Pantoprazole sodium liposomes freeze-dry preparations and method of preparing the same

A technology of pantoprazole sodium fat and pantoprazole sodium, which is applied in the field of pantoprazole sodium liposome freeze-dried preparations, can solve the quality requirements that injections are difficult to reach the expiration date, poor stability of pantoprazole sodium, etc. problem, to achieve the effect of solving the problem of quality stability, safety proof, and reduction of toxic and side effects

Inactive Publication Date: 2009-10-14
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Poor stability at present pantoprazole sodium, current injection is difficult to reach the quality requirement problem of expiration date, the object of the present invention is to provide a kind of pantoprazole sodium liposome lyophilized preparation, by wrapping with liposome, to solve its stability problem

Method used

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  • Pantoprazole sodium liposomes freeze-dry preparations and method of preparing the same
  • Pantoprazole sodium liposomes freeze-dry preparations and method of preparing the same
  • Pantoprazole sodium liposomes freeze-dry preparations and method of preparing the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Pantoprazole Sodium 20g

[0029] Soy Lecithin 60g

[0030] Cholesterol 20g

[0031] Vitamin E 80mg

[0032] Disodium hydrogen phosphate 15g

[0033] Sodium dihydrogen phosphate 5g

[0034] Mannitol 200g

[0035] Preparation Process:

[0036] (1) Take by weighing 60 g of soybean lecithin, 20 g of cholesterol and 80 mg of vitamin E, dissolve them in chloroform, and mix them uniformly to form a liposome solution. The liposome solution was placed on a thin film evaporator, and the chloroform was released under reduced pressure to obtain a lipid film.

[0037] (2) Weigh 15 g of disodium hydrogen phosphate and 5 g of sodium dihydrogen phosphate according to the prescription, dissolve and prepare a phosphate buffer solution with a pH value of 6.0 to 8.0. Add phosphate buffer solution into the lipid film, and after the lipid is completely hydrated, prepare liposomes with a high-pressure homogenizer, check that the particle size of the liposomes is qualified, and set asid...

Embodiment 2

[0042] Pantoprazole Sodium 40g

[0043] Soy Lecithin 150g

[0044] Cholesterol 40g

[0045] Vitamin E 160mg

[0046] Citric acid 20g

[0047] Sodium citrate 50g

[0048] Glucose 800g

[0049] Preparation Process:

[0050] (1) Weigh 150 g of soybean lecithin, 40 g of cholesterol and 160 mg of vitamin E in the prescribed amount, dissolve them in chloroform, and mix them uniformly. The liposome solution was placed on a thin wax evaporator, and the chloroform was removed under reduced pressure to obtain a lipid film.

[0051] (2) Weigh 20 g of citric acid and 50 g of sodium citrate according to the prescription and dissolve to prepare a citrate buffer solution with a pH value of 6.0-8.0. Add the citrate buffer solution into the prepared lipid film, and after the lipid film is completely hydrated, prepare liposomes with a high-pressure homogenizer, check that the particle size of the liposomes is qualified, and set aside.

[0052] (3) Take by weighing 40g of pantoprazole so...

Embodiment 3

[0056] Pantoprazole Sodium 40g

[0057] Soy Lecithin 60g

[0058] Cholesterol 20g

[0059] Vitamin E 80mg

[0060] Citric acid 5g

[0061] Sodium citrate 12g

[0062] Mannitol 200g

[0063] Preparation Process:

[0064] (1) Weigh 60 g of soybean lecithin, 20 g of cholesterol and 80 mg of vitamin E in the prescribed amount, dissolve them in chloroform, and mix them evenly. The liposome solution was placed on a thin wax evaporator, and the chloroform was removed under reduced pressure to obtain a lipid film.

[0065] (2) Weigh 5 g of citric acid and 12 g of sodium citrate according to the prescription and dissolve to prepare a citrate buffer solution with a pH value of 6.0-8.0. Add the citrate buffer solution into the lipid film, and after the lipid film is completely hydrated, prepare liposomes with a high-pressure homogenizer, check that the particle size of the liposomes is qualified, and set aside.

[0066] (3) Take by weighing 40g of pantoprazole sodium, dissolve in...

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Abstract

The invention discloses a freeze-dried preparation of pantoprazole sodium liposomes, wherein pantoprazole sodium is encapsulated in antioxidant-containing liposomes made of soybean lecithin and cholesterol. The freeze-dried preparation is administered intravenously with stable quality, less toxicity and high effectiveness.

Description

technical field [0001] The invention relates to a pantoprazole sodium liposome freeze-dried preparation, which belongs to the technical field of medicine. Background technique [0002] Pantoprazole sodium is a proton pump inhibitor that inhibits the final step of gastric acid production by covalently binding to two sites of the H+-K+ATPase system of gastric parietal cells. This effect is dose-dependent and inhibits both basal and stimulated gastric acid secretion. The combination of this product with H+-K+ATPase can cause its anti-secretion effect of gastric acid to last for more than 24 hours. It is suitable for acute upper gastrointestinal bleeding such as duodenal ulcer, gastric ulcer, acute gastric mucosal lesions, and compound gastric ulcer. [0003] Pantoprazole sodium is an alkaline drug, its aqueous solution can turn pink in a short period of time, it is easily deteriorated and destroyed when exposed to light, high temperature, and water, and its stability is very ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4439A61K9/127A61K47/24A61P1/04
Inventor 王名
Owner HAINAN LINGKANG PHARMA CO LTD
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