Preparation method of parathyroid hormone (PTH) microneedle

A micro-needle and micro-needle sticker technology, applied in the directions of micro-needles, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc. The effect of swelling capacity

Pending Publication Date: 2021-04-13
SHANGHAI JIAO TONG UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The purpose of the present invention is to provide a method for preparing parathyroid hormone microneedles for the inconvenience caused by frequent injection of PTH, safety and cost.

Method used

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  • Preparation method of parathyroid hormone (PTH) microneedle
  • Preparation method of parathyroid hormone (PTH) microneedle
  • Preparation method of parathyroid hormone (PTH) microneedle

Examples

Experimental program
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Effect test

Embodiment 1

[0049] Embodiment 1, take PVA, CMC-Na and Dextran as the preparation of the PTH microneedle of material

[0050] figure 1 The preparation process of PTH microneedles is disclosed, that is, the polymer solution is poured on the mold with micropore arrays, the polymer solution fills the micropores, the film is removed after freezing and thawing, and the PTH microneedles can be obtained after drying. The preparation process is simple . Specific steps are as follows:

[0051]First prepare PVA aqueous solution (10-30%, w / w, be 15% in the present embodiment) and CMC-Na (3%-10%, w / w sodium carboxymethyl cellulose, be 5% in the present embodiment ) and Dextran (dextran 3%-10%, w / w, 7% in the present embodiment) mixed aqueous solution, according to a certain ratio (PTH, PVA aqueous solution, dextran and sodium carboxymethylcellulose mixed The mass ratio of the three in the aqueous solution is 1 / 6 / 3) Fully mix the PTH and the above two solutions. Then the prepared medicinal solution...

Embodiment 2

[0058] The release kinetics of embodiment 2, PTH microneedle

[0059] In order to investigate the release of PTH, the microneedles prepared above were placed in a Franz diffusion cell device, the release solution was PBS with pH = 7.4, stirred at 100 rpm at 37°C, the top of the microneedles was covered with a plastic film, and samples were taken at regular intervals. ELISA kit was used to measure PTH concentration. After calculation, the cumulative release curve of PTH is obtained, the result is as follows Figure 5 ;Depend on Figure 5 It can be seen that the drug release process is stable.

Embodiment 3

[0060] Example 3, Investigation on the Uniformity of Drug Loading of PTH Microneedles

[0061] The PTH microneedles are loaded with PTH in the polymer solution. In order to verify the uniformity of PTH dispersion in the solution, we investigated the uniformity of the drug loading of the microneedles. Put the three pieces of microneedles into the PBS buffer solution with pH=7.4, place them in 37→water-bath shaker for 3h, shake well after the end, take the leaching solution, and use the PTH-ELISA kit to measure the leaching solution of the microneedles respectively. The result obtained is as Figure 6 ;Depend on Figure 6 It can be seen that the drug loading uniformity is good.

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Abstract

The invention discloses a preparation method of a parathyroid hormone (PTH) microneedle. The preparation method comprises the following steps of: pouring an aqueous solution of a polymer material containing PTH on a mould with a micropore matrix, filling all micropores with the polymer solution, performing freezing and unfreezing circulation on the mould poured with the PTH solution, and finally performing film uncovering and drying. The preparation process is simple; the processing conditions are mild; and furthermore, no organic solvent is contacted in the whole process. The PTH is loaded in a polymer material which can swell after being in contact with body fluid, so that the release of drugs is realized. PTH is used as a macromolecular protein drug; due to poor stability, the administration route is still limited to injection administration; the administration frequency is high; and great inconvenience is caused. The PTH microneedle can reduce the pain caused by injection to a great extent, has huge advantages in the aspects of safety, cost and the like, and can provide better administration path selection for PTH.

Description

technical field [0001] The invention belongs to the technical field of transdermal drug delivery systems, and relates to a method for preparing parathyroid hormone (hereinafter referred to as PTH) microneedles. The method of needle preparation. Background technique [0002] The main function of PTH is to regulate the metabolism of calcium and phosphorus in vertebrates, to promote the increase of blood calcium level and the decrease of blood phosphorus level. At present, PTH is a macromolecular protein drug. Due to its poor stability, the route of administration is still limited to injection. Frequent administration will cause great inconvenience. PTH microneedles can greatly reduce the pain caused by injection, and at the same time show great advantages in many aspects such as safety and cost, and can provide a better route of administration for PTH. [0003] Microneedle refers to a small needle array with a length of less than 1mm. Since it only pierces the stratum corneu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/29A61K9/00A61M37/00A61K47/32A61K47/36A61P3/12A61P3/14
CPCA61K38/29A61K9/0021A61K47/32A61K47/36A61P3/14A61P3/12A61M37/0015A61M2037/0053A61M2037/0046
Inventor 石磊金拓吴飞于如月张宇桐
Owner SHANGHAI JIAO TONG UNIV
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