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Parcetamol pseudoephedrine hydrochloride and dextromethorphan hydrochloride capsule and preparation method thereof

A technology of capsules and empty capsules, which is applied in capsule delivery, medical preparations containing active ingredients, and pharmaceutical formulas, etc. It can solve problems such as inability to ensure complete dissolution of acetaminophen, cumbersome operating process steps, and failure to change electrostatic adsorption. Achieve good drug synergy, easy to mix evenly, and avoid electrostatic adsorption

Active Publication Date: 2011-10-26
HAINAN HULUWA PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] Chinese patent ZL200610049248.2 discloses a preparation method of an orally disintegrating acetaminophen pseudoanaminamine tablet: acetaminophen is mixed with part of the filler and granulated, and the other two main ingredients are chlorpheniramine maleate and hydrochloric acid. Pseudoephedrine is dissolved in a coating solution to make a solution, sprayed and coated on the obtained acetaminophen granules, and then coated with a coating material for taste-masking coating on the sprayed acetaminophen granules to obtain taste-masking granules, and then Mix the obtained taste-masking granules with other excipients, and press them into tablets to obtain orally disintegrating tablets of acetaminophen and pseudoanaminamine; the preparation method is relatively cumbersome to operate, and the coating equipment is used, which increases the input cost of production, and at the same time This method cannot guarantee the complete dissolution of acetaminophen, and the prepared orally disintegrating tablets of acetaminophen and pseudoannamin will have a gritty feeling after taking, and the disintegration time limit is unqualified
The product prepared by this method has poor content uniformity and fails to change the electrostatic adsorption produced by acetaminophen

Method used

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  • Parcetamol pseudoephedrine hydrochloride and dextromethorphan hydrochloride capsule and preparation method thereof
  • Parcetamol pseudoephedrine hydrochloride and dextromethorphan hydrochloride capsule and preparation method thereof
  • Parcetamol pseudoephedrine hydrochloride and dextromethorphan hydrochloride capsule and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0039] Prescription: 200 mesh paracetamol 325g, 200 mesh anhydrous dextromethorphan hydrobromide 15g, 200 mesh pseudoephedrine hydrochloride 30g, 200 mesh polyvinylpyrrolidone 20g, 200 mesh hydroxypropyl methylcellulose 25g, 200 mesh carboxymethyl 5g sodium starch glycolate, 3.5g 200 mesh magnesium stearate and an appropriate amount of purified water.

[0040] Wherein, the adhesive polyvinylpyrrolidone needs to be configured into a 10% polyvinylpyrrolidone aqueous solution before use. The configuration method is: weigh 20 g of polyvinylpyrrolidone and 180 g of purified water, dissolve the polyvinylpyrrolidone in purified water, stir Uniformly dissolving is the aqueous solution containing 10% polyvinylpyrrolidone.

[0041] Preparation method:

[0042] (1) Take 325g of acetaminophen and 25g of hydroxypropyl methylcellulose and mix evenly to obtain a mixture, which is set aside;

[0043] (2) Add 15 g of anhydrous dextromethorphan hydrobromide and 30 g of pseudoephedrine hydroch...

Embodiment 2

[0046]Prescription: 100 mesh paracetamol 162.5g, 140 mesh anhydrous dextromethorphan hydrobromide 7.5g, 100 mesh pseudoephedrine hydrochloride 15g, 170 mesh polyvinylpyrrolidone 10g, 120 mesh hydroxypropyl methylcellulose 12.5g, 100 Mesh sodium carboxymethyl starch 2.5g, 100 mesh magnesium stearate 2g and an appropriate amount of purified water.

[0047] Wherein the binder polyvinylpyrrolidone needs to be configured into a 10% polyvinylpyrrolidone aqueous solution by weight before use. The configuration method is: weigh 10 g of polyvinylpyrrolidone and 90 g of purified water, dissolve the polyvinylpyrrolidone in purified water, stir Uniformly dissolving is the aqueous solution containing 10% polyvinylpyrrolidone.

[0048] Preparation method:

[0049] (1) Take 162.5g of paracetamol and 12.5g of hydroxypropyl methylcellulose and mix evenly to obtain the mixture, which is set aside;

[0050] (2) Add 7.5 g of anhydrous dextromethorphan hydrobromide and 15 g of pseudoephedrine hy...

Embodiment 3

[0053] Prescription: 140 mesh paracetamol 487.5g, 100 mesh anhydrous dextromethorphan hydrobromide 22.5g, 100 mesh pseudoephedrine hydrochloride 45g, 100 mesh polyvinylpyrrolidone 30g, 100 mesh hydroxypropyl methylcellulose 37.5g, 170 Mesh sodium carboxymethyl starch 7.5g, 170 mesh magnesium stearate 4g and an appropriate amount of purified water.

[0054] Wherein the binder polyvinylpyrrolidone needs to be configured into a 10% polyvinylpyrrolidone aqueous solution before use. The configuration method is: weigh 30 g of polyvinylpyrrolidone and 270 g of purified water, dissolve the polyvinylpyrrolidone in purified water, stir Uniformly dissolving is the aqueous solution containing 10% polyvinylpyrrolidone.

[0055] Preparation method:

[0056] (1) Take 487.5g of paracetamol and 37.5g of hydroxypropyl methylcellulose and mix evenly to obtain the mixture, which is set aside;

[0057] (2) Add 22.5 g of anhydrous dextromethorphan hydrobromide and 45 g of pseudoephedrine hydrochl...

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Abstract

The invention discloses a parcetamol pseudoephedrine hydrochloride and dextromethorphan hydrochloride capsule. Based on 1,000 capsules, the content of the two-component ibuprofen capsules is prepared from the following raw materials: 162.5-487.5g of paracetamol, 7.5-22.5g of anhydrous dextromethorphan hydrobromide, 15-45g of pseudoephedrine hydrochloride, 10-30g of polyvinyl pyrrolidone, 12.5-37.5g of hydroxypropyl methyl cellulose, s2.5-7.5g of odium carboxy methyl starch, 2-4g of magnesium stearate and a proper amount of purified water. The invention also discloses a preparation method of the capsules, which comprises the following steps: adding a mixed water solution of anhydrous dextromethorphan hydrobromide and pseudoephedrine hydrochloride into a mixture of paracetamol and hydroxypropyl methyl cellulose, evenly mixing, adding a polyvinyl pyrrolidone water solution, evenly mixing, making into soft wood, granulating, drying, straightening, adding sodium carboxymethyl starch and magnesium stearate, evenly mixing, and filling to obtain the two-component ibuprofen capsules. The method has low cost and a simple process, and is suitable industrial production. The produced capsules have good quality, good fluidity of paracetamol and good content uniformity, and can better exert the synergistic effect of medicinal components. Also, after administration of the two-component ibuprofen capsules, people do not have gritty feeling.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a Shuangfen pseudoephedrine capsule and a preparation method thereof. Background technique [0002] Cold and cold are acute upper respiratory tract infectious diseases caused by viruses or bacteria. Symptoms are pharyngeal congestion, swelling and pain, nasal congestion, sneezing, coughing, headache and fever, sore limbs, general malaise, etc. Although there are some medicines for treating colds in my country, there is a lack of effective medicines for comprehensive control of these symptoms. [0003] Shuangfen Pseudoephedrine Capsules is a preparation with acetaminophen (ATP), dextromethorphan hydrobromide (DMP) and pseudoephedrine hydrochloride (PE) as the active ingredients of the drug; among them, acetaminophen can regulate the body temperature through the hypothalamus And produce antipyretic effect; Pseudoephedrine hydrochloride has the selective contraction of upp...

Claims

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Application Information

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IPC IPC(8): A61K31/485A61K31/167A61K31/137A61K9/48A61P29/00A61P31/16A61P11/14
Inventor 刘全国陈克领瞿仁平
Owner HAINAN HULUWA PHARMA GRP CO LTD
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