Gelatin-free bivalent renal syndrome vaccine freeze-drying protective agent

A technology of jelly and gelatin, which is applied in the direction of inorganic non-active ingredients, medical preparations of non-active ingredients, medical preparations containing active ingredients, etc., and can solve problems such as uncertain ingredients, allergic reactions, and gelatin that can easily cause allergic reactions, etc. , to achieve the effect of reducing the harm of the incidence of side effects and increasing the safety and effectiveness

Inactive Publication Date: 2016-03-30
ZHEJIANG VACIN BIO PHARMA LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The prior art Shuangshenmiao cryopreservative contains gelatin components. Because the gelatin is derived from natural animal extracts, there are uncontrollable defects such as uncertain components and contamination by foreign substances, which makes gelatin easily cause allergic reactions.
It has been reported that some children's recipients' allergy to the MMR combination vaccine is caused by the gelatin i

Method used

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  • Gelatin-free bivalent renal syndrome vaccine freeze-drying protective agent
  • Gelatin-free bivalent renal syndrome vaccine freeze-drying protective agent
  • Gelatin-free bivalent renal syndrome vaccine freeze-drying protective agent

Examples

Experimental program
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Effect test

preparation example Construction

[0042] preparation of dilutions,

[0043] Put raw material A in the diluent formula in a beaker, add diluent D and stir to dissolve at a stirring speed of 100 rpm for 1 minute, then add raw material B and raw material C and stir to dissolve at a stirring speed of 100 rpm Minutes, stirring for 2 minutes, after that, add diluent D to make the total volume constant to 1000 ml, stir and mix, stirring speed 100 rpm, stirring for 5 minutes, after that, adjust the pH value with 20% pharmaceutical grade hydrochloric acid Adjust to 7.4±0.1, sterilize with moist heat, obtain diluent, stand-by;

Embodiment 1

[0045] Product name: Gelatin-free Double Kidney Seedling Freezing Preservative-Type 1

[0046] formula:

[0047] Raw material 1: sucrose, pharmaceutical grade, 50 grams;

[0048] Raw material 2: glycine, analytically pure, 25 grams;

[0049] Raw material 3: human serum albumin, biological products, 0.2 g;

[0050] Raw material 4: arginine, analytically pure, 2 grams;

[0051] Raw material 5: mannitol, analytically pure, 2 grams;

[0052] Diluent: Phosphate buffer saline PBS, pH7.4±0.1, balance, ml;

[0053] The formula unit is the material ratio of 1000 ml unit capacity;

[0054] Preparation Process:

[0055] Step 1. Dissolve raw material 1, raw material 2, raw material 4 and raw material 5 in the gel-free cryoprotectant formula in 200 ml of the diluent in a beaker, stir to dissolve, and stir at a stirring speed of 100 rpm. It takes 2 minutes, after that, add raw material 3, stir and mix, the stirring speed is 100 rpm, and it takes 5 minutes to stir, after that, add the...

Embodiment 2

[0058] Product name: Gelatin-free double kidney seedling cryopreservative-type 2

[0059] formula:

[0060] Raw material 1: sucrose, pharmaceutical grade, 50 grams;

[0061] Raw material 2: glycine, analytically pure, 45 grams;

[0062] Raw material 3: human serum albumin, biological products, 0.2 g;

[0063] Raw material 4: arginine, analytically pure, g;

[0064] Raw material 5: mannitol, analytically pure, g;

[0065] Diluent: Phosphate buffer saline PBS, pH7.4±0.1, balance, ml;

[0066] The formula unit is the material ratio of 1000 ml unit capacity;

[0067] Preparation Process:

[0068]Step 1. Dissolve raw material 1, raw material 2, raw material 4 and raw material 5 in the gel-free cryoprotectant formula in 200 ml of the diluent in a beaker, stir to dissolve, and stir at a stirring speed of 100 rpm. It takes 2 minutes, after that, add raw material 3, stir and mix, the stirring speed is 100 rpm, and it takes 5 minutes to stir, after that, add the diluent to make t...

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PUM

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Abstract

The invention discloses a gelatin-free bivalent renal syndrome vaccine freeze-drying protective agent, and provides a formula and a preparation technology of the freeze-drying protective agent. According to the bivalent renal syndrome vaccine freeze-drying protective agent prepared from saccharose, glycine, human serum albumin, arginine, mannitol and a phosphate buffer solution, the problems and defects that in the prior art, an anaphylactic reaction and a fever reaction exist are avoided, so that for the freeze-drying protective agent of a bivalent inactivated vaccine for a hemorrhagic fever with renal syndromes, the defect of gelatin is overcome, and the purposes of eliminating the anaphylactic reaction and the fever reaction are achieved.

Description

technical field [0001] The invention relates to a freeze-drying protective agent for vaccines, in particular to a freeze-drying agent for double-kidney vaccines without gelatin components, which is used for making freeze-dried preparations of inactivated vaccines for bivalent renal syndrome hemorrhagic fever. Background technique [0002] Vaccine freeze-drying protective agent, referred to as cryoprotectant, is a protective agent added to the vaccine to prevent the sex change of the vaccine due to freeze-drying when the vaccine is made into a freeze-dried preparation; to make a bivalent renal syndrome hemorrhagic fever inactivated vaccine Freeze-drying agent for freeze-dried preparations, referred to as Shuangshenmiao cryoprotectant. [0003] The cryoprotectant for Shuangshen Miao in the prior art contains gelatin components. Since the gelatin is derived from natural animal extracts, there are uncontrollable defects such as uncertain components and contamination by exogenous...

Claims

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Application Information

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IPC IPC(8): A61K47/26A61K47/18A61K47/42A61K47/22A61K47/02A61K39/125A61K9/19A61P31/14
CPCA61K47/26A61K9/19A61K39/12A61K47/02A61K47/183A61K47/22A61K47/42C12N2760/12134
Inventor 王卜勇张行陈道芳方斌奇杨文韬章文彬
Owner ZHEJIANG VACIN BIO PHARMA LTD
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