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
Patent Information
- Authority / Receiving Office
- CN · China
- Current Assignee / Owner
- Publication Date
- 2009-01-07
Smart Images
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Abstract
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...
Examples
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
[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
[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...