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Liposome injection based on drug combination of mezlocillin sodium and sulbactam sodium

A technology of mezlocillin sodium sulbactam sodium and mezlocillin sodium, which is applied in the field of medicine, can solve the problems of protection of active ingredients mezlocillin sodium and sulbactam sodium, influence on clinical curative effect, poor product stability, etc., and achieve improvement Drug therapeutic index, reduction of drug side effects, and high encapsulation efficiency

Inactive Publication Date: 2010-08-18
HAINAN MEILAN SMITH KLINE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This patent has improved the purity of the preparation to a certain extent, but it is only obtained by simple aseptic packaging of the two components, and there is no corresponding protection for the active components mezlocillin sodium and sulbactam sodium, resulting in poor product stability , seriously affected the clinical efficacy

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Embodiment 1 mezlocillin sodium sulbactam sodium pharmaceutical composition liposome injection preparation

[0039] Prescription (specification 2.5g)

[0040] Mezlocillin Sodium 200g

[0041] Sulbactam Sodium 50g

[0042] Hydrogenated Soy Lecithin 250g

[0043] Octadecylamine 30g

[0044] Trehalose 200g

[0045] Lactose 100g

[0046] Sodium bisulfite 0.5g

[0047] making process

[0048] (1) 250g of hydrogenated soybean lecithin and 30g of octadecylamine are dissolved in 1500ml of a mixed solvent of isopropanol and ethyl acetate at a volume ratio of 1:2, and placed on a rotary thin film evaporator to remove the organic solvent under reduced pressure to obtain After the phospholipid film is formed, add 600 ml of phosphoric acid-disodium hydrogen phosphate buffer solution with a pH value of 6.0 and stir to dissolve to obtain a blank liposome solution;

[0049] (2) Dissolve 200g of mezlocillin sodium and 50g of sulbactam sodium in 800ml of water for injection, mix ...

Embodiment 2

[0051] Example 2 Mezlocillin Sodium Sulbactam Sodium Pharmaceutical Composition Liposome Injection Preparation

[0052] Prescription (specification 3.75g)

[0053] Mezlocillin Sodium 300g

[0054] Sulbactam Sodium 75g

[0055] Hydrogenated Soy Lecithin 675g

[0056] Octadecylamine 150g

[0057] Trehalose 600g

[0058] Lactose 300g

[0059] Sodium bisulfite 7.5g

[0060] making process

[0061] (1) 675g of hydrogenated soybean lecithin and 150g of octadecylamine are dissolved in a mixed solvent of isopropanol and ethyl acetate with a volume ratio of 1:2 in 2000ml, and placed on a rotary thin film evaporator to remove the organic solvent under reduced pressure to obtain After the phospholipid film was formed, 1000 ml of phosphoric acid-disodium hydrogen phosphate buffer solution with a pH value of 6.0 was added to stir and dissolve to obtain a blank liposome solution;

[0062] (2) Dissolve 300g of mezlocillin sodium and 75g of sulbactam sodium in 1000ml of water for inje...

Embodiment 3

[0064] Example 3 Mezlocillin Sodium Sulbactam Sodium Pharmaceutical Composition Liposome Injection Preparation

[0065] Prescription (specification 2.5g)

[0066] Mezlocillin Sodium 200g

[0067] Sulbactam Sodium 50g

[0068] Hydrogenated Soy Lecithin 350g

[0069] Octadecylamine 60g

[0070] Trehalose 300g

[0071] Lactose 150g

[0072] Sodium bisulfite 2g

[0073] The preparation process was the same as in Example 2, and the liposome injection of the mezlocillin sodium sulbactam sodium pharmaceutical composition was prepared. The components of each prescription and parts by weight of comparative examples 1-3 are as in Table 1.

[0074] Table 1 comparative ratio prescription composition

[0075] components

[0076] components

[0077] Prepare mezlocillin sodium sulbactam sodium pharmaceutical composition liposome injection according to the above prescription components, and the preparation method is the same as in Example 1.

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PUM

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Abstract

The invention provides a liposome injection based on a drug combination of mezlocillin sodium and sulbactam sodium. The liposome injection comprises the following components: mezlocillin sodium, sulbactam sodium, liposome carriers, frozen and dried supporting agent and optional existing antioxidant, wherein the liposome carriers are particularly hydrogenated soybean phosphatidylcholine and octadecylamine. The liposome injection of the invention has good preparation stability, prevents the liposome from being cracked under the action of dehydration, fusion and ice crystal generation in the freezing-drying process, and keeps good entrapment rate of the liposome after re-dissolution through hydration.

Description

technical field [0001] The invention relates to an antibiotic liposome preparation, in particular to a mezlocillin sodium sulbactam sodium pharmaceutical composition liposome injection and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Mezlocillin is a penicillin-like broad-spectrum antibiotic, which mainly plays a bactericidal effect by interfering with the synthesis of bacterial cell walls; sulbactam has no antibacterial activity against other bacteria except for Neisseriaceae and Acinetobacter, but sulbactam has no antibacterial activity against bacteria caused by Most important β-lactamases produced by β-lactam antibiotic-resistant strains have irreversible inhibitory effects. Sulbactam can prevent drug-resistant bacteria from destroying penicillins and cephalosporins, and sulbactam has obvious synergistic effects with penicillins and cephalosporins. [0003] The compound preparation of mezlocillin sodium and su...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/431A61K31/43A61K9/127A61K47/18A61K47/24A61P31/04
Inventor 杨明贵
Owner HAINAN MEILAN SMITH KLINE PHARMA
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