Thymalfasin in-situ gel preparation and preparation method thereof

A new technology of in situ gel and thymus method, applied in the directions of antiviral agents, pharmaceutical formulations, aerosol delivery, etc., can solve the problems of peak and valley phenomenon of blood drug concentration, short drug action time, adverse reactions, etc., to avoid The peak and trough of blood drug concentration, the clear structure of skin and connective tissue, the effect of alleviating pain

Active Publication Date: 2013-06-19
HYBIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, Thymofasin only has a common injection form, and the peak and valley phenomenon of blood drug concentration occurs after each injection, which can easily cause adverse reactions in the body, and the drug action time is short; in addition, it is recommended to inject twice a week in clinical application , continuous administration for 6 months, the long-term injection has brought great pain and inconvenience to the patient, resulting in poor compliance of the patient, based on these two problems existing in Thymusfaxin ordinary injection, a long-acting long-acting injection is urgently needed clinically And the new preparation of thymus method with sustained release effect can reduce the pain of patients and improve the compliance of patients

Method used

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  • Thymalfasin in-situ gel preparation and preparation method thereof
  • Thymalfasin in-situ gel preparation and preparation method thereof
  • Thymalfasin in-situ gel preparation and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0048] Example 1 Preparation of new in situ gel preparation of thymus method

[0049] Weigh 25g of PLGA (Mn=10000, LA:GA=75:25), add it into 100mL NMP solvent, mix well, and prepare a polymer solution, then add 3.5g of thymus method new raw material, heat and stir at constant temperature (temperature 30℃ , 100rpm) for 20 minutes to form a translucent drug-loaded sol system, which is sterilized by γ-ray radiation.

Embodiment 2

[0050] Example 2 Preparation of new in situ gel preparation of thymus method

[0051] Weigh 30g of PLGA (Mn=15000, LA:GA=50:50), add it to 100mL NMP solvent, mix well, and prepare a polymer solution, then add 3.5g of thymus method new raw material, heat and stir at constant temperature (temperature 30℃ , 120rpm) for 20 minutes to form a translucent drug-loaded sol system, which is sterilized by γ-ray radiation.

Embodiment 3

[0052] Example 3 Preparation of new in situ gel preparation of thymus method

[0053] Weigh 25g PLGA (Mn=20000, LA:GA=50:50) and 4g poloxamer 407, dissolve in 110mL NMP, mix well, and prepare a polymer solution, then add 3g thymofasin, heat and stir at constant temperature (Temperature 30°C, 100rpm) for 25 minutes to form a translucent drug-loaded sol system, which is sterilized by γ-ray radiation.

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Abstract

The invention relates to the field of pharmaceutic preparations, and in particular relates to a thymalfasin in-situ gel preparation and a preparation method thereof. The thymalfasin in-situ gel preparation is composed of thymalfasin, an in-situ gel material and an organic solvent, wherein the mass-volume ratio of the thymalfasin, the in-situ gel material and the organic solvent based on g / g / mL is (2-4.5):(15-35):(100-150). The thymalfasin in-situ gel preparation provided by the invention has sustained release function, can be used for preventing the peak valley phenomenon of blood concentration, reducing the admission time as the medicament action time is long, greatly easing the pain of patients and improving the compliance of the patients and has no irritation for the skin and connective tissues. The method for preparing the thymalfasin in-situ gel preparation is simple, high in medicament loading capacity and low in cost, and is conductive to large-scale production.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a new thymus in situ gel preparation and a preparation method thereof. Background technique [0002] Viral hepatitis B, referred to as hepatitis B, is a disease caused by the hepatitis B virus infection of the body, divided into two types: acute hepatitis B and chronic hepatitis B. Among them, chronic hepatitis B refers to a type of hepatitis B that is clinically manifested as chronic hepatitis when the virus test is positive, the course of the disease exceeds half a year, or the date of onset is unclear. The clinical manifestations are fatigue, fear of eating, nausea, abdominal distension, and pain in the liver area. Symptoms include hepatomegaly, moderate hardness, mild tenderness, chronic liver disease, facial features, spider moles, liver palms, splenomegaly, liver function abnormalities or persistent abnormalities, eventually leading to liver failure , liver cirrh...

Claims

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Application Information

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IPC IPC(8): A61K9/06A61K38/22A61P31/20A61P1/16
Inventor 颜携国陶安进马亚平袁建成
Owner HYBIO PHARMA
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