Oxybuprocaine gastroscope lubricating fluid capable of being orally taken, and preparation method of oxybuprocaine gastroscope lubricating fluid capable of being orally taken

A technology for oxybucaine hydrochloride and lubricating liquid, which is applied in the field of oral oxybucaine hydrochloride gastroscope lubricating liquid and its preparation, can solve the problems of necrosis, unsuitability for oral administration, nausea and vomiting, and achieves outstanding defoaming performance, Excellent lubricating function and the effect of reducing mechanical damage

Active Publication Date: 2020-04-03
郑州弘新医疗科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

③ The prescription of Obuvacaine Hydrochloride Gel contains brogeramine (benzalkonium bromide), which tastes extremely bitter ("The Latest National Manual of Standards for Pharmaceutical Excipients", edited by Xiao Sanguan, China Medical Science and Technology Electronic Publishing House, July 2006 , page 552), the field of vision is not clear enough (good rate 42.5%)
Its patented formula has the following disadvantages: ① The main purpose of brogeramine is a disinfectant and antiseptic, and it tastes extremely bitter. Oral administration can cause nausea and vomiting, and concentrated solutions can cause esophageal damage or necrosis ("Clinical Medication Notes Chemical Drugs and Biological Products Volume" Pharmacopoeia 2010 Edition , page 1203), shaking easily produces a lot of foam, not suitable for oral administration
② No defoamer, no lubricant, which affects the clarity of gastroscopy and the lubrication effect when the gastroscope is inserted
③Disodium edetate is mainly used as a chelating agent, but there is no chelated metal ion in the prescription, so the use is not very clear

Method used

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  • Oxybuprocaine gastroscope lubricating fluid capable of being orally taken, and preparation method of oxybuprocaine gastroscope lubricating fluid capable of being orally taken
  • Oxybuprocaine gastroscope lubricating fluid capable of being orally taken, and preparation method of oxybuprocaine gastroscope lubricating fluid capable of being orally taken

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] An oral lubricating solution for oxybucaine hydrochloride for gastroscopy, which consists of the following raw materials (per 1000 mL): 200 g of glycerin, 30 g of simethicone, 2 g of oxybucaine hydrochloride, 20 g of sodium alginate, and the balance is purified water.

[0028] The preparation method of oxybucaine hydrochloride gastroscope lubricating liquid comprises the following steps:

[0029] (1) 2g oxybucaine hydrochloride was dissolved in 200mL purified water to obtain the first mixture;

[0030] (2) Add 30g of simethicone to 200g of glycerin, and stir at 300rpm for 10min to obtain the second mixture;

[0031] (3) Add 20g of sodium alginate and the first mixture into the second mixture, stir at 300rpm for 5min, then add purified water to make up to 1000mL, stir evenly, filter, fill in a 10mL oral liquid bottle, and circulate at 100°C Steam sterilize for 30 minutes, that is.

Embodiment 2

[0033] An oral lubricating solution for oxybucaine hydrochloride for gastroscopy, which consists of the following raw materials (per 1000 mL): 100 g of glycerin, 15 g of simethicone, 1 g of oxybucaine hydrochloride, 10 g of sodium alginate, and the balance is purified water.

[0034] The preparation method of oxybucaine hydrochloride gastroscope lubricating liquid comprises the following steps:

[0035] (1) Dissolve 1 g of oxybucaine hydrochloride in 300 mL of purified water to obtain the first mixture;

[0036] (2) Add 15g of simethicone to 100g of glycerin, and stir at 400rpm for 10min to obtain the second mixture;

[0037] (3) Add 10g of sodium alginate and the first mixture into the second mixture, stir at 400rpm for 5min, then add purified water to make up to 1000mL, stir evenly, filter, fill in a 10mL oral liquid bottle, and circulate at 100°C Steam sterilize for 30 minutes, that is.

Embodiment 3

[0039] An oral lubricating solution for oxybucaine hydrochloride for gastroscopy, which consists of the following raw materials (per 1000 mL): 300 g of glycerin, 45 g of simethicone, 3 g of oxybucaine hydrochloride, 30 g of sodium alginate, and the balance is purified water.

[0040] The preparation method of oxybucaine hydrochloride gastroscope lubricating liquid comprises the following steps:

[0041] (1) 3g oxybucaine hydrochloride was dissolved in 300mL purified water to obtain the first mixture;

[0042] (2) Add 45g of simethicone to 300g of glycerin, and stir at 300rpm for 15min to obtain the second mixture;

[0043] (3) Add 30g of sodium alginate and the first mixture to the second mixture, stir at 300rpm for 10min, then add purified water to make up to 1000mL, stir evenly, filter, fill in a 10mL oral liquid bottle, and circulate at 100°C Steam sterilize for 30 minutes, that is.

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Abstract

The invention discloses oxybuprocaine gastroscope lubricating fluid capable of being orally taken, and a preparation method of the oxybuprocaine gastroscope lubricating fluid capable of being orally taken. The lubricant consists of the following raw materials of glycerine, dimeticone, oxybuprocaine, sodium alginate and purified water. The oxybuprocaine gastroscope lubricating fluid capable of being orally taken disclosed by the invention has the following advantages that the oxybuprocaine gastroscope lubricating fluid capable of being orally taken is free from bitter components, and the glycerine is sweet in taste, so that discomfort reactions of nausea, vomiting and the like of a patient can be improved; the defoaming properties are outstanding, so that gastroscopy view fields are clear;the lubricating functions are good, so that mechanical damage to the upper gastrointestinal in the gastroscope inserting process can be reduced; additionally adding bacteriostasis antibacterial agentsis not needed; and the oxybuprocaine gastroscope lubricating fluid capable of being orally taken has synergistic effects in the respects of lubrication, thickening and anaesthesia. Clinical data indicates that the lubricating effects of the oxybuprocaine gastroscope lubricating fluid capable of being orally taken are increased by 12.5% than those of oxybuprocaine gel, the defoaming effects are increased by 50%, under the condition that the dosage of the oxybuprocaine is 33% lower than that of the oxybuprocaine gel the anaesthesia and analgesic effects are increased by 6.9%, and the deliciousrate is increased by 52.8%.

Description

technical field [0001] The invention belongs to the field of medical devices, and in particular relates to an oral orally available oxybucaine hydrochloride gastroscope lubricating liquid with oxybucaine hydrochloride as an auxiliary function and a preparation method thereof. Background technique [0002] Gastroscopy is currently the most commonly used and reliable method for diagnosing gastrointestinal diseases. It can directly observe the condition of the patient's stomach, which cannot be replaced by other inspection methods. However, patients often experience strong nausea and vomiting during the examination, and some patients even refuse gastroscopy due to fear. In addition, the process of inserting the mirror is also likely to cause complications such as digestive tract damage and pain and discomfort. Before undergoing gastroscopy, patients often involuntarily swallow a large amount of saliva, which produces a certain amount of foam in the stomach. The foam mixes with...

Claims

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Application Information

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IPC IPC(8): A61K49/00A61K31/245A61K31/734A61K47/10A61K47/34A61K47/36A61P23/02A61P29/00
CPCA61K49/0004A61K31/245A61K31/734A61K47/10A61K47/34A61K47/36A61P23/02A61P29/00A61K2300/00
Inventor 朱澳璇朱格生
Owner 郑州弘新医疗科技有限公司
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