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Olopatadine composition and preparation method thereof

A technology of olopatadine and its composition, which is applied in the field of olopatadine composition and its preparation, can solve the problems of less adverse reactions and lack of stability, reduce repair time, improve drug safety, and prevent deterioration and sourness Effect

Active Publication Date: 2019-05-28
JIANG SU PHARMAMAXCORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Therefore, still lack a kind of olopatadine formulation with strong stability and few adverse reactions in the prior art

Method used

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  • Olopatadine composition and preparation method thereof
  • Olopatadine composition and preparation method thereof
  • Olopatadine composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] The composition ratio of the present embodiment is as shown in the following table 1:

[0039] Table 1

[0040] component name

Weight percentage % (w / w)

weight

Olopatadine Hydrochloride

0.665

0.665g

sodium pyruvate

0.1

0.1g

Pyruvate

0.4

0.4g

Sodium chloride

0.6

0.6g

Edetate disodium

0.01

0.01g

Benzalkonium chloride

0.01

0.01g

hydrochloric acid and sodium hydroxide

Adjust pH to 3.5~3.9

Adjust pH to 3.5~3.9

purified water

Add purified water to total weight

Add purified water to a total weight of 100g

[0041] The preparation steps are as follows:

[0042] 1. Add 90% of the prescribed amount of purified water into the liquid mixing tank;

[0043] 2. Add pyruvate, sodium pyruvate, sodium chloride, edetate disodium, benzalkonium chloride and stir until completely dissolved;

[0044] 3. Add olopatadine hydrochloride, adjust the pH to 3.5-3.9 with hy...

Embodiment 2

[0048] The composition ratio of the present embodiment is as shown in the following table 2:

[0049] Table 2

[0050] component name

Weight percentage % (w / w)

weight

Olopatadine Hydrochloride

0.665

0.665g

Pyruvate

0.5

0.5g

Sodium chloride

0.6

0.6g

Edetate disodium

0.01

0.01g

sodium benzoate

0.05

0.05g

hydrochloric acid and sodium hydroxide

Adjust pH to 3.5~3.9

Adjust pH to 3.5~3.9

purified water

Add purified water to total weight

Add purified water to a total weight of 100g

[0051] The preparation steps are as follows:

[0052] 1. Add 90% of the prescribed amount of purified water into the liquid mixing tank;

[0053] 2. Add pyruvic acid, sodium chloride, disodium edetate and sodium benzoate and stir until completely dissolved;

[0054] 3. Add olopatadine hydrochloride, adjust the pH to 3.5-3.9 with hydrochloric acid / sodium hydroxide solution, and stir thorou...

Embodiment 3

[0058] The composition ratio of the present embodiment is as shown in the following table 3:

[0059] table 3

[0060] component name

Weight percentage % (w / w)

weight

Olopatadine Hydrochloride

0.665

0.665g

Disodium phosphate

0.9

0.9g

Sodium chloride

0.5

0.5g

Edetate disodium

0.02

0.02g

Benzalkonium chloride

0.01

0.01g

hydrochloric acid and sodium hydroxide

Adjust pH to 3.5~3.9

Adjust pH to 3.5~3.9

purified water

Add purified water to total weight

Add purified water to a total weight of 100g

[0061] The preparation steps are as follows:

[0062] 1. Add 90% of the prescribed amount of purified water into the liquid mixing tank;

[0063] 2. Add disodium hydrogen phosphate, sodium chloride, edetate disodium, benzalkonium chloride and stir until completely dissolved;

[0064] 3. Add olopatadine hydrochloride, adjust the pH to 3.5-3.9 with hydrochloric acid / sodium h...

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PUM

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Abstract

The invention provides an olopatadine composition. The composition consists of olopatadine, pyruvic acid and / or pyruvate, osmotic pressure regulator, metal ion complexing agent, preservative, pH regulator and purified water. The composition disclosed by the invention can increase the stability of olopatadine, decrease irritation to nasal mucous membranes, accelerate the recovery of nasal mucous membranes, alleviate the uncomfortable symptoms of the nose and increase the safety of olopatadine in use.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an olopatadine composition and a preparation method thereof. Background technique [0002] With the progress of society and the improvement of people's quality of life, diseases caused by various parasitic diseases, malnutrition and bacterial infections are gradually decreasing, but diseases caused by various allergies are on the rise, including allergic conjunctivitis, allergic rhinitis (AR) , bronchial asthma, dermatitis, eczema, chronic urticaria, anaphylactic shock and other diseases. So far, the incidence of allergic diseases in my country is as high as 37.74%, among which the prevalence of allergic rhinitis has reached 1% to 2%, and the highest can reach 6.32%. According to reports, there are 300 million bronchial asthma patients and 400 million allergic rhinitis patients in the world, 50% of which are in developing countries and have not received timely and e...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/335A61K47/12A61P11/02A61P37/08
Inventor 蒋志君曹青日陆小娟于鹤云秦飞
Owner JIANG SU PHARMAMAXCORP
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