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Ceftiofur hydrochloride lipidosome injection and preparation method thereof

The technology of ceftiofur hydrochloride and cephalosporin hydrochloride is applied in the field of ceftiofur hydrochloride liposome preparation and preparation of ceftiofur hydrochloride liposome injection, which can solve the problems of poor compliance and frequent administration, and achieve the encapsulation efficiency High, slow release effect, uniform particle size effect

Inactive Publication Date: 2017-04-26
RINGPU TIANJIN BIOLOGICAL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Solve the problems of frequent clinical administration and poor compliance of existing products

Method used

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  • Ceftiofur hydrochloride lipidosome injection and preparation method thereof
  • Ceftiofur hydrochloride lipidosome injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Prescription (Specification 10%)

[0032] Ceftiofur Hydrochloride 100g

[0033] Lecithin Niacinamide 100g

[0034] Cholesterol 100g

[0035] Bianze-78 10g

[0036] Sodium dihydrogen phosphate 30g

[0037] Disodium hydrogen phosphate 250g

[0038] Vitamin E 30g

[0039] Dichloromethane 200ml

[0040] Water for injection 1L

[0041] Preparation Process:

[0042] 1) Dissolve 30 g of sodium dihydrogen phosphate and 250 g of disodium hydrogen phosphate in 1 L of water for injection to prepare a phosphate buffer, and adjust the pH to 6 with 0.1 mol / L of sodium hydroxide solution and 2% phosphoric acid. 100g of ceftiofur hydrochloride was dissolved in phosphate buffered saline to obtain an aqueous phase;

[0043]2) Dissolve 100g lecithin nicotinamide, 100g cholesterol and 10g Bianze-78 in dichloromethane to obtain an organic phase. Add the organic phase to the water phase under the condition of heating in a water bath at 50-60°C, mix evenly, and shear at high speed w...

Embodiment 2

[0046] Prescription (Specification 10%)

[0047] Ceftiofur Hydrochloride 100g

[0048] Hydrogenated Soy Phosphatidylcholine (HSPC) 909g

[0049] Cholesterol 91g

[0050] Cholesterol-PEG2000 50g

[0051] Potassium dihydrogen phosphate 150g

[0052] Dipotassium hydrogen phosphate 10g

[0053] Sodium sulfite 150g

[0054] Chloroform 500ml

[0055] Water for injection 1L

[0056] Preparation Process:

[0057] 1) Dissolve 150 g of potassium dihydrogen phosphate and 10 g of dipotassium hydrogen phosphate in 1 L of water for injection to prepare a phosphate buffer solution, and adjust the pH to 7.5 with 0.1 mol / L sodium hydroxide solution and 2% phosphoric acid. 100g of ceftiofur hydrochloride was dissolved in phosphate buffered saline to obtain an aqueous phase;

[0058] 2) 909g of hydrogenated soybean phosphatidylcholine (HSPC), 91g of cholesterol and 50g of cholesterol-PEG2000 were dissolved in chloroform to obtain an organic phase. Add the organic phase to the water pha...

Embodiment 3

[0061] Prescription (Specification 10%)

[0062] Ceftiofur Hydrochloride 100g

[0063] Distearoylphosphorylcholine (DSPC) 416.7g

[0064] Cholesterol 83.3g

[0065] Cholesterol-PEG1000 30g

[0066] Potassium dihydrogen phosphate 80g

[0067] Dipotassium hydrogen phosphate 200g

[0068] Sodium metasulfite 80g

[0069] Absolute ethanol 100ml

[0070] Water for injection 1L

[0071] Preparation Process:

[0072] 1) Dissolve 80 g of potassium dihydrogen phosphate and 200 g of dipotassium hydrogen phosphate in 1 L of water for injection to prepare a phosphate buffer, and adjust the pH to 6 with 0.1 mol / L of sodium hydroxide solution and 2% phosphoric acid. 100g of ceftiofur hydrochloride was dissolved in phosphate buffered saline to obtain an aqueous phase;

[0073] 2) Dissolve 416.7g of distearoylphosphorylcholine (DSPC), 83.3g of cholesterol and 30g of cholesterol-PEG1000 in absolute ethanol to obtain an organic phase. Add the organic phase to the water phase under the ...

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Abstract

The invention relates to the field of pharmaceutical preparations, in particular to a ceftiofur hydrochloride lipidosome injection and a preparation method thereof. The ceftiofur hydrochloride lipidosome injection contains ceftiofur hydrochloride, a buffer salt system, a lipidosome matrix, an additive and an antioxidant, and ceftiofur hydrochloride lipidosome is prepared through a high-pressure homogenization method. The lipidosome obtained through the method has the high encapsulation efficiency on ceftiofur hydrochloride and can achieve a slow releasing effect on medicine.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, and relates to a ceftiofur hydrochloride liposome preparation, in particular to a method for preparing ceftiofur hydrochloride liposome injection with specific raw materials and auxiliary materials and a preparation process. Background technique [0002] Ceftiofur (ceftiofur) is the first third-generation cephalosporin antibiotic for livestock and poultry, and its chemical name is 7-[2-(2-amino-4-thiazolyl)-2-(methylimino) Acetylamino]-3-[(2-furancarbonyl)thiomethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-1-carboxylic acid, Molecular formula is C l9 h 17 N 5 o 7 S 3 , the molecular weight is 523.55. It was first synthesized by Bernard Labeeuw et al. in 1984. It has a lactam ring and a furan chain in its structure, which has a strong killing effect on both Gram-positive and negative bacteria. After entering the body, the furan chain is first degraded. , to produce a metabolite ...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K31/546A61K47/04A61K47/28A61K47/24A61P31/04
Inventor 张珺李旭东刘爱玲聂丽娜李梁
Owner RINGPU TIANJIN BIOLOGICAL PHARMA
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