A compound long-acting in situ gel injection for treating chronic hepatitis B and its preparation method

A gel injection, chronic hepatitis B technology, applied in the field of medicine, can solve the problems of patients forgetting to take medicine, affecting curative effect, and long treatment cycle

Active Publication Date: 2015-12-23
HYBIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, on the market, both interferon and thymofasin are only common injections, and the treatment cycle is long (more than one year on average), requiring frequent and long-term administration. Generally, interferon is injected once every other day and thymofasin is subcutaneously injected twice a week. , it is easy to bring compliance and forgetting medication problems to patients, and ultimately affect the curative effect, so it is necessary and feasible to develop a new compound long-acting injection containing interferon and thymus method for chronic hepatitis B, currently Interferon and thymofaxin compound long-acting injection has not been reported yet

Method used

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  • A compound long-acting in situ gel injection for treating chronic hepatitis B and its preparation method
  • A compound long-acting in situ gel injection for treating chronic hepatitis B and its preparation method
  • A compound long-acting in situ gel injection for treating chronic hepatitis B and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] Weigh 15 mg of interferon a-2b and dissolve it in sterile water for injection, add 35 mg of zinc hydroxide that has been micronized and sterilized, and vortex and mix for 10 minutes to form 1 g of zinc salt interferon a-2b solution.

[0065] Weigh 2.6g PLGA (weight average molecular weight 10000, intrinsic viscosity 0.10dl / g-0.20dl / g, LA:GA=75:25), 0.9g poloxamer 407 and 18g NMP, mix well, and prepare polymer solution , then add 0.30g of Thymofaxin raw material, ultrasonically dissolve, after complete dissolution, add 1g of zinc salt interferon a-2b solution, heat at constant temperature and stir at high speed (temperature 30°C, 10000rpm) for 5min, to form a drug-loaded sol system containing particles , after electron beam sterilization, the compound long-acting in situ gel injection is obtained. The drug loading amount of interferon was detected by HPLC to be 0.37%, and the encapsulation efficiency was 95%. The drug loading of thymus method was 7.18%, and the encapsul...

Embodiment 2

[0069] Weigh 20 mg of interferon a-2a and dissolve it in sterile water for injection, add 55 mg of zinc chloride after micronization and sterilization, and vortex and mix for 10 minutes to form 1 g of zinc salt interferon a-2a solution.

[0070] Weigh 4.0g PLGA (weight-average molecular weight 15000, intrinsic viscosity 0.10dl / g-0.25dl / g, LA:GA=65:35), 2.0g methylcellulose and 45g ethyl lactate, mix well, and prepare a polymer Then add 0.80g of Thymusfaxin raw material drug, ultrasonically dissolve, add 1g of zinc salt interferon a-2a solution after complete dissolution, heat at constant temperature and stir at high speed (temperature 30°C, 10000rpm) for 7min to form drug-loaded particles The sol system is sterilized by electron beams to obtain the compound long-acting in-situ gel injection. The drug loading amount of interferon was detected by HPLC to be 0.33%, and the encapsulation efficiency was 97%. The drug loading capacity of thymus method was 12.53%, and the encapsulat...

Embodiment 3

[0074] Weigh 25 mg of interferon a-1b and dissolve it in sterile water for injection, add 55 mg of magnesium hydroxide that has been micronized and sterilized, and vortex and mix for 10 minutes to form a solution of 1 g of magnesium salt interferon a-1b.

[0075] Weigh 3.75g PLA (weight-average molecular weight 15000, intrinsic viscosity 0.10dl / g-0.25dl / g), 3.75g Carbomer 934 and 35g acetone, mix well, prepare polymer solution, and then add thymus method new API 0.75g, ultrasonically dissolved, after complete dissolution, add 1g of magnesium salt interferon a-1b solution, heat at constant temperature and high-speed stirring (temperature 30°C, 10000rpm) for 5min, to form a drug-loaded sol system containing particles, sterilized by electron beams, The compound long-acting in situ gel injection is obtained. The drug loading amount of interferon was detected by HPLC to be 0.28%, and the encapsulation efficiency was 98%. The drug loading of thymus method was 12.44%, and the encaps...

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Abstract

The invention relates to the technical field of medicine, and discloses a compound in-situ gel long-acting injection for treating chronic hepatitis and a preparation method thereof. The compound in-situ gel long-acting injection for treating chronic hepatitis, disclosed by the invention, is prepared from 5-24 parts of zinc salt interferon a or magnesium salt interferon a, 150-800 parts of thymalfasin, 1800-12000 parts of in-situ gel materials, and 8000-100000 parts of solvent. The compound in-situ gel long-acting injection disclosed by the invention is prepared from the thymalfasin, the interferons and proper in-situ gel materials. Thus, the administration frequency is reduced; the medicine effect can be stably and lastingly released for a long period of time; the compound in-situ gel long-acting injection is free of obvious toxic and side effects, and high in medicine concentration and encapsulation efficiency; the product quality is superior to the specified standard; the compound in-situ gel long-acting injection is suitable for popularization and application in treatment of the chronic hepatitis.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a compound long-acting in-situ gel injection for treating chronic hepatitis B and a preparation method thereof. Background technique [0002] Hepatitis B virus (HBV) infection is one of the most common viral infections in humans. There are about 300 million chronic HBV infected people in the world, most of whom are in Asia. Chronic HBV carriers account for about 10% to 15% of the Chinese population. Liver cirrhosis and hepatocellular carcinoma account for 2% and 1% of chronic hepatitis B (CHB) patients each year, respectively, and this figure is still on the rise. 90% of patients with hepatitis B can go to the hospital for treatment, and on average about 40% of patients relapse and are admitted to hospital for treatment. [0003] A large number of studies have proved that interferon is currently recognized as an effective drug for the treatment of viral hepatitis at home and ab...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/06A61K38/21A61K38/16A61P31/20
Inventor 颜携国陶安进马亚平袁建成
Owner HYBIO PHARMA
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