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Freeze dry betahistine hydrochloride injection and method for preparing the same

A technology of freeze-dried powder injection and betahistine, which is applied in the field of betahistine hydrochloride for injection and its preparation, can solve problems such as unsatisfactory stability, increase effectiveness and safety, reduce degradation products, and stabilize sex-enhancing effect

Active Publication Date: 2011-10-05
CHINA NAT MEDICINES GUORUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Betahistine hydrochloride raw materials and tablets have been included in the "Chinese Pharmacopoeia" 2000 edition, and the preparations that have been listed include tablets, oral liquids, and injections, but the stability is not ideal

Method used

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Examples

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Embodiment Construction

[0027] In this embodiment, 1000 sticks were prepared with 20 g of betahistine hydrochloride, 80 g of mannitol and 1000 ml of water for injection.

[0028] The specific preparation method is:

[0029] Get the used amount of betahistine hydrochloride and mannitol, place it in a sterilized container, add 900 ml of water for injection, stir to make it dissolve, adjust the pH value of the solution between 4.5-6, add sterilized water for injection to 1000 ml; add 0.0025% of the prepared amount of 767-type activated carbon for needles, stir for 30 minutes, pass through a 0.45-micron microporous membrane for coarse filtration and decarbonization, and then pass through a 0.22-micron microporous membrane for final fine filtration, press 1 The milliliters are divided into control antibiotic bottles, freeze-dried at low temperature for 40 hours, then stoppered, capped and packaged under aseptic conditions.

[0030] In the specific preparation process, freeze-drying at low temperature for...

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Abstract

Disclosed is a rreeze dry betahistine hydrochloride injection and method for preparation, which comprises betahistine hydrochloride and excipient, wherein the excipient is one selected from mannitol, sodium chloride, dextran, glucose, lactose, sorbic alcohol or their mixture.

Description

Technical field: [0001] The invention relates to betahistine hydrochloride for injection and a preparation method thereof. Background technique: [0002] Betahistine hydrochloride, its chemical name is: N-methyl-2-pyridylethylamine dihydrochloride. [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. It is used to treat various vertigo syndromes, Meniere's syndrome and related vertigo symptoms and vertebral-basilar artery insufficiency, etc. [0004] Betahistine hydrochloride crude drug and tablet have been included in the 2000 edition of "Chinese Pharmacopoeia", and the preparations that have been listed include tablet, oral liquid, and injection, but the stability is not i...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4402A61K9/19A61P1/08A61P9/10
Inventor 陈学峰
Owner CHINA NAT MEDICINES GUORUI PHARMA
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