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Dezocine oral preparation

An oral preparation, the technology of dezocine, which is applied in the field of dezocine oral preparations for the treatment of pain, can solve the problems of drug absorption and effect influence, oral preparation absorption instability, difficulties, etc., to achieve therapeutic effect and no toxic adverse effects Effect

Inactive Publication Date: 2018-08-17
YANGTZE RIVER PHARM GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the absorption of oral preparations is unstable. Dezocine is mainly glucuronidated in the liver and excreted in the form of glucuronic acid conjugates when administered by injection.
The hepatic first-pass effect has a greater impact on drug absorption and action. On the other hand, there are no reports of oral adverse reactions of dezocine. Oral dezocine may have adverse reactions different from injections. These adverse reactions need Avoid adverse reactions through proper dosage and prescription
Therefore it is very difficult to develop an oral formulation of dezocine according to the prior art

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Embodiment 1: Preparation of dezocine oral solution

[0038] Dezocine oral solution

[0039]

[0040] Preparation method: Weigh the crushed and sieved dezocine raw material, add the above-mentioned prescription amount of purified water and lactic acid, adjust the pH value to 3.8 after dissolving, and filter to sterilize.

Embodiment 2

[0041] Embodiment 2: preparation of dezocine tablet

[0042] Dezocine tablet prescription:

[0043]

[0044] Preparation method: Weigh the pulverized and sieved dezocine raw material, mix it with the above prescription amount of lactose, microcrystalline cellulose, sodium starch glycolate, add 10% hypromellose solution and mix evenly to make a suitable The soft material is passed through a 16-mesh sieve to make granules, dried at 60°C, and the dry granules are granulated through a 20-mesh sieve, added with magnesium stearate, mixed evenly, and compressed into tablets.

Embodiment 3

[0045] Example 3: Preparation of Dezocine Sustained Release Tablets

[0046] Dezocine extended-release tablets prescription:

[0047]

[0048] Preparation method: Weigh the crushed and sieved dezocine raw material, mix it with the above prescription amount of microcrystalline cellulose and povidone K30, then add 5% PVP 80% ethanol solution and mix to make a suitable soft material , passed through a 16-mesh sieve, made into granules, dried at 60°C, passed through a 18-mesh dry granule for granulation, added hypromellose (K4M) and magnesium stearate, mixed evenly, pressed into tablets, and coated.

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PUM

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Abstract

The invention discloses a dezocine oral preparation. The dezocine oral preparation is suitable for unit preparations, and is prepared from 5-150 mg of dezocine and any pharmaceutically acceptable ingredients of the oral preparation. In addition, the invention further discloses a preparation method and application of the oral preparation. The clinical tests prove that within the dosage range, the dezocine oral preparation has the similar blood concentration compared with commercially available dezocine injection, the adverse reaction is slight, and drug administration is more convenient.

Description

[0001] This application is a divisional application of the application number 201510080325.X and the invention name "Dezocine Oral Preparation" submitted on February 13, 2015 technical field [0002] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to an oral preparation of dezocine, a preparation method of the preparation, and an application for treating pain. Background technique [0003] Dezocine, its chemical name is: 13-amino-5,6,7,8,9,10,11,12-octahydro-5-methyl-5,11-methylenebenzocyclo Decen-3-ol. CAS: 53648-55-8. [0004] The structural formula is as follows: [0005] [0006] Dezocine is a powerful opioid analgesic, which acts as both an agonist and an antagonist. It has different characteristics from other opioids through its affinity for receptor subtypes. Its analgesic The effect is stronger than that of pentazocine, and it is less addictive. It is mainly used in the treatment of moderate to severe pain ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/135A61P25/04
Inventor 葛光华刘景龙马晓军杨菡石晶萍李浩冬董达文
Owner YANGTZE RIVER PHARM GRP CO LTD
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