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Preparation method of sisomicin sulfate sterile powder for injection

A technology of sisomicin sulfate and sterile powder injection, which is applied in the directions of non-active ingredients medical preparations, medical preparations containing active ingredients, powder transportation, etc., can solve the problem of large power consumption of freeze dryers and stable products It can solve the problems of poor performance and high production cost, and achieve the effect of low impurity content, good stability and high safety.

Inactive Publication Date: 2021-08-06
HAINAN GENERAL & KANGLI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, because the freeze-drying method is to quickly freeze the sterile solution of the drug, and then slowly heat it to sublimate the water in the solution to prepare the powder injection, the prepared powder injection is mainly composed of amorphous crystals, so there are many degradation substances and product stability. Poor and other issues
At the same time, due to the large power consumption of the freeze dryer, the production cost of this method is relatively high.

Method used

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  • Preparation method of sisomicin sulfate sterile powder for injection
  • Preparation method of sisomicin sulfate sterile powder for injection
  • Preparation method of sisomicin sulfate sterile powder for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Embodiment 1 A kind of preparation method of sisomicin sulfate sterile powder injection for injection

[0025] The present embodiment is a preparation method of sisomicin sulfate sterile powder injection for injection, and the specific preparation process includes the following steps performed in sequence:

[0026] Boil water for injection and let it cool for later use;

[0027] Under nitrogen protection, take 500 mL of boiled water for injection, add 1 g of L-cysteine ​​and stir to fully dissolve, use a 0.45 μm microporous membrane to filter to remove insoluble substances and some residual bacterial microorganisms, and cool to 15 ° C ( Recorded as the first cooling), add 100g of sisomicin sulfate and stir to dissolve, use a small amount of aqueous solution containing 0.1mol / L sodium citrate and 0.1mol / L sodium hydroxide to adjust the pH value to 5.5, and maintain the system throughout the process. The temperature is 15°C, then 2g of medicinal activated carbon is added...

Embodiment 2～6

[0029] Embodiment 2~6 Preparation method of sisomicin sulfate sterile powder injection for injection

[0030] Embodiments 2-6 are respectively a kind of preparation method of sisomicin sulfate aseptic powder injection for injection, their steps are basically the same as those of embodiment 1, and the difference is only in the amount of raw materials and process parameters. For details, please refer to the details. Table 1:

[0031] List of various process parameters in Table 1 Examples 2 to 6

[0032]

[0033]

[0034] The contents of other parts of Examples 2 to 6 are the same as those of Example 1.

[0035] The sisomicin sulfate sterile powder for injection prepared in Examples 1 to 6 has good stability, high content of the main drug, few impurities, and excellent resolubility.

experiment example 1

[0036] Experimental Example 1 Determination of performance of sisomicin sulfate sterile powder injection for injection

[0037] Comparative Examples 1 to 6 are the comparative tests of the preparation process of sisomicin sulfate sterile powder injection for injection in Example 1 [specification 0.1g (calculated by sisomicin)], and the differences are only as follows:

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Abstract

The invention provides a preparation method of a sisomicin sulfate sterile powder for injection, and belongs to the technical field of medicine preparation. The preparation method comprises the following steps: under protection of inert gas, taking water for injection, adding an antioxidant for dissolution, then cooling to 20 DEG C or below, adding sisomicin sulfate for dissolution, adjusting a pH value to 5.0-5.5, then decoloring, sterilizing and filtering, cooling to 0-5 DEG C, slowly dropwise adding ethanol to for solvent crystallization, and drying the obtained crystal to obtain the sisomicin sulfate sterile powder for injection. The sisomicin sulfate sterile powder for injection is prepared by selecting proper process conditions and adopting a solvent crystallization method, and the obtained product is good in stability, low in impurity content, high in safety, excellent in resolubility and beneficial to long-term storage.

Description

technical field [0001] The invention relates to the preparation of sterile powder injections, in particular to a preparation method of sisomicin sulfate sterile powder injections for injection. Background technique [0002] Sisomicin sulfate is a new aminoglycoside antibiotic used to treat infections caused by Staphylococcus, Escherichia coli, Proteus, Pseudomonas aeruginosa, Serratia, Klebsiella pneumoniae and other bacteria. [0003] The mechanism of action of sisomicin sulfate is to combine with the 30S subunit of bacterial ribosome to inhibit the synthesis of bacterial proteins. Sisomicin sulfate plays an antibacterial effect by hindering the synthesis of bacterial sensitive proteins. The bacteria have broad and strong biological activities, and the antibacterial spectrum is similar to that of gentamicin. In vitro studies have shown that sisomicin sulfate is effective against gram-negative bacteria such as Staphylococcus aureus and Escherichia coli, Klebsiella, Proteus,...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/7048A61K47/02A61K47/18A61K47/20A61P31/04
CPCA61K31/7048A61K9/19A61K9/0019A61K47/20A61K47/183A61K47/02A61P31/04Y02A50/30
Inventor 肖汉文符永红林方育林小雪唐雄肇
Owner HAINAN GENERAL & KANGLI PHARMA
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