Preparation method of freeze-dried powder soluble microneedle

A freeze-dried powder and microneedle technology, applied in the field of microneedles, can solve the problems of reducing the deliverable amount of freeze-dried powder, failing to form a needle structure, and insufficient mechanical strength of freeze-dried powder, so as to achieve long-term storage, avoid waste, Realize the effect of storage

Pending Publication Date: 2022-07-22
厦门薇针医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The technical problem to be solved by the present invention is: the mechanical strength of the freeze-dried powder is not enough to form a needle structure that can pierce the skin, so it is mixed with a soluble material that requires better strength as a needle structure, which reduces the deliverability of the freeze-dried powder quantity

Method used

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  • Preparation method of freeze-dried powder soluble microneedle
  • Preparation method of freeze-dried powder soluble microneedle
  • Preparation method of freeze-dried powder soluble microneedle

Examples

Experimental program
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Effect test

Embodiment 1

[0032] Example 1, as figure 1 As shown in K, a lyophilized powder soluble microneedle includes a plurality of soluble hollow needles 1 and a substrate 5, and the soluble hollow needles 1 are detachably fixed on the substrate 5 to form a microneedle array. Specifically, the substrate There is an effervescent separation layer 6 between 5 and the soluble hollow needle body 1 , and the soluble hollow needle body 1 is detachably fixed on the base 5 through the effervescent separation layer 6 . An oil-soluble protective layer 3 is provided on the inner surface of the soluble hollow needle body 1 , and freeze-dried powder 2 is filled in the inner cavity of the soluble hollow needle body 1 . The dissolvable hollow needle body 1 can also be detachably fixed on the substrate 5 using other solutions, such as the solution disclosed in Chinese Patent Document CN104069585A for detachable fixing.

[0033] The material of the soluble hollow needle 1 can be hyaluronic acid, collagen, silk pro...

Embodiment 2

[0050] Example 2 is basically the same as Example 1, except that the oil-soluble protective layer 3 is a polylactic acid waterproof protective layer. The method for preparing the polylactic acid waterproof protective layer on the inner surface of the soluble hollow needle body 1 made of hyaluronic acid is as follows: pour the ethyl acetate solution dissolved in polylactic acid into the upper port of the micropores of the drying mold 4-1, and the concentration is 0.5% , by heating the solution to evaporate the ethyl acetate solvent to dryness, the hyaluronic acid microneedle film will deposit a layer of polylactic acid waterproof protective layer.

Embodiment 3

[0051] Example 3, compared with the lyophilized powder soluble microneedle in Example 1, is different in that the needle opening 7 of the soluble hollow needle body 1 is on the side of the soluble hollow needle body 1 . And in the process of preparing the microneedle with the soluble hollow needle body 1, the filling of the lyophilized powder is completed.

[0052] The preparation method of the lyophilized powder soluble microneedle specifically includes the following steps:

[0053] (1') The dissolvable hollow needle body 1 is prepared through a microneedle mold. The microneedle mold includes a female mold 4-2 and a male mold 4-3, and the side of the female mold 4-2 has a boss for forming the needle port 7 of the soluble hollow needle body 1 .

[0054] This step is more specific as follows: figure 2 As shown in a, 2b and 2c, deionized water and sodium hyaluronate powder are stirred and mixed to obtain a concentration of 5% gelatinous hyaluronic acid. In the mold 4-2, the ...

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Abstract

The invention relates to the technical field of microneedles, in particular to a preparation method of a freeze-dried powder soluble microneedle. The preparation method of the microneedle comprises a freeze-dried powder filling step, before the freeze-dried powder filling step, an oil-soluble protective layer is prepared on the surface of the soluble hollow needle body, then the soluble hollow needle body is filled with a freeze-dried powder raw material aqueous solution in the freeze-dried powder filling step, and the microneedle is prepared through a freeze-drying process. The freeze-dried powder raw material water solution becomes freeze-dried powder in the inner cavity of the soluble hollow needle body, and the freeze-dried powder filling step is completed. The freeze-dried powder needle has the beneficial effects that the freeze-dried powder raw material is filled in the form of a solution, the filling operability is high, and then the freeze-dried powder raw material is freeze-dried in the soluble hollow needle body, so that the freeze-dried powder raw material is not wasted. When a freeze-dried powder raw material aqueous solution is filled, the oil-soluble protective layer can protect the soluble hollow needle body from being dissolved, and meanwhile, the oil-soluble protective layer can be dissolved under the action of oily components of skin tissues without residues.

Description

technical field [0001] The invention relates to the technical field of microneedles, in particular to a preparation method of freeze-dried powder soluble microneedles. Background technique [0002] Freeze-dried powder is a sterile powder injection preparation prepared by freezing functional raw material solutions such as medicinal liquids in a vacuum, and subliming and drying the water. Draining the water in the functional raw material solution in a low temperature environment can effectively prevent the changes in the physicochemical and biological properties of the product, with less damage to the biological tissue and cell structure, and can effectively preserve many heat-sensitive drugs, such as proteins, microorganisms and other biological products. The activity of the active ingredient retains its original medicinal effect, which improves the stability of the preparation, avoids contamination, prolongs the shelf life of the preparation, and facilitates transportation. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K47/36A61M37/00
CPCA61K9/0021A61K47/36A61M37/0015A61M2037/0061A61M2037/0046A61M2037/0053
Inventor 游学秋
Owner 厦门薇针医药科技有限公司
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