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Hydrochloric acid boanmycin liposomes and preparation method thereof

The technology of bonomycin hydrochloride and bleomycin hydrochloride is applied in the field of bleomycin hydrochloride liposome and its preparation, and can solve the problems of affecting in vivo behavior, affecting the therapeutic effect and toxicity of encapsulated drugs, and the like, To achieve the effect of reducing the cost of freeze-drying, reducing the dose and convenient clinical use

Inactive Publication Date: 2009-08-26
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The particle size of the final product can significantly affect its in vivo behavior, which in turn affects the therapeutic efficacy and toxicity of the encapsulated drug

Method used

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  • Hydrochloric acid boanmycin liposomes and preparation method thereof
  • Hydrochloric acid boanmycin liposomes and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Embodiment 1: the preparation of Boanmycin hydrochloride liposome preparation

[0029] Boanmycin Hydrochloride 4.0g

[0030] Egg yolk lecithin 24.2g

[0031] Cholesterol 8.2g

[0032] Vitamin E 0.1g

[0033] Citric acid 4.5g

[0034] Sodium citrate 4.8g

[0035] Sodium hydroxide 8.5g

[0036] The rest is water for injection

[0037]

[0038] Total 800g

[0039] Preparation Process:

[0040] Weigh the prescribed amount of phospholipids and cholesterol and disperse them into an appropriate amount of pH4.0 citric acid-sodium citrate buffer solution, stir at 30°C until uniformly dispersed; add the above solution into a high-pressure micro-jet, and repeat at 200 atmospheres Operate 10 times to get a translucent solution; take 2ml of liposome solution, and use calcium carbonate solution to adjust the pH value of the solution to 9.0; add 4.0g of Boanmycin hydrochloride to the above solution, and...

Embodiment 2

[0042] Embodiment 2: the preparation of Boanmycin hydrochloride liposome freeze-dried preparation

[0043]Boanmycin Hydrochloride 8.3g

[0044] Soy Lecithin 120.2g

[0045] Cholesterol 40.5g

[0046] Vitamin E 0.2g

[0047] Citric acid 12.5g

[0048] Sodium citrate 12.8g

[0049] Lactose 160.6g

[0050] Sodium bicarbonate 24.2g

[0051] The rest is water for injection

[0052]

[0053] Total 800g

[0054] Preparation Process:

[0055] Weigh the prescribed amount of phospholipids and cholesterol and disperse them into an appropriate amount of pH4.0 citric acid-sodium citrate buffer solution, stir at 50°C until uniformly dispersed; add the above solution into a high-pressure micro-jet, and repeat at 400 atmospheres After 25 operations, a translucent solution was obtained; lactose was added to 2ml of the above solution, and freeze-dried to obtain a white freeze-dried powder. Rehydrate the liposome freez...

Embodiment 3

[0057] Embodiment 3: the preparation of boanmycin hydrochloride liposome freeze-dried preparation

[0058] Boanmycin Hydrochloride 24.6g

[0059] Distearoylphosphatidylcholine 240.2g

[0060] Cholesterol 80.2g

[0061] Vitamin E 0.2g

[0062] Trehalose 120.6g

[0063] Lactose 120.5g

[0064] Citric acid 24.2g

[0065] Sodium citrate 24.1g

[0066] Anhydrous sodium carbonate 40.8g

[0067] The rest is water for injection

[0068]

[0069] Total 800g

[0070] Preparation Process:

[0071] Weigh the prescribed amount of phospholipids and cholesterol and disperse them into an appropriate amount of pH 4.0 citric acid-sodium citrate buffer solution, stir at 70°C until uniformly dispersed; add the above solution into a high-pressure microjet, and repeat at 800 atmospheres Operate 30 times to obtain a translucent solution; add lactose and trehalose to 2ml of the above solution, and spray dry to obtain a wh...

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Abstract

The invention relates to the field of pharmaceutical preparation, in particular to hydrochloric acid boanmycin liposomes and a preparation method thereof. The hydrochloric acid boanmycin liposome comprises the hydrochloric acid boanmycin liposomes, phospholipids, cholesterin, citric acid, and sodium citrate, gradient regulator which respectively have the following mass percent: 0.5-3.0%, 3-30%, 1-10%, 0.5-3%, and 1-5%. The phospholipids is lecithin, double stearoyl phosphatidyl choline (DSPC), dipalmitoyl phosphatidyl choline (DPPC), dioleoyl phosphatidyl choline (DOPC) and the like. The invention is prepared by adopting the PH gradient method. Compared with the prior art, the hydrochloric acid boanmycin liposomes of the invention can reduce dosage, toxic side effect on human body and production cost and has the advantages such as targeting at some specific organs. The hydrochloric acid boanmycin liposomes of the invention can be prepared into parenteral solution or further prepared into freeze-dried powder hydrochloric acid boanmycin liposomes by adding a supporting agent.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to boanmycin hydrochloride liposome and a preparation method thereof. Background technique [0002] Boanmycin hydrochloride (boanmycin hydrochloride, BAM) is a domestic first-class anti-cancer drug developed by the Institute of Pharmaceutical Biotechnology, Chinese Academy of Medical Sciences. Its chemical structure is completely consistent with that of bleomycin A6 reported abroad. Experimental studies have shown that the drug has the characteristics of broad anticancer spectrum, high curative effect, low toxicity, multiple routes of administration (muscular or intravenous injection, arterial cannulation), and no obvious bone marrow suppression. The phase I clinical research results of boanmycin hydrochloride show that its main toxic and side effects include mild to moderate fever, mild gastrointestinal reactions, local induration of injection, and pulmonary ...

Claims

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Application Information

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IPC IPC(8): A61K9/127A61K47/24A61K38/14A61P35/00
Inventor 李铁福方亮刘宇金鑫
Owner SHENYANG PHARMA UNIVERSITY
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