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Preparation method of coated tablet containing acetaminophen and tramadol hydrochloride

A technology of acetaminophen and tramadol hydrochloride, applied in the field of pharmaceutical preparations, can solve the problems of difficult control of starch slurry viscosity, cumbersome starch slurry preparation process, poor granule compressibility, etc., and achieve good bioavailability and quality safety , Ease of large-scale production, high similarity effect

Active Publication Date: 2021-11-26
DUODUO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The existing tramadol paracetamol tablets use cornstarch to prepare starch slurry as a binder. The starch slurry preparation process is cumbersome, the viscosity of the starch slurry is not easy to control, and the compressibility of the produced granules is poor. lobes

Method used

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  • Preparation method of coated tablet containing acetaminophen and tramadol hydrochloride
  • Preparation method of coated tablet containing acetaminophen and tramadol hydrochloride
  • Preparation method of coated tablet containing acetaminophen and tramadol hydrochloride

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Experimental program
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Effect test

Embodiment 1-2

[0041] Embodiment 1-2, preparation of paracetamol trama coated tablet

[0042] The prescription and preparation method for preparing 1000 paracetamol-tramadol coated tablets (specification: containing 325 mg of acetaminophen and 37.5 mg of tramadol hydrochloride) are provided.

[0043] The prescription is shown in Table 1, and the unit is mg;

[0044] In the prescription, film coating premix 15B620001-CN.

[0045] Table 1 Prescription of paracetamol and trama coated tablets

[0046]

[0047]

[0048] Prepare as follows:

[0049] a, pretreatment: take by weighing prescription quantity tramadol hydrochloride (100 orders), paracetamol (120 orders), powdery cellulose, pregelatinized starch, carboxymethyl starch sodium cross 60 mesh sieves, take by weighing prescription quantity The auxiliary materials, spare;

[0050] b. Adhesive preparation: Weigh the prescription amount of adhesive and add appropriate amount of water to prepare the adhesive for later use;

[0051] c. ...

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Abstract

The invention discloses a preparation method of a coated tablet containing acetaminophen and tramadol hydrochloride. The preparation method comprises the following steps that S1, active component, a filling agent and a disintegrating agent are mixed to obtain premixed powder; the active components are the acetaminophen and the tramadol hydrochloride, and the mass ratio of the acetaminophen to the tramadol hydrochloride is 325: 37.5; S2, in the stirring process, an adhesive is added into the premixed powder, and wet particles are obtained through granulation; the adhesive is hydroxypropyl cellulose EF or hydroxypropyl methylcellulose E5; S3, the wet particles are dried and then subjected to size stabilization, then a lubricating agent is added for mixing, and total mixed particles are obtained; S4, the total mixed particles are tabletted to obtain tablets; and S5, the tablets are coated to obtain the tablet. According to the preparation method, the granulation process is simple and convenient to operate, the problems of poor compressibility, tablet cracking and the like of the acetaminophen are solved, the acetaminophen and the tramadol hydrochloride have high similarity, the preparation process is stable, the large-scale production is convenient, and the good bioavailability and the good quality safety are provided.

Description

technical field [0001] The invention relates to a preparation method of a coated tablet containing acetaminophen and tramadol hydrochloride, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Tramadol hydrochloride is a non-opioid central analgesic. Although it can also bind to opioid receptors, its affinity is very weak. Tramadol is a racemate, its (+) enantiomer acts on opioid receptors, while the (-) enantiomer inhibits the reuptake of norepinephrine at neuronal synapses and increases extraneuronal serotonin concentration. Thereby affecting the transmission of pain sensation and producing analgesic effect. [0003] Acetaminophen is a non-opioid analgesic that inhibits central prostaglandin synthase in the hypothalamic thermoregulatory center. Reduce the synthesis and release of prostaglandins PGE1, bradykinin and histamine, etc., and produce antipyretic and analgesic effects. [0004] Tramadol Aminophen Tablets is compounded...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/167A61K31/137A61K9/36A61K9/30A61K9/28A61K47/38A61P29/00
CPCA61K31/167A61K31/137A61K9/2866A61K9/2853A61K9/2813A61K9/2054A61P29/00A61K2300/00
Inventor 左文丽关贵彬蹇小兵李贵森何翔焦玉红
Owner DUODUO PHARMA
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