Ozagrel sodium medicinal composition for injection
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A technology for sodium ozagrel and the composition is applied in the field of pharmaceutical composition of ozagrel and its preparation, which can solve the problems of inconvenience in use, storage and transportation, and achieves reduction of market risk, stability to light, and simple and easy method. Effect
Inactive Publication Date: 2012-05-02
TIANJIN HANKANG PHARMA BIOTECH
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[0024] The ozagrel sodium injection produced by the prior art has very strict requiremen...
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Embodiment 1
[0094] Every 1000 described ozagrel sodium pharmaceutical compositions, its formula consists of:
[0095] Sodium Ozagrel 40g
[0096] Sodium citrate 4g
[0097] Edetate Calcium Sodium 0.02g
[0098] Add water for injection to 2L
[0099] Preparation process: Take 90% of the prescribed amount of water for injection, at a temperature of 55-65°C, add the prescribed amount of sodium citrate and edetate calcium sodium, stir and dissolve; add the prescribed amount of ozagrel sodium and edetate calcium Sodium, stir until completely dissolved; measure the initial pH value, adjust the pH value range to 7.5-9.5 with 4% sodium hydroxide solution and 10% sodium citrate solution according to the initial pH value; add medicinal charcoal to the mixture, and stir; Suction filtration, add water for injection to the full amount, mix evenly; fine filtration; filling; sterilization; light inspection; storage; to obtain ozagrel sodium injection.
Embodiment 2
[0101] Every 1000 described ozagrel sodium pharmaceutical compositions, its formula consists of:
[0102] Sodium Ozagrel 100g
[0103] Sodium citrate 10g
[0104] Edetate Calcium Sodium 0.05g
[0105] Add water for injection to 5L
[0106] Preparation process: Take 90% of the prescribed amount of water for injection, at a temperature of 55-65°C, add the prescribed amount of sodium citrate and calcium sodium edetate, stir to dissolve; add the prescribed amount of ozagrel sodium, and stir until completely dissolved ; Measure the initial pH value, according to the initial pH value, use 4% sodium hydroxide solution and 10% sodium citrate solution to adjust the pH value range to 7.5-9.5; add medicinal charcoal, stir; suction filter, supplement water for injection To the full amount, mix evenly; fine filter; fill; sterilize;
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Abstract
The invention discloses an ozagrel sodium medicinal composition for injection. Ozagrel sodium injection consists of ozagrel sodium, sodium citrate and calcium disodium edetate, wherein each piece of injection contains 40-100 mg of ozagrel sodium, 4-10 mg of sodium citrate and 0.02-0.05 mg of calcium disodium edentate. A preparation method of the composition comprises the following steps of: adding a prescription dose of sodium citrate and calcium disodium edentate into a prescription dose of 90 percent injection water at the temperature of 55-65 DEG C and stirring to dissolve; adding a prescription dose of ozagrel sodium and stirring until the ozagrel sodium is fully dissolved; measuring an initial pH value, and adjusting the pH value to be within a range of 7.5-9.5 by using 4 percent sodium hydroxide solution and 10 percent sodium citrate solution according to the initial pH value; adding medicinal carbon and stirring; performing extraction filtration, replenishing injection water to full amount and uniformly mixing; performing fine filtration; canning; sterilizing; performing light inspection; and warehousing to obtain the ozagrel sodium injection. The ozagrel sodium medicinal composition has high light stability, clarity and stability and does not produce crystals, and has the more obvious advantages of improving the product yield, reducing the cost, realizing industrialization and guaranteeing better application to clinical use.
Description
technical field [0001] The invention relates to medicines in the field of medicine, in particular to an ozagrel sodium pharmaceutical composition for injection that is stable to light, does not produce crystals, and has good stability and a preparation method thereof. Background technique [0002] Ischemic cerebrovascular disease (ischemic stroke) is caused by the temporary or permanent reduction of blood flow in an arterial blood supply area due to embolism or hemorrhage. Its pathological process involves complex temporal and spatial cascade reactions, and its mechanism is related to Ca + Overload, free radical damage and other factors are related. Ozagrel Sodium (Ozagrel Sodium) has a specific inhibitory effect on thromboxane A synthetase, and its pharmacological effects mainly include: anti-platelet aggregation, dilating blood vessels. In addition, ozagrel also has the effect of inhibiting lipid peroxidation, can reduce the generation of free radicals, can directly scave...
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