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Compound potassium guaiacolsulfonate oral solution and preparation method thereof

A technology of potassium guaiacol sulfonate and oral solution is applied in the directions of pharmaceutical formulations, dispersion liquid delivery, medical preparations of non-active ingredients, etc. The effect of preventing oxidation

Active Publication Date: 2017-03-22
广东南国药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Compound potassium guaiacol sulfonate oral solution has low stability and is not conducive to preservation. It is prone to crystallization after long-term storage, and it is easy to oxidize and deepen in color. The drug is unstable and affects the use of the drug

Method used

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  • Compound potassium guaiacolsulfonate oral solution and preparation method thereof
  • Compound potassium guaiacolsulfonate oral solution and preparation method thereof
  • Compound potassium guaiacolsulfonate oral solution and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Preparation:

[0025] (a) dissolving the xylitol of formula quantity in the purified water that has boiled 15~20min;

[0026] (b) adding sodium citrate, citric acid, ammonium chloride, and potassium guaiacolsulfonate in the formula amount to the solution obtained in step (a) in sequence;

[0027] (c) The benzoic acid of formula quantity is completely dissolved in 50mL propylene glycol, after the solution that generates is added in the solution of step (b) gained, lemon essence is added step (b) gained solution;

[0028] (d) join the antioxidant, promethazine hydrochloride of formula quantity in the solution of step (c) gained;

[0029] (e) Add purified water and propylene glycol to the formula amount to the solution obtained in step (d), adjust the pH of the solution to 5.0-6.0 with a pH regulator, stir evenly, filter, fill, and sterilize.

Embodiment 2

[0031] 1000mL oral solution contains the following ingredients:

[0032] Promethazine hydrochloride 0.9g, potassium guaiacol sulfonate 23g, ammonium chloride 9g, citric acid 4.2g, sodium citrate 0.7g, xylitol 0.5g, benzoic acid 1.0g, lemon essence 1.0mL, 0.01g of vitamin C, appropriate amount of sodium bicarbonate, 200mL of propylene glycol, and purified water as the rest.

[0033] Repeat the preparation method in Example 1, but the antioxidant is vitamin C, the pH regulator is sodium bicarbonate, and the pH value of the adjusted solution is 5.0.

Embodiment 3

[0035] 1000mL oral solution contains the following ingredients:

[0036] Promethazine hydrochloride 1.1g, potassium guaiacol sulfonate 26g, ammonium chloride 11g, citric acid 4.5g, sodium citrate 0.73g, xylitol 2.8g, benzoic acid 1.3g, lemon essence 1.4mL, 0.3g of vitamin C, appropriate amount of sodium bicarbonate, 100mL of propylene glycol, and purified water as the rest.

[0037] Repeat the preparation method in Example 1, but the antioxidant is vitamin C, the pH regulator is sodium bicarbonate, and the pH value of the adjusted solution is 6.0.

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PUM

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Abstract

The invention relates to a medicinal composition for treating phlegm and relieving cough, and in particular relates to a high-stability compound potassium guaiacolsulfonate oral solution and a preparation method thereof. The composition comprises the following components: potassium guaiacolsulfonate, promethazine hydrochloride, ammonium chloride, citric acid, sodium citrate, xylitol, benzoic acid, an antioxidant, a pH regulator and propylene glycol and purified water as solvents. The compound potassium guaiacolsulfonate oral solution prepared by the method has the advantages of high stability during storage process, low tendency to crystallization, long validity period and the like, and effectively ensures the quality of a medicine and the safety of patient's medication.

Description

technical field [0001] The invention relates to a pharmaceutical composition for reducing phlegm and relieving cough, in particular to a highly stable compound oral potassium guaiacol sulfonate solution and a preparation method thereof. Background technique [0002] Compound potassium guaiacol sulfonate oral solution is used for cough and phlegm caused by cold and allergic bronchitis. The prescription contains potassium guaiacol sulfonate, promethazine hydrochloride, ammonium chloride and auxiliary materials. Potassium guaiacol sulfonate is a powerful expectorant, which increases the secretion of respiratory glands, dilutes sputum, and is easy to cough up; promethazine hydrochloride is an antihistamine, which can resist telangiectasia caused by allergic reactions. It reduces capillary permeability, has mild antispasmodic effect on bronchial smooth muscle, and also has obvious central stabilizing effect and certain antitussive effect; ammonium chloride is a salt expectorant,...

Claims

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Application Information

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IPC IPC(8): A61K33/20A61K9/08A61K47/10A61K47/22A61P11/14A61P11/10A61K31/5415A61K31/185
CPCA61K9/0095A61K31/185A61K31/194A61K31/5415A61K33/20A61K47/10A61K47/22A61K2300/00
Inventor 庞华兴白玉春贺登科
Owner 广东南国药业有限公司
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