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Alkaline phosphatase micro-/nano-particle and preparation method thereof

A phosphatase nano- and micro-particle technology, which is applied in the fields of pharmaceutical formulations, medical preparations containing active ingredients, metabolic diseases, etc., can solve the problems of patients' pain, cumbersome operation, etc., and achieve good dispersion performance and small particle size.

Active Publication Date: 2012-10-24
常熟紫金知识产权服务有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, AKP produces disease treatment effects mainly through injection, but the injection method is not only cumbersome to operate, but also brings a certain degree of pain to patients, especially for patients who need long-term medication.

Method used

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  • Alkaline phosphatase micro-/nano-particle and preparation method thereof
  • Alkaline phosphatase micro-/nano-particle and preparation method thereof
  • Alkaline phosphatase micro-/nano-particle and preparation method thereof

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preparation example Construction

[0030] The present invention also discloses a preparation method for preparing the above-mentioned alkaline phosphatase nanoparticles, such as figure 1 shown, including the following steps,

[0031] S1: Mix the stabilizer and dispersant in a certain proportion, stir and dissolve, and prepare a mixed solution;

[0032] S2: adding a certain proportion of alkaline phosphatase to the mixed solution prepared in step S1, stirring and dissolving, fully mixing, and preparing a nano-spray drying preparation solution;

[0033] S3: Spray-dry the nano-spray drying preparatory solution obtained in step S2 by using nano-spray drying technology.

[0034] Preferably, in step S1, the mass ratio of the stabilizer to the dispersant is 1:100-100:1.

[0035] Preferably, in step S2, the mass ratio of the stabilizer, dispersant and alkaline phosphatase is 1:100-100:1.

[0036] Preferably, in step S2, the concentration of the obtained nano-spray drying preparation solution is 1×10 −5 ~ 100 g / mL.

...

Embodiment 1

[0040] Weigh 0.60 g of β-cyclodextrin and 0.10 g of alkaline phosphatase into 100 mL of ultrapure water, stir in an ice bath until completely dissolved, and filter through a filter membrane with a pore size of 0.45 μm to obtain a nano spray drying preparation solution. Then the obtained nano-spray drying preparation solution is subjected to nano-spray drying, and the process parameters of nano-spray drying are set as follows: the inlet temperature of the spray drying cylinder is 100°C, the spray rate is 100%, the feed rate mode is 1, and the gas flow rate is 130L / min, spray cap aperture 4μm.

[0041] The detection and characterization results of the alkaline phosphatase nanoparticle produced by the above process: the yield of alkaline phosphatase nanoparticle is 75%; the enzyme activity retention rate is 65%; 90% of the particle size distribution is 0.40-3.50 μm; scanning electron microscope observation shows that the average particle size distribution is about 2 μm, and the ...

Embodiment 2

[0043] Weigh 0.33g of β-cyclodextrin, 0.27g of L-leucine and 0.10g of alkaline phosphatase into 100mL of ultrapure water, stir in an ice bath until completely dissolved, and filter through a filter membrane with a pore size of 0.45μm to obtain a nano-spray drying preparation solution. Then the obtained nano-spray drying preparation solution is subjected to nano-spray drying, and the process parameters of nano-spray drying are set as follows: the inlet temperature of the spray drying cylinder is 100°C, the spray rate is 100%, the feed rate mode is 1, and the gas flow rate is 130L / min, spray cap aperture 4μm.

[0044] The detection and characterization results of the alkaline phosphatase nanoparticles prepared by the above process: the yield rate is 68%; the enzyme activity retention rate is 95%; The particle size distribution is about 1 μm, and the shape is smooth and wrinkled spheres; the in vitro lung deposition efficiency is 86%.

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Abstract

The invention discloses an alkaline phosphatase micro- / nano-particle which comprises alkaline phosphatase as drug and adjuvants at weight ratio of 1:100-100:1. The adjuvants comprise stabilizer and dispersant at weight ratio of 1:100-100:1. The micro- / nano-particle has yield of 20-98%, average particle size of 0.1-10 micrometer, bio-active drug activity retention rate of 50-100%, and in-vitro lung deposition efficiency of 10-98%. The micro- / nano-particle with small and uniform particle size and good dispersivity can be delivered into lung in multiple lung inhalation preparation forms, can effectively maintain drug bioactivity, and has excellent lung inhalation efficiency, no gastrointestinal tract degradation effect and no liver first pass effect during application course, and good patient compliance due to non-invasive treatment manner.

Description

technical field [0001] The invention relates to the field of medicine preparation, in particular to a nanoparticle of an alkaline phosphatase pharmaceutical composition and a preparation method of the nanoparticle. Background technique [0002] Alkaline phosphatase (alkaline phosphatase, hereinafter referred to as AKP) is a homodimeric protein, which can hydrolyze various natural and synthetic phosphate monoester compound substrates in an alkaline environment, including nucleic acids, proteins, alkaloids, etc. The phosphate group on the substrate molecule is removed to generate phosphate ions and free hydroxyl groups. It is generally believed that AKP is closely related to bone calcification. AKP in osteoblasts produces phosphoric acid, which is deposited in bone with calcium. Although clinically elevated AKP is more common, there are still a large number of diseases including severe chronic nephritis, celiac disease, anemia, cachexia, hypothyroidism or hypothyroidism in ch...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K9/12A61K9/72A61K38/46A61P3/00
Inventor 李浩莹郭静
Owner 常熟紫金知识产权服务有限公司
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