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Immediately-release haemophilus Type B conjugate vaccine soluble microneedle and preparation method thereof

A Haemophilus influenzae-conjugated vaccine technology is applied in the field of immediate-release Haemophilus influenzae type b conjugated vaccine soluble microneedle patch and its preparation, and can solve the problems of wasting antigen vaccines, poor immunization effect, and unsuitable inoculation times.

Pending Publication Date: 2020-01-14
LIAONING CHENGDA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The Chinese patents with application numbers CN201310071361.0 and CN201620500195.0 respectively provide a slow-release soluble microneedle and a preparation method, but this technology is not suitable for vaccines with a small number of vaccinations and vaccines that need to be released immediately
[0006] The Chinese patent with application number CN201710854856.9 provides a quick-release soluble microneedle and its preparation method, but this technology does not add corresponding adjuvants, resulting in poor immunization effect and wasting more antigen vaccines

Method used

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  • Immediately-release haemophilus Type B conjugate vaccine soluble microneedle and preparation method thereof
  • Immediately-release haemophilus Type B conjugate vaccine soluble microneedle and preparation method thereof
  • Immediately-release haemophilus Type B conjugate vaccine soluble microneedle and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Example 1: Preparation of Haemophilus influenzae type b conjugate vaccine soluble microneedle patch without adjuvant added

[0029] Prepared by the following method:

[0030] 1) Preparation of needle solution: dissolve the water-soluble polymer material (taking PVP and Gantrez as an example, based on a content ratio of 3:1, but not limited to this), Haemophilus influenzae type b conjugate vaccine, etc. in water , as a needle matrix solution.

[0031] 2) Preparation of the base solution: the flexible polymer material (take hypromellose as an example, but not limited thereto) is dissolved in water as the base solution.

[0032] 3) Preparation of soluble microneedles: inject the needle body solution into the microneedle female mold, centrifuge at 4000rpm for 20min, scrape off the excess needle body solution, put it in a normal temperature drying oven for 1h, then add the base layer solution, and centrifuge again at 4000rpm for 20min , put the negative mold of the microne...

Embodiment 2

[0036] Embodiment 2: Comparison of the dissolution performance of the soluble microneedle patch prepared in Example 1 in the skin

[0037] After the soluble microneedles of Haemophilus influenzae type b conjugate vaccine were prepared according to the different prescriptions of the above-mentioned Example 1, the microneedles were pressed into the skin of 6 different rats with the thumb, and the microneedles were pressed into the skin of 6 different rats at 0.2 min, 0.5 min, 1 min, and 2 min respectively. , 3min, 4min, 5min, 6min, 7min and other time points, the microneedles were pulled out, and the intradermal dissolution of the microneedles was observed through a microscope. The results are shown in Table 2.

[0038] Table 2 Intradermal dissolution of each microneedle (n=6)

[0039]

[0040] It can be seen from Table 2 that the dissolution rate of No. 2 prescription in the microneedle skin is better than other prescriptions, so the water-soluble material in the needle bod...

Embodiment 3

[0041] Example 3: Preparation of adjuvanted Haemophilus influenzae type b conjugate vaccine soluble microneedle patch

[0042] With reference to Examples 1 and 2, it is prepared by the following method:

[0043] 1) Preparation of the needle body solution: the water-soluble polymer material PVP and Gantrez (according to the content ratio of 3:1), Haemophilus influenzae type b conjugate vaccine, heat-resistant protective agent (taking trehalose as an example, But not limited thereto) and adjuvant (see the adjuvant prescription in Table 3) were dissolved in water as the needle matrix solution. In this embodiment, in order to eliminate unnecessary influencing factors, the contents of water-soluble polymer materials and heat-resistant protective agents are limited to fixed values ​​for the convenience of statistics, but it is not limited thereto.

[0044] 2) Preparation of the base solution: the flexible polymer material (take hypromellose as an example, but not limited thereto) i...

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Abstract

The invention provides an immediately-release haemophilus Type B conjugate vaccine soluble microneedle patch, which comprises a needle body and a basal layer. The needle body comprises a haemophilus Type B conjugate vaccine, an adjuvant and a water-soluble polymer material. The basal layer is a flexible polymer material. The content ratio of the adjuvant to the haemophilus Type B conjugate vaccineis (1: 1) to (2: 1). The adjuvant is one or more of SPO1, astragalus polysaccharide, 3-De-O-acylated monophosphoryl lipid A. The haemophilus Type B conjugate vaccine soluble microneedle patch provided by the invention can achieve a balanced Th1 / Th2 type immune response and a rapid release of the vaccine in skin tissues.

Description

technical field [0001] The invention relates to the technical field of microneedle administration of vaccines, and provides a soluble microneedle patch for immediate release of Haemophilus influenzae type b conjugate vaccine and a preparation method thereof. Background technique [0002] Haemophilus influenzae type b (Hib) conjugate vaccine is composed of purified capsular polysaccharide of Haemophilus influenzae type b covalently combined with tetanus toxoid (or other carrier proteins). Haemophilus influenzae type b is a common commensal bacterium in the nasopharynx of children. Before the vaccine is applied, most children will carry Hib for a certain period of time, sometimes for several months, but the bacterial colonization rate varies greatly with age and socioeconomic status. Big. In areas with high Hib vaccination rates, bacterial colonization of the nasopharynx is very low due to the herd immunity effect of Hib conjugate vaccines. Although only a small proportion o...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/102A61K39/385A61K39/39A61K9/00A61K47/38A61P31/04
CPCA61K9/0021A61K47/38A61K39/102A61K39/39A61K39/385A61P31/04A61K2039/6037A61K2039/55583A61K2039/55572A61K2039/55594A61K2039/57
Inventor 张庶民马凤森周荔葆廖辉陈中秋刘苗苗吴铮辛小韵
Owner LIAONING CHENGDA BIOTECH
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