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Levamlodipine besylate tablets

A technology of levamlodipine besylate and levo-amlodipine besylate, which is applied in the field of levamlodipine besylate tablets, can solve the problems of complex process, increase of impurities, and decrease of hygroscopicity, and achieve low impurity content and complete dissolution , the effect of stable quality

Active Publication Date: 2012-09-19
HEBEI RENHE YIKANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Other patents may use inclusion methods to increase the stability of raw materials, but the process is complex, and they will also be in contact with water during the preparation process and heated during the drying process, which will inevitably increase impurities; or use the method of tablet film coating, Reduce its hygroscopicity and increase the stability during storage, but it adopts wet granulation process, which will also cause an increase in impurities during the preparation process, and the moisture-proof coating will also have a certain impact on dissolution; patent 200910186862.7 uses a new type of tablet press powder feeding Powder
Dry powder compression, but did not provide quality, stability and dissolution data, and the problem of moisture resistance of the preparation has not been resolved

Method used

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  • Levamlodipine besylate tablets
  • Levamlodipine besylate tablets
  • Levamlodipine besylate tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1～3

[0018] Embodiment 1~3 Levoamlodipine besylate tablet

[0019] Example

[0020] Preparation process: Mix the prescribed amount of levamlodipine besylate and pregelatinized starch, then add other ingredients, mix evenly, and press into tablets to obtain the product.

experiment example 1

[0021] Experimental Example 1 Stability study under high temperature conditions (60°C, without packaging)

[0022] The levamlodipine besylate sheet that embodiment 1~3 makes is detected by national standard WS1-(X-020)-2002Z, and compares with reference drug 1-3, and the result is as follows:

[0023]

[0024] *Comparative sample 1: prepared according to Example 1 of ZL201010134110.9 (the same below).

[0025] **Comparative drug 2: prepared according to Example 1 of CN200910186862.7 (the same below).

[0026] ***Comparative drug 3: prepared according to Example 1 of ZL200910147904.6 (the same below).

experiment example 2

[0027] Experimental Example 2 Stability study under high humidity conditions (25°C, RH92.5%, no packaging)

[0028] The levamlodipine besylate sheet that embodiment 1~3 makes is detected by national standard WS1-(X-020)-2002Z, and compares with reference drug 1-3, and the result is as follows:

[0029]

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PUM

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Abstract

The invention provides levamlodipine besylate tablets. The levamlodipine besylate tablets have the characteristics of high stability, low impurity content, complete dissolution and the like.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a levamlodipine besylate tablet. Background technique [0002] Levoamlodipine besylate, namely (-) 3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro -6-Methyl-3,5-pyridinedicarboxylate benzenesulfonate is a calcium channel blocker, which blocks extracellular calcium ions from cardiac muscle and vascular smooth muscle from entering cells through the calcium channel (slow channel) of the cell membrane, Direct relaxation of vascular smooth muscle, has antihypertensive effect. The mechanism of action of this product for relieving angina pectoris has not been fully determined, but it can reduce myocardial ischemia through the following effects: expand peripheral arterioles, reduce peripheral resistance (afterload), thereby reducing myocardial energy consumption and oxygen demand; normal expansion and ischemia The coronary arteries and coronary arterioles in the region i...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4422A61K47/38A61P9/12
Inventor 李春英
Owner HEBEI RENHE YIKANG PHARMA
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