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Bleomycin hydrocloride lipidosome injection

A technology of pingyangmycin hydrochloride and pingyangmycin hydrochloride, which is applied in the field of pingyangmycin hydrochloride liposome injection, liposome injection and preparation method thereof, and can solve the problems of low bioavailability, complicated preparation process and insufficient stability Good and other problems, to achieve the effect of protecting shape and stability, good molding support, and improving stability

Inactive Publication Date: 2013-04-17
海南路易丹尼生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] CN101536987A discloses a microsphere vascular embolism containing anti-angioma drug sodium alginate and its preparation method and application. The above-mentioned anti-angioma drug is Pingyangmycin, sodium morrhuate, urea or bleomycin, the stability of the drug is not good enough, and the particle size and encapsulation rate are difficult to measure and control, resulting in low bioavailability, and the preparation process is too Complex, not suitable for industrial mass production
[0012] He Fuchang, Research on the anti-tumor effect of Pingyangmycin magnetic liposome on human mucoepidermoid carcinoma in vivo, "Journal of Practical Stomatology", No. 02, 1997, pages 108-110, which discloses the development of Pingyangmycin Observation of the anti-tumor effect of magnetic liposomes on human mucoepidermoid carcinoma in vivo, evaluating its feasibility as a new carrier for tumor-directed treatment, but did not disclose the composition of Pingyangmycin magnetic liposomes

Method used

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  • Bleomycin hydrocloride lipidosome injection
  • Bleomycin hydrocloride lipidosome injection
  • Bleomycin hydrocloride lipidosome injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] The preparation of embodiment 1 pingyangmycin hydrochloride liposome injection

[0057] The ingredients used in the prescription (1000 vials) and their weights are as follows:

[0058]

[0059]

[0060] Adopt preparation technology to prepare pingyangmycin hydrochloride liposome injection:

[0061] (1) Dissolve 10g of cholesterol succinate, 40g of distearoylphosphatidylethanolamine and 8g of polyoxyethylene 40 hydrogenated castor oil in 200ml of ethanol and isopropanol at a volume ratio of 1:3 under slow magnetic stirring at about 50°C The lipid solution was obtained in a mixed organic solvent, and the above solution was pre-frozen at -50°C for 2 hours, then frozen at -40°C for 10 hours, then sublimated to 20°C for 12 hours, and finally dried at 30°C for 6 hours to obtain Forms a loose, spongy dry solid;

[0062] (2) Dissolve 4 g of pingyangmycin hydrochloride in 1000 ml of potassium dihydrogen phosphate-dipotassium hydrogen phosphate buffer solution with a pH...

Embodiment 2

[0065] The preparation of embodiment 2 pingyangmycin hydrochloride liposome injection

[0066] The ingredients used in the prescription (1000 vials) and their weights are as follows:

[0067]

[0068]

[0069] Adopt preparation technology to prepare pingyangmycin hydrochloride liposome injection:

[0070](1) Dissolve 7.5g of cholesterol succinate, 30g of distearoylphosphatidylethanolamine and 7g of polyoxyethylene 40 hydrogenated castor oil in 200ml of ethanol and isopropyl at a volume ratio of 1:3 under slow magnetic stirring at about 50°C. The lipid solution was obtained in a mixed organic solvent of alcohol. The above solution was pre-frozen at -60°C for 4 hours, then frozen at -50°C for 13 hours, then sublimated to 25°C for 15 hours, and finally dried at 35°C for 8 hours. A dry solid forming a loose sponge was obtained;

[0071] (2) Dissolve 4 g of pingyangmycin hydrochloride in 1000 ml of potassium dihydrogen phosphate-dipotassium hydrogen phosphate buffer solut...

Embodiment 3

[0074] The preparation of embodiment 3 pingyangmycin hydrochloride liposome injection

[0075] The ingredients used in the prescription (1000 vials) and their weights are as follows:

[0076]

[0077] Adopt preparation technology to prepare pingyangmycin hydrochloride liposome injection:

[0078] (1) Dissolve 10g of cholesterol succinate, 40g of distearoylphosphatidylethanolamine and 12g of polyoxyethylene 40 hydrogenated castor oil in 200ml of ethanol with a volume ratio of 1:3 under magnetic stirring at about 50°C. Pre-freeze the above solution at -55°C for 3 hours, then freeze at -45°C for 11 hours, then sublimate to 23°C for 13 hours, and finally dry at 33°C for 7 hours , to obtain a dry solid that forms a loose spongy shape;

[0079] (2) Dissolve 8 g of pingyangmycin hydrochloride in 1000 ml of potassium dihydrogen phosphate-dipotassium hydrogen phosphate buffer solution with a pH value of 5.8, add 12 g of trehalose, and stir evenly to obtain an aqueous phase;

[...

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Abstract

The invention discloses a bleomycin hydrocloride lipidosome injection and a preparation method thereof. The lipidosome injection is prepared by using bleomycin hydrocloride, cholesteryl succinate, distearyl phosphatidyl ethanolamine, polyoxyethylene 40 hydrogenated castor oil, trehalose and mannitol. The bleomycin hydrocloride lipidosome injection disclosed by the invention has the advantage of appropriate particle size, uniform distribution, good stability, higher encapsulation efficiency and lower leaking rate; and the preparation method disclosed by the invention has the advantage of good reproducibility and is suitable for large-scale industrial production.

Description

technical field [0001] The invention relates to a liposome injection and a preparation method thereof, in particular to a pingyangmycin hydrochloride liposome injection and a preparation method thereof, and belongs to the technical field of medicine. Background technique [0002] Hemangioma is the most common benign tumor in humans, and hemangioma of the liver is one of the most common benign tumors. Pingyangmycin is a broad-spectrum anti-cancer antibiotic produced by Pingyang mold, and its main component is bleomycin A 5 , can inhibit thymidine from entering DNA to release free nucleobases, and decompose and destroy them, thereby inhibiting DNA synthesis and cutting DNA chains, interfering with cell division and reproduction, affecting cell metabolism, and promoting cell necrosis. Pingyangmycin is a new type of antineoplastic drug that is relatively safe, has few side effects, and has basically no damage to the hematopoietic system and immune system. [0003] Pingyangmyci...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K9/00A61K38/14A61K47/44A61P35/00
Inventor 王平
Owner 海南路易丹尼生物科技有限公司
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