Non-ionic surface active agent-containing Latanoprost eye drop and preparation method thereof

A technology of latanoprost and non-ionic surface, which is applied in the field of latanoprost eye drops containing non-ionic surfactant and its preparation, and can solve the problems of waste of raw materials and the like

Active Publication Date: 2011-04-27
SHANGHAI XINYI JINZHU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The inventors of the present invention have found through a lot of research that adding non-ionic surfactants in latanoprost eye drops can greatly improve its stability, and simultaneously using polyethersulfone (PES) filter membranes to filter latanoprost can also solve the problem. raw material waste

Method used

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  • Non-ionic surface active agent-containing Latanoprost eye drop and preparation method thereof
  • Non-ionic surface active agent-containing Latanoprost eye drop and preparation method thereof
  • Non-ionic surface active agent-containing Latanoprost eye drop and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0072] The equipment used in embodiment 1 is as follows:

[0073] Ultrasonic cleaner CQ-25-6B, purchased from Shanghai Xinchao Ultrasonic Cleaning Instrument Co., Ltd.; filter MEMBRANE, available from MILLIPORE Corporation.

[0074] The eye drop preparation technology of embodiment 1 comprises the steps:

[0075] (1) Weigh the disodium hydrogen phosphate, sodium dihydrogen phosphate and sodium chloride shown in the table below, add water for injection to 100mL, stir and dissolve to prepare a buffer solution, and set aside.

[0076] (2) Weigh the Latan raw materials shown in the table below, Cremophor EL and benzalkonium chloride are placed in the barrel

[0077] (3) Mix the materials described in step (2) uniformly to obtain a uniform mixture.

[0078] (4) Add 20 mL of buffer solution to the homogeneous mixture obtained in step (3), and place it in an ultrasonic instrument to sonicate until it dissolves completely to obtain a solution.

[0079] (5) Add the remaining buffe...

Embodiment 2

[0086] The impact of the Cremophor EL of embodiment 2 different concentrations on content

[0087] Preparation technology is the same as embodiment 1

[0088] Prepare different latanoprost eye drops according to the following prescription and the above-mentioned process, and adopt the HPLC method to detect the content of latanoprost before and after filtration:

[0089]

[0090]

[0091] All the above prescriptions can form a clear solution.

Embodiment 3

[0092] Embodiment 3 Various material filter membranes are on the influence of content after filtration

[0093]Prepare 1000mL (prescription magnification ten times) liquid medicine according to prescription 2 among the embodiment 1, divide into several parts, filter the filter membrane of different materials, all are 0.22um.

[0094] Filter material (membrane or filter element)

Content before filtration%

Content after filtration%

Content drop %

Polypropylene (PP)

99.82

90.12

9.70

Polyethersulfone (PES)

99.82

99.33

0.49

Polytetrafluoroethylene (PTFE)

99.82

94.81

5.01

Mixed Cellulose Ester (CN-CA)

99.82

97.32.

2.50

[0095] filter material

Manufacturer

Polypropylene (PP) folded filter element

Shanghai Xingwei Huiye Filtration Equipment Co., Ltd.

Polyethersulfone (PES) folded filter element

Shanghai Xianwei Filtration Equipment Fact...

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PUM

PropertyMeasurementUnit
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Abstract

The invention provides a Latanoprost composition which comprises a therapeutically effective amount of Latanoprost, a non-ionic surface active agent and a pharmaceutically acceptable carrier. The invention also provides a method for preparing the Latanoprost composition. The Latanoprost composition can solve the problem that the Latanoprost eye drop is easily adsorbed by a filter membrane in the preparation process. Besides, the non-ionic surface active agent-containing Latanoprost eye drop and the preparation method thereof can improve the stability of the Latanoprost eye drop at high temperature, reduce the creation of related substances and lower the transport refrigeration requirements.

Description

technical field [0001] The invention relates to a latanoprost eye drop and a preparation method thereof, in particular to a latanoprost eye drop containing a nonionic surfactant and a preparation method thereof. Background technique [0002] Latanoprost eye drops is a drug for the treatment of glaucoma and ocular hypertension, which can lower eye pressure by promoting water outflow. Latanoprost eye drops went on the market in the U.S. in 1996, and trade name Xalatan eye drops, its disclosed prescription is latanoprost 0.005%, benzalkonium chloride (preservative) 0.02%, and auxiliary material is sodium chloride, Sodium hydrogen phosphate monohydrate and disodium hydrogen phosphate anhydrous. The pH of the commercially available latanoprost eye drops is 6.7, and the osmotic pressure is 267mOsM. [0003] As we all know, the preparation process of eye drops is generally liquid preparation-filtration-filling, wherein filtration is 0.22 micron sterile filtration and is a necessa...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/5575A61K47/34A61K9/08A61P27/06A61P27/02A61J3/00A61K47/14A61K47/26A61K47/44
Inventor 乌旭琼
Owner SHANGHAI XINYI JINZHU PHARMA
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