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A kind of thymosin chitosan microsphere oral pharmaceutical preparation and preparation method thereof

A technology of chitosan microspheres and pharmaceutical preparations, applied in drug combinations, pharmaceutical formulations, antineoplastic drugs, etc., can solve the problems of low bioavailability and waste, and achieve intestinal slow release, high yield, and low cost Effect

Inactive Publication Date: 2011-11-30
铁岭鹿宝堂药业集团有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, the use of tablets will cause a lot of unnecessary waste
[0009] Although some progress has been made in the research of oral dosage forms of thymosin, the low bioavailability is still a big problem to be solved

Method used

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  • A kind of thymosin chitosan microsphere oral pharmaceutical preparation and preparation method thereof
  • A kind of thymosin chitosan microsphere oral pharmaceutical preparation and preparation method thereof
  • A kind of thymosin chitosan microsphere oral pharmaceutical preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Example 1 Extraction of pig thymosin by low pH value method

[0044] Raw material: pig thymus, source: commercially available

[0045] The preparation method is as follows:

[0046] 1) Remove the fat from the pig thymus and wash it with distilled water. Take 90 g of thymus and grind it with distilled water at a ratio of 1:3 (w / v, 90 g / 270 ml).

[0047] 2) Adjust the pH value to 3.5 with 4mol / L HCl.

[0048] 3) Repeated freezing and thawing at -20°C for 3 times, 24 hours each time.

[0049] 4) After thawing at room temperature, centrifuge at 7000rpm at 4°C for 30min, and keep the supernatant.

[0050] 5) Use 4mol / L NaOH to adjust the pH value to 6.8±0.2.

[0051] 6) Heat in a water bath at 80°C for 5 minutes, and immediately cool at -20°C for 12 hours.

[0052] 7) After melting, centrifuge at 7000rpm at 4°C for 30min, and keep the supernatant.

[0053] 8) Filter with four layers of filter paper and then filter with a 0.22 μm filter membrane to sterilize.

[0054] 9)...

Embodiment 2

[0057] Example 2 A new porcine thymosin chitosan microsphere oral pharmaceutical preparation

[0058] The preparation method is as follows:

[0059] 1) Weigh 1g of chitosan fine powder, dissolve it in 2% (w / v) acetic acid solution, dilute to 100ml, make a chitosan acetic acid solution with a concentration of 1% by mass to volume, and fully swell overnight .

[0060] 2) Take NaCl and 35 mg of porcine thymosin obtained according to the method of Example 1 according to Table 1, add it to 3.5 ml of chitosan acetic acid solution, stir until completely dissolved, and use it as the water phase.

[0061] Get 7ml oil phase according to table 1.

[0062] 3) Add the water phase to the oil phase drop by drop (the dropping speed is maintained at 1 drop / second), and stir with a magnetic stirrer at a certain stirring speed for 30 minutes to form a stable W / O emulsion.

[0063] 4) Add 25% glutaraldehyde dropwise to the W / O emulsion, stir with magnetic force, the stirring time is as shown i...

Embodiment 3

[0073] Embodiment 3, a kind of new porcine thymosin chitosan microsphere oral pharmaceutical preparation

[0074] The preparation method is as follows:

[0075] 1) Take by weighing 1g, 2g, 3g chitosan fine powder respectively, dissolve in the acetic acid solution of 2% (v / v), dilute to 100ml, make according to mass volume ratio, concentration is respectively 1%, 2%, 3% chitosan acetic acid solution, fully swell overnight.

[0076] 2) a certain amount of NaCl and a certain amount of pig thymosin obtained by the method of embodiment 1 are added in the 7ml chitosan acetic acid solution, NaCl and thymosin are 1: 1 by weight, the weight of chitosan and thymosin is such as table 2, Stir until completely dissolved, as the water phase.

[0077] Get the liquid paraffin containing 7% Span80 as the oil phase; the volume ratio of the oil phase and the water phase is shown in Table 2.

[0078] 3) The water phase was added dropwise to the oil phase (the dropping speed was maintained at 1...

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Abstract

The invention relates to a porcine thymosin chitosan microsphere oral pharmaceutical preparation and a preparation method thereof. The adopted technical scheme is: a new porcine thymosin chitosan microsphere oral pharmaceutical preparation, which uses chitosan to microencapsulate the porcine thymosin peptide to obtain the porcine thymosin chitosan microsphere oral pharmaceutical preparation. The preparation method is as follows: dissolve chitosan in acetic acid solution to form chitosan acetic acid solution; add inorganic salt and thymosin into chitosan acetic acid solution, stir until completely dissolved, and use it as the water phase; mix the liquid containing emulsifier paraffin as the oil phase; adding the water phase to the oil phase drop by drop, stirring; adding a cross-linking agent drop by drop, stirring, for cross-linking and solidification; centrifuging, washing and drying the obtained product. The invention realizes the slow drug release of thymosin in vivo, and further provides a basis for clinical treatment and auxiliary administration of thymosin.

Description

technical field [0001] The invention belongs to the field of food and pharmacy, and in particular relates to a novel thymosin chitosan microsphere oral pharmaceutical preparation and a preparation method thereof. Background technique [0002] Thymosin is a polypeptide hormone secreted by thymus tissue epithelial cells. In 1966, Golden extracted it from calf thymus, and since then named this biologically active substance thymosin. Its molecular weight is concentrated below 10,000 Da, and it is a complex of several polypeptides. Since thymosin has obvious immunomodulatory effects, tumor adjuvant therapy, and hepatitis adjuvant therapy in clinical applications, thymosin, whether extracted from animals or synthesized by molecular methods, has attracted more and more attention in the field of medicine and health care. . [0003] However, thymosin, as a small biologically active peptide, has a very short half-life (about 30s) in vivo, so the research on its dosage form is becom...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/50A61K38/22A61K47/36A61P37/02A61P35/00A61P1/16
Inventor 胡风庆战荣荣
Owner 铁岭鹿宝堂药业集团有限公司
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