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A kind of pharmaceutical composition and preparation for children

A pediatric, sesquihydrate technology, applied in the field of medicine, can solve problems such as optimization and difficult process

Active Publication Date: 2018-07-03
广东金城金素制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It can be seen that the prepared liposomes are mainly small unilamellar liposomes, and the volume of the inner aqueous phase is small, thus resulting in C 18 h 16 N 8 Na 2 o 7 S 3 3.5H 2 The encapsulation efficiency of O is only about 30%, and it is difficult to further improve it through process optimization

Method used

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  • A kind of pharmaceutical composition and preparation for children
  • A kind of pharmaceutical composition and preparation for children
  • A kind of pharmaceutical composition and preparation for children

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Weigh 3.2 g of hydrogenated soybean lecithin and 1.2 g of cholesterol as a film-forming substance, and 0.13 g of N-(β-D-glucopyranose) octanamide as a film-forming substance stabilizer, and dissolve the above mixture with 120 mL ether / chloroform The 1:1 mixture was dissolved; to it was added 18 h 16 N 8 Na 2 o 7 S 3 3.5H 2 20mL of PBS buffer solution with a pH value of 5.5, ultrasonically make the mixed system into a homogeneous system; evaporate the organic solvent under reduced pressure until a gel is formed, add 10mL of PBS buffer solution with a pH value of 5.5 for hydration reaction, and the temperature is 25°C , the hydration time is 2.5h; then continue to evaporate under reduced pressure for 15 minutes; after ultrasonication, let it stand for 2h at a temperature of 4°C to obtain the above C 18 h 16 N 8 Na 2 o 7 S 3 3.5H 2 O Composition of pharmaceutical entities.

Embodiment 2

[0048] Weigh 3.2 g of hydrogenated soybean lecithin and 1.2 g of cholesterol as a film-forming substance, and 0.11 g of N-(β-D-glucopyranose) octanamide as a film-forming substance stabilizer, and mix the above mixture with 120 mL ether / chloroform The 1:1 mixture was dissolved; to it was added 18 h 16 N 8 Na 2 o 7 S 3 3.5H 2 15 mL of PBS buffer solution with a pH value of 5.5, ultrasonically make the mixed system into a homogeneous system; evaporate the organic solvent under reduced pressure until a gel is formed, add 15 mL of PBS buffer solution with a pH value of 5.5 for hydration reaction, and the temperature is 30°C , the hydration time is 1.5h; then continue to evaporate under reduced pressure for 15 minutes; after ultrasonication, let it stand for 1h at a temperature of 4°C to obtain the above C 18 h 16 N 8 Na 2 o 7 S 3 3.5H 2 O Composition of pharmaceutical entities.

Embodiment 3

[0050] Weigh 3.2 g of hydrogenated soybean lecithin and 1.2 g of cholesterol as a film-forming substance, and 0.15 g of N-(β-D-glucopyranose) octanamide as a film-forming substance stabilizer, and mix the above mixture with 120 mL ether / chloroform The 1:1 mixture was dissolved; to it was added 18 h 16 N 8 Na 2 o 7 S 3 3.5H 2 25mL of PBS buffer solution with a pH value of 5.5, ultrasonically make the mixed system into a homogeneous system; evaporate the organic solvent under reduced pressure until a gel is formed, add 5mL of PBS buffer solution with a pH value of 5.5 for hydration reaction, and the temperature is 20 ℃, the hydration time is 4h; then continue to evaporate under reduced pressure for 15 minutes; after ultrasonication, let stand at 4℃ for 3h to obtain the above C 18 h 16 N 8 Na 2 o 7 S 3 3.5H 2 O Composition of pharmaceutical entities.

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Abstract

The invention discloses a C18H16N8Na2O7S33.5H2O drug entity composition for children and a preparation thereof. The composition contains the following raw materials: hydrogenated lecithin, cholesterol, C18H16N8Na2O7S33 and D-glucopyranose amide, wherein hydrogenated lecithin and cholesterol are taken as film forming substances, and D-glucopyranose amide is taken as a film forming substance stabilizer.

Description

technical field [0001] The invention belongs to the field of medicine; relates to a C 18 h 16 N 8 Na 2 o 7 S 3 3.5H 2 O pharmaceutical entity composition, especially a new type of pediatric use C 18 h 16 N 8 Na 2 o 7 S 3 3.5H 2 O Pharmaceutical entity compositions and preparations. Background technique [0002] C 18 h 16 N 8 Na 2 o 7 S 3 3.5H 2 The chemical name of O is: [6R[6α,7β(Z)]]-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-1,2, 4-triazin-3-yl)thio]methyl]-7-[[(2-amino-4-thiazolyl)(methoxyimino)acetyl]amino]-8-oxo-5-thio Hetero-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid disodium salt triple hemihydrate, molecular weight 661.6, belongs to β-lactam cephalosporins. In 1969, the Swiss company Roche began to study the structure and biological activity of cephalosporins, and discovered and synthesized C for the first time in 1978. 18 h 16 N 8 Na 2 o 7 S 3 3.5H 2 O, codenamed Ro-13-9904. Japan also started in 1978 C 18 h 16 N 8 Na 2 o 7 S ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/546A61K9/14A61K47/26A61P31/04
CPCA61K9/145A61K31/546A61K47/26
Inventor 朱旭伟周白水傅苗青李秋荣黄嘉玲
Owner 广东金城金素制药有限公司
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