Composition of Essentiale Phospholipids injection and preparation method thereof

Abstract

The invention relates to a compound of phosphatide bilineurine powder injection and relative preparation. Wherein, the inventive product can avoid benzenemethanol, to be stably used. And its components contain phosphatide bilineurine, cholate and support agent. The invention uses special method and treatment. The inventive product via frozen and dried is made into white or yellow powder injection, which can be diluted before vein injection.

Description

technical field

[0001] The invention relates to the field of pharmacy, in particular to a composition for polyene phosphatidylcholine powder injection for injection and a preparation method thereof. Background technique

[0002] Polyene phosphatidylcholine (PPC) is the main component of phospholipids (PL), which contains unsaturated fatty acid bonds on the triglyceride backbone of phospholipids—that is, arachidonic acid (AA) and docosahexa Phosphatidylcholine of enoic acid (DHA). Phospholipids are the basic components of human cells and tissue membranes. They play an important role in the process of cell regeneration. They cannot be synthesized by the human body and must be ingested from the outside world. Therefore, they are called essential phospholipids (EPL). EPL has a stabilizing, repairing and protective effect on liver cell membranes. Based on the fact that in various liver diseases, the ultrastructure of liver cell membrane and mitochondria is damaged and accompani...

Examples

Embodiment 1

[0025] Under nitrogen and aseptic conditions, weigh 10.0 g of refined soybean lecithin, add a small amount of ethanol to dissolve, add 8.0 g of sodium cholate and 4.0 g of mannitol to dissolve, fully stir and dissolve to make a transparent solution, add, add 1 mol / L sodium hydroxide solution to adjust the pH value to 8.0, add water for injection to 100ml, mix well, filter through a 0.22μm microporous membrane, pack in vials, fill with nitrogen after freeze-drying, plug, and roll the cap to seal. , each bottle containing polyene phosphatidylcholine 200-1500mg white to yellowish powder injection.

Embodiment 2

[0027] Under nitrogen and aseptic conditions, weigh 10.0 g of refined soybean lecithin, add a small amount of methanol to dissolve, add 6.0 g of sodium deoxycholate, 3.0 g of glycine and water for injection, fully stir and dissolve to form a transparent solution, and adjust the pH value To 8.6, add water for injection to 100ml, mix well, filter through a 0.22μm microporous membrane, pack in vials, fill with nitrogen, stopper, cap, and seal after freeze-drying, and each bottle contains polyene Phosphatidylcholine 200-1500 mg white to slightly yellow powder injection.

Embodiment 3

[0029] Under nitrogen and aseptic conditions, weigh 10.0 g of refined soybean lecithin, dissolve in ethanol, add 4.5 g of sodium glycocholate, 6.0 g of lactose and water for injection, fully stir and dissolve to form a transparent solution, and adjust the pH value to 7.0, add water for injection to 100ml, mix well, filter through a 0.22μm microporous membrane, pack in vials, fill with nitrogen, stopper, cap, and seal after freeze-drying, and each bottle contains polyene phospholipids. Acylcholine 200-1500 mg white to slightly yellow powder injection.

technical field

[0001] The invention relates to the field of pharmacy, in particular to a composition for polyene phosphatidylcholine powder injection for injection and a preparation method thereof. Background technique

[0002] Polyene phosphatidylcholine (PPC) is the main component of phospholipids (PL), which contains unsaturated fatty acid bonds on the triglyceride backbone of phospholipids—that is, arachidonic acid (AA) and docosahexa Phosphatidylcholine of enoic acid (DHA). Phospholipids are the basic components of human cells and tissue membranes. They play an important role in the process of cell regeneration. They cannot be synthesized by the human body and must be ingested from the outside world. Therefore, they are called essential phospholipids (EPL). EPL has a stabilizing, repairing and protective effect on liver cell membranes. Based on the fact that in various liver diseases, the ultrastructure of liver cell membrane and mitochondria is damaged and accompani...

Examples

Embodiment 1

[0025] Under nitrogen and aseptic conditions, weigh 10.0 g of refined soybean lecithin, add a small amount of ethanol to dissolve, add 8.0 g of sodium cholate and 4.0 g of mannitol to dissolve, fully stir and dissolve to make a transparent solution, add, add 1 mol / L sodium hydroxide solution to adjust the pH value to 8.0, add water for injection to 100ml, mix well, filter through a 0.22μm microporous membrane, pack in vials, fill with nitrogen after freeze-drying, plug, and roll the cap to seal. , each bottle containing polyene phosphatidylcholine 200-1500mg white to yellowish powder injection.

Embodiment 2

[0027] Under nitrogen and aseptic conditions, weigh 10.0 g of refined soybean lecithin, add a small amount of methanol to dissolve, add 6.0 g of sodium deoxycholate, 3.0 g of glycine and water for injection, fully stir and dissolve to form a transparent solution, and adjust the pH value To 8.6, add water for injection to 100ml, mix well, filter through a 0.22μm microporous membrane, pack in vials, fill with nitrogen, stopper, cap, and seal after freeze-drying, and each bottle contains polyene Phosphatidylcholine 200-1500 mg white to slightly yellow powder injection.

Embodiment 3

[0029] Under nitrogen and aseptic conditions, weigh 10.0 g of refined soybean lecithin, dissolve in ethanol, add 4.5 g of sodium glycocholate, 6.0 g of lactose and water for injection, fully stir and dissolve to form a transparent solution, and adjust the pH value to 7.0, add water for injection to 100ml, mix well, filter through a 0.22μm microporous membrane, pack in vials, fill with nitrogen, stopper, cap, and seal after freeze-drying, and each bottle contains polyene phospholipids. Acylcholine 200-1500 mg white to slightly yellow powder injection.