Unlock instant, AI-driven research and patent intelligence for your innovation.

Perindopril amlodipine double-layer tablet and preparation method thereof

A technology of indopril amlodipine double-layer and indopril tablets, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve problems affecting stability, etc., and achieve Ensure stability, good formability, high drug absorption and bioavailability

Pending Publication Date: 2022-06-28
JIANGSU SINOBIOPHARMA
View PDF0 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, direct mixing of lactose and amlodipine for tablet compression will cause a condensation reaction, which will affect stability, so it is necessary to prepare a bilayer tablet containing a perindopril sheet layer and an amlodipine sheet layer

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Perindopril amlodipine double-layer tablet and preparation method thereof
  • Perindopril amlodipine double-layer tablet and preparation method thereof
  • Perindopril amlodipine double-layer tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] (1) Perindopril sheet

[0027]

[0028]

[0029] (2) Amlodipine sheet

[0030] component per tablet (mg) Granules (%, w / w) Amlodipine 6.94 69 microcrystalline cellulose 64 64 Anhydrous calcium phosphate 21 21 Magnesium stearate 4 4 Colloidal silica 4 4

[0031] Preparation:

[0032] (1) Preparation of perindopril lamellar granules

[0033] Take the arginine perindopril, microcrystalline cellulose, lactose, magnesium stearate and silicon dioxide in the above formula and mix them evenly, as perindopril granules.

[0034] (2) Preparation of amlodipine lamellar granules

[0035] Take amlodipine besylate, microcrystalline cellulose, anhydrous calcium phosphate, magnesium stearate and silicon dioxide in the above prescription and mix them uniformly, as amlodipine lamellar particles.

[0036] (3) The perindopril lamellar granules obtained in step (1) and the amlodipine lamellar granules obtained in (2) are loaded in...

Embodiment 2

[0038] (1) Perindopril sheet

[0039] component per tablet (mg) Granules (%, w / w) Arginine perindopril 10 10 microcrystalline cellulose 20 20 lactose 62 62 Magnesium stearate 4 4 Colloidal silica 4 4

[0040] (2) Amlodipine sheet

[0041] component per tablet (mg) Granules (%, w / w) Amlodipine 6.94 6.7 microcrystalline cellulose 66 64 Anhydrous calcium phosphate 22 21 Magnesium stearate 4 4 Colloidal silica 4 4

[0042] The preparation method is the same as in Example 1.

Embodiment 3

[0044] (1) Perindopril sheet

[0045] component per tablet (mg) Granules (%, w / w) Arginine perindopril 10 10 microcrystalline cellulose 21 21 lactose 62 61 Magnesium stearate 4 4 Colloidal silica 4 4

[0046] (2) Amlodipine sheet

[0047] component per tablet (mg) Granules (%, w / w) Amlodipine 6.94 7 microcrystalline cellulose 63 64 Anhydrous calcium phosphate 20 20 Magnesium stearate 4 4 Colloidal silica 4 4

[0048] The preparation method is the same as in Example 1.

[0049] The samples of perindopril and amlodipine bilayer tablets obtained in Examples 1-3 were placed continuously for 6 months under the conditions of 40°C ± 2°C and relative humidity of 75% ± 5%. Monthly sampling and determination of related substances in samples, the results are shown in the following table:

[0050]

[0051] From the above stability data from 0 months to 6 months, it can be known th...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

Abstract

The invention provides a perindopril and amlodipine double-layer tablet and a preparation method thereof, the perindopril and amlodipine double-layer tablet comprises a perindopril tablet layer and an amlodipine tablet layer, the perindopril tablet layer contains arginine perindopril, microcrystalline cellulose, lactose, magnesium stearate and colloidal silicon dioxide; the amlodipine sheet layer contains amlodipine besylate, microcrystalline cellulose, anhydrous calcium phosphate, magnesium stearate and colloidal silicon dioxide. According to the preparation method of the perindopril amlodipine double-layer tablet, provided by the invention, the high stability of the perindopril arginine and the amlodipine besylate is ensured, so that the quality and the curative effect of the perindopril amlodipine double-layer tablet are ensured. The preparation method is simple, low in production cost and suitable for industrial production.

Description

technical field [0001] The invention relates to a perindopril amlodipine bilayer tablet and a preparation method thereof, belonging to the technical field of medicine preparation. Background technique [0002] L-Arginine (2S, 3aS, 7aS)-1-N-[(S)-1 ethoxycarbonylbutyl]-L-alanyl)perindole-2-carboxylate. [0003] The chemical structural formula is as follows: [0004] [0005] Amlodipine is a calcium channel blocker (calcium ion antagonist) that blocks the passage of calcium ions across the membrane into myocardial and vascular smooth muscle cells. Chemical name: 3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5 - Dipicolinate. The chemical structural formula is as follows: [0006] [0007] Since drug resistance is more likely to occur in the treatment of hypertension with a single drug, and the possibility of toxic side effects is also greater with a larger dose, it is difficult to achieve the target in a short period of time with a...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/24A61K47/38A61K47/04A61K47/26A61K47/02A61K38/05A61K31/4422A61P9/12
CPCA61K9/2086A61K9/2054A61K9/2009A61K9/2018A61K38/05A61K31/4422A61P9/12A61K2300/00
Inventor 黄乐群李玉凤
Owner JIANGSU SINOBIOPHARMA