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Pharmaceutical composition for injection and its medicine box

A composition and injection technology, which can be used in drug combinations, antipyretics, nervous system diseases, etc., and can solve problems such as strong vascular stimulation

Inactive Publication Date: 2008-03-26
沈阳华泰药物研究有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] Now the inventor is surprised to find that, according to the general injection preparation process, according to the ratio preparation of tramadol hydrochloride (37.5mg) and paracetamol (325mg) compound already on the market, make propatamol hydrochloride and tramadol hydrochloride Multiple injection preparations, followed the instructions for use of Tramadol Hydrochloride Injection and Propatamol Hydrochloride Powder Injection, and found that the injection caused strong vascular stimulation, which is unacceptable for injections

Method used

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  • Pharmaceutical composition for injection and its medicine box
  • Pharmaceutical composition for injection and its medicine box

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Example 1. Preparation of samples

[0026] 1) Preparation of tramadol hydrochloride and propadamol hydrochloride mixture

[0027] Commercially available tramadol hydrochloride and propadamol hydrochloride were used, and according to general injection preparation requirements, the ratio of tramadol hydrochloride 37.5 mg and propadamol hydrochloride 642.5 mg was prepared into sterile powder for injection for later use.

[0028] 2) Sodium citrate solution

[0029] According to the general injection solution preparation method, prepare 2.5% sodium citrate injection solution for later use.

[0030] 3) Mix the sample prepared in step 1 with 5 ml of 2.5% sodium citrate injection solution for later use.

Embodiment 2

[0031] Example 2. Preparation of the kit

[0032] 1) According to the general injection preparation method, each bottle contains 37.5 mg of tramadol hydrochloride and 642.5 mg of propatamol hydrochloride to prepare a sterile powder for injection as one of the bottles.

[0033] 2) According to the general injection preparation method, configure 0.125g / 5ml of sodium citrate injection as another bottle.

[0034] 3) Pack both bottles in the same box. In use, the sodium citrate solution is injected into the bottles of tramadol hydrochloride and propatamol hydrochloride, and after being dissolved, it is diluted with a solvent for injection.

Embodiment 3

[0035] Example 3. Vascular irritation test

[0036] 1. Test material

[0037] 1.1 Test substance: Take the kit of Example 2, dissolve tramadol hydrochloride and propatamol hydrochloride in the sodium citrate solution therein, and then mix with 100 0.9% normal saline to make a solution.

[0038] Control: in the kit of Example 2, only tramadol hydrochloride and propatamol hydrochloride were used, and were mixed with 100 0.9% normal saline to prepare a solution.

[0039] 1.2 Dosage setting: the administration volume of test substance and control is 10ml / kg.

[0040] 1.3 Animals: rabbits, Japanese large-eared whites, weighing 2.4-3.0 kg, provided by Shenyang Shuangyi Laboratory Animal Research Institute.

[0041] Laboratory animal production license number: SCXK (Liao) 2003-0012. Laboratory animal use license number:

[0042] SYXK (Liao) 2003-0024.

[0043] 1.4 Test conditions: temperature: 22~24℃, relative humidity: 34~50%

[0044] 2. Test methods and results

[0045] Five...

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Abstract

The present invention relates to an injection medicine composition containing propacetamol hydrochloride and tramadol hydrochloride. It is characterized by that said injection medicine composition also contains sodium citrate so as to raise the safety of said injection medicine composition.

Description

technical field [0001] The present invention relates to a pharmaceutical composition for injection containing propatamol hydrochloride and tramadol hydrochloride and a packaging medicine box of the components of the pharmaceutical composition. Background technique [0002] The chemical name of propatamol hydrochloride is N,N-diethylglycine[4-(acetamido)]phenyl hydrochloride. The structure is as follows: [0003] [0004] It is the prodrug of acetaminophen, which has antipyretic and analgesic effects after being decomposed into its active ingredient acetaminophen in the body. [0005] The chemical name of tramadol hydrochloride is: (±)-E-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol hydrochloride. The structure is as follows: [0006] [0007] The Chinese invention patent with the application number of 98107417.0 (a divisional application of 92112594.1) discloses the pharmaceutical composition of paracetamol and tramadol hydrochloride. This document reve...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/221A61K47/12A61P29/02A61P25/04A61K31/135
Inventor 王鹏
Owner 沈阳华泰药物研究有限公司
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