Enoxacin preparation and preparation process thereof

A technology of enoxacin and preparations, applied in the field of pharmaceutical engineering, can solve problems such as complex preparation process and difficult control of related substances, achieve the effects of expanding the scope of clinical application, simple and convenient production process design, and improving product quality

Inactive Publication Date: 2003-08-06
HENAN HAOMAI PHARMA +1
View PDF0 Cites 3 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Considering that enoxacin itself is insoluble in water, the preparation process using gluconic acid salification method is relatively complicated, and the related substances are difficult to control

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0029] Take enoxacin 0.1g to about 80ml of water for injection, add 5N acetic acid to adjust the pH of the solution, during the process of adding acetic acid, enoxacin gradually dissolves, when the enoxacin is completely dissolved, the liquid The pH value is 4.85. Continue to add 5N acetic acid, and when the pH of the medicinal solution drops to 2.86, it is found that a small amount of crystallization is separated out in the medicinal solution. Continuing to add acid will continue to increase the amount of crystallization. It can be seen from the above examples that by adjusting the pH value of the medicinal solution with acetic acid, when the pH of the medicinal solution is controlled within a certain range (pH2.86-4.85), the solubility of enoxacin in the aqueous solution can be greater than 100mg / 100ml. Target.

example 2

[0031] Using 10% lactic acid as the pH regulator, using the same operation steps, can also dissolve 0.1g of enoxacin in less than 100ml of water for injection, and with the increase of the amount of lactic acid added, there is no re-crystallization Precipitation phenomenon. Under the conditions of this experiment, the maximum pH value of the drug solution that completely dissolves enoxacin is 4.95.

example 3

[0033] Using 1N hydrochloric acid as the pH regulator, the same operation steps can also dissolve 0.1g of enoxacin in less than 100ml of water for injection, and with the increase of the amount of hydrochloric acid, there is no re-precipitation of crystals . Under the conditions of this experiment, the maximum pH value of the drug solution that completely dissolves enoxacin is 5.02.

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

PUM

No PUM Login to view more

Abstract

The present invention provides an enoxacin preparation which can be injection or powder for injection and its preparation method. Said invention utilizes the method of raising solubility of enoxacin in water and selecting proper isoosmotic regulating agent to make it into transfusion preparation for clinical application. Its preparation method includes the following steps: (a) utilizing pH regulating agent (acid or alkali) to raise the solubility of exnoxacin in water and make it obtain the clinical required medicine concentration; and (b) screening proper isoosmotic regulating agent and making it stable in expiry date. Said medicine is high in antibacterial activity for aerobic gram-negative bacterium, and is applicable to clinical intravenous drip for curing infection due to sensitive bacteria.

Description

Technical field [0001] The invention belongs to pharmaceutical engineering, and relates to the drug composition and preparation technology of fungicides, in particular to the drug composition, preparation and preparation technology of enoxacin. The drug has high antibacterial activity against aerobic Gram-negative bacilli, is suitable for clinical intravenous infusion, and is mainly used for most infections caused by sensitive bacteria. Background technique [0002] Enoxacin was first developed by Dainippon Pharmaceutical Co., Ltd. in Japan, and it was launched in August 1985. The dosage form is oral tablet, the specification is 0.1g, and the trade name is Flumark. Approved for import in 1995 (Certificate No. of API: X950029, Registration No. of Tablet: X950028), valid for 3 years. During this period, a number of domestic pharmaceutical companies have developed enoxacin raw materials, tablets, capsules and other preparations as a second-class new drug, and have obtained a l...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

Application Information

Patent Timeline
no application Login to view more
IPC IPC(8): A61K9/08A61K31/496A61P31/04
Inventor 陈长谭
Owner HENAN HAOMAI PHARMA
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Try Eureka
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap