Novel pharmaceutical composition containing analgesic

A technology of composition and analgesic, which is applied in the field of preparation of sustained-release dosage forms, and can solve problems such as poor analgesic effect

Inactive Publication Date: 2011-03-23
苏州世林医药技术发展有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

When taking immediate-release preparations, it is easy to reduce the efficacy of short half-life, and the analgesic effect is not good

Method used

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  • Novel pharmaceutical composition containing analgesic
  • Novel pharmaceutical composition containing analgesic
  • Novel pharmaceutical composition containing analgesic

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1～3

[0026] Unit: mg

[0027] raw material

[0028] tramadol hydrochloride

[0029] The manufacturing method adopts general wet granulation. After sieving the drugs other than magnesium stearate and hydroxypropyl methylcellulose through a No. 35 sieve (500 μm), put them into a high-speed rotary machine and mix for 2 to 4 minutes. Then put in an appropriate amount of adhesive liquid, and after about 2-3 minutes of bonding, put it into the boiling drying machine, and dry it at a temperature of 60-70 degrees until the drying reduction is 0.5-3.0%. The dried granules are shaken and sieved with a No. 18 sieve to granulate, put into a V-shaped mixer together with magnesium stearate and mix for 3 minutes, and be compressed into tablets with a size of 4 to 8 kgf with a tablet machine.

[0030] The prepared tablets were subjected to a dissolution test under the following conditions:

[0031] - Dissolution test method: Stirring method

[0032] - Eluate: .pH1.2 (900mL) ...

Embodiment 4～6

[0041] Unit: mg

[0042] raw material

Example 1

Example 2

Example 3

Acetaminophen

325.0

325.0

325.0

Silica Dispersion

3.0

3.0

3.0

Sodium starch glycolate

15.0

15.0

15.0

Polyvinylpyrrolidone (PVP K-25)

64.5

25.0

12.0

Low-substituted hydroxypropyl cellulose L-HPC

18.1

57.6

70.6

Yellow No. 4

0.4

0.4

0.4

Magnesium stearate

4.0

4.0

4.0

Total

430.0

430.0

430.0

[0043] In order to judge the manufactured tablets, the capping process was observed with the naked eye during the manufacturing process, and the dissolution test under the same conditions as the sustained-release preparation was carried out, and the release was measured when the preparation was disintegrated to more than 80%. Test results: No capping phenomenon was observed in Examples 4 and 5, but ca...

Embodiment 7～9

[0048] :mg

[0049] raw material

[0050]Test results In Examples 7 to 9, there is no decapping phenomenon, and the disintegration time of Example 9 using cross-linked polyvinylpyrrolidone is 8 minutes, which is the fastest.

[0051]

[0052] Polyvinylpyrrolidone was cross-linked using a disintegrant, and its productivity and disintegration time were evaluated.

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PUM

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Abstract

The invention discloses a compound slow release preparation prepared from acetaminophen and tramadol hydrochloride for the first time, realizes taking medicine twice per day, and reduces non-indication of patients to the medicine, and the sustained medicine effect can achieve abirritation for a long time.

Description

technical field [0001] The invention relates to the preparation of a slow-release dosage form of acetaminophen+trama hydrochloride compound preparation, belonging to the field of innovative pharmaceutical preparations. Background technique [0002] Acetaminophen is a non-steroidal anti-inflammatory drug with a half-life of 1 to 2 hours. It has better analgesic and anti-inflammatory effects when administered for a short period of time. Chronic patients need to take it frequently for analgesic and anti-inflammatory treatments. Therefore, in order to rapidly exert the drug effect, it is necessary to combine the immediate-release preparation with the sustained-release preparation for continuous analgesia and anti-inflammation, or to use a preparation containing both immediate-release and sustained-release properties. [0003] Regarding the immediate-release preparation, take US Patent No. 6,217,907 as an example. In the prescription, sodium starch glycolate and microcrystalline ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/167A61K31/137A61K9/24A61P29/00
Inventor 崔载胜南庚太郑载勋金志太
Owner 苏州世林医药技术发展有限公司
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