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Ceftizoxime sodium liposome injection

A technology of cefizoxime sodium and liposome, applied in the field of medicine, can solve the problems of low bioavailability, poor stability, poor reconstitution and the like, and achieve the effects of high bioavailability, good stability and good resolubility

Inactive Publication Date: 2010-07-21
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The ceftizoxime sodium preparations sold on the market are powders directly aseptically packaged as raw materials, which have poor stability, and related substances increase significantly after long-term storage, poor reconstitution, and low bioavailability

Method used

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  • Ceftizoxime sodium liposome injection
  • Ceftizoxime sodium liposome injection
  • Ceftizoxime sodium liposome injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] The preparation of embodiment one ceftizoxime sodium liposome lyophilized preparation

[0031] Prescription (specification 0.05g)

[0032] Ceftizoxime Sodium 5g

[0033] Soy Lecithin 23g

[0034] Cholesterol 23g

[0035] Sodium dihydrogen phosphate 5g

[0036] Disodium hydrogen phosphate 15g

[0037] Sorbitol 18g

[0038] Vitamin E 7g

[0039] Diethyl ether 200ml

[0040] Preparation Process:

[0041] A Dissolve 5g of sodium dihydrogen phosphate and 15g of disodium hydrogen phosphate in 100ml of water for injection to make a phosphate buffer, and adjust the pH to 7.0 with 0.1mol / L sodium hydroxide solution and 1% phosphoric acid solution;

[0042] B Melt 23g of soybean lecithin and 23g of cholesterol in 200ml of ether at 70°C, add phosphate buffer with a pH value of 7.0, stir and mix evenly, wait until the organic solvent is completely evaporated, transfer to a tissue masher and stir at high speed 10-30min, filter and sterilize;

[0043] C, add 5g of ceftizoxi...

Embodiment 2

[0044] The preparation of embodiment biscetizoxime sodium liposome lyophilized preparation

[0045] Prescription (specification 0.1g)

[0046] Ceftizoxime Sodium 10g

[0047] Egg yolk lecithin 27g

[0048] Cholesterol 27g

[0049] Sodium dihydrogen phosphate 15g

[0050] Disodium hydrogen phosphate 45g

[0051] Sodium chloride 32g

[0052] Sodium sulfite 9g

[0053] Isopropanol 400ml

[0054] Preparation Process:

[0055]A Dissolve 15g sodium dihydrogen phosphate and 45g disodium hydrogen phosphate in 300ml water for injection to make phosphate buffer, and adjust the pH to 6.5 with 0.1mol / L sodium hydroxide solution and 1% phosphoric acid solution;

[0056] B Melt 27g of egg yolk lecithin and 27g of cholesterol in 400ml of isopropanol at 70°C, add phosphate buffer with a pH value of 6.5, stir and mix evenly, and transfer to a tissue masher after the organic solvent has evaporated completely Stir at high speed for 10-30 minutes, filter and sterilize;

[0057] C, after...

Embodiment 3

[0058] The preparation of embodiment three ceftizoxime sodium liposome freeze-dried preparation

[0059] Prescription (specification 0.2g)

[0060] Ceftizoxime Sodium 20g

[0061] Soy Lecithin 18g

[0062] Cholesterol 18g

[0063] Sodium dihydrogen phosphate 5g

[0064] Disodium hydrogen phosphate 15g

[0065] Mannitol 16g

[0066] Thiourea 6g

[0067] Diethyl ether 200ml

[0068] Preparation Process:

[0069] A Dissolve 5g of sodium dihydrogen phosphate and 15g of disodium hydrogen phosphate in 100ml of water for injection to make a phosphate buffer, and adjust the pH to 7.8 with 0.1mol / L sodium hydroxide solution and 1% phosphoric acid solution;

[0070] B Melt 18g of soybean lecithin and 18g of cholesterol in 200ml of ether at 70°C, add phosphate buffer with a pH value of 7.8, stir and mix evenly, wait until the organic solvent is completely evaporated, transfer to a tissue masher and stir at high speed 10-30min, filter and sterilize;

[0071] C, after adding 20g ...

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Abstract

The invention relates to ceftizoxime sodium liposome injection and a preparation method therof. The ceftizoxime sodium liposome freezing-drying preparation comprises ceftizoxime sodium, buffer salt system, liposome matrix, freezing-drying excipient and antioxidant. By selecting particular buffer salt system and the liposome matrix, the ceftizoxime sodium liposome injection has good formation and parcel rate as well as good stability.

Description

technical field [0001] The invention relates to the technical field of medicine, and relates to a ceftizoxime sodium preparation, in particular to a method for preparing ceftizoxime sodium liposome injection with specific raw materials and auxiliary materials and a preparation process. technical background [0002] Ceftizoxime sodium, chemical name: [6R-[6(,7((Z)]]-7[[2,3-dihydro-2-imino-4-thiazolyl)(methoxyimino) Acetyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt, molecular formula C 13 h 12 N 5 NaO 5 S 2 , molecular weight 405.38, structural formula: [0003] [0004] Ceftizoxime sodium is a third-generation cephalosporin with broad-spectrum antibacterial effect and is stable to broad-spectrum lactamase (including penicillinase and cephalosporinase) produced by various Gram-positive and Gram-negative bacteria. Enterobacteriaceae such as Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis have strong antibacterial effec...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K9/127A61K31/546A61P31/04
Inventor 陶灵刚
Owner HAINAN LINGKANG PHARMA CO LTD
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