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Mitoxantrone or mitoxantrone hydrochloride liposome injection and its preparing process

A technology of mitoxantrone hydrochloride ester and mitoxantrone hydrochloride, which is applied in the field of preparation of mitoxantrone or mitoxantrone hydrochloride, and achieves the effects of reducing production cost, improving stability and high drug efficacy

Inactive Publication Date: 2005-04-06
常州太平洋药物研究所有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But so far, there is no liposomal product of mitoxantrone on the market

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Preparation prescription (1000ml capacity):

[0053] Mitoxantrone 500mg

[0054] Dimyristate Lecithin (DMPC) 6g

[0055] Cholesterol 1.3g

[0056] Vitamin E 7.8mg

[0057] Citric acid 1150mg

[0058] Anhydrous Sodium Carbonate 800mg

[0059] Sucrose 90g

[0060] Histamine 5g

[0061] Water for injection to the required volume

[0062] The preparation process is as follows:

[0063] Select phospholipids, cholesterol and vitamin E according to the formula to be dissolved in chloroform and mix uniformly; Remove the chloroform in the solution under reduced pressure with a rotary evaporator to form a lipid film; The citric acid solution of gained mitoxantrone is used to hydrate the lipid film, the hydration temperature is generally between 60°C-65°C, and the hydration time is 15-30 minutes; the gained rice is adjusted with 0.5M anhydrous sodium carbonate aqueous solution The pH of the toxantrone liposome suspension was 7.2±0.2, and then kept at 60°C-65°C for 10-30 m...

Embodiment 2

[0065] Preparation prescription (1000ml capacity):

[0066] Mitoxantrone 1000mg

[0067] Dimyristate Lecithin (DMPC) 12g

[0068] Cholesterol 2.5g

[0069] Vitamin E 15mg

[0070] Citric acid 2300mg

[0071] Anhydrous Sodium Carbonate 1600mg

[0072] Sucrose 90g

[0073] Histidine 5g

[0074] Water for injection to the required volume

[0075] The preparation process is as follows:

[0076]Select phospholipids, cholesterol and vitamin E according to the formula to be dissolved in chloroform and mix uniformly; Remove the chloroform in the solution under reduced pressure with a rotary evaporator to form a lipid film; The citric acid solution of gained mitoxantrone is used to hydrate the lipid film, the hydration temperature is generally between 60°C-65°C, and the hydration time is 15-30 minutes; the gained rice is adjusted with 0.5M anhydrous sodium carbonate aqueous solution The pH of the toxantrone liposome suspension was 7.2±0.2, and then kept at 60°C-65°C for 10-30 ...

Embodiment 3

[0078] Preparation prescription (1000ml capacity):

[0079] Mitoxantrone 1000mg

[0080] Hydrogenated Soy Lecithin (HSPC) 13.9g

[0081] Cholesterol 2.5g

[0082] Vitamin E 15mg

[0083] Citric acid 2300mg

[0084] Anhydrous Sodium Carbonate 1600mg

[0085] Sucrose 90g

[0086] Histidine 5g

[0087] Water for injection to the required volume

[0088] The preparation process is as follows:

[0089] Select phospholipids, cholesterol and vitamin E according to the formula to be dissolved in chloroform and mix uniformly; Remove the chloroform in the solution under reduced pressure with a rotary evaporator to form a lipid film; The citric acid solution of gained mitoxantrone is used to hydrate the lipid film, the hydration temperature is generally between 60°C-65°C, and the hydration time is 30-60 minutes; the gained rice is adjusted with 0.5M anhydrous sodium carbonate aqueous solution The pH of the toxantrone liposome suspension was 7.2±0.2, and then kept at 60°C-65°C fo...

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Abstract

Disclosed is a bangosome injection of mitoxantrone or and its preparing technique. The injection comprises of mitoxantrone, phospholipid, cholesterol, anti oxidant additive, organic acid, alkali, sugar, buffer and water for injection, the preparing technique includes preparation of lipid film, packaging medicine, homogenization of bangosome, purifying or solidifying bangosome, constant volume, degerming, subpackage and reposition and so on. The has remarkable stability, high ratio of packaging medicine, low cost, few poisonous side-effect and simple preparing technique.

Description

technical field [0001] The invention relates to a preparation of mitoxantrone or mitoxantrone hydrochloride, in particular to a liposome injection of mitoxantrone or mitoxantrone hydrochloride, and also relates to a preparation process of the medicine. Background technique [0002] Mitoxantrone or mitoxantrone hydrochloride is an anthracycline antitumor antibiotic, and its mechanism of action is mainly that mitoxantrone molecules enter the nucleus and bind to DNA, thereby inhibiting nucleic acid synthesis and mitosis, leading to cell death. Mitoxantrone or mitoxantrone hydrochloride is mainly used for malignant lymphoma, breast cancer and acute leukemia, for lung cancer, melanoma, soft tissue sarcoma, multiple myeloma, liver cancer, colorectal cancer, kidney cancer, prostate cancer, intrauterine Membranous cancer, testicular tumor, ovarian cancer and head and neck cancer are also effective. [0003] Compared with doxorubicin hydrochloride, the long-term and short-term toxic...

Claims

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Application Information

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IPC IPC(8): A61K9/127A61K31/136A61P35/00
Inventor 贺明贺欣周金鸿
Owner 常州太平洋药物研究所有限公司
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