A kind of lubricating liquid of oral oxybucaine hydrochloride gastroscope and preparation method thereof

Abstract

The invention discloses an oral lubricating liquid of oxybucaine hydrochloride for gastroscope and a preparation method thereof. The lubricant is composed of the following raw materials: glycerin, simethicone, oxybucaine hydrochloride, sodium alginate and purified water. The invention has the following advantages: 1. It does not contain bitter ingredients, and the glycerin tastes sweet, which can improve discomfort reactions such as nausea and vomiting of patients. 2. The defoaming performance is outstanding, and the visual field of gastroscopy is clear. 3. Excellent lubricating function, reducing mechanical damage to the upper digestive tract during lens insertion. 4. There is no need to add additional antibacterial and antibacterial agents. 5. It has a synergistic effect in lubrication, thickening and anesthesia. Clinical data show that the lubricating effect of the present invention is 12.5 percentage points higher than that of Obucaine Hydrochloride Gel, and the defoaming effect is 50 percentage points higher than that of Obucaine Hydrochloride Gel. When the dosage of bucaine is lower than 33% of oxybucaine hydrochloride gel, it increases by 6.9 percentage points, and the palatable rate increases by 52.8 percentage points.

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...

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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

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