Stable levocetirizine hydrochloride oral solution and preparation method thereof

A technology of levocetirizine hydrochloride and oral solution, which is applied in the field of levocetirizine hydrochloride oral solution and its preparation, can solve the problems of difficult degradation and toxicity, and achieve the effects of low toxicity, simple prescription and high safety

Inactive Publication Date: 2020-12-01
CHONGQING HUAPONT PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In the current prior art, most of the preservatives added to the composition are aromatic hydrocarbon compounds, which are toxic and difficult to degrade in the living body

Method used

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  • Stable levocetirizine hydrochloride oral solution and preparation method thereof
  • Stable levocetirizine hydrochloride oral solution and preparation method thereof
  • Stable levocetirizine hydrochloride oral solution and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 8

[0043] The preparation method of embodiment 8 levocetirizine hydrochloride oral solution

[0044] ① Dissolving sorbitol: Dissolve the prescribed amount of sorbitol in an appropriate amount of purified water, heat and control the temperature at 45°C to 50°C, stir for 30 minutes to completely dissolve the sorbitol, and then cool.

[0045]②Add auxiliary materials: add prescription amount of sodium saccharin, prescription amount of sodium acetate, prescription amount of propylene glycol, prescription amount of glycerin, and prescription amount of propionic acid into the preparation tank.

[0046] ③Adjust the pH value: add an appropriate amount of glacial acetic acid to adjust the pH value to 5.0-5.6 to obtain a matrix solution.

[0047] ④Add the main drug and supplement purified water: add an appropriate amount of purified water, add levocetirizine hydrochloride to it, and stir until the main drug is completely dissolved. Then add pure water to the solution until the volume of th...

Embodiment 9

[0048] Embodiment 9 antibacterial efficacy experiment

[0049] Examples 1-7 and Comparative Examples 1 and 2 were all prepared according to the above-mentioned process, and their antibacterial efficacy was tested, specifically referring to the antibacterial efficacy inspection method 1121 of the Four General Rules of the Chinese Pharmacopoeia 2015 Edition. The results are shown in Table 2.

[0050] Table 2 Bacteriostatic efficacy test results

[0051]

[0052] The test results show that the levocetirizine hydrochloride oral solution prepared in Examples 1-7 meets the judgment standard of "oral preparation" under the general rule 1121 antibacterial efficacy test method of the Chinese Pharmacopoeia 2015 edition. The effective antibacterial effect can be maintained in the range of 0.05%-0.15% propionic acid volume percentage.

Embodiment 10

[0053] Embodiment 10 taste test experiment

[0054] The mouthfeel test was carried out on 30 healthy subjects in a blind method, and the results are shown in Table 3.

[0055] Table 3 taste test experiment and results

[0056]

[0057] Note: +++ means good taste, ++ means good taste, + means average taste, - means poor taste, -- means poor taste.

[0058] In the experimental results, more than half of the 30 subjects rated the mouthfeel of Example 5 as good, and the acceptability of Examples 1, 2, 3, 4, 6, 7 and Comparative Example 1 was better. Mouthfeel evaluations for Example 2 were generally poor and poor. It shows that when the volume percentage of propionic acid exceeds 0.15%, the mouthfeel is sour, and the acceptance among the crowd is low.

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Abstract

The invention belongs to the field of pharmaceutical preparations, and particularly relates to a stable levocetirizine hydrochloride oral solution and a preparation method thereof. According to the levocetirizine hydrochloride oral solution, propionic acid is used as a preservative, and a volume percentage of propionic acid in the levocetirizine hydrochloride oral solution is 0.05%-0.15%. Propionic acid is added into the levocetirizine hydrochloride oral solution, and compared with a traditional preservative, propionic acid has the same preservative effect, and is smaller in toxicity and higher in safety. The levocetirizine hydrochloride oral solution prepared by the invention has the advantages of high stability, simple prescription, smaller preservative toxicity and higher safety, and the method for preparing the levocetirizine hydrochloride oral solution is simple to operate and easy for industrial production.

Description

[0001] This patent is a divisional application for the invention of "a stable levocetirizine hydrochloride oral solution and its preparation method". The original application number is: 201711338009.3, and the application date is December 14, 2017. technical field [0002] The invention belongs to the field of pharmaceutical preparations, in particular to a stable levocetirizine hydrochloride oral solution and a preparation method thereof. Background technique [0003] Chronic urticaria is a relatively common skin disease. The age span of its onset is large and there are repeated attacks. After the onset, patients often have obvious symptoms such as wheals and itching, which affect the quality of life of patients. At present, the etiology of chronic urticaria in most patients cannot be determined, which increases the difficulty of clinical drug treatment. [0004] The specific pathogenesis of chronic urticaria is not yet clear, but existing clinical studies have shown that d...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/12A61K31/495A61P17/00A61P37/08
CPCA61K47/12A61K9/0095A61K31/495A61K9/08A61P17/00A61P37/08Y02A50/30
Inventor 刘均胜许佳杨平高保川肖丽黄真
Owner CHONGQING HUAPONT PHARMA
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