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Preparation method for compound preparation comprising aspirin and alkaline drugs

A technology for aspirin and alkaline drugs, applied in the field of double-layer coating preparation, which can solve problems such as swelling, easy moisture absorption, and easy layering of double-layer tablets

Inactive Publication Date: 2010-01-27
北京迈劲医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, the coating also solves the problems of easy delamination of double-layer tablets and easy expansion after moisture absorption.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0011] Aspirin layer (10000 tablets)

[0012] Aspirin 3300g

[0013] Tartaric acid 33g

[0014] Sodium carboxymethyl starch 80g

[0015] Silica 50g

[0016] Buffer layer (10000 pieces)

[0017] Aluminum Magnesium Carbonate 1000g

[0018] Compressible starch 500g

[0019] 10% PVPk30 in 90% ethanol solution 1500ml

[0020] Silica 15g

[0021] Coating solution (10000 tablets)

[0022] Hydroxypropyl Methyl Cellulose 150g

[0023] Ethyl cellulose 30g

[0024] Polyethylene glycol 50g

[0025] Titanium dioxide 20g

[0026] 85% ethanol 3000ml

[0027] Preparation method: Mix the prescribed amount of aspirin and tartaric acid, press it into 10-mesh granules through a dry granulator, and then mix it with sodium carboxymethyl starch and silicon dioxide to make aspirin layer granules; mix aluminum magnesium carbonate with compressible starch After homogenization, use 10% PVPk30 in 90% ethanol solution to make soft material, granulate through 18# screen, and dry the wet granul...

Embodiment 2

[0029] Aspirin layer (10000 tablets)

[0030] Aspirin 3000g

[0031] Starch 495g

[0032] Tartaric acid 33g

[0033] Silica 50g

[0034] Buffer layer (10000 pieces)

[0035] Aluminum Magnesium Carbonate 1000g

[0036] Starch 500g

[0037] 10% PVPk30 in 90% ethanol solution 1500ml

[0038] Silica 15g

[0039] Coating solution (10000 tablets)

[0040] Hydroxypropyl Methyl Cellulose 150g

[0041] Ethyl cellulose 30g

[0042] Polyethylene glycol 50g

[0043] Titanium dioxide 20g

[0044] 85% ethanol 3000ml

[0045] Preparation method: mix prescription amount of aspirin, starch and tartaric acid, press dry granulator into 10-mesh granules, add silicon dioxide and mix to make aspirin granules; after mixing aluminum magnesium carbonate and starch, use 90% of 10% PVPk30 The soft material is made of ethanol solution, granulated through a 18# screen, and the wet granules are dried at 80°C to obtain dry granules; the two-layer granules are pressed into a double-layer tablet ...

Embodiment 3

[0047] Aspirin layer (10000 tablets)

[0048] Aspirin 5000g

[0049] Compressible starch 430g

[0050] Citric acid 33g

[0051] Low-substituted hydroxypropyl cellulose 65g

[0052] Sodium Lauryl Sulfate 50g

[0053] Buffer layer (10000 pieces)

[0054] Calcium carbonate 450g

[0055] Magnesium Oxide 550g

[0056] Lactose 500g

[0057] 10% PVPk30 in 90% ethanol solution 1500ml

[0058] Sodium Lauryl Sulfate 15g

[0059] Coating solution (10000 tablets)

[0060] Hydroxypropyl Methyl Cellulose 250g

[0061] Ethyl cellulose 60g

[0062] Glycerin 80g

[0063] Titanium dioxide 20g

[0064] 85% ethanol 5000ml

[0065]Preparation method: Mix prescription amount of aspirin, compressible starch and tartaric acid, press dry granulator into 10-mesh granules, then add low-substituted hydroxypropyl methylcellulose and sodium lauryl sulfate and mix evenly, as Aspirin layer granules; calcium carbonate and magnesium oxide are mixed with starch to make soft materials with 90% eth...

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Abstract

The invention relates to a preparation method for a compound preparation comprising aspirin and alkaline drugs. The main technical points of the invention are that: the aspirin is prepared by dry granulation; the granulated aspirin and granules prepared by alkaline medicaments are pressed into double-layer tablets by a double-layer tablet machine; and then the double-layer tablets are coated. The aspirin is not stable and is easily hydrolyzed to generate free salicylic acid, so the dry granulation is adopted; the prepared double-layer tablets can prevent that the alkaline drugs quicken hydrolyzation of the aspirin; and the prepared coated tablets can be moistureproof, prevent that double layers of the double-layer tablets from being separated or expanded, and guarantee quality and stablity of products.

Description

technical field [0001] The invention relates to a compound preparation made of aspirin and basic medicine, which adopts a double-layer coating preparation method. Background technique [0002] The compound preparation composed of high-dose aspirin and basic drugs has antipyretic, analgesic and anti-inflammatory effects, and the compound preparation composed of low-dose aspirin and basic drugs can inhibit platelet aggregation and prevent thrombosis. This type of compound preparation has obvious advantages: on the one hand, it can reduce the adverse stimulation of aspirin to the stomach, and significantly reduce the incidence of gastrointestinal mucosal erosion and ulcer; on the other hand, it can also increase its absorption, and alkaline drugs can empty the stomach. Speed ​​up, so that aspirin quickly enters the main absorption site - the small intestine. Aspirin blocks thromboxane A 2 Synthesis, damage the gastric mucosa, cause mild erosion of the gastric mucosa to form u...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K31/616A61K33/06A61K47/04A61P29/00
Inventor 马超钟加胜
Owner 北京迈劲医药科技有限公司
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