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Composition and preparation method thereof as well as oral liquid and preparation method of oral liquid

A composition and solution technology, applied in the direction of drug combination, active ingredient of heterocyclic compound, pharmaceutical formula, etc.

Active Publication Date: 2015-06-03
BEIJING HANMI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

So far, there is still no effective solution to the incompatibility between montelukast sodium and levocetirizine hydrochloride

Method used

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  • Composition and preparation method thereof as well as oral liquid and preparation method of oral liquid
  • Composition and preparation method thereof as well as oral liquid and preparation method of oral liquid
  • Composition and preparation method thereof as well as oral liquid and preparation method of oral liquid

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] The preparation of embodiment 1 oral liquid

[0044] The prescription of oral liquid is shown in Table 1. All operations were performed under dark conditions.

[0045] Table 1 Prescription of Oral Solution

[0046] prescription composition prescription dosage Montelukast sodium (mg) 104 Levocetirizine hydrochloride (mg) 100 Meglumine (mg) 10 Hydroxypropyl-β-cyclodextrin (mg) 15000 Acesulfame K (mg) 50 Grape essence (mg) 60 Cetylpyridinium chloride (mg) 100 water (mL) 100 pH 7.38

[0047] Dissolve cetylpyridinium chloride in water, add meglumine and acesulfame potassium and stir to dissolve, add hydroxypropyl-β-cyclodextrin and stir to dissolve, add grape essence and stir to dissolve, add montelukast sodium and stir to dissolve, and obtain montelukast sodium Lukast sodium solution.

[0048] Dissolve levocetirizine hydrochloride in water, and adjust the pH to 7 with 1% sodium hydroxide to obtain levoc...

Embodiment 2

[0049] Embodiment 2 preparation of oral liquid

[0050] The prescription of oral liquid is as shown in table 2. All operations were performed under dark conditions.

[0051] Table 2 Prescription of Oral Solution

[0052]

[0053]

[0054] Dissolve cetylpyridinium chloride in water, add potassium sorbate and acesulfame potassium and stir to dissolve, add hydroxypropyl-β-cyclodextrin and stir to dissolve, add grape essence and stir to dissolve, add montelukast sodium and stir to dissolve, and obtain montelukast sodium Lukast sodium solution.

[0055] Dissolve levocetirizine hydrochloride in water and adjust the pH to 6.5 with 1% sodium hydroxide to obtain levocetirizine hydrochloride solution. Add levocetirizine hydrochloride solution to the above-mentioned montelukast sodium solution, and stir while adding to obtain the product.

Embodiment 3

[0056] Embodiment 3 preparation of oral liquid

[0057] The prescription of oral liquid is as shown in table 3. All operations were performed under dark conditions.

[0058] Table 3 Prescription of Oral Solution

[0059] prescription composition prescription dosage Montelukast sodium (mg) 50 Levocetirizine hydrochloride (mg) 500 Meglumine (mg) 40 Hydroxypropyl-β-cyclodextrin (mg) 20000 Acesulfame K (mg) 10 Grape essence (mg) 200 Cetylpyridinium chloride (mg) 200 water (mL) 100 pH 7.92

[0060] [0060] Dissolve cetylpyridinium chloride in water, add meglumine and acesulfame potassium and stir to dissolve, add hydroxypropyl-β-cyclodextrin and stir to dissolve, add grape essence and stir to dissolve, add montelukast sodium and stir to dissolve, and obtain montelukast sodium Lukast sodium solution.

[0061] Dissolve levocetirizine hydrochloride in water, and adjust the pH to 8 with 1% sodium hydroxide to obta...

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PUM

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Abstract

The invention relates to the field of medicinal preparations, in particular to a composition and a preparation method thereof as well as an oral liquid and a preparation method of the oral liquid. The preparation method of the composition comprises the following steps: mixing montelukast sodium with first water to obtain a montelukast sodium solution; mixing levocetirizine hydrochloride with second water and adjusting the pH value to 6.5-9 to obtain a levocetirizine hydrochloride solution; mixing the montelukast sodium solution with the levocetirizine hydrochloride solution to obtain the composition. The montelukast sodium in the oral liquid provided by the invention is high in stability; the composition does not contain an organic solvent or a surfactant; medication of children is facilitated; and the preparation technology is simple.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a composition and a preparation method thereof, an oral liquid and a preparation method thereof. Background technique [0002] Allergic rhinitis (allergic rhinitis, AR) is a multifactorial disease induced by the interaction of genes and the environment. It is a mediator mainly mediated by IgE after exposure to allergens in atopic individuals. (mainly histamine) release, and a variety of immune active cells and cytokines involved in the nasal mucosa non-infectious inflammatory disease. There are three necessary conditions for its occurrence: ① specific antigen is the substance that causes the body's immune response; ② atopic individual is the so-called individual difference and allergic constitution; ③ specific antigen meets the atopic individual. Specific antigens are derived from animals, plants, insects, fungi or occupational substances, such as mites, pollen, animal...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/495A61K9/00A61K47/02A61P11/02A61P37/08A61K31/47
Inventor 闫学文方翼杨慧君成仁基
Owner BEIJING HANMI PHARMA CO LTD
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