Acidum citricum nolvadex capsule and preparation method thereof

A technology of tamoxifen and citric acid, applied in the field of medicine, can solve the problems of slow dissolution, poor stability, low drug absorption and bioavailability, etc., and achieves the advantages of simple preparation, stable preparation, prevention and slowing down of drug decomposition. Effect

Inactive Publication Date: 2008-09-24
孙向阳
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In view of this, in order to solve the problems of slow dissolution rate of existing tamoxifen citrate preparations, low drug absorption and bioavailability or poor stability, the present invention provides a drug that can avoid light, moisture, prevent and slow down drug decomposition , tamoxifen citrate capsules with simple preparation, low cost, stable preparation and high bioavailability

Method used

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  • Acidum citricum nolvadex capsule and preparation method thereof
  • Acidum citricum nolvadex capsule and preparation method thereof
  • Acidum citricum nolvadex capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] 1. Weigh an appropriate amount of povidone K30 and add ethanol to prepare a solution with a concentration of 10% by weight, and set aside.

[0023] 2. Crush tamoxifen citrate and pass through a 100-mesh sieve, and microcrystalline cellulose, crospovidone, starch, and magnesium stearate are respectively passed through a 100-mesh sieve for later use.

[0024] 3. Weigh 15.17g of tamoxifen citrate, 70g of starch, 60g of microcrystalline cellulose, and 5g of crospovidone, put them in a wet granulator and mix them well, add an appropriate amount of binder, and stir to make a soft material. Wet granules were made through a 20-mesh sieve.

[0025] 4. Dry the wet granules in an oven at 50-60°C for 1-2 hours.

[0026] 5. Sorting the dry granules through a 14-mesh sieve.

[0027] 6. Transfer the dry granules to a V-shaped blender, add 0.75g of magnesium stearate and mix well.

[0028] 7. After measuring the percentage of tamoxifen citrate in the granules, fill the capsules and ...

Embodiment 2

[0030] The implementation is basically the same as in Example 1, the difference is that

[0031] The weight of each component is 30.34 g of tamoxifen citrate, 75 g of starch, 90 g of microcrystalline cellulose, 5 g of crospovidone, and 1 g of magnesium stearate.

[0032] The following two tables are the long-term stability test data of tamoxifen citrate capsules prepared according to Examples 1 and 2 respectively.

[0033]

[0034]

[0035]

[0036] The test data shows that the tamoxifen citrate capsules prepared according to the content of the present invention have no significant change in each main index after long-term storage, and the product has good stability and safety, high dissolution rate, and guaranteed curative effect.

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Abstract

The invention discloses a citric acid tamoxifen capsule and consists of 5 to 25 percent of citric acid tamoxifen, 35 to 55 percent of starch, 35 to 50 percent of microcrystalline cellulose, 2 to 5 percent of PVPP and 0.2 to 0.5 percent of magnesium stearate according to the weight percentage.

Description

Technical field: [0001] The invention belongs to the technical field of medicine, and in particular relates to a tamoxifen citrate capsule and a preparation method thereof. technical background: [0002] Tamoxifen citrate is a non-steroidal anti-estrogen drug. Since its introduction in the 1970s, it has been used as a standard treatment drug for breast cancer hormone therapy. It is used in clinical practice for patients with various types and stages of breast cancer. In recent years, tamoxifen citrate is not only the first-line drug for breast cancer endocrine therapy, but also used for the prevention and treatment of breast cancer. About 4.5 million patients worldwide use tamoxifen to treat breast cancer every year. [0003] Tamoxifen citrate is insoluble in water, and its in vivo bioavailability and in vitro dissolution characteristics have a certain correlation. Currently clinically used tamoxifen citrate preparations are tamoxifen citrate dispersible tablets or oral sol...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/138A61K47/30A61P35/00
Inventor 孙向阳
Owner 孙向阳
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