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Tablet composition of levamlodipine besylate salt hydrate, tablet made therefrom and related preparation method

A technology of levo-amlodipine besylate and dipine salt, which is applied in the fields of levo-amlodipine besylate hydrate and levo-amlodipine salt hydrate. Large-scale promotion and application, cheap and easy-to-obtain raw materials

Active Publication Date: 2018-11-09
SHIHUIDA PHARMA GRP (JILIN) LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Since levamlodipine besylate hydrate and appropriate amount of auxiliary materials are mixed and packed into capsules, the levamlodipine besylate hydrate contacts more air, and the light-shielding effect is not good.

Method used

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  • Tablet composition of levamlodipine besylate salt hydrate, tablet made therefrom and related preparation method
  • Tablet composition of levamlodipine besylate salt hydrate, tablet made therefrom and related preparation method
  • Tablet composition of levamlodipine besylate salt hydrate, tablet made therefrom and related preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] Levoamlodipine besylate salt hydrate was purchased from Shihuida Pharmaceutical Group (Jilin) ​​Co., Ltd.; starch and dextrin were purchased from Weifang Shengtai Pharmaceutical Co., Ltd.; sodium carboxymethyl starch was purchased from Weifang Lite Composite Materials Co., Ltd.; Magnesium stearate was purchased from Shandong Xinda Biotechnology Co., Ltd.

[0056] The formula is as follows:

[0057]

[0058] The active ingredient of the crude drug is levamlodipine, the weight of the above-mentioned formula pressed tablet is 125 mg, and the content of levamlodipine is 2.5 mg. Industrialized spray drying equipment prepares 90kg at a time, and calculates according to the multiple amplification of the above formula.

[0059] Brief description of the preparation process: (1) 100% starch and 50% sodium carboxymethyl starch are placed at the bottom of the spray dryer, and the wind speed is adjusted to suspend the particles in the entire space of the dryer; (2) 100% dextrin ...

Embodiment 2

[0063] The formula is as follows:

[0064]

[0065] The active ingredient of the crude drug is levamlodipine, the weight of the above-mentioned formula pressed tablet is 125 mg, and the content of levamlodipine is 1.25 mg. Industrialized spray drying equipment prepares 90kg at a time, and calculates according to the multiple amplification of the above formula.

[0066] Brief description of the preparation process: (1) 100% starch and 50% sodium carboxymethyl starch are placed at the bottom of the spray dryer, and the wind speed is adjusted to suspend the particles in the entire space of the dryer; (2) 100% dextrin is added with appropriate amount of hot water and stirred to make a paste , the paste is sprayed to the suspended particles through the nozzle, and the particles are dried after an appropriate time. The number of dried particles should be able to pass through a 100-mesh sieve. A 60-80 mesh sieve is suitable, and (4) the sieved plain granules, the pulverized raw d...

Embodiment 3

[0071] The formula is as follows:

[0072]

[0073] The active ingredient of the crude drug is levamlodipine, the weight of the above-mentioned formula compressed tablet is 125 mg, and the content of levamlodipine is 10 mg. Industrialized spray drying equipment prepares 90kg at a time, and calculates according to the multiple amplification of the above formula.

[0074] Brief description of the preparation process: (1) 100% starch and 50% sodium carboxymethyl starch are placed at the bottom of the spray dryer, and the wind speed is adjusted to suspend the particles in the entire space of the dryer; (2) 100% dextrin is added with appropriate amount of hot water and stirred to make a paste , the paste is sprayed to the suspended particles through the nozzle, and the particles are dried after an appropriate time. The number of dried particles should be able to pass through a 100-mesh sieve. A 60-80 mesh sieve is suitable, and (4) the sieved plain granules, the pulverized raw ...

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Abstract

The invention provides a tablet composition of levamlodipine besylate salt hydrate. The tablet composition of the levamlodipine besylate salt hydrate comprises the following components in part by weight: 1.84-14.75 parts of levamlodipine besylate salt hydrate, 20-60 parts of starch, 20-50 parts of dextrin, 10-40 parts of sodium carboxymethyl starch and a proper amount of magnesium stearate by which each 125 parts of the tablet composition of the levamlodipine besylate salt hydrate contains 1.25-10.0 parts of levamlodipine besylate. The invention also provides a levamlodipine besylate salt hydrate tablet prepared from the tablet composition and a related preparation method. The tablet composition of the levamlodipine besylate salt hydrate is skillful in design, the components are low in price and easy to obtain, cost is low, the prepared levamlodipine besylate salt hydrate tablet is high in stability, good in dissolution rate and good in content uniformity, requirements of hardness and friability are met under the condition of high-speed tabletting, and the tablet composition is suitable to be widely popularized and used.

Description

technical field [0001] The present invention relates to the technical field of levamlodipine salt hydrate, more specifically, to the technical field of levamlodipine besylate salt hydrate, in particular to a tablet combination of levamlodipine besylate salt hydrate Objects, tablets made therefrom, and related preparation methods. Background technique [0002] The physical and chemical properties of levamlodipine besylate salt hydrate and amlodipine besylate salt are very different, and its molecular formula and structural formula are respectively: [0003] The molecular formula of levamlodipine besylate hydrate is: C 20 h 25 ClN 2 o 5 ·C 6 h 6 o 3 S·2H 2 O, the structural formula is: [0004] [0005] The molecular formula of amlodipine besylate salt is: C 20 h 25 ClN 2 o 5 ·C 6 h 6 o 3 S, the structural formula is: [0006] [0007] The melting point of levamlodipine besylate salt hydrate is much lower than that of amlodipine besylate salt hydrate. Th...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/4422A61K47/40
Inventor 张喜田薛传校
Owner SHIHUIDA PHARMA GRP (JILIN) LTD
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