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Ambroxol hydrochloride oral solution and preparation method thereof

A technology for oral administration and solution of ambroxol hydrochloride, which is applied in the field of oral ambroxol hydrochloride solution and its preparation, can solve the problems of unstable dosage form of oral solution, affecting patients' willingness to use, hidden dangers of drug safety, etc., and achieves extended shelf life and enhanced use Willingness, the effect of stable production process

Inactive Publication Date: 2015-12-30
NANJING REAL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, there are four kinds of ambroxol hydrochloride dosage forms: oral solution, tablet, capsule, and sustained-release capsule. Because the oral solution dosage form is unstable, it is generally necessary to add preservatives to prolong the shelf life, which brings hidden dangers to drug safety; and the existing product taste Poor, greatly affecting patients' willingness to use

Method used

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  • Ambroxol hydrochloride oral solution and preparation method thereof
  • Ambroxol hydrochloride oral solution and preparation method thereof
  • Ambroxol hydrochloride oral solution and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-6

[0032] Prepare ambroxol hydrochloride oral solution according to the ratio of raw materials in the following table 1:

[0033] Table 1, ambroxol hydrochloride oral solution raw material proportioning

[0034]

[0035] The preparation method is as follows:

[0036] 1) Pretreatment of raw and auxiliary materials

[0037] Grind the menthol and sodium saccharin and pass through a 60-mesh sieve for later use;

[0038] 2) Dosing

[0039] a. Add menthol to 50°C pure water, stir and dissolve to make a 3 mg / ml menthol solution; add sodium hydroxide to pure water to prepare a sodium hydroxide solution;

[0040] b. Add propylene glycol to purified water, reflux and stir for 2min; then add ambroxol hydrochloride and reflux and stir for 10min until completely dissolved; Glycerin, menthol solution and orange essence were respectively refluxed and stirred for 2 minutes until they were evenly mixed;

[0041] c. Adjust the pH with sodium hydroxide solution, make up to volume with purif...

Embodiment 7

[0048] 1. Stability testing

[0049] One group of ambroxol hydrochloride oral solution is randomly selected in embodiment 1-6 and carries out following inspection successively, and testing result is as follows:

[0050] 1) Influencing factor detection data:

[0051] a) Light factor

[0052]

[0053] b) Temperature 40°C

[0054]

[0055] c) Temperature 60°C

[0056]

[0057] 2) Low temperature freeze-thaw cycle detection

[0058] a) Low temperature cycle test data

[0059] Investigation conditions: including three cycles, each cycle should be at 4°C for 2 days, and then at 40°C for 2 days under accelerated conditions.

[0060]

[0061] b) Freeze-thaw cycle detection data

[0062] Investigation conditions: Including three cycles, each cycle should be under the condition of -10--20°C for 2 days, and then under the accelerated condition of 40°C for 2 days.

[0063]

[0064] 3) Accelerated detection

[0065]

[0066] 4) Long-term detection

[0067]

[...

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Abstract

The invention discloses ambroxol hydrochloride oral solution. Each 10 ml of the ambroxol hydrochloride oral solution comprises the followings: 30 mg of ambroxol hydrochloride, 80-120 mg of propylene glycol, 30-70 mg of a wetting agent, 750-850 mg of a corrigent, 3.5-4.1 mg of a pH buffer pair and the balance of purified water; the wetting agent is glycerinum; the corrigent is a composite of sorbitol, saccharin sodium, menthol and flavoring orange essence; the pH value of the ambroxol hydrochloride oral solution is 4.8-5.2. The invention further discloses a preparation method of the ambroxol hydrochloride oral solution. Through adjusting the formula and the pH value of the oral solution, and under the premise of not adding a preservative, the stability of the oral solution is greatly improved, the expiration date is prolonged, and the taste is better.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to an ambroxol hydrochloride oral solution and a preparation method thereof. Background technique [0002] Ambroxol is the eighth active metabolite of benzylcycline bromide, which stimulates mucociliary clearance. Ambroxol hydrochloride acts on the secretory cells of the respiratory tract, thereby inhibiting the secretion of mucous substances in the respiratory tract, and can promote the secretion of serous fluid, thereby effectively decomposing the polysaccharide fibers in the acidic protein in the sputum in the respiratory tract, And it can prevent and inhibit the synthesis of its protein, reduce and dilute the concentration of sputum, make the sputum can be easily excreted from the body, and avoid the accumulation of sputum, which has been extensively studied in clinical use. [0003] At present, there are four kinds of ambroxol hydrochloride dosage forms: oral solution, table...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/137A61K47/10A61K47/12A61K47/04A61K47/22A61P11/10
Inventor 于居超李玉凤杜显龙
Owner NANJING REAL PHARMA
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