CN1748788A - Recombinant human interferon alpha 26 injection of prefilled injector package - Google Patents
Recombinant human interferon alpha 26 injection of prefilled injector package Download PDFInfo
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- CN1748788A CN1748788A CN 200510084224 CN200510084224A CN1748788A CN 1748788 A CN1748788 A CN 1748788A CN 200510084224 CN200510084224 CN 200510084224 CN 200510084224 A CN200510084224 A CN 200510084224A CN 1748788 A CN1748788 A CN 1748788A
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Abstract
The recombinant human interferon alpha-2b injection in pre-filled injector package features that each injection includes 1, 3 or 5 mega IU of recombinant human interferon alpha-2b and contains albumin protecting agent in 0.5-2.0 wt%. The product of the present invention is packed in and applied with disposable sterilized pre-filled injector, and this ensures no secondary pollution, safe administration and accurate amount.
Description
Technical field
The present invention relates to a kind of interferon injection, more particularly, relate to a kind of recombinant human interferon alpha 2 b injection of prefilled injector package.
Background technology
Recombinant human interferon alpha 2 b has effects such as broad-spectrum antiviral, antitumor, inhibition cell proliferation and raising immunologic function.Interferon and cell surface receptor zygotic induction cell produce multiple antiviral protein, suppressing virus breeds in cell, improve immunologic function, comprise the phagocytic function that strengthens macrophage, enhancing lymphocyte function cytotoxicity and the NK cell sexual cell of target cell.
At present, widely used injection mainly contains 2 big classes:
(1) liquid infusion agent: also claim injection, be commonly called as " liquid drugs injection ".System is mixed with solution (aqueous or non-aqueous), suspension or emulsion, the preparation that forms in the ampoule bottle of packing into, cillin bottle or the multi-dose container with medicine.General water soluble drug requires to reach quick-acting after injection, so polygamy becomes the composite solution (as adding ethanol, propylene glycol, glycerol etc. in the aqueous solution in addition) of aqueous solution or water.Some medicine should not be made aqueous solution, as indissoluble in water or for prolonging drug effect etc. after the injection, can be made into oil solution, water or oil suspension, emulsion.
(2) injectable powder: be commonly called as " powder pin ".The some drugs less stable, make be easy to behind the solution decompose rotten.In order to keep stable, this class medicine generally can adopt aseptic manipulation, the sterilization powdered drug of injection is packed in cillin bottle or other appropriate vessel, or wiring solution-forming makes powder ampoule agent for injection again after lyophilization, face the time spent with suitable solvent dissolving or suspendible.
But, all there is defective in above-mentioned 2 kinds of injections, for example, for the liquid infusion agent, no matter be that ampoule bottle or XiLin are bottled, all need during clinical practice to draw medicinal liquid with syringe, secondary pollution takes place, in addition in complex operation easily, ampoule bottle fractures rate up to 10% in transportation, and medical personnel are scratched by the ampoule bottle fragment through regular meeting; And 1 ampoule bottle is after fractureing, and what be inhaled into can reach more than 20,000 greater than the microgranule more than 0.5 micron, and the venothrombotic danger of the clasticity that causes patient is arranged.And injectable powder needs to dissolve again before use, operates more loaded down with trivial detailsly, and secondary pollution takes place easily.
Commercially available recombinant human interferon alpha 2 b injection mainly exists with above-mentioned 2 types at present, similarly has above-mentioned defective.So, be necessary to develop the recombinant human interferon alpha 2 b injection of new packing.The Beijing KaiYin Bioisystech Co., Ltd complies with this demand, has prepared the recombinant human interferon alpha 2 b injection of prefilled injector package.
Summary of the invention
The invention provides the recombinant human interferon alpha 2 b injection of prefilled injector package, wherein comprise the recombinant human interferon alpha 2 b injection that 1,000,000 IU/ prop up, 3,000,000 IU/ prop up or 5,000,000 IU/ prop up.
In above-mentioned recombinant human interferon alpha 2 b injection, described recombinant human interferon alpha 2 b is preferably expressed by the LIB strain, makes through AKTA tomography devices purification.
In above-mentioned recombinant human interferon alpha 2 b injection, preferably also comprise the albumin protective agent of 0.5-2.0 weight %.
In above-mentioned recombinant human interferon alpha 2 b injection, the pyrogen level is preferably lower than 0.25EU/300 ten thousand IU.
The recombinant human interferon alpha 2 b injection of above-mentioned prefilled injector package is to form with the fill of interferon stock solution under aseptic condition.
Product of the present invention has following advantage:
1, use disposable pre-filled sterilizing syringe, directly administration, the secondary pollution that produces when effectively avoiding injectable powder to use, medication is safer, and consumption is more accurate;
2, three bevel needles do not have the pain injection, make things convenient for the chronic patients life-time service, improve patient's compliance;
3, be beneficial to patient's preceding self-administration of sleeping, make symptoms such as the easier tolerance heating of patient, class flu sample, improve the quality of living;
4, adopt single independent packaging, make things convenient for the patient to carry and use.
The specific embodiment
Further explain the present invention with embodiment below, but protection scope of the present invention is not restricted to these embodiment.The various improvement that those skilled in the art carries out on this basis are still in protection scope of the present invention.
The stability of continuous three batch samples of embodiment 1 pre-filled syringe packing aqueous injection:
The stability experiment result of the continuous three batches of production samples of pre-charge injector packing aqueous injection is as shown in table 1.
Carrying out different temperatures shelf stability result of the test with 100,300,5,000,000 unit products, is t with time, is vertical coordinate with the logarithm that is equivalent to 0 month active percent, is log (C/C
0) to the scatterplot of t, and do trend analysis, the results are shown in Table 2-4.
Pre-filled syringe is packed continuous three batch samples in 2-8 ℃, 20-25 ℃, 37 ℃ study on the stability result, 6 months artifacts of product learn activity be equivalent to 0 month active 102%, meet quality standard.The packaging material of aqueous injection pre-filled syringe packing do not influence the biologic activity of recombinant human interferon alpha 2 b.
Variation such as appearance luster, clarity:
Pre-charge injector packing recombinant human interferon alpha 2 b aqueous injection in 2-8 ℃, 20-25 ℃, 37 ℃ deposit 6 months after finished product appearance luster, clarity, pH value do not find to change, sterility test is all qualified.Biologic activity does not have difference before depositing He after depositing.
Table 1: recombinant human interferon alpha 2 b injection (pre-charge injector packing) stability test result
The specification lot number | Storage temperature | Test item | Resting period (moon) | ||||||
0 | 1 | 2 | 3 | 4 | 5 | 6 | |||
200208011 | 2-8℃ | Interferon alpha 2 b activity (* 10 6Ten thousand IU/ml) | 1.25 | 1.24 | 1.25 | 1.26 | 1.21 | 1.26 | 1.24 |
PH value | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | ||
The color and luster clarity | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | ||
Sterility test | Negative | Negative | Negative | Negative | Negative | Negative | Negative | ||
20-25℃ | Interferon alpha 2 b activity (* 10 6Ten thousand IU/ml) | 1.25 | 1.26 | 1.24 | 1.23 | 1.23 | 1.22 | 1.21 | |
PH value | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | ||
The color and luster clarity | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | ||
Sterility test | Negative | Negative | Negative | Negative | Negative | Negative | Negative | ||
37℃ | Interferon alpha 2 b activity (* 10 6Ten thousand IU/ml) | 1.25 | 1.18 | 1.23 | 1.31 | 1.24 | 1.16 | 1.09 | |
PH value | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | ||
The color and luster clarity | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | ||
Sterility test | Negative | Negative | Negative | Negative | Negative | Negative | Negative | ||
200208013 | 2-8℃ | Interferon alpha 2 b activity (* 10 6Ten thousand IU/ml) | 4.03 | 3.98 | 3.93 | 3.91 | 3.98 | 3.96 | 3.91 |
PH value | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 |
The color and luster clarity | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | ||
Sterility test | Negative | Negative | Negative | Negative | Negative | Negative | Negative | ||
20-25℃ | Interferon alpha 2 b activity (* 10 6Ten thousand IU/ml) | 4.03 | 3.97 | 3.96 | 3.96 | 3.95 | 3.94 | 3.94 | |
PH value | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | ||
The color and luster clarity | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | ||
Sterility test | Negative | Negative | Negative | Negative | Negative | Negative | Negative | ||
37℃ | Interferon alpha 2 b activity (* 10 6Ten thousand IU/ml) | 4.03 | 3.94 | 3.82 | 3.86 | 3.93 | 3.79 | 3.54 | |
PH value | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | ||
The color and luster clarity | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | ||
Sterility test | Negative | Negative | Negative | Negative | Negative | Negative | Negative | ||
200208015 | 2-8℃ | Interferon alpha 2 b activity (* 10 6Ten thousand IU/ml) | 5.85 | 5.85 | 5.85 | 5.83 | 5.80 | 5.81 | 5.80 |
PH value | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | ||
The color and luster clarity | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | ||
Sterility test | Negative | Negative | Negative | Negative | Negative | Negative | Negative | ||
20-25℃ | Interferon alpha 2 b activity (* 10 6Ten thousand IU/ml) | 5.85 | 5.86 | 5.85 | 5.86 | 5.84 | 5.83 | 5.83 | |
PH value | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 |
The color and luster clarity | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | ||
Sterility test | Negative | Negative | Negative | Negative | Negative | Negative | Negative | ||
37℃ | Interferon alpha 2 b activity (* 10 6Ten thousand IU/ml) | 5.85 | 5.98 | 6.01 | 6.14 | 5.99 | 5.98 | 5.85 | |
PH value | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | ||
The color and luster clarity | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | ||
Sterility test | Negative | Negative | Negative | Negative | Negative | Negative | Negative | ||
200208021 | 2-8℃ | Interferon alpha 2 b activity (* 10 6Ten thousand IU/ml) | 1.21 | 1.19 | 1.23 | 1.20 | 1.17 | 1.19 | 1.17 |
PH value | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | ||
The color and luster clarity | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | ||
Sterility test | Negative | Negative | Negative | Negative | Negative | Negative | Negative | ||
20-25℃ | Interferon alpha 2 b activity (* 10 6Ten thousand IU/ml) | 1.21 | 1.27 | 1.27 | 1.24 | 1.23 | 1.22 | 1.2 | |
PH value | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | ||
The color and luster clarity | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | ||
Sterility test | Negative | Negative | Negative | Negative | Negative | Negative | Negative | ||
37℃ | Interferon alpha 2 b activity (* 10 6Ten thousand IU/ml) | 1.21 | 1.18 | 1.23 | 1.31 | 1.24 | 1.16 | 1.09 | |
PH value | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 |
The color and luster clarity | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | ||
Sterility test | Negative | Negative | Negative | Negative | Negative | Negative | Negative | ||
200208023 | 2-8℃ | Interferon alpha 2 b activity (* 10 6Ten thousand IU/ml) | 4.12 | 4.06 | 3.99 | 4.15 | 4.05 | 3.95 | 3.93 |
PH value | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | ||
The color and luster clarity | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | ||
Sterility test | Negative | Negative | Negative | Negative | Negative | Negative | Negative | ||
20-25℃ | Interferon alpha 2 b activity (* 10 6Ten thousand IU/ml) | 4.12 | 4.02 | 4.02 | 4.01 | 4.01 | 4.00 | 3.98 | |
PH value | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | ||
The color and luster clarity | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | ||
Sterility test | Negative | Negative | Negative | Negative | Negative | Negative | Negative | ||
37℃ | Interferon alpha 2 b activity (* 10 6Ten thousand IU/ml) | 4.12 | 4.39 | 3.98 | 3.92 | 4.09 | 3.96 | 3.86 | |
PH value | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | ||
The color and luster clarity | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | ||
Sterility test | Negative | Negative | Negative | Negative | Negative | Negative | Negative | ||
200208025 | 2-8℃ | Interferon alpha 2 b activity (* 10 6Ten thousand IU/ml) | 5.74 | 5.69 | 5.70 | 5.78 | 5.77 | 5.77 | 5.75 |
PH value | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 |
The color and luster clarity | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | ||
Sterility test | Negative | Negative | Negative | Negative | Negative | Negative | Negative | ||
20-25℃ | Interferon alpha 2 b activity (* 10 6Ten thousand IU/ml) | 5.74 | 5.76 | 5.76 | 5.75 | 5.71 | 5.74 | 5.74 | |
PH value | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | ||
The color and luster clarity | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | ||
Sterility test | Negative | Negative | Negative | Negative | Negative | Negative | Negative | ||
37℃ | Interferon alpha 2 b activity (* 10 6Ten thousand IU/ml) | 5.74 | 5.67 | 5.63 | 5.79 | 5.67 | 5.67 | 5.61 | |
PH value | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | ||
The color and luster clarity | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | ||
Sterility test | Negative | Negative | Negative | Negative | Negative | Negative | Negative | ||
200208031 | 2-8℃ | Interferon alpha 2 b activity (* 10 6Ten thousand IU/ml) | 1.28 | 1.27 | 1.27 | 1.32 | 1.28 | 1.26 | 1.26 |
PH value | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | ||
The color and luster clarity | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | ||
Sterility test | Negative | Negative | Negative | Negative | Negative | Negative | Negative | ||
20-25℃ | Interferon alpha 2 b activity (* 10 6Ten thousand IU/ml) | 1.28 | 1.25 | 1.25 | 1.23 | 1.22 | 1.22 | 1.22 | |
PH value | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 |
The color and luster clarity | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | ||
Sterility test | Negative | Negative | Negative | Negative | Negative | Negative | Negative | ||
37℃ | Interferon alpha 2 b activity (* 10 6Ten thousand IU/ml) | 1.28 | 1.27 | 1.32 | 1.40 | 1.38 | 1.30 | 1.18 | |
PH value | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | ||
The color and luster clarity | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | ||
Sterility test | Negative | Negative | Negative | Negative | Negative | Negative | Negative | ||
200208033 | 2-8℃ | Interferon alpha 2 b activity (* 10 6Ten thousand IU/ml) | 4.10 | 3.92 | 3.89 | 3.13 | 4.06 | 4.00 | 3.98 |
PH value | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | ||
The color and luster clarity | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | ||
Sterility test | Negative | Negative | Negative | Negative | Negative | Negative | Negative | ||
20-25℃ | Interferon alpha 2 b activity (* 10 6Ten thousand IU/ml) | 4.10 | 4.05 | 4.05 | 4.04 | 4.04 | 4.03 | 4.02 | |
PH value | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | ||
The color and luster clarity | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | ||
Sterility test | Negative | Negative | Negative | Negative | Negative | Negative | Negative | ||
37℃ | Interferon alpha 2 b activity (* 10 6Ten thousand IU/ml) | 4.10 | 3.91 | 3.92 | 3.86 | 3.83 | 3.81 | 3.79 | |
PH value | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 |
The color and luster clarity | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | ||
Sterility test | Negative | Negative | Negative | Negative | Negative | Negative | Negative | ||
200208035 | 2-8℃ | Interferon alpha 2 b activity (* 10 6Ten thousand IU/ml) | 5.77 | 5.92 | 5.94 | 5.9 | 5.88 | 5.86 | 5.84 |
PH value | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | ||
The color and luster clarity | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | ||
Sterility test | Negative | Negative | Negative | Negative | Negative | Negative | Negative | ||
20-25℃ | Interferon alpha 2 b activity (* 10 6Ten thousand IU/ml) | 5.77 | 5.73 | 5.7 | 5.72 | 5.71 | 5.71 | 5.7 | |
PH value | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | ||
The color and luster clarity | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | ||
Sterility test | Negative | Negative | Negative | Negative | Negative | Negative | Negative | ||
37℃ | Interferon alpha 2 b activity (* 10 6Ten thousand IU/ml) | 5.77 | 5.67 | 5.63 | 5.79 | 5.67 | 5.67 | 5.61 | |
PH value | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | 7.10 | ||
The color and luster clarity | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | Achromaticity and clarification | ||
Sterility test | Negative | Negative | Negative | Negative | Negative | Negative | Negative |
Table 2:
2-8 ℃ of stability test pre-charge injector packing of recombinant human interferon alpha 2 b injection (1,000,000 IU/ prop up specification) | ||||||||
The resting period t month | 0 | 1 | 2 | 3 | 4 | 5 | 6 | |
Active C ((* 10 6Ten thousand IU/ml) | 200208011 | 1.25 | 1.24 | 1.25 | 1.26 | 1.21 | 1.26 | 1.24 |
200208021 | 1.21 | 1.19 | 1.23 | 1.20 | 1.17 | 1.19 | 1.17 | |
200208031 | 1.28 | 1.27 | 1.27 | 1.32 | 1.28 | 1.26 | 1.26 | |
Active C ((* 10 6Ten thousand IU/ml) meansigma methods | 1.246667 | 1.233333 | 1.25 | 1.26 | 1.22 | 1.236667 | 1.223333 | |
C/C 0Be equivalent to 0 month active % meansigma methods | 1 | 0.989305 | 1.002674 | 1.010695 | 0.991979 | 0.97861 | 0.981283 | |
Log(C/C 0) | 0.0014 | -0.00467 | 0.00116 | 0.00462 | -0.0035 | -0.00939 | -0.00821 | |
t 0.9 | 25.7 |
2-8 ℃ of stability test pre-charge injector packing of recombinant human interferon alpha 2 b injection (3,000,000 IU/ prop up specification) | ||||||||
The resting period t month | 0 | 1 | 2 | 3 | 4 | 5 | 6 | |
Active C ((* 10 6Ten thousand IU/ml) | 20020801 3 | 4.03 | 3.98 | 3.93 | 3.91 | 3.98 | 3.96 | 3.91 |
20020802 3 | 4.12 | 4.06 | 3.99 | 4.15 | 4.05 | 3.95 | 3.93 | |
20020803 3 | 4.10 | 3.92 | 3.89 | 3.13 | 4.06 | 4.00 | 3.98 | |
Active C ((* 10 6Ten thousand IU/ml) meansigma methods | 4.083333 | 3.986667 | 3.936667 | 3.73 | 4.03 | 3.97 | 3.94 | |
C/C 0Be equivalent to 0 month active % meansigma methods | 1 | 0.976327 | 0.964082 | 0.913469 | 0.986939 | 0.972245 | 0.964898 | |
Log(C/C 0) | 0 | -0.0189 | -0.01939 | -0.03931 | -0.00401 | -0.00852 | -0.01552 |
t 0.9 | 25.7 |
2-8 ℃ of stability test pre-charge injector packing of recombinant human interferon alpha 2 b injection (5,000,000 IU/ prop up specification) | ||||||||
The resting period t month | 0 | 1 | 2 | 3 | 4 | 5 | 6 | |
Active C ((* 10 6Ten thousand IU/ml) | 20020801 5 | 5.85 | 5.85 | 5.85 | 5.83 | 5.80 | 5.81 | 5.80 |
20020802 5 | 5.74 | 5.69 | 5.70 | 5.78 | 5.77 | 5.77 | 5.75 | |
20020803 5 | 5.77 | 5.92 | 5.94 | 5.9 | 5.88 | 5.86 | 5.84 | |
Active C ((* 10 6Ten thousand IU/ml) meansigma methods | 5.786667 | 5.82 | 5.83 | 5.836667 | 5.816667 | 5.813333 | 5.796667 | |
C/C 0Be equivalent to 0 month active % meansigma methods | 1 | 1.00576 | 1.007488 | 1.008641 | 1.005184 | 1.004608 | 1.001728 | |
Log(C/C 0) | 0 | 0 | -0.01276 | 0.004161 | -0.00377 | -0.00987 | -0.01881 | |
t 0.9 | 25.7 |
Table: 3
20-25 ℃ of stability test pre-charge injector packing of recombinant human interferon alpha 2 b injection (1,000,000 IU/ prop up specification) | ||||||||
The resting period t month | 0 | 1 | 2 | 3 | 4 | 5 | 6 | |
Active C ((* 10 6Ten thousand IU/ml) | 200208011 | 1.25 | 1.26 | 1.24 | 1.23 | 1.23 | 1.22 | 1.21 |
200208021 | 1.21 | 1.27 | 1.27 | 1.24 | 1.23 | 1.22 | 1.2 | |
200208031 | 1.28 | 1.27 | 1.27 | 1.32 | 1.28 | 1.26 | 1.26 | |
Active C ((* 10 6Ten thousand IU/ml) meansigma methods | 1.246667 | 1.266667 | 1.26 | 1.263333 | 1.246667 | 1.233333 | 1.223333 |
C/C 0Be equivalent to 0 month active % meansigma methods | 1 | 1.016043 | 1.010695 | 1.013369 | 1 | 0.989305 | 0.981283 |
Log(C/C 0) | 0 | 0.006912 | 0.00462 | 0.005768 | 0 | -0.00467 | -0.00821 |
t 0.9 | 25.7 |
20-25 ℃ of stability test pre-charge injector packing of recombinant human interferon alpha 2 b injection (3,000,000 IU/ prop up specification) | ||||||||
The resting period t month | 0 | 1 | 2 | 3 | 4 | 5 | 6 | |
Active C ((* 10 6Ten thousand IU/ml) | 200208013 | 4.03 | 3.97 | 3.96 | 3.96 | 3.95 | 3.94 | 3.94 |
200208023 | 4.12 | 4.02 | 4.02 | 4.01 | 4.01 | 4.00 | 3.98 | |
200208033 | 4.10 | 4.05 | 4.05 | 4.04 | 4.04 | 4.03 | 4.02 | |
Active C ((* 10 6Ten thousand IU/ml) meansigma methods | 4.083333 | 4.013333 | 4.01 | 4.003333 | 4 | 3.99 | 3.98 | |
C/C 0Be equivalent to 0 month active % meansigma methods | 1 | 0.982857 | 0.982041 | 0.980408 | 0.979592 | 0.977143 | 0.974694 | |
Log(C/C 0) | 0 | -0.00751 | -0.00787 | -0.00859 | -0.00895 | -0.01004 | -0.01113 | |
t 0.9 | 25.7 |
20-25 ℃ of stability test pre-charge injector packing of recombinant human interferon alpha 2 b injection (5,000,000 IU/ prop up specification) | ||||||||
The resting period t month | 0 | 1 | 2 | 3 | 4 | 5 | 6 | |
Active C ((* 10 6Ten thousand IU/ml) | 200208015 | 5.85 | 5.86 | 5.85 | 5.86 | 5.84 | 5.83 | 5.83 |
200208025 | 5.74 | 5.76 | 5.76 | 5.75 | 5.71 | 5.74 | 5.74 | |
200208035 | 5.77 | 5.73 | 5.7 | 5.72 | 5.71 | 5.71 | 5.7 | |
Active C ((* 10 6Ten thousand IU/ml) meansigma methods | 5.786667 | 5.783333 | 5.77 | 5.776667 | 5.753333 | 5.76 | 5.756667 |
C/C 0Be equivalent to 0 month active % meansigma methods | 1 | 0.999424 | 0.99712 | 0.998272 | 0.99424 | 0.995392 | 0.994816 |
Log(C/C 0) | 0 | -0.00025 | -0.00125 | -0.00075 | -0.00251 | -0.00201 | -0.00226 |
t 0.9 | 25.7 |
Table: 4
37 ℃ of stability test pre-charge injector packings of recombinant human interferon alpha 2 b injection (1,000,000 IU/ prop up specification) | ||||||||
The resting period t month | 0 | 1 | 2 | 3 | 4 | 5 | 6 | |
Active C ((* 10 6Ten thousand IU/ml) | 200208011 | 1.25 | 1.18 | 1.23 | 1.31 | 1.24 | 1.16 | 1.09 |
200208021 | 1.21 | 1.18 | 1.23 | 1.31 | 1.24 | 1.16 | 1.09 | |
200208031 | 1.28 | 1.27 | 1.32 | 1.40 | 1.38 | 1.30 | 1.18 | |
Active C (* 10 6Ten thousand IU/ml) meansigma methods | 1.303333 | 1.28 | 1.236667 | 1.226667 | 1.206667 | 1.186667 | 1.173333 | |
C/C 0Be equivalent to 0 month active % meansigma methods | 1 | 0.982097 | 0.948849 | 0.941176 | 0.925831 | 0.910486 | 0.925831 | |
Log(C/C 0) | 0 | -0.00785 | -0.0228 | -0.02633 | -0.03347 | -0.04073 | -0.03347 | |
t 0.9 | 25.7 |
37 ℃ of stability test pre-charge injector packings of recombinant human interferon alpha 2 b injection (3,000,000 IU/ prop up specification) | ||||||||
The resting period t month | 0 | 1 | 2 | 3 | 4 | 5 | 6 | |
Active C (* 10 6Ten thousand IU/ml) | 200208013 | 4.03 | 3.94 | 3.82 | 3.86 | 3.93 | 3.79 | 3.54 |
200208023 | 4.12 | 4.39 | 3.98 | 3.92 | 4.09 | 3.96 | 3.86 | |
200208033 | 4.10 | 3.91 | 3.92 | 3.86 | 3.83 | 3.81 | 3.79 | |
Active C ((* 10 6Ten thousand IU/ml) meansigma methods | 4.083333 | 4.08 | 3.906667 | 3.88 | 3.95 | 3.853333 | 3.73 |
C/C 0Be equivalent to 0 month active % meansigma methods | 1 | 0.999184 | 0.956735 | 0.950204 | 0.967347 | 0.943673 | 0.967347 |
Log(C/C 0) | 0 | -0.00035 | -0.01921 | -0.02218 | -0.01442 | -0.02518 | -0.01442 |
t 0.9 | 25.7 |
37 ℃ of stability test pre-charge injector packings of recombinant human interferon alpha 2 b injection (5,000,000 IU/ prop up specification) | ||||||||
The resting period t month | 0 | 1 | 2 | 3 | 4 | 5 | 6 | |
Active C ((* 10 6Ten thousand IU/ml) | 200208015 | 5.85 | 5.98 | 6.01 | 6.14 | 5.99 | 5.98 | 5.85 |
200208025 | 5.74 | 5.67 | 5.63 | 5.79 | 5.67 | 5.67 | 5.61 | |
200208035 | 5.77 | 5.67 | 5.63 | 5.79 | 5.67 | 5.67 | 5.61 | |
Active C ((* 10 6Ten thousand IU/ml) meansigma methods | 5.786667 | 5.756667 | 5.906667 | 5.906667 | 5.776667 | 5.773333 | 5.69 | |
C/C 0Be equivalent to 0 month active % meansigma methods | 1 | 0.994816 | 1.020737 | 1.020737 | 0.998272 | 0.997696 | 0.983295 | |
Log(C/C 0) | 0 | -0.00226 | 0.008914 | 0.008914 | -0.00075 | -0.001 | -0.00732 | |
t 0.9 | 25.7 |
Claims (4)
1. the recombinant human interferon alpha 2 b injection of prefilled injector package is characterized in that, wherein comprises the recombinant human interferon alpha 2 b injection that 1,000,000 IU/ prop up, 3,000,000 IU/ prop up or 5,000,000 IU/ prop up.
2. recombinant human interferon alpha 2 b injection as claimed in claim 1 is characterized in that, wherein said recombinant human interferon alpha 2 b is expressed by the K12 strain, makes through AKTA tomography devices purification.
3. recombinant human interferon alpha 2 b injection as claimed in claim 1 is characterized in that, wherein also comprises the albumin protective agent of 0.5-2.0 weight %.
4. recombinant human interferon alpha 2 b injection as claimed in claim 1 is characterized in that, wherein the bacterial endotoxin level is lower than 0.25EU/300 ten thousand IU.
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CN111494611A (en) * | 2020-06-08 | 2020-08-07 | 长春生物制品研究所有限责任公司 | Interferon injection liquid packaged by cartridge bottle multi-dose pen type injection combination |
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CN111494611A (en) * | 2020-06-08 | 2020-08-07 | 长春生物制品研究所有限责任公司 | Interferon injection liquid packaged by cartridge bottle multi-dose pen type injection combination |
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