is tended to balance, maintain homergy path, thus play myocardium protecting action; It can ensure the normal energy supply of ATP, therefore, can guarantee the normal operation of ionic pump normal function and permeable membrane sodium-potassium stream, maintains the stable of intracellular environment; Intracellular acidosis can be reduced and stop the gathering of sodium and calcium in myocardial cell; And the cytolysis that can be caused by Cell protection contractile function and restriction oxygen-derived free radicals and inner film injury play film protective effect.Trimetazidine Hydrochloride does not affect hemodynamics, does not also reduce heart rate, blood pressure, can significantly reduce angina pectoris attacks frequency, have evident in efficacy, can share with other drug, better tolerance, untoward reaction are little, low toxin.In addition, documents and materials result shows, the treatment that Trimetazidine Hydrochloride also can be used in stable angina pectoris, heart failure, ischemic cardiomyopathy, ischemia/reperfusion injury and coronary artery bypass grafting, percutaneous coronary are got involved, determined curative effect.Therefore, Trimetazidine Hydrochloride has good value for clinical application and application prospect, receives the concern of increasing researcher.
The Trimetazidine Hydrochloride dosage form of having gone on the market at present has conventional tablet, capsule, slow releasing tablet, discloses a kind of trimetazidine slow releasing tablet and preparation method thereof in authorized patent CN102670537B.This slow releasing tablet sustained-release matrix material used is the complex of Kollidon SR and ethyl cellulose, and slow-release material used is expensive, is unsuitable for commercially producing.Disclose Trimetazidine Hydrochloride in patent of invention CN102133195A and delay controlled release micro pill and preparation method thereof.This slow controlled release micro pill structure comprises from the inside to the outside celphere, Trimetazidine Hydrochloride medicine layer, slow controlled release coating layer; preparation method obtains celphere by centrifugal coating granulator; put be kept in motion in centrifugal coating granulator while; moistening to celphere with the mixed liquor of spray gun to its spray adhesive and wetting agent; by powder feeder unit, Trimetazidine Hydrochloride raw material is spread on celphere after wetting equably; obtain pastille micropill, outside pastille micropill, then carry out slow controlled release coat and get final product.This preparation method is loaded down with trivial details, complex process, and manufacturing cycle is long, and in preparation process, process parameter control point is too much, is unfavorable for Follow-up Industry.Patent of invention CN102657608A discloses a kind of trimetazidine composition and method of making the same, and its dosage form is injection, high without slow release formulation safety, the advantage that patient complies with, and the stability of this dosage form needs to be investigated.Patent of invention CN102885795A also discloses a kind of trimetazidine hydrochloride sustained-release tablets and preparation method thereof, this slow releasing tablet also needs to carry out follow-up coating operations after having suppressed, in view of the feature that Trimetazidine Hydrochloride is unstable under illumination condition, necessary for follow-up enrobing processes slow releasing tablet, but too increase preparation cost simultaneously, extend manufacturing cycle.
Trimetazidine hydrochloride sustained-release capsule of the present invention prepares micropill after only Trimetazidine Hydrochloride need being mixed homogeneously with filler, slow-release material, dry, fill capsule, technique is simple, this dosage form just can lucifuge without the need to coating simultaneously, while improve the stability of medicine, save cost, be suitable for industrialization and produce.In addition, slow release formulation can increase take medicine safety and the compliance of patient, has good market prospect.
Summary of the invention
The object of the invention is to the problem mentioned for background technology, provide a kind of and can improve slow release formulation of the antianginal cardiovascular drugs of the defect of prior art and preparation method thereof, particularly a kind of trimetazidine hydrochloride sustained-release capsule and preparation method thereof.
The technical scheme of the present invention realizing above-mentioned purpose is as follows:
A kind of trimetazidine slow releasing capsule, it is characterized in that described trimetazidine slow releasing capsule is obtained by the slow-release micro-pill fill capsule containing trimetazidine, slow-release micro-pill Mechanism of Drug Release is the release of skeleton control type.
Above-mentioned slow-release micro-pill consists of the following composition: the trimetazidine of 1-40%, the sustained-release matrix material of 5-40%, the binding agent of 1-15%, the filler of 20-80%.The trimetazidine of preferred 10-30%, the sustained-release matrix material of 10-25%, the binding agent of 1-10%, the filler of 40-70%.More preferably the trimetazidine of 10-20%, the sustained-release matrix material of 15-30%, the binding agent of 1-10%, the filler of 50-70%.
Above-mentioned trimetazidine slow releasing capsule, is characterized in that described sustained-release matrix material is selected from water-insoluble framework material if ethyl cellulose, polyethylene, polysiloxanes and hydrophilic gel framework material are as one or more in hypromellose, methylcellulose, sodium carboxymethyl cellulose, polyvinyl alcohol.
Described trimetazidine slow releasing capsule, is characterized in that described binding agent is mixed with certain density aqueous solution or alcohol-water solution by hypromellose, hyprolose, polyvidone and obtains.
Describedly state trimetazidine slow releasing capsule, it is characterized in that described filler is one or more in lactose, sucrose, mannitol, microcrystalline Cellulose, pregelatinized Starch, starch, calcium hydrogen phosphate.
Described trimetazidine slow releasing capsule, it is characterized in that described sustained-release matrix Advantageous materials is selected from hydrophilic gel framework material one or more, one or more more preferably in hypromellose, sodium carboxymethyl cellulose and polyvinyl alcohol.
Above-mentioned trimetazidine slow releasing capsule, it is characterized in that described filler is selected from lactose, sucrose, microcrystalline Cellulose, starch, pregelatinized Starch one or more.
Described trimetazidine slow releasing capsule, it is characterized in that described filler is selected from lactose, sucrose, microcrystalline Cellulose, starch one or more.
Above-mentioned trimetazidine slow releasing capsule, is characterized in that trimetazidine slow releasing capsule is prepared from by following steps:
(1) trimetazidine raw material pulverizing is crossed 100 mesh sieves;
(2) add binding agent after being mixed homogeneously with filler, slow-release material by above-mentioned raw materials, be prepared into suitable soft material;
(3) above-mentioned soft material is placed in extrusion-spheronization pelletizing machine and prepares micropill, dry, cross 30 mesh sieves;
(4) fill capsule, to obtain final product.
Described trimetazidine slow releasing capsule is applicable to the prophylactic treatment of angina pectoris attacks, and dizzy and complementary symptomatic treatment that is tinnitus, belongs to antianginal cardiovascular drugs.
Detailed description of the invention
Further illustrate the present invention by embodiment below, understand a kind of trimetazidine hydrochloride sustained-release capsule and preparation method thereof further, but the present invention is not limited.
The tablet of following embodiment and comparative example's compacting, if not otherwise indicated, all carries out fill by 2# capsule shells.
Embodiment 1
Preparation technology:
(1) Trimetazidine Hydrochloride raw material pulverizing is crossed 100 mesh sieves;
(2) the PVP K30 aqueous solution of 5% is prepared;
(3) with above-mentioned binding agent soft material after the raw material after pulverizing and the hypromellose K15M of recipe quantity, microcrystalline Cellulose being mixed;
(4) soft material is added in extrusion-spheronization pelletizing machine prepare micropill;
(5) micropill is dried to moisture and is less than light 30 mesh sieve after 3% in 50 DEG C of baking ovens;
(6) fill capsule.
Embodiment 2
Preparation technology:
(1) Trimetazidine Hydrochloride raw material pulverizing is crossed 100 mesh sieves;
(2) the PVP K30 aqueous solution of 5% is prepared;
(3) with above-mentioned binding agent soft material after the raw material after pulverizing and the HPMC K4M of recipe quantity, lactose being mixed;
(4) soft material is added in extrusion-spheronization pelletizing machine prepare micropill;
(5) micropill is dried to moisture and is less than light 30 mesh sieve after 3% in 50 DEG C of baking ovens;
(6) fill capsule.
Embodiment 3
Preparation technology:
(1) Trimetazidine Hydrochloride raw material pulverizing is crossed 100 mesh sieves;
(2) the PVP K30 aqueous solution of 5% is prepared;
(3) with above-mentioned binding agent soft material after the raw material after pulverizing and the sodium carboxymethyl cellulose of recipe quantity, sucrose being mixed;
(4) soft material is added in extrusion-spheronization pelletizing machine prepare micropill;
(5) micropill is dried to moisture and is less than light 30 mesh sieve after 3% in 50 DEG C of baking ovens;
(6) fill capsule.
Embodiment 4
Preparation technology:
(1) Trimetazidine Hydrochloride raw material pulverizing is crossed 100 mesh sieves;
(2) the PVP K30 aqueous solution of 5% is prepared;
(3) with above-mentioned binding agent soft material after the raw material after pulverizing and the sodium carboxymethyl cellulose of recipe quantity, HPMC K4M, starch being mixed;
(4) soft material is added in extrusion-spheronization pelletizing machine prepare micropill;
(5) micropill is dried to moisture and is less than light 30 mesh sieve after 3% in 50 DEG C of baking ovens;
(6) fill capsule.
Embodiment 5
| Micropill composition | Part by weight (%) |
| Trimetazidine Hydrochloride | 14.58 |
| Hypromellose K100M | 10.41 |
| Starch | 66.66 |
| Polyvidone | 8.33 |
Preparation technology:
(1) Trimetazidine Hydrochloride raw material pulverizing is crossed 100 mesh sieves;
(2) the PVP K30 aqueous solution of 5% is prepared;
(3) with above-mentioned binding agent soft material after the raw material after pulverizing and the hypromellose K100M of recipe quantity, starch being mixed;
(4) soft material is added in extrusion-spheronization pelletizing machine prepare micropill;
(5) micropill is dried to moisture and is less than light 30 mesh sieve after 3% in 50 DEG C of baking ovens;
(6) fill capsule.
Embodiment 6
| Micropill composition | Part by weight (%) |
| Trimetazidine Hydrochloride | 14.58 |
| Hypromellose K15M | 12.50 |
| Hypromellose K100M | 4.17 |
| Microcrystalline Cellulose | 60.41 |
| Polyvidone | 8.33 |
Preparation technology:
(1) Trimetazidine Hydrochloride raw material pulverizing is crossed 100 mesh sieves;
(2) the PVP K30 aqueous solution of 5% is prepared;
(3) with above-mentioned binding agent soft material after the raw material after pulverizing and hypromellose K100M, the hypromellose K15M of recipe quantity, microcrystalline Cellulose being mixed;
(4) soft material is added in extrusion-spheronization pelletizing machine prepare micropill;
(5) micropill is dried to moisture and is less than light 30 mesh sieve after 3% in 50 DEG C of baking ovens;
(6) fill capsule.
Comparative example 1
| Label composition | Part by weight (%) |
| Trimetazidine Hydrochloride | 17.77 |
| Hypromellose K15M | 20.30 |
| Microcrystalline Cellulose | 55.84 |
| Polyvidone | 5.08 |
| Silicon dioxide | 0.508 |
| Magnesium stearate | 0.508 |
Preparation technology:
(1) Trimetazidine Hydrochloride raw material pulverizing is crossed 100 mesh sieves;
(2) the PVP K30 aqueous solution of 5% is prepared;
(3) with above-mentioned binding agent soft material after the raw material after pulverizing and the hypromellose K15M of recipe quantity, microcrystalline Cellulose being mixed;
(3) in said mixture, silicon dioxide and magnesium stearate is added, tabletting after mixing, sheet heavy 187mg, hardness 60-80N.
Test example 1: dissolution test
Medium: 900ml 0.1N hydrochloric acid dissolving-out method: paddle method 100rpm
Trial target: self-control preparation and commercially available product Vastarel MR
Experimental result:
Test example 2: preparation stability is tested
Compare Trimetazidine Hydrochloride preparation prepared by embodiment of the present invention 1-6 and comparative example 1 and control formulation according to influence factor's test method (Chinese Pharmacopoeia version in 2010 two annex) and place related substance growth pattern after 10 days, respectively place 10 days under high temperature 60 DEG C ± 2 DEG C and illumination are 4500lx ± 500lx condition respectively, investigate related substance growth pattern.
Experimental result:
Know that the trimetazidine hydrochloride sustained-release capsule manufacturing techniques adopting prescription of the present invention and preparation method to prepare is simple by upper table, completely, good stability, has higher actual application value in release.
Claims (9)
1. a trimetazidine slow releasing capsule, is characterized in that:
(1) the trimetazidine slow releasing capsule described in is obtained by the slow-release micro-pill fill capsule containing trimetazidine, and slow-release micro-pill Mechanism of Drug Release is the release of skeleton control type;
(2) consist of the following composition: the trimetazidine of 1-40%, the sustained-release matrix material of 5-40%, the binding agent of 1-15%, the filler of 20-80%.
2. slow-release micro-pill according to claim 1 consists of the following composition: the trimetazidine of 10-20%, the sustained-release matrix material of 5-25%, the binding agent of 1-10%, the filler of 50-70%.
3. trimetazidine slow releasing capsule according to claim 1, is characterized in that described sustained-release matrix material is selected from water-insoluble framework material if ethyl cellulose, polyethylene, polysiloxanes and hydrophilic gel framework material are as one or more in hypromellose, methylcellulose, sodium carboxymethyl cellulose, polyvinyl alcohol.
4. trimetazidine slow releasing capsule according to claim 1, is characterized in that described binding agent is mixed with certain density aqueous solution or alcohol-water solution by hypromellose, hyprolose, polyvidone and obtains.
5., according to the trimetazidine slow releasing capsule described in claim 1, it is characterized in that described filler is one or more in lactose, sucrose, mannitol, microcrystalline Cellulose, pregelatinized Starch, starch, calcium hydrogen phosphate.
6. trimetazidine slow releasing capsule according to claim 3, it is characterized in that described sustained-release matrix Advantageous materials is selected from hydrophilic gel framework material in hypromellose, sodium carboxymethyl cellulose and polyvinyl alcohol one or more; Wherein hyprolose is selected from one or more in HPMC K4M, K15M and K100M.
7. according to the trimetazidine slow releasing capsule described in claim 5, it is characterized in that described filler is selected from lactose, sucrose, microcrystalline Cellulose, starch one or more.
8. trimetazidine slow releasing capsule according to claim 1, is characterized in that trimetazidine slow releasing capsule is prepared from by following steps:
(1) trimetazidine raw material pulverizing is crossed 100 mesh sieves;
(2) add binding agent after being mixed homogeneously with filler, slow-release material by above-mentioned raw materials, be prepared into suitable soft material;
(3) above-mentioned soft material is placed in extrusion-spheronization pelletizing machine and prepares micropill, dry, cross 30 mesh sieves;
(4) fill capsule, to obtain final product.
9. trimetazidine slow releasing capsule according to claim 1 is applicable to the prophylactic treatment of angina pectoris attacks, and dizzy and complementary symptomatic treatment that is tinnitus, belongs to antianginal cardiovascular drugs.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201410663900.4A CN104473905A (en) | 2014-11-20 | 2014-11-20 | Trimetazidine hydrochloride sustained-release capsule and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201410663900.4A CN104473905A (en) | 2014-11-20 | 2014-11-20 | Trimetazidine hydrochloride sustained-release capsule and preparation method thereof |
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| CN201410663900.4A Pending CN104473905A (en) | 2014-11-20 | 2014-11-20 | Trimetazidine hydrochloride sustained-release capsule and preparation method thereof |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105362252A (en) * | 2015-10-09 | 2016-03-02 | 北京万全德众医药生物技术有限公司 | Sustained-release capsule containing levodopa and carbidopa and preparation method of sustained-release capsule |
| CN105616358A (en) * | 2016-02-17 | 2016-06-01 | 南京卓泰医药科技有限公司 | Trimetazidine sustained-release mini-pill composition and method for preparing same |
| CN109646417A (en) * | 2018-06-14 | 2019-04-19 | 深圳翰宇药业股份有限公司 | A kind of Trimetazidine sustained release tablets and preparation method thereof |
| CN109908096A (en) * | 2017-12-12 | 2019-06-21 | 武汉武药科技有限公司 | A kind of trimetazidine hydrochloride sustained-release tablets and preparation method thereof |
| CN111888476A (en) * | 2020-08-17 | 2020-11-06 | 深圳市道科思医药有限公司 | Modified release pharmaceutical composition of trimetazidine dihydrochloride |
| CN112315942A (en) * | 2020-11-04 | 2021-02-05 | 南京康川济医药科技有限公司 | Trimetazidine hydrochloride sustained release preparation and preparation method thereof |
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| CN102552217A (en) * | 2010-12-20 | 2012-07-11 | 天津市凯文生物科技有限公司 | Trimetazidine sustained release capsule and preparation method thereof |
| CN102885795A (en) * | 2012-10-31 | 2013-01-23 | 广州帝奇医药技术有限公司 | Trimetazidine dihydrochloride sustained-release tablet and preparation method thereof |
| CN103565751A (en) * | 2013-10-17 | 2014-02-12 | 广州帝奇医药技术有限公司 | Long-acting sustained-release pellet and preparation method thereof |
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| CN1994280A (en) * | 2006-12-20 | 2007-07-11 | 山东省医药工业研究所 | Sustained-release micro-pellet of trimetazidine and preparation process thereof |
| CN102552217A (en) * | 2010-12-20 | 2012-07-11 | 天津市凯文生物科技有限公司 | Trimetazidine sustained release capsule and preparation method thereof |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105362252A (en) * | 2015-10-09 | 2016-03-02 | 北京万全德众医药生物技术有限公司 | Sustained-release capsule containing levodopa and carbidopa and preparation method of sustained-release capsule |
| CN105616358A (en) * | 2016-02-17 | 2016-06-01 | 南京卓泰医药科技有限公司 | Trimetazidine sustained-release mini-pill composition and method for preparing same |
| CN105616358B (en) * | 2016-02-17 | 2018-12-07 | 南京卓康医药科技有限公司 | A kind of sustained-release micro-pellet of trimetazidine composition and preparation method thereof |
| CN109908096A (en) * | 2017-12-12 | 2019-06-21 | 武汉武药科技有限公司 | A kind of trimetazidine hydrochloride sustained-release tablets and preparation method thereof |
| CN109646417A (en) * | 2018-06-14 | 2019-04-19 | 深圳翰宇药业股份有限公司 | A kind of Trimetazidine sustained release tablets and preparation method thereof |
| CN109646417B (en) * | 2018-06-14 | 2020-10-16 | 深圳翰宇药业股份有限公司 | Trimetazidine sustained release tablet and preparation method thereof |
| CN111888476A (en) * | 2020-08-17 | 2020-11-06 | 深圳市道科思医药有限公司 | Modified release pharmaceutical composition of trimetazidine dihydrochloride |
| CN112315942A (en) * | 2020-11-04 | 2021-02-05 | 南京康川济医药科技有限公司 | Trimetazidine hydrochloride sustained release preparation and preparation method thereof |
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Application publication date: 20150401 |