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Stable medicine combination

A composition and drug technology, applied in the field of stable pharmaceutical compositions, can solve the problems of pharmaceutical compositions failing to meet the storage period requirements, restrictions on large-scale popularization and use, and difficult operation of formulated products, so as to achieve fast and rapid onset of effect Thoroughly absorbed, low-cost effect

Active Publication Date: 2009-01-07
NANJING CHIA TAI TIANQING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] A disadvantage of rosuvastatin calcium is that it degrades easily under certain conditions, such as higher temperature or higher humidity environments, forming the main The products are (3R, 5S) lactone degradation products and oxidation products, which makes it difficult to prepare the product, and the prepared pharmaceutical composition cannot meet the storage period requirements
Although the fluidized bed drying method can speed up the drying speed and reduce the exposure time of the composition particles under hot and humid conditions, the fluidized bed equipment is very expensive, and it also needs to be equipped with a large-scale compressed air system, and the particles are lost during the drying process. bigger
High production costs limit the large-scale popularization and use of this method in China

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Raw material name 1000 tablets dosage (g)

[0029] Rosuvastatin calcium 10.4 (equivalent to rosuvastatin 10g)

[0030] Micronized silica gel 6

[0031] Microcrystalline Cellulose 80

[0032] Lactose 95

[0033] Crospovidone (internal addition) 8

[0034] Crospovidone (additional) 8

[0035] Povidone K 30 5

[0036] Appropriate amount of water

[0037] Magnesium Stearate 2

[0038] Gastric-soluble film coating premix appropriate amount

[0039] Pass rosuvastatin calcium and micro-powder silica gel through a 100-mesh sieve and mix evenly, add the prescribed amount of microcrystalline cellulose, lactose, crospovidone (internal addition), and povidone through a 80-mesh sieve, and mix well . Add an appropriate amount of water-based soft material to the powder, pass through a 20-mesh sieve to granulate, blow dry at 45°C, pass the dry granules through a 20-mesh sieve for granulation, add the prescribed amount of crospovidone (additional), mix properly an...

Embodiment 2

[0041] Raw material name 1000 tablets dosage (g)

[0042] Rosuvastatin calcium 5.2 (equivalent to rosuvastatin 5g)

[0043] Micronized silica gel 5

[0044] Pregelatinized starch 60

[0045] Mannitol 75

[0046] Low-substituted hydroxypropyl cellulose 5

[0047] 3% hypromellose (E 5 ) aqueous solution appropriate amount

[0048] Magnesium Stearate 1

[0049] Gastric-soluble film coating premix appropriate amount

[0050] Pass rosuvastatin calcium and micropowder silica gel through a 100-mesh sieve and mix evenly, add pregelatinized starch, mannitol, and low-substituted hydroxypropyl cellulose in the prescribed amount and pass through an 80-mesh sieve, and mix well. Add an appropriate amount of 3% hydroxypropyl methylcellulose aqueous solution to the powder to make a soft material, pass through a 20-mesh sieve to granulate, dry at 45°C, dry the dry granules through a 20-mesh sieve, add the prescribed amount of magnesium stearate, well mixed. After detecting the interme...

Embodiment 3

[0052] Raw material name 1000 tablets dosage (g)

[0053] Rosuvastatin calcium 20.8 (equivalent to rosuvastatin 20g)

[0054] Micronized silica gel 10

[0055] Microcrystalline Cellulose 60

[0056] Cross-linked hydroxypropyl methylcellulose 9

[0057] Appropriate amount of water

[0058] Stearic acid 0.8

[0059] Gastric-soluble film coating premix appropriate amount

[0060] Pass rosuvastatin calcium and micropowder silica gel through a 100-mesh sieve and mix evenly, add the prescribed amount of microcrystalline cellulose and cross-linked hydroxypropyl methylcellulose that pass through an 80-mesh sieve, and mix well. Add an appropriate amount of water-based soft material to the powder, pass through a 24-mesh sieve to granulate, blow dry at 45°C, pass the dry granules through a 24-mesh sieve for granulation, add the prescribed amount of stearic acid passed through a 80-mesh sieve, and mix well. After detecting the intermediate content and water content, the tablet is pr...

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Abstract

The invention relates to a stable oral pharmaceutical composition, particularly to a pharmaceutical composition comprising rosuvastatin calcium, micropowder silica gel and pharmaceutically-acceptable adjuvants, and a preparation method and an application thereof.

Description

technical field [0001] The present invention relates to a stable pharmaceutical composition, in particular to rosuvastatin calcium: bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[formazan A stable pharmaceutical composition of (methylsulfonyl)amino]pyrimidin-5-yl]-(3R,5S)-3,5-dihydroxyhept-6-enoic acid]calcium salt (as shown in formula I). [0002] [0003] Formula I Background technique [0004] Rosuvastatin calcium is a potent 3-hydroxy-3-methylglutaryl coenzyme A reductase (HMGCoA reductase) inhibitor, which can be used in the treatment of hypercholesterolemia, hyperlipoproteinemia and atherosclerosis It is better than other statins on the market in reducing low-density lipoprotein (LDL-C) and increasing high-density lipoprotein (HDL-C), and it is well tolerated and safe. For "super statin". [0005] One disadvantage of rosuvastatin calcium is that it is easily degraded under certain circumstances, such as in a higher temperature or higher humidity environment, and th...

Claims

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Application Information

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IPC IPC(8): A61K31/505A61K47/02A61P3/06A61P9/10
Inventor 董平谢华陈智林张喜全
Owner NANJING CHIA TAI TIANQING PHARMA
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