Production method for composite lactose for injection
A production method and technology for injection, which are applied in the field of medicine, can solve the problems of not meeting the requirements of injections, insufficient freeze-drying protection efficiency, and low purity of lactose, and achieve a simple and feasible purification process, improve freeze-drying protection efficiency, and be environmentally friendly. Effect
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Embodiment 1
[0025] 1. Weigh 100g of crude lactose, add 400ml of purified water, stir and heat to 30°C, make it completely dissolve to form a lactose solution;
[0026] 2. Filter the crude lactose solution with an ultrafiltration column with a molecular weight cut-off of 3000MW;
[0027] 3. Perform nanofiltration on the ultrafiltered lactose solution;
[0028] 4. Add the filtered lactose into 150ml of purified water, stir and heat to 70°C to completely dissolve into a lactose solution;
[0029] 5. Add 450ml of ethanol to the lactose solution in step 4, stir and cool to 10°C to precipitate crystals, and keep this process for 0.5 hours;
[0030] 6. Centrifuge the solution with crystals in a filter bag centrifuge to collect the crystals;
[0031] 7. Take 99 grams of crystals and 100 ml of 1% hydroxypropyl methylcellulose solution, mix well, and then spray dry.
Embodiment 2
[0033] 1. Weigh 20Kg of crude lactose, add 62L of purified water, stir and heat to 40°C, make it completely dissolve to form a lactose solution;
[0034] 2. Filter the crude lactose solution with an ultrafiltration column with a molecular weight cut-off of 3000MW;
[0035] 3. Perform nanofiltration on the ultrafiltered lactose solution;
[0036] 4. Add the filtered lactose into 30L of purified water, stir and heat to 70°C to completely dissolve into a lactose solution;
[0037] 5. Add 100L of ethanol to the lactose solution in step 4, stir and cool to 10°C to precipitate crystals, and keep this process for 1 hour;
[0038] 6. Centrifuge the solution with crystals in a filter bag centrifuge to collect the crystals;
[0039] 7. Take 97 grams of crystals and 100ml of 3% hydroxypropyl methylcellulose solution, mix well and then spray dry.
Embodiment 3
[0041] 1. Weigh 20Kg of crude lactose, add 62L of purified water, stir and heat to 35°C to completely dissolve to form a lactose solution;
[0042] 2. Filter the crude lactose solution with an ultrafiltration column with a molecular weight cut-off of 3000MW;
[0043] 3. Perform nanofiltration on the ultrafiltered lactose solution;
[0044] 4. Add the filtered lactose into 32L of purified water, stir and heat to 70°C to completely dissolve into a lactose solution;
[0045] 5. Add 100L of ethanol to the lactose solution in step 4, stir and cool to 10°C to precipitate crystals, and keep this process for 1 hour;
[0046] 6. Centrifuge the solution with crystals in a filter bag centrifuge to collect the crystals;
[0047] 7. Take 98g of crystals and 100ml of 2% hydroxypropyl methylcellulose solution, mix well, and then spray dry.
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