Stable candesartan cilexetil amlodipine pharmaceutical composition and its preparation method

A technology of candesartan cilexetil and amlodipine, which is applied in the direction of drug combinations, pharmaceutical formulas, and medical preparations of non-active ingredients, etc., can solve the problem of decreased stability of amlodipine, without consideration of candesartan and amlodipine Dipine interaction and stability issues, increased oxidative degradation impurities, etc., to achieve the effects of shortening tablet production time, reducing labor hours, and reducing production costs

Active Publication Date: 2012-10-24
福安药业集团庆余堂制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Chinese patent CN200710306664 discloses a compound preparation of candesartan cilexetil and amlodipine, which is used to treat hypertension, but does not consider the interaction and stability of candesartan and amlodipine in compound candesartan cilexetil and amlodipine tablets sexual problems
[0014] Polyethylene glycol can improve the stability of candesartan cilexetil and reduce the impurities of deacetylcandesartan cilexetil, but polyethylene glycol interacts with amlodipine, resulting in a decrease in the stability of amlodipine. Increases oxidative degradation impurities

Method used

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  • Stable candesartan cilexetil amlodipine pharmaceutical composition and its preparation method
  • Stable candesartan cilexetil amlodipine pharmaceutical composition and its preparation method
  • Stable candesartan cilexetil amlodipine pharmaceutical composition and its preparation method

Examples

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Comparison scheme
Effect test

Embodiment 1

[0037] The following are specific examples of the present invention, but it does not mean that the present invention is limited to the following examples. Embodiment 1 (candesartan cilexetil 8mg / amlodipine 5mg)

[0038]

[0039] Preparation process (direct powder compression): Amlodipine besylate, candesartan cilexetil, mannitol, microcrystalline cellulose, hydroxypropylmethylcellulose, croscarmellose sodium, Polyethylene glycol 6000, yellow iron oxide, and magnesium stearate were mixed in a V-shaped blender for 15 minutes, and pressed into tablets with a rotary tablet machine, with a tablet weight of about 127mg.

Embodiment 2

[0040] Embodiment 2 (candesartan cilexetil 8mg / amlodipine 2.5mg)

[0041]

[0042] Preparation process (direct powder compression): the prescription amount of amlodipine besylate, candesartan cilexetil, mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium carboxymethyl starch, polyethylene glycol 4000. Mix yellow iron oxide and magnesium stearate in a multi-dimensional motion mixer for 10 minutes, and compress into tablets with a rotary tablet press, with a tablet weight of about 124mg.

Embodiment 3

[0043] Embodiment 3 (candesartan cilexetil 8mg / amlodipine 5mg)

[0044]

[0045]

[0046] Preparation process (direct powder compression): the prescribed amount of amlodipine besylate, candesartan cilexetil, lactose, pregelatinized starch, hydroxypropyl cellulose, crospovidone, polyethylene glycol 6000 , yellow iron oxide and magnesium stearate were mixed in a high-speed stirring granulator for 15 minutes, and then compressed by a rotary tablet machine, with a tablet weight of about 122mg. Embodiment 4 (candesartan cilexetil 8mg / amlodipine 5mg)

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PUM

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Abstract

The invention relates to a stable candesartan cilexetil and amlodipine pharmaceutical-containing composition and its preparation method. The invention is characterized in that a) each tablet contains 4mg-8mg of candesartan cilexetil, b) each tablet contains 2-10mg of amlodipine or its pharmaceutically acceptable salt, c) each tablet contains polyethylene glycol, wherein the weight of polyethylene glycol accounts for 2-10% of the tablet, and d) the tablet is prepared by a compressed tablet technology by using a dry method.

Description

technical field [0001] A stable pharmaceutical composition containing candesartan cilexetil and amlodipine and a preparation method thereof, is characterized in that: [0002] (a) Each tablet contains 4mg-8mg of candesartan cilexetil; [0003] (b) Each tablet contains 2-10 mg of amlodipine or a pharmaceutically acceptable salt thereof; [0004] (c) The amount of polyethylene glycol contained in each tablet is 2-10% of the tablet weight; [0005] (d) The tablet is prepared by a dry compression process. Background of the invention [0006] At present, the incidence of hypertension is increasing year by year, the current situation of treatment is still very severe, and the control rate of hypertension is still low. Studies have shown that the prevalence of hypertension in Chinese adults over the age of 18 is 18.8%, and the number of patients exceeds 160 million. The awareness rate of hypertension is 30.2%, the treatment rate is 24.7%, and the control rate is 6.1%. Up to two...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4422A61K31/4184A61K9/20A61K47/34A61P9/12
Inventor 王显著黄华陈晓华吉杰标黄毅
Owner 福安药业集团庆余堂制药有限公司
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