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Method for preparing liposome

A technology of liposomes and blank liposomes, which is applied in liposome delivery, sanitary equipment for toilets, medical preparations of non-active ingredients, etc., can solve problems such as loss, control content loss, and improve encapsulation rate effect

Inactive Publication Date: 2018-07-31
JIANGSU HENGRUI MEDICINE CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Prior art CN102271659A, CN105982857A, CN102935066A, CN1994279A, CN103830182A disclose the preparation method of irinotecan hydrochloride liposome injection, but none of the pre-filtration in the liposome preparation method and the filter time drug in the sterilization filtration system The experimental conditions such as the temperature of the liquid, the filter element, the pipeline, and the drying of the filter element to control its moisture content will explain whether the content of the sample and auxiliary materials is lost.

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  • Method for preparing liposome
  • Method for preparing liposome
  • Method for preparing liposome

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Embodiment 1, the preparation of irinotecan hydrochloride liposome injection

[0041] prescription

[0042] Table 1. Comparison of different irinotecan hydrochloride liposome prescriptions

[0043]

[0044] Preparation:

[0045] Dissolve the prescribed amount of hydrogenated soybean lecithin (HSPC) and cholesterol (CHOL) in an appropriate amount of absolute ethanol to obtain a lipid solution, mix it with 100mL of ammonium sulfate solution, remove the ethanol under reduced pressure to obtain a crude blank liposome; use high-pressure homogenization Machine 1000bar homogenization for 5 cycles, and then extrude liposomes to control its particle size through extrusion equipment (extruder spreads 2 pieces of 0.1 μm extrusion film, extrude 5 times); add the prepared DSPE-PEG2000 aqueous solution, Stir and incubate for 20 minutes, dialyze the blank liposomes with a tangential flow ultrafiltration device, and supplement phosphate buffer saline continuously in the middle to ...

Embodiment 2

[0047] Embodiment 2, the investigation of sterilization filter condition

[0048] (1) Determination conditions of drug sample content:

[0049] Chromatographic conditions: the chromatographic column is filled with octadecylsilane bonded silica gel (Ultimate XB-C18, 250×4.6mm, 5μm);

[0050] Mobile phase: 0.05mol / L phosphate buffer (take 6.8g of potassium dihydrogen phosphate, add 800mL of water, 10mL of triethylamine, dropwise add phosphoric acid to adjust the pH to 4.0, add water to 1000mL to obtain)-methanol-acetonitrile ( 45:55:5, volume ratio) is mobile phase;

[0051] The detection wavelength is 254nm, the flow rate is 1.0mL / min, and the column temperature is 30°C;

[0052] Injection volume: 20μL;

[0053] Record chromatogram, calculate the content of irinotecan hydrochloride trihydrate in need testing solution by external standard method.

[0054] (2) Determination conditions of edetate calcium and sodium content:

[0055] Chromatographic conditions: the chromatogra...

Embodiment 3

[0090] Embodiment 3, filter element drying treatment, the impact of residual moisture on drug content

[0091] The filter element needs to be sterilized before use. After sterilization, soak it in water for 30 minutes to check whether the bubble point is qualified, and then put it in a hot electric oven to dry. Install the dried filter to the corresponding position according to the mark, open the valves related to the compressed air heat exchange and the filter inlet, and purge each filter element for 70 minutes. After the end, take out the filter and weigh it. weight difference.

[0092] Content determination conditions:

[0093] Chromatographic conditions: the chromatographic column is filled with octadecylsilane bonded silica gel (Ultimate XB-C18, 250×4.6mm, 5μm);

[0094] Mobile phase: 0.05mol / L phosphate buffer (take 6.8g of potassium dihydrogen phosphate, add 800mL of water, 10mL of triethylamine, dropwise add phosphoric acid to adjust the pH to 4.0, add water to 1000m...

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Abstract

The present invention relates to a method for preparing a liposome. Specifically, the present invention relates to a method for preparing a liposome in the field of medicines, whether loss of contentof a sample and an auxiliary material is caused due to experimental conditions such as the temperature of a drug liquid, a filter element and a pipe and the controlled moisture content of the filter element after drying during filtration in a prefiltering and sterilization filtration system of a method for preparing an irinotecan hydrochloride liposome injection is investigated, according to the method, the drug liquid is controlled in a fixed temperature range during sterilization filtration, so that the content loss of a drug and the auxiliary material can be effectively controlled, the encapsulation efficiency is improved, and the quality of the final product can be improved; the method reduces the loss of the auxiliary material during filtration and improves the encapsulation efficiency.

Description

technical field [0001] The invention relates to a liposome preparation method, an injection containing the liposome and a preparation method thereof. Background technique [0002] Liposome is a bilayer microvesicle similar to a biological membrane structure, and is a lipid particle containing phospholipid components. As a drug carrier, it has the characteristics of targeting, long-lasting effect, improving drug stability, biodegradability, non-immunogenicity and toxicity. [0003] In view of the above problems in clinical use, how to protect the lactone ring structure of this type of drug and reduce or avoid its destruction as much as possible has become a hot issue in the development of this type of drug preparation. Utilizing the special bilayer structure and characteristics of the liposome, the drug is encapsulated in the internal water phase of the liposome, which can effectively protect the lactone ring. The ammonium sulfate gradient method was used to prepare irinote...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/127A61K31/4745A61K47/24A61P35/00A61L2/02
CPCA61K9/0019A61K9/1271A61K9/1278A61K31/4745A61K47/24A61L2/0017A61L2202/21
Inventor 仝新勇李杰邹爱峰周银王燕平
Owner JIANGSU HENGRUI MEDICINE CO LTD
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