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Liposome injection of pharmaceutical composition of amoxicillin sodium and clavulanate potassium

A technology of amoxicillin sodium clavulanate potassium and clavulanate potassium, which is applied in the field of medicine and can solve the problems of no protection, poor stability, and poor clarity of the active ingredient, so as to improve the therapeutic index and high stability of the drug , the effect of improving stability

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

[0003] Chinese patent CN101647779A discloses a new injection of amoxicillin sodium clavulanate potassium compound powder and its preparation technology. It also does not take any protection measures for the active ingredients, and has poor stability and poor clarity after reconstitution.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Example 1 Preparation of Amoxicillin Sodium Clavulanate Potassium Pharmaceutical Composition Liposomal Injection

[0027] Prescription (specification 0.3g)

[0028] Amoxicillin Sodium 25g

[0029] Potassium Clavulanate 5g

[0030] Egg Yolk Phosphatidylinositol 25g

[0031] Sodium taurocholate 2.5g

[0032] Trehalose 22.5g

[0033] Sorbitol 7.5g

[0034] tert-butyl-p-hydroxyanisole 0.5g

[0035] making process

[0036] (1) 25g egg yolk phosphatidylinositol and 2.5g sodium taurocholate are dissolved in the mixed solvent of 1: 2 acetone and dichloromethane in 500ml volume ratio, place the organic solvent under reduced pressure on the rotary thin film evaporator, The phospholipid film was obtained, and 300 ml of dipotassium hydrogen phosphate-potassium dihydrogen phosphate buffer solution with a pH value of 5.8 was added to stir and dissolve to obtain a blank liposome solution;

[0037] (2) Dissolve 25g of amoxicillin sodium and 5g of potassium clavulanate in 300ml ...

Embodiment 2

[0039] Example 2 Amoxicillin Sodium Clavulanate Potassium Pharmaceutical Composition Liposome Injection Preparation

[0040] Prescription (specification 0.6g)

[0041] Amoxicillin Sodium 50g

[0042] Potassium clavulanate 10g

[0043] Egg Yolk Phosphatidylinositol 100g

[0044] Sodium taurocholate 20g

[0045] Trehalose 82.5g

[0046] Sorbitol 27.5g

[0047] tert-Butyl-p-Hydroxyanisole 10g

[0048] making process

[0049] (1) 100g egg yolk phosphatidylinositol and 20g sodium taurocholate are dissolved in a mixed solvent of acetone and dichloromethane with a volume ratio of 1:2 in 800ml, 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 400 ml of dipotassium hydrogen phosphate-potassium dihydrogen phosphate buffer solution with a pH value of 5.8 and stir to dissolve to obtain a blank liposome solution;

[0050] (2) Dissolve 50g of amoxicillin sodium and 10g of potassium cla...

Embodiment 3

[0052] Example 3 Amoxicillin Sodium Clavulanate Potassium Pharmaceutical Composition Liposome Injection Preparation

[0053] Prescription (specification 1.2g)

[0054] Amoxicillin Sodium 100g

[0055] Potassium clavulanate 20g

[0056] Egg Yolk Phosphatidylinositol 100g

[0057] Sodium taurocholate 40g

[0058] Trehalose 90g

[0059] Sorbitol 30g

[0060] tert-Butyl-p-Hydroxyanisole 2g

[0061] The preparation process was the same as in Example 2, and amoxicillin sodium clavulanate potassium pharmaceutical composition liposome injection was prepared.

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PUM

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Abstract

The invention provides a liposome injection of a pharmaceutical composition of amoxicillin sodium and clavulanate potassium, which consists of amoxicillin sodium, clavulanate potassium, a liposome carrier, a lyoprotectant and a freely optional antioxidant, wherein the liposome carrier is egg yolk phosphatidylinositol and sodium taurocholate. The liposome injection has good preparation stability, liposome can avoid the fracture due to dehydration, fusion, ice crystal generation and the like during the freeze-drying process, and the liposome can still keep the good encapsulation rate after hydration and redissolution.

Description

technical field [0001] The invention relates to an antibiotic liposome preparation, in particular to a liposome injection of amoxicillin sodium clavulanate potassium pharmaceutical composition and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Amoxicillin is a broad-spectrum penicillin antibiotic, and clavulanate potassium itself has only weak antibacterial activity, but has a strong broad-spectrum β-lactamase inhibitory effect. The combination of the two can protect amoxicillin from β-lactamase hydrolysis. The antibacterial spectrum of this product is the same as that of amoxicillin, and it has been expanded. It has a good effect on enzyme-producing Staphylococcus aureus, Staphylococcus epidermidis, coagulase-negative staphylococcus and enterococci, and has good effects on certain β-lactamase-producing Enterobacteriaceae, Haemophilus influenzae, and Moraxella catarrhalis , Bacteroides fragilis, etc. also have good ...

Claims

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Application Information

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IPC IPC(8): A61K31/43A61K31/424A61K9/127A61K47/24A61K47/20A61P31/04
Inventor 杨明贵
Owner HAINAN MEILAN SMITH KLINE PHARMA
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