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Temsirolimus for injection and preparation method thereof

A technology for injection and dispersant, applied in the field of temsirolimus for injection and its preparation, to achieve the effects of ensuring stability, reducing injection pain, and strong patient dependence

Active Publication Date: 2013-05-15
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation has few ingredients in the prescription, and the preparation method is convenient and easy, which improves the shortcomings of the existing complicated prescription process, and greatly reduces the alcohol and other ingredients that are likely to cause injection pain, and is safer and more reliable.

Method used

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  • Temsirolimus for injection and preparation method thereof
  • Temsirolimus for injection and preparation method thereof
  • Temsirolimus for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Embodiment 1 Preparation of Temsirolimus for Injection

[0029] Tesirolimus 0.25g

[0030] Tween 80 10g

[0031] Ascorbic acid 0.02g

[0032] Dissolve 0.25g temsirolimus in an appropriate amount of absolute ethanol, stir to dissolve, add 0.02g of ascorbic acid, shake well, add 10g of Tween 80, mix well, remove ethanol by freeze dryer, and pack in cillin bottle, cork and cap.

Embodiment 2

[0033] Embodiment 2 Preparation of Temsirolimus for Injection

[0034] Tesirolimus 0.25g

[0035] Tween 80 10g

[0036] α-Tocopherol 0.09g

[0037] Dissolve 0.25g temsirolimus in an appropriate amount of absolute ethanol, stir to dissolve, add 0.09g α-tocopherol, shake well, add 10g Tween 80, mix well, remove ethanol by freeze dryer, and divide Put it in a vial, cork and cap it.

Embodiment 3

[0038] Embodiment 3 Preparation of Temsirolimus for Injection

[0039] Tesirolimus 0.25g

[0040] Tween 80 8g

[0041] Alpha-Tocopherol 0.078g

[0042] Dissolve 0.25g temsirolimus in an appropriate amount of absolute ethanol, stir to dissolve, add 0.078g α-tocopherol, shake well, add 8g Tween 80, mix well, remove ethanol by freeze dryer, and divide Put it in a vial, cork and cap it.

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and concretely relates to temsirolimus for injection and a preparation method thereof. The preparation method comprises dissolving a prescribed amount of temsirolimus and an anti-oxidant in anhydrous alcohol, mixing uniformly, adding a dispersant, re-mixing uniformly, freeze drying and removing the ethanol to obtain the temsirolimus. The preparation provided by the invention is few in prescription component; and the preparation method is convenient and easy, improves disadvantages of complex technology in present prescription, and greatly minimizes components such as alcohols and the like that may cause injection pain, thereby being relatively safe and reliable.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a temsirolimus for injection and a preparation method thereof. Background technique [0002] Temsirolimus is the 42-bis-hydroxymethyl propionate of rapamycin, which exhibits cell growth and proliferation inhibition in vivo, and can delay the time of tumor cell development or tumor recurrence. Temsirolimus binds to the cellular protein FKBP and forms a complex that inhibits the enzyme mTOR (mammalian target of rapamycin). Inhibition of mTOR's kinase activity inhibits various signal transduction pathways, including cellular The cell proliferation activated by kinetochore regulates the transcription of mRNAs of some key proteins in the G1 phase of the cell cycle and the transcription induced by IL-2, thereby inhibiting the progression of the cell cycle from G1 to S, thereby producing an anticancer effect. [0003] Temsirolimus has been shown to inhib...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/436A61P35/00A61P35/02
Inventor 赵志全冯中
Owner SHANDONG NEWTIME PHARMA
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