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Brand new drug composition and preparation method thereof

A composition and drug technology, applied in the field of medicine, can solve the problems of not giving more technical inspiration, not specifically disclosing the composition and dosage of excipients and their preparation methods, etc., so as to prevent congestive heart failure and the incidence of adverse reactions Low, reduce the effect of adverse reactions

Active Publication Date: 2012-09-26
HAINAN JINRUI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But, how to select suitable adjuvant type and dosage to provide a kind of pharmaceutical composition containing levamlodipine besylate and fosinopril sodium two kinds of pharmaceutical active ingredients, and adopt suitable method to prepare into suitable dosage form, now There are no more technical inspirations given in the technology
Although CN101653440A discloses a composition containing amlodipine salt and puril, it does not specifically disclose the composition and dosage of auxiliary materials in the pharmaceutical composition with amlodipine and fosinopril sodium as active ingredients and its preparation method

Method used

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  • Brand new drug composition and preparation method thereof
  • Brand new drug composition and preparation method thereof
  • Brand new drug composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0097] [embodiment 1] preparation of levamlodipine besylate crystal

[0098] 1) dissolving levamlodipine besylate in a mixed solvent of dichloromethane and ethanol to obtain a dichloromethane / ethanol solution of levamlodipine besylate;

[0099] 2) Add n-heptane dropwise to the dichloromethane / ethanol solution of levamlodipine besylate obtained in step 1) under an ultrasonic field until crystallization occurs;

[0100] 3) Turn off the ultrasonic field, let stand, filter, wash the filter cake with dichloromethane and ethanol respectively, and dry to obtain the levamlodipine besylate crystal.

[0101] Gained levamlodipine besylate crystals use Cu-K α rays to measure characteristic peaks in the X-ray powder diffraction pattern that are 8.0°, 12.1°, 15.4°, 17.0°, 19.8°, 21.6°, 23.0° at 2θ °, 24.3°, 25.7°, 27.4°, 30.7° and 33.5° display, such as figure 1 shown.

[0102] Below is embodiment 2-9, and preparation method is with embodiment 1, and its concrete process parameter is sho...

Embodiment 3

[0118] The sieving in step 1) of embodiment 3 and embodiment 4 is to pass through a 100 mesh sieve, the drying in step 2) is to dry at 80°C for 2 hours, and the sieving is to pass through a 80 mesh sieve;

Embodiment 5

[0119] The sieving in step 1) of Example 5 and Example 6 is to pass through a 90-mesh sieve, the drying in step 2) is to dry at 70°C for 3 hours, and the sieving is to pass through a 70-mesh sieve;

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Abstract

The invention relates to a brand new drug composition and a preparation method thereof. The drug composition is prepared from the following active ingredients and pharmaceutical excipients in parts by weight: 2-10 parts of levamlodipine besylate, 10-100 parts of fosinopril sodium, 40-120 parts of microcrystalline cellulose, 30-90 parts of pregelatinized starch, 5-25 parts of croscarmellose sodium, 3-7 parts of silica and 1-3 parts of magnesium stearate, wherein levamlodipine besylate and fosinopril sodium are taken as the active ingredients. The drug composition has a treatment effect on suchcardiovascular diseases as hypertension, angina and the like, is better, has good stability, is faster in disintegration, can realize simultaneous release of levamlodipine besylate and fosinopril sodium in the same drug and ensures levamlodipine besylate and fosinopril sodium to have excellent dissolution rates. The method adopts a direct powder compression technology, has the advantages of simple technology, short production period and low production cost and is easy to realize industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a brand-new pharmaceutical composition with levoamlodipine besylate and fosinopril sodium as active ingredients and a preparation method thereof. Background technique [0002] Fosinopril, Chinese alias: 4-cyclohexyl-1-[[[2-methyl-1-(1-propionyloxy)propoxy](4-phenylbutyl)phosphinyl]acetyl] -L-proline, English name: Fosinopril, molecular formula: C 30 h 46 NO 7 P, molecular weight: 563.66, structural formula as follows: [0003] [0004] Fosinopril is a new phosphorus-containing angiotensin-converting enzyme inhibitor (ACEI) drug that was launched in China in 2007. As a prodrug, it has a weak direct inhibitory effect on ACE, but it is slowly and incompletely absorbed after oral administration, and is rapidly transformed into a more active diacid metabolite fosinoprilat. Fosinoprilat inhibits ACE activity through the combination of secondary phosphate groups and...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/675A61K31/4422A61K9/28A61P9/12A61P9/10
Inventor 马鹰军钟正明罗韬王小树
Owner HAINAN JINRUI PHARMA CO LTD