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Autolytic microneedle transdermal patch and preparation method thereof

A self-dissolving microneedle and transdermal patch technology, which can be used in sheet delivery, pharmaceutical formulations, allergic diseases, etc., can solve problems such as the difficulty in inducing Th1-type cellular immunity, and achieve enhanced humoral immune response, induction of cellular immunity, avoid cost-increasing effects

Active Publication Date: 2016-02-10
BEIJING CAS MICRONEEDLE TECH LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0010] The present invention uses endogenous oligomeric hyaluronic acid and / or low molecular weight heparan sulfate as the microneedle matrix material and vaccine adjuvant in the self-dissolving microneedle transdermal patch at the same time, without adding exogenous adjuvant To enhance the immunogenicity of the antigen and solve the problem that the existing transcutaneous immunization technology is difficult to induce Th1 cell immunity

Method used

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  • Autolytic microneedle transdermal patch and preparation method thereof
  • Autolytic microneedle transdermal patch and preparation method thereof
  • Autolytic microneedle transdermal patch and preparation method thereof

Examples

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preparation example Construction

[0040] (1) Preparation of the mold: there are 36 (6×6 rows) microneedles with a height of about 650 microns on the support surface, the cone angle of the largest cross-section of the microneedles is 35 degrees, and the base area is a quadrangular pyramid with a base area of ​​0.5cm×0.5cm Stainless steel master mold, take a mixture of 10 grams of pre-polymerized polydimethylsiloxane and 1 gram of crosslinking agent (SYLGARD184, silicone elastomer, Dowcorning) and cover it on the master mold, and place it at a temperature of 80 ° C for 30 minutes Left and right, obtain the mold that the surface has the required number of pinholes that match the shape and quantity of the microneedle body on the master mold;

[0041] (2) Mix 5 mg of HBsAg loaded with 5 micrograms of Trihala blue (used to visualize the distribution of the target drug in the self-dissolving microneedles) in PBS and 5 mg of 10% by weight trehalose solution Cover the above-mentioned mixed solution into the mold with p...

Embodiment 2

[0044] Example 2 Make the DNA vaccine self-dissolving microneedle transdermal patch represented by the DNA vaccine VR-S2S expressing the hepatitis B surface antigen gene (S)

[0045] (1) Preparation of the mold: there are 81 (9×9 rows) microneedles with a height of about 500 microns on the surface, the cone angle of the largest cross-section of the microneedles is 30 degrees, and the base area is conical stainless steel with a base area of ​​0.5cm×0.5cm For the master mold, take a mixture of 10 grams of pre-polymerized polydimethylsiloxane and 1 gram of crosslinking agent (SYLGARD184, silicone elastomer, Dowcorning) and cover it on the master mold, and place it at a temperature of 80 ° C for about 30 minutes , obtaining a mold with a required number of pinholes on the surface that are adapted to the shape and quantity of the microneedle needles on the master mold;

[0046] (2) 10 mg of VR-S2S solution in PBS loaded with 10 micrograms of Tripan blue (used to visualize the distr...

Embodiment 3

[0049] Example 3 Making the virus vector vaccine self-dissolving microneedle transdermal patch represented by the adenovirus vector vaccine rMVA-E4 expressing the hepatitis B surface antigen gene (S)

[0050] (1) Preparation of the mold: there are 484 (22×22 rows) microneedles with a height of about 300 microns on the surface, the cone angle of the largest cross-section of the microneedles is 45 degrees, and the base area is an octagonal pyramid-shaped stainless steel mother with a base area of ​​1cm×1cm Mold, take a mixture of 10 grams of prepolymerized polydimethylsiloxane and 1 gram of crosslinking agent (SYLGARD184, silicone elastomer, Dowcorning) and cover it on the master mold, and place it at a temperature of 80 ° C for about 30 minutes. Obtain the mold with the required number of pinholes on the surface that are adapted to the shape and quantity of the microneedle body on the master mold;

[0051] (2) 20 mg of PBS solution loaded with 200 micrograms of rMVA-E4 and 20 m...

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Abstract

The invention belongs to an autolytic microneedle in the technical field of transdermal drug delivery and especially relates to an autolytic microneedle transdermal patch and a preparation method thereof. In the invention, endogenic oligomerized hyaluronic acid and / or low-molecular-weight heparan sulfate are employed as a microneedle substrate material and a vaccine adjuvant at the same time to prepare the autolytic microneedle in which a vaccine is loaded, thereby preparing the autolytic microneedle transdermal patch in the invention. The autolytic microneedle transdermal patch can achieve effective transcutaneous immune of the vaccine and enhance humoral immune response of the vaccine. Compared with intramuscular injection immune and other autolytic microneedle transcutaneous immune in the prior art, the autolytic microneedle transdermal patch can significantly enhance cellullar immunologic response of the vaccine.

Description

technical field [0001] The invention belongs to the self-dissolving microneedle in the technical field of transdermal administration, in particular to a self-dissolving microneedle transdermal patch and a preparation method thereof. Background technique [0002] At present, most vaccines are vaccinated by subcutaneous or intramuscular injection, which has problems such as pain, professional operation, unsatisfactory pharmacokinetic curve of the vaccine, and repeated use of injection needles will cause the spread of infectious diseases. Therefore, research on new vaccine delivery systems with good compliance, convenience, high efficiency and safety has always been a hot spot in the field of vaccines. Transcutaneous immunization (Transcutaneous immunization, TCI) refers to the topical application of vaccine antigens and (or) adjuvants on the skin surface to elicit an immune response. Skin is an ideal site for vaccine immunization, which contains more abundant antigen-presenti...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K39/39A61K47/36A61P37/04
Inventor 高云华邱玉琴
Owner BEIJING CAS MICRONEEDLE TECH LTD
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