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Tamoxifen citrate freeze-dried powder injection

A technology of tamoxifen and freeze-dried powder injection, applied in the field of tamoxifen citrate freeze-dried powder injection, can solve the problems of low bioavailability and high cost

Active Publication Date: 2014-01-08
NANTONG GUANGTAI BIOCHEM PROD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this preparation has high cost and low bioavailability, and cannot be well used in clinical practice.

Method used

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  • Tamoxifen citrate freeze-dried powder injection
  • Tamoxifen citrate freeze-dried powder injection
  • Tamoxifen citrate freeze-dried powder injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Tamoxifen Citrate 86g

[0027] The composition of sorbitol, dextran and lactose (the weight ratio of the three is 3.2:5.5:2) 233g

[0028] The composition of arginine and glutathione (the weight ratio of the two is 1.6:5.7) 14.5g

[0029] Disodium edetate 10g

[0030] Hydrochloric acid solution (0.1mol / l) appropriate amount to adjust the pH to 6.5

[0031] Add water for injection to 1000ml

[0032] Preparation:

[0033] Weigh the prescribed amount of tamoxifen citrate, sorbitol, dextran, lactose, arginine, glutathione and disodium edetate respectively, add to water for injection, stir well to dissolve, add activated carbon , adsorption, decarburization and filtration. The hydrochloric acid solution adjusted the pH to 6.5. After filtering with a 0.22μm filter membrane, fill it into washed, dried and sterilized vials, each containing 3mL, half-press the cap, turn on the freeze dryer, cool down to -40°C, freeze-dry, crimp the cap, and check ,Package.

Embodiment 2

[0035] Tamoxifen Citrate 86g

[0036] The composition of mannitol, glucose and dextran (the weight ratio of the three is 3:5:2) 233g

[0037] The composition of arginine and glutathione (the weight ratio of the two is 1.6:5.7) 14.5g

[0038] Disodium edetate 10g

[0039] Hydrochloric acid solution (0.1mol / l) appropriate amount to adjust the pH to 6.5

[0040] Add water for injection to 1000ml

[0041] Preparation method is the same as embodiment 1

Embodiment 3

[0043] Tamoxifen Citrate 86g

[0044] The composition of sorbitol, dextran and lactose (the weight ratio of the three is 3.2:5.5:2) 233g

[0045] The composition of cysteine ​​hydrochloride and glutathione (the weight ratio of the two is 1:5) 14.5g

[0046] Disodium edetate 10g

[0047] Hydrochloric acid solution (0.1mol / l) appropriate amount to adjust the pH to 6.5

[0048] Add water for injection to 1000ml

[0049] Preparation method is the same as embodiment 1

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Abstract

The invention relates to a tamoxifen citrate freeze-dried powder injection which comprises tamoxifen citrate, a composition of sorbitol, dextran and lactose in a weight ratio of 3.2:5.5:2, a composition of arginine and glutathione in a weight ratio of 1.6:5.7, and disodium ethylenediamine tetraacetate.

Description

technical field [0001] The application relates to a kind of tamoxifen citrate freeze-dried powder injection. Background technique [0002] Tamoxifen (TAM) is a non-steroidal compound approved by the US Food and Drug Administration in 1977 for the treatment of metastatic breast cancer in postmenopausal women. After nearly 30 years of application history, it is now also used to prevent the occurrence of breast cancer. TAM belongs to the first generation of selective estrogen receptor modulators (selective estrogen receptor modulators, SERMs), which have dual effects of estrogen agonism and estrogen antagonism, and this effect depends on different germlines, tissues and gene expression types, Different target organs or target cells have different effects. For example, TAM produces antagonizing estrogen in mammary gland tissue, while it produces estrogen agonizing effect in uterus and bone tissue. TAM competes with estrogen for the estrogen receptor (ER) in the cytoplasm of t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K47/26A61K47/18A61K31/138A61P35/00
Inventor 李春涛李申邱俊
Owner NANTONG GUANGTAI BIOCHEM PROD
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