Eye drops containing rupatadine fumarate and preparation method thereof

A technology of rupatadine fumarate and eye drops, which is applied in the field of medicine, can solve problems such as limited curative effect, and achieve the effects of small toxic and side effects, convenient industrial production, and easy operation

Inactive Publication Date: 2018-11-23
广州君博医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The above-mentioned liquid preparation does not need to be injected, reduces the eye damage to the user, and is safe to use, but there are still certain limitations in the curative effect on symptoms such as allergic conjunctivitis and keratitis

Method used

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  • Eye drops containing rupatadine fumarate and preparation method thereof
  • Eye drops containing rupatadine fumarate and preparation method thereof
  • Eye drops containing rupatadine fumarate and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0020] The present invention also provides a preparation method of the eye drops, which can adopt various existing preparation techniques for preparing eye drops; the present invention also provides the preparation method of the eye drops, comprising the following steps: taking an appropriate amount of water for injection to dissolve rupatadine acid and Tribulus terrestris extract to obtain solution A; then take an appropriate amount of water for injection to dissolve the eye drop auxiliary materials to obtain solution B; then mix solution A and solution B, and add the rest of the water for injection to obtain the product.

[0021] The present invention also provides a preparation method when the eye drops contain a thickener, which includes the following steps: take an appropriate amount of water for injection to dissolve rupatadine fumarate and Tribulus terrestris extract to obtain solution A; then take an appropriate amount for injection Dissolve the auxiliary materials of t...

Embodiment 1-3

[0026] Table 1: Formula table of embodiment 1-3 eye drops

[0027]

[0028]

[0029] According to the technical scheme of the present invention, the adjuvant species that can be selected for preparing eye drops containing rupatadine fumarate are not limited to the species listed in the above table, and the following multiple options can also be selected:

[0030] As bacteriostatic agent, any bacteriostatic agent called in pharmacy can be used, and its consumption is according to the conventional dosage in pharmacy. For example, ① 0.002%-0.005% thimerosal; ② quaternary ammonium salts (including benzalkonium chloride, benzalkonium bromide), dumiphene, spirityl, etc., the effective concentration is 0.002%-0.01%; ③ alcohols, commonly used 0.3- 0.6% chlorobutanol; ④ Parabens, commonly used 0.03-0.06% ethylparaben; ⑤ Acids, such as 0.01-0.08% tricolic acid. The concentrations of the above substances are all volume-weight percentages, that is, every 100 milliliters contains gr...

experiment example 1

[0034] Stability test of experimental example 1 rupatadine fumarate eye drops

[0035] Accelerated test: the 0.3% rupatadine fumarate eye drops prepared by the method of Example 2 of the present invention was put into a constant temperature and humidity box under the commercially available packaging conditions, at a temperature of 40°C ± 2°C and a relative humidity of 25°C. %±5%, samples were taken on time at the 1st, 2nd, 3rd, and 6th months respectively, and measured according to the relevant requirements of the Chinese Pharmacopoeia 2015 edition. The results are shown in Table 1:

[0036] Table 1: Stability test data table

[0037]

[0038] Long-term test: 0.3% rupatadine fumarate eye drops prepared according to the method of Example 2 of the present invention was put into a constant temperature and humidity box under the commercially available packaging conditions, and the temperature was 25°C ± 2°C, and the relative humidity was 40°C. % ± 5%, samples were taken on time...

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Abstract

The invention discloses eye drops containing rupatadine fumarate. The eye drops are prepared from the following components: the rupatadine fumarate, a tribulus terrestris extract, pharmaceutically-acceptable ingredients for the eye drops and and water for injection, wherein every 100 mL of the eye drops contains 0.1-0.5 g of rupatadine fumarate, the weight ratio of the rupatadine fumarate to the tribulus terrestris extract is 1:(1-3). The invention further provides a preparation method for the eye drops. The eye drops have the advantages of being good in treatment effect, stable in property, small in toxic and side effects and the like.

Description

technical field [0001] The invention relates to the field of medicine, in particular to an eye drop containing rupatadine fumarate and a preparation method thereof. Background technique [0002] Allergic conjunctivitis is a common and frequent factor of blindness. If left untreated, it can cause irreversible vision loss. Many ophthalmologists at home and abroad have conducted a lot of research on this disease process, including clinical diagnosis and treatment and experimental research, but there is still no ideal treatment plan. [0003] Studies have shown that histamine is the most inflammatory mediator in the early stage of allergic reaction and when symptoms appear, and PAF is another important inflammatory mediator in airway inflammation. Inhibiting the activity of inflammatory mediators such as histamine is the focus of treatment of inflammation. Rupatadine is the only anti-allergic drug currently on the market that has both antihistamine effects and platelet-activati...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K36/185A61K31/4545A61P37/08A61P27/02
CPCA61K9/0048A61K9/08A61K31/4545A61K36/185A61K47/32A61K47/38A61P27/02A61P37/08A61K2300/00
Inventor 谭上彬王延东崔明黄俊杰陈宇明
Owner 广州君博医药科技有限公司
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