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Capsule containing candesartan cilexetil and preparation method thereof

A technology of candesartan cilexetil and capsules, which is applied in the field of capsules containing candesartan cilexetil and its preparation, can solve the problems of gelatin capsules, such as changes in the in vitro dissolution behavior, and achieve the effect of stable dissolution performance

Inactive Publication Date: 2010-01-13
JIANGSU TIANYISHI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] So far, there are no reports of changes in in vitro dissolution behavior or decreased dissolution of gelatin capsules containing candesartan cilexetil during storage and their solutions.

Method used

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  • Capsule containing candesartan cilexetil and preparation method thereof
  • Capsule containing candesartan cilexetil and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Candesartan cilexetil 4.0mg

[0034] PEG 4000 15.0mg

[0035] Microcrystalline Cellulose 65.0mg

[0036] Pregelatinized starch 40.0mg

[0037] Sodium starch glycolate 25.5mg

[0038]Magnesium stearate 0.5mg

[0039]

[0040] Total 150.0mg

[0041] Preparation process: take the prescription amount of raw and auxiliary materials, mix well, wet granulate, dry at 50 degrees, and fill HPMC capsules.

[0042] Example 1 comparison

[0043] The prescription and preparation process are the same as in Example 1, only the capsule shell used is a gelatin capsule shell.

Embodiment 2

[0045] Candesartan cilexetil 10.0mg

[0046] Lactose 84.0mg

[0047] Corn starch 20.0mg

[0048] PEG 6000 6.0mg

[0049] Hydroxypropyl Cellulose 4.0

[0050] Carmellose Calcium 5.6mg

[0051] Magnesium stearate 0.4mg

[0052]

[0053] Total 130.0mg

[0054] Preparation process: In a granulator equipped with a stirrer, the prescribed amount of candesartan cilexetil, hydrochlorothiazide, PEG 6000, and water are mixed, the mixture is added to other auxiliary material mixtures, granulated and dried to obtain granules, and then Add carmellose calcium and magnesium stearate. The resulting mixture was filled with hydroxypropylmethylcellulose (HPMC) capsules.

[0055] Example 2 comparison

[0056] The prescription and preparation method are the same as in Example 2, only the capsule shell used is a gelatin capsule shell.

Embodiment 3

[0058] Candesartan cilexetil 10.0mg

[0059] Hydrochlorothiazide 12.5mg

[0060] Lactose 71.5mg

[0061] Corn starch 20.0mg

[0062] PEG 6000 6.0 mg

[0063] Hydroxypropyl Cellulose 4.0mg

[0064] Carmellose Calcium 5.6mg

[0065] Magnesium stearate 0.4mg

[0066] (water) 0.024ml

[0067]

[0068] Total 130.0mg

[0069] Preparation process: In a granulator equipped with a stirrer, the prescribed amount of candesartan cilexetil, hydrochlorothiazide, PEG 6000, and water are mixed, the mixture is added to other auxiliary material mixtures, granulated and dried to obtain granules, and then Add carmellose calcium and magnesium stearate. The resulting mixture was filled with hydroxypropylmethylcellulose (HPMC) capsules.

[0070] Example 3 comparison

[0071] The prescription and preparation method are the same as in Example 3, only the capsule shell used is a gelatin capsule shell.

[0072] The hydroxypropylmethylcellulose (HPM...

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Abstract

The invention discloses a capsule containing candesartan cilexetil and the contents of the capsules comprise candesartan cilexetil or other active ingredients compounded with the candesartan cilexetil, a low melting-point oiliness compound, at least one disintegrating agent and at least one lubricating agent; and a capsule shell thereof is a hydroxypropyl methyl cellulose capsule shell. The invention also discloses a preparation method of the capsule containing candesartan cilexetil. The capsule containing candesartan cilexetil uses the capsule shell containing hydroxypropyl methyl cellulose and a large quantity of disintegrating agents, thereby achieving stable dissolution performance; moreover, the dissolution situation is almost invariant after long period (two years) of storage, the dissolution rate has no significant difference compared with newly prepared capsules.

Description

technical field [0001] The invention relates to a pharmaceutical preparation of candesartan cilexetil, in particular to a capsule containing candesartan cilexetil which has good dissolution properties and remains stable after long-term storage and a preparation method thereof. Background technique [0002] Active ingredient in candesartan cilexetil oral solid pharmaceutical composition, (±)-2-ethoxy-1-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl ]-4-yl]-methyl]-1Hbenzimidazole-7-carboxylic acid-1-[(cyclohexyloxycarbonyl)oxy]ethyl ester, as an angiotensin II receptor inhibitor, its The effect of blood pressure and treatment of congestive heart disease has been confirmed in clinical trials. [0003] The angiotensin II receptor inhibitor candesartan cilexetil has various crystal forms, among which the C crystal is relatively stable. The crystalline form is relatively stable to heat, light, and humidity when it is placed alone in a solid state, but when it is prepared into solid dosa...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K47/38A61K31/4184A61K31/549A61K31/4422A61K31/40A61P9/12A61P9/04
Inventor 傅雪琦赵邦爱王锐
Owner JIANGSU TIANYISHI PHARMA
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