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Bilobalide bi-layer osmotic pump control tablet and preparation method thereof

A technology of osmotic pump controlled release and ginkgolide, which is applied in the direction of pharmaceutical formulas, medical preparations containing active ingredients, blood diseases, etc., can solve the problems of large individual differences and blood drug fluctuations, so as to improve compliance and reduce Toxic and side effects, the effect of avoiding the peak and valley phenomenon

Inactive Publication Date: 2014-02-26
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the preparation is a slow non-constant release drug, and the gastrointestinal environment in the human body has a great influence on the release and absorption of the drug, and there are certain blood drug fluctuations, and the individual differences are large

Method used

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  • Bilobalide bi-layer osmotic pump control tablet and preparation method thereof
  • Bilobalide bi-layer osmotic pump control tablet and preparation method thereof
  • Bilobalide bi-layer osmotic pump control tablet and preparation method thereof

Examples

Experimental program
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Effect test

example 1

[0024] Tablet prescription:

[0025] Drug-containing layer

[0026] Ginkgolides 100mg

[0027] Sodium chloride 40mg

[0028] Polyoxyethylene N750 200mg

[0029] Magnesium Stearate 4mg

[0030] booster layer

[0031] Polyoxyethylene WSR 303 100mg

[0032] Sodium chloride 20mg

[0033] Magnesium Stearate 2mg

[0034] Coating film prescription:

[0035] Cellulose acetate 30g

[0036] Polyethylene glycol 4g

[0037] Solvent Prescription for Dissolving Coating Material

[0038] Acetone 1000mL

[0039] Distilled water 15mL

[0040] Preparation Process:

[0041] Pass the drug, polyoxyethylene, sodium chloride and magnesium stearate in the prescription amount of the drug-containing layer through an 80-mesh sieve, mix evenly, and pass the polyoxyethylene, sodium chloride and magnesium stearate in the prescription amount in the ...

example 2

[0043] Tablet prescription:

[0044] Drug-containing layer

[0045] Ginkgolides 100mg

[0046] Lactose 60mg

[0047] Gum Arabic 200mg

[0048] Talc 4mg

[0049] booster layer

[0050] Polyoxyethylene WSR301 80mg

[0051] Sodium chloride 20mg

[0052] Talc 2mg

[0053] Coating film prescription:

[0054] Ethyl cellulose 30g

[0055] Polyethylene glycol 5g

[0056] Solvent Prescription for Dissolving Coating Material

[0057] Acetone 1000mL

[0058] Distilled water 15mL

[0059] Preparation Process:

[0060] Pass the drug, gum arabic, lactose and talcum powder in the prescribed amount of the drug layer through an 80 mesh sieve, and mix evenly; pass the polyoxyethylene, sodium chloride and talcum powder in the prescription amount in the booster layer through an 80 mesh sieve, mix evenly, and use 10 No. punch twice and pressu...

example 3

[0062] Tablet prescription:

[0063] Drug-containing layer

[0064] Ginkgolides 100mg

[0065] Mannitol 60mg

[0066] Sodium Alginate 250mg

[0067] Micronized silica gel 4mg

[0068] booster layer

[0069] Polyoxyethylene WSR Coagulant 100mg

[0070] Sodium chloride 25mg

[0071] Micronized silica gel 2mg

[0072] Coating film prescription:

[0073] Cellulose acetate 30g

[0074] Hypromellose 6g

[0075] Solvent Prescription for Dissolving Coating Material

[0076] Acetone 1000mL

[0077] Distilled water 15mL

[0078] Preparation Process:

[0079] Pass the drug, sodium alginate, mannitol, and micropowdered silica gel in the prescription amount of the drug layer through an 80-mesh sieve, and mix evenly; pass the polyoxyethylene, sodium chloride, and micropowdered silica gel in the prescription amount of the booster layer thr...

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Abstract

The invention belongs to the field of medical technologies, and provides a bilobalide bi-layer osmotic pump controlled tablet and a preparation method thereof. An osmotic pump is composed of a drug-containing layer, a boosting layer and a coating film, wherein the drug-containing layer is composed of the following components in percentage by weight: 10-50% of bilobalide, 30-80% of a suspension agent, 0-20% of osmotic-pressure active substances, and the balance of other accessories; the boosting layer is composed of the following components in percentage by weight: 50-82% of a swelling agent, 13-45% of osmotic-pressure active substances, and 0.5-5% of a lubricant; and the semipermeable coating film comprises 10-20 g of semipermeable polymer materials and 2-5 g of a water-soluble pore-foaming agent in every 100 tablets. The active ingredient bilobalide mainly comprises bilobalide A and bilobalide B, and the total amount of the bilobalide A and the bilobalide B is not less than 90%; and the bilobalide bi-layer osmotic pump control tablet can realize the synchronous constant-speed release of the compositions in preparations, so that the stability of plasma concentration can be maintained, the toxic and side effects of drugs can be lowered, the number of times of drug administration can be reduced, and the compliance of patients can be improved.

Description

technical field [0001] The invention relates to a ginkgolide double-layer osmotic pump controlled-release tablet and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Ginkgolides (Ginkgolides, GG) are the main medicinal components of Ginkgo biloba extract, which are diterpene lactone compounds, which mainly include ginkgolides A, B, C, J, M and bilobalide. Modern medical research has found that ginkgolide has the functions of promoting blood circulation, removing blood stasis, dredging channels and soothing collaterals, and resisting platelet aggregation. It can be widely used in diseases such as senile dementia, cardiovascular and cerebrovascular diseases, bronchial asthma, and organ transplantation. Ginkgolide can bind to the platelet activating factor (PAF) receptor, is a strong PAF antagonist, effectively prevents platelet aggregation and thrombus formation, and is widely used in the prevention and treatme...

Claims

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Application Information

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IPC IPC(8): A61K31/365A61K9/44A61P9/00A61P9/10A61P25/28A61P11/06A61P37/06A61P7/02
Inventor 杨星钢梁静阁朱志红赵倩倩潘卫三
Owner SHENYANG PHARMA UNIVERSITY
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