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A kind of stable oral solution of mepheniramine ammonium and preparation method thereof

An oral solution and a stable technology, which are applied in the field of fenamicin ammonium oral solution and its preparation, can solve the problems of poor inclusion compound stability, reduced ammonium chloride content, poor stability and the like, and achieve improved stability, increased solubility, The effect of improving safety

Active Publication Date: 2022-05-03
HEFEI IND PHARMA INST CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the clinical treatment of cough and phlegm tends to take effect quickly, and the inclusion process of beta-cyclodextrin is complicated, the inclusion rate is unstable, and the stability of the inclusion complex is poor.
In addition, there are many auxiliary materials in the prescription, the preparation process is complicated, and it contains preservatives, which have certain toxicity.
[0004] In addition, the study found that the mepheniramine syrup that has been on the market has poor stability, and the main drug ammonium chloride is incompatible with sucrose. During storage, brown precipitates often appear, and at the same time, the ammonium chloride content decreases.

Method used

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  • A kind of stable oral solution of mepheniramine ammonium and preparation method thereof
  • A kind of stable oral solution of mepheniramine ammonium and preparation method thereof
  • A kind of stable oral solution of mepheniramine ammonium and preparation method thereof

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Experimental program
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Effect test

Embodiment 1

[0033] Embodiment 1 (preparation of oral liquid)

[0034] Recipe ratio:

[0035]

[0036] Preparation Process:

[0037] Dextromethorphan Hydrobromide, Chlorpheniramine Maleate, Ammonium Chloride, Citric Acid, Sodium Citrate, Propylene Glycol, Cherry Essence, Amaranth are taken by weighing prescription quantity;

[0038] Add dextromethorphan hydrobromide, chlorpheniramine maleate, and ammonium chloride to propylene glycol and stir to dissolve, then add citric acid, sodium citrate, cherry essence, amaranth and part of freshly boiled and cooled purified water , stir until uniform;

[0039] Use citric acid to adjust the pH to 4.5-5.8, add freshly boiled and cooled purified water to make up to the full amount, mix for 15 minutes, and filter with a 0.45um filter. For filling, the bottle is a brown polyester bottle with a childproof cap.

Embodiment 2

[0040] Embodiment 2 (preparation of oral liquid)

[0041] Recipe ratio:

[0042]

[0043] Preparation Process:

[0044] Dextromethorphan hydrobromide, chlorpheniramine maleate, ammonium chloride, citric acid, sodium citrate, propylene glycol, apple essence, chlorophyll were weighed in prescription quantities;

[0045] Add dextromethorphan hydrobromide, chlorpheniramine maleate, and ammonium chloride to propylene glycol and stir to dissolve; then add citric acid, sodium citrate, apple essence, chlorophyll, and part of freshly boiled and cooled purified water, Stir until uniform;

[0046] Use citric acid to adjust the pH to 4.5-5.8, add freshly boiled and cooled purified water to make up to the full amount, mix for 15 minutes, and filter with a 0.45 μm filter. For filling, the bottle is a brown polyester bottle with a childproof cap.

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Abstract

The invention provides a stable oral solution of mepheniramine ammonium and a preparation method thereof. Mepheniramine ammonium oral solution of the present invention comprises dextromethorphan hydrobromide 0.03~0.3% (w / v), chlorpheniramine maleate 0.01~0.2% (w / v), ammonium chloride 0.1~3.0% % (w / v), pH regulator 0.02-5% (w / v), fragrance 0.01-2% (w / v), colorant 0.008-0.1% (w / v) and water, the oral solution It also contains 10% to 25% (w / v) of propylene glycol. The mephenamine ammonium oral solution of the present invention can take effect quickly; the prescription does not contain sucrose, which avoids incompatibility with ammonium chloride; does not contain preservatives, which improves the safety of the solution; The propylene glycol increases the solubility of dextromethorphan hydrobromide; and the propylene glycol content of 10% to 25% has obvious bacteriostasis effect, and there is no need to add preservatives.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a stable mephenamine ammonium oral solution and a preparation method thereof. Background technique [0002] Mepheniramine ammonium syrup is a marketed drug, which is a syrup composed of dextromethorphan hydrobromide, chlorpheniramine maleate and ammonium chloride, and is used to eliminate or relieve pain caused by upper respiratory tract infections and allergic reactions. Cough, thick and thick sputum, or accompanied by nasal congestion, runny nose, and sneezing. At present, there is no similar compound oral solution on the market in China. [0003] Patent CN200910180940 discloses a compound sustained-release oral solution, which achieves a sustained-release effect by encapsulating dextromethorphan with beta-cyclodextrin, and improves the taste and water solubility of dextromethorphan. However, the clinical treatment of cough and expectorant tends to take effect quick...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/485A61K31/4402A61K47/10A61K47/02A61P11/10A61P11/14
CPCA61K31/485A61K31/4402A61K9/0095A61K47/10A61K47/02A61P11/10A61P11/14A61K2300/00
Inventor 何广卫苏峰陈娟娟毕东辉王会
Owner HEFEI IND PHARMA INST CO LTD
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