Chlorpheniramine maleate compound and pharmaceutical composition thereof

A technology of chlorpheniramine acid compound and composition, which is applied in the field of chlorpheniramine maleate compound and pharmaceutical composition thereof, can solve problems such as complicated preparation method, and achieves enhancement of drug efficacy, narrowing of gap and peak time and half-life shortening effect

Active Publication Date: 2014-05-14
ANHUI YOUCARE KAIYUE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Although the above method effectively controls the absorption and utilization of three different drug active ingredients in the body, so that the blood drug concentration of the three drug active ingredien

Method used

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  • Chlorpheniramine maleate compound and pharmaceutical composition thereof
  • Chlorpheniramine maleate compound and pharmaceutical composition thereof
  • Chlorpheniramine maleate compound and pharmaceutical composition thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] [embodiment 1] the preparation of chlorpheniramine maleate compound

[0056] 1) Prepare the crude product solution: add the crude chlorpheniramine maleate into a mixed solvent prepared from chloroform and ethanol, heat to 50°C, stir to dissolve, filter to remove insoluble particles, and obtain a crude product solution for later use;

[0057] 2) Preparation of a crystallization solvent: prepare a crystallization solvent with acetone and diethyl ether at a volume ratio of 1.0:10, and the volume of the crystallization solvent is 10 times the weight of the crude chlorpheniramine maleate;

[0058] 3) Crystallization: under stirring, add the crystallization solvent obtained in step 2) to the crude product solution obtained in step 1), and solids precipitate out; 4 times the weight of the crude product of pheniramine, the temperature of the solution is controlled at 50°C during the whole dropping process; after dropping, cool to 5°C and let stand for 3h, filter, wash, and dry ...

Embodiment 2-9

[0062]

[0063] The obtained chlorpheniramine maleate compound of embodiment 2-9 is measured with powder X-ray diffractometry, and the X-ray powder diffraction pattern that represents with 2θ ± 0.2 ° diffraction angle is the same as embodiment 1.

preparation Embodiment 1

[0064] [Preparation Example 1] Preparation of Ibuprofen Pseudopheniramine Tablets

[0065] prescription:

[0066] Tablets:

[0067]

[0068] Preparation:

[0069] (1) Weigh the raw and auxiliary materials according to the stated dosage; pulverize the ibuprofen and pseudoephedrine hydrochloride so that they all pass through a 80-mesh sieve, and set aside; grind the chlorpheniramine maleate through a 100-mesh sieve, and set aside;

[0070] (2) Preparation of adhesive: take another 12.1g of starch, add 18.15g of purified water, stir and mix to obtain a starch suspension; add 1.8g of polysorbate 80 to 102.85g of purified water and boil it, then add it under stirring Put it into the starch suspension to get starch paste, weigh it, subtract the actual weight from the theoretical weight of 134.9g, calculate the purified water lost in the process of boiling water, supplement the lost part to the theoretical amount, and make 10% starch paste, put Cool to 50-60°C for later use;

...

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PUM

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Abstract

The invention belongs to the technical field of medicine, and particularly relates to a chlorpheniramine maleate compound and a pharmaceutical composition of the chlorpheniramine maleate compound. The chlorpheniramine maleate compound has a chemical structure formula seen in the formula (I) and is measured through an X-ray power diffraction measurement method, and an X-ray power diffraction pattern which is expressed by a diffraction angle of 2 theta+/-0.2 degrees can be seen in the drawing 1. The chlorpheniramine maleate compound is a new crystal form compound different from existing chlorpheniramine maleate in the prior art. The time to peak and the half-life period of chlorpheniramine in pseudoephedrine hydrochloride and chlorphenamine maleate tablets prepared through the new crystal form compound are obviously shortened, the differences between the time to peak and the half-life period of the chlorpheniramine and the time to peak and the half-life period of ibuprofen and the differences between the time to peak and the half-life period of the chlorpheniramine and the time to peak and the half-life period of the pseudoephedrine hydrochloride are reduced, time for allowing concentration of active ingredients of the three types of medicine in blood to reach the effective concentration and time for allowing activity of the active ingredients of the three types of medicine to fade away are kept the same as much as possible, and therefore the pharmacological function of the pseudoephedrine hydrochloride and chlorphenamine maleate tablets is enhanced cooperatively.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to a chlorpheniramine maleate compound and a pharmaceutical composition thereof. Background technique [0002] Ibuprofen is an effective prostaglandin synthase inhibitor with antipyretic, analgesic and anti-inflammatory effects; it is almost insoluble in water, but easily soluble in sodium hydroxide or sodium carbonate test solution. It is easy to absorb after oral administration and rectal absorption after administration. Tmax (representing the time taken from taking the medicine to the peak blood concentration) is about 0.92±0.33h. When the dosage is 200mg, the blood concentration is 22μg / ml~27μg / ml; When the dosage is 23μg / ml~45μg / ml; when the dosage is 600mg, it is 43μg / ml~57μg / ml. Half-life T after a single dose 1 / 2 Generally 1.82h. [0003] Pseudoephedrine hydrochloride has selective vasoconstriction, eliminates congestion and swelling of nasopharyngeal mucosa, relieves s...

Claims

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Application Information

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IPC IPC(8): C07D213/38A61K31/4402A61P29/00A61P11/02A61K31/192A61K31/137
CPCC07D213/38
Inventor 李琦杨磊
Owner ANHUI YOUCARE KAIYUE PHARMA
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