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Nifedipine composition and preparation method thereof

A technology for nifedipine and nifedipine, which is applied in directions such as drug combinations, pharmaceutical formulations, and non-active ingredients medical preparations, can solve problems such as increasing economic costs, reducing medication compliance, and increasing coating processes, thereby improving the The effect of stability, maintaining drug content and stable release

Active Publication Date: 2022-07-15
DISHA PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

During the preparation process, it needs to be protected from light all the time. The finished product often needs to be coated or packaged in brown aluminum-plastic packaging to avoid light. The increase of the coating process increases the economic cost, and it needs to be taken immediately after being taken out of the aluminum-plastic plate. The elderly It is often easy to ignore light-proof storage after medication, which greatly reduces the compliance of medication

Method used

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  • Nifedipine composition and preparation method thereof
  • Nifedipine composition and preparation method thereof
  • Nifedipine composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Example 1. Prescription:

[0022] Material name Dosage share Nifedipine 20g 20 servings microcrystalline cellulose 118g 118 servings pregelatinized starch 45g 45 servings alginate 10g 10 servings sodium bicarbonate 5g 5 servings Sodium stearate 2g 2 servings

[0023] Preparation:

[0024] Step 1: Adhesive preparation: Weigh 10g of kainate and add it into purified water at 75°C to prepare a solution with a concentration of 8%, add 5g of sodium bicarbonate, and measure pH=7.02. Then, 20 g of nifedipine was added, and the mixture was homogenized by a laboratory high-shear dispersing homogenizer emulsifier with a rotating speed of 25,000 rpm.

[0025] Step 2: Dry mixing: Weigh 118 g of microcrystalline cellulose and 45 g of pre-interleaved starch, add them to a wet granulator, set a stirring speed of 300 rpm and a chopping speed of 600 rpm, and mix for 5 minutes.

[0026] Step 3: Granulation: The mixed solut...

Embodiment 2

[0032] Material name Dosage share Nifedipine 20g 20 servings microcrystalline cellulose 130g 130 servings pregelatinized starch 35g 35 servings alginate 6g 6 servings sodium bicarbonate 8g 8 servings Sodium stearate 1g 1 serving

[0033] Preparation method: 1000 tablets were prepared with reference to the preparation method in Example 1, the difference was that 8% karate solution was prepared, 8 g of sodium bicarbonate was added, pH=7.47 was measured, and the solution was kept at 38°C, and the recipe quantity was referred to the dosage of Example 2.

Embodiment 3

[0035] Material name Dosage share Nifedipine 20g 20 servings microcrystalline cellulose 104g 104 servings pregelatinized starch 55g 55 servings alginate 14g 14 servings sodium bicarbonate 4g 4 parts Sodium stearate 3g 3 copies

[0036] Preparation method: prepare 1000 pieces with reference to the preparation method of Example 1, the difference lies in the configuration and configuration of 8% kelp solution, add 4g of sodium bicarbonate, measure pH=6.52, the solution is kept at 42°C, and the recipe quantity refers to the dosage of Example 3 .

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Abstract

The invention relates to a preparation method of a composition, in particular to a preparation method of a nifedipine sustained-release composition, and belongs to the technical field of pharmaceutical preparations. According to the nifedipine sustained-release tablet, the red algae glue and the sodium bicarbonate are added into the medicine auxiliary materials, the stability and stable release of the nifedipine sustained-release tablet under the illumination condition are remarkably improved through combined use of the red algae glue and the sodium bicarbonate, meanwhile, the nifedipine sustained-release tablet can be randomly broken at equal proportion to be taken, and each part can keep uniform medicine content and stable release.

Description

technical field [0001] The invention relates to a preparation method of a composition, in particular to a preparation method of a nifedipine sustained-release composition, and belongs to the technical field of pharmaceutical preparations. Background technique [0002] Nifedipine, chemical name is 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydro-3,5-pyridinedicarboxylic acid dimethyl ester, molecular formula is C 17 H 18 N 2 O 6 , molecular weight is 346.34, CAS number is 21829-25-4, yellow crystalline powder, easily soluble in acetone or chloroform, slightly soluble in ethanol, almost insoluble in water. [0003] Nifedipine is a first-generation calcium antagonist, a calcium ion inflow blocker developed and marketed by the German Bayer Company in the 1970s. It can increase coronary blood flow, inhibit myocardial contraction, relieve angina pectoris, and has a rapid effect. It is one of the safe and effective first-line antihypertensive drugs currently recognized as one of the ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4422A61K47/36A61K47/02A61P9/12
CPCA61K31/4422A61K9/205A61K9/2009A61P9/12
Inventor 杨德斌都书晓梁君
Owner DISHA PHARMA GRP
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