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Palonosetron hydrochloride lipidosome injection

A technology of injection and agar, which is applied in the field of pharmaceutical preparations, can solve the problems of low stability of ordinary injection preparations, and achieve the effects of high quality, uniform particle size distribution and high 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

[0007] It can be seen from the patent that the prescription and process have been carefully researched and screened, but the problem of low stability of ordinary injection preparations still cannot be escaped

Method used

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  • Palonosetron hydrochloride lipidosome injection
  • Palonosetron hydrochloride lipidosome injection
  • Palonosetron hydrochloride lipidosome injection

Examples

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preparation example Construction

[0062] According to another aspect of the present invention, the preparation method of above-mentioned palonosetron hydrochloride liposome injection is provided, the method comprises the following steps:

[0063] (1) Dissolve cholesterol, soybean phosphatidylserine, phosphatidylglycerol, soybean sterol and Tween 80 in buffered saline solution to make blank liposomes;

[0064] (2) The blank liposomes prepared above were sterilized by flowing steam, and then sonicated twice for 20 minutes each time;

[0065] (3) Under sterile conditions, add palonosetron hydrochloride to the liposome in molten state, and add trehalose under constant stirring;

[0066] (4) Quickly freeze, then return to room temperature, constant volume, stir evenly, filter through a 0.22 μm microporous membrane, fill, and obtain palonosetron hydrochloride liposome injection.

[0067] In the method according to the present invention, in step (1), the buffered saline solution is selected from one of phosphate buf...

Embodiment 1

[0074] Example 1 Preparation of Palonosetron Hydrochloride Liposomal Injection

[0075] The raw materials used are as follows:

[0076]

[0077] The preparation process is as follows:

[0078] (1) Dissolve 6.5g of soybean phosphatidylserine, 2.5g of phosphatidylglycerol, 3.25g of soybean sterol and 1.5g of Tween 80 in 500ml of disodium hydrogen phosphate-sodium dihydrogen phosphate buffer solution with a pH of 7.0 to make a blank Liposomes;

[0079] (2) The blank liposomes prepared above were sterilized by flowing steam, and then sonicated twice for 20 minutes each time;

[0080] (3) Under sterile conditions, add 0.25 g of palonosetron hydrochloride to the liposome in molten state, and add 3.25 g of trehalose under constant stirring;

[0081] (4) Quickly freeze at -40°C, then return to room temperature, add water for injection to a volume of 5000ml, stir evenly, filter with a 0.22μm microporous membrane, fill (5ml / bottle), and obtain 1000 bottles of palonosetron hydrochl...

Embodiment 2

[0082] Example 2 Preparation of Palonosetron Hydrochloride Liposomal Injection

[0083] The raw materials used are as follows:

[0084]

[0085] The preparation process is as follows:

[0086] (1) Dissolve 5g of soybean phosphatidylserine, 2.5g of phosphatidylglycerol, 2.5g of soybean sterol and 1.25g of Tween 80 in 500ml of disodium hydrogen phosphate-sodium dihydrogen phosphate buffer solution with a pH of 7.0 to make a blank fat plastid;

[0087] (2) The blank liposomes prepared above were sterilized by flowing steam, and then sonicated twice for 20 minutes each time;

[0088] (3) Under sterile conditions, add 0.25 g of palonosetron hydrochloride to the liposome in molten state, and add 2.5 g of trehalose under constant stirring;

[0089] (4) Quickly freeze at -40°C, then return to room temperature, add water for injection to a volume of 5000ml, stir evenly, filter with a 0.22μm microporous membrane, fill (5ml / bottle), and obtain 1000 bottles of palonosetron hydrochlo...

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Abstract

The invention discloses a palonosetron hydrochloride lipidosome injection and a preparation method thereof. The lipidosome injection is prepared by using palonosetron hydrochloride, soybean phosphatidylserine, phosphatidyl glycerol, soyasterol, Tween 80 and trehalose according to a specific weight ratio. The hydrochloride thiamphenicol glycinate lipidosome injection disclosed by the invention has the advantage of good preparation stability and a lipidosome cannot be cracked due to melting, ice crystals and the like in the refrigerating process; after the hydrochloride thiamphenicol glycinate lipidosome injection is stored for a long time, the lipidosome is also kept with good encapsulation efficiency; the quality of a preparation product is improved, the retention time of a drug in systemic circulation is prolonged, the biological availability of the drug is increased, toxic and side effects are reduced and a curative effect is obviously improved; and moreover, the palonosetron hydrochloride lipidosome injection disclosed by the invention has the advantage of simple preparation method 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 palonosetron hydrochloride liposome injection and a preparation method thereof, and belongs to the technical field of pharmaceutical preparations. Background technique [0002] Palonosetron hydrochloride, chemical name: 2-[(S)-1-azabicyclo[2.2.2]octane-3-yl]-2,3,3a(S),4,5,6- Hexahydro-1H-benzoisoquinolin-1-one hydrochloride, molecular formula: C 19 h 24 N 2 O HCl, molecular weight: 332.87, its structural formula is as follows: [0003] [0004] Palonosetron acid is white or off-white crystalline powder, odorless and tasteless; soluble in water, insoluble in ethanol. It is a highly efficient and highly selective 5-HT3 receptor antagonist. It is the fourth 5-HT3 receptor antagonist approved by the FDA for the treatment of acute nausea and vomiting caused by chemotherapy drugs, and the first approved Drugs that can be used for delayed nausea and vomi...

Claims

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Application Information

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IPC IPC(8): A61K9/127A61K31/473A61K47/36A61P1/08
Inventor 王平
Owner 海南路易丹尼生物科技有限公司
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