Analytical method of hepatitis B vaccine

A technology of hepatitis B vaccine and analysis method, which is applied in the field of analysis of hepatitis B vaccine, and can solve the problem of low analysis rate

Pending Publication Date: 2020-10-30
华北制药金坦生物技术股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The purpose of the present invention is exactly to provide a kind of analysis method of hepatitis B vaccine, to solve the problem that existing method analysis rate is low

Method used

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  • Analytical method of hepatitis B vaccine

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Experimental program
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Effect test

Embodiment 1

[0022] Mix the hepatitis B vaccine samples of the same batch with sulfuric acid, hydrochloric acid, and phosphoric acid respectively, and put them in a water bath at 37°C for half an hour after mixing, then add the protective agent Triton100, and then bathe in a water bath at 37°C for half an hour. Among them, the concentrations of the three acids were all 1mol / L, and the volume ratio of the sample to the acid was 1:2. Several parallel experiments were done and the resolution rate was determined. The results are shown in Table 2.

[0023] Table 2:

[0024] acid type Resolution mean / % hydrochloric acid 70.1250A sulfuric acid 47.3125B phosphoric acid 44.8750B

[0025] Data without the same letter indicate significant differences.

[0026] It can be seen from the above that the analysis effect of hydrochloric acid is better.

Embodiment 2

[0028] The same batch of hepatitis B vaccine samples were mixed with hydrochloric acid at a volume ratio of 1:1, 1:2, and 1:5, and then placed in a water bath at 37°C for half an hour, then added the protective agent Triton100, and then bathed in a water bath at 37°C for half an hour. Among them, the concentration of hydrochloric acid used is 1mol / L, several parallel experiments are done and the resolution rate is determined, the results are shown in Table 3.

[0029] table 3:

[0030] Volume ratio Resolution mean / % 1:1 76.7500A 1:2 70.1250B 1:5 67.3125C

[0031] Data without the same letter indicate significant differences.

[0032] It can be seen from the above that the analysis effect is better when the ratio of product to hydrochloric acid is 1:1.

Embodiment 3

[0034] The same batch of hepatitis B vaccine samples were mixed with hydrochloric acid at a volume ratio of 1:1. After mixing, they were placed in a water bath at 37°C for 0.5h, 1h, 2h, and 3h, and then the protective agent Triton100 was added, followed by a water bath at 37°C for half an hour. Among them, the concentration of hydrochloric acid used is 1mol / L, several parallel experiments are done and the resolution rate is determined, the results are shown in Table 3.

[0035] table 3:

[0036] Water bath time / h Resolution mean / % 3 88.1875A 2 88.6250A 1 78.6875B 0.5 72.8125C

[0037] Data without the same letter indicate significant differences.

[0038] It can be seen from the above that the analysis effect is better when the water bath is 2h.

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Abstract

The invention provides an analytical method of a hepatitis B vaccine. The analytical method comprises the following steps: (a) repeatedly freezing and thawing a hepatitis B vaccine sample at-15 DEG Cor below for at least one time, (b) mixing the freeze-thawed hepatitis B vaccine sample with hydrochloric acid in a volume ratio of 1: (1-2), and incubating at 37 DEG C for 1-3 hours, and (c) finally,adding a protective agent Triton100, and carrying out water bath for 1-3 hours at 37 DEG C to finish analysis. According to the present invention, the effective components in the hepatitis B vaccinecan be effectively separated from the adjuvant, such that the effective components can be accurately monitored through the immunoassay kit. Due to the fact that the analysis rate of previous analysisliquid is low, an existing method for determining the activity of the hepatitis B vaccine is an animal method, animal experiments can be effectively replaced after a new analysis mode is invented, andanimal cost is saved.

Description

technical field [0001] The invention relates to the technical field of hepatitis B vaccine content detection, in particular to a method for analyzing the hepatitis B vaccine. Background technique [0002] The aluminum hydroxide adjuvant for vaccines is usually added to the aluminum salt solution to form a precipitate of uncharged neutral substances that aggregate with each other. Aggregates also undergo bimolecular and multimolecular condensation through hydroxyl bridges to form macromolecules. Alkali is added to aluminum salts to obtain fluffy flocculent aluminum hydroxide precipitates. Because they contain more coordination water, the aluminum hydroxide precipitates are loosely gathered together, sometimes called crystalline aluminum partial hydroxide AlO(OH). [0003] Aluminum hydroxide is an amphoteric compound with an isoelectric point (pI) of 11.4. It is positively charged in a buffer solution with a pH close to that of the interstitial fluid of the body, and can well...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/29A61P1/16A61P31/20
CPCA61K39/12A61P1/16A61P31/20A61K2039/55505C12N2730/10134
Inventor 张亚利陈会珍刘海侠胡忠玉王英洪庆福何鹏方鑫甄文晓张卫婷李微曹倩倩孙晓琪孟苗焦晓宁杨玉凤
Owner 华北制药金坦生物技术股份有限公司
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