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Pharmaceutical composition as well as preparation method and application thereof

A technology of composition and medicine, which is applied in the field of pharmaceutical composition and its preparation, can solve the problems of weak therapeutic effect on allergic rhinitis and inability to quickly suppress rhinitis, and achieve avoidance of liver first-pass effect, rapid and complete nasal absorption, good compliance

Active Publication Date: 2020-12-25
南京科默生物医药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The formulations of Bepotastine Besilate on the global market are mainly tablets and eye drops. Allergic rhinitis is treated in the form of systemic administration. Its therapeutic effect on allergic rhinitis is not strong, and rhinitis cannot be quickly suppressed. and other symptoms

Method used

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  • Pharmaceutical composition as well as preparation method and application thereof
  • Pharmaceutical composition as well as preparation method and application thereof
  • Pharmaceutical composition as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] 1. Prescription

[0039]

[0040]

[0041] 2. Preparation method

[0042] Crush bepotastine besilate to particle size D 90 At 2-10μm, then fully mix the raw and auxiliary materials (except pH adjusters and preservatives) and water in the prescribed amount, adjust the pH of the mixed solution to 6.5 with 0.1mol / L sodium hydroxide, and finally add benzalkonium chloride to mix Evenly, fill, and add a spray pump to obtain a suspension nasal spray.

Embodiment 2

[0044] 1. Prescription

[0045]

[0046] 2. Preparation method

[0047] Crush bepotastine besilate to particle size D 90 At 2-10 μm, then fully mix the raw and auxiliary materials (except pH adjusters and preservatives) and water in the prescribed amount, adjust the pH of the mixed solution to 5.0 with 0.1mol / L sodium hydroxide, and finally add benzalkonium chloride and mix well , filling, and adding a spray pump to obtain a suspension nasal spray.

Embodiment 3

[0049] 1. Prescription

[0050]

[0051] 2. Preparation method

[0052] Crush bepotastine besilate to particle size D 90 At 2-10 μm, then fully mix the raw and auxiliary materials (except pH regulator and preservative) and water in the prescribed amount, adjust the pH of the mixed solution to 6.0 with sodium hydroxide, and finally add benzalkonium chloride to mix evenly, fill, Add a spray pump for a nasal spray suspension.

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Abstract

The invention discloses a pharmaceutical composition as well as a preparation method and application thereof. The pharmaceutical composition comprises bepotastine besilate, a tackifier, a tension agent, a preservative and a pH regulator, wherein the granularity D90 of the bepotastine besilate is 2-10 [mu]m. The preparation method of the pharmaceutical composition comprises the following steps of (1) pre-treating the bepotastine besilate; and (2) preparing the pharmaceutical composition. The preparation method is simple and easy to implement, and the prepared pharmaceutical composition enters the nasal cavity through a portable spraying device, is convenient to administrate, takes effect quickly, can release drugs slowly, is high in bioavailability, stable in product quality and small in irritation to the nasal cavity, and can be used as an antihistamine drug.

Description

technical field [0001] The invention relates to a pharmaceutical composition and its preparation method and application, in particular to a pharmaceutical composition for effectively treating respiratory inflammation, its preparation method and application. Background technique [0002] The chemical name of Bepotastine Besilate is (+)-(S)-4-(4-(4-chlorophenyl-2-pyridylmethoxy)piperidine)butyric acid benzenesulfonic acid Salt, the chemical structure is as follows: [0003] [0004] Histamine H jointly developed by Tanabe Seiyaku and Ube Industries of Japan 1 Receptor antagonist, listed for the first time in Japan in 2000, the trade name is Talion (Tan Liang), which is a 10mg white film-coated tablet. It has been imported in China for the treatment of allergic rhinitis, urticaria, itching caused by skin diseases (eczema, dermatitis, prurigo, skin pruritus), nervous deafness. [0005] Bepotastine and its pharmacologically acceptable salts on histamine H 1 The receptor ha...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/12A61K9/10A61K31/4545A61K47/36A61K47/38A61P37/08
CPCA61K31/4545A61P37/08A61K9/0043A61K9/12A61K47/38A61K47/36A61K9/10
Inventor 代孔恩张孝清
Owner 南京科默生物医药有限公司
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