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Prasugrel sesquihydrate and its preparation method
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A sesquihydrate and hydrate technology, applied in the field of medicine, can solve the problems of moisture absorption, weight gain, difficult purification, high impurity content, etc.
Active Publication Date: 2015-12-23
TIANJIN HANKANG PHARMA BIOTECH
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[0009] Prasugrel has great advantages in effectiveness and safety, but in the actual production process, the applicant found that there are problems such as difficult purification, high impurity content and certain moisture absorption and weight gain in the preparation process of prasugrel
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Embodiment 1
[0054] In a 10L reaction kettle equipped with stirring, thermometer, and condenser, add 300 grams of prasugrel, 970.0ml of isobutanol, 16.5ml of tetrahydrofuran, and 980.0ml of water, start stirring, heat until dissolved, and naturally cool the filtrate to 25°C- 30°C, then let it stand for 4 hours to precipitate crystals, filter, and dry indoors to obtain 254.6 grams of white crystals of prasugrel sesquihydrate, with a melting point of 120.3°C-121.9°C and a content of 99.76%. Impurities are less than 0.06%. Determined by Karl Fischer method, it contains 6.72% (weight percent) of water.
[0055] Microparticles or microspheres are prepared by combining the compounds of the present invention with a pharmaceutically acceptable solid or liquid carrier, and optionally with pharmaceutically acceptable adjuvants and vehicles, using standard and conventional techniques. The composition is used for preparing oral preparations and injections. It is given by way of example only and in n...
Embodiment 2
[0057] Tablets containing prasugrel sesquihydrate
[0058] Prescription: Prasugrel sesquihydrate 10.7g, microcrystalline cellulose 12g, pregelatinized starch 16g, sodium starch glycolate 5g, lactose 210g, PEG-4000 25g, magnesium stearate 6g, polysaccharide 30g Vitamin K30, 33 grams of croscarmellose sodium, appropriate amount of distilled water, made into 10,000 tablets.
[0059] Process:
[0060] Preparation of tablet core: according to the determined prescription, the main ingredient and auxiliary materials are mixed uniformly, granulated, and the granules are ventilated and dried below 40°C, granulated with a 16 mesh sieve, added magnesium stearate and remaining starch, and compressed into tablets to obtain final product .
[0061] Isolation layer coating: add talcum powder to 5% polyvinylpyrrolidone (PVP) absolute ethanol solution, stir evenly, and prepare a 20% suspension as the isolation layer coating solution. Coating is carried out in a fluidized bed, and the proces...
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Abstract
The invention belongs to the technical field of medicine, and specifically relates to prasugrel sesquihydrate and a preparation method thereof. The prasugrel sesquihydrate obtained in the invention contains one and a half crystal waters, and has the advantages of high purity and good stability, Even under high humidity conditions, the hygroscopic weight gain is not obvious; the inhibitory effect on platelet aggregation, prasugrel sesquihydrate increases nearly 20%. The present invention also relates to the application of the composition of the hydrate to treat diseases of the cardiovascular and cerebrovascular systems.
Description
technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to prasugrel hydrate and a preparation method thereof, and also relates to the application of the hydrate composition in treating diseases of the cardiovascular and cerebrovascular systems. Background technique [0002] History of vascular disease is a systemic disease with different clinical manifestations due to the different sites of thrombosis, and the occurrence of vascular events in one vessel means that the risk of vascular events in other vessels increases. According to statistics, the death caused by atherosclerotic thrombosis accounts for 28.7% of the total death of the population, mainly due to coronary artery events and cerebral artery events, followed by other peripheral arterial diseases, and two or even three vascular lesions may coexist . The pathological basis of vascular events is atherosclerosis, and the first step in pathophysiology is platelet acti...
Claims
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