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Clopidogrel dispersible tablet and preparation method thereof

A clopidogrel and dispersible tablet technology is applied to medical preparations containing active ingredients, pharmaceutical formulations, organic active ingredients, etc., and can solve the problems of low bioavailability, long tablet disintegration time, single taking method, and the like, To achieve the effect of short disintegration time, rapid drug dissolution and convenient administration

Inactive Publication Date: 2010-06-23
BEIJING HOPE HUGE PHARM SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The disintegration time of the tablet is long, the bioavailability is low, and the method of administration is single

Method used

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  • Clopidogrel dispersible tablet and preparation method thereof
  • Clopidogrel dispersible tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] prescription:

[0027] Clopidogrel 75g

[0028] Dextrin 20g

[0029] Microcrystalline Cellulose 103 30g

[0030] Mannitol 15g

[0031] Crospovidone 8.5g

[0032] Aspartame 0.25g

[0033] Micronized silica gel 0.5g

[0034] Magnesium stearate 0.5g

[0035] BHA 0.25g

[0036]

[0037] 1000 pieces

[0038] Weigh the prescribed amount of clopidogrel, crospovidone, microcrystalline cellulose 103, mannitol, dextrin, aspartame, and micropowder silica gel through a 24-mesh sieve to mix them evenly. Add the prescribed amount of BHA into 30% ethanol solution of 8% povidone and mix evenly, then add the solution into the mixed fine powder of raw and auxiliary materials, and stir to make soft material. Pass the soft material through a 20-mesh sieve to make granules. Dry at 70°C for 4 hours, pass through a 20-mesh sieve, add magnesium stearate, mix well, and press into tablets.

Embodiment 2

[0040] prescription:

[0041] Clopidogrel 75g

[0042] 20g pregelatinized starch

[0043] Microcrystalline Cellulose 103 25g

[0044] Sodium carboxymethyl starch 27.5g

[0045] Aspartame 0.25g

[0046] Micronized silica gel 0.5g

[0047] Magnesium stearate 0.5g

[0048] BHA 0.25g

[0049] 30% ethanol solution of 8% povidone appropriate amount

[0050]

[0051] 1000 pieces

[0052] Weigh the prescribed amount of clopidogrel, pregelatinized starch, microcrystalline cellulose 103, sodium carboxymethyl starch, and aspartame through a 24-mesh sieve to mix them evenly. Add the prescribed amount of BHA into 30% ethanol solution of 8% povidone and mix evenly, then add the solution into the mixed fine powder of raw and auxiliary materials, and stir to make soft material. Pass the soft material through a 20-mesh sieve to make granules. Dry at 70°C for 4 hours, pass through a 20-mesh sieve, add micropowder silica gel and magnesium steara...

Embodiment 3

[0053] Example 3: Prescription

[0054]Clopidogrel 75g

[0055] 10g pregelatinized starch

[0056] Microcrystalline Cellulose 103 30g

[0057] Sodium carboxymethyl starch 22g

[0058] Crospovidone 11.5g

[0059] Aspartame 0.25g

[0060] Micronized silica gel 0.5g

[0061] Magnesium stearate 0.5g

[0062] BHA 0.25g

[0063] 30% ethanol solution of 8% povidone appropriate amount

[0064]

[0065] 1000 pieces

[0066] Weigh the prescribed amount of clopidogrel, pregelatinized starch, microcrystalline cellulose 103, sodium carboxymethyl starch, crospovidone, and aspartame and pass through a 24-mesh sieve to mix them evenly. Add the prescribed amount of BHA into 30% ethanol solution of 8% povidone and mix evenly, then add the solution into the mixed fine powder of raw and auxiliary materials, and stir to make soft material. Pass the soft material through a 20-mesh sieve to make granules. Dry at 70°C for 4 hours, pass through a 20-m...

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Abstract

The invention discloses a clopidogrel dispersible tablet and a preparation method thereof, in particular relates to a clopidogrel hydrogensulfate preparation and a preparation method thereof. The clopidogrel hydrogensulfate preparation is used for curing various thrombosis induced by platelet aggregation. The clopidogrel hydrogensulfate preparation and the preparation method with short disintegration time, excellent dispersed state, quick drug dissolution and convenience and flexibility of taking have the characteristics of improving the medication compliance of the patients, ensuring the therapeutic effect of the drug and the like.

Description

technical field [0001] The invention discloses a clopidogrel dispersible tablet and a preparation method thereof. Specifically, it relates to a clopidogrel bisulfate preparation and a preparation method. For the treatment of various thrombotic conditions induced by platelet aggregation, including stable or unstable angina, diseases of the cardiovascular and cerebrovascular systems, such as vascular embolic diseases associated with atherosclerosis and diabetes, such as unstable angina pectoris, diabetic heart disease, angioplasty, coronary artery bypass surgery, intraarterial coronary artery bypass surgery, endarterectomy or placement of intravascular metal stents after stenosis, or reembolization with thrombolysis, myocardial infarction, Peripheral arterial disease, vascular embolic disease associated with hemodialysis. Background technique [0002] Thrombotic disease induced by platelet aggregation has become a multiple disease. People's anti-platelet aggregation drug re...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4365A61P7/02
Inventor 王翰斌郑明月
Owner BEIJING HOPE HUGE PHARM SCI
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