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Epirubicin liposome as well as preparation method and preserving method thereof

一种表阿霉素脂、表阿霉素的技术，应用在医药领域，达到好药效、降低毒性的效果

Active Publication Date: 2013-08-14
JIANGXI HERBFINE HI TECH
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] There are still some deficiencies in the above two patents in terms of giving full play to the efficacy of epirubicin, reducing toxicity and industrialization

Method used

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  • Epirubicin liposome as well as preparation method and preserving method thereof

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Embodiment 1

[0033] Hydrogenated soybean lecithin (HSPC) and N-(carbonyl-methoxypolyethylene glycol-2000)-1,2-distearoyl-sn-glycero-3-phosphoethanolamine (DSPE-mPEG2000) in a molar ratio of 90 :10 dispersed in 300mM pH4 citric acid buffer solution at 70°C. After 1000 bar high-pressure homogenization, blank liposomes with a phospholipid concentration of 100 mg / ml and an average particle size of 50-300 nm were obtained. Add 2.0ml of epirubicin (5.0mg / ml) in trehalose (1g / ml) aqueous solution and 1.5ml of 0.4mM sodium carbonate solution into 2.0ml of blank liposomes, and incubate at 60°C for 30min. Then drug-loaded liposomes and blank liposomes were stored at -20°C. Liposomes without addition of cryoprotectant mPEG and trehalose were prepared by the same method. After storage at -20°C, the change in particle size was detected, and the results are shown in Table 1. The results showed that the particle size of the blank and drug-loaded liposomes added with the cryoprotectant did not change s...

Embodiment 2

[0037] Prepare epirubicin liposomes according to the method of Example 1, store the sample at -20°C for 6 months, and measure the content and particle size of the sample at the initial moment, 1 month, 3 months, and 6 months respectively , encapsulation efficiency, burst release percentage and pH value, the results are shown in Table 2. The results showed that the properties of the liposomes did not change significantly within 6 months, which proved that the storage method was reasonable and feasible.

[0038] time Content (epirubicin) (mg / ml) Particle size (nm) Encapsulation rate (%) Burst release percentage (%) pH value initial 2.01 101 99.9 8 7.88 1 month 1.99 103 99.8 7 7.91 3 months 1.97 104 99.7 8 7.87 6 months 1.98 107 99.8 9 7.92

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Abstract

The invention belongs to the field of pharmaceutical preparation and relates to an epirubicin liposome as well as a preparation method and a preserving method of the epirubicin liposome. The epirubicin liposome is formed by epirubicin and at least one phospholipid as, well as at least one surface active agent or one cryoprotectant or cholesterol which may be contained. The preserving method comprises the following types: preservation at normal temperature, refrigeration preservation, freezing preservation and freezing and drying preservation.

Description

Technical field: [0001] The invention belongs to the technical field of medicine and relates to a microparticle preparation in the field of drug delivery, more specifically a liposome made of epirubicin and appropriate auxiliary materials, and a preparation method and a storage method thereof. Background technique: [0002] Epirubicin (Epirubicin, EPI) is an anthracycline anti-tumor antibiotic synthesized by Italian scholar Arcamone in 1975 through a semi-synthetic pathway. The mechanism of action is to directly intercalate between DNA base pairs, interfere with the transcription process, and prevent mRNA Therefore, it has effects on all stages of the cell cycle. It is a non-specific drug for the cell cycle and mainly acts on the nucleus. At present, epirubicin is mainly used clinically for various solid tumors such as acute leukemia and malignant lymphoma, breast cancer, ovarian cancer, bladder cancer, testicular cancer, gastric cancer, and liver cancer. There are many a...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/127A61K31/704A61K47/28A61K47/32A61K47/34A61P35/00A61P35/02
Inventor 罗晓健李翔陈兰英李俊苏丹刘微雷景邦杨世林
Owner JIANGXI HERBFINE HI TECH
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