CN203123076U - Telmisartan/amlodipine tablet - Google Patents
Telmisartan/amlodipine tablet Download PDFInfo
- Publication number
- CN203123076U CN203123076U CN 201320109098 CN201320109098U CN203123076U CN 203123076 U CN203123076 U CN 203123076U CN 201320109098 CN201320109098 CN 201320109098 CN 201320109098 U CN201320109098 U CN 201320109098U CN 203123076 U CN203123076 U CN 203123076U
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- Prior art keywords
- telmisartan
- amlodipine
- tablet
- utility
- model
- Prior art date
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- Expired - Lifetime
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- Medicinal Preparation (AREA)
Abstract
The utility model provides a telmisartan/amlodipine tablet which comprises an amlodipine micro-pill and a telmisartan granular layer, wherein the amlodipine micro-pill is wrapped in the telmisartan granular layer. The telmisartan/amlodipine tablet disclosed by the utility model has a special product structure, so that the stability of the telmisartan/amlodipine tablet is significantly enhanced, the degradation of medicinal compositions is effectively avoided, and a guarantee is provided for the quality safety of compound tablets.
Description
Technical field
This utility model relates to a kind of stable telmisartan amlodipine sheet.
Background technology
Hypertension is the most common cardiovascular diseases, is that the interior weight of global range is to public health problem.Chinese residents nutrition in 2004 and Health Situation survey result show that China 18 years old and above resident's hypertension prevalence are 18.8%, estimate that national number of patients surpasses 1.6 hundred million.Compared with 1991, prevalence rises 31%, and number of patients increases about more than 7,000 ten thousand people.1998, China's cerebrovascular occupied second of urbanite's cause of death, ranks first in the rural area.The whole nation is annual dead to surpass 1,000,000, and the patient of survival is about 5,000,000～6,000,000, wherein leaves deformity in various degree more than 75%, has caused white elephant for individual, family and society.Spell out in the hypertension practice guidelines that Europe cardiovascular and hypertension coordination board delivered in 2007, most primary hypertension patients, especially the higher patient of basic blood pressure needs to use the Drug therapy more than 2 kinds, can't realize the hypertensive purpose of control with single medicine.Be used alone antihypertensive drug and often can not receive good curative effect, it is the hypertension therapeutic scheme of actively being recommended at present that low dose is united the use different types of drugs.On October 16th, 2009 drugs approved by FDA the telmisartan Amlodipine Besylate Tablet compound formulation listing of German Boehringer Ingelheim drugmaker (trade name:
), be used for the treatment of hypertension.
Telmisartan is insoluble in water, be prepared into preparation after, absorption difference, bioavailability are low, weak curative effect.In order to guarantee the bioavailability of telmisartan, the Telmisartan formulations of having gone on the market (as: telmisartan sheet etc.) all is after telmisartan is prepared into sodium salt, and refabrication becomes preparation, uses clinically at last, in order to improve bioavailability and curative effect.Amlodipine Besylate Tablet is faintly acid, when it is in alkaline environment, will make Amlodipine Besylate Tablet dissociate into amlodipine.From the structural formula of amlodipine, as can be seen, a fat key is arranged, facile hydrolysis under alkali condition.In preparation, telmisartan sodium is sodium salt, band alkalescence, two kinds of raw materials mix, can produce incompatibility, free and the hydrolysis of amlodipine will be caused, so two kinds of active component methods direct and mixed with excipients can not be applied to telmisartan and amlodipine compound tablet, otherwise the instability of amlodipine will be caused.Therefore, provide a kind of compound tablet that has good stability, seem particularly important.
The utility model content
The purpose of this utility model is to provide a kind of telmisartan amlodipine sheet that has good stability.
This utility model provides a kind of telmisartan amlodipine sheet, and it comprises amlodipine micropill and telmisartan granular layer; Wherein, telmisartan granular layer internal package has the amlodipine micropill.
Further, described amlodipine micropill is provided with coatings outward.
In this utility model, described amlodipine can the benzene sulfonate form exist.
This utility model telmisartan amlodipine sheet possesses special product structure, and the stability of telmisartan and amlodipine compound tablet is significantly improved, and has effectively avoided the degraded of active ingredient, for the quality safety of compound tablet provides guarantee.
Description of drawings
Fig. 1 structural representation of the present utility model.
Wherein, 1-amlodipine micropill, 2-telmisartan granular layer.
The specific embodiment
As shown in Figure 1, this utility model provides a kind of telmisartan amlodipine sheet, and it comprises amlodipine micropill 1 and telmisartan granular layer 2; Wherein, telmisartan granular layer 2 internal package have amlodipine micropill 1.Said structure can be avoided the contact of ingredient, effectively improves the stability of compound tablet.
In order further to improve stability, outside amlodipine micropill 1, also can add coatings.
Below by test example explanation the beneficial effects of the utility model.
The contrast of test example 1 this utility model tablet and existing tablet
Method according to embodiment 3 among patent CN101780078 embodiment 1 and the CN102008469 makes corresponding control sample respectively; Supplementary material proportioning with reference in the above-mentioned patent application prepares this utility model tablet (micropill coating) according to this utility model structure.
Control sample and this utility model tablet are carried out 6 months contrast of accelerated test (40 ℃ ± 2 ℃, RH75% ± 5%) investigation, concrete data such as following table.
Table 1 study on the stability result of the test
By above-mentioned experimental result as can be seen:
6 months study on the stability result of the accelerated test of this utility model tablet (40 ℃ ± 2 ℃, RH75% ± 5%) obviously is better than patent (CN102008469), patent (CN101780078).Be enough to illustrate ad hoc structure of the present utility model, significantly improved the stability of telmisartan and amlodipine compound tablet, effectively avoided the degraded of active ingredient, for the quality safety of compound tablet provides guarantee.
Claims (2)
1. telmisartan amlodipine sheet, it is characterized in that: it comprises amlodipine micropill (1) and telmisartan granular layer (2); Wherein, telmisartan granular layer (2) internal package has amlodipine micropill (1).
2. telmisartan amlodipine sheet according to claim 1 is characterized in that: the outer coatings that is provided with of described amlodipine micropill (1).
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201320109098 CN203123076U (en) | 2012-03-12 | 2013-03-11 | Telmisartan/amlodipine tablet |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210063595.6 | 2012-03-12 | ||
| CN201210063595 | 2012-03-12 | ||
| CN 201320109098 CN203123076U (en) | 2012-03-12 | 2013-03-11 | Telmisartan/amlodipine tablet |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN203123076U true CN203123076U (en) | 2013-08-14 |
Family
ID=48487981
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201310076765.9A Active CN103127108B (en) | 2012-03-12 | 2013-03-11 | Telmisartan amlodipine tablet, and preparation method and use thereof |
| CN 201320109098 Expired - Lifetime CN203123076U (en) | 2012-03-12 | 2013-03-11 | Telmisartan/amlodipine tablet |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201310076765.9A Active CN103127108B (en) | 2012-03-12 | 2013-03-11 | Telmisartan amlodipine tablet, and preparation method and use thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (2) | CN103127108B (en) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR102406616B1 (en) * | 2019-12-19 | 2022-06-10 | 대원제약주식회사 | A pharmaceutical composition comprising angiotensin receptor blocker and preparation method thereof |
| CN115025057B (en) * | 2022-07-20 | 2023-05-30 | 江苏亚邦爱普森药业有限公司 | Amlodipine besylate folic acid tablet and preparation method thereof |
| CN115944600B (en) * | 2022-12-01 | 2024-05-28 | 山东齐都药业有限公司 | Oral tablet containing telmisartan and amlodipine besylate and preparation method thereof |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2582049C (en) * | 2004-11-05 | 2010-08-24 | Boehringer Ingelheim International Gmbh | Bilayer tablet comprising telmisartan and amlodipine |
| CN101780078B (en) * | 2010-02-10 | 2012-02-29 | 威特(湖南)药业有限公司 | Compound preparation of telmisartan and amlodipine and preparation method thereof |
| CN102028670A (en) * | 2010-09-06 | 2011-04-27 | 邓俐丽 | Composite capsule containing telmisartan and calcium ion channel antagonist |
| CN102008469B (en) * | 2010-11-16 | 2012-12-12 | 武汉武药科技有限公司 | Method for preparing telmisartan amlodipine tablets |
-
2013
- 2013-03-11 CN CN201310076765.9A patent/CN103127108B/en active Active
- 2013-03-11 CN CN 201320109098 patent/CN203123076U/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| CN103127108A (en) | 2013-06-05 |
| CN103127108B (en) | 2015-01-21 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| CX01 | Expiry of patent term | ||
| CX01 | Expiry of patent term |
Granted publication date: 20130814 |