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Preparation method of drug loaded emulsion

A medicated emulsion and a technology for emulsions, which are applied in the field of preparing drug-carrying emulsions, can solve the problems of organic solvent residue and long time, and achieve the effects of avoiding drug degradation, simple process, and facilitating large-scale industrial production.

Inactive Publication Date: 2010-12-08
SHANGHAI HENGRUI PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] If the drug is dissolved in the water phase or the oil phase, it generally takes a long time. For the chemically unstable drug, degradation products may be generated during the dissolution process; if an organic solvent is used, it will involve the problem of organic solvent residue

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Vinorelbine Tartrate 0.05%

[0042] soybean oil 5%

[0043] Yolk Lecithin 2%

[0044] Add water for injection to 100%

[0045] Under the protection of an inert gas, weigh 50g of soybean oil and preheat to 75°C; add 20g of egg yolk lecithin to an appropriate amount of water for injection, stir evenly to form a water phase, and preheat to 75°C; under high-speed stirring, add the water phase to In the oil phase, mix evenly, and homogenize with a high-pressure homogenizer to make a blank emulsion, add 0.5g of vinorelbine tartrate, adjust the pH value to 8.0, set the volume to 1000ml, and mechanically stir until the particle size is below 1000nm, 0.22μm Membrane filtration sterilization, filling, nitrogen filling, melting sealing.

Embodiment 2

[0047]Vinorelbine 0.2%

[0048] soybean oil 5%

[0049] Yolk Lecithin 2%

[0050] Add water for injection to 100%

[0051] Under the protection of an inert gas, weigh 50g of soybean oil and preheat to 75°C; add 20g of egg yolk lecithin to an appropriate amount of water for injection, stir evenly to form a water phase, and preheat to 75°C; under high-speed stirring, add the water phase to In the oil phase, mix evenly, and homogenize with a high-pressure homogenizer to make a blank emulsion, add 2g of vinorelbine, adjust the pH value to 8.0, set the volume to 1000ml, stir mechanically until the particle size is below 1000nm, and use a 0.22μm filter membrane Sterilize by filtration, fill, fill with nitrogen, and melt seal.

Embodiment 3

[0053] Bupivacaine Hydrochloride 0.1%

[0054] Castor Oil 10%

[0055] Soy Lecithin 2%

[0056] Anhydrous sodium sulfite 0.2%

[0057] Glycerin 2.5%

[0058] Add water for injection to 100%

[0059] Under the protection of an inert gas, weigh 100g of castor oil and preheat to 60°C; add 20g of soybean lecithin, 2g of anhydrous sodium sulfite and 25g of glycerin to an appropriate amount of water for injection, stir evenly to form a water phase, and preheat to 60°C; Under stirring, mix the oil phase and the water phase evenly, and homogenize through a high-pressure homogenizer to make a blank emulsion, add 0.1g of bupivacaine hydrochloride, adjust the pH value to 7.0, set the volume to 1000ml, and mechanically stir to the particle size Less than 1000nm, 0.22μm membrane filtration sterilization, filling, nitrogen filling, melting sealing.

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PUM

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Abstract

The invention provides a preparation method of a drug loaded emulsion, which can reduce degradation of a drug in a preparation process. The method comprises the following steps: a, preparing a blank emulsion without drug ingredients; and b, adding an effective treatment amount of the drug in the blank emulsion. The technology process is simple, avoids the use of an organic solvent, and is suitable for industrial production in a large scale.

Description

technical field [0001] The invention relates to a method for preparing a drug-loaded emulsion, in particular to a method for preparing a drug-loaded emulsion by adding drugs into a blank emulsion. Background technique [0002] Emulsions are widely used clinically, among which fat emulsion has been used as a carrier for parenteral administration for more than 40 years. targeting. In recent years, based on the mature preparation technology of fat emulsion, the research of drug-loaded emulsion has attracted more and more attention. The drug-loaded product can not only achieve therapeutic effect, but also provide energy for patients, which is more conducive to the recovery of patients. [0003] According to the particle size of the developed product, drug-loaded emulsions are divided into submicroemulsions and nanoemulsions. The particle size of submicroemulsion is between 100-1000nm, the appearance is opaque, turbid or milky, and its stability is not as good as that of nanoem...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K47/44
CPCA61K9/1075A61K9/107A61P25/18A61P25/26A61P29/00A61P3/02A61P31/00A61P31/10A61P31/12A61P35/00A61P37/06A61P37/08A61P5/00A61P9/00A61K9/10A61K9/48
Inventor 仝新勇王海凤于力陈亮石远
Owner SHANGHAI HENGRUI PHARM CO LTD
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