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Preparation technique of protein medicine microsphere carrier with small grain size

A protein and technology technology, which is applied in the field of preparation of protein drug microsphere carrier, can solve the problems of uneven particle size distribution, loss of protein activity, inconvenience of treatment, etc., and achieve the effect of uniform microsphere size, ensuring effectiveness and ensuring consistency

Inactive Publication Date: 2004-02-25
DALIAN INST OF CHEM PHYSICS CHINESE ACAD OF SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But so far, injection is still the only route of drug administration for clinical application of this type of drug, and the resulting problems are: ①The half-life of the drug in the blood is short, requiring frequent injections for a long time; ②The treatment is inconvenient and the patient's treatment compliance is poor; ③Injection dosage form The production, storage and transportation conditions are harsh and the cost is high; ④The "separation" of medicine and medicine will limit the market share of injection-type drugs; popular
However, during the preparation process, a large amount of organic solvent needs to be added to the system, high-speed stirring (200-1000rpm) or ultrasonic emulsification is required, the volatile solvent needs to be heated, the oil phase adsorbed on the surface of the microspheres needs to be fully washed, and the high shear force generated by stirring Not conducive to the maintenance of activity of embedded biological substances
These factors lead to the loss of protein activity and the reduction of encapsulation efficiency, which limits the practical application of the process, and the particle size of the microspheres prepared by this method is generally 150-300 μm, with a wide particle size distribution, which cannot meet the requirements of oral absorption.
The spray drying method can realize the large-scale preparation of microspheres. With reference to this method, 10 μm BSA-loaded chitosan / alginate microspheres were obtained. The particle size of the microspheres can be less than 10 μm, but there are uneven particle size distribution and convective heating The high temperature and shearing of the gas cause the loss of protein activity, serious wall adhesion and large loss of dead space volume, etc.

Method used

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  • Preparation technique of protein medicine microsphere carrier with small grain size
  • Preparation technique of protein medicine microsphere carrier with small grain size
  • Preparation technique of protein medicine microsphere carrier with small grain size

Examples

Experimental program
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Effect test

example 1

[0030] Raw material composition: 20mg / mLHb, 3% (wt / v) sodium alginate, 0.5% (v / v) Tween 20;

[0031] Gel bath composition: 2% (wt / v) CaCl2, 0.5% (wt / v) polyvinyl alcohol, 2% (v / v) Tween 20, 20% (v / v) propanol;

[0032] Output voltage: 250V;

[0033] Pulse frequency: 140Hz;

[0034] Pinhole inner diameter: 300μm;

[0035] Raw material liquid output speed: 10mL / hr;

[0036] The pressure is 0.15Mpa.

[0037] Under the above conditions, H-b-loaded microspheres with a particle size of ≤10 μm can be prepared, among which 3-7 μm microspheres account for more than 80%, and the size of the microspheres is uniform and the shape is good. The encapsulation efficiency of Hb in microspheres was 64%.

example 2

[0039] Raw material composition: 10mg / mLHb, 3% (wt / v) sodium alginate, 1% (v / v) Tween 80;

[0040] Gel bath composition: 2% (wt / v) BaCl 2 , 0.5% (wt / v) polyvinyl alcohol, 2% (v / v) Tween 80, 30% (v / v) propanol;

[0041] Output voltage: 275V;

[0042] Pulse frequency: 140Hz;

[0043] Pinhole inner diameter: 300μm;

[0044] Raw material liquid output speed: 10mL / hr;

[0045] The pressure is 0.05Mpa.

[0046] Under the above conditions, the average particle size of the prepared Hb-loaded microspheres was 6.9 μm, and the microspheres were uniform in size and good in shape. The encapsulation efficiency of Hb in microspheres was 67%.

[0047] According to the foregoing, it can be seen that the effect of the invention is:

[0048] 1. The present invention adopts the electrostatic liquid drop method microsphere preparation technology, which can prepare protein microsphere carriers with a microsphere particle size ≤ 10 μm and a narrow particle size distribution, such as figure 1 ,...

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Abstract

The preparation technique of protein medicine microsphere carrier with small grain size includes the following processes: under the condition of a certain pressure applying electric field and pulse frequency between pinhole and gel bath, making the mixed soliquoid of sodium alginate and hemoglobin pass through pinhole and drop into the gel bath containing divalent cation, and solidifying so as toobtain the alginate microphere for carrying protein. The main component of raw material liquor includes sodium alginate, Hb, non-ionic surfactant, and the main component of gel bath includes CaCl2 orBaCl2, polyvinyl alcohol, propanol and non-ionic surfactant.

Description

technical field [0001] The invention relates to a preparation technology of a protein drug microsphere carrier, in particular to a preparation technology of a protein drug microsphere carrier with a particle diameter of less than 10 μm. Background technique [0002] Due to their strong pharmacological effects and low toxicity and side effects, protein and polypeptide drugs (such as insulin, interferon, interleukin, etc.) have received much attention in the treatment of major diseases such as diabetes, hepatitis, and cancer. But so far, injection is still the only route of drug administration for clinical application of this type of drug, and the resulting problems are: ①The half-life of the drug in the blood is short, requiring frequent injections for a long time; ②The treatment is inconvenient and the patient's treatment compliance is poor; ③Injection dosage form The production, storage and transportation conditions are harsh and the cost is high; ④The "separation" of medic...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K38/16A61K47/12
Inventor 马小军薛伟明刘袖洞任吉伦
Owner DALIAN INST OF CHEM PHYSICS CHINESE ACAD OF SCI
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