Freeze dried powder injection of tramadol hydrochloride and its preparation process

A technology of tramadol hydrochloride and freeze-dried powder injection, which is applied in the direction of freeze-dried transportation, powder transportation, pharmaceutical formulations, etc., can solve the problems of poor stability, inconvenient transportation and carrying, and achieve improved stability and easy transportation and carrying. Effect

Active Publication Date: 2006-02-22
CSPC OUYI PHARM CO LTD
View PDF0 Cites 1 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although tramadol hydrochloride injection can avoid the direct impact of oral preparations on

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

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Freeze dried powder injection of tramadol hydrochloride and its preparation process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] Raw materials and dosage

[0049] 1000 grams of tramadol hydrochloride and 1000 grams of mannitol, take the above tramadol hydrochloride and mannitol, add 16000ml of water for injection, stir at high speed until dissolved, adjust the pH value to 6.0, add 1‰ of activated carbon and stir for about 30 minutes, and Filter the solution, remove gac, get an appropriate amount of solution and measure the content according to the method under the content item of tramadol hydrochloride in the Pharmacopoeia in 2000, add water for injection to determine the volume to about 20000ml according to the actual measurement content (contain tramadol hydrochloride 50mg to the volume in 1ml), first use Filter twice with 0.45 μm cellulose membrane, and then filter twice with 0.22 μm cellulose membrane, then prepare for canning;

[0050] Debug the canning machine, and fill it according to the theoretical content of 100% (1ml).

[0051] Put the canned samples into the freeze dryer, first pre-f...

Embodiment 2

[0054] Raw materials and dosage

[0055] 1000 grams of tramadol hydrochloride and 1500 grams of glucose, take the above tramadol hydrochloride and glucose, add 16000ml of water for injection, stir at high speed until dissolved, adjust the pH value to 6.0, add 1‰ of activated carbon and stir for about 30 minutes, dissolve the solution Filter, remove gac, get appropriate amount of solution and measure content by the method under the content item of tramadol hydrochloride in Pharmacopoeia 2000, add water for injection to determine the volume about 25000ml according to the actual determination content (according to 1ml containing tramadol hydrochloride 50mg volume), first use 0.45 After filtering twice with a μm cellulose membrane, and then twice with a 0.22 μm cellulose membrane, prepare for canning;

[0056] Debug the canning machine, and fill it according to the theoretical content of 100% (1ml).

[0057] Put the canned sample into the freeze dryer, first pre-freeze the sample...

Embodiment 3

[0060] Raw materials and dosage

[0061] Tramadol hydrochloride 1000g, sodium lactobionate 500g, take the above tramadol hydrochloride and sodium lactobionate, add 16000ml water for injection, stir at high speed until dissolved, adjust the pH value to 6.0, add 1‰ of activated carbon and stir for about 30 Minutes, filter the solution, remove gac, get an appropriate amount of solution and measure the content according to the method under the content item of tramadol hydrochloride in the Pharmacopoeia in 2000, add water for injection to make up about 20000ml according to the actual measured content (according to 1ml containing tramadol hydrochloride 50mg constant volume) , first filter twice with a 0.45μm cellulose membrane, then filter twice with a 0.22μm cellulose membrane, and prepare for canning;

[0062]Debug the canning machine, and fill it according to the theoretical content of 100% (1ml).

[0063] Put the canned sample into the freeze dryer, first pre-freeze the sample ...

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 invention discloses a freeze dried powder injection of tramadol hydrochloride and its preparation process, wherein the powder injection contains effective amount of tramadol hydrochloride and corresponding medicinal filling agent and water for injection. The preparing process comprises the following steps, (1) dissolving tramadol hydrochloride raw material and filling agent with right amount of water for injection, filtering and loading, (2) pre-freezing to -45 to -40 deg C, thermally insulating 3 hours, slowly elevating temperature to 25 deg C, (3) thermally insulating 2-3 hours at 25 deg C., finally carrying out germ-free fusion sealing.

Description

technical field [0001] The invention relates to a pharmaceutical preparation and a preparation method thereof, in particular to a tramadol hydrochloride freeze-dried powder injection and a preparation method thereof. technical background [0002] Tradomer hydrochloride is a non-opioid central analgesic commonly used in clinical practice. It has a morphine-like effect and its chemical composition is ethanol. Currently commercially available tramadol hydrochloride preparations include tablets, capsules, drops and liquid injections. In clinical application, it is found that the incidence of adverse reactions of tramadol hydrochloride oral preparations of nausea and vomiting is as high as about 20%. The impact of tramadol hydrochloride drops on the gastrointestinal tract of patients is more serious (Wu Kongming et al. "Chinese Oncology Clinic" 1994, 21: 693). Although tramadol hydrochloride injection can avoid the direct impact of oral preparations on the gastrointestinal trac...

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): A61K31/137A61K9/19A61P25/04
Inventor 齐新英郭卫芹魏淑辉智彩辉
Owner CSPC OUYI PHARM CO LTD
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