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Preparation method of high-stability amlodipine atorvastatin calcium tablet

A technology of atorvastatin calcium and amlodipine, which can be used in pharmaceutical formulations, metabolic diseases, cardiovascular system diseases, etc., and can solve problems such as solubility and stability.

Inactive Publication Date: 2015-05-27
CHINA RESOURCES SAIKE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] During the research on the formulation process of compound amlodipine atorvastatin calcium tablets, we found that atorvastatin calcium not only has the problem of solubility, but also has the problem of stability, which is easy to produce under acid-base high temperature and oxidation conditions. degradation

Method used

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  • Preparation method of high-stability amlodipine atorvastatin calcium tablet
  • Preparation method of high-stability amlodipine atorvastatin calcium tablet

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Embodiment 1

[0058] Patents CN101185646A (prescription 1) and CN20152341U (prescription 2) describe the preparation of prescriptions, which are used together with the original research tablet for stability studies under accelerated conditions (40°C / 75%). Investigate the impact of conventional microcrystalline cellulose and different processes. The prescription list is as follows:

[0059]

[0060]

[0061] Preparation Process:

[0062] The preparation process of prescription 1 is the same as embodiment 2.

Embodiment 2

[0066] The present invention is also not limited to this embodiment for the prescription and technology of compound amlodipine atorvastatin calcium tablet. We selected microcrystalline cellulose with different peroxide contents from the market to prepare amlodipine atorvastatin calcium tablets; compared the results of three microcrystalline cellulose stability related substances, the results showed that the peroxide value of microcrystalline cellulose For the prescription of 35ppm, the oxidative degradation impurities are significantly reduced. The prescription list is as follows:

[0067]

[0068]

[0069] Preparation Process:

[0070] ① Raw and auxiliary materials batching process:

[0071] A. Accurately weigh croscarmellose sodium (internal added part), microcrystalline cellulose, pregelatinized starch, and hydroxypropyl cellulose according to the prescription quantity, put them into plastic bags separately, and mark them well.

[0072] B. The processing procedure ...

Embodiment 3

[0092] Embodiment 3, peroxide determination method in microcrystalline cellulose

[0093] A. Titanium trichloride-sulfuric acid test solution: Take 20ml of 15% titanium trichloride solution, carefully mix it with 13ml of sulfuric acid in an ice bath, add an appropriate amount of concentrated hydrogen peroxide solution until yellow appears, heat until white smoke is emitted, and put Cool, dilute with water repeatedly and evaporate until the solution is nearly colorless, add water to obtain a colorless solution, add water to 100ml, filter, and obtain.

[0094] B. Operate at 20-25°C, take 4.0g of microcrystalline cellulose, put it in a 100ml measuring bottle, add about 80ml of water, shake for 10 minutes, add water to the mark, shake well, filter, take 25ml of the filtrate, add three Titanium chloride-sulfuric acid test solution 2.0ml, shake well, stand for 30 minutes, as the test solution; take the above-mentioned continued filtrate 25ml, add 2.0ml of 13% (V / V) sulfuric acid sol...

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Abstract

The invention relates to a preparation method of a high-stability amlodipine atorvastatin calcium tablet. The preparation method of the high-stability amlodipine atorvastatin calcium tablet is characterized in that the amount of peroxide in microcrystalline cellulose is controlled. The preparation method of the high-stability amlodipine atorvastatin calcium tablet comprises the following steps: A, granulating of atorvastatin calcium, concretely comprising the steps of firstly dissolving a surfactant in water, adding a binding agent, stirring and dissolving, secondly mixing atorvastatin calcium, calcium carbonate, other diluents and a disintegrant, thirdly, granulating, and fourthly, drying wet granules obtained in the step three, so that dry atorvastatin calcium granules are prepared; and B, preparing of finished granules, concretely comprising the steps of firstly adding amlodipine besylate, a disintegrant and a flow aid into the dry atorvastatin calcium granules, secondly, uniformly mixing powder obtained in the step one in a mixing machine, thirdly, adding a lubricating agent, and uniformly mixing, and fourthly, pressing the powder into tablets.

Description

technical field [0001] The invention relates to the technical field of pharmacy, in particular to a preparation method of highly stable amlodipine atorvastatin calcium tablets. Background technique [0002] High blood pressure and dyslipidemia are important risk factors for atherosclerosis, coronary heart disease and other cardiovascular and cerebrovascular diseases. Cardiovascular disease is already one of the most common and serious diseases that endanger human health. The survey shows that hyperlipidemia among the middle-aged and elderly people in my country has accounted for more than 50%, and the total incidence rate of the population is 7-8%. It is reported that 43% of patients with hyperlipidemia suffer from hypertension. Therefore, it is of great social and economic significance to develop a drug that can treat both hypertension and hyperlipidemia. Patent CN101185646A discloses a pharmaceutical composition of amlodipine and atorvastatin calcium, which is used for ...

Claims

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Application Information

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IPC IPC(8): A61K31/4422A61K9/32A61K9/36A61K47/38A61P3/06A61P9/12A61P9/10A61K31/40
Inventor 苏小楠高超蒋玲敏邹江杨琰王文峰白沙沙
Owner CHINA RESOURCES SAIKE PHARMA
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