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Fosfomycin calcium composition freeze-dried tablet and preparation method thereof

A technology of fosfomycin calcium and its composition, which is applied in the field of fosfomycin calcium composition freeze-dried tablets and its preparation, to achieve the effects of improving bioavailability, improving formability, and large dissolution rate

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

[0008] 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 producing fosfomycin calcium freeze-dried tablets by freeze-drying process

Method used

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  • Fosfomycin calcium composition freeze-dried tablet and preparation method thereof
  • Fosfomycin calcium composition freeze-dried tablet and preparation method thereof
  • Fosfomycin calcium 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 8.5-9.6, then heat to 72°C and keep for 120 minutes to make 9% (W / V ) of cornstarch 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 100 g of fosfomycin calcium, add it to 1 L of corn-sucrose solution, and stir for 30 minutes.

[0032] E. After measuring the content of fosfomycin calcium in the ...

Embodiment 2

[0035]

[0036] A. Weigh 130g of corn starch, add 900ml of purified water and stir, use a pH regulator to control the pH of the solution at 8.5-9.6, 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 100 grams of fosfomycin calcium (calculated as 1000 tablets), add 1L corn-sucrose solution, and stir for 30 minutes.

[0040] E. After measuring the conte...

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Abstract

The invention provides a fosfomycin calcium composition freeze-dried tablet and a preparation method thereof, and relates to the technical field of medicines and medicine production. The fosfomycin calcium composition freeze-dried tablet comprises fosfomycin calcium, starch and cane sugar, wherein the starch and the cane sugar are used as auxiliary materials, and heating process processing is performed on common corn starch, so that the bonding and disintegrating functions of the starch in the tablet can be improved, and the formability of the tablet is improved; the fosfomycin calcium composition freeze-dried tablet only needs the starch and the cane sugar which are used as the auxiliary materials. The fosfomycin calcium composition freeze-dried tablet adopts a freeze-drying process that temperature is reduced and increased for two times, and the process that the 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 that the bioavailability of the tablet is improved. The tablet disclosed by the invention overcomes the defects of a common fosfomycin calcium tablet, and has the characteristics that the types and the dosage of the auxiliary materials in the fosfomycin calcium tablet are reduced, the tablet has a high dissolution rate and high bioavailability, and the curative effect and the safety of clinical medication are guaranteed.

Description

technical field [0001] The invention relates to the technical field of medicine and medicine production, in particular to a freeze-dried tablet of fosfomycin calcium composition and a preparation method thereof. Background technique [0002] Fosfomycin calcium antibiotics are used for simple lower urinary tract infection and intestinal infection caused by sensitive bacteria. It has a significant effect on enteritis, bacillary dysentery, urinary tract infection, skin and soft tissue infection, respiratory tract infection, dacryocystitis, stye, vaginitis, and cervicitis. [0003] Structural formula: [0004] Molecular weight: 194.14 [0005] Ordinary fosfomycin calcium tablets contain many types and quantities of excipients, generally fillers, lubricants, disintegrants, binders, flavoring agents, etc., according to the second part of the Chinese Pharmacopoeia (2010 edition) phosphorus The quality standard of fosfomycin calcium tablets is qualified when the dissolution rat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/665A61K47/36A61K47/26A61P31/04
Inventor 夏明月李彪石金友汪金灿郝结兵
Owner HAINAN WEI KANG PHARMA QIANSHAN
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