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Tapentadol hydrochloride injection and preparation method thereof

A technology for tapentadol hydrochloride and injection, which is applied in the preparation of tapentadol hydrochloride small-volume injection and the field of tapentadol hydrochloride small-volume injection, which can solve the problems of slow absorption and distribution, low bioavailability, and Slow effect and other problems, to achieve the effect of fast distribution, high bioavailability, and fast onset of action

Active Publication Date: 2016-01-20
CUREGEN JIANGSU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] Due to the first-pass effect of the liver, the existing oral preparations have the disadvantages of low bioavailability, slow absorption and distribution, and slow onset of action.

Method used

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  • Tapentadol hydrochloride injection and preparation method thereof
  • Tapentadol hydrochloride injection and preparation method thereof
  • Tapentadol hydrochloride injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] prescription:

[0031]

[0032] Preparation Process:

[0033] Weigh the prescribed amount of tapentadol hydrochloride, add an appropriate amount of water for injection to dissolve, add 0.6% activated carbon for injection, heat and stir at 50°C to 60°C for 30min, filter and decarbonize, cool to room temperature, and dissolve with 1mol / L trihydrate Adjust the pH value to 5.5-6.5 with sodium acetate, add water for injection to the full amount, measure the intermediate content and pH value, filter through a 0.22μm microporous membrane after passing the test, fill in 2ml ampoule bottles, fill 2ml in each bottle, and store at 121°C Autoclave for 20 minutes, label, pack, and get the finished product after passing the inspection.

Embodiment 2

[0035] prescription:

[0036]

[0037] Preparation Process:

[0038] Weigh the prescribed amount of tapentadol hydrochloride, add an appropriate amount of water for injection to dissolve, add the prescribed amount of sodium bisulfite, dissolve, add 0.6% activated carbon for injection needles, keep stirring at 50°C-60°C for 30min, filter and decarbonize , cooled to room temperature, adjusted the pH value to 5.5-6.5 with 1mol / L sodium acetate trihydrate, added water for injection to the full amount, measured the intermediate content and pH value, filtered through a 0.22μm microporous membrane after passing the test, and filled in 2ml ampere In bottles, each bottle is filled with 2ml, sterilized by autoclaving at 121°C for 20 minutes, labeled, packaged, and the finished product is obtained after passing the inspection.

Embodiment 3

[0040] prescription:

[0041]

[0042] Preparation Process:

[0043] The preparation method is the same as in Example 1 except that the auxiliary materials added are different.

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Abstract

A hydrochloric tapentadol injection and a preparation method thereof. The injection comprises an effective amount of an active ingredient of hydrochloric tapentadol salt or tapentadol alkali, a pharmaceutical carrier that is pharmaceutically acceptable for preparing an injection, and an additive.

Description

1. Technical field [0001] The invention relates to a new dosage form of tapentadol hydrochloride, in particular to tapentadol hydrochloride small volume injection. The invention also relates to a preparation method of tapentadol hydrochloride small volume injection. 2. Background technology [0002] On November 20, 2008, the FDA approved tapentadol hydrochloride immediate-release oral tablets for the relief of moderate to severe acute pain. The approved specifications are 50mg, 75mg and 100mg respectively. Japan also approved Tapentadol Hydrochloride Sustained Release Tablets for the relief of moderate to severe acute pain. The approved specifications are 50mg, 100mg, 150mg, 200mg and 250mg respectively. John Jenkins, director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, said in a statement issued by the FDA that the approval of the drug provides health care professionals with another option for the relief of moderate to severe acute pain...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/137A61P25/04
CPCA61K9/0019A61K31/137A61P25/04
Inventor 吴仁荣
Owner CUREGEN JIANGSU PHARMA
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