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Oral solid lipid nano-particle preparation of calcitonin and preparation method thereof

A technology of solid lipid nanometer and lipid nanoparticle is applied in the field of medicines for regulating blood calcium and their preparation, and can solve the problems of non-absorption and the like

Active Publication Date: 2011-10-12
上海宝龙药业股份有限公司
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  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, based on the fact that calcitonin is easily degraded in the gastrointestinal tract, this oral preparation can only be sent back to the gastrointestinal tract for local treatment, and cannot be absorbed into the circulatory system to play a clinical role in regulating blood calcium concentration.
Before this patent was declared, there was no oral calcitonin preparation that could be used for clinical regulation of blood calcium treatment in China, which was listed or disclosed to enter clinical research. For pharmaceutical work, this is still a major challenge for the pharmaceutical industry

Method used

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  • Oral solid lipid nano-particle preparation of calcitonin and preparation method thereof
  • Oral solid lipid nano-particle preparation of calcitonin and preparation method thereof
  • Oral solid lipid nano-particle preparation of calcitonin and preparation method thereof

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Experimental program
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Effect test

Embodiment 25

[0080] Take 450 μl of the drug stock solution, 24ml of ethanol, and a total of 400mg of the carrier (monoside ester / stearic acid / oleic acid is 14 / 5 / 1), heat and dissolve at 60°C, pour into the aqueous phase medium (distilled water / 0.01 % sodium cholate), stirring for 5 to 10 minutes. Pre-freeze the nanoparticle suspension in a low-temperature refrigerator at -70°C for 12 hours. After thawing, centrifuge at 25,000×g for 30 minutes, and the precipitate is the collected nanoparticles.

[0081] The determination methods of indirect and direct encapsulation efficiency are the same as in Example 1, except that in the process of direct encapsulation efficiency determination, the melting solvent is PBS solution (pH 1.2) containing 1.0% poloxamer 188. It was found that the direct encapsulation efficiency of the nanoparticle sample was 87.1%.

[0082] Freeze-drying: the nanoparticles obtained by centrifugation were transferred to a freeze-drying container with 0.01% sodium cholate, pre...

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Abstract

The invention discloses an oral solid lipid nano-particle preparation of calcitonin, which is a particle suspension containing 0.01 percent sodium cholate in a water phase, wherein lipid nano-particles comprise an active medicament component and a lipid material forming the particles. Simultaneously, the preparation method comprises the following steps: dissolving or melting a medicament and a carrier in an organic solvent phase together; quickly infusing the organic phase into the water phase stirred at a low temperature to form a lipid nano-particle dispersion liquid; standing, melting and performing high-speed centrifugal separation on the lipid nano-particle dispersion liquid to obtain a nano-particle deposition; and dispersing the deposition to obtain a target oral calcitonin lipid nano-particle dispersion liquid. The oral solid lipid nano-particle preparation uses the lipid material as a structural matrix material, and the oral solid lipid nano-particle preparation of the calcitonin is prepared through reasonable component proportion to prevent the medicament from leaking in an aqueous medium and release the medicament in modes of in vivo esterase degradation and the like, thus the aim that the medicament contained in a nano-carrier can adjust the serum calcium concentration more reasonably and more safely through biomembranes of mammals is achieved.

Description

technical field [0001] The invention relates to a medicine capable of regulating blood calcium and a preparation method thereof, in particular to a calcitonin preparation and a preparation method thereof. Background technique [0002] Calcitonin is a hormone secreted by thyroid parafollicular cells. It is a polypeptide composed of 32 amino acids, with 1 to 7 disulfide chains, and a prolylamino group at the carboxyl terminal. Calcitonin for clinical application can come from salmon, (salmon calcitonin, Salcalcitonin), pig (porcine calcitonin), eel (elcatonin, Elcatonin) and the like. The source of calcitonin is different, the sequence of amino acids in its structure is also different, and the activity is also different. The activity of salmon calcitonin is much higher than those of pigs, cattle, sheep and humans. Currently, human and salmon calcitonin can be synthesized for clinical use. [0003] The role of calcitonin is mainly to reduce blood calcium through the regulatio...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/127A61K9/10A61K38/23A61K47/28A61P5/22
Inventor 郦小平康小玉
Owner 上海宝龙药业股份有限公司
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