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Ticagrelor sesquihydrate capsule and preparation method thereof

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

Inactive Publication Date: 2015-05-27
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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  • Ticagrelor sesquihydrate capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] The formula composition of ticagrelor sesquihydrate capsules made into 1000 capsules is as follows:

[0050] Ticagrelor Sesquihydrate 95g

[0051] Mannitol 23.3g

[0052] Micronized silica gel 0.17g

[0053] 10% pregelatinized starch solution appropriate amount.

[0054] Preparation:

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

[0056] 2) Take the prescribed amount of ticagrelor sesquihydrate and mannitol, mix them evenly, then add an appropriate amount of 10% pregelatinized starch solution to make a soft material, pass through a 20-mesh sieve and granulate to obtain ticagrelor sesquihydrate Hemihydrate wet granules;

[0057] 3) Dry the above wet granules of ticagrelor sesquihydrate at 40°C until the water content is less than 5%, to obtain dry granules of ticagrelor sesquihydrate

[0058] 4) Pass the dry granules...

Embodiment 2

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

[0061] Sampling time (min) 5 10 20 30 45 60 Ticagrelor Sesquihydrate Capsules 83.7 90.2 97.8 98.5 100.2 99.9 Ticagrelor Sesquihydrate Tablets 58.2 84.2 93.2 97.8 98.6 99.2 Ticagrelor 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 ticagrelor sesquihydrate capsule of the present invention is better than that of the ticagrelor sesquihydrate tablet and the ticagrelor tablet, and the dissolution tendency is faster.

Embodiment 3

[0064] Effects of Platelet Aggregation on Beagle Dogs

[0065] Test drugs: ticagrelor sesquihydrate capsules; normal saline; ticagrelor sesquihydrate tablets; ticagrelor tablets.

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

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Abstract

The invention belongs to the technical field of medicine and relates to a ticagrelor sesquihydrate capsule and a preparation method thereof. The ticagrelor sesquihydrate capsule has the advantages of simple process, low cost, high bioavailability, and platelet aggregation inhibition ability improved by almost 10%. The invention also relates to a use of the ticagrelor sesquihydrate capsule in treatment on cardio-cerebrovascular system diseases.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a ticagrelor 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] Vascular disease is a systemic disease. The clinical manifestations are different due to the different sites of thrombosis. A vascular event occurs in one vessel, which 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 activation. T...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/519A61K47/36A61K47/10A61K47/04A61P7/02
Inventor 严洁李轩
Owner TIANJIN HANKANG PHARMA BIOTECH
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