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Rupatadine fumarate emulsion type nasal spray agent and preparation method thereof

A technology of rupatadine fumarate and nasal spray, which is applied in the field of medicine, can solve the problems of large dosage and slow onset of action, and achieve good anti-allergic effects, reduce dosage, and reduce adverse drug reactions

Pending Publication Date: 2019-09-06
扬子江药业集团江苏紫龙药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Aiming at the shortcomings of the existing rupatadine fumarate tablets and capsules in the treatment of allergic rhinitis with slow onset of action, large dosage and obvious adverse reactions, the present invention aims to provide a drug with fast onset of action, small dosage and low adverse reactions. The rupatadine fumarate emulsion type nasal drop that is easy to use and can clean the nasal cavity with little reaction and its preparation method

Method used

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  • Rupatadine fumarate emulsion type nasal spray agent and preparation method thereof
  • Rupatadine fumarate emulsion type nasal spray agent and preparation method thereof
  • Rupatadine fumarate emulsion type nasal spray agent and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] The prescription composition of rupatadine fumarate emulsion nasal drops is shown in Table 1.

[0025] Table 1. Prescription of Rupatadine Fumarate Emulsion Form Nasal Drops

[0026]

[0027]

[0028] Preparation method of rupatadine fumarate emulsion nasal drops:

[0029] (1) Preparation of oil phase: accurately weigh the recipe quantities of rupatadine fumarate, ethyl oleate / mint oil (10:1, w / w), vortex evenly, and preheat in a 60°C water bath;

[0030] (2) preparation of water phase: accurately weigh the sodium chloride, ethylparaben and polysorbate 20 of the recipe quantity in water for injection, preheat and dissolve in 60 ℃ water bath;

[0031] (3) Preparation of colostrum: adding the oil phase obtained in step (1) to the water phase obtained in step (2), emulsifying with a high-speed shearing homogenizer for 2-5min, 5000-10000rpm;

[0032] (4) Adjust pH value: adjust pH to 5.5-6.5 with citric acid aqueous solution, add water for injection to the recipe am...

Embodiment 2

[0035] The prescription composition of rupatadine fumarate emulsion nasal drops is shown in Table 2.

[0036] Table 2. Prescription of Rupatadine Fumarate Emulsion Form Nasal Drops

[0037]

[0038] Preparation method of rupatadine fumarate emulsion nasal drops:

[0039] (1) Preparation of oil phase: Accurately weigh the recipe quantities of rupatadine fumarate and medium-chain triglyceride, vortex evenly, and preheat in a 60°C water bath;

[0040] (2) preparation of water phase: accurately take by weighing the sodium chloride, sodium benzoate and polyoxyethylene 40 hydrogenated castor oil of the recipe quantity in water for injection, preheat and dissolve in 60 ℃ water bath;

[0041] (3) Preparation of colostrum: adding the oil phase obtained in step (1) to the water phase obtained in step (2), emulsifying with a high-speed shearing homogenizer for 2-5min, 5000-10000rpm;

[0042] (4) Adjust pH value: adjust pH to 5.5-6.5 with citric acid aqueous solution, add water for i...

Embodiment 3

[0045] The prescription composition of rupatadine fumarate emulsion nasal drops is shown in Table 3.

[0046] Table 3. Recipe of Rupatadine Fumarate Emulsion Nasal Drops

[0047]

[0048] Preparation method of rupatadine fumarate emulsion nasal drops:

[0049] (1) Preparation of oil phase: Accurately weigh the recipe quantities of rupatadine fumarate and castor oil, vortex evenly, and preheat in a 60°C water bath;

[0050] (2) Preparation of aqueous phase: accurately weigh the sodium chloride, ethylparaben and poloxamer 188 of the recipe in water for injection, preheat and dissolve in a 60°C water bath;

[0051] (3) Preparation of colostrum: adding the oil phase obtained in step (1) to the water phase obtained in step (2), emulsifying with a high-speed shearing homogenizer for 2-5min, 5000-10000rpm;

[0052] (4) Adjust pH value: adjust pH to 5.5-6.5 with citric acid aqueous solution, add water for injection to the recipe amount, and filter;

[0053] (5) Sterilization and...

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Abstract

The invention relates to the biomedical technical field, and in particular, relates to a rupatadine fumarate emulsion type nasal spray agent and a preparation method thereof. A prescription of nasal drops contains the following medicinal-grade components by mass: 2-5% of rupatadine fumarate, 5-25% of an oil phase, 10-20% of an emulsifier, 40-65% of an aqueous phase, 0.5-5% of an osmotic pressure regulation agent, 0.05-0.1% of a bacteriostatic agent, and 0.5-5% of a pH regulator. A nose drop liquid is prepared by emulsification with a high-speed shearing homogenizer, aseptic operation is carried out, and the nose drop liquid are sub-packed in a special spray device.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to a pharmaceutical spray and a preparation method thereof, in particular to a rupatadine fumarate emulsion-type nasal spray and a preparation method thereof. Background technique [0002] Allergic rhinitis, also known as allergic rhinitis, refers to the non-infectious inflammation of the nasal mucosa that is mainly mediated by IgE-mediated mediator release after atopic individuals are exposed to allergens, and involves a variety of immune active cells and cytokines. disease. The incidence of allergic eye closure has been on the rise in recent years. Histamine is an inflammatory mediator mediated by IgE in the early and middle stages of allergy and allergic symptoms; platelet-activating factor is another important inflammatory mediator in anterior airway inflammation. Inhibiting the activity of inflammatory mediators such as histamine and platelet activating factor is the main measu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/12A61K31/4545A61P11/02A61P37/08
CPCA61K9/12A61K9/0043A61K31/4545A61K47/44A61P11/02A61P37/08
Inventor 戚小兵史彦斌王少华赵小伟
Owner 扬子江药业集团江苏紫龙药业有限公司
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