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Freeze dried powder injection of tramadol hydrochloride and its preparation process

A technology of tramadol hydrochloride and freeze-dried powder injection, which can be used in freeze-dried delivery, powder delivery, pharmaceutical formulation and other directions, can solve the problems of inconvenient transportation and portability, poor stability, etc., and achieves stability, porosity, and formability. Good, easy to transport effect

Active Publication Date: 2008-12-03
CSPC OUYI PHARM CO LTD
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  • 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 the gastrointestinal tract, its stability is poor and it is inconvenient to transport and carry

Method used

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  • Freeze dried powder injection of tramadol hydrochloride and its preparation process
  • Freeze dried powder injection of tramadol hydrochloride and its preparation process
  • Freeze dried powder injection of tramadol hydrochloride and its preparation process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Raw materials and dosage

[0051] 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;

[0052] Debug the canning machine, and fill it according to the theoretical content of 100% (1ml).

[0053] Put the canned samples into the freeze dryer, first pre-f...

Embodiment 2

[0056] Raw materials and dosage

[0057] 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;

[0058] Debug the canning machine, and fill it according to the theoretical content of 100% (1ml).

[0059] Put the canned samples into the lyophilizer, first pre-freeze the sample...

Embodiment 3

[0062] Raw materials and dosage

[0063]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;

[0064] Debug the canning machine, and fill it according to the theoretical content of 100% (1ml).

[0065] Put the canned sample into the freeze dryer, first pre-freeze the sample ...

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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

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Application Information

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Patent Type & Authority Patents(China)
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
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