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Crystalline form of hydrochlorothiazide and application thereof

A technology of hydrochlorothiazide and crystal form, which is applied in the field of medicinal chemistry, can solve the problems of slow dissolution of hydrochlorothiazide and poor production utilization, and achieve the effects of improving dissolution effect, solving slow dissolution speed and effective therapeutic effect

Inactive Publication Date: 2010-03-03
CHINA RESOURCES SAIKE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the oral preparations containing hydrochlorothiazide produced in my country generally have the problems of slow dissolution of hydrochlorothiazide and poor production availability

Method used

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  • Crystalline form of hydrochlorothiazide and application thereof
  • Crystalline form of hydrochlorothiazide and application thereof
  • Crystalline form of hydrochlorothiazide and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Hydrochlorothiazide Tablets

[0040] components

quantity

Hydrochlorothiazide

25g

microcrystalline cellulose

60g

lactose

48.5g

Low-substituted hydroxypropyl cellulose

7g

povidone k30

8g

Micropowder silica gel

0.75g

Magnesium stearate

0.75g

[0041] Preparation method: sieve the raw and auxiliary materials for later use; take hydrochlorothiazide, microcrystalline cellulose, starch, mannitol, sodium carboxymethyl starch, and low-substituted hydroxypropyl cellulose and mix evenly; then add micronized silica gel and magnesium stearate Mix well; tablet that is.

[0042] The preparation method of hydrochlorothiazide is as follows: dissolve 100 g of hydrochlorothiazide in 500 ml of 4% sodium hydroxide aqueous solution, add dropwise 10% hydrochloric acid, precipitate hydrochlorothiazide crystals, suction filter, and dry the product to obtain hydrochlorothiazide cryst...

Embodiment 2

[0044] Valsartan Hydrochlorothiazide Tablets

[0045] components

quantity

Valsartan

80g

Hydrochlorothiazide

12.5g

starch

60g

microcrystalline cellulose

30g

Sodium carboxymethyl starch

10g

Magnesium stearate

1g

10% povidone k30

20ml

[0046] Preparation method: take valsartan, hydrochlorothiazide, starch, and microcrystalline cellulose and sieve separately for later use; the above-mentioned raw and auxiliary materials are mixed and mixed evenly when passing through a 100-mesh sieve; Granulate with a mesh sieve; dry the granules in a drying oven at 50°C; add sodium carboxymethyl starch and magnesium stearate to mix, pass through a 18-mesh sieve for granulation; compress into tablets; coat plain tablets to obtain the product.

[0047] The preparation method of hydrochlorothiazide is as follows: dissolve 100 g of hydrochlorothiazide in 250 ml of 5% sodium hydroxide aq...

Embodiment 3

[0049] Irbesartan Hydrochlorothiazide Capsules

[0050] components

quantity

Irbesartan

150g

Hydrochlorothiazide

12.5g

starch

30g

microcrystalline cellulose

40g

lactose

25g

Crospovidone

10g

Magnesium stearate

1.5g

5% povidone k30 aqueous solution

40ml

[0051] Preparation method: sieve each raw and auxiliary material for later use; take irbesartan, hydrochlorothiazide, starch, microcrystalline cellulose, lactose, and cross-linked povidone and mix evenly; add 5% povidone solution in the prescribed amount to make a soft material ; Sieve through a 40-mesh granulation; dry the granules in a drying oven at 50°C; add magnesium stearate to the dry granules, pass through a 30-mesh granule; pack the granules into capsules.

[0052] The preparation method of hydrochlorothiazide is as follows: dissolve 100 g of hydrochlorothiazide in 1000 ml of an aqueous solutio...

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Abstract

The invention relates to a crystalline form of hydrochlorothiazide and an application thereof; the crystalline form of hydrochlorothiazide has the following diffraction angles of powder X diffractionapproximately: 16.581 degrees, 18.641 degrees, 19.060 degrees, 20.879 degrees, 21.401 degrees, 24.598 degrees, 25.880 degrees, 26.279 degrees, 27.981 degrees, 28.402 degrees, 28.819 degrees, 33.480 degrees, 34.199 degrees and 41.879 degrees; the crystalline form of hydrochlorothiazide has the infrared peaks: 3390.97 cm <-1>, 3363.00cm <-1>, 3266.56 cm <-1>, 3171.08 cm <-1>, 1603.86cm <-1>, 1520.92cm <-1>, 1372.40 cm <-1>, 1328.03 cm <-1>, 1174.69 cm <-1>, 1158.29 cm <-1>, 1060.88 cm <-1>, 777.34 cm <-1> and 546.84 cm <-1>; and the crystalline form of hydrochlorothiazide has the melting pointof 263-266 DEG C.

Description

technical field [0001] The invention belongs to the field of medicinal chemistry and relates to a crystal form of diuretic hydrochlorothiazide and its application. Background technique [0002] Hydrochlorothiazide is a common intermediate-effect diuretic. It is available as a single product or a compound product used in combination with various types of antihypertensive drugs. It is mainly used clinically to treat edema diseases and hypertension. It has been widely used for many years, and there are many manufacturers, and there are great differences in the raw materials of hydrochlorothiazide from different manufacturers. At present, the oral preparations containing hydrochlorothiazide produced in my country generally have the problems of slow dissolution of hydrochlorothiazide and poor production availability. [0003] Our research found that this problem can be effectively solved by changing the crystal form. Therefore, we screened and prepared hydrochlorothiazide crysta...

Claims

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Application Information

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IPC IPC(8): C07D285/28A61K31/549A61P7/10A61P9/04A61P1/16A61P13/12A61P5/38A61P5/30A61P9/00A61P9/12A61P7/12A61K31/41A61K31/4184A61K31/4178A61K31/138A61K31/55A61K38/05A61K31/40
Inventor 沈泽闫起强蒋玲敏
Owner CHINA RESOURCES SAIKE PHARMA
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