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Thermostable ACYW135 group meningococcal-epidemic encephalitis B combined vaccine soluble microneedle patch

A combined vaccine and soluble technology, applied in the directions of microneedles, needles, microorganisms, etc., can solve the problems of differences in the mechanical properties of soluble microneedles, no stability solution, single JE vaccine, etc., and achieve high mechanical strength of the needle body. Painless and minimally invasive administration, good immune effect

Pending Publication Date: 2021-07-16
LIAONING CHENGDA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This technical solution adopts the delivery method of injection administration, which is also the most commonly used method for vaccination at present. The disadvantage of injection administration is that it brings strong pain stimulation, which is easy to cause patient intolerance, and requires professional Medical staff operation
[0011] Existing literature does not relate to the stability solution of the soluble microneedle of meningitis-JE combined vaccine, only involves a single Japanese encephalitis vaccine or meningitis vaccine stabilizer, such as the document "Bacterial Vaccines for Humans" (Wang Bingrui, Microbiology Advances in Immunology, 2002 (1): 47-55.) mentioned that the commonly used stabilizer for meningococcal vaccines is lactose, and another example is the document "Freeze-dried Japanese encephalitis inactivated vaccine (Vero cells) non-animal source stabilizer Screening of JE vaccines" (Zhang Jin, Chinese Journal of Biological Products, 2009, 22(11): 68-70.) mentions that the commonly used stabilizer for JE vaccine is human serum albumin
However, considering that the physical and chemical properties of combined vaccines have changed compared with those of single vaccines, and the formulations of the vaccines mentioned in the above literature are all injections, which are also very different from soluble microneedles. Therefore, whether the stabilizers lactose and human albumin It is also applicable to the soluble microneedles of ECM-JE combined vaccine, there is uncertainty
[0012] Secondly, as mentioned in the document "Matrix Materials and Composite Materials for Constructing Dissolvable Microneedles" (Zhang Jie, Ma Fengsen, Zhan Haohui, etc., Materials Herald, 2017, 31(19):129-134.), different types Combinations of different materials lead to significant differences in the mechanical properties of dissolvable microneedles

Method used

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  • Thermostable ACYW135 group meningococcal-epidemic encephalitis B combined vaccine soluble microneedle patch
  • Thermostable ACYW135 group meningococcal-epidemic encephalitis B combined vaccine soluble microneedle patch
  • Thermostable ACYW135 group meningococcal-epidemic encephalitis B combined vaccine soluble microneedle patch

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Example 1 Preparation of Soluble Microneedles of ACYW135 ECM-JE Combined Vaccine

[0031] The soluble microneedle of ACYW135 group ECM-JE combined vaccine to be prepared in the present invention includes a needle body and a backing, and the needle body is composed of ACYW135 group ECM-JE combined vaccine, a vaccine stabilizer and a suitable matrix material.

[0032] The preparation method of the soluble microneedles of the ACYW135 group meningitis-JE combined vaccine is as follows:

[0033] Mix ACYW135 meningococcal meningitis-JE combined vaccine, vaccine stabilizer and matrix material according to the prescription ratio, add deionized water to fully dissolve it, and form a uniform needle body fluid. Take an appropriate amount of needle body liquid and pour it into the polydimethylsiloxane female mold, so that the needle body liquid is completely immersed in the hole of the female mold, and then put it into a high-speed centrifuge, set the speed at 4000r / min, and centri...

Embodiment 2

[0034] Example 2 Relevant tests of soluble microneedles of ACYW135 ECM-JE combined vaccine

[0035] 1. Stability test of ACYW135 ECM-JE combined vaccine

[0036] ①The stability determination method of ACYW135 meningococcal meningitis vaccine is determined by determining the partition coefficient (KD) and recovery rate of the vaccine antigen polysaccharide in the gel chromatographic column:

[0037]After the prepared microneedles were stored at 37°C for 1 week, the samples were divided into two batches, and one batch was dissolved in the mobile phase. About 1 ml of the test sample (containing 3-5 mg of polysaccharide antigen) was taken and added to In the calibrated chromatographic column, elute with the mobile phase, collect the eluate with a component collector, collect 5ml in each tube, measure the phosphorus content in each tube of the eluate according to the phosphorus determination method (general rule 3103), and use the test sample The phosphorus content of each tube of...

Embodiment 3

[0044] The type of vaccine stabilizer of embodiment 3 is investigated on the influencing factors of vaccine stability

[0045] Set the mass ratio of microneedle matrix material and ACYW135 ECM-JE combined vaccine to a certain value, only change the type of vaccine stabilizer, and explore the effect of different vaccine stabilizers on the ACYW135 ECM-JE combined vaccine in soluble microneedles. Impact of vaccine protection.

[0046] In this embodiment, the type of vaccine stabilizer is selected as: a combination of one or more of human albumin, lactose, raffinose, sodium glutamate, sodium chloride, and sorbitol, corresponding to the prescriptions in Table 1 (Table 1 is the general table of prescriptions after removing some unreasonable prescriptions).

[0047] Table 1. Recipes of dissolvable microneedles containing different stabilizers

[0048] No. human serum albumin lactose Raffinose sodium glutamate Sodium chloride Sorbitol 1 - - - - - - ...

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Abstract

The invention discloses a thermostable ACWY135 group meningococcal-epidemic encephalitis B combined vaccine soluble microneedle patch, which comprises a needle body and a backing, the needle body is composed of an ACWY135 group meningococcal-epidemic encephalitis B combined vaccine, a stabilizer and a matrix material, and the stabilizer is a mixture of sodium glutamate and raffinose. The ACWY135 group meningococcal-epidemic encephalitis B combined vaccine soluble microneedle prepared by the invention is good in immune effect and high in needle body mechanical strength, and is expected to replace the existing epidemic cerebrospinal meningitis vaccine and epidemic encephalitis B vaccine combined injection to realize painless minimally invasive administration.

Description

technical field [0001] The invention relates to the technical field of administration of meningitis-JE combined vaccine, in particular to a heat-stable soluble microneedle patch of ACYW135 group meningitis-JE combined vaccine. Background technique [0002] Epidemic cerebrospinal meningitis (meningococcal meningitis for short) is an acute respiratory infectious disease caused by Neisseria meningitidis. Meningococcal meningitis has the characteristics of many bacterial flora and flora drift. The flora of epidemic meningococcal meningitis in China has changed from the original group A to group C, and bacteria groups such as W135 and Y have begun to appear, showing a pattern of diverse flora. Therefore, only ACYW135 group meningococcal polysaccharide vaccine can prevent ECM more effectively. [0003] Epidemic Japanese encephalitis is an acute infectious disease caused by Japanese encephalitis virus that affects the central nervous system. It mostly occurs in the Far East of As...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/12A61K39/095A61K47/18A61K47/36A61P31/04A61P31/14A61M37/00
CPCA61K39/095A61K39/12A61K47/183A61K47/36A61K2039/52A61K2039/525A61K2039/54A61M37/0015A61M2037/0053A61P31/04A61P31/14C12N2770/36034A61K2300/00Y02A50/30
Inventor 张庶民周荔葆马凤森廖辉修雪亮刘苗苗吴铮徐国标王一平吴琼
Owner LIAONING CHENGDA BIOTECH
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