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Aspirin and clopidogrel hydrogen sulfate compound preparation and preparation method thereof

A compound formulation of clopidogrel hydrogen sulfate and a technology of clopidogrel hydrogen sulfate are applied in the field of medicine and can solve the problems of blockage, high growth of salicylic acid, precipitation of talc and the like

Pending Publication Date: 2021-04-02
LEPU PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The purpose of the patent of the present invention is to provide a compound tablet of aspirin and clopidogrel bisulfate and its preparation method, aiming at the problem that the coating formula of the tablet on the market is easy to settle, the coating process is not easy to control, and the aspirin hydrolysis product salicylic acid has a high growth rate. Problem, the present invention optimizes the enteric-coating prescription and process through research, solves the problems of talcum powder precipitation and blocking during the aspirin enteric-coating process, improves the process fluency and improves its sample stability at the same time

Method used

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  • Aspirin and clopidogrel hydrogen sulfate compound preparation and preparation method thereof
  • Aspirin and clopidogrel hydrogen sulfate compound preparation and preparation method thereof
  • Aspirin and clopidogrel hydrogen sulfate compound preparation and preparation method thereof

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Experimental program
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Effect test

Embodiment 1-3

[0050] The preparation of embodiment 1-3 aspirin tablet

[0051] Table 1: Preparation prescription of aspirin tablet

[0052]

[0053] Preparation Process:

[0054] 1. After crushing aspirin with a hammer mill at 2000rpm, pass through a 1.0mm sieve and add cornstarch into a three-dimensional motion mixer for 30min at 25Hz;

[0055] 2. Put the mixed material into the dry granulator, the feeding speed is 25-50r / min, the pressure wheel speed is 10-25r / min, the oil pressure is 5-8MPa, the crushing speed is 120r / min, and the pre-sizing sieve is 8 mesh , the pre-sizing speed is 60-80r / min, the final sizing sieve is 20 mesh, and the final sizing speed is 60-80r / min. The prepared granules are sieved with a vibrating sieve (20 mesh, 80 mesh), and the granules between the 20-80 mesh sieves are collected.

[0056] 3. Add the prepared aspirin starch granules, microcrystalline cellulose and colloidal silicon dioxide into a three-dimensional motion mixer and mix for 20 minutes at 25 H...

Embodiment 4-8

[0058] Embodiment 4-8: Preparation of aspirin enteric-coated tablet core

[0059] Table 2: Preparation recipe of aspirin enteric-coated tablet core

[0060]

[0061]

[0062] Preparation Process:

[0063] 1. Enteric layer coating:

Embodiment 4-5

[0065] Coating solution configuration:

[0066] A: Add the prescribed amount of Tween 80 and 1 / 2 the amount of triethyl citrate and glyceryl monostearate to an appropriate amount of hot purified water at 70-80°C to prepare a solution with a solid content of 15%, stir and dissolve Homogeneously emulsify and disperse, add the remaining purified water (after removing the hot water in configuration A and purified water in configuration B) after emulsification, stir evenly and cool down to below 30°C;

[0067] B: Add the remaining 1 / 2 amount of triethyl citrate and talcum powder to an appropriate amount of purified water for homogenization and emulsification for 5-10 minutes to make a solution with a solid content of 20%;

[0068] Add the prepared solution A into solution B under stirring, add the suspension into Eudragit L30D aqueous dispersion (solid content 30wt%) under stirring, continue stirring for 1 hour and pass through a 60-mesh sieve.

[0069] Coating parameters: Put the...

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Abstract

The invention discloses an aspirin and clopidogrel hydrogen sulfate compound preparation and a preparation method thereof, and belongs to the field of pharmaceutical preparations. The aspirin and clopidogrel hydrogen sulfate compound preparation is prepared by mixing and tabletting an aspirin enteric-coated tablet core and clopidogrel hydrogen sulfate quick-release particles. An aspirin enteric-coated tablet is composed of a drug-containing element tablet and two layers of coatings including an enteric coating and an isolation layer coating. Due to the fact that talcum powder and glyceryl monostearate are combined for use, the glyceryl monostearate has a hydrophobic effect, production of salicylic acid can be better slowed down, aspirin stability is better, and an inner isolation layer does not need to be added; and clopidogrel hydrogen sulfate granules are prepared by hot melting granulation. The aspirin and clopidogrel hydrogen sulfate compound preparation can achieve the characteristics that clopidogrel or a medicinal salt thereof can be quickly released in the stomach and the aspirin enteric-coated tablet can be released in the intestinal tract. The preparation method has the advantages of smooth production process, high production capacity, good stability and the like.

Description

technical field [0001] The invention belongs to the technical field of medicines, and relates to a compound preparation of aspirin and clopidogrel bisulfate and a preparation method thereof. Background technique [0002] Clopidogrel bisulfate is a platelet aggregation inhibitor jointly developed and promoted by Sanofi Pharmaceuticals Inc and Bristol-Myers Squibb Company, first launched on November 17, 1997 It was approved for marketing in the U.S. on the 1st, and the marketed dosage form is a tablet with a specification of 75mg. The approved indication is to reduce atherosclerotic events (myocardial infarction, stroke and vascular death) in the following patients: recent stroke patients, recent myocardial infarction patients or patients with confirmed peripheral arterial disease. Subsequently, the product has new specifications (25mg, 300mg) and new indications (for acute coronary syndrome) and has been approved for marketing in many countries and regions. [0003] Aspirin...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K9/36A61K9/32A61K9/16A61K31/4365A61K31/616A61K47/38A61K47/36A61K47/32A61K47/26A61P7/02A61P9/10
CPCA61K31/616A61K31/4365A61K9/2077A61K9/2866A61K9/284A61K9/2886A61K9/1652A61K9/1641A61K9/1623A61P7/02A61P9/10A61K2300/00
Inventor 赵素华骆献丽朱建中张明
Owner LEPU PHARMACEUTICAL CO LTD
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