Quality standard for paracetamol and tramadol hydrochloride capsules

A kind of paracetamol and trama, quality standard technology, applied in the quality standard field of paracetamol and tramadol capsules, to achieve the effect of scientific quality standard

Active Publication Date: 2017-01-25
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 standard for paracetamol and tramadol hydrochloride capsules
  • Quality standard for paracetamol and tramadol hydrochloride capsules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] 1. Materials and reagents:

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

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

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

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

[0048] 2. Experiment content:

[0049] 2.1 Characters:

[0050] Take three batches of test samples respectively. After removing the capsule shell, the co...

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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 drug quality standards, in particular to the quality standards of paracetamol and tramadol capsules. Background technique [0002] Pain is a common clinical multiple disease that mostly depends on drug treatment. However, single drug treatment has certain shortcomings in terms of efficacy and toxic side effects. Compound preparations enhance the therapeutic effect of drugs, control toxic side effects, and make it more effective Accurate and safer. [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 surgery, surgical procedures, postoperative pain, etc.; acetaminophen (C 8 H 9 NO 2 ) Is an acetanilide antipyretic and analgesic, which is clinically used to treat pain with definite curative effect and high safety. Paracetamol and tramadol capsules are mainly composed of two components, acetaminophen a...

Claims

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Application Information

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Patent Type & Authority Applications(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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