Busulfan composition freeze-dried tablet and preparation method thereof

The technology of busulfan and composition is applied in the field of busulfan composition freeze-dried tablet and preparation thereof, and achieves the effects of large dissolution rate, high bioavailability, and guaranteed curative effect and safety.

Inactive Publication Date: 2015-04-29
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Starch is the basic excipient of oral solid preparations. It is formed by the polymerization of glucose molecules. It is often used as a binder, diluent and disintegrating agent in tablets. It is cheap and easy to obtain, and is safe for the human body. However, starch is used alone as an excipient There is no report on the production of Busulfan freeze-dried tablets by freeze-drying process

Method used

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  • Busulfan composition freeze-dried tablet and preparation method thereof
  • Busulfan composition freeze-dried tablet and preparation method thereof
  • Busulfan composition freeze-dried tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027]

[0028] A. Weigh 100g of cornstarch, add 900ml of purified water and stir, use a pH regulator to control the pH of the solution at 6.5, then heat to 72°C and keep for 120 minutes to make 9% (W / V) corn starch solution.

[0029] B. Measure 45ml of purified water, boil, add 85g of sucrose, stir, after dissolving, continue heating to 100°C, filter with refined cotton, wash the filter with an appropriate amount of hot distilled water, combine the lotion and filtrate, let cool, add Add appropriate amount of distilled water to make the whole volume into 100mL, stir well to obtain B solution.

[0030] C. Mix the solution obtained in step A with the solution obtained in step B, fully stir for 30 minutes, and then lower the solution to normal temperature to obtain a corn-sucrose solution.

[0031] D. Weigh 0.5 g of busulfan, add it into 1 L of corn-sucrose solution, and stir for 30 minutes.

[0032] E. After measuring the content of busulfan in the medicinal solution, divid...

Embodiment 2

[0035]

[0036] A. Weigh 130g of cornstarch, add 900ml of purified water and stir, use a pH regulator to control the pH of the solution at 4-5, then heat to 72°C and keep for 120 minutes to make 13% (W / V) cornstarch solution.

[0037] B. Measure 45ml of purified water, boil, add 85g of sucrose, stir, after dissolving, continue heating to 100°C, filter with refined cotton, wash the filter with an appropriate amount of hot distilled water, combine the lotion and filtrate, let cool, add Add appropriate amount of distilled water to make the whole volume into 100mL, stir well to obtain B solution.

[0038] C. Mix the solution obtained in step A with the solution obtained in step B, fully stir for 30 minutes, and then lower the solution to normal temperature to obtain a corn-sucrose solution.

[0039] D, take by weighing 0.5 gram of busulfan (calculated as 1000 tablets), add 1L of corn-sucrose solution, and stir for 30 minutes.

[0040] E. After measuring the content of busulfa...

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Abstract

The invention provides a busulfan composition freeze-dried tablet and a preparation method thereof, and relates to the technical field of medicines and medicine production. The busulfan composition freeze-dried tablet comprises busulfan, starch and cane sugar, wherein the starch and the cane sugar are taken as auxiliary materials. Common corn starch is treated by a heating process, so that the bonding and disintegration functions of the starch in the tablet can be improved, and the formability of the tablet is improved. The busulfan composition freeze-dried tablet only needs two auxiliary materials namely the starch and the cane sugar. The busulfan composition freeze-dried tablet adopts the freeze-drying process that temperature is reduced and increased for two times respectively, and the process that temperature is reduced and increased for two times enables the formability of the tablet to be better and increases the dissolution rate of the tablet so as to improve the biological availability of the tablet; the tablet overcomes the defects of a common busulfan tablet, the types and dosage of auxiliary materials in the busulfan tablet are reduced, the dissolution rate of the tablet is high, the biological availability of the tablet is high, and the curative effect and the safety of clinical medication are ensured.

Description

technical field [0001] The invention relates to the technical field of medicine and medicine production, in particular to a freeze-dried tablet of a busulfan composition and a preparation method thereof. Background technique [0002] Busulfan is an antineoplastic drug. This product is a non-specific drug for cell cycle, mainly used in G1 phase and M phase. Low doses of this product inhibit the generation of bone marrow granulocytes, and have little effect on red blood cells and lymphocytes. In large doses, it has almost no effect on red blood cells and lymphocytes. In large doses, it can inhibit the production of red blood cells and lymphocytes. Due to the selective effect, it has a significant effect on chronic myelogenous leukemia. [0003] Molecular formula C 6 h 14 o 6 S 2 [0004] Molecular weight 246.29 [0005] This product is a sulfonic acid bifunctional alkylating agent, which enters the human body to open the ring structure of the sulfonate group, and d...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/255A61K47/36A61K47/26A61P35/00A61P35/02
Inventor 余丹涛石金友汪金灿郝结兵吴函峰
Owner HAINAN WEI KANG PHARMA QIANSHAN
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