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A kind of olopatadine composition and preparation method thereof

A technology of olopatadine and its composition, applied in the field of olopatadine composition and its preparation, capable of solving problems such as lack of stability and few adverse reactions

Active Publication Date: 2021-05-28
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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  • A kind of olopatadine composition and preparation method thereof
  • A kind of olopatadine composition and preparation method thereof
  • A kind of 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 hydrochloric acid / sodium hydroxide solution, and stir ...

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 thoroughly;

[0055] 4. Add purified water to final...

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 hydroxide solution, and stir thoroughly;

[00...

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Abstract

The present invention provides an olopatadine composition, which comprises olopatadine, pyruvate and / or pyruvate, osmotic pressure regulator, metal ion complexing agent, preservative, pH regulator and purified water. The composition of the invention can improve the stability of the olopatadine, reduce the irritation to the nasal mucosa, accelerate the repair of the nasal mucosa, relieve nasal symptoms and improve the drug safety of the olopatadine.

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 Patents(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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