Quality Standards for Tramadol Capsules

A technology of tramadol acetaminophen and quality standards, applied in the field of quality standards of tramadol acetaminophen capsules, achieving the effect of scientific quality standards

Active Publication Date: 2020-08-25
SHANXI GOODDOCTOR PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Pain is a common multiple-occurrence disease in clinical practice, and it mostly depends on the treatment of drugs. However, single drug treatment has certain defects in its curative effect and toxic and side effects. Accurate and more secure

Method used

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  • Quality Standards for Tramadol Capsules
  • Quality Standards for Tramadol Capsules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] 1. Materials and reagents:

[0044] Instruments: Agilent 1200 high performance liquid chromatography, Mettler XS-205 electronic balance;

[0045] Reagents: Methanol and tetrahydrofuran are chromatographically pure, triethylamine, phosphoric acid and potassium dihydrogen phosphate are analytically pure, and water is self-made ultrapure water;

[0046] Sample: Tramadol paracetamol capsules (140601, 140602, 140603), provided by Shanxi Good Doctor Pharmaceutical Co., Ltd.;

[0047] Reference substances: paracetamol (batch number: 100018-200408), tramadol hydrochloride (batch number: 171242-201005), cis-tramadol hydrochloride (batch number: 171255-201103), p-aminophen (batch number: 100802-201002 ), from China National Institute for the Control of Pharmaceutical and Biological Products and China National Institute for Food and Drug Control.

[0048] 2. Experimental content:

[0049] 2.1 Characters:

[0050] Take a few capsules of the test product from three batches respect...

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Abstract

Paracetamol and tramadol hydrochloride capsules are a compound preparation made with paracetamol and tramadol hydrochloride and paracetamol. The invention discloses a quality standard for paracetamol and tramadol hydrochloride capsules. Based on a quality standard for paracetamol and tramadol hydrochloride and paracetamol, modifications are made to character indexes, related substance and paracetamol inspection, and dissolution detecting and content measuring method, a quality standard for paracetamol and tramadol hydrochloride capsules is established, and the quality of paracetamol and tramadol hydrochloride capsules is controlled scientifically, regularly and effectively.

Description

technical field [0001] The invention relates to the field of medicine quality standards, in particular to the quality standards of Tramadol Capsules of Amphenol Tramadol. Background technique [0002] Pain is a common multiple-occurrence disease in clinical practice, and it mostly depends on the treatment of drugs. However, single drug treatment has certain defects in its curative effect and toxic and side effects. Accurate and more secure. [0003] Tramadol hydrochloride (C 16 h 25 NO 2 HCl) is a non-opioid central analgesic, which is widely used clinically for moderate and severe acute and chronic pain and pain operations, surgical operations, and postoperative pain relief; acetaminophen (C 8 h 9 NO 2 ) is an acetanilide antipyretic and analgesic drug, which has definite curative effect and high safety for clinically treating pain. Tramadol Capsules is mainly composed of acetaminophen and tramadol hydrochloride. It is a compound preparation, which is a new dosage fo...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 耿福昌耿福能
Owner SHANXI GOODDOCTOR PHARMA CO LTD
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