CN1176718C - Thymosin alpha-1 microball prepn and its prepn process - Google Patents
Thymosin alpha-1 microball prepn and its prepn process Download PDFInfo
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- CN1176718C CN1176718C CNB021361819A CN02136181A CN1176718C CN 1176718 C CN1176718 C CN 1176718C CN B021361819 A CNB021361819 A CN B021361819A CN 02136181 A CN02136181 A CN 02136181A CN 1176718 C CN1176718 C CN 1176718C
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- thymosin
- talpha1
- microball
- microsphere
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Abstract
The present invention relates to a novel preparation of thymosin alpha1(Talpha1)-a Talpha1 microballoon preparation and a preparation method thereof, which relates to the technical field of medicine. Talpha1 is a polypeptide with immune functions and is mainly used for treating viral hepatitis. The Talpha1 preparation used in clinic at present is sterile powder for injection and has the defects of single administration route, hypodermic injection and high condition requirement for preservation and operation. In the method, Talpha1 is prepared into a protein microballoon preparation, the Talpha1 microballoon has the advantages of easy preservation and easy use, and the protein microballoon preparation not only can effectively ensure the bioactivity of Talpha1, but also can be applied to the wound surface, taken orally, taken by the cavity channels, etc.
Description
Technical field:
The present invention relates to medical technical field, is a kind of novel form-microball preparation of thymosin and preparation method thereof.
Background technology:
Thymosin (thymosin α 1, be called for short T α 1) be a kind of polypeptide with immunologic function, clinically viral hepatitis that are used for the treatment of more, its aminoacid sequence is-Ser-Asp-Ala-Ala-Val-Asp-Thr-Ser-Ser-Glu-Ile-Thr-Thr-Lys-Asp-Leu-Lys-Glu-Lys-Lys-Glu-Val-Val-Glu-Glu-Ala-Glu-Asn-[Goldstein A L, Low T L, McAdoo M, McClure J, Thurman G B, Rossio J, Lai C Y, Chang D, Wang S S, HarveyC, Ramel A H, Meienhofer.J.Thymosin alpha 1:isolation and sequence analysis ofan immunological active thymic peptide.Proc Natl Acad Sci USA, 1977,74 (2): 725～729]].T α 1 preparation has only a kind of dosage form-----powder ampoule agent for injection at present, and route of administration is single, is subcutaneous injection, and condition is had relatively high expectations in preservation and use.
Summary of the invention:
The present invention is prepared into T α 1 protein microsphere novel form with T α 1, and protein microsphere is compared with the egg albumen powder injection, can improve protein stability, effectively guarantees protein active, prolongs biological half-life, and has the slow release effect.T α 1 is made microsphere, preserve easily, easy to use, not only can effectively guarantee the biological activity of T α 1, can also carry out such as number of ways administrations such as wound surface, oral, tracts.As available T α 1 microsphere of the treatment of burn wound is directly spread on wound surface, also can treat viral hepatitis, malignant tumor, immune deficiency disorder and wound, war wound etc. by multiple route of administration such as wound surface, oral, tracts, this has just opened up T α 1 new route of administration and indication for T α 1.
T α 1 method for preparing microsphere is as follows:
One, reagent and material
S212-40 constant speed blender Shanghai Shen Sheng Bioisystech Co., Ltd
It is 3000 Shandong Prov. Medical Apparatus ﹠ Instrument Research Inst that the Acetic acid, hydroxy-, bimol. cyclic ester lactide gathers polymer (PLGA 25: 75) molecular weight
Polyvinyl alcohol (PVA) Shanghai chemical reagents corporation
Tween80 Shanghai chemical reagents corporation
Span80 Shanghai chemical reagents corporation
Two, operating procedure
1. preparation Emulsion: with Tween80 or Span80 is emulsifying agent, a certain amount of T α 1 is emulsifiable in 5～20% the PLGA dichloromethane solution, and the control preparation temperature is 15 ± 2 ℃;
2. prepare T α 1 microsphere: under agitation the Emulsion for preparing is slowly splashed in the aqueous solution of 0.5～10%PVA, mixing speed is 300～1000rpm; Stir after 10 minutes, an amount of distilled water of impouring in this system continues to stir again, organic solvent is volatilized form the pastille microsphere.Centrifugal collection microsphere, distilled water repeatedly washs, and lyophilization promptly gets T α 1 microsphere.
T α 1 microsphere features smooth surface, the rounding that make, size is more even, and particle diameter is between 50～200 μ m, has good stability, and envelop rate is about 20%.Pharmacodynamic study shows that this T α 1 microsphere can effectively promote to scald or the healing of wound and wound surface.
The specific embodiment:
Embodiment 1: preparation T α 1 microsphere
With Span80 is emulsifying agent, and 3～5mg T α 1 is emulsifiable in the dichloromethane solution that 10ml contains 10%PLGA, and the control preparation temperature is 15 ± 2 ℃, T α 1 Emulsion; Under agitation T α 1 Emulsion for preparing is slowly splashed in the aqueous solution of 2%PVA, mixing speed is 800rpm; Stir after 10 minutes, impouring 500ml distilled water in this system continues to stir again, organic solvent is volatilized form the pastille microsphere.Centrifugal collection microsphere, with 60ml distillation washing 3 times, lyophilization obtains the 2.5g microsphere.The particle diameter of microsphere is 75～100 μ m, and envelop rate is 20.8%.
Zoopery: select for use Xiao Bai pig about 15kg as laboratory animal, scalded 10 seconds for 75 ± 2 ℃ with constant temperature permanent hair styling instrument the anesthesia back, set up the dark II ° of scalding model that diameter is 2.5cm at the pig epidermis, give T α 1 microsphere in wound surface after the debridement, the dosage of T α 1 is respectively 80 μ g and 160 μ g, repaste is smeared anti-infective SD-Ag frost, gauze wrapping, and only to give wound surface that the SD-Ag frost gives T α 1 microsphere in contrast.Experimental result is: used the wound surface of T α 1 microsphere to rise at the 9th day and just begun healing, heal substantially to the 19th day wound surface, and also significantly do not healed for the wound surface of T α 1 microsphere up to the 19th day.Illustrate that it is effective to treatment burn wound that T α 1 microsphere spreads on wound surface.
Claims (3)
1, the preparation method of thymosin microball preparation may further comprise the steps:
(1) preparation thymosin Emulsion:
Emulsifying agent Tween80 or Span80 and 3～5mg thymosin are emulsifiable in the dichloromethane solution that 10ml contains 5～20%PLGA, and temperature is 15 ± 2 ℃, thymosin Emulsion;
(2) preparation thymosin microball preparation:
Under stirring condition the Emulsion for preparing is slowly splashed in the aqueous solution that contains 0.5～10%PVA, stirred 10 minutes, speed is 300～1000rpm, and impouring 500ml distilled water in this system continues to stir again, organic solvent is volatilized form the pastille microsphere.
2, the prepared thymosin microball preparation of the described preparation method of claim 1.
3, the application of the described thymosin microball preparation of claim 2 in preparation treatment viral hepatitis, malignant tumor, immune deficiency disorder and wound, war wound, burn medicine.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB021361819A CN1176718C (en) | 2002-07-25 | 2002-07-25 | Thymosin alpha-1 microball prepn and its prepn process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB021361819A CN1176718C (en) | 2002-07-25 | 2002-07-25 | Thymosin alpha-1 microball prepn and its prepn process |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1398637A CN1398637A (en) | 2003-02-26 |
| CN1176718C true CN1176718C (en) | 2004-11-24 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB021361819A Expired - Fee Related CN1176718C (en) | 2002-07-25 | 2002-07-25 | Thymosin alpha-1 microball prepn and its prepn process |
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| Country | Link |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1319593C (en) * | 2005-02-01 | 2007-06-06 | 浙江大学 | Oral enteric-coated microsphere of Thymosin and preparation thereof |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101669905B (en) * | 2009-09-08 | 2011-06-01 | 中国人民解放军第二军医大学 | Thymosin alpha1 injection-type subcutaneous implant |
| CN102106828B (en) * | 2011-02-25 | 2013-04-24 | 深圳翰宇药业股份有限公司 | Thymalfasin sustained-release microsphere preparation and preparation method thereof |
-
2002
- 2002-07-25 CN CNB021361819A patent/CN1176718C/en not_active Expired - Fee Related
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1319593C (en) * | 2005-02-01 | 2007-06-06 | 浙江大学 | Oral enteric-coated microsphere of Thymosin and preparation thereof |
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| Publication number | Publication date |
|---|---|
| CN1398637A (en) | 2003-02-26 |
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