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Adriacin or adriacin hydrochloride liposome injection and its preparing process

A technology of doxorubicin hydrochloride lipid and doxorubicin hydrochloride, which is applied in the field of preparation of doxorubicin or doxorubicin hydrochloride, can solve problems such as unsatisfactory process conditions, achieve excellent stability, low toxic and side effects, and reduce production costs Effect

Active Publication Date: 2005-03-16
常州金远药业制造有限公司
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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

[0059] Preparation prescription (25ml volume):

[0060] Adriamycin Hydrochloride 50mg

[0061] Distearic Lecithin (DSPC) 320mg

[0062] Distearate Phosphatidylglycerol (DSPG) 68mg

[0063] Cholesterol 95mg

[0064]Vitamin E 1.2mg

[0065] Citric acid 560mg

[0066] Anhydrous Sodium Carbonate 800mg

[0067] Sucrose about 2250mg

[0068] Glycine about 125mg

[0069] Water for injection to the required volume

[0070] The preparation process is as follows:

[0071] 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 generally between 55°C and 65°C to obtain a blank liposome suspension; after complete hydration, use a high-pressure homogenizer to prepare liposomes to an average part...

Embodiment 2

[0073] Preparation prescription (25ml volume):

[0074] Adriamycin Hydrochloride 50mg

[0075] Hydrogenated Soy Lecithin (HSPC) 380mg

[0076] Dimyristate Phosphatidylglycerol (DMPG) 50mg

[0077] Cholesterol 110mg

[0078] Vitamin E 1.0mg

[0079] Succinic acid 300mg

[0080] Sodium Hydroxide 170mg

[0081] Lactose about 1125mg

[0082] Glycine about 95mg

[0083] Water for injection to the required volume

[0084] The preparation process is as follows:

[0085] 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 chloroform and methanol in the solution under reduced pressure to form a lipid film; prepare a 0.25M succinic acid solution, acid solution to hydrate the lipid film, and 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 homogenizer to prepare ...

Embodiment 3

[0087] Preparation prescription (25ml volume):

[0088] Adriamycin Hydrochloride 50mg

[0089] Hydrogenated Soy Lecithin (HSPC) 360mg

[0090] Distearate Phosphatidylglycerol (DSPG) 80mg

[0091] Cholesterol 110mg

[0092] Vitamin E 0.8mg

[0093] Citric acid 620mg

[0094] Sodium Hydroxide 520mg

[0095] Sucrose about 2250mg

[0096] Glycine about 125mg

[0097] Water for injection to the required volume

[0098] The preparation process is as follows:

[0099] 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 generally between 55°C and 65°C to obtain a blank liposome suspension; after complete hydration, use a high-pressure homogenizer to prepare liposomes to an average parti...

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Abstract

The invention discloses an Adriacin or adriacin hydrochloride liposome injection and its preparing process, wherein the injection is prepared from Adriacin or adriacin hydrochloride, neutral phosphatide, negative electric charge phosphatide, cholesterin, anti-oxidant, organic acid, alkali, sugar, buffering agent and water for injection through the steps of preparing margin liposome, homogenizing the liposome, preparing Adriacin or adriacin hydrochloride liposome and their suspension, keeping constant volume, degerming, split charging and conserving.

Description

technical field [0001] The invention relates to a preparation of doxorubicin or doxorubicin hydrochloride, in particular to a liposome injection of doxorubicin or doxorubicin hydrochloride, and also relates to a preparation process of the medicine. Background technique [0002] Doxorubicin hydrochloride (DOX-HCL) is the hydrochloride salt of anthracycline broad-spectrum antitumor antibiotic doxorubicin. Its mechanism of action is mainly that doxorubicin molecules enter the nucleus and bind to DNA, thereby inhibiting nucleic acid synthesis and mitosis. Doxorubicin hydrochloride has a broad-spectrum anti-experimental tumor effect, and also has an inhibitory effect on topoisomerase, which can be applied to acute leukemia, malignant lymphoma, multiple myeloma, lung cancer, breast cancer, bladder cancer, testicular cancer , Thyroid cancer, soft tissue tumors, osteosarcoma, neuroblastoma, etc., can also be used for gastric cancer, colorectal cancer, liver cancer, esophageal cancer...

Claims

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Application Information

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IPC IPC(8): A61K9/127A61K31/704A61P35/00
Inventor 贺明贺欣
Owner 常州金远药业制造有限公司
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