Influenza vaccine temperature-sensitive gel freeze-dried product for nasal mucosa administration

A technology of thermosensitive gel and influenza vaccine, applied in the field of influenza vaccine thermosensitive gel freeze-dried products, can solve the problems of uncertainty of biological activity, poor stability, influence of thermosensitive properties of thermosensitive gel, etc., and achieve the effect of ensuring drug stability

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

[0006] Usually add stabilizers, preservatives, surfactants, antioxidants and other auxiliary materials to solve the shortcomings of "poor stability and low activity" of thermosensitive gels. Therefore, it does not fundamentally solve the effect of water on the activity of the drug; ②The addition of preservatives and antioxidants is likely to cause incompliance to patients who are actively administered influenza vaccines
The disadvantages of this technical solution are: ① The object of the freeze-dried preparation provided is a small molecule chemical drug. Whether the macromolecular biological drug of the influenza vaccine can be applied mechanically, there is uncertainty in the measured biological activity; Whether the adjuvant can still have reversible thermal gelation in vaccine drugs is uncertain; ③ whether the freeze-dried product after long-term storage can have reversible thermal gelation is also uncertain;
The applicant has known from preliminary experiments that the addition of adjuvants and vaccine stabilizers in influenza vaccines will have a greater impact on the temperature-sensitive properties of the temperature-sensitive gel

Method used

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  • Influenza vaccine temperature-sensitive gel freeze-dried product for nasal mucosa administration
  • Influenza vaccine temperature-sensitive gel freeze-dried product for nasal mucosa administration
  • Influenza vaccine temperature-sensitive gel freeze-dried product for nasal mucosa administration

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Embodiment 1 Preparation of Influenza Vaccine Thermosensitive Gel Freeze-dried Product and Solvent

[0021] The influenza vaccine temperature-sensitive gel freeze-dried product to be prepared in the present invention is composed of influenza vaccine and temperature-sensitive gel solids, and the component contents in the temperature-sensitive gel solids are as shown in Table 1:

[0022] Table 1. Solid Content of Influenza Vaccine Thermosensitive Gel

[0023] Gel material (wt%) Gel additive (wt%) Lyoprotectant (wt%) Phosphate buffer matrix (wt%) 80 2.6 to be determined to be determined

[0024] The solvent to be prepared in the present invention consists of vaccine adjuvant and solvent.

[0025] Preparation of influenza vaccine thermosensitive gel: Dissolve the prescribed amount of CS and lyoprotectant in an appropriate amount of PBS, slowly add the prescribed amount of P407 and P188 under magnetic stirring at 4°C, swell at 4°C for 12h-48h, ta...

Embodiment 2

[0028] The impact of the kind of embodiment 2 lyoprotectant on the temperature-sensitive gel of influenza vaccine

[0029] Set the mass proportion of lyoprotectant in the preparation to a certain value, and only change the type of lyoprotectant to explore the influence of different types of lyoprotectant on the performance of influenza vaccine thermosensitive gel.

[0030] By measuring the hemagglutinin content before and after lyophilization, the lyoprotectant is screened, and the screening method is as follows: the standard antigen product is subjected to original times (4 / 4), 3 / 4, 2 / 4, and 0.9% sterile sodium chloride solution. For 1 / 4-fold dilution, add one well for each dilution, add one well for each dilution of vaccine samples, 12 μl per well, place in a horizontal wet box, and diffuse at room temperature for at least 18 hours. After adding the sample, soak the gel plate in 0.9% sterile sodium chloride solution for 60 minutes, take out the gel, place it on the filter pa...

Embodiment 3

[0037] Example 3 The Effect of the Content of Lyoprotectant in the Gel Solids on Influenza Vaccine Thermosensitive Gel

[0038] On the basis of Example 2, only the amount of lyoprotectant was changed to explore the effect of different amounts of lyoprotectant on the performance of the influenza vaccine thermosensitive gel.

[0039] Use a viscometer to measure the gel viscosity of the temperature-sensitive gel, and the test method is as follows:

[0040] Place the prepared gel solution in a beaker with a diameter of not less than 70mm, and place it in a constant temperature water bath at 25°C for 0.5h. Use the NDJ-1 viscometer to measure the viscosity of the sample. When measuring, the reading indicated by the pointer on the scale dial multiplied by the specific coefficient on the coefficient table is the absolute viscosity of the solution. Each group was measured 3 times in parallel, and the results were averaged.

[0041] When the viscosity is between 200 and 300mPa·s, it i...

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PUM

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Abstract

The invention discloses an influenza vaccine temperature-sensitive gel freeze-dried product. The influenza vaccine temperature-sensitive gel freeze-dried product comprises an influenza vaccine and a freeze-dried protective additive, wherein the freeze-dried protective additive is a combination of cane sugar and mannitol. According to the influenza vaccine temperature-sensitive gel freeze-dried product, the freeze-dried protective additive with specific types and contents is selected, and different solvents are screened, so that the influenza vaccine temperature-sensitive gel freeze-dried product is prepared, not only has reversible thermal gelation, but also can ensure the drug stability of vaccine in long-term storage.

Description

technical field [0001] The invention relates to the technical field of administration of influenza vaccines, in particular to a thermosensitive gel freeze-dried product of influenza vaccine administered through nasal mucosa. Background technique [0002] Currently, the approved influenza vaccines are all injections, which mainly induce a strong systemic immune response. However, most pathogens preferentially infect their hosts through the mucosal surfaces of the gastrointestinal, respiratory, genitourinary, or eyes, and systemic vaccine delivery against infectious diseases routinely using injections fails to induce robust mucosal immune responses. In contrast, nasal mucosal delivery of vaccines can induce not only systemic IgG antibody responses, but also mucosal IgA antibody responses. Due to the presence of approximately 400 microvilli per cell, the nasal mucosa provides a large surface area (approximately 150-160 cm2), the large surface area of ​​the nasal epithelium all...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K9/06A61K39/145A61K39/39A61K47/26A61P31/16
CPCA61K9/19A61K9/06A61K9/0043A61K39/12A61K39/39A61K47/26A61P31/16C12N2760/16134A61K2039/543A61K2039/525A61K2039/55583A61K2039/55511A61K2300/00Y02A50/30
Inventor 张庶民周荔葆马凤森杨文腰廖辉修雪亮吴铮刘苗苗徐国标王一平
Owner LIAONING CHENGDA BIOTECH
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