Prasugrel sesquialter hydrate capsule and preparation method thereof

A technology of sesquihydrate and capsules, which is applied in the field of medicine, can solve the problem of low complications of severe bleeding, and achieve the effects of good dissolution, fast dispersion, and no obvious difference in loading volume

Inactive Publication Date: 2014-06-11
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Studies have shown that trifluxal and aspirin have no difference in preventing serious cardiovascular events in patients with peripheral arteriosclerotic occlusive disease, but the incidence of serious bleeding complications is significantly lower than that of aspirin group

Method used

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  • Prasugrel sesquialter hydrate capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] The formulation of Prasugrel Sesquihydrate Capsules for 1000 capsules is as follows:

[0050] Prasugrel Sesquihydrate 5g

[0051] Mannitol 23.3g

[0052] Micronized silica gel 0.17g

[0053] 10% pregelatinized starch solution appropriate amount

[0054] Preparation:

[0055] 1) Drying prasugrel sesquihydrate and mannitol respectively, pulverizing and passing through a 200-mesh sieve to obtain prasugrel sesquihydrate powder and mannitol powder respectively;

[0056] 2) Take the prescribed amount of prasugrel sesquihydrate and mannitol, mix them evenly, then add 10% pregelatinized starch solution in an appropriate amount to make a soft material, pass through a 20-mesh sieve for granulation, and obtain prasugrel sesquihydrate Wet particles;

[0057] 3) drying the above-mentioned prasugrel sesquihydrate wet granules at 40°C until the water content is less than 7%, to obtain dry prasugrel sesquihydrate granules;

[0058] 4) Pass the dry granules of prasugrel sesquihydr...

Embodiment 2

[0060] Dissolution comparison results of prasugrel sesquihydrate capsules and prasugrel sesquihydrate tablets of the present invention

[0061] Sampling time (min) 5 10 20 30 45 60 Prasugrel Sesquihydrate Capsules 83.7 90.2 97.8 98.5 100.2 99.9 Prasugrel Sesquihydrate Tablets 58.2 84.2 93.2 97.8 98.6 99.2 Prasugrel Tablets 58.23 66.23 70.34 80.46 90.23 99.34

[0062] It can be seen from the above table that the dissolution tendency of the prasugrel sesquihydrate capsule of the present invention is better than that of the prasugrel sesquihydrate tablet and the prasugrel tablet, and the dissolution tendency is faster.

Embodiment 3

[0064] Effects of Platelet Aggregation on Beagle Dogs

[0065] Test drug: prasugrel sesquihydrate capsules; normal saline; prasugrel sesquihydrate tablets; prasugrel tablets.

[0066] Tested animals: 32 Beagle dogs, half male and half male, were randomly divided into ① blank control group (normal saline); ② Prasugrel sesquihydrate capsules; ③ Prasugrel sesquihydrate tablets; ④ Prasugrel sesquihydrate tablets; slices; 8 test animals in each group.

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Abstract

The invention belongs to the technical field of a medicine, and particularly relates to a prasugrel sesquialter hydrate capsule and a preparation method thereof. The prasugrel sesquialter hydrate capsule disclosed by the invention has the advantages that the prasugrel sesquialter hydrate capsule is simple and convenient in process, low in cost and high in bioavailability, and the inhibiting effect on platelet aggregation caused by the prasugrel sesquialter hydrate capsule is improved by about 10%. The invention also relates to application of the capsule for treating a cardiocerebral vascular system disease.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a prasugrel sesquihydrate capsule and a preparation method thereof, and also relates to the application of the capsule 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 ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/4365A61P7/02
Inventor 严洁李轩
Owner TIANJIN HANKANG PHARMA BIOTECH
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