Glycoprotein composition which almost does not contain subunit
A technology of composition and glycoprotein, which is applied in the field of purification of protein drugs, can solve problems such as unreasonable formula of raw materials, easy inactivation of glycoprotein, and no curative effect
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[0062] The present invention also provides a method for preparing a glycoprotein composition, the method comprising the steps of:
[0063] (a) raising the temperature of the pre-frozen glycoprotein-containing aqueous solution to the sublimation drying temperature at a heating rate of 0.05-5° C. / minute under vacuum, and maintaining it for 1-30 hours; and
[0064] (b) Elevate the temperature to the analytical drying temperature at a rate of 0.05-5° C. / min, and maintain it for 1-20 hours to obtain a composition containing glycoprotein, and the composition preferably contains a freeze-dried powder of glycoprotein. Said composition is a composition of glycoproteins whose subunit content is not more than 10 wt%.
[0065] The advantages of the present invention are:
[0066] The freeze-drying method provided can reduce or hardly generate subunit degradation, thereby maintaining the activity of the glycoprotein, reducing the generation of impurities, and obtaining a glycoprotein almo...
Embodiment 1
[0078] Freeze-drying of FSH
[0079] Prepare 50mL of 0.01M sodium dihydrogen phosphate solution (adjust the pH to about 6.5 with NaOH), add 2g of lactose, stir to dissolve, and filter with a 0.22μm filter. Take 10 mL of the filtrate, add 10.0 mg of the above-mentioned high-purity FSH (purchased from Shanghai Tianwei Biopharmaceutical Co., Ltd.) (biological potency is 8817 international units / mg), after complete dissolution, the eutectic point of this solution is about -2 ℃, put it into a lyophilizer (purchased from Virtis), and freeze-dry according to the following procedure:
[0080] 1. Prefreeze the shelf at -40°C for 3 hours;
[0081] 2. Cold trap to -45°C;
[0082] 3. Start the vacuum pump;
[0083] 4. The shelf temperature is raised from -40°C to -10°C at a rate of 0.125°C / min, and the shelf temperature reaches -10°C and maintained for 15 hours;
[0084] 5. The shelf temperature is raised from -10°C to +20°C at a rate of 0.3°C / min, and the shelf temperature reaches +2...
Embodiment 2
[0101] Preparation of FSH freeze-dried injection
[0102] A typical example of the production of 10,000 vials of FSH freeze-dried injections, each containing 75IU FSH, is as follows:
[0103] A calculated amount (in units of biological potency) of FSH essence was dissolved in 50 mL of pyrogen-free water for injection, if necessary, adjusted to pH 6.5±0.2 with HCl or NaOH, and then sterile-filtered with a 0.22 μm filter .
[0104] Dissolve 100 g of lactose in 2 L of pyrogen-free water for injection, adjust the pH to 6.5 ± 0.2 with HCl or NaOH if necessary, and perform sterile filtration with a 0.22 μm filter. Then add it to the above FSH solution, dilute to 7.5L with pyrogen-free water for injection, and mix well. The eutectic point of this solution is about -2°C.
[0105] The above solution was divided into ampoules, 0.75mL per bottle, and freeze-dried according to the following procedure:
[0106] 1. Prefreeze the shelf at -40°C for 3 hours;
[0107] 2. Cold trap to -45°...
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