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Rifampin lyophilized powder and preparation method thereof

A technology for freeze-dried powder injection and rifampicin, which is applied in the field of rifampicin freeze-dried powder for injection and its preparation, can solve the problems of reduced potency, easy decomposition, etc., and achieves low content of related substances, good stability, and clinical use. The effect of high safety

Active Publication Date: 2014-01-29
南通丝乡丝绸有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Rifampicin is almost insoluble in water, and its molecule contains 1,4-naphthalenediol functional group, which is easily oxidized into corresponding quinone derivatives under alkaline conditions, and is easily decomposed by light to reduce the potency

Method used

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  • Rifampin lyophilized powder and preparation method thereof
  • Rifampin lyophilized powder and preparation method thereof
  • Rifampin lyophilized powder and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Rifampicin: 20g

[0022] Tartaric acid and sorbic acid: 12g tartaric acid + 10g sorbic acid

[0023] Macrogol 400: 55g

[0024] PH regulator: appropriate amount

[0025] Water for injection: 2000ml

[0026] Process:

[0027] 1. Take the prescribed amount of tartaric acid and sorbic acid, add 50% water for injection, heat to 50-55°C, stir to dissolve, take the prescribed amount of rifampicin and add it to the solution, stir to dissolve and continue to stir for 15 minutes.

[0028] 2. Take the prescribed amount of polyethylene glycol 400, add 40% water for injection, stir for 15 minutes, and adjust the pH to 3.0-3.5 with hydrochloric acid.

[0029] 3. Combine solutions 1 and 2, adjust the pH to 6.3-6.5 with a pH regulator (sodium hydroxide solution), add water for injection to the full amount, add 0.15% activated carbon for needles, stir for 25 minutes, filter for decarburization, intermediate Inspection, after passing the test, use a 0.22 μm filter membrane to filte...

Embodiment 1

[0031] Rifampicin: 20g

[0032] Tartaric acid and sorbic acid: 12g tartaric acid + 10g sorbic acid

[0033] PH regulator: appropriate amount

[0034] Water for injection: 2000ml

[0035] Process:

[0036] 1. Take the prescribed amount of tartaric acid and sorbic acid, add 80% water for injection, heat to 50-55°C, stir to dissolve, take the prescribed amount of rifampicin and add it to the solution, stir to dissolve and continue to stir for 15 minutes.

[0037] 2. Use a pH regulator (sodium hydroxide solution) to adjust the pH to 6.3-6.5, add water for injection to the full amount, add 0.15% activated carbon for needles, stir for 25 minutes, filter for decarburization, check the intermediate, and use 0.22 μm after passing the test Membrane filter to sterilize, pour the filtrate into vials, and freeze-dry to obtain freeze-dried powder injections, which are packaged after passing the inspection.

Embodiment 2

[0039] Rifampicin: 20g

[0040] Macrogol 400: 55g

[0041] pH regulator: appropriate amount

[0042] Water for injection: 2000ml

[0043] Process:

[0044] 1. Take the prescribed amount of polyethylene glycol 400, add 80% water for injection, stir for 15 minutes, and adjust the pH to 3.0-3.5 with hydrochloric acid. Add the rifampicin of prescription quantity into the solution, stir and dissolve and continue to stir for 15 minutes.

[0045] 2. Use a pH regulator (sodium hydroxide solution) to adjust the pH to 6.3-6.5, add water for injection to the full amount, add 0.15% activated carbon for needles, stir for 25 minutes, filter for decarburization, check the intermediate, and use 0.22 μm after passing the test Membrane filter to sterilize, pour the filtrate into vials, and freeze-dry to obtain freeze-dried powder injections, which are packaged after passing the inspection.

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Abstract

The invention relates to rifampin lyophilized powder. The rifampin lyophilized powder is prepared from the following raw materials: 20g of rifampin, 12g of tartaric acid, 10g of sorbic acid, 55g of polyethylene glycol 400 and 2000ml of water for injection; and the pH is adjusted to 6.3-6.5.

Description

technical field [0001] The invention relates to rifampicin freeze-dried powder injection and a preparation method thereof. Background technique [0002] Rifampicin is a semi-synthetic antibiotic obtained from the genus Streptomyces. It is currently one of the most important anti-tuberculosis drugs. It is mainly used to treat tuberculosis and other tuberculosis. It can also be used for drug-resistant Legionella and β2-lactamase resistance. bacteria, Streptococcus epidermidis, Staphylococcus aureus, and anaerobic bacteria. The commonly used dosage forms of rifampicin in China are tablets, capsules and compound preparations, etc. Recently, dosage forms such as powder injections and injections have appeared in the market. Rifampicin is almost insoluble in water, and its molecule contains 1,4-naphthalenediol functional group, which is easily oxidized to corresponding quinoid derivatives under alkaline conditions, and is easily decomposed by light to reduce the potency. [0003]...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/496A61K47/42A61K47/12A61P31/06A61P31/04
Inventor 金春来
Owner 南通丝乡丝绸有限公司
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