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 h

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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