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Disodium clodronate liposome injection

A technology of clodronate disodium lipid and clodronate disodium, which is applied in the field of medicine and can solve problems such as content reduction, low bioavailability, and poor stability of common dosage forms

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

[0008] The dosage forms of disodium clodronate currently on the market are capsules, injections and powder injections prepared by common preparation technology. However, common dosage forms have poor long-term storage stability, decreased content, and bioavailability low level problem

Method used

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  • Disodium clodronate liposome injection
  • Disodium clodronate liposome injection
  • Disodium clodronate liposome injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] Embodiment 1 clodronate disodium liposome freeze-dried powder injection

[0049] prescription:

[0050]

[0051] Preparation Process:

[0052] (1) Dissolve 600g of distearoylphosphatidylglycerol, 150g of cholesterol and 150g of polyoxyethylene 40 hydrogenated castor oil in 2000ml of chloroform, mix well, and remove the chloroform under reduced pressure on a rotary thin film evaporator to obtain the Lipid film;

[0053] (2) Dissolve 300g of disodium clodronate in 1000ml of citrate buffer solution with a pH of 6.4, then add it to the above-mentioned lipid film, shake and stir for 20 minutes at a speed of 500-1000r / min to make the phospholipid film Complete hydration, high-speed homogeneous emulsification with a tissue masher for 5-10 minutes at a speed of 10,000 r / min, and filtration with a 0.45 μm microporous membrane to obtain a liposome suspension;

[0054] (3) Dilute the volume to 2000ml with water for injection, filter through a 0.45μm microporous membrane, sub...

Embodiment 2

[0055] Embodiment 2 clodronate disodium liposome injection

[0056] prescription:

[0057]

[0058] Preparation Process:

[0059] (1) Dissolve 150g of distearoylphosphatidylglycerol, 300g of cholesterol and 30g of polyoxyethylene 40 hydrogenated castor oil in 2000ml of chloroform, mix well, and remove chloroform under reduced pressure on a rotary thin film evaporator to obtain Lipid film;

[0060] (2) Dissolve 300g of disodium clodronate in 1000ml of citrate buffer solution with a pH of 6.4, then add it to the above-mentioned lipid film, shake and stir for 20 minutes at a speed of 500-1000r / min to make the phospholipid film Complete hydration, high-speed homogeneous emulsification with a tissue masher for 5-10 minutes at a speed of 10,000 r / min, and filtration with a 0.45 μm microporous membrane to obtain a liposome suspension;

[0061] (3) Dilute the volume to 5000ml with water for injection, filter through a 0.45μm microporous membrane, fill, 5ml each, melt seal, and s...

Embodiment 3

[0062] Embodiment 3 clodronate disodium liposome injection

[0063] prescription:

[0064]

[0065] Preparation Process:

[0066] (1) Dissolve 300g of distearoylphosphatidylglycerol, 60g of cholesterol and 60g of polyoxyethylene 40 hydrogenated castor oil in 2000ml of chloroform, mix well, and remove the chloroform under reduced pressure on a rotary thin film evaporator to obtain the Lipid film;

[0067] (2) Dissolve 300g of disodium clodronate in 1000ml of citrate buffer solution with a pH of 6.4, then add it to the above-mentioned lipid film, shake and stir for 20 minutes at a speed of 500-1000r / min to make the phospholipid film Complete hydration, high-speed homogeneous emulsification with a tissue masher for 5-10 minutes at a speed of 10,000 r / min, and filtration with a 0.45 μm microporous membrane to obtain a liposome suspension;

[0068] (3) Dilute the volume to 5000ml with water for injection, filter through a 0.45μm microporous membrane, fill, 5ml each, melt seal...

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Abstract

The invention discloses disodium clodronate liposome injection and a preparation method thereof. The disodium clodronate liposome injection with excellent quality is made of disodium clodronate, distearoyl phosphatidyl glycerol, cholesterol, polyoxyethylene (40) hydrogenated castor oil according to specific weight ratio. Compared with the existing preparation, the injection has the advantages that the stability and the bioavailability of the injection are greatly improved, drug release is stable, the quality of injection products is improved, the toxic and side effect is reduced, and the curative effect is more obvious.

Description

technical field [0001] The invention relates to a new preparation of clodronate disodium, in particular to a clodronate disodium liposome injection and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Bone metastasis of malignant tumors is one of the common complications of advanced tumors. Once bone metastasis occurs, patients often experience unbearable bone pain, which seriously affects the quality of life of patients. [0003] Bisphosphonates are currently recognized as effective drugs for the treatment of bone metastases. After the first and second generation bisphosphonates have been on the market for more than ten years, they have become effective in relieving bone pain, preventing the progression of bone lesions, and improving quality of life. , to prevent bone-related events and other important roles in the palliative care of bone metastases. [0004] Bisphosphonates are a group of drugs structurally similar ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K33/42A61K9/127A61K47/44A61P35/04
Inventor 王平
Owner 海南路易丹尼生物科技有限公司
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