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Clopidogrel bisulfate liposome solid preparation
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A technology of minodronate and solid preparations, which is applied in the field of medicine to achieve the effects of high encapsulation rate, excellent dissolution, and good sustained release effect
Inactive Publication Date: 2012-08-08
HAINAN YONGTIAN PHARMA INST
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[0016] However, the challenge in preparing liposomes lies in selecting the appropriate liposome composition and formulation
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[0093] Adopt the following production process to prepare minodronic acid liposome tablet:
[0094] (1) Accurately weigh 1g of minodronic acid, 80g of soybean lecithin, 20g of dioleoylphosphatidylglycerol, 50g of cholesterol, and 50g of Tween 80, and dissolve them in 1000ml of tetrahydrofuran and tert-butanol mixed solvent with a volume ratio of 2:1 in, stir to dissolve;
[0095] (2) Place the above solution in an eggplant-shaped bottle, remove methylenechloride and isopropanol under reduced pressure in a 45°C water bath, and form a uniform transparent film on the wall of the bottle;
[0096] (3) Add 800ml of phosphatebuffer solution with a pH value of 7.0 to the eggplant-shaped bottle, and continue to rotate in a 45°C water bath under normal pressure to swell and hydrate the film;
[0097] (4) The above solution is filtered with a 0.45 μm microporous membrane, and the filtrate is placed in a -20°C ...
[0103] Adopt following production process to prepare minodronic acid liposome tablet:
[0104] (1) Accurately weigh 1g of minodronic acid, 60g of soybean lecithin, 15g of dioleoylphosphatidylglycerol, 50g of cholesterol, and 40g of Tween 80, and dissolve them in 1000ml of tetrahydrofuran and tert-butanol mixed solvent with a volume ratio of 2:1 in, stir to dissolve;
[0105] (2) Place the above solution in an eggplant-shaped bottle, remove methylenechloride and isopropanol under reduced pressure in a 45°C water bath, and form a uniform transparent film on the wall of the bottle;
[0106] (3) Add 600ml of phosphatebuffer solution with a pH value of 7.0 to the eggplant-shaped bottle, and continue to rotate in a water bath at 45°C under normal pressure to swell and hydrate the film;
[0107] (4) The above solution is filtered with a 0.45 μm microporous membrane, and the filtrate is placed in a -20°C refrigerat...
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Abstract
The invention discloses a clopidogrel bisulfate liposomesolid preparation and a preparation method thereof. The method is to prepare liposome from an active ingredientclopidogrel bisulfate, and soybean lecithin, dioleoyl phosphatidylglycerole, cholesterol and tween 80 in a specific combination. The prepared liposome greatly improves stability, dissolution rate and bioavailability of a drug, andhas stable and lasting action and notable curative effect. The preparation provided by the invention improves product quality of a preparation and reduces toxic and side effects.
Description
technical field [0001] The invention relates to a new solid preparation of minodronic acid, in particular to a minodronic acid liposome solid preparation and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Minodronic acid (Clopidogrel Bisulfate), developed by Japan's Yamanouchi Pharmaceutical Company, was developed and marketed in Japan in 2002, and the market development was authorized to Japan's Ono Pharmaceutical Company. In January 2009, the minodronic acid tablet (trade name Bonoteo / Recalbon) originally developed by Astellas and Ono was approved in Japan for the first time. It is the third generation azaaryl bisphosphonate derivative for the treatment of osteoporosis. things. The chemical name of minodronic acid is: 1-hydroxy-2-[imidazo(1,2-a)pyridin-3-yl]ethylene)bisphosphonic acid monohydrate, molecular formula: C 9 h 12 N 2 o 7 P 2 ·H 2 O, molecular weight: 340.16, structural formula as follows: [000...
Claims
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