Freeze-dried liposome composition of water-soluble medicament and preparation method thereof
A technology of liposome freeze-drying and water-soluble drugs, which is applied in the field of medicine, can solve the problems of water-soluble drugs leakage, long-term stable storage, aggregation fusion encapsulation rate between particles, etc., to avoid drug leakage and improve stability Effect
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Embodiment 1
[0041] Original adjuvant: water-soluble drug is 0.2g of doxorubicin hydrochloride, 0.9g of phospholipid, DSPE-mPEG2000 0.4g of polyethylene glycol derivatized phospholipid, 0.25g of cholesterol, sugar lyophilized protective agent is sucrose 14.0 g, Cyclodextrin or cyclodextrin derivative freeze-dried protective agent is 1.25g of hydroxypropyl-β-cyclodextrin.
[0042] The preparation method is as follows:
[0043] Dissolve phospholipids, polyethylene glycol derivatized phospholipids and cholesterol in 500ml of organic solvent 99.5% ethanol to obtain clear liquid A; put clear liquid A in a 60℃ water bath, and mix 250ml of the first buffer ammonium sulfate solution (250mM ) While stirring, add it to the transparent liquid A, and extrude the resultant with a high-pressure homogenizer to obtain a blank liposome D with an average particle diameter of about 90 nm; add a second buffer to the obtained blank liposome D Replace the first buffer ammonium sulfate of the external phase of blank...
Embodiment 2
[0046] Original adjuvants: Daunorubicin hydrochloride 0.2g, HSPC 1.2g, DSPE-mPEG2000 0.6g, cholesterol 1.0g, sucrose 13.0g, hydroxypropyl-β-cyclodextrin 2.5g Preparation method: same as in Example 1, wherein , The temperature of the water bath is 76℃, and the encapsulation temperature is 105℃.
[0047] Three batches of products were prepared, and the products obtained were Examples 2-1, 2-2, and 2-3 respectively.
Embodiment 3
[0048] Example 3 Original adjuvants: Doxorubicin hydrochloride 0.2g, HSPC 0.32g, DSPE-mPEG2000 0.18g, cholesterol 0.2g, sucrose 13.9g, hydroxypropyl-α-cyclodextrin 0.78g.
[0049] Preparation method: Same as in Example 1, the organic solvent was replaced with 99.5% methanol (1000ml), the second buffer was replaced with citrate (10mM) 250ml; the other components were unchanged; at the same time, the temperature of the water bath was 65°C and the encapsulation temperature was 80 ℃.
[0050] Three batches of products were prepared, and the products obtained were Example 3-1, Example 3-2, and Example 3-3.
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