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Medicine containing amlodipine besylate and lisinopril dehydrate and preparation method thereof

A technology of amlodipine besylate and dihydrate, which is applied in the field of medicine, can solve the problems of unqualified tablet content uniformity, unqualified friability, complicated production process, etc., and achieve the reduction of types of excipients, high production efficiency, easy-to-handle effects

Inactive Publication Date: 2017-01-18
成都尚药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The purpose of the present invention is to provide a medicine containing amlodipine besylate and lisinopril dihydrate and its preparation method, aiming at solving the problems of high safety risk and complex production process in the preparation of existing lisinopril medicines. It consumes a lot of energy, and it is easy to cause unqualified content uniformity of the tablet. The hardness of the obtained tablet is very poor, and the surface is rough, and the brittleness is easily unqualified.

Method used

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  • Medicine containing amlodipine besylate and lisinopril dehydrate and preparation method thereof
  • Medicine containing amlodipine besylate and lisinopril dehydrate and preparation method thereof
  • Medicine containing amlodipine besylate and lisinopril dehydrate and preparation method thereof

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preparation example Construction

[0034] Such as figure 1 As shown, the preparation method of the medicine containing amlodipine besylate and lisinopril dihydrate of the embodiment of the present invention comprises the following steps:

[0035] S101: Mixing, raw and auxiliary materials are mixed in an equal and increasing manner;

[0036] S102: tableting, the mixture obtained by mixing is directly powder-pressed into tablets.

[0037] Step S101 specifically includes:

[0038] A. In parts by weight, mix 2.5 to 10 parts of amlodipine besylate, 5 to 20 parts of lisinopril and 2 to 10 parts of disintegrant to obtain the mixture ①;

[0039] B. Mix 7.5-30 parts of the filler with the mixture ① of the step A to obtain the mixture ②;

[0040] C. Mix 15-60 parts of filler with the mixture ② of step B to obtain the mixture ③;

[0041] D. Mix the remaining 27.5-110 parts of filler and 0.5-2 parts of lubricant with the mixture ③ in step C to obtain the mixture ④.

[0042] In the preparation method, the mixing time i...

Embodiment 1

[0048] Embodiment 1 amlodipine besylate lisinopril tablet prescription: (in 1000 tablets, unit: g)

[0049]

[0050] Preparation Process:

[0051] (1) mix:

[0052] A, 5g amlodipine besylate, 10g lisinopril and 4g polacrilin potassium were mixed for 5min;

[0053] B, 27g microcrystalline cellulose is mixed with the mixture that step A obtains for 5min;

[0054]C, 54g microcrystalline cellulose is mixed with the mixture that step B obtains for 5min;

[0055] D, the remaining 99g microcrystalline cellulose and 1g sodium fumarate were mixed with the mixture obtained in step C for 15min;

[0056] (2) Tablet compression: the mixture obtained in step D is compressed into tablets, and the tablet hardness is 8kgf.

Embodiment 2

[0057] Example 2 Amlodipine besylate lisinopril tablet prescription: (in 1000 tablets, unit: g)

[0058]

[0059] Preparation Process:

[0060] (1) mix:

[0061] A, 5g amlodipine besylate, 5g lisinopril and 2.5g sodium carboxymethyl starch were mixed for 5min;

[0062] B, 13g pregelatinized starch is mixed with the mixture that step A obtains for 5min;

[0063] C, 26g pregelatinized starch is mixed with the mixture that step B obtains for 5min;

[0064] D, remaining 48g pregelatinized starch and 1g magnesium stearate were mixed with the mixture obtained in step C for 15min;

[0065] (2) Tablet compression: the mixture obtained in step D is compressed into tablets, and the tablet hardness is 9kgf.

[0066] The application effect of the present invention will be described in detail below in conjunction with detection.

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Abstract

The invention discloses a medicine containing amlodipine besylate and lisinopril dehydrate and a preparation method thereof. Per unit of the preparation is composed of, by weight, 2.5-10 parts of amlodipine besylate, 5-20 parts of lisinopril, 50-200 parts of a filler, 2-10 parts of a disintegrating agent and 0.5-2 parts of a lubricant. A preparation method of the medicine comprises the following steps: mixing: mixing the raw materials and auxiliary materials by an equivalent incremental mode; and tabletting: carrying out direct powder compression on the mixture obtained by the mixing. An amlodipine besylate-lisinopril tablet prepared from the above medicine by the above technology has the following advantages: use of auxiliary materials such as an adhesive, etc. is omitted in comparison with the prior art; the formula is simple; and safety is greatly raised; raw materials and auxiliary materials are mixed by the equivalent incremental mode in the preparation technology so as to ensure content uniformity of the medicine; and steps of granulation, drying and size stabilization, etc. are omitted, the technology is easy to operate, production efficiency is high, and the technology is very suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to a medicine containing amlodipine besylate and lisinopril dihydrate and a preparation method thereof. Background technique [0002] Amlodipine besylate, its chemical name is: (±) 3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4 Dihydro-6-methyl-3,5-pyridinedicarboxylic acid diester benzenesulfonate; Molecular formula: C 20 h 25 ClN 2 o 5 ·C 6 h 6 o 3 S; molecular weight: 567.08; structural formula is as follows: [0003] [0004] Amlodipine besylate is a dihydropyridine calcium antagonist, which can selectively inhibit the transmembrane entry of calcium ions into smooth muscle cells and cardiomyocytes, directly acts on vascular smooth muscle, reduces peripheral vascular resistance, and thereby lowers blood pressure. Lisinopril dihydrate, its chemical name is: 1-{N 2 -[(S)-1-carboxy-3-phenylpropyl]-L-lysyl}-L-proline dihydrate; molecular formula: C 21 ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4422A61K38/05A61K9/20A61K47/36A61K47/38
CPCA61K31/4422A61K9/2054A61K9/2059A61K9/2095A61K38/05A61K2300/00
Inventor 张会潘小峰
Owner 成都尚药科技有限公司
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