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Ratio karoo amine slice and preparing technique thereof

A kind of bicalutamide tablet, the technology of bicalutamide, be applied in the field of bicalutamide tablet and preparation technology

Inactive Publication Date: 2008-06-18
SHANGHAI FOSUN PHARMA (GROUP) CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
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Problems solved by technology

No other significant effects in general pharmacological tests

Method used

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  • Ratio karoo amine slice and preparing technique thereof
  • Ratio karoo amine slice and preparing technique thereof
  • Ratio karoo amine slice and preparing technique thereof

Examples

Experimental program
Comparison scheme
Effect test

example 1-3

[0063] Example of Bicalutamide Tablets (1000 Tablets)

[0064]

[0065] Operation process:

[0066] 1. Bicalutamide is micronized (below 25um), and the excipients are passed through a 100-mesh sieve.

[0067] 2. Weigh the prescribed amount of bicalutamide, lactose, and sodium carboxymethyl starch.

[0068] 3. Put the prescribed amount of bicalutamide, lactose, and sodium carboxymethyl starch into a high-speed wet granulator, stir at a low speed for 3 minutes, stir at a high speed for 2 minutes, add 2% HPMC aqueous solution to granulate, and stir at a low speed (120 rpm) for 3 minutes .

[0069] 4. Ventilate and dry at 65-75°C for 1-2 hours, and sieve with 16 meshes for granulation.

[0070] 5. Add the prescribed amount of magnesium stearate, mix for 50 turns (15 minutes), and take samples to determine the content and moisture of the intermediate.

[0071] 6. According to the determination result of the intermediate content, the weight of the plain tablet is calculated a...

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Abstract

The invention provides a bicalutamide tablet and the related preparation process. The invention adopts new tablet formula and new technique and overcomes the shortcomings in prior art. The technique of the invention is favorable for scale-type industrial production and the product is improved in quality and is good in dissolution.

Description

Technical field: [0001] The invention belongs to the technical field of pharmaceutical preparations. It specifically relates to bicalutamide tablets and a preparation process. Background technique: [0002] Prostate cancer is currently the most common malignant tumor in men, ranking second in incidence. At present, the main clinical treatment methods include surgical castration, estrogen therapy and luteinizing hormone analog therapy. However, due to the refractoriness of some patients to hormone therapy, relapse often occurs within 18 to 24 months after treatment, and is related to the later life of the patient. Therefore, it is very necessary to find potent and longer-lasting therapeutic drugs. [0003] Bicalutamide is a pure antiandrogen with no other endocrine activity. There are no other significant effects in general pharmacological tests. In long-term dosing studies, dogs at doses greater than ED with prostate atrophy 50 When the value is 25 times, it causes mil...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/167A61P35/00A61P13/08
Inventor 熊洁包玉林蔡胜
Owner SHANGHAI FOSUN PHARMA (GROUP) CO LTD
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