Stable levocetirizine hydrochloride oral solution and preparation method of same

A technology of levocetirizine hydrochloride and oral solution, which is applied in the field of levocetirizine hydrochloride oral solution and its preparation, can solve problems such as toxicity and difficult to degrade, and achieve the effects of low toxicity, good stability and simple prescription

Inactive Publication Date: 2018-03-23
CHONGQING HUAPONT PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In the current prior art, most of the preservatives added to the composition ar...

Method used

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  • Stable levocetirizine hydrochloride oral solution and preparation method of same
  • Stable levocetirizine hydrochloride oral solution and preparation method of same
  • Stable levocetirizine hydrochloride oral solution and preparation method of same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 8

[0042] The preparation method of embodiment 8 levocetirizine hydrochloride oral solution

[0043] 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.

[0044] 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.

[0045] 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.

[0046] 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 the...

Embodiment 9

[0047] Embodiment 9 antibacterial efficacy experiment

[0048] 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.

[0049] Table 2 Bacteriostatic efficacy test results

[0050]

[0051] 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

[0052] Embodiment 10 taste test experiment

[0053] The mouthfeel test was carried out on 30 healthy subjects in a blind method, and the results are shown in Table 3.

[0054] Table 3 taste test experiment and results

[0055]

[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 medicine preparations, and particularly relates to a stable levocetirizine hydrochloride oral solution and a preparation method of same. Propionic acid is used asa preservative in the oral solution, volume percentage of the propionic acid being 0.05-0.15% in the oral solution. In the levocetirizine hydrochloride oral solution, the propionic acid is added, sothat the preservative effect as same as that of conventional preservatives is achieved, while toxicity is reduced and safety is increased. The levocetirizine hydrochloride oral solution has high stability and simple formula, is lower in toxicity of the preservative and has better safety. The preparation method is simple in operations and is easy to carry out industrially.

Description

technical field [0001] 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 [0002] 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. [0003] The specific pathogenesis of chronic urticaria is not yet clear, but existing clinical studies have shown that drugs, chronic infections, food, etc. may cause chronic urticaria. The onset of chronic urticaria has caused great distress to the daily life of the patient, thus affecting the patient's mental state and work. Levocetirizine is developed on the basis...

Claims

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Application Information

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IPC IPC(8): A61K47/12A61K9/08A61K31/495A61P17/00
CPCA61K9/0095A61K9/08A61K31/495A61K47/12A61P17/00A61P37/08Y02A50/30
Inventor 刘均胜许佳杨平高保川肖丽黄真
Owner CHONGQING HUAPONT PHARMA
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