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Parathyroid hormone 1-34 nasal spray as well as preparation method and application thereof

A parathyroid hormone and nasal spray technology, applied in the field of biomedicine, can solve pain and other problems, achieve the effects of easy portability, prevention and treatment of osteoporosis, and improvement of compliance

Active Publication Date: 2020-02-07
ACADEMY OF MILITARY MEDICAL SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Since the treatment cycle of PTH (1-34) is generally the shortest 6 months and the longest is no more than 2 years, professional medical personnel are asked to inject daily in the relatively long treatment cycle. There is a greater mental burden, and it will also cause pain at the injection site

Method used

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  • Parathyroid hormone 1-34 nasal spray as well as preparation method and application thereof
  • Parathyroid hormone 1-34 nasal spray as well as preparation method and application thereof
  • Parathyroid hormone 1-34 nasal spray as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example 1

[0062] Preparation Example 1: Preparation of PTH(1-34) nasal spray sample 1

[0063] Prepare 0.4M pH7.4 phosphate buffer: 7.48 mg of sodium dihydrogen phosphate and 73.12 mg of disodium hydrogen phosphate are dissolved in water to prepare 0.4M phosphate buffer.

[0064] Weigh 80 mg of PTH (1-34) and dissolve it in water to prepare a 40 mg / mL mother solution, accurately measure 0.25 mL of PTH (1-34) mother solution, add an appropriate amount of 0.4M phosphate buffer (final concentration is 0.1M), add HS·15 100mg, then add 0.08mg of benzalkonium chloride, finally use water to make up to 1mL, mix thoroughly, put into a bottle and fill with nitrogen. The concentration of PTH(1-34) in the formulation was 10 mg / mL.

preparation example 2

[0065] Preparation Example 2: Preparation of PTH(1-34) nasal spray sample 2

[0066] Prepare 0.4M pH7.4 phosphate buffer: 7.48 mg of sodium dihydrogen phosphate and 73.12 mg of disodium hydrogen phosphate are dissolved in water to prepare 0.4M phosphate buffer.

[0067] Weigh 80mg of PTH(1-34) and dissolve it in water to make 40mg / mL mother liquor, accurately measure 0.25mL of PTH(1-34) mother liquor, add appropriate amount of 0.4M pH7.4 phosphate buffer (final concentration is 0.1M), Add an appropriate amount of hyaluronidase 1000U, then add 0.08 mg of benzalkonium chloride, and finally dilute to 1 mL with water, mix well, put it into a bottle and fill it with nitrogen. The concentration of PTH(1-34) in the formulation was 10 mg / mL.

preparation example 3

[0068] Preparation Example 3: Preparation of PTH(1-34) nasal spray sample 3

[0069] First prepare 0.1M pH7.4 phosphate buffer: 1.87 mg of sodium dihydrogen phosphate and 18.28 mg of disodium hydrogen phosphate.

[0070] Next, prepare 0.4M pH7.4 phosphate buffer: 7.48 mg of sodium dihydrogen phosphate and 73.12 mg of disodium hydrogen phosphate are dissolved in water to prepare 0.4M phosphate buffer.

[0071] Weigh an appropriate amount HS·15, ​​using distilled water to prepare a 400mg / mL concentrated solution.

[0072] Weigh 80 mg of PTH (1-34) and dissolve it in water to prepare a 40 mg / mL mother solution, accurately measure 0.25 mL of PTH (1-34) mother solution, add an appropriate amount of 0.4M phosphate buffer (final concentration is 0.1M), add 0.25 mL 400mg / mL HS·15 concentrated solution, 1000 U of hyaluronidase, and 0.08 mg of benzalkonium chloride were added, and finally the volume was adjusted to 1 mL with water, mixed well, put into a bottle and filled with ni...

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Abstract

The invention relates to a parathyroid hormone 1-34 pharmaceutical composition and a preparation method thereof. Specifically, the invention relates to a parathyroid hormone 1-34 pharmaceutical composition, which contains parathyroid hormone 1-34 as an active ingredient and a pharmaceutically acceptable carrier, and the carrier at least comprises a buffer solution, a penetration enhancer, a stabilizer and a preservative. The parathyroid hormone 1-34 pharmaceutical composition is a parathyroid hormone 1-34 nasal spray or a nasal spray combination. The parathyroid hormone 1-34 nasal spray or thenasal spray combination prepared by the method has the advantages that the first-pass effect is avoided, and the bioavailability is high; the effect taking is fast; the administration is convenient,the patient compliance is strong, the nasal spray is subjected to nasal mucosa absorption in the use process, and can be used for favorably reducing the pain of injection administration of polypeptidedrugs and the like.

Description

technical field [0001] The invention belongs to the field of biomedicine, and relates to a parathyroid hormone 1-34 nasal spray, its preparation method and application. Background technique [0002] Human parathyroid hormone 1-34 (hereinafter referred to as PTH(1-34)) is the amino-terminal 1-34 fragment of a single-chain polypeptide hormone containing 84 amino acid residues secreted by parathyroid chief cells. Fragment 1-34 retains full osteogenic activity. The endogenous 84 amino acid PTH is the main regulator of calcium and phosphorus metabolism in the kidney and bone. The physiological effects of PTH include regulation of bone metabolism, renal tubular reabsorption of calcium and phosphorus, and intestinal calcium absorption. The effects of PTH and PTH(1-34) on bone depend on the systemic drug dose. Once-daily administration of PTH (1-34) has a higher stimulating activity on osteoblasts than osteoclasts, and can stimulate new bone formation on trabecular and cortical b...

Claims

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Application Information

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IPC IPC(8): A61K9/12A61K47/02A61K38/29A61K38/47A61P19/10
CPCA61K9/0043A61K38/29A61K38/47A61K47/02A61P19/10C12Y302/01035A61K2300/00
Inventor 郑爱萍高静王丹张慧杜祎萌苏玉怀刘倩花亚冰
Owner ACADEMY OF MILITARY MEDICAL SCI
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