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Betahistine hydrochloride injection and its production technology

A technology of betahistine and injection, which is applied in the field of betahistine hydrochloride injection and its preparation, can solve the problems of inability to inject intramuscularly, unsatisfactory safety, and unsatisfactory stability, so as to facilitate storage and improve stability sexual effect

Inactive Publication Date: 2012-03-07
HENAN FUREN HUAIQINGTANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, the existing betahistine hydrochloride injection in the market is composed of betahistine hydrochloride, medicinal charcoal and water for injection. Not ideal, not convenient for storage, transportation and use
Betahistine hydrochloride sodium chloride injection is made up of betahistine hydrochloride, sodium chloride, medicinal charcoal and water for injection, and the specification is 500ml: betahistine hydrochloride 0.02g and sodium chloride 4.5g, although Good stability, but only for intravenous infusion, not intramuscular injection
The terminal sterilization level of betahistine hydrochloride for injection is low, and the safety of clinical drug use is not ideal

Method used

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Embodiment Construction

[0018] Betahistine hydrochloride injection of the present invention is composed of betahistine hydrochloride, sodium chloride, medicinal charcoal and fresh water for injection; wherein, every 1000ml of said betahistine hydrochloride injection contains 5g of betahistine hydrochloride , 9g sodium chloride, 1g medicinal charcoal, and the rest are fresh water for injection.

[0019] The production process of the present invention is: unscrambling → washing, drying, bottle extinguishing → preparation → potting → sterilization, leak detection → light inspection → packaging → storage.

[0020] 1. Washing, drying, and extinguishing the bottle: the cleaned bottle is placed in a bottle washing machine, rough washed with purified water (water temperature 50°C-60°C) by ultrasonic waves, finely washed with water for injection, and placed in a tunnel oven at 300°C-320°C , Sterilization time ≥ 4 minutes.

[0021] 2. Preparation: Measure the water for injection into the dilute preparation ta...

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PUM

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Abstract

The invention relates to a betahistine hydrochloride injection and its preparation method. Each betahistine hydrochloride injection of 1000ml contains 5g of etahistine hydrochloride, 9g of common salt, 1g of medicinal charcoal and the balance being fresh injection water. The preparation method of the betahistine hydrochloride injection is characterized by comprising the following steps of: a, dissolving common salt by the use of injection water; b, adding betahistine hydrochloride into a liquid medicine obtained from the step a with stirring for dissolution, adjusting pH to 5.0-5.5 by the use of 2.5 mol / L of sodium hydroxide, and adding injection water up to the full amount; c, adding medicinal charcoal into the liquid medicine obtained from the step b, stirring for 10 minutes, standing for 20 minutes, and filtering through a tianium rod filter and 0.45 micron and 0.22 micron of a filter; d, placing a sealed intermediate product into a sterilization cabinet, using circulating vapor of 100 DEG C, and sterilizing for 30 minutes. The betahistine hydrochloride injection provided by the invention has good stability, is convenient to store, transport and use, and can be used in the forms of intravenous infusion and intramuscular injection.

Description

technical field [0001] The invention relates to a betahistine hydrochloride injection and a preparation method thereof. Background technique [0002] Betahistine hydrochloride, whose chemical name is N-methyl-2-pyridylethylamine dihydrochloride, is easily soluble in water, slightly soluble in ethanol, and almost insoluble in acetone. [0003] Betahistine hydrochloride is a histamine drug. Pharmacological studies have shown that it can significantly improve microcirculation, increase inner ear arterial blood flow, reduce inner ear venous pressure and promote endolymphatic absorption. It can also increase the stability of inner ear hair cells and reduce vestibular conduction of nerves. Betahistine hydrochloride injection is used for Meniere's syndrome, and can also be used for postural vertigo and tinnitus caused by cerebral arteriosclerosis, ischemic cerebrovascular disease and hypertension. [0004] The domestic marketed injections of this product include Betahistine Hydro...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/4402A61K47/02A61P9/10A61P9/12A61P27/16
Inventor 朱永杰白宗锋陈水库
Owner HENAN FUREN HUAIQINGTANG PHARMA