Pharmaceutical composition for treating proliferative diseases of hematopoietic system

A composition and drug technology, applied in the field of pharmaceutical preparations, can solve problems such as long hospital stay, increased complications, and increased treatment expenditure

Inactive Publication Date: 2018-01-12
JIANGSU GENALZA BIOPHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This way of administration leads to increased risk factors such as long hospital stay, increased treatment expenditure, and increased complications

Method used

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  • Pharmaceutical composition for treating proliferative diseases of hematopoietic system
  • Pharmaceutical composition for treating proliferative diseases of hematopoietic system
  • Pharmaceutical composition for treating proliferative diseases of hematopoietic system

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Cytarabine / Annamycin Nano Lipid Particle Injection

[0022] prescription:

[0023]

[0024] Preparation Process:

[0025] (1) Dissolve cytarabine in 150mL water for injection;

[0026] (2) Distearoylphosphatidylcholine, distearoylphosphatidylglycerol, cholesterol and Annamycin were dissolved in 300mL absolute ethanol;

[0027] (3) Remove absolute ethanol by rotary evaporating (2), add (1) and hydrate at 55°C for 1 hour to form crude lipid particles;

[0028] (4) pass the crude lipid particle through a high-pressure homogenizer at 1000 bar for 3 cycles, keep the temperature of the material below 30°C, and reduce the particle size to about 200nm;

[0029] (5) Ultrafiltration removes unencapsulated medicine;

[0030] (6) Dilute the nano-lipid particles to 1000mL

[0031] Fill 10mL / bottle into 10mL neutral borosilicate glass vials, stopper and cover to obtain cytarabine / Annamycin nano lipid particle injection.

Embodiment 2

[0033] Cytarabine / 4-desmethoxydaunorubicin hydrochloride nano lipid particle injection

[0034] prescription:

[0035]

[0036]

[0037] Preparation Process:

[0038] (1) Dissolve cytarabine in 150mL water for injection;

[0039] (2) Hydrogenated soybean phosphatidylcholine, methoxypolyethylene glycol-distearoylphosphatidylethanolamine and cholesterol are dissolved in 150mL absolute ethanol;

[0040] (3) After the two are mixed evenly, use an IKA high-speed shearing machine to mix at 10,000 rpm, add 450 mL of water for injection, and mix at 6,000 rpm;

[0041] (4) The above solution is transferred to a rotary evaporator, and the organic solvent is slowly evaporated to obtain the crude lipid particle;

[0042] (5) Pass the crude lipid particle through a high-pressure homogenizer at 1000 bar for 3 cycles, keep the temperature of the material below 30°C, and reduce the particle size to about 200nm;

[0043] (6) Ultrafiltration removes unencapsulated medicine, adjusts th...

Embodiment 3

[0047] Cytarabine / 4-desmethoxydaunorubicin Hydrochloride Nano Lipid Particles for Injection

[0048] prescription:

[0049]

[0050] Preparation Process:

[0051] (1) Dissolve cytarabine in 150mL water for injection;

[0052](2) Distearoylphosphatidylcholine, distearoylphosphatidylglycerol and cholesterol are dissolved in 150mL absolute ethanol;

[0053] (3) After the two are mixed evenly, mix evenly with an IKA high-speed shearing machine at 10000rpm, add 450mL of an aqueous solution containing sucrose in the prescribed amount, and mix evenly at 6000rpm;

[0054] (4) The above solution is transferred to a rotary evaporator, and the organic solvent is slowly evaporated to obtain the crude lipid particle;

[0055] (5) Pass the crude lipid particle through a high-pressure homogenizer at 1000 bar for 3 cycles, keep the temperature of the material below 30°C, and reduce the particle size to about 200nm;

[0056] (6) Ultrafiltration removes unencapsulated medicine, adjusts t...

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Abstract

The invention relates to a novel pharmaceutical composition. Cytosine arabinoside and antharcycline antibiotics are co-encapsulated to prepare the pharmaceutical composition. The provided pharmaceutical composition can stably maintain the ratio of cytosine arabinoside to antharcycline antibiotics to be in a range in human body; the synergistic effect can be exerted maximally; and the pharmaceutical composition is used to treat proliferative diseases of a hematopoietic system, in particular, acute leukemia.

Description

technical field [0001] The invention relates to a novel pharmaceutical composition co-encapsulated with cytarabine and anthracycline antibiotics, and belongs to the technical field of pharmaceutical preparations. Background technique [0002] Hematopoietic proliferative diseases include leukemia, malignant lymphoma, multiple myeloma, and other diseases. Among them, acute myelogenous leukemia (AML) is a common type of hematopoietic proliferative diseases. For the treatment of AML, the current international recommended treatment guidelines are combined "7+3" regimen: daunorubicin 90mg / m 2 Or 4-desmethoxydaunorubicin 12mg / m 2 Combined with standard dose cytarabine. Cytarabine (Cytarabine, Ara-C) is a cell cycle specific anti-tumor inhibitor, which significantly affects cells in the S phase of cell division. In cells, cytarabine is converted into cytarabine-5'- triphosphate (ara-CTP) as its active metabolite. At present, it is believed that ara-CTP mainly plays a role by in...

Claims

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Application Information

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IPC IPC(8): A61K31/7068A61K9/50A61P35/00A61P35/02A61K31/704
Inventor 冯皓
Owner JIANGSU GENALZA BIOPHARMA CO LTD
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