Docetaxel liposome sterile lyophilized preparation and preparation method thereof

A technology of long-circulating liposomes and docetaxel, which is used in medical preparations, pharmaceutical formulations, powder delivery and other directions of non-active ingredients, and can solve problems such as preparation stability inspection, inability to reconstitute liposomes, and drug leakage. , to achieve the effect of favorable stability, low price and easy access
CN102085189BInactive Publication Date: 2013-01-02QILU PHARMA CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
QILU PHARMA CO LTD
Publication Date
2013-01-02
Estimated Expiration
Not applicable · inactive patent

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Abstract

The invention relates to a docetaxel liposome sterile lyophilized preparation and preparation method thereof, and the docetaxel liposome sterile lyophilized preparation comprises docetaxel, natural lecithin, PEG-DSPE, cholesterol, a protective agent for lyophilization, and buffer salts. The natural lecithin, PEG-DSPE, cholesterol, and docetaxel are dissolved in a organic solvent; a buffer solution containing the protective agent for lyophilization is added into mixed solution; the solution is incubated for 10-60 min for decreasing the average particle size of the liposome to 50-200 nm; and the preparation is obtained after bacilli-eliminated filtration and lyophilization. The docetaxel liposome prepared by the invention has the advantages of less toxic and side effect and higher curative effect when compared with commercially available ordinary injections at present. The preparation method of the invention is simple and practical, and is applicable to industrial production; and the prepared docetaxel liposome has high encapsulation efficiency and good stability.
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Description

technical field

[0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a liposome sterile freeze-dried preparation of fat-soluble drug docetaxel and a preparation method thereof. Background technique

[0002] Docetaxel (also known as docetaxel) injection, which was successfully developed by the French company Rhone-Planck-Anle in 1986, is another new type of anti-microtubule drug after paclitaxel. It was first launched in Mexico in April 1995. It was subsequently listed in Britain, the United States, France, Italy, Germany, Japan and other countries.

[0003] Compared with paclitaxel, docetaxel has less efflux in and out of cells and has a significant effect of inducing apoptosis at low dose. Many in vitro and clinical studies have confirmed that docetaxel has a radiosensitizing effect on a variety of tumor cells and does not aggravate the radiation damage of normal tissues. The affinity of docetaxel is twice that of paclitax...

Claims

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