A kind of preparation method of anti-hepatitis B immune ribonucleic acid freeze-dried powder injection
A freeze-dried powder injection and ribonucleic acid technology, applied in the field of preparation of anti-hepatitis B immune RNA freeze-dried powder injection, can solve the problems of small loss of active ingredients, long sealed storage period, caking or incomplete dissolution, etc., and achieve control Homogeneity, the effect of reducing reconstitution time
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[0024] The invention provides a kind of preparation method of anti-hepatitis B immune ribonucleic acid freeze-dried powder injection, comprising the following steps:
[0025] a) mixing anti-hepatitis B immune ribonucleic acid, excipients and water for injection to obtain mixed solution A;
[0026] b) filtering, freezing and drying the mixed solution A in sequence to obtain the anti-hepatitis B immune ribonucleic acid freeze-dried powder injection;
[0027] The mass ratio of the anti-hepatitis B immune ribonucleic acid, excipients and water for injection is 1:(2-15):(200-600).
[0028] In the present invention, the anti-hepatitis B immune ribonucleic acid, excipients and water for injection are mixed to obtain mixed solution A. In the present invention, the anti-hepatitis B immune ribonucleic acid is the main drug, and the source of the anti-hepatitis B immune ribonucleic acid is not particularly limited in the present invention, and commercially available products well known ...
Embodiment 1
[0042] The preparation specification is 1000 anti-hepatitis B immune ribonucleic acid freeze-dried powder injections of 4mg / support:
[0043] (1) First, 4 g of anti-hepatitis B immune ribonucleic acid was added to 1000 g of water for injection, and 20 g of dextran was added and stirred for 8 minutes at 25° C. to obtain a mixed solution A.
[0044] (2) The above-mentioned mixed solution A is finely filtered through a 0.45 μm microporous filter element and a 0.22 μm microporous filter element in turn, then filled and half-tamped; then the product is placed in a freeze dryer and frozen at -35°C After 2 hours, control the heating rate at 7°C / h to 38°C, and then dry for 3 hours to obtain the anti-hepatitis B immune ribonucleic acid freeze-dried powder injection. The observed product properties are white freeze-dried loose block or powder.
[0045] The reconstitution time of the anti-hepatitis B immune ribonucleic acid freeze-dried powder injection obtained by the preparation method...
Embodiment 2
[0047] Preparation specification is 1000 anti-hepatitis B immune ribonucleic acid freeze-dried powder injections of 2mg / support:
[0048] (1) First, 2 g of anti-hepatitis B immune ribonucleic acid was added to 1000 g of water for injection, and 20 g of dextran was added and stirred for 8 min at 25° C. to obtain a mixed solution A.
[0049] (2) The above-mentioned mixed solution A is finely filtered through a 0.45 μm microporous filter element and a 0.22 μm microporous filter element in turn, then filled and half-tamped; then the product is placed in a freeze dryer and frozen at -35°C After 2 hours, control the heating rate at 7°C / h to 38°C, and then dry for 3 hours to obtain the anti-hepatitis B immune ribonucleic acid freeze-dried powder injection. The observed product properties are white freeze-dried loose block or powder.
[0050] According to the test method provided in Example 1, the reconstitution time of the anti-hepatitis B immune ribonucleic acid freeze-dried powder ...
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