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Preparation method of candesartan cilexetil and hydrochlorothiazide compound tablet

A technology of candesartan medoxomil and hydrochlorothiazide is applied in the directions of non-active ingredient medical preparations, medical preparations containing active ingredients, and pill delivery, etc. Conducive to commercial production, simple process, and the effect of improving dissolution rate

Pending Publication Date: 2021-10-01
江苏宇锐医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Candesartan cilexetil is a drug that is insoluble in water. In order to improve the bioavailability of insoluble drugs, patent application CN101890024A discloses a composition containing solid dispersion and its preparation method. All raw materials need to be pulverized, and The sieving process used to make the one-sided appearance and color uniform is relatively complicated, and the temperature of the dried material is relatively high, preferably 50-60°C, and there is a certain risk in the stability of the material

Method used

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  • Preparation method of candesartan cilexetil and hydrochlorothiazide compound tablet
  • Preparation method of candesartan cilexetil and hydrochlorothiazide compound tablet
  • Preparation method of candesartan cilexetil and hydrochlorothiazide compound tablet

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] The following formulations shown in Table 1 were used to compare the effects of different processes of Examples 1-5 on the in vitro dissolution and appearance of the tablet.

[0043] Table 1

[0044]

[0045]

[0046] Preparation Process:

[0047] (1) Polyethylene glycol is dissolved in 835g of water until it is completely dissolved, then hydroxypropyl cellulose is added and dissolved until clarified to obtain a binder solution added with a stabilizer;

[0048] (2) Dispersing yellow iron oxide and red iron oxide in the aqueous solution of (1) under stirring;

[0049] (3) adding candesartan cilexetil to the solution of (2) under stirring to prepare a suspension;

[0050] (4) After mixing lactose and corn starch, pass through a 30-mesh sieve and add to the fluidized bed, and spray the suspension containing candesartan cilexetil into the fluidized bed at a material temperature of 25-30°C for preparation. grain;

[0051] (5) After the granulation is finished, dry ...

Embodiment 2

[0055] Preparation Process:

[0056] (1) Dissolve polyethylene glycol in 835g of water until it is completely dissolved, then add hydroxypropyl cellulose and dissolve until clear;

[0057] (2) Dispersing yellow iron oxide and red iron oxide in the aqueous solution of (1) under stirring;

[0058] (3) After mixing candesartan cilexetil, lactose and cornstarch, pass through a 30-mesh sieve and add to the fluidized bed, and spray the prepared solution of (2) onto the fluidized bed at a material temperature of 25-30°C Carry out granulation in; (embodiment 1 is that candesartan cilexetil is added in the aqueous solution of binding agent and stabilizer, and embodiment 2 is that candesartan cilexetil and lactose, cornstarch are mixed in dry powder form and then added to in a fluidized bed);

[0059] (5) After the granulation is finished, dry until the moisture is about 1%, and pass through a 30-mesh sieve for granulation;

[0060] (6) Add hydrochlorothiazide, carmellose calcium and...

Embodiment 3

[0066] Preparation Process:

[0067] (1) Dissolve polyethylene glycol in 835g of water until it is completely dissolved, then add hydroxypropyl cellulose and dissolve until clear;

[0068] (2) Dispersing yellow iron oxide and red iron oxide in the aqueous solution of (1) under stirring;

[0069] (3) adding candesartan cilexetil to the solution of (2) under stirring to prepare a suspension;

[0070] (4) After mixing hydrochlorothiazide, lactose and corn starch, pass through a 30-mesh sieve and add to the fluidized bed, and spray the suspension containing candesartan cilexetil into the fluidized bed at a material temperature of 25-30°C to granulate;

[0071] (5) After the granulation is finished, dry until the moisture is about 1%, and pass through a 30-mesh sieve for granulation;

[0072] (6) add carmellose calcium and magnesium stearate according to particle weight and mix homogeneously;

[0073] (7) Use 8.5*5mm punched sheet to get it.

[0074] Get respectively the candi...

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Abstract

The invention discloses a preparation method of candesartan cilexetil and hydrochlorothiazide compound tablets, which comprises the following steps: adding candesartan cilexetil into an adhesive aqueous solution or an adhesive aqueous solution added with a stabilizer to prepare a suspension, spraying the suspension into an auxiliary material by adopting a fluidized bed, granulating, adding hydrochlorothiazide, and tabletting, so that the prepared tablets are high in uniformity. The dispersion degree of candesartan cilexetil can be improved by adding candesartan cilexetil into an aqueous solution of an adhesive to prepare a suspension, and hydrochlorothiazide is added into prepared candesartan cilexetil particles, so that the direct contact area between hydrochlorothiazide and candesartan cilexetil is reduced, the dissolution behavior of candesartan cilexetil is improved, and the dissolution rate of candesartan cilexetil is increased. And the content uniformity of the obtained sample is high.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a candesartan cilexetil hydrochlorothiazide tablet and a preparation method thereof. Background technique [0002] Candesartan cilexetil (also known as: Candesartan cilexetil, Candesartan cilexetil). It is the latest new antihypertensive drug, which reduces blood pressure by specifically blocking the vasoconstriction and aldosterone secretion mediated by angiotensin II. It is a white crystalline powder, easily soluble in chloroform, and in absolute ethanol Slightly soluble, almost insoluble in water. The structural formula is as follows: [0003] [0004] Candesartan cilexetil is a drug that is insoluble in water. In order to improve the bioavailability of insoluble drugs, patent application CN101890024A discloses a composition containing solid dispersion and its preparation method. All raw materials need to be pulverized, and The sieving process used to make the on...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/549A61K47/38A61K47/26A61K47/32A61K47/36A61P9/12A61K31/4184
CPCA61K9/2095A61K9/2054A61K9/2018A61K9/2027A61K9/2059A61K31/4184A61K31/549A61P9/12A61K2300/00
Inventor 董文敏冯小龙李杨殷学治
Owner 江苏宇锐医药科技有限公司
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