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Compound drug for curing colds and preparation technology thereof

A technology of compound prescriptions and medicines, which is applied in the field of compound medicines for the treatment of colds and its preparation technology, can solve problems such as reaching the therapeutic concentration at the same time and maintaining it for a certain period of time, unbalanced release of active ingredients of the medicine, and large differences in blood drug concentration curves. Improve bioavailability, improve medical compliance, and take convenience

Active Publication Date: 2010-05-05
TIANSHENG PHARMA GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the differences in the absorption and half-life of the above three drugs, the plasma concentration curves of the three drugs are quite different, and the therapeutic concentration cannot be reached at the same or similar time and maintained for a certain period of time. If taken frequently, it may cause drugs with long half-lives not to be eliminated in time, thus accumulating in the body, resulting in some side effects; drugs with short half-lives cannot maintain effective blood drug concentration and fail to achieve therapeutic effect
[0006] At present, the compound drug containing the active ingredients of the above three drugs has been listed in the United States. It is a common preparation made by conventional traditional preparation technology. The absorption and half-life of each drug are different, the release of active ingredients of each drug is uneven, and the drug effect is not ideal

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] A compound medicine for treating colds, which comprises the following components: in parts by weight, ibuprofen 200g, pseudoephedrine hydrochloride 30g, chlorpheniramine maleate 2g, hydroxypropyl methylcellulose 30g, polyethylene glycol 6000 3g, 50g of cross-linked PVP, 70g of lactose, 0.05g of Tween 80 aqueous solution of 0.04~0.06g / ml and 5g of magnesium stearate; make tablets according to the following steps:

[0051] A. Take 170g of ibuprofen powder, pass the above-mentioned pseudoephedrine hydrochloride powder through a 100-mesh sieve, take 29.85g of hydroxypropyl methylcellulose powder, put it in a fluidized bed of a boiling granulator, mix evenly, and heat to 60-80°C Dissolve the rest of the hydroxypropyl methylcellulose in a 50% ethanol solution by volume to form a 1% hydroxypropylmethylcellulose solution, add the 1% hydroxypropylmethylcellulose Vegetable solution is granulated at high speed, and the spraying is stopped when the granules are well formed; after d...

Embodiment 10

[0058] A compound medicine for treating colds, which comprises the following components: in parts by weight, ibuprofen 100g, pseudoephedrine hydrochloride 17g, chlorpheniramine maleate 1.5g, hydroxypropyl methylcellulose 19g, polyethylene glycol 1.8g of alcohol 6000, 35g of cross-linked PVP, 0.03g of 0.04-0.06g / ml Tween 80 aqueous solution and 2.8g of silicon dioxide; make capsules according to the following steps:

[0059] A. 80g of ibuprofen, pseudoephedrine hydrochloride and 99.95g of hydroxypropyl methylcellulose were crushed through a 100-mesh sieve respectively, mixed evenly with a high-efficiency wet granulator, and 0.05g of hydroxypropylmethylcellulose was dissolved in A 1% hydroxypropyl methylcellulose solution by mass percentage is prepared in an ethanol solution with a volume percentage of 50%, and the 1% hydroxypropyl methylcellulose solution is added to high-speed granulation, and dried to obtain sustained-release granules;

[0060] B. Mix chlorpheniramine maleate...

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PUM

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Abstract

The invention relates to a compound drug for curing colds and a preparation technology thereof. The compound drug consists of active components of Ibuprofen, pseudoephedrinehydrochloride, chlorphenamine maleate with effective doses and proper amount of pharmaceutic adjuvants, which is characterized by preparing lbuprofen with a partial effective dose and pseudoephedrinehydrochloride with an effective dose into a sustained-release preparation; preparing ibuprofen with a residual effective dose and chlorphenamine maleate with an effective dose into an immediate-release preparation; and preparing the sustained-release preparation and the immediate-release preparation into various drug preparations according to conventional methods. The invention adopts the sustained-release technology and the immediate-release technology, effectively controls absorption and use of the three different drug active components in vivo, enables the blood concentration of the three drug active components to achieve effective curative concentration and coincidence in decreasing time, thus enhancing the pesticide effect of the compound drug in the invention cooperatively and improving bioavailability of the compound drug in the invention.

Description

technical field [0001] The invention relates to a compound medicine for treating colds and a preparation process 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 one dose 1 / 2 Generally 1.82h. [0003] Pseudoephedrine hydrochloride has selective vasoconstriction, eliminates congestion and swelling of nasopharyngeal mucosa, relieves symptoms such as nasal congestion, is easily dissolved in wat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4402A61K31/192A61K31/137A61K9/24A61K9/52A61P29/00
Inventor 李天泉谈宗华昝琼
Owner TIANSHENG PHARMA GROUP
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