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Oral fluorouracil emulsion and preparation method thereof

A technology of fluorouracil oral milk and uracil oral milk, which is applied in the field of medicine and its preparation, can solve the problems of fluorouracil oral milk stratification, abnormal production, turbidity, etc., and achieves simple and easy preparation method, low production cost and stable good sex effect

Active Publication Date: 2011-01-12
HUNAN ZHONGHE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Fluorouracil oral milk is prone to stratification during the preparation process, or stratification and turbidity appear again after a period of storage
This technical problem has been plagued by the product manufacturers, so that some manufacturers have been unable to produce normally after applying for new drugs

Method used

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  • Oral fluorouracil emulsion and preparation method thereof
  • Oral fluorouracil emulsion and preparation method thereof
  • Oral fluorouracil emulsion and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Preparation method step of the present invention is as follows:

[0027] (1) Configure the water phase: add purified water to the batching tank and heat, add sodium hydroxide and sodium saccharin and heat until the sodium hydroxide and sodium saccharin are completely dissolved, then add fluorouracil and ethylparaben, start stirring and dissolve, heat up and boil .

[0028] (2) Configure the oil phase: heat up the vegetable oil and keep it warm for sterilization, then cool down.

[0029] (3) Emulsification: After emulsifying the water phase and soybean lecithin for 60 minutes, add polysorbate-80 into the emulsifier and stir, then add the oil phase, then add the remaining water phase and supplement the evaporated water. After emulsification is complete, cool down, add vanilla essence and orange essence, and stir well.

[0030] (4) Homogenization: Homogenize using a high-pressure homogenizer.

[0031] (5) Filling

[0032] (6) Sterilization: The filled glass bottles are...

Embodiment 2

[0043] (1) Configure the water phase: add purified water to the batching tank and heat up to 75°C, add 3g of sodium hydroxide and 0.5g of sodium saccharin and heat to 100°C, after the sodium hydroxide and sodium saccharin are completely dissolved, then add fluorouracil 15g and 0.5g of ethylparaben are turned on and stirred to dissolve, heated up and boiled for 5 minutes, and kept at 95-100°C.

[0044] (2) Prepare the oil phase: heat 200g of vegetable oil to 112°C, heat it for 15 minutes to sterilize, and cool down to 90°C.

[0045] (3) Emulsification: 60% of the water phase, 18g of soybean lecithin was emulsified for 60 minutes, then added polysorbate-8035g into the emulsifier and stirred for 30 minutes, then added the oil phase and continued to stir for 15 minutes, then added the remaining water phase and replenished to evaporate water and stirred for 30 minutes. The temperature of the whole emulsification process is controlled at 95-100°C. After the emulsification is compl...

Embodiment 3

[0051] (1) Configure the water phase: add purified water to the batching tank and heat up to 85°C, add 4g of sodium hydroxide and 0.7g of sodium saccharin and heat to 100°C, after the sodium hydroxide and sodium saccharin are completely dissolved, add fluorouracil 16g and 0.6g of ethylparaben are turned on and stirred to dissolve, heated up and boiled for 3 minutes, and kept at 95-100°C.

[0052] (2) Prepare the oil phase: heat up 220g of vegetable oil to 115°C, heat it for 20 minutes to sterilize, and cool down to 89°C.

[0053] (3) Emulsification: 60% of the water phase, 25g of soybean lecithin, emulsified for 60 minutes, then added polysorbate-8025g into the emulsifier and stirred for 30 minutes, then added the oil phase and continued to stir for 10 minutes, then added the remaining water phase and replenished to evaporate water and stirred for 30 minutes. The temperature of the whole emulsification process is controlled at 95-100°C. After the emulsification is complete, ...

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Abstract

The invention relates to an oral fluorouracil emulsion which comprises the following components in percentage by weight: 1-5 percent of fluorouracil, 20-40 percent of other auxiliary materials and 60-80 percent of purified water, wherein the auxiliary materials comprise one or more of soyabean lecithin, vegetable oil, sodium hydroxide, polysorbicester-80, vanilla, saccharin sodium, orange essence and ethylparaben. The product of the invention conforms to the requirement on the Chinese pharmacopoeia and has the advantages of good stability and no demixing turbidness.

Description

Technical field: [0001] The invention relates to a medicine and a preparation method thereof, in particular to a fluorouracil oral milk and a preparation method thereof. Background technique: [0002] Fluorouracil belongs to antimetabolite antineoplastic drugs. This product has a broad anti-cancer spectrum and is clinically used for digestive tract cancer. It is often used in combination with mitomycin, doxorubicin or cytarabine. It is also commonly used as adjuvant chemotherapy after surgery and intestinal perfusion during surgery. For primary or metastatic liver cancer, the drug is injected continuously through an arterial catheter or an infusion pump. For choriocarcinoma, a higher dose or combined use with actinomycin D has a better effect. Also used for breast cancer, ovarian cancer, lung cancer, cervical cancer, gastric cancer, bladder cancer and pancreatic cancer. [0003] Fluorouracil is a cycle-specific drug that is mainly metabolized and broken down in the liver...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K31/513A61P35/00
Inventor 叶建南毛友雷良平
Owner HUNAN ZHONGHE PHARMA