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Preparation method of hepatitis b human immunoglobulin for intravenous injection

A technology of immunoglobulin and hepatitis B, which is applied in the direction of digestive system, antiviral agents, drug combinations, etc., can solve the problems of relapse, reduce hepatitis B, and cannot be used in large doses for liver transplant patients, so as to prevent and treat recurrence Effect of recurrence, quality index improvement

Active Publication Date: 2009-02-04
SHENZHEN WEIGUANG BIOLOGICAL PROD
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Problems solved by technology

[0005] In view of the above-mentioned problems existing in the prior art, the present invention provides a preparation method and products of human hepatitis B immunoglobulin for intravenous injection, which adopts low temperature alcohol protein separation, low pH incubation virus inactivation and nano membrane virus filtration double Virus inactivation and / removal process, preparation of specific hepatitis B immunoglobulin suitable for intravenous injection, to solve the problem that hepatitis B immunoglobulin cannot be used in large doses for liver transplant patients at present in China, and reduce the risk of liver transplantation for liver transplant patients Probability of Hepatitis B Recurrence

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  • Preparation method of hepatitis b human immunoglobulin for intravenous injection

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preparation example Construction

[0023] refer to figure 1 , the preparation method concrete steps of human hepatitis B immunoglobulin (pH4) for intravenous injection of the present invention are as follows:

[0024] 1) For the combined plasma, adjust the protein concentration to 40-50g / L with physiological saline, adjust the final pH of the suspension to 6.00±0.05 with pH4.00 acetate buffer, and adjust with 95% ethanol below -20°C The concentration of ethanol in the solution is 20%, adjust the reaction temperature to -5.0±0.5°C, continue to stir and react for 2 hours, let it stand overnight, and centrifuge to collect the precipitate to obtain FI+II+III (ie component I+II+III);

[0025] Among them, pH4.00 acetate buffer contains 108.08g of sodium acetate and 228.8ml of anhydrous acetic acid per liter of buffer;

[0026] Calculation of ethanol amount: V 95％乙醇 =0.267×V 悬液 (L)

[0027] m 95％乙醇 =0.83×V 95％乙醇 (Kg).

[0028] 2) Completely stir and dissolve the FI+II+III precipitate with 0-2°C cold...

Embodiment 1

[0046] 1) Combine 285L of plasma, add 64L of 0.9% NaCl, adjust the pH of the solution to 5.88 with pH4.00 acetate buffer, adjust the final concentration of ethanol to 20% with 94L of 95% ethanol at -22°C, and retest the final pH of the solution 6.00, the final solution temperature was -4.5°C, stirred for 2 hours, allowed to stand overnight, and centrifuged to obtain 18.3kg of FI+II+III precipitate.

[0047] 2) Completely dissolve 18.3kg of FI+II+III precipitate with 230L of water for injection at 0.5°C, adjust the pH of the solution to 4.85 with the above buffer I, add 215L of water for injection, stir for 1 hour, and adjust the solution with the above buffer II The pH is 5.30, add 220L of cold water for injection, the conductivity is 1.05ms / cm, -21.5°C, 120.2L of 95% ethanol, the final concentration of ethanol is adjusted to 14%, the final pH is 5.35, the temperature is -3.5°C, and stirred for 2 hours Let stand overnight, and centrifuge to obtain a supernatant with a volume o...

Embodiment 2

[0056] 1) Combine 337.1L of plasma, add 81.5L of 0.9% NaCl, adjust the pH of the solution to 5.85 with pH4.00 acetate buffer, adjust the final concentration of ethanol to 20% with 112.8L of 95% ethanol at -22°C, and repeat the test The final pH of the solution was 6.05, the final solution temperature was -5.0°C, stirred for 2 hours, allowed to stand overnight, and centrifuged to obtain 23 kg of FI+II+III precipitate.

[0057] 2) Completely dissolve 23kg of FI+II+III precipitate with 300L of water for injection at 0.5°C, adjust the pH of the solution to 4.80 with the above buffer I, add 300L of water for injection, stir for 1 hour, and adjust the pH of the solution with the above buffer II To 5.25, add 221L of cold water for injection, conductivity of 1.15ms / cm, -21°C, 145.3L of 95% ethanol to adjust the final concentration of ethanol in the solution to 14%, the final pH is 5.30, temperature -4.0°C, and stir for 2 hours. Place overnight, centrifuge, and the volume of the supern...

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Abstract

The invention relates to the preparation method of HBIG of human for mainline. The preparation method comprises the steps that: by a low-temperature ethanol separation method, firstly, FI + II + III precipitation is separated from mixed-immune plasma, then is put into water for injection to be dissolved for a second separation and the supernatant is filtered for a third separation to get FII precipitation; finally, the FII precipitation with a part by weight is put into 5-6 parts of water for injection to be dissolved, the pH is adjusted to be 4.00 minus or plus 0.05, the solution is filtered with a film, and processed by hyperfiltration and dealcoholization, aseptic filtration, virus-inactivating, degerming and split charging. The invention adopts the low-temperature ethanol, applies low pH incubation inactivation and nano-membrane virus to filter double virus inactivation / removal technique; each step has the reduction, inactivation, removal effects on the known probable virus in the blood; compared with the current intramuscular injection products, the purity of products, antibody titer, and the quality indicators such as the content of polymer and the content of protein which reduce the products, and anti-complement activity are all improved to a certain extent.

Description

technical field [0001] The invention relates to a preparation method of blood products, in particular to a preparation method of human hepatitis B immunoglobulin for intravenous injection, which adopts low-pH ethanol protein separation method for protein separation, applies low pH virus incubation and nano-membrane virus filtration Dual virus inactivation / removal method to prepare high-purity, high-titer, low-protein human hepatitis B immunoglobulin for intravenous administration. Background technique [0002] Intramuscular injection of human hepatitis B immunoglobulin for the prevention of hepatitis B has been widely used in my country, but because of its low purity and high protein concentration, it cannot be used for intravenous injection, and can only be used for intramuscular injection to prevent hepatitis B virus And block the mother-to-child vertical transmission of hepatitis B virus, but cannot be used in large doses in liver transplantation due to liver cirrhosis cau...

Claims

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Application Information

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IPC IPC(8): A61K39/395A61P1/16A61P31/20
Inventor 黄肖武洪计灵张信许强李昆成张战杨海峰郭采平李冲之
Owner SHENZHEN WEIGUANG BIOLOGICAL PROD
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