Intranasal insulin preparation and preparation method thereof

An insulin and preparation technology, which is applied in the preparation of nasal insulin preparations, the preparation of nasal insulin preparations, and the application field of nasal insulin preparations, can solve problems such as failure to meet the requirements of clinical treatment of diabetes mellitus

Inactive Publication Date: 2015-04-22
WUHAN JIANYU BIOPHARML TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These inventions have not been able to meet the requirements of clinical treatment of diabetes

Method used

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  • Intranasal insulin preparation and preparation method thereof
  • Intranasal insulin preparation and preparation method thereof
  • Intranasal insulin preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0115] Human insulin was used to prepare experimental nasal insulin preparations.

[0116] Table 1. A group of nasal insulin preparations for animal experiments consisting of the following ingredients and concentrations in phosphate buffer.

[0117]

[0118] Table 2. Another group of nasal insulin preparations for animal experiments, which consists of the following ingredients and concentrations dissolved in phosphate buffer.

[0119]

[0120] Certain cell-penetrating peptides described in Table 1 and Table 2 are cell-penetrating peptides containing 16 amino acids:

[0121] Arg Trp Phe Lys Ile Gln Met Gln Ile Arg Arg Trp Lys Asn Lys Lys

[0122] A certain cell-penetrating peptide described in Table 1 and Table 2 can also be a cell-penetrating peptide containing 18 amino acids:

[0123] Arg Gln Ile Lys Ile Trp Phe Gln Asn Arg Arg Met Lys Trp Lys Lys Gly Gly

[0124] The preparation method of above-mentioned insulin preparation, its steps are:

[0125] 1. Accurately we...

Embodiment 2

[0134] Preparation of Nasal Insulin Preparation for Experimental Use of Porcine Insulin

[0135] Table 3. A group of nasal insulin preparations for animal experiments, which consist of the following components and concentrations dissolved in medical sterile water.

[0136]

[0137] Table 4. Another group of nasal insulin preparations for animal experiments, which consists of the following ingredients and concentrations dissolved in medical sterile water.

[0138]

[0139] Certain cell-penetrating peptides described in Table 3 and Table 4 are cell-penetrating peptides containing 16 amino acids:

[0140] Arg Trp Phe Lys Ile Gln Met Gln Ile Arg Arg Trp Lys Asn Lys Lys

[0141] Certain cell-penetrating peptides described in Table 3 and Table 4 can also be cell-penetrating peptides containing 14 amino acids:

[0142] Arg Trp Phe Lys Ile Gln Gln Arg Arg Trp Lys Asn Lys Lys

[0143] The preparation method of the insulin preparation described above, its steps are the same as ...

Embodiment 3

[0145] Preparation of Experimental Nasal Insulin Preparations Using Insulin Analogs

[0146] Table 5. A group of nasal insulin preparations for animal experiments, consisting of the following components and concentrations dissolved in phosphate buffer.

[0147]

[0148] Table 6. Another group of nasal insulin preparations for animal experiments, which consists of the following ingredients and concentrations dissolved in medical sterile water.

[0149]

[0150] The insulin analog described in Table 5 and Table 6 is insulin aspart.

[0151] Certain cell-penetrating peptides described in Table 5 and Table 6 are cell-penetrating peptides containing 18 amino acids:

[0152] Arg Trp Phe Lys Ile Gln Met Gln Ile Arg Arg Trp Lys Asn Lys Lys Arg Arg

[0153] A certain cell-penetrating peptide described in Table 5 and Table 6 can also be a cell-penetrating peptide containing 14 amino acids:

[0154] Arg Gln Ile Lys Ile Trp GlnArg Arg Met Lys Trp Lys Lys

[0155] The preparation...

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Abstract

The invention discloses an intranasal insulin preparation and a preparation method thereof. The intranasal insulin preparation is commonly formed by cell-penetrating peptide dissolved in a liquid-phase carrier and insulin. The cell-penetrating peptide is polypeptide molecule containing specific sequences of amino acids, so that the insulin can be promoted to enter into a human body through a mucosa of a nasal cavity, and the plasma glucose level is regulated. The preparation method of the preparation comprises the main preparing steps of: dissolving the therapeutic dose of insulin by hydrochloric acid; diluting to be required concentration by the liquid-phase carrier; regulating pH to be neutral by sodium hydroxide; mixing with a specific volume of cell-penetrating peptide; filtering and degerming; and storing at low temperature. The preparation can be applied to the surface of the mucosa of the nasal cavity of a person or an animal through an intranasal feeder. Compared with a subcutaneous insulin infusion preparation with the same dosage, according to the intranasal insulin preparation, the relative drug absorption rate is about 80 percent, and the bioavailability reaches more than 60 percent. The cell-penetrating peptide and the insulin have no stimulation on the mucosa of the nasal cavity, the amino acids can be degraded in vivo, the half-life period is short, and the safety is high.

Description

technical field [0001] The invention relates to the technical field of non-injection insulin. Specifically, it relates to a nasal insulin preparation; it also relates to a preparation method of the nasal insulin preparation; and it also relates to the application of the nasal insulin preparation. Background technique [0002] Physiology and pharmacology of insulin: Insulin is a protein hormone secreted by pancreatic beta cells containing 51 amino acids, with a molecular weight of 5808 Daltons, involved in regulating glucose metabolism and controlling blood sugar levels. Absolute or relative insufficiency of insulin in the body can lead to diabetes. The main clinical manifestations are "three excesses and one deficiency" (polydipsia, polyuria, polyphagia, and weight loss), urine sugar, hyperglycemia, and various complications. There are currently about 60 million diabetic patients in China, many of whom need to use exogenous insulin to regulate blood sugar levels for life (s...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/28A61K47/42A61P3/10
Inventor 李健学李志刚余丽莉
Owner WUHAN JIANYU BIOPHARML TECH
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