Composite tramadol hydrochloride formulation and preparation process thereof

A technology of tramadol hydrochloride and preparations, which is applied in the directions of pill delivery, pharmaceutical formulations, and medical preparations containing active ingredients, etc., can solve problems such as affecting the quality of life of patients, difficult to achieve curative effects, addiction, and toxic and side effects. , to achieve the effect of being easy to take and transport, reducing addiction, and taking effect quickly

Inactive Publication Date: 2006-04-26
周卓和
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] Pain is a common and frequently-occurring disease in clinical practice, which will bring great pain to patients and seriously affect the quality of life of patients.
Drug treatment of pain, especially relying on a single drug for treatment, is difficult to achieve satisfactory effects in terms of curative effect, addiction and side effects, and there are always shortcomings in different aspects. Therefore, people consider using different analgesic mechanisms. Medications that work through multiple pain-relieving pathways to achieve therapeutic goals

Method used

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  • Composite tramadol hydrochloride formulation and preparation process thereof
  • Composite tramadol hydrochloride formulation and preparation process thereof
  • Composite tramadol hydrochloride formulation and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0074] Pass acetaminophen (Huzhou Kangquan Pharmaceutical Co., Ltd.), tramadol hydrochloride (Shandong Xinhua Pharmaceutical Co., Ltd.) and sodium carboxymethyl starch (Huzhou Food and Chemical United Company) respectively through a 100-mesh sieve to get tramadol hydrochloride Add 42g of paracetamol, 325g of acetaminophen, and 7.5g of sodium carboxymethyl starch, mix well, add appropriate amount of water, make soft material, pass through a 20-mesh sieve to make wet granules, blow dry at 50°C, and use a 20-mesh sieve Whole grain, add magnesium stearate (Huzhou Food Chemical United Company) 2.5g, measure content, calculate filling amount, fill No. 0 capsule, pack, put in storage, check, get 1000 capsules of finished product. Each capsule contains tramadol hydrochloride 42mg and acetaminophen 325mg. Capsules can better cover the bitter taste of the main drug, release faster, take effect quickly, provide patients with more choices in use, and are easy to take and transport.

Embodiment 2

[0076] Pass paracetamol, tramadol hydrochloride and carboxymethyl starch sodium through 100 mesh sieves respectively, take tramadol hydrochloride 40g, paracetamol 350g, carboxymethyl starch sodium 7.5g, fully mix, add water appropriate amount, prepare Make soft materials, pass through a 20-mesh sieve to make wet granules, blow dry at 55°C, granulate with a 20-mesh sieve, add 2.5g of magnesium stearate, measure the content, calculate the filling amount, fill the No. 0 capsule, Packing, warehousing, inspection, and 1000 finished capsules were obtained.

Embodiment 3

[0078] Pass paracetamol, tramadol hydrochloride and carboxymethyl starch sodium through 100 mesh sieves respectively, take tramadol hydrochloride 45g, paracetamol 300g, carboxymethyl starch sodium 7.5g, fully mix, add water appropriate amount, prepare Make soft materials, pass through a 20-mesh sieve to make wet granules, blow dry at 60°C, granulate with a 20-mesh sieve, add 2.5g of magnesium stearate, measure the content, calculate the filling amount, fill the No. 0 capsule, Packing, warehousing, inspection, and 1000 finished capsules were obtained.

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Abstract

The invention relates to a composite tramadol hydrochloride formulation and preparation process, wherein the compound preparation can be made into the forms of capsules or dispersing tablets, each 1000 capsules or 1000 dispersing tablets comprise tramadol hydrochloride 40-45g, acetaminopher 300-350g, sodium carboxymethyl starch 7.5-25g, and magnesium stearate 2.5-5g.

Description

technical field [0001] The invention relates to a compound tramadol hydrochloride preparation and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Tramadol hydrochloride chemical name: (±)-E-2[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol hydrochloride, tramadol hydrochloride molecular formula: C 16 h 25 NO 2 .HCl, tramadol hydrochloride molecular weight: 299.84, tramadol hydrochloride chemical structural formula: [0003] [0004] Tramadol hydrochloride is a non-opioid central analgesic. Although it can also bind to opioid receptors, its affinity is very weak. The affinity for μ receptors is equivalent to 1 / 6000 of morphine, and the affinity for κ and δ receptors The affinity is only 1 / 25 of the μ receptor. Tramadol is a racemate, and its (+) enantiomer acts on opioid receptors, while the (-) enantiomer inhibits the reuptake of norepinephrine by neuronal synapses and increases extraneuronal 5-...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/167A61K9/20A61K9/48A61K31/137A61P25/04
Inventor 周卓和
Owner 周卓和
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