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Preparation process of amlodipine besylate tablet

A technology of amlodipine besylate tablets and amlodipine besylate, applied in pill delivery, cardiovascular system diseases, drug combination, etc., can solve the problems of poor therapeutic effect of variant angina pectoris, achieve excellent therapeutic effect, Guarantee the effect of product quality and reasonable design of preparation process

Inactive Publication Date: 2017-11-21
KANGBOSHI PHARMA LIAONING
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, the amlodipine besylate sheet medicine is relatively poor for the treatment of essential hypertension and chronic stable angina variant angina pectoris, and still cannot meet the needs of use. Therefore, the invention provides a kind of amlodipine besylate sheet. Preparation process to standardize and standardize the production process to ensure product quality

Method used

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  • Preparation process of amlodipine besylate tablet
  • Preparation process of amlodipine besylate tablet
  • Preparation process of amlodipine besylate tablet

Examples

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Comparison scheme
Effect test

Embodiment 1

[0028] A kind of preparation technology of amlodipine besylate sheet, comprises the following steps:

[0029] (1) Material preparation process: the amlodipine besylate sheet is made of the following raw materials: amlodipine besylate, microcrystalline cellulose, starch, anhydrous calcium hydrogen phosphate, sodium carboxymethyl starch, starch paste, Medicinal alcohol, magnesium stearate and talc;

[0030] The workshop issues batch production instructions and batch packaging instructions according to the production plan of the production department and fills in the requisition list respectively. The preparation workshop executes the requisition list and goes to the raw and auxiliary material warehouse to receive amlodipine besylate, microcrystalline cellulose, starch, and anhydrous hydrogen phosphate Calcium, carboxymethyl starch sodium, starch paste, medicinal ethanol, magnesium stearate and talcum powder; get PVC hard sheets, aluminum foil, instructions, small boxes, and cart...

Embodiment 2

[0076] A kind of preparation technology of amlodipine besylate sheet, what embodiment 2 is different from embodiment 1 is: step (3) weighing batching process: take by weighing following raw material according to parts by weight: amlodipine besylate 3kg, Starch 30kg, anhydrous calcium hydrogen phosphate 6kg, carboxymethyl starch sodium 8kg, microcrystalline cellulose 25kg, starch paste 4kg, medicinal ethanol 10kg, magnesium stearate 0.1kg, talcum powder 0.1kg; step (4) wet granulation Process: including the following steps: take 3kg of starch and put it into a granulator, add 3kg of amlodipine besylate, 6kg of anhydrous calcium hydrogen phosphate, mix for 5 minutes, then add 4kg of sodium carboxymethyl starch and mix for 5 minutes, then add microcrystalline 10kg of cellulose, mixed for 5 minutes, finally added the remaining starch and microcrystalline cellulose and mixed for 30 minutes, added 50kg of binder, started the stirring level I, chopped the first level, mixed for 600 se...

Embodiment 3

[0078] A kind of preparation technology of amlodipine besylate sheet, what embodiment 3 is different from embodiment 1 is: step (3) weighing batching process: take by weight following raw material: amlodipine besylate 4kg, 40kg of starch, 3.5kg of anhydrous calcium hydrogen phosphate, 15kg of sodium starch glycolate, 32kg of microcrystalline cellulose, 8kg of starch paste, 15kg of medicinal ethanol, 1kg of magnesium stearate, 1kg of talcum powder; step (4) wet granulation process : comprising the following steps: get 5kg of starch and put it into a granulator, add 4kg of amlodipine besylate, 3.5kg of anhydrous calcium hydrogen phosphate, mix for 5 minutes, then add 6kg of sodium starch glycolate and mix for 5 minutes, then add microcrystalline 15kg of cellulose, mixed for 5 minutes, and finally added the remaining starch and microcrystalline cellulose and mixed for 30 minutes, added 50kg of binder, started the stirring stage I, chopped the stage I, mixed for 600 seconds, and ma...

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Abstract

The invention discloses a preparation process of an amlodipine besylate tablet. The preparation process comprises the following steps: (1) material preparation process: the amlodipine besylate tablet is prepared from the following raw materials: amlodipine besylate, microcrystalline cellulose, starch, anhydrous calcium hydrophosphate, carboxymethyl starch sodium, starch paste, medicinal ethanol, magnesium stearate and talcum powder; (2) raw auxiliary material pretreatment process; (3) ingredient weighing process; (4) wet-process granulation process; (5) granulating and total mixing process; (6) tableting process; (7) aluminum plastic packaging process; (8) finished product packaging process. The preparation process of the amlodipine besylate tablet, disclosed by the invention, has the beneficial effects that the design is reasonable, the production process is normalized and standardized, and the product quality is ensured; the amlodipine besylate tablet prepared by the preparation process disclosed by the invention has an excellent treatment effect on essential hypertension, chronic stable angina and variant angina.

Description

technical field [0001] The invention relates to a pharmaceutical composition, in particular to a preparation process of amlodipine besylate tablets. Background technique [0002] Amlodipine besylate is a dihydropyridine calcium antagonist (calcium antagonist or slow channel blocker). The contraction of cardiac and smooth muscles depends on the entry of extracellular calcium ions into the cells through specific ion channels. This product selectively inhibits the transmembrane entry of calcium ions into smooth muscle cells and cardiomyocytes, and its effect on smooth muscle is greater than that on cardiac muscle. Product name: The legal name is Amlodipine Besylate Tablets; the English name is Amlodipine Besylate Tablets. [0003] At present, the amlodipine besylate sheet medicine is relatively poor for the treatment of essential hypertension and chronic stable angina variant angina pectoris, and still cannot meet the needs of use. Therefore, the invention provides a kind of ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4422A61K47/38A61P9/10A61P9/12
CPCA61K9/2059A61K31/4422
Inventor 张丽慧
Owner KANGBOSHI PHARMA LIAONING
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