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Temsirolimus for injection and preparation method thereof

A unique technology for injection, which is applied in the field of temsirolimus for injection and its preparation, to achieve the effect of less prescription ingredients, reduce injection pain, and avoid the risk of clinical use

Pending Publication Date: 2018-03-09
LUNAN PHARMA GROUP CORPORATION
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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

[0024]

[0025] Preparation Process:

[0026] 1. Bottle washing, sterilizing and drying: the vials are first cleaned by an ultrasonic bottle washing machine, and then sterilized and dried by a sterilizing dryer at 320°C for later use.

[0027] 2. Butyl rubber stopper treatment: clean the butyl rubber stopper with a stopper cleaning machine, sterilize it with steam at 121°C for 20 minutes, and dry it for later use.

[0028] 3. Put the powder containing temsirolimus in each vial, add a rubber stopper halfway, and put it into a freeze dryer.

[0029] 4. Extract the vacuum through the freeze dryer, press the plug and roll the cap to get it.

Embodiment 2

[0031]

[0032] Preparation Process:

[0033] 1. Bottle washing, sterilizing and drying: the vials are first cleaned by an ultrasonic bottle washing machine, and then sterilized and dried by a sterilizing dryer at 320°C for later use.

[0034] 2. Butyl rubber stopper treatment: clean the butyl rubber stopper with a stopper cleaning machine, sterilize it with steam at 121°C for 20 minutes, and dry it for later use.

[0035] 3. Put the powder containing temsirolimus in each vial, add a rubber stopper halfway, and put it into a freeze dryer.

[0036] 4. Extract the vacuum through the freeze dryer, backfill with nitrogen, press the plug and roll the cap.

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PUM

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Abstract

The invention belongs to the field of a medicine preparation and relates to temsirolimus for injection and a preparation method thereof. Temsirolimus raw material powder serves as an only component, no additive is added, split charging is conducted directly, and the influence on the product quality by oxygen is avoided by a vacuumizing mode or a mode of backfilling insert gas after vacuumizing. Long-term storage and acceleration experiments of powder injection indicate that the product quality is stable. The preparation has few formula components, the preparation method is convenient and practical, the defect that the existing formula process is complex is improved, components, such as alcohol, capable of bring injection pain easily, are greatly reduced, and safety and reliability are achieved. The most important thing to note is that the product prepared the technology can achieve high stability during preservation at room temperature, and product transportation and clinical use are facilitated.

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): A61K9/19A61K31/436A61P35/00
CPCA61K9/0019A61K9/19A61K31/436
Inventor 张贵民冯中郝贵周秦士慧董其松李娜
Owner LUNAN PHARMA GROUP CORPORATION
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