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Application of liposome to treatment of chronic viral hepatitis B

A technology of viral hepatitis and liposome, which is applied in the direction of liposome delivery, antiviral agents, organic active ingredients, etc., can solve the problems of chronic hepatitis B virus without liposome, and achieve good stability in vitro , The preparation process is simple, and the effect of maintaining stability

Inactive Publication Date: 2017-08-11
JIANGSU MENDEL GENE TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At present, there is no report that liposome itself is used as a drug for the treatment of chronic hepatitis B

Method used

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  • Application of liposome to treatment of chronic viral hepatitis B
  • Application of liposome to treatment of chronic viral hepatitis B
  • Application of liposome to treatment of chronic viral hepatitis B

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Embodiment 1: liposome preparation and property analysis

[0030] (1) Liposome preparation, concentration and lyophilization:

[0031] The following raw materials were used to prepare the liposomes of this embodiment: soybean lecithin, cholesterol, palmitic acid, vitamin E, mannitol (20% sterile aqueous solution), human albumin (concentration is 20% solution), ether, ethanol and phosphate buffer (pH 6.5, 0.1 mM).

[0032]The liposomes were prepared by high-pressure injection and secondary emulsification. Add 14.1166g of soybean lecithin, 2.3202g of cholesterol, 0.4630g of palmitic acid, and 0.8514g of vitamin E to dissolve in 300mL of ether; filter the above solution through a 0.2μm microporous membrane into an emulsification bottle, and then add 300mL of ethanol to form an emulsion ( W / O); inject the obtained above-mentioned emulsion into 14.4L water, control the reaction temperature to be 40°C and stir at the same time, form the emulsion (W / O / W) twice, and gradual...

Embodiment 2

[0038] Embodiment 2: the selection of liposome lyophilization excipient

[0039] Freeze-drying and excipient of liposome: compare the volume ratio of liposome concentrate, different excipients (human albumin, povidone K30) and their concentration on the shrinkage of liposome shape after freeze-drying The results are shown in Table 1.

[0040] Table 1: The volume ratio of liposome concentrate and the effect of excipients and their concentration on lyophilization

[0041]

[0042] Note: *The volume of liposome concentrate accounts for the volume percentage of emulsion.

[0043] As can be seen from Table 1, when liposomes are lyophilized, when the concentrated volume of liposomes is 25-50% of the final emulsion volume, adding 1% human albumin as an excipient can ensure that the lipid The body shape does not shrink after freeze-drying.

Embodiment 3

[0044] Embodiment 3: the therapeutic effect of liposome in chronic hepatitis B patient

[0045] In this example, the finished liposome prepared in Example 1 is used to treat selected patients with chronic hepatitis B, and to explore its therapeutic effect and effect on chronic hepatitis B.

[0046] (1) Selection of subjects: 119 patients with chronic hepatitis B were selected as subjects. The details of the subjects are as follows:

[0047]

[0048] (2) Administration method: administer by subcutaneous injection on the upper arm, and give 900 μg liposome finished product each time; 28 weeks subcutaneous injection 6 times.

[0049] (3) Efficacy evaluation: chronic hepatitis B patients were treated with the liposomes of the embodiment of the present invention 1, and the peripheral blood of the test patients was collected respectively at 12, 28, 32, 40, 52, 64, and 76 weeks , HBeAg / anti-HBe conversion rate, serum HBV virus titer and serum alanine aminotransferase (ALT) co...

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Abstract

The invention relates to application of a liposome to preparation of a drug for treating chronic viral hepatitis B, wherein the liposome is prepared from a substance containing phospholipid and cholesterol. The invention further relates to application of the liposome to preparation of drugs for promoting serology conversion, namely hepatitis B E antibody positive conversion and hepatitis B E antigen negative conversion, of chronic viral hepatitis B patients, for reducing the titer of hepatitis B virus in peripheral blood serum of chronic viral hepatitis B patients, for reducing the concentration of glutamic-pyruvic transaminase in peripheral blood serum of chronic viral hepatitis B patients, and for maintaining the stability of a T cell receptor repertoire of chronic viral hepatitis B patients.

Description

technical field [0001] The invention relates to the technical field of liposomes, in particular to the use of liposomes for treating chronic hepatitis B. Background technique [0002] Hepatitis B virus is a global disease caused by hepatitis B virus (HBV), mainly characterized by liver inflammatory lesions and can cause multiple organ damage. According to the report of the World Health Organization: global hepatitis B virus infection accounts for about 30% of the population, that is, about 1.8 billion people in the world have been infected with hepatitis B virus, of which about 35 million people are chronically infected, and the latter shows persistence Viremia. Globally, China is a highly prevalent area of ​​hepatitis B virus, with about 120 million hepatitis B virus carriers and about 30 million chronic hepatitis B patients. Viral hepatitis B is mostly transmitted during the perinatal period, with onset in adolescence and exacerbation in young adults. Therefore, most of...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/127A61K9/19A61K47/42A61K47/32A61P1/16A61P31/20
CPCA61K9/0019A61K9/127A61K9/19A61K47/32A61K47/42A61K31/355A61K47/12A61K47/22A61K47/24
Inventor 吴玉章
Owner JIANGSU MENDEL GENE TECH CO LTD
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