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Gentamycin sulfate injection containing buffer agent

A technology of gentamicin sulfate and injection, which is applied in the direction of medical preparations of non-active ingredients, inorganic non-active ingredients, active ingredients of heterocyclic compounds, etc., and can solve the problem of increasing

Inactive Publication Date: 2012-10-31
TIANJIN JINYAO GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chinese patent application 200910074602.0 discloses a gentamicin sulfate injection and a preparation method thereof, the auxiliary materials are p-hydroxybenzoate, sodium bisulfite, and EDTA-2Na, and the pH of the injection is adjusted to 5.5-6.0, but the injection sterilization method disclosed in the application is filter sterilization. According to the existing process and formula of the application, we found that when high-temperature sterilization was used to produce gentamicin sulfate injection, The obtained product has a high content of related substances, and the related substances increase more after high-temperature sterilization, and the related substances increase rapidly with the storage time, and cannot meet the requirements of the 2010 Chinese Pharmacopoeia within the entire validity period
[0004] In addition, the Chinese document "Separation and Structure Research of the Main Components of Gentamicin" (Zheng Shengyi et al., Antibiotics, 1980, 5(1); 5-11) pointed out that carbon dioxide can form amino groups with the free base of gentamicin Formic acid esters, thereby become the source of impurity, and add sodium carbonate to adjust pH in the prior art, also can produce a certain amount of carbonic acid gas when sodium carbonate reacts with weakly acidic gentamycin sulfate thereby generate impurity. Therefore, reduce gentamycin sulfate Improving the content of related substances of damycin and improving its stability has become the main technical problem to be solved at present

Method used

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  • Gentamycin sulfate injection containing buffer agent
  • Gentamycin sulfate injection containing buffer agent
  • Gentamycin sulfate injection containing buffer agent

Examples

Experimental program
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Effect test

Embodiment 1

[0034] Preparation Process

[0035] 1) Prepare the prescription amount of pH buffer, add the prescription amount of sodium sulfite and sodium bisulfite and stir until completely dissolved, make up the water for injection to 90% of the prescription volume, and use it for later use;

[0036] 2) Add the prescribed amount of gentamycin sulfate to the standby solution prepared in 1), stir until it is completely dissolved, add 1 g of medicinal charcoal to the standby solution prepared in 2), stir well and let stand for 10 minutes;

[0037] 3) Filter and make up the water for injection to the prescription amount;

[0038] 4) After fine filtration until the visible foreign matter is qualified, potting;

[0039] 5) High temperature sterilization, ready.

Embodiment 2

[0041] Preparation Process

[0042] 1) Prepare the prescription amount of pH buffer, add the prescription amount of sodium bisulfite and stir until it is completely dissolved, make up the water for injection to 90% of the prescription volume, and set aside;

[0043] 2) Add the prescription amount of gentamicin sulfate to the standby solution prepared in 1), and set aside;

[0044] 3) Add 3g of medicinal charcoal to the ready-to-use solution prepared in 2), stir it evenly and leave it for 10 minutes;

[0045] 4) Filter to make up the water for injection to the prescription amount;

[0046] 5) After fine filtration until the visible foreign matter is qualified, potting;

[0047] 6) High temperature sterilization, ready.

[0048] The preparation process of Example 3-15 is the same as that of Example 2, wherein in Examples 4, 7-10, and 12-15, sodium sulfite is replaced with sodium metabisulfite;

Embodiment 16

[0049] The preparation process of Example 16 is the same as that of Example 1

[0050] The formula table of the control example, other prescriptions are the same as the corresponding numbered example, no pH buffering agent is added, sodium carbonate is used as the pH adjuster, adjusted to the same pH value of the corresponding numbered example, and the prescription amount is also calculated according to the amount of 1000 bottles

[0051]

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Abstract

The invention discloses gentamycin sulfate injection containing a buffer agent. Each milliliter of injection consists of 18 to 45 milligrams of gentamycin sulfate, an antioxidant, a pH buffer agent and the balance of injection water, wherein the antioxidant is one of sodium sulfite, sodium bisulfite or sodium pyrosulfite. The injection is characterized in that the pH value of the pH buffer agent is 5.5 to 6.0.

Description

Technical field [0001] The invention relates to a gentamicin sulfate medicine for injection and a preparation method thereof. Background technique [0002] Gentamicin sulfate is an aminoglycoside antibiotic that has been widely used. Existing gentamicin sulfate injection, the auxiliary materials are water for injection and sodium bisulfite or sodium metabisulfite, which can be injected intramuscularly or intravenously after dilution. [0003] The 2005 edition of the Chinese Pharmacopoeia does not provide for the related substances of gentamicin sulfate injection, but in the 2010 edition of the Chinese Pharmacopoeia, it is stipulated that the related substances of gentamicin sulfate should be less than 5%. Chinese patent application 200910074602.0 discloses a gentamicin sulfate injection and a preparation method thereof. The auxiliary materials are paraben, sodium bisulfite, and EDTA-2Na, and sodium carbonate solution is used to adjust the pH of the injection to 5.5-6.0, but the i...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/36A61K47/02A61K47/12A61P31/04
Inventor 杨国存于润芳林劼张岚吴媛媛都惠芳赵路侯宁肖敏霞刘明志
Owner TIANJIN JINYAO GRP
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