Drop pills of amlodipine maleate and preparation method thereof

A kind of technology of amlodipine maleate and maleic acid, which is applied in the field of medicines with special dosage forms, preparation of medicines, and medicines for treating hypertension and angina pectoris

Inactive Publication Date: 2006-12-20
TIANNIAN PHARMA HARBIN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Currently only tablets a...

Method used

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  • Drop pills of amlodipine maleate and preparation method thereof
  • Drop pills of amlodipine maleate and preparation method thereof
  • Drop pills of amlodipine maleate and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

specific Embodiment approach 1

[0075] (1) material preparation

[0076] According to the active ingredient of the drug is amlodipine maleate, the matrix is ​​polyethylene glycol 1500-20000, stearic acid, sodium stearate, glycerin gelatin, poloxamer, polyoxyl 40 stearate, shellac , polyoxyethylene monostearate, polyether, sodium carboxymethyl starch or sodium lauryl sulfate pharmaceutical excipients or a mixture of two or more of them in any proportion, maleic acid The ratio of amlodipine to the substrate is 1:2-10 in g or Kg; according to the composition of the membrane material, it is hypromellose 1.0-1.2g, titanium dioxide 0.8-1.0g, talcum powder 1.0-1.2g, iron oxide yellow 0.10-0.15g, polysorbate-80 0.4-0.5g, add 80% ethanol to 50ml ratio to prepare raw materials;

[0077] (2) Preparation of dropping pills

[0078] a. Pass the raw materials through a 100-120 mesh sieve, weigh polyethylene glycol-6000 and poloxamer in proportion, heat and melt them in a water bath at 80°C, cool to 65°C and add the presc...

specific Embodiment approach 2

[0084] (1) material preparation

[0085] Containing amlodipine maleate 6.42g, polyethylene glycol-6000 35g, poloxamer 6g in the dropping pills of 47.5mg per 1000 pills; The drop pill that every pill weight is 47.5mg needs hypromellose 1.0g, titanium dioxide 0.8g, talcum powder 1.0g, iron oxide yellow 0.15g, polysorbate-80 0.4g, 80% ethanol to add to the ratio preparation of 50ml good membrane material;

[0086] (2) Preparation of dropping pills

[0087] a. Pass the raw materials through a 100-120 mesh sieve, weigh polyethylene glycol-6000 and poloxamer in proportion, heat and melt them in a water bath at 80°C, cool to 65°C and add the prescribed amount of ammonia maleate Clodipine, heat and stir at 60°C until uniform.

[0088] b. Keep warm at 60°C. After adjusting the temperature of the cooling liquid, adjust the weight of the pellets to reach the specified weight. Drop them into the simethicone cooling liquid at a constant speed. The drops will shrink, form, and solidify i...

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PUM

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Abstract

The invention relates to a maleic acid amiloride horizotnal ball and relative preparation, wherein it is formed by active maleic acid amiloride horizontal and relative base; the active component is the maleic acid amiloride horizontal; the base is the carbowax 1500-20000, geoceric acid, sodium stearate, dodecyl sodium sulfate, etc; the ratio between the maleic acid amiloride horizontal and said base is 1:2-10 as g or kg; and the invention also comprises film material whose components are hydroxypropylmethylcellulose at 1.0-1.2g, titania at 0.8-1.0g, talcum powder at 1.0-1.2g, iron oxide yellow at 0.10-0.15g, sorbate-80 at 0.4-0.5g, and 80% alcohol to be 50ml. The invention has simple operation, low cost and high effect.

Description

(1) Technical field [0001] The invention relates to a medicine, specifically a medicine for treating hypertension and angina pectoris, especially a medicine with a special dosage form. The present invention also relates to the preparation method of the medicine in this special dosage form. (2) Background technology [0002] Amlodipine, as a drug for the treatment of hypertension and angina pectoris, can be used alone or in combination with other drugs such as β-blockers or thiazide diuretics or nitrates. Amlodipine offers a broad safety profile for patients. No effect on heart rate; no effect on cardiac conduction; no effect on myocardial contractility at clinical doses in hemodynamic studies; no adverse effect on metabolic parameters (such as blood lipids, plasma insulin, blood glucose levels, or insulin sensitivity); and others Commonly used drugs have no interaction. Amlodipine is well tolerated, and the incidence of adverse reactions is less than that of nifedipine an...

Claims

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Application Information

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IPC IPC(8): A61K31/4422A61K9/20A61P9/10A61P9/12
Inventor 赵伟庆柳志强翟斌崔卫东
Owner TIANNIAN PHARMA HARBIN
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