Xiyanping lipidosome injection

A technology for injections and liposomes, applied in the field of medicine, can solve the problems of easy aggregation, fusion, and leakage of encapsulated drugs in liposomes, and achieve the effects of improving bioavailability, low leakage rate, and improving the quality of preparation products

Inactive Publication Date: 2014-11-19
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

[0011] The stability of liposomes has long been an important problem that has limited the wide application of liposomes. Liposomes are generally prone to aggregation and fusion, resulting in leakage of encapsulated drugs. Therefore, the industrial preparation of pharmaceutical liposomes that meet the stability requirements It is not easy, and those with general experience in the pharmaceutical field clearly know that they face various technical difficulties in the preparation of pharmaceutical liposomes, all of which are by no means expected to be solved by existing theories, and many difficulties need to be overcome

Method used

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preparation example Construction

[0056] On the other hand, the present invention also provides a preparation method of Xiyanping liposome injection, specifically comprising the following preparation steps:

[0057] (1) Dissolve phosphatidylcholine distearate, soybean phosphatidylinositol, soybean sterol and sodium deoxycholate in an organic solvent under slow magnetic stirring at about 55°C to obtain a lipid solution, and dissolve the above solution Freeze-drying until the drying is complete to obtain a dry solid that forms a loose spongy shape;

[0058] (2) Dissolve Xiyanping in phosphate buffer solution, add povidone, and stir evenly to obtain an aqueous phase;

[0059] (3) Under slow magnetic stirring at about 45°C, add the solid in step 1 into the water phase in step 2, then perform gradient homogenization at 500bar to 700bar for 7 to 9 times, and filter with a 0.22μm microporous membrane to obtain Xiyanping liposome;

[0060] (4) Under the protection of nitrogen, adjust the pH value of the Xiyanping li...

Embodiment 1

[0075] The preparation of embodiment 1 Xiyanping liposome injection

[0076] Prescription: (100 sticks)

[0077] The components and weights of the raw and auxiliary materials used are as follows:

[0078]

[0079]

[0080] Prepare Xiyanping liposome injection by preparation process:

[0081] (1) Dissolve 300g of phosphatidylcholine distearate, 150g of soybean phosphatidylinositol, 100g of soybean sterol and 50g of sodium deoxycholate in 900mL of The lipid solution was obtained in a mixed organic solvent of tert-butanol and methanol, and the above solution was pre-frozen at -60°C for 2 hours, then frozen at -40°C for 16 hours, then sublimated to 20°C for 12 hours, and finally dried at 30°C After 3 hours, a loose spongy dry solid was obtained;

[0082] (2) Dissolve 25g of Xiyanping in 10,000ml of phosphate buffer solution with a pH of 7.8, add 75g of povidone, and stir evenly to obtain an aqueous phase;

[0083] (3) Under slow magnetic stirring at about 45°C, add the...

Embodiment 2

[0085] The preparation of embodiment 2 Xiyanping liposome injection

[0086] Prescription: (100 sticks)

[0087] The components and weights of the raw and auxiliary materials used are as follows:

[0088]

[0089]

[0090] Prepare Xiyanping liposome injection by preparation process:

[0091] (1) Dissolve 125g of phosphatidylcholine distearate, 50g of soybean phosphatidylinositol, 37.5g of soybean sterol and 12.5g of sodium deoxycholate in 300mL under slow magnetic stirring at about 55°C with a volume ratio of 2: 1 in a mixed organic solvent of tert-butanol and methanol to obtain a lipid solution. The above solution was pre-frozen at -70°C for 4 hours, then frozen at -50°C for 18 hours, then sublimated to 25°C for 14 hours, and finally at 35°C. ℃ and dried for 5 hours to obtain a loose spongy dry solid;

[0092] (2) Dissolve 12.5g of Xiyanping in 5000ml of phosphate buffer solution with a pH of 7.8, add 25g of povidone, and stir evenly to obtain an aqueous phase;

...

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Abstract

The invention discloses an Xiyanping lipidosome injection and a preparation method thereof. The lipidosome injection is prepared by using Xiyanping, phosphatidylcholine distearate, soybean phospholipid phosphatidyl-inositol, soyasterol, deoxysodium cholate, trehalose and povidone. The Xiyanping lipidosome injection disclosed by the invention has the advantages of small particle size, uniformity in distribution, good stability, good encapsulation efficiency and lower leaking rate; according to the invention, the dissolution rate of the Xiyanping is improved and the biological availability and curative effect of a medicine are enhanced; and the preparation method 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 Xiyanping liposome injection and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Xiyanping is a sulfonated product of andrographolide, easily soluble in water, soluble in methanol, and slightly soluble in ethanol. According to the formula and extraction process given in the national drug standard WS-10862 (ZD-0863)-2002, Xiyanping injection is a kind of detoxification with heat-clearing and detoxifying properties. Injection preparations for the treatment of infections, bronchial pneumonia, viral pneumonia, suppurative diseases, gynecological inflammation and postoperative fever have been clinically verified for many years, with stable quality and definite curative effect. They are commonly used in clinics and families to treat the above diseases. Pharmaceutical preparations. Zhan Huizhong, Simult...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/00A61K9/127A61K31/365A61K47/32A61P31/12
Inventor 王平
Owner 海南路易丹尼生物科技有限公司
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