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Fulvestrant containing oil needle preparation

A technology of fulvestrant and oil injection, applied in the field of non-aqueous ester solvent, fulvestrant injectable oil injection preparation, intramuscular injection oil injection preparation, excipient soybean oil, which can solve irritation, etc. question

Inactive Publication Date: 2013-05-08
南京承创医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Such as: the ricinoleate excipient involved in Chinese Patent No. ZL01803546.9, its injection site may cause side effects such as irritation

Method used

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  • Fulvestrant containing oil needle preparation
  • Fulvestrant containing oil needle preparation
  • Fulvestrant containing oil needle preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Preparation of oil injection preparation of fulvestrant (50mg / ml)

[0017]

[0018] Weigh the 96% ethanol and benzyl alcohol of the prescribed amount to mix, add the fulvestrant of the prescribed amount, stir and dissolve.

[0019] Add the prescribed amount of benzyl benzoate, stir, and mix well.

[0020] Add the soybean oil for injection of prescription quantity to make preparation solution into final weight, stir, mix homogeneously.

[0021] Add 5 g of activated carbon, stir at 25°C for 30 minutes, filter through a 0.45μm filter membrane to remove carbon, and then filter through a 0.22μm filter membrane to sterilize.

[0022] Determination of intermediate content.

[0023] Under aseptic conditions, the filtrate was filled in 5ml ampoule bottles with a filling volume of 5.25ml, covered with sterile nitrogen gas, and sealed by fusing.

Embodiment 2

[0025] Preparation of oil injection preparation of fulvestrant (50mg / ml)

[0026]

[0027] Weigh the 96% ethanol and benzyl alcohol of the prescribed amount to mix, add the fulvestrant of the prescribed amount, stir and dissolve.

[0028] Add the prescribed amount of benzyl benzoate, stir, and mix well.

[0029] Add the soybean oil for injection of prescription quantity to make preparation solution into final weight, stir, mix homogeneously.

[0030] Add 5 g of activated carbon, stir at 25°C for 30 minutes, filter through a 0.45μm filter membrane to remove carbon, and then filter through a 0.22μm filter membrane to sterilize.

[0031] Determination of intermediate content.

[0032] Under aseptic conditions, the filtrate was filled in 5ml ampoule bottles with a filling volume of 5.25ml, covered with sterile nitrogen gas, and sealed by fusing.

Embodiment 3

[0033] Example 3: Study on the Stability of Oil Injection Preparation of Fulvestrant

[0034] In accordance with the quality standards for the application of fulvestrant oil injection preparations for clinical research and the investigation items listed in the stability test of injections in the second appendix of the Chinese Pharmacopoeia 2010 edition "Guiding Principles for Drug Stability Tests", we stabilized this product. sex inspection.

[0035] Influencing factor test

[0036] Influencing factor test method: Take this product (batch number: 20120521), remove the outer packaging, and place it at 25°C and light intensity of 4500Lx for 10 days, and take samples for inspection on the 5th and 10th days respectively. The content of vestrant and related substances are the main indicators of investigation, and the stability of the preparation to temperature and light is compared with the data of 0 days. The results are shown in Table 1.

[0037] Table 1 Influencing factor tes...

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Abstract

The invention relates to a fulvestrant containing oil needle preparation for intramuscular injection. An excipient of the oil needle preparation is soybean oil for injection. The oil needle preparation is filled in a glass ampoule bottle under an aseptic condition. The fulvestrant containing oil needle preparation has the advantages that as the excipient, the soybean oil for injection is considered as a totally non-toxic and non-irritating substance; and relevant side effects caused by long-term contacts of the excipient, pharmaceutically acceptable alcohols and non-aqueous ester solvents with plastic products are avoided by selecting the glass ampoule bottle to contain the oil needle preparation.

Description

Technical field: [0001] The present invention relates to fulvestrant (its chemical name is 7α-[9-(4,4,5,5,5-pentafluoropentylsulfinyl)nonyl]estra-1,3,5(10)- Triene-3,17β-diol) oil injection preparations, in particular to fulvestrant injectable oil injection preparations, and especially to intramuscular injectable oil injection preparations. The present invention also relates to the excipients soybean oil, at least one pharmaceutically acceptable alcohol and a pharmaceutically acceptable non-aqueous ester solvent. Background technique: [0002] Fulvestrant is an estrogen receptor antagonist without agonist effect. It binds, blocks and degrades estrogen receptors in breast tumor cells, thereby blocking the growth of tumor cells under the action of estrogen. [0003] In recent years, preparations for treating breast cancer have been continuously developed in this field, but side effects are common. For example: the ricinoleic acid ester excipient involved in Chinese Patent No...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/565A61K47/44A61P5/32A61P35/00
Inventor 刘连华阙瑞琪孙平刘倩
Owner 南京承创医药科技有限公司
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