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Aspirin-contained enteric capsules and preparation method thereof

A technology of aspirin and enteric-coated capsules, which is applied in the field of aspirin preparations, can solve the problems of aggregation of pellets, affecting the dissolution and release of aspirin, and failure to achieve drug efficacy, and achieve the effect of preventing pellets from sticking together

Active Publication Date: 2019-12-06
BEIJING XINLINGXIAN MEDICAL TECH DEV CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, the main method of preparing aspirin enteric-coated preparations is to coat the pericardial isolation layer of the pills and then coat the enteric-coated layer, but because the enteric-coated materials generally contain Surfactant will quickly dissolve in the solution within the appropriate pH range. Since the enteric coating material cannot be quickly dispersed in the solution, a local high-concentration enteric coating material solution will be formed, which has strong viscosity and causes pellets to aggregate. On the contrary, it affects the dissolution and release of aspirin, and cannot realize the drug effect

Method used

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  • Aspirin-contained enteric capsules and preparation method thereof
  • Aspirin-contained enteric capsules and preparation method thereof
  • Aspirin-contained enteric capsules and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Embodiment 1: preparation embodiment (outer insulation layer 2g, thicker)

[0041]

[0042]

[0043] Preparation process: 1. Raw and auxiliary materials are sieved for later use.

[0044] 2. For adhesive preparation, add polyvinylpyrrolidone k30 into water, stir until completely dissolved, add malic acid into the above solution, and continue stirring until completely dissolved.

[0045] 3. Total mixing Add aspirin, microcrystalline cellulose, lactose, and cross-linked polyvinylpyrrolidone in sequence to the wet granulation mixer for mixing.

[0046] 4. Preparation of soft material Add the binder solution to the total blended powder, stir at 100 rpm, shear at 1200 rpm, and run for 3 minutes to obtain a soft material for use.

[0047] 5. Pelletizing The prepared soft material is extruded by an extrusion and spheronization machine, and the extrusion frequency is 30HZ

[0048] Cut and round the obtained strips at a frequency of 20HZ for 1min

[0049] 15HZ 1min.

...

Embodiment 2

[0055] Embodiment 2: preparation embodiment (no outer barrier layer, promptly without barrier layer 2)

[0056]

[0057]

[0058] Preparation Process:

[0059] 1. Raw and auxiliary materials are sieved for later use.

[0060] 2. For adhesive preparation, add polyvinylpyrrolidone k30 into water, stir until completely dissolved, add malic acid into the above solution, and continue stirring until completely dissolved.

[0061] 3. Total mixing Add aspirin, microcrystalline cellulose, lactose, and cross-linked polyvinylpyrrolidone in sequence to the wet granulation mixer for mixing.

[0062] 4. Preparation of soft material Add the binder solution to the total blended powder, stir at 100 rpm, shear at 1200 rpm, and run for 3 minutes to obtain a soft material for use.

[0063] 5. Pelletizing The prepared soft material is extruded by an extrusion and spheronization machine, and the extrusion frequency is 30HZ

[0064] Cut and round the obtained strips at a frequency of 20HZ f...

Embodiment 3

[0071] Preparation Example (best ratio, 2.5g of isolation layer)

[0072] Types of raw materials Dosage for 1000 capsules (g) aspirin 100 Microcrystalline Cellulose PH301 12 lactose 3 Crospovidone 6 natural d-tartaric acid 2 Hypromellose (isolation layer 1) 2.0 Hypromellose (isolation layer 2) 0.5 Polyvinylpyrrolidone K30 2.1 Sodium dodecyl sulfate 0.42 Methacrylic acid-ethyl acrylate polymer (1:1) L30-D55 72.15 triethyl citrate 2.16 water 43.29 capsule shell 1000(grains)

[0073] Preparation Process:

[0074] 1. Raw and auxiliary materials are sieved for later use.

[0075] 2. For adhesive preparation, add polyvinylpyrrolidone k30 into water, stir until completely dissolved, add malic acid into the above solution, and continue stirring until completely dissolved.

[0076] 3. Total mixing Add aspirin, microcrystalline cellulose, lactose, and cross-linked polyvinylpyrrolidone in seque...

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Abstract

The invention relates to an aspirin preparation, in particular to aspirin-contained enteric capsules. The aspirin-contained enteric capsules are characterized in that the capsules comprise mini-pillsand coating, wherein the mini-pills contain aspirin, an adhesive, a diluent, a wetting agent, a disintegrant, a stabilizing agent and a surfactant, and the coating mainly comprises two isolating layers and an enteric coat layer. A mature production line is provided, the aspirin-contained enteric capsules are particularly suitable for industrialized production, the prepared aspirin-contained enteric capsules are good in stability and high in dissolution rate, the quality of the aspirin-contained enteric capsules is basically consistent with that of original developed enteric tablet products, and fluctuation of plasma concentration can be effectively improved.

Description

technical field [0001] The invention relates to an aspirin preparation, in particular to an enteric-coated capsule containing aspirin. Background technique [0002] Aspirin, also known as acetylsalicylic acid, is an antipyretic and analgesic with a long history and has been clinically used for hundreds of years. It is used for colds, fever, headache, toothache, arthralgia, rheumatism. It can also inhibit platelet aggregation and is used for the prevention and treatment of ischemic heart disease, angina pectoris, cardiopulmonary infarction, and cerebral thrombosis. It is also effective in angioplasty and bypass grafting. [0003] When used for a long time, the main side effect of aspirin is that it stimulates the stomach. Even if it is used in low doses, there is still an increased risk of gastric ulcer. The most common way to solve this problem is to prepare enteric-coated preparations. Enteric-coated preparations refer to the preparations that do not release or hardly r...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/62A61K31/616A61P29/00A61P7/02A61P9/10
CPCA61K9/5073A61K9/5047A61K9/5042A61K9/5026A61K31/616A61P29/00A61P7/02A61P9/10
Inventor 汲守信李利芳
Owner BEIJING XINLINGXIAN MEDICAL TECH DEV CO LTD
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