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Soluble microneedle patch containing purified protein derivatives of tuberculin, and preparation method of soluble microneedle patch

A technology for tuberculin and protein derivatives, which is applied in the field of soluble microneedle patches loaded with pure protein derivatives of tuberculin and its preparation, which can solve the problem of high dissolution rate, poor rigidity, and high dissolution rate. Slowness and other problems, to achieve good skin puncture strength, conducive to popularization and use, and good compliance

Active Publication Date: 2018-01-12
广州新济生物医药研究院有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, most of the current soluble microneedles have disadvantages such as poor rigidity and low skin penetration rate, making it difficult to effectively achieve intradermal drug delivery; and the existing soluble microneedles have slow swelling and dissolving speeds in the skin, resulting in drug release. Slow, it can still be used for long-acting therapeutic agents, but for skin test agents such as tuberculin drugs, it needs to be used quickly, and the reaction of the skin should be observed, so that the dissolution rate of the microneedle into the skin and the effect of the drug High release speed requirements, the existing dissolvable microneedles are difficult to meet the requirements

Method used

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  • Soluble microneedle patch containing purified protein derivatives of tuberculin, and preparation method of soluble microneedle patch
  • Soluble microneedle patch containing purified protein derivatives of tuberculin, and preparation method of soluble microneedle patch
  • Soluble microneedle patch containing purified protein derivatives of tuberculin, and preparation method of soluble microneedle patch

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] The soluble microneedle patch loaded with tuberculin pure protein derivative provided in this example was prepared by the following method:

[0055] (1) Preparation of needle solution: Accurately weigh 0.25 g of sodium hyaluronate with an average molecular weight of 8,000, 0.3 g of hydroxyethyl starch with an average molecular weight of 40,000, 0.1 g of polyvinylpyrrolidone with an average molecular weight of 12,000, 0.1 g of glucosamine, Amino acid 0.03g, sodium dihydrogen phosphate 10mg, 300ug / ml tuberculin pure protein derivative water solution for injection 2.0ml, mix, dissolve and swell.

[0056] (2) Preparation of flexible base layer solution: Accurately weigh 8.0 g of hydroxypropyl methylcellulose (the viscosity of 10% aqueous solution is 5 mPa.s), 15.0 g of hydroxypropyl cellulose (the viscosity of 10% aqueous solution is 300 mPa.s), .s), 0.30g of sodium hyaluronate with an average molecular weight of 4 million, 80g of water for injection, vortex, mix evenly, an...

Embodiment 2

[0061] The soluble microneedle patch loaded with tuberculin pure protein derivative provided in this example was prepared by the following method:

[0062] (1) Preparation of needle solution: Accurately weigh 0.3 g of sodium hyaluronate with an average molecular weight of 8,000, 0.15 g of hydroxyethyl starch with an average molecular weight of 20,000, 0.15 g of polyvinylpyrrolidone with an average molecular weight of 30,000, glutamic acid 0.15 g, 8 mg of sodium dihydrogen phosphate, 2.0 ml of aqueous solution of water for injection of tuberculin pure protein derivatives at 600 ug / ml, mix, dissolve and swell.

[0063] (2) Preparation of flexible base layer solution: Accurately weigh 20.0 g of hydroxypropyl methylcellulose (the viscosity of a 10 wt % aqueous solution is 5 mPa.s), 1.0 g of sodium hyaluronate with an average molecular weight of 2 million, and water for injection 80g, vortex, mix well and dissolve.

[0064] (3) Preparation of soluble microneedle patch loaded with ...

Embodiment 3

[0074] For the soluble microneedles prepared in Example 1-2 and Comparative Example 1, compare the hardness, puncture property and solubility of the microneedles, and the specific evaluation and comparison methods are as follows:

[0075] (1) Microneedle hardness test

[0076] The prepared microneedle patch was cut into a 10×10 array patch (100 needles), and the needle tip was placed on the horizontal test platform of the TMS-PRO food property analyzer of the FTC company in the United States, and passed through the P / 6 flat-head stainless steel Cylindrical probe, at a stable speed of 0.1mm / sec, excitation force 0.05N, apply axial vertical force, set measurement parameters, probe descending speed 10mm / min, probe compression speed, probe lifting speed, compression 90%, acquisition Rate 200pps / s. The analyzer records the mechanical changes during the probe contact with the needle tip until reaching the preset compression amount (microneedle height 400 μm). After the test is com...

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Abstract

The invention relates to a soluble microneedle patch containing purified protein derivatives of tuberculin, and a preparation method of the soluble microneedle patch. The soluble microneedle patch comprises a substrate and a needle body, wherein the substrate is prepared from a first polymer material; the needle body is prepared from the purified protein derivatives of tuberculin and a needle bodyshaping material; the weight of the purified protein derivatives of tuberculin accounts for 0.04-0.10% of the total weight of the needle body; the needle body shaping material is prepared from secondpolymer materials and small molecule materials, wherein the second polymer materials are at least one selected from hyaluronic acid or sodium salt thereof, hydroxyethyl starch, polyvinylpyrrolidone and polyethylene glycol, and the small molecule materials are at least one selected from water-soluble small molecule weight sugar, slightly acidic water-soluble amino acids and slightly acidic water-soluble salts; the mass ratio of the second polymer materials to the small molecule materials is equal to 3 to (8 to 1). The soluble microneedle patch has good puncture strength and rapid dissolution velocity in vivo.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a soluble microneedle patch loaded with tuberculin pure protein derivatives and a preparation method thereof. Background technique [0002] According to the 2009 World Health Organization Global Tuberculosis Survey Report, the number of new combined disease patients in the world reached 9.27 million every year. As one of the countries with a high burden of tuberculosis, China has 200,000 deaths due to tuberculosis every year. The prevention and control situation is still very serious. The early diagnosis of tuberculosis is the key link and factor to control the spread of tuberculosis. Therefore, the simple diagnostic technology in the early stage determines the detection rate of tuberculosis patients. Imaging, etiology, serum antibody detection and other technologies are realized. [0003] Tuberculin test, as an auxiliary means for early diagnosis of tubercul...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K47/36A61K47/32A61K47/26A61K47/18A61K47/02A61K49/00A61M37/00
Inventor 陈航平李革张敏敏
Owner 广州新济生物医药研究院有限公司
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