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Olopatadine hydrochloride eye drop and preparation method thereof

A technology of olopatadine hydrochloride and olopatadine, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve problems such as easy recurrence, achieve improved stability, high stability effect

Inactive Publication Date: 2020-09-25
ZHEJIANG JIANFENG PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it is prone to relapse after drug discontinuation

Method used

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  • Olopatadine hydrochloride eye drop and preparation method thereof
  • Olopatadine hydrochloride eye drop and preparation method thereof
  • Olopatadine hydrochloride eye drop and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] Embodiment 1: prepare olopatadine hydrochloride eye drops (as figure 1 shown)

[0065] ①Bottle washing, stopper washing and sterilization

[0066] To receive the bottle used for olopatadine hydrochloride eye drops of 5ml size, start the XH2S60 vertical bottle washing machine according to the "Standard Operating Procedure for Eye Drop Bottle Washing Procedure", and wash the bottle with water for injection filtered through a 0.22μm filter element, for injection The water pressure is ≥0.2MPa, the circulating water pressure is ≥0.2MPa, the compressed air pressure is ≥0.2MPa, and the circulating water temperature is 30-50°C. Check it every 2 hours. Dry after cleaning. The drying temperature is set at 60°C, the temperature is controlled at 55-68°C, and the drying section maintains positive pressure. The dried bottles are packed into double-layer polyethylene plastic bags in 2500 pieces / bag, and the deviation of the number of bottles in each bag is controlled within 10%. Sq...

Embodiment 2

[0088] The detection method of the olopatadine hydrochloride eye drops described in embodiment 1, the method comprises:

[0089] 1. Detection of related substances

[0090] 1) Polar impurities

[0091] f) Accurately weigh an appropriate amount of olopatadine hydrochloride reference substance, dissolve and dilute it with mobile phase to make a solution containing about 0.2 mg of olopatadine hydrochloride in every 1 ml, as the stock solution of olopatadine hydrochloride reference substance, measure 10 ml, Add 1ml of 30% hydrogen peroxide solution, mix well, add 2 drops of 50% sodium hydroxide solution, and let it stand for more than 30 minutes to obtain the impurity B control solution; take another olopatadine E-isomer and olopatadine An appropriate amount of formaldehyde impurity reference substance was dissolved with mobile phase and diluted to a solution containing 20 μg per 1 ml, which was used as impurity reference substance stock solution; measure 3ml of impurity B contro...

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Abstract

The invention relates to the field of pharmaceutical preparations, and particularly provides a novel olopatadine hydrochloride eye drop. The olopatadine hydrochloride eye drop comprises olopatadine hydrochloride, a buffer agent, an osmotic pressure regulator, a preservative, a pH regulator and a solvent.

Description

technical field [0001] The application relates to the field of pharmaceutical preparations, in particular, it provides a new olopatadine hydrochloride eye drops and a preparation method thereof. Background technique [0002] Allergic conjunctivitis, also known as allergic conjunctivitis, is a hypersensitivity reaction of the conjunctiva to external allergens. It mainly includes type I allergy and type IV allergy, among which allergic conjunctivitis caused by type I allergy is the most common. Allergic conjunctivitis caused by type Ⅰ allergy is immediate, mainly referring to allergic conjunctivitis including seasonal allergic conjunctivitis, perennial allergic conjunctivitis, giant papillary conjunctivitis, vernal keratoconjunctivitis, atopic Keratoconjunctivitis, etc.; allergic conjunctivitis caused by type Ⅳ allergy was delayed, mainly bullous conjunctivitis. [0003] The most common symptom of allergic conjunctivitis is eye itching, which can occur in almost all patients...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/335A61K47/18A61P27/02A61P37/08A61J3/00G01N30/02G01N30/06G01N30/86
CPCA61J3/00A61K9/0048A61K9/08A61K31/335A61K47/186A61P27/02A61P37/08G01N30/02G01N30/06G01N30/8679
Inventor 蒋晓萌黄金龙庞熊施存元张明寅
Owner ZHEJIANG JIANFENG PHARM CO LTD
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