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Composition and its preparation method, oral liquid and its preparation method

A composition and solution technology, applied in the directions of drug combination, active ingredients of heterocyclic compounds, pharmaceutical formulations, etc.

Active Publication Date: 2017-06-30
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 its preparation method, oral liquid and its preparation method
  • Composition and its preparation method, oral liquid and its preparation method
  • Composition and its preparation method, oral liquid and its preparation method

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] 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 obtain levoce...

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Abstract

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. The preparation method of the composition is as follows: mixing montelukast sodium with the first water to obtain a montelukast sodium solution; mixing levocetirizine hydrochloride with the second water to adjust the pH value to 6.5-9 to obtain Levocetirizine hydrochloride solution; get montelukast sodium solution and levocetirizine hydrochloride solution to mix. The montelukast sodium in the oral liquid provided by the invention has high stability, does not contain organic solvents and surfactants, is convenient for children to take medicine, and has a simple preparation process.

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 Patents(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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