Injection of liposome of daunorubicin or hydrochloric daunorubicin and preparationmethod

A technology of daunorubicin hydrochloride and daunorubicin, which is applied in the directions of liposome delivery, medical preparations containing active ingredients, organic active ingredients, etc., can solve problems such as unsatisfactory process conditions, achieve excellent stability, Stability-enhancing effect

Inactive Publication Date: 2005-06-15
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

So far, the process conditions to solve the above three factors are not ideal

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Preparation prescription (1000ml capacity):

[0048] Daunorubicin Hydrochloride 500mg

[0049] Distearic acid lecithin (DSPC) 5.3g

[0050] Distearic acid phosphatidylglycerol (DSPG) 1.7g

[0051] Cholesterol 1.0g

[0052] Vitamin E 7.5mg

[0053] Citric acid 1150mg

[0054] Anhydrous Sodium Carbonate 800mg

[0055] Sucrose 90g

[0056] Glycine 5g

[0057] Water for injection to the required volume

[0058] The preparation process is as follows:

[0059] Dissolve phospholipids, cholesterol and vitamin E in chloroform according to the formula and mix them evenly; use a rotary evaporator to remove the chloroform in the solution under reduced pressure to form a lipid film; prepare a 0.05M citric acid solution, and use the citric acid solution to hydrate the lipids film, the hydration temperature is between 60°C and 65°C to obtain a blank liposome suspension; after complete hydration, use a high-pressure homogenizer to prepare liposomes until the average particle s...

Embodiment 2

[0061] Preparation prescription (1000ml capacity):

[0062] Daunorubicin Hydrochloride 2000mg

[0063] Distearic Lecithin (DSPC) 21g

[0064] Distearate Phosphatidylglycerol (DSPG) 7g

[0065] Cholesterol 3.8g

[0066] Vitamin E 30mg

[0067] Citric acid 4600mg

[0068] Anhydrous Sodium Carbonate 3200mg

[0069] Sucrose 90g

[0070] Glycine 5g

[0071]Water for injection to the required volume

[0072] The preparation process is as follows:

[0073] Dissolve phospholipids, cholesterol and vitamin E in chloroform according to the formula and mix them evenly; use a rotary evaporator to remove the chloroform in the solution under reduced pressure to form a lipid film; prepare a 0.3M citric acid solution, and use the citric acid solution to hydrate the lipids film, the hydration temperature is between 60°C and 65°C to obtain a blank liposome suspension; after complete hydration, use a high-pressure homogenizer to prepare liposomes until the average particle size is 80nm, ...

Embodiment 3

[0075] Preparation prescription (1000ml capacity):

[0076] Daunorubicin Hydrochloride 1000mg

[0077] Hydrogenated Soy Lecithin (HSPC) 9g

[0078] Dimyristate Phosphatidylglycerol (DMPG) 5g

[0079] Cholesterol 1.6g

[0080] Vitamin E 15mg

[0081] Citric acid 2300mg

[0082] Anhydrous Sodium Carbonate 1600mg

[0083] Lactose 90g

[0084] Glycine 5g

[0085] Water for injection to the required volume

[0086] The preparation process is as follows:

[0087] Select phospholipids, cholesterol and vitamin E according to the formula and dissolve them in 2:1 chloroform-methanol and mix them evenly; use a rotary evaporator to remove the chloroform and methanol in the solution under reduced pressure to form a lipid film; prepare a 0.30M citric acid solution, use lemon acid solution to hydrate the lipid film, the hydration temperature is generally between 65 °C ± 3 °C to obtain a blank liposome suspension; after the hydration is complete, use a high-pressure particle homogeni...

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PUM

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Abstract

A lipid injection of Zhengdingmycin or zhengdingmycin hydrochloride is prepared from Zhengdingmycin or zhengdingmycin hydrochloride, neutral phosphide, negative-charge phosphide, cholesterol, antioxidizing agent, organic acid, alkali, sugar, buffer and the water for injection through preparing liposome, homogenizing coating, purifying, solidifying, and sterilizing. Its advantages are high stability and low toxic by-effect.

Description

technical field [0001] The invention relates to a preparation of daunorubicin or daunorubicin hydrochloride, in particular to a daunorubicin or daunorubicin hydrochloride liposome injection, and also relates to a preparation process of the medicine. Background technique [0002] Daunorubicin or daunorubicin hydrochloride is an anthracycline broad-spectrum antitumor antibiotic. Its mechanism of action is mainly through its insertion into the DNA double helix and binding to DNA to change its template. This chimerism can lead to DNA space Structural barriers, thereby inhibiting DNA and RNA polymerases, preventing DNA and RNA synthesis. Daunorubicin hydrochloride has a broad-spectrum anti-experimental tumor effect, and is mainly used for acute lymphocytic or myeloid leukemia that is resistant to commonly used anti-tumor drugs. It also has a certain effect on lymphosarcoma, neuroblastoma, osteosarcoma, skeletal muscle tumor and choriocarcinoma. Although daunorubicin hydrochlori...

Claims

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Application Information

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IPC IPC(8): A61K9/127A61K31/704A61P35/00
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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